PARAMETER RESPONSIVE QUALITY INDICATORS HAVING SHELF-STABLE SUB-ASSEMBLIES

A multiplicity of heat responsive quality indicator (HRQI) assemblies, for use in a quality management system for products, each having a plurality of indicator states operative to provide an indication of quality of a product with which the indicator is associated, each HRQI assembly including a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one coloring material diffuser and at least one indicator template and at least one heat responsive coloring material (HRCM) which is flowable at a temperature exceeding an upper temperature threshold, and which, when injected into the NHRQI sub-assembly, converts the NHRQI sub-assembly to the HRQI assembly, which is responsive to changes in temperature over time in exceedance of the upper temperature threshold, for changing an appearance of the HRQI assembly.

FIELD OF THE INVENTION

The present invention relates to quality management systems and methodologies and to indicators useful in such systems and methodologies.

BACKGROUND OF THE INVENTION

Various types of variable barcoded indicators for indicating exceedance of product affecting parameter thresholds are known.

SUMMARY OF THE INVENTION

The present invention seeks to provide improved quality management systems and methodologies as well as indicators useful in such systems and methodologies.

There is thus provided in accordance with a preferred embodiment of the present invention, for use in a quality management system for products, a multiplicity of heat responsive quality indicator (HRQI) assemblies, each having a plurality of indicator states operative to provide an indication of quality of a product with which the indicator is associated, each HRQI assembly including a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one coloring material diffuser and at least one indicator template and at least one heat responsive coloring material (HRCM) which is flowable at a temperature exceeding an upper temperature threshold, and which, when injected into the NHRQI sub-assembly, converts the NHRQI sub-assembly to the HRQI assembly, which is responsive to changes in temperature over time in exceedance of the upper temperature threshold, for changing an appearance of the HRQI assembly.

In accordance with a preferred embodiment of the present invention, the multiplicity of HRQI assemblies are characterized in that the at least one HRCM, once injected into the shelf-stable, NHRQI sub-assembly, is initially maintained under temperature conditions, which are not in exceedance of the upper temperature threshold, such that the at least one HRCM is not flowable.

Preferably, the plurality of indicator states includes a pre-supply visible state, indicating that the at least one HRCM has not yet been injected into the at least one coloring material diffuser of the NHRQI sub-assembly and a post-supply visible state, indicating that the at least one HRCM has been injected into the at least one coloring material diffuser of the NHRQI sub-assembly. Additionally or alternatively, the plurality of indicator states includes at least a first over-temperature visible state, indicating that the at least one HRQI assembly has been exposed to a temperature in exceedance of the upper temperature threshold for at least a first over-temperature cumulative time duration. Additionally, the plurality of indicator states includes at least a second over-temperature visible state, indicating that the HRQI assembly has been exposed to a temperature in exceedance of the upper temperature threshold for at least a second over-temperature cumulative time duration. Additionally, the plurality of indicator states includes at least a third over-temperature visible state, indicating that the HRQI assembly has been exposed to a temperature in exceedance of the upper temperature threshold for at least a third over-temperature cumulative time duration.

In accordance with a preferred embodiment of the present invention the at least one indicator template includes a multiplicity of machine-readable indicia. Additionally, the multiplicity of machine-readable indicia includes a multiplicity of barcodes. Additionally, the changing an appearance of the HRQI assembly includes changing an appearance of at least one of the multiplicity of barcodes. Additionally or alternatively, a single one of the multiplicity of machine-readable indicia is machine readable at all times.

In accordance with a preferred embodiment of the present invention, the indicator template includes at least one human sensible indicium.

Preferably, the HRQI assembly further includes a cold responsive coloring material and the plurality of indicator states includes at least one under-temperature visible state indicating that the HRQI assembly has been exposed to a temperature below a lower temperature threshold for at least an under-temperature time duration. Additionally, the cold responsive coloring material forms part of the at least one indicator template, for changing an appearance of the HRQI assembly. Additionally or alternatively, the cold responsive coloring material forms part of at least one human sensible indicium, for changing an appearance of the HRQI assembly.

In accordance with a preferred embodiment of the present invention the NHRQI sub-assembly also includes an aperture for injecting the HRCM therethrough. Additionally, the aperture is sealed by adhering the HRQI assembly to a container.

There is also provided in accordance with another preferred embodiment of the present invention, for use in a quality management system for products, a multiplicity of heat responsive quality indicator (HRQI) assemblies, each having a plurality of indicator states operative to provide an indication of quality of a product with which the indicator is associated, each HRQI assembly including a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one coloring material diffuser and at least one indicator template, a first heat responsive coloring material (HRCM) which is flowable at a first temperature exceeding a first upper temperature threshold and a second heat responsive coloring material (HRCM) which is flowable at a second temperature exceeding a second upper temperature threshold, wherein the first HRCM and the second HRCM, when injected into the at least one coloring material diffuser of the NHRQI sub-assembly, convert the NHRQI sub-assembly to the HRQI assembly, the HRQI assembly being responsive to changes in temperature over time in exceedance of each of the first upper temperature threshold and the second upper temperature threshold, for changing an appearance of the HRQI assembly.

In accordance with a preferred embodiment of the present invention each of the HRQI assemblies further includes an additional coloring material diffuser for the diffusion of the second HRCM.

In accordance with a preferred embodiment of the present invention the NHRQI sub-assembly further includes a first aperture for injecting the first HRCM therethrough and a second aperture for injecting the second HRCM therethrough.

There is further provided in accordance with yet another preferred embodiment of the present invention, for use in a quality management system for products, a multiplicity of heat responsive quality indicator (HRQI) assemblies each having a plurality of indicator states operative to provide an indication of quality of a product with which the indicator is associated, each HRQI assembly including an initial heat responsive quality indicator (IHRQI) sub-assembly including at least one indicator template and at least a first heat responsive coloring material (HRCM) which is flowable at a first temperature exceeding a first upper temperature threshold and a second heat responsive coloring material (HRCM) which is flowable at a second temperature exceeding a second upper temperature threshold, the second HRCM, when injected into the IHRQI sub-assembly, converting the IHRQI sub-assembly to the HRQI assembly, the HRQI assembly being responsive to changes in temperature over time in exceedance of each of the first upper temperature threshold and the second upper temperature threshold, for changing an appearance of the HRQI assembly.

In accordance with a preferred embodiment of the present invention each of the IHRQI sub-assemblies further includes a coloring material diffuser for the diffusion of at least one of the first HRCM and the second HRCM. Preferably, each of the HRQI assemblies further includes a first coloring material diffuser for the diffusion of the first HRCM and a second coloring material diffuser for the diffusion of the second HRCM. Additionally or alternatively, the IHRQI sub-assembly further includes at least one aperture for injecting the second HRCM therethrough.

There is still further provided in accordance with still another preferred embodiment of the present invention a quality management system for products including a multiplicity of heat responsive quality indicator (HRQI) assemblies, whose appearance is changeable and being operative to provide a machine-readable indication of exceedance of at least one threshold and an indicator reader operative to read the HRQI assemblies and to provide output indications of product quality status, each of the multiplicity of HRQI assemblies including a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one coloring material diffuser and at least one indicator template and a heat responsive coloring material (HRCM) which is flowable at a temperature exceeding an upper temperature threshold, and which, when injected into the NHRQI sub-assembly, converts the NHRQI sub-assembly to an HRQI assembly, which is responsive to changes in temperature over time in exceedance of the upper temperature threshold, for changing an appearance of the indicator.

In accordance with a preferred embodiment of the present invention the multiplicity of HRQI assemblies are characterized in that the HRCM, once injected into the shelf-stable, NHRQI sub-assembly, is initially maintained under temperature conditions, which are not in exceedance of the upper temperature threshold, such that the HRCM is not flowable.

In accordance with a preferred embodiment of the present invention the appearance of the HRQI assemblies is further operative to provide a machine-readable indication that the HRCM has not yet been injected into the at least one coloring material diffuser of the NHRQI sub-assembly and a machine-readable indication that the HRCM has been injected into the at least one coloring material diffuser of the NHRQI sub-assembly.

In accordance with a preferred embodiment of the present invention the machine-readable indication of exceedance of at least one threshold includes at least one of a first machine-readable indication of exceedance of a first threshold and a second machine-readable indication of exceedance of a second threshold. Additionally, the first threshold includes an upper temperature threshold and at least a first over-temperature cumulative time duration and the second threshold includes an upper temperature threshold and at least a second over-temperature cumulative time duration.

In accordance with a preferred embodiment of the present invention the machine-readable indication of exceedance of at least one threshold further includes a third machine-readable indication of exceedance of a third threshold. Additionally, the third threshold includes an upper temperature threshold and at least a third over-temperature cumulative time duration.

Preferably, the indicator template includes a multiplicity of machine-readable indicia. Additionally, the multiplicity of machine-readable indicia includes a multiplicity of barcodes. Additionally, the changing an appearance of the HRQI assembly includes changing an appearance of at least one of the multiplicity of barcodes. Additionally or alternatively, a single one of the multiplicity of machine-readable indicia is machine readable at all times.

In accordance with a preferred embodiment of the present invention the indicator template includes at least one human sensible indicium.

Preferably, the HRQI assembly further includes a cold responsive coloring material and the appearance of the HRQI assembly is operative to provide a machine-readable indication that the HRQI assembly has been exposed to a temperature below a lower temperature threshold for at least an under-temperature time duration. Additionally, the cold responsive coloring material forms part of at least one changeable barcode, for changing an appearance of the HRQI assembly. Additionally or alternatively, the cold responsive coloring material forms part of at least one human sensible indicium, for changing an appearance of the HRQI assembly.

In accordance with a preferred embodiment of the present invention the NHRQI sub-assembly also includes an aperture for injecting the HRCM therethrough. Additionally, the aperture is sealed by adhering the HRQI assembly to a container.

There is further provided in accordance with yet another preferred embodiment of the present invention a system for manufacture of heat responsive quality indicator (HRQI) assemblies including a non-heat responsive quality indicator (NHRQI) sub-assembly provider, providing a multiplicity of shelf-stable, NHRQI sub-assemblies, each of the sub-assemblies including at least one coloring material diffuser and at least one indicator template and a heat responsive coloring material supplier (HRCMS) operative to inject a heat responsive coloring material (HRCM) into each of the multiplicity of shelf-stable, NHRQI sub-assemblies, the HRCM being flowable at a temperature exceeding an upper temperature threshold, and which, when injected into the NHRQI sub-assembly by the HRCMS, converts the NHRQI sub-assembly to an HRQI assembly, which is responsive to changes in temperature over time in exceedance of the upper temperature threshold, for changing an appearance of the indicator and is operative to provide a machine-readable indication of exceedance of at least one threshold.

In accordance with a preferred embodiment of the present invention the HRCMS also includes a heating assembly, operative to maintain the HRCM at a temperature at which the HRCM is flowable during the injection thereof into the NHRQI sub-assembly.

In accordance with a preferred embodiment of the present invention the system also includes a container association module operative to affix the HRQI assembly to a product container. Additionally, the HRCM is injected into the NHRQI sub-assembly immediately prior to affixing the HRQI assembly to a product package.

In accordance with a preferred embodiment of the present invention the system also includes a container association module operative to affix the NHRQI sub-assembly to a product package and the HRCM is injected into the NHRQI sub-assembly following affixing the NHRQI sub-assembly to a product package.

Preferably, the HRCMS includes the container association module. Alternatively, the container association module is separate from the HRCMS.

In accordance with a preferred embodiment of the present invention the system also includes an HRCM cooler operative to lower a temperature of the HRCM to a temperature below the upper temperature threshold, such that the HRCM is not flowable, after the injection thereof into the NHRQI sub-assembly. Preferably, the HRCMS includes the HRCM cooler. Alternatively, the HRCM cooler is separate from the HRCMS.

In accordance with a preferred embodiment of the present invention the system also includes an indicator reader operative to read the HRQI assembly and to provide output indications of a status of the HRQI assembly.

There is even further provided in accordance with still another preferred embodiment of the present invention a quality management system for products including a multiplicity of heat responsive quality indicator (HRQI) assemblies, whose appearance is changeable and being operative to provide a machine-readable indication of exceedance of at least one threshold and an indicator reader operative to read the HRQI assemblies and to provide output indications of product quality status, each of the multiplicity of HRQI assemblies including a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one coloring material diffuser and at least one indicator template, a first heat responsive coloring material (HRCM) which is flowable at a first temperature exceeding a first upper temperature threshold and a second heat responsive coloring material (HRCM) which is flowable at a second temperature exceeding a second upper temperature threshold, the first HRCM and the second HRCM, when injected into the at least one coloring material diffuser of the NHRQI sub-assembly, converting the NHRQI sub-assembly to the HRQI assembly, the HRQI assembly being responsive to changes in temperature over time in exceedance of each of the first upper temperature threshold and the second upper temperature threshold, for changing an appearance of the HRQI assembly.

In accordance with a preferred embodiment of the present invention the system also includes a quality indication computer operative to communicate with the indicator reader. Additionally, the system also includes a database, including at least an event description table and a product status table.

In accordance with a preferred embodiment of the present invention the at least one coloring material diffuser includes a first coloring material diffuser for the diffusion of the first HRCM and a second coloring material diffuser for the diffusion of the second HRCM.

Preferably, the NHRQI sub-assembly also includes a first aperture for injecting the first HRCM therethrough and a second aperture for injecting the second HRCM therethrough. Additionally, each of the first aperture and the second aperture are sealed by adhering the HRQI assembly to a container.

There is also provided in accordance with another preferred embodiment of the present invention a method of quality management for products including associating a multiplicity of heat responsive quality indicator (HRQI) assemblies, each of whose appearance is changeable and is operative to provide an indication of exceedance of at least an upper temperature threshold, with a corresponding multiplicity of product packages, each of the multiplicity of HRQI assemblies including a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one indicator template and a heat responsive coloring material (HRCM) which is flowable at a temperature exceeding the upper temperature threshold, and which, when injected into the NHRQI sub-assembly, converts the NHRQI sub-assembly to an HRQI assembly, which is responsive to changes in temperature over time in exceedance of the upper temperature threshold for changing an appearance of the indicator template, the associating including injecting the HRCM into the shelf-stable, NHRQI sub-assembly when the HRCM is in a flowable state, immediately after the injecting, lowering a temperature of the HRCM to a temperature below the upper temperature threshold, such that the HRCM is not flowable, thereby creating the HRQI assemblies, whose appearance is changeable and is operative to provide an indication of exceedance of the upper temperature threshold and affixing the HRQI assembly to a product package.

Preferably, the injecting the HRCM into the shelf-stable, NHRQI sub-assembly includes maintaining the HRCM at a temperature at which the HRCM is flowable during the injecting thereof into the NHRQI sub-assembly. Additionally, the maintaining the HRCM at a temperature at which the HRCM is flowable during the injecting thereof into the NHRQI sub-assembly includes heating the HRCM.

In accordance with a preferred embodiment of the present invention the associating includes injecting the HRCM into the shelf-stable, NHRQI sub-assembly immediately prior to the affixing.

Preferably, the lowering the temperature of the HRCM and the affixing include a single step. Alternatively, the lowering the temperature of the HRCM and the affixing include separate steps.

In accordance with a preferred embodiment of the present invention each of the NHRQI sub-assemblies further includes an aperture and the injecting includes injecting the HRCM into the NHRQI sub-assembly through the aperture. Additionally, the affixing the HRQI assembly to the product package also includes sealing the aperture, preventing an egress of the HRCM therefrom.

In accordance with a preferred embodiment of the present invention the appearance of the indicator template is further operative to provide a machine-readable indication that the HRCM has not yet been injected into the NHRQI sub-assembly and a machine-readable indication that the HRCM has been injected into the NHRQI sub-assembly.

In accordance with a preferred embodiment of the present invention the indication of exceedance of at least an upper temperature threshold includes at least one of a first machine-readable indication of exceedance of a first upper temperature threshold and a second machine-readable indication of exceedance of a second upper temperature threshold. Additionally, the exceedance of the first upper temperature threshold includes exceeding the first upper temperature threshold for at least a first over-temperature cumulative time duration and the exceedance of the second upper temperature threshold includes exceeding the second upper temperature threshold for at least a second over-temperature cumulative time duration.

In accordance with a preferred embodiment of the present invention the machine-readable indication of exceedance of at least one upper temperature threshold further includes a third machine-readable indication of exceedance of a third upper temperature threshold. Additionally, the exceedance of the third upper temperature threshold includes exceeding the third upper temperature threshold for at least a third over-temperature cumulative time duration.

In accordance with a preferred embodiment of the present invention the indicator template includes a multiplicity of machine-readable indicia. Additionally, the multiplicity of machine-readable indicia includes a multiplicity of barcodes. Additionally, the changing an appearance of the HRQI assembly includes changing an appearance of at least one of the multiplicity of barcodes. Preferably, a single one of the multiplicity of machine-readable indicia is machine readable at all times.

In accordance with a preferred embodiment of the present invention the indicator template includes at least one human sensible indicium.

In accordance with a preferred embodiment of the present invention the HRQI assembly further includes a cold responsive coloring material and the appearance of the HRQI assembly is operative to provide a machine-readable indication that the HRQI assembly has been exposed to a temperature below a lower temperature threshold for at least an under-temperature time duration. Additionally, the cold responsive coloring material forms part of at least one changeable barcode, for changing an appearance of the HRQI assembly. Additionally or alternatively, the cold responsive coloring material forms part of at least one human sensible indicium, for changing an appearance of the HRQI assembly.

There is still further provided in accordance with yet another preferred embodiment of the present invention a method of quality management for products including associating a multiplicity of heat responsive quality indicator (HRQI) assemblies, each of whose appearance is changeable and is operative to provide an indication of exceedance of at least a first upper temperature threshold and a second upper temperature threshold, with a corresponding multiplicity of product packages, each of the multiplicity of HRQI assemblies including a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one indicator template, a first heat responsive coloring material (HRCM) which is flowable at a first temperature exceeding the first upper temperature threshold and a second heat responsive coloring material (HRCM) which is flowable at a second temperature exceeding the second upper temperature threshold, the first HRCM and the second HRCM, when injected into the NHRQI sub-assembly, converting the NHRQI sub-assembly to an HRQI assembly, the HRQI assembly being responsive to changes in temperature over time in exceedance of each of the first upper temperature threshold and the second upper temperature threshold for changing an appearance of the indicator template; the associating including injecting the first HRCM and the second HRCM into the shelf-stable, NHRQI sub-assembly when the first HRCM and the second HRCM are in a flowable state, immediately after the injecting, lowering a temperature of the first HRCM and the second HRCM to a temperature below the first upper temperature threshold and the second upper temperature threshold, such that the first HRCM is not flowable and the second HRCM is not flowable, thereby creating the HRQI assemblies, whose appearance is changeable and is operative to provide an indication of exceedance of the upper temperature threshold and affixing the HRQI assembly to a product package.

In accordance with a preferred embodiment of the present invention each of the HRQI assemblies further includes at least one coloring material diffuser for the diffusion of at least one of the first HRCM and the second HRCM.

Preferably, the injecting the first HRCM and the second HRCM into the shelf-stable, NHRQI sub-assembly is performed prior to the affixing the HRQI assembly to the product package.

There is yet further provided in accordance with a further preferred embodiment of the present invention a method of quality management for products including providing a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one indicator template, injecting, at an injection temperature, a heat responsive coloring material (HRCM) which is flowable at a temperature exceeding an upper temperature threshold into the NHRQI sub-assembly, the injection temperature exceeding the upper temperature threshold, thereby converting the NHRQI sub-assembly to a heat responsive quality indicator (HRQI) assembly, which is operative to display different ones of a plurality of indicator states in response to changes in temperature over time in exceedance of the upper temperature threshold for changing an appearance of the indicator template and affixing the HRQI assembly to a product package.

In accordance with a preferred embodiment of the present invention the HRCM is injected into the NHRQI sub-assembly immediately prior to affixing the HRQI assembly to the product package.

In accordance with a preferred embodiment of the present invention the affixing the HRQI assembly to the product package further includes lowering the temperature of the HRCM.

In accordance with a preferred embodiment of the present invention the method includes lowering the temperature of the HRCM prior to the affixing the HRQI assembly to the product package.

In accordance with a preferred embodiment of the present invention the NHRQI sub-assembly further includes an aperture and the injecting includes injecting the HRCM into the NHRQI sub-assembly through the aperture. Additionally, the affixing the HRQI assembly to the product package also includes sealing the aperture, preventing an egress of the HRCM therefrom.

In accordance with a preferred embodiment of the present invention the appearance of the HRQI assembly is further operative to provide a machine-readable indication that the HRCM has not yet been injected into the NHRQI sub-assembly and a machine-readable indication that the HRCM has been injected into the NHRQI sub-assembly.

Preferably, the plurality of indicator states includes at least a first over-temperature visible state, indicating that the HRQI assembly has been exposed to a temperature in exceedance of the upper temperature threshold for at least a first over-temperature cumulative time duration. Additionally, the plurality of indicator states includes at least a second over-temperature visible state, indicating that the HRQI assembly has been exposed to a temperature in exceedance of the upper temperature threshold for at least a second over-temperature cumulative time duration. Additionally, the plurality of indicator states includes at least a third over-temperature visible state, indicating that the HRQI assembly has been exposed to a temperature in exceedance of the upper temperature threshold for at least a third over-temperature cumulative time duration.

In accordance with a preferred embodiment of the present invention the indicator template includes a multiplicity of machine-readable indicia. Additionally, the multiplicity of machine-readable indicia includes a multiplicity of barcodes. Additionally, the changing an appearance of the HRQI assembly includes changing an appearance of at least one of the multiplicity of barcodes. Preferably, a single one of the multiplicity of machine-readable indicia is machine readable at all times.

In accordance with a preferred embodiment of the present invention the indicator template includes at least one human sensible indicium.

In accordance with a preferred embodiment of the present invention the HRQI assembly further includes a cold responsive coloring material and the appearance of the HRQI assembly is operative to provide a machine-readable indication that the HRQI assembly has been exposed to a temperature below a lower temperature threshold for at least an under-temperature time duration. Additionally, the cold responsive coloring material forms part of at least one changeable barcode, for changing an appearance of the HRQI assembly. Additionally or alternatively, the cold responsive coloring material forms part of at least one human sensible indicium, for changing an appearance of the HRQI assembly.

There is also provided in accordance with yet another preferred embodiment of the present invention a method of quality management for products including providing a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one indicator template, injecting, at a first injection temperature, a first heat responsive coloring material (HRCM) which is flowable at a first temperature exceeding a first upper temperature threshold into the NHRQI sub-assembly, injecting, at a second injection temperature, a second heat responsive coloring material (HRCM) which is flowable at a second temperature exceeding a second upper temperature threshold into the NHRQI sub-assembly, the injecting the first HRCM and the injecting the second HRCM converting the NHRQI sub-assembly to an HRQI assembly, the HRQI assembly being operative to display different ones of a plurality of indicator states in response to changes in temperature over time in exceedance of each of the first upper temperature threshold and the second upper temperature threshold for changing an appearance of the indicator template and affixing the HRQI assembly to a product package.

In accordance with a preferred embodiment of the present invention the first injection temperature exceeds the first upper temperature threshold and the second injection temperature exceeds the second upper temperature threshold.

In accordance with a preferred embodiment of the present invention the method also includes heating at least one of the first HRCM and the second HRCM during the injecting thereof into the NHRQI sub-assembly.

Preferably, the injecting the first HRCM and the injecting the second HRCM are both performed prior to the affixing the HRQI assembly to the product package.

There is further provided in accordance with another preferred embodiment of the present invention a quality management system for products including a first multiplicity of first heat responsive quality indicator (HRQI) assemblies, whose appearance is changeable and being operative to provide a machine-readable indication of exceedance of at least one first threshold, each of the first multiplicity of first HRQI assemblies including a first shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one coloring material diffuser and at least one first indicator template and a first heat responsive coloring material (HRCM) which is flowable at a temperature exceeding a first upper temperature threshold, and which, when injected into the first NHRQI sub-assembly, converts the first NHRQI sub-assembly to one of the first HRQI assemblies, which is responsive to changes in temperature over time in exceedance of the first upper temperature threshold, for changing an appearance of the first indicator and a second multiplicity of second heat responsive quality indicator (HRQI) assemblies, whose appearance is changeable and being operative to provide a machine-readable indication of exceedance of at least one second threshold, each of the second multiplicity of second HRQI assemblies including a second shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly including at least one coloring material diffuser and at least one second indicator template and a second heat responsive coloring material (HRCM) which is flowable at a temperature exceeding a second upper temperature threshold, and which, when injected into the at least one coloring material diffuser of the second NHRQI sub-assembly, converts the second NHRQI sub-assembly to one of the second HRQI assemblies, which is responsive to changes in temperature over time in exceedance of the second upper temperature threshold, for changing an appearance of the second indicator.

In accordance with a preferred embodiment of the present invention the first multiplicity of first HRQI assemblies are each associated with one of a plurality of product packages, the second multiplicity of second HRQI assemblies are each associated with a container, the container containing at least some of the product packages and a relationship between the first upper temperature threshold and the second upper temperature threshold is at least partially determined by an extent of thermal communication between the product packages contained within the container and an ambient environment to which the second HRQI assembly is exposed.

There is yet further provided in accordance with still another preferred embodiment of the present invention a quality management system for products including a multiplicity of quality parameter responsive quality indicator (QPRQI) assemblies and an indicator reader operative to read the QPRQI assemblies and to provide output indications of product quality status, each of the multiplicity of QPRQI assemblies being responsive to changes in a value of a quality parameter, for changing an appearance of the QPRQI assembly when the quality parameter exceeds a threshold, each of the multiplicity of QPRQI assemblies including a shelf-stable, non-quality parameter responsive quality indicator (NQPRQI) sub-assembly including at least one coloring material diffuser and at least one indicator template and a quality parameter responsive coloring material (QPRCM) which, when injected to the at least one coloring material diffuser of the NQPRQI sub-assembly, converts the NQPRQI sub-assembly to an QPRQI assembly.

In accordance with a preferred embodiment of the present invention the NQPRQI further includes at least one aperture for injecting the QPRCM therethrough.

There is still further provided in accordance with yet a further preferred embodiment of the present invention, for use in a quality management system for products, a multiplicity of heat responsive quality indicator (HRQI) assemblies each operative to provide an indication of quality of a product with which the indicator is associated, each HRQI assembly including a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly and at least one heat responsive coloring material (HRCM), which, when injected into the NHRQI sub-assembly, converts the NHRQI sub-assembly to the HRQI assembly, which is responsive to changes in temperature over time in exceedance of the upper temperature threshold.

In accordance with a preferred embodiment of the present invention the NHRQI further includes at least one aperture for injecting the HRCM therethrough.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reference is now made toFIGS.1A-1E, which, together, are a simplified illustration of a system and methodology for quality management constructed and operative in accordance with a preferred embodiment of the present invention. As seen inFIGS.1A-1E, there is shown a quality management system and methodology for products including a multiplicity of quality parameter responsive quality indicator (QPRQI) assemblies, such as heat responsive quality indicator (HRQI) assemblies, here shown in the form of changeable barcode indicators, each operative to provide a visible indication, which is preferably machine-readable, and more preferably barcode-reader-readable, indicating an exceedance of at least one threshold by at least one product quality affecting parameter, at least one indicator reader, operative to read the HRQI assemblies and to provide output indications, and a product type responsive indication interpreter, operative to receive the output indications and to provide human sensible, product quality status outputs.

Each of the QPRQI assemblies of the present invention are characterized by a physical appearance that changes when the QPRQI assembly is exposed to a quality parameter either above an upper quality parameter threshold or below a lower quality parameter threshold. For example, as explained in further detail hereinbelow, an appearance of an HRQI changes as a result of the HRQI being exposed to temperatures above an upper temperature threshold for a predetermined time duration or below a lower temperature for a predetermined time duration.

For simplicity and ease of understanding, the terms “upper temperature threshold” and “lower temperature threshold” are used throughout this document. However, it is understood that if the QPRQI assembly or portions thereof are responsive to a quality parameter other than heat, “upper temperature threshold” and “lower temperature threshold” have a meaning of “upper quality parameter threshold” and “lower quality parameter threshold,” respectively, wherein the “quality parameter threshold” is a threshold value of a quality parameter to which the QPRQI or portions thereof are operative to respond. For example, a QPRQI operative to respond to pH may have an upper quality parameter threshold and lower quality parameter threshold which are each defined in accordance with a standard pH scale. Similarly, a QPRQI operative to respond to humidity or moisture may have an upper quality parameter threshold and lower quality parameter threshold which are each defined in accordance with a percentage of water vapor in a given volume of air.

Preferably, in addition to receiving the output indications provided by the indicator reader the indication interpreter may also receive product-related parameters, such as product type, for example “live attenuated influenza vaccine” (LAIV), and product manufacturing date. Additionally or alternatively, the indication interpreter may receive other parameters, for example information relating to the HRQI assembly, such as a range of parameters sensed by the HRQI assembly and the time and place at which at least part of the HRQI assembly was manufactured. Additionally or alternatively, the indication interpreter may also receive parameters relating to the source of the output indications provided, for example, whether the output indications were provided by a hand-held device during inspection, or by a checkout scanner, for example the checkout scanner of a pharmacy or grocery store.

The product-related parameters and the other parameters, such as those relating to the HRQI assembly, may be provided by the HRQI assembly itself or by an additional, separate indicator, such as a barcode-bearing indicator. As a further alternative, these parameters may be provided by, inter alia, sensors, a priori information otherwise available to the indication interpreter or manual entry.

The indication interpreter preferably forms part of, or is otherwise connected to, a quality indication computer, which may be remote from the indicator reader and which preferably includes a decision table providing product quality status outputs based on the output indications provided by the indicator reader and the additional parameters.

It is appreciated that the additional parameters may be provided via another part of the same barcode or by another barcode associated with the same product. Alternatively, the additional parameters may be provided by other methods, such as using RFID technology.

The term “barcode” is used herein to refer to a machine-readable optical code. In the examples in the specification, linear, or one-dimensional, bar codes are illustrated. It is appreciated that the invention may be additionally applicable to two-dimensional bar codes, including, inter alia, QR codes. Similarly, the invention may be applicable to other optical indicators and indicia, particularly, but not limited to, vaccine vial monitors (VVMs), which may be machine-readable, human sensible, or both machine-readable and human sensible.

The HRQI assembly may incorporate a product code, which may include a checksum, such as a European Article Number (EAN) or a Universal Product Code (UPC). The examples shown in the description which follows all illustrate the use of an EAN code. Alternatively, the HRQI assembly may incorporate an Interleaved 2 of 5 (ITF) barcode, Code 128 barcode, Code 32 barcode or any other suitable barcode or optical indicator.

It is appreciated that the fully assembled HRQI assembly is temperature-sensitive and indicates exposure of the HRQI assembly to a temperature, or other suitable quality parameter, in exceedance of a predetermined threshold. The temperature, or other suitable quality parameter, experienced by the HRQI assembly is a useful proxy for a temperature, or other suitable quality parameter, experienced by contents of a package or carton with which the HRQI assembly is associated. Thus, for example, a temperature history of a vial of vaccine can be monitored by monitoring a temperature history of an HRQI assembly affixed to the vial of vaccine.

However, in order for the temperature history of the HRQI assembly to be a useful proxy for the temperature history of the package or carton with which the HRQI assembly is associated, the HRQI assembly must be stored under particular storage conditions before association with the package or carton. For example, an HRQI assembly which indicates exceedance of a first upper temperature threshold and a second upper temperature threshold must be stored at temperatures below both the first upper temperature threshold and a second upper temperature threshold prior to association with a package or carton whose temperature is to be monitored.

It is a particular feature of the present invention that the HRQI assembly of the present invention includes a non-heat responsive portion, such as a non-heat responsive quality indicator (NHRQI) sub-assembly, and a heat responsive portion, such as heat responsive coloring material (HRCM). Preferably, the non-heat responsive portion of the HRQI assembly and the heat responsive portion of the HRQI assembly are stored separately, and are only combined with one another immediately prior to an association of the HQRI assembly with a package whose temperature is to be monitored.

This advantageously lowers the need for temperature-controlled storage of the HRQI assembly, since until the non-heat responsive portion of the HRQI assembly, such as the NHRQI sub-assembly, and the heat responsive portion of the HRQI assembly are combined to form a fully assembled HRQI assembly, both the non-heat responsive portion of the HRQI assembly and the heat responsive portion of the HRQI assembly may be stored at temperatures exceeding a predetermined upper temperature threshold designed to be monitored by the fully assembled HRQI assembly, without affecting the operation or usefulness of the HRQI assembly.

For example, a typical indicator which is operative to provide indications of exceedance of 8 degrees Celsius for a predetermined time duration must be stored below 8 degrees prior to associated with a package or carton. Otherwise, a user cannot differentiate between an exceedance of 8 degrees Celsius by the HRQI assembly alone or by the HRQI assembly and the package or carton together. Storing HRQI assemblies at temperatures below 8 degrees Celsius, however, can be onerous and expensive.

In contrast, an HRQI assembly of the present invention which is operative to provide indications of exceedance of 8 degrees Celsius for a predetermined time duration is provided to a maker, distributor or user of a package or carton as a separate heat-responsive portion and non-heat responsive portion. Advantageously, both the heat-responsive portion of the HRQI assembly and the non-heat responsive portion of the HRQI assembly of the present invention can be stored at temperatures in exceedance of 8 degrees Celsius for an extended period of time without affecting the operation or usefulness of the HRQI assembly. As described hereinbelow, the heat-responsive portion of the HRQI assembly and the non-heat responsive portion of the HRQI assembly are preferably combined to form a fully assembled HRQI assembly substantially immediately prior to an association of the HRQI assembly with a package or carton, and only after the HRQI assembly is fully assembled does the HRQI assembly begin to monitor temperature history.

The term “immediately prior to” is used herein to refer to a relatively short time period prior to an event, such as a time period of less than one hour, less than 45 minutes, less than 30 minutes, less than 15 minutes, less than 10 minutes, less than 5 minutes, less than 3 minutes, less than 1 minute, less than 30 seconds, less than 10 seconds, or less than 1 second.

Turning now toFIGS.1A-1E, the present invention is illustrated in the context of a typical application, here a vaccine processing plant and distribution chain. A heat responsive quality indicator (HRQI) assembly100, which is preferably machine-readable, but need not be, is attached to or otherwise incorporated into each of a plurality of packages101, each of which is embodied here as a vial, such as a vaccine vial. Package101bearing HRQI assembly100is typically an individual package suitable for use by an end-user, such as a medical practitioner or a patient. It is appreciated that in the illustrated embodiment, the contents of package101are sensitive to low temperatures, and should not be used if package101has ever been frozen or exposed to temperatures of 0° C. (32° F.) or lower. Additionally, in the illustrated embodiment, the contents of package101are sensitive to elevated temperatures, and should not be used if package101has been exposed to a predetermined upper temperature threshold for an over-temperature cumulative time duration.

It is appreciated that although package101is exemplified herein with reference toFIGS.1A-7Eas a vial, such as a vaccine vial, package101may be any suitable package, including a package containing, inter alia, at least one of a food product, a beverage product, a medical product, a scientific product, a manufacturing product, a biological specimen and a botanical product.

In accordance with a preferred embodiment of the present invention, a suitable heat responsive coloring material supplier (HRCMS), such as an HRCMS indicated by reference numeral102, supplies a heat responsive coloring material (HRCM) to HRQI assemblies100at the same location as that at which HRQI assemblies100are associated with packages101. The HRCM is characterized by a viscosity and melting point such that the HRCM is flowable at temperatures above an upper temperature threshold and is not flowable at temperatures below the upper temperature threshold.

In a preferred embodiment of the present invention, the association of HRQI assembly100with package101is embodied as an affixation of HRQI assembly100to package101, and more particularly as an adherence of HRQI assembly100to package101. Preferably, HRCMS102is operative to be used as part of an automated assembly system, such as a conveyer belt system. However, HRCMS102may also be used as part of a manual assembly system, such as described hereinbelow.

As is described in more detail hereinbelow with reference toFIGS.2-3D and5-6D, HRCMS102preferably supplies the HRCM to a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly103, thereby producing HRQI assembly100. Preferably, HRCMS102supplies the HRCM to the NHRQI sub-assembly103by injecting the HRCM into the NHRQI sub-assembly103. Preferably, HRQI assembly100is produced immediately prior to associating HQRI assembly100with package101. In a preferred embodiment of the present invention, HRCMS102both produces HRQI assembly100, by supplying the HRCM to NHRQI sub-assembly103, and associates HRQI assembly100with package101, preferably by affixing HRQI assembly100to package101, and more preferably by adhering HRQI assembly100to package101. In a preferred embodiment of the present invention, HRCMS102uses an injection module104to inject the HRCM into NHRQI sub-assembly103. Preferably, injection module104includes a heating assembly, such as a resistive heating assembly, thereby maintaining the HRCM at a temperature at which the HRCM is flowable during the supply thereof to NHRQI sub-assembly103.

It is appreciated that as used herein, “heat responsive” is used to indicate an element or system that changes as a result of heat, wherein “heat” is used to indicate a temperature exceeding an upper temperature threshold, such as a temperature at which the HRCM is flowable. Similarly, as used herein, “non-heat responsive” is used to indicate an element or system that does not change as a result of heat, wherein “heat” is used to indicate a temperature exceeding an upper temperature threshold, such as a temperature at which the HRCM is flowable.

For simplicity and ease of understanding, “heat responsive” is used throughout this document. However, it is understood that if the QPRQI assembly or portions thereof are responsive to a quality parameter other than heat, “heat responsive” has a meaning of “quality parameter responsive,” wherein the “quality parameter” is a quality parameter to which the QPRQI or portions thereof are operative to respond, such as, inter alia, moisture, force, pressure, pH and elapsed time. For example, descriptions of NHRQI sub-assemblies and initial heat responsive quality indicator (IHRQI) sub-assemblies forming part of HRQI assemblies are understood to include respective non-quality parameter responsive quality indicator (NQPRQI) sub-assemblies and initial quality parameter responsive quality indicator (IQPRQI) sub-assemblies forming part of QPRQI assemblies.

Additionally, as used herein, “shelf-stable” is used to describe a product or an indicator which can be readily stored under typical warehouse conditions, such as under a standard range of values of temperature, pH, humidity and pressure, to which human beings are typically exposed, without any appreciable loss of functionality or shortening of shelf-life of the product or the indicator. For example, as used herein “shelf-stable” and “non-heat responsive” quality indicators sub-assemblies do not require refrigeration prior to being included in a heat-responsive quality indicator assembly.

As seen inFIG.1A, an additional heat responsive quality indicator (HRQI) assembly105, which is preferably similar to or the same as HRQI assemblies100, is associated with a carton106containing multiple packages101bearing HRQI assemblies100. In a preferred embodiment of the present invention, the association of HRQI assembly105with carton106is embodied as an affixation of HRQI assembly105to carton106, and more particularly as an adherence of HRQI assembly105to carton106. Preferably, HRQI assembly105is produced immediately prior to affixing HQRI assembly105to carton106.

It is appreciated that carton106may be formed of cardboard, but need not be. More generally, carton106is preferably a suitable container containing one, and more typically a plurality of, packages101. For example, carton106may be embodied as, inter alia, a box, a bag, an envelope, a polystyrene foam container, a crate, a barrel, a drum, a pallet and a shipping container.

Preferably a heat responsive coloring material supplier (HRCMS), such as an HRCMS indicated by reference numeral107, supplies an HRCM to HRQI assemblies105at the same location as that at which HRQI assemblies105are associated with cartons106. Typically, HRCMS107is similar to HRCMS102, but may be placed at a location which is different from the location of HRCMS102. In a preferred embodiment of the present invention, the HRQI assembler uses an injection module to inject the HRCM into a shelf-stable, NHRQI sub-assembly108. Preferably, the injection module of HRCMS107includes a heating assembly, such as a resistive heating assembly, thereby maintaining the HRCM at a temperature at which the HRCM is flowable during the supply thereof to NHRQI sub-assembly108. Alternatively, the HRCM may be injected into NHRQI sub-assemblies108by HRCMS102.

As seen in the example illustrated inFIG.1A, HRCMS107is a stand-alone system, and is operative to be used as part of a manual assembly system, such as an assembly system wherein a worker manually retrieves an HRQI assembly105from HRCMS107for manual association with a carton106. In another embodiment of the present invention, HRCMS107is operative to be used as part of an automated assembly system, such as a conveyer belt system. In such an automated embodiment, HRCMS107preferably both produces HRQI assemblies105, by supplying the HRCM to NHRQI sub-assemblies108, and associates each HRQI assembly105with a carton106, preferably by affixing HRQI assemblies105to corresponding cartons106, and more preferably by adhering HRQI assemblies105to corresponding cartons106.

Different types of HRQI assemblies100and105may be employed for different types of packages. For example, HRQI assembly105used on carton106containing individual packages101may be more or less accurate than or have a larger or smaller dynamic range of indications than HRQI assembly100used on individual package101. Thus, HRQI assembly105may respond to a larger or smaller dynamic range of temperatures and/or times than that to which an HRQI assembly100responds. Additionally or alternatively, HRQI assembly105associated with a carton106may include an indicator capable of indicating exceedance of additional thresholds, not included in HRQI assemblies100associated with individual packages101contained therein, or fewer thresholds than HRQI assemblies100associated with individual packages101contained therein.

In one embodiment of the present invention, a relationship between the dynamic range of temperatures and/or times to which an HRQI assembly105responds and the dynamic range of temperatures and/or times to which an HRQI assembly100responds is at least partially determined by an extent of thermal communication between a package101inside carton106and an ambient environment to which HRQI assembly105is exposed. Thus, for example, if a carton106has a relatively high thermal conductance, the dynamic range of temperatures and/or times to which an HRQI assembly105responds and the dynamic range of temperatures and/or times to which an HRQI assembly100responds are preferably fairly similar to one another. However, if a carton106has a relatively low thermal conductance, the dynamic range of temperatures and/or times to which an HRQI assembly105responds and the dynamic range of temperatures and/or times to which an HRQI assembly100responds are preferably fairly dissimilar to one another, more specifically HRQI assembly105is preferably more tolerant of extreme temperatures and times than is a corresponding HRQI assembly100.

As described in more detail hereinbelow with reference toFIGS.2-7E, in the illustrated embodiment ofFIGS.1A-1E, NHRQI sub-assemblies103and HRQI assemblies100each include a plurality of barcodes110. Similarly, NHRQI sub-assemblies108and HRQI assemblies105each include a plurality of barcodes111. As seen inFIGS.1A-1E, HRQI assemblies100preferably have a pre-supply visible state I, as seen in enlargement circle A ofFIG.1A, a post-supply visible state II, as seen in enlargement circles B ofFIG.1Aand B ofFIG.1C, and a first over-temperature visible state III, as seen in enlargement circle A ofFIG.1D, indicating an exceedance of an upper temperature threshold, for example 8 degrees Celsius, for at least a first over-temperature cumulative time duration, for example one hour. HRQI assemblies100preferably also have a second over-temperature visible state IV, as seen in enlargement circle A ofFIG.1C, indicating an exceedance of the upper temperature threshold for at least a second over-temperature cumulative time duration, for example four hours.

In the embodiment illustrated inFIGS.1A-1E, HRQI assemblies100further have an under-temperature visible state V, as seen in enlargement circle B ofFIG.1D, which indicates an exposure to a temperature below a lower temperature threshold, for example 2 degrees Celsius, for an under-temperature time duration. Each of the lower temperature threshold and the under-temperature time duration is preferably selected based on specific parameters of the package101to be monitored by the HRQI assembly100associated therewith. In one embodiment of the present invention, the under-temperature time duration is very short, preferably less than 60 seconds, more preferably less than 30 seconds, more preferably less than 15 seconds, even more preferably less than 10 seconds and most preferably less than 5 seconds. In another embodiment of the present invention, the under-temperature time duration is relatively long, and may be, for example, 5 minutes, 10 minutes, 20 minutes, 30 minutes or 45 minutes.

In one embodiment of the present invention, the under-temperature time duration is a cumulative time duration. In this embodiment, if the under-temperature time duration is, for example, 30 minutes, when HRQI assembly100is exposed to a temperature below the lower temperature threshold for 10 minutes, then is exposed to a temperature above the lower temperature threshold for an hour, and thereafter is exposed to a temperature below the lower temperature threshold for an additional 20 minutes, then HRQI assembly100assumes under-temperature visible state V.

In another embodiment of the present invention, HRQI assembly100only assumes under-temperature visible state V when exposed to a temperature below the lower temperature threshold for an uninterrupted under-temperature time duration. In this embodiment, if the under-temperature time duration is, for example 30 minutes, when HRQI assembly100is exposed to a temperature below the lower temperature threshold for 10 minutes, then is exposed to a temperature above the lower temperature threshold for an hour, and only thereafter is exposed to a temperature below the lower temperature threshold for an additional 20 minutes, then HRQI assembly100does not assume under-temperature visible state V. However, when HRQI assembly100is exposed to a temperature below the lower temperature threshold for an uninterrupted interval of 30 minutes, then HRQI assembly100does assume under-temperature visible state V.

In an alternative embodiment of the present invention, HRQI assembly100is not operative to assume under-temperature visible state V.

It is appreciated that NHRQI sub-assemblies103typically only assume visible states I and V described above with reference to HRQI assemblies100.

In a preferred embodiment of the present invention, as described hereinbelow with reference toFIGS.2-4D, a different single one of barcodes110is machine-readable at each of visible states I, II, III, IV and V. For example, in the example illustrated inFIGS.1A-1E, visible state I is read as 7290003804191, visible state II is read as 7290003804108, visible state III is read as 7290003804122, visible state IV is read as 7290003804115 and visible state V is read as 7290003804139. In one embodiment of the present invention, at least some of the characters associated with a numeric or alphanumeric code are a quality code.

In another preferred embodiment of the present invention, as described hereinbelow with reference toFIGS.5-7E, at least one of visible states I, II, III, IV and V may not be associated with any of barcodes110. Instead, the one or more visible states I, II, III, IV and V which are not associated with any of barcodes110is associated with a change in HRQI assembly100that is readily human sensible, machine-readable or both human sensible and machine-readable.

HRQI assemblies100are preferably assembled by supplying HRCM thereto, as described hereinbelow with reference toFIGS.2-3DandFIGS.5-6D.

It is appreciated that in addition to providing an indication of temperature, HRQI assemblies100and/or105may be operative to provide an indication of at least one alternative or additional quality parameter, including, inter alia, moisture, force, pressure, pH and elapsed time.

It is appreciated that the HRCM is one type of a quality parameter responsive coloring material (QPRCM). QPRCM is typically embodied as one or more of inter alia, a temperature sensitive coloring material such as an HRCM, a pH sensitive coloring material useful in litmus paper and a humidity responsive coloring material such as silica gel.

In the illustrated embodiment, HRQI assemblies105preferably have a pre-supply visible state VI, as seen in enlargement circle D ofFIG.1A, a post-supply visible state VII, as seen in enlargement circles C & G ofFIG.1A, and a first over-temperature visible state VIII, as seen in enlargement circles C & D ofFIG.1B, indicating an exceedance of an upper temperature threshold, for example 8 degrees Celsius, for at least a first over-temperature cumulative time duration, for example one hour. HRQI assemblies105preferably also have a second over-temperature visible state IX, as seen in enlargement circles F ofFIG.1Aand A & B ofFIG.1B, indicating an exceedance of the upper temperature threshold for at least a second over-temperature cumulative time duration, for example four hours. In the embodiment illustrated inFIGS.1A-1E, as seen in enlargement circle E ofFIG.1A, HRQI assemblies105further have an under-temperature visible state X, which indicates an exposure to a temperature below a lower temperature threshold for an under-temperature time duration. In one embodiment of the present invention, the under-temperature time duration is very short, preferably less than 60 seconds, more preferably less than 30 seconds, more preferably less than 15 seconds, even more preferably less than 10 seconds and most preferably less than 5 seconds. In another embodiment of the present invention, the under-temperature time duration is relatively long, and may be, for example, 5 minutes, 10 minutes, 20 minutes, 30 minutes or 45 minutes.

In one embodiment of the present invention, the under-temperature time duration is a cumulative time duration. In this embodiment, if the under-temperature time duration is, for example, 30 minutes, when HRQI assembly105is exposed to a temperature below the lower temperature threshold for 10 minutes, then is exposed to a temperature above the lower temperature threshold for an hour, and thereafter is exposed to a temperature below the lower temperature threshold for an additional 20 minutes, then HRQI assembly100assumes under-temperature visible state X.

In another embodiment of the present invention, HRQI assembly100only assumes under-temperature visible state X when exposed to a temperature below the lower temperature threshold for an uninterrupted under-temperature time duration. In this embodiment, if the under-temperature time duration is, for example 30 minutes, when HRQI assembly105is exposed to a temperature below the lower temperature threshold for 10 minutes, then is exposed to a temperature above the lower temperature threshold for an hour, and only thereafter is exposed to a temperature below the lower temperature threshold for an additional 20 minutes, then HRQI assembly105does not assume under-temperature visible state X. However, when HRQI assembly105is exposed to a temperature below the lower temperature threshold for an uninterrupted interval of 30 minutes, then HRQI assembly105does assume under-temperature visible state X.

In an alternative embodiment of the present invention, HRQI assembly105is not operative to assume under-temperature visible state X.

It is appreciated that NHRQI sub-assemblies108typically only assume visible states VI and X described above with reference to HRQI assemblies105.

In a preferred embodiment of the present invention, as described hereinbelow with reference toFIGS.4A-4D, a different one of barcodes111is machine-readable at each of visible states VI, VII, VIII, IX and X. In another preferred embodiment of the present invention, as described hereinbelow with reference toFIGS.7A-7E, at least one of visible states VI, VII, VIII, IX and X is not associated with a particular one of barcodes111. Instead, the one or more visible states VI, VII, VIII, IX and X which are not associated with a particular one of barcodes111is associated with a change in HRQI assembly105that is readily human sensible, machine-readable or both human sensible and machine-readable, but preferably is not associated with a particular barcode111.

It is appreciated that a numerical sequence of a particular one of barcodes111which is machine-readable at each of visible states VI, VII, VIII, IX and X may differ from a numerical sequence of a particular one of barcodes110. Alternatively, a numerical sequence of a particular one of barcodes111which is machine-readable at each of visible states VI, VII, VIII, IX and X may be the same as a numerical sequence of one of barcodes110. If the same barcode numerical sequence is associated with a visible state of both HRQI assemblies100and HRQI assemblies105, then an identity of an HRQI assembly read by a barcode reader is preferably provided to an indication interpreter by other indicia located thereon or any other suitable method, for example by a manual entry to a database.

It is appreciated that the upper temperature thresholds, the lower temperature thresholds and the predetermined cumulative amounts of time may be selected as appropriate for a given application.

Additionally, in another embodiment of the present invention, HRQI assemblies100and/or105provide an indication of continuous amounts of time spent either above or below a predetermined temperature threshold or thresholds. In other words, HRQI assemblies100and/or105only show an exceedance of a predetermined temperature threshold or thresholds if a time spent over such a threshold or thresholds is a consecutive time, and HRQI assemblies100and/or105begin counting the time from 0 seconds if a temperature of HRQI assemblies100and/or105falls below the threshold or thresholds for a minimum period of time. Thus, in such an embodiment, HRQI assemblies100and/or105provide an indication of a consecutive amount of time spent above a temperature threshold.

In such an embodiment, an HRQI assembly100and/or105preferably indicates that a temperature of the HRQI assembly100and/or105exceeded a temperature threshold, such as 8 degrees Celsius, for a time period of 4 consecutive hours. However, such a label preferably would not provide a warning if a temperature of the HRQI assembly100and/or105exceeds the threshold for 3 consecutive hours, thereafter remains below the threshold, such as at a temperature of 5 degrees Celsius, for a minimum duration, such as 30 minutes, and thereafter exceeds the threshold for an additional 1 hour.

In a preferred embodiment of the present invention, following a supply of HRCM to NHRQI sub-assembly103to form HRQI assembly100, HRQI assembly100associated with a specific package101remains in visible state II as long as the temperature of the specific package101neither exceeds the upper temperature threshold for at least the first over-temperature cumulative time duration nor falls below the lower temperature threshold for at least the under-temperature time duration, as seen particularly in enlargement circle B ofFIG.1A. Similarly, in an alternative embodiment wherein HRQI assembly100is not operative to assume visible state V, HRQI assembly100associated with a specific package101remains in visible state II as long as a temperature of the specific package101does not exceed the upper temperature threshold for at least the first over-temperature cumulative time duration.

As seen in enlargement circles C & G ofFIG.1A, in the illustrated embodiment of the present invention, following a supply of HRCM to NHRQI sub-assembly108to form HRQI assembly105, HRQI assembly105associated with a specific carton106remains in visible state VII as long as the temperature of the specific carton106neither exceeds the upper temperature threshold for at least the first over-temperature cumulative time duration, nor falls below the lower temperature threshold for at least the under-temperature time duration. Similarly, in an alternative embodiment wherein HRQI assembly105is not operative to assume visible state X, HRQI assembly105associated with a specific carton106remains in visible state VI as long as a temperature of the specific carton106does not exceed the upper temperature threshold for at least the first over-temperature cumulative time duration.

If, however, as seen in enlargement circle E ofFIG.1A, the temperature of a specific carton106falls below the lower temperature threshold, HRQI assembly105associated with the specific carton106assumes visible state X. For example, if one of cartons106is stored next to a faulty ventilation duct, thereby exposing that carton106to a temperature of 1 degree Celsius, the HRQI assembly105associated with that carton106assumes visible state X. Preferably, visible state X is irreversible, and the HRQI assembly105remains in visible state X notwithstanding that the temperature of HRQI assembly105and the associated carton106subsequently exceeds the lower temperature threshold.

As further seen inFIG.1A, if during loading of truck A, as indicated by reference numeral112, one or more cartons106is exposed to a temperature of at least 8 degrees Celsius for a period of four and a half hours, which is longer than the second over-temperature cumulative time duration of four hours, corresponding HRQI assemblies105assume visible state IX, as seen in enlargement circle F. Preferably, HRQI assemblies105in visible state IX cannot revert to any of visible states VI, VII or VIII, notwithstanding that a temperature of that carton106and corresponding HQRI assembly105subsequently drops below the upper temperature threshold. Upon a delivery of these cartons106, these cartons106are preferably inspected to determine whether the temperature of the HQRI assemblies100and associated packages101inside the cartons106exceeded predetermined time and temperature thresholds.

Accordingly, upon inspection, as upon delivery, as seen inFIG.1B, the HRQI assemblies105attached to the cartons106which were exposed to a temperature of at least 8 degrees Celsius for a period of four and a half hours may be read using a conventional barcode reader113, such as a hand-held barcode reader113or an automated barcode reader113. Hand-held barcode reader113may be embodied as any suitable barcode reader, such as, inter alia, a smartphone running a barcode-reading application. Barcode reader113, upon reading barcodes111on HRQI assembly105in visible state IX, preferably provides information to a quality indication computer115which enables quality indication computer115to provide an immediate indication of a quality status, such as a BAD indication116. This BAD indication116indicates that at some time in a history of the HRQI assembly105read by barcode reader113, the HRQI assembly105and the carton106with which it is associated exceeded the upper temperature threshold for at least the second over-temperature cumulative time duration and that this may have rendered one or more of the products in carton106unacceptable for use.

In a preferred embodiment of the present invention, quality indication computer115preferably maintains or communicates with a database which preferably includes at least an event description table, associating various visible states of HRQI assemblies101and105with various events, such as injection of ink and exposure to a temperature in exceedance of a particular temperature threshold for a particular time duration, and a product status table, associating various events with product types, product descriptions, and product quality statuses.

It is appreciated that until the cartons106are opened, which normally occurs only upon delivery, it is impractical to visually inspect the HRQI assemblies100which are attached to the individual packages101inside the cartons106. Depending on circumstances, a temperature of individual packages101within a carton106may or may not have exceeded the upper temperature threshold for at least the second over-temperature cumulative time duration, and the HRQI assemblies100which are attached to the packages101may or may not be in visible state III or visible state IV. This normally can only be seen upon opening cartons106, as shown inFIG.1C.

It is appreciated that the time and temperature thresholds of HRQI assemblies100and105, placed on individual packages101and cartons106containing them, respectively, may be related in order to provide highly effective cold chain management. For example, HRQI assemblies105may provide a time in temperature warning even if, upon inspection, HRQI assemblies100show that individual packages101have not experienced unacceptable temperatures. It is appreciated that, preferably, the thresholds of HRQI assemblies100and105may be calibrated with respect to each other based, inter alia, on empirical data, in order to minimize the number of required inspections of individual packages101, to generally avoid a situation where HRQI assembly105provides a ‘BAD’ indication for a carton106, while all HRQI assemblies100within carton106provide acceptable indications.

As further seen inFIG.1A, if, during loading of truck B, the temperature outside of truck B reaches 10 degrees Celsius for 30 minutes, which is less than the predetermined duration of one hour, the HRQI assemblies105associated with cartons106in truck B remain in visible state VII, as seen at reference numeral117.

At any stage, such as upon delivery, HRQI assemblies105can be read with barcode reader113, which preferably communicates with remote quality indication computer115and provides an immediate indication of a quality status, such as an OK indication118. It is appreciated that normally, until delivery, it is impractical to visually inspect HRQI assemblies100on individual packages101.

As stated hereinabove with relation to loading of truck A, it is preferable that HRQI assemblies105provide a warning of an exceedance of the upper temperature threshold for at least the first over-temperature time duration even if, upon inspection, HRQI assemblies100show that individual packages101have not experienced unacceptable temperatures for unacceptable durations. Accordingly, upon subsequent reading of indicators100on packages101inside a carton106for which no such warning was provided, it is not expected that the indicators100will indicate exceedance of a corresponding exceedance of the upper temperature threshold for at least the first over-temperature time duration.

As seen inFIG.1B, if, during vehicle breakdown of truck B, the temperature outside of the cartons106is 15 degrees Celsius, which is more than the upper temperature threshold of 8 degrees Celsius, for 90 minutes, which is more than the predetermined total duration of one hour, the HRQI assemblies105assume visible state VIII, as seen at reference numeral119. It is appreciated that once HQRI assembly105assumes visible state VIII it cannot revert to either of visible states VI or VII, notwithstanding that the temperature of the HQRI assembly105and the associated carton106subsequently drops below the upper temperature threshold.

Typically, upon delivery, HRQI assemblies105are preferably read using barcode reader113. Barcode reader113, upon reading barcodes111in visible state VIII, preferably provides information to the quality indication computer115which enables quality indication computer115to provide an immediate indication of a quality status, such as a “W” indication120. This “W” indication120indicates that at some time in the history of the HRQI assembly105, the carton106to which it was attached was at a temperature greater than the upper temperature threshold for at least the first over-temperature cumulative time duration and, while unlikely, this may have rendered one or more of the products in carton106unacceptable for use. It is appreciated that normally, until cartons106are opened, typically following delivery, it is impractical to visually inspect indicators100on individual packages101.

Depending on the circumstances, the temperatures of the individual packages101within the cartons106may or may not have exceeded the upper temperature threshold for at least the first over-temperature time duration and the HRQI assemblies100which are attached to the packages101may or may not be in the visible state III or visible state IV. This normally can only be seen upon opening cartons106and inspecting HQRI assemblies100associated with individual packages101, as shown inFIG.1C.

As further seen inFIG.1Band indicated by reference numeral121, upon inspection, as upon delivery, the HRQI assemblies105attached to the cartons106which were delivered by truck A may be read, preferably using barcode reader113. If, as seen inFIG.1A, during loading of truck A, one or more cartons106were exposed to a temperature of at least 8 degrees Celsius for a period of four and a half hours, the HRQI assemblies105of these cartons assumed the visible state IX, indicating exceedance of the upper temperature threshold for at least the second over-temperature cumulative time duration. Barcode reader113, upon reading barcodes111in visible state IX, preferably provides information to quality indication computer115which enables quality indication computer115to provide an immediate indication of a quality status, such as a BAD indication116.

In contrast, the HRQI assemblies105of other cartons106which were not exposed to a temperature of 8 degrees Celsius for a period of at least four hours remained in visible state VII. Barcode reader113, upon reading the HQRI assemblies105with barcodes111in visible state VII, preferably provides information to the quality indication computer115which enables quality indication computer115to provide an OK indication, similar to OK indication118.

Turning now specifically toFIG.1C, it is seen that upon opening the cartons106of packages101which were delivered by truck B, as indicated by reference numeral123, the HRQI assemblies100attached to the packages101may be read by barcode reader113. In this example, the HRQI assemblies100of some of the packages101are in visible state II, indicating that notwithstanding that HRQI assembly105on carton106indicates an exceedance of the upper temperature threshold for at least the first over-temperature cumulative time duration, some of the HRQI assemblies100associated with some of packages101, particularly those at the interior of the carton106, may not have exceeded the upper temperature threshold for the first or second over-temperature cumulative time duration, and may be acceptable for use.

Barcode reader113preferably communicates with a remote quality indication computer115and provides an OK indication124to an inspector, indicating that the temperature of some of packages101did not exceed the upper temperature threshold for at least the first over-temperature cumulative time duration.

This OK indication124is in contrast to the “W” indication120provided by the HRQI assemblies105associated with the cartons106containing these packages101as the result of refrigeration breakdown of truck B, as indicated by reference numeral119inFIG.1B. As stated hereinabove with relation to truck A loading, HRQI assemblies105associated with cartons106may provide a time in temperature warning even if, upon inspection, HRQI assemblies100associated with individual packages101show that individual packages101have not experienced unacceptable temperatures.

As is further stated hereinabove, the thresholds of HRQI assemblies100and105may be calibrated with respect to each other based, inter alia, on empirical data, in order to minimize the number of required inspections of individual packages101, to generally avoid a situation where an HRQI assembly105provides a ‘BAD’ indication for a carton106, while all HRQI assemblies100within the carton106with which that HRQI assembly105is associated provide acceptable indications. It is appreciated that the thresholds of HRQI assemblies100and105are thus not necessarily the same thresholds as indicated in the example ofFIGS.1A-1E, which are provided for illustration purposes only. For example, a BAD indication for a carton106containing packages101all having an OK indication can be prevented if HRQI assemblies105attached to the cartons106are calibrated to indicate the exceedance of a higher time or temperature threshold than that of HRQI assemblies100on packages101.

As further seen inFIG.1Cand indicated by reference numeral125, upon opening the cartons106of packages101which were delivered by truck A and for which a BAD indication has already been provided by the HRQI assemblies105associated therewith during loading of truck A, as seen inFIG.1A, it is seen that as least some of the HRQI assemblies100assumed visible state IV. It is appreciated that once HQRI assembly100assumes visible state IV, the HRQI assembly100preferably cannot thereafter revert to any of states I, II and III, notwithstanding that the temperature of the HQRI assembly100and associated package101subsequently drops below the upper temperature threshold.

Accordingly, upon inspection, as upon delivery, HRQI assembly100is read, preferably using barcode reader113. Barcode reader113, upon reading barcodes110of HQRI assembly100in visible state IV, preferably provides information to quality indication computer115which enables quality indication computer115to provide an immediate indication of a quality status, such as a BAD indication126. This BAD indication126indicates that at some time in the history of the HRQI assembly100, the package101to which it was attached was at a temperature exceeding the upper temperature threshold for more than at least the second over-temperature cumulative time duration, and that this event has rendered the product in package101unacceptable for use.

As indicated by reference number127, it is noted that it is undesirable for a carton106to be associated with a NHRQI sub-assembly108, without that NHRQI sub-assembly108having been supplied with an HRCM. In such a case, as seen in enlargement circle C inFIG.1C, the NHRQI sub-assembly108preferably displays pre-supply visible state VI. Barcode reader113, upon reading barcodes111of NHRQI sub-assembly108in pre-supply visible state VI, preferably provides information to quality indication computer115which enables quality indication computer115to provide an immediate indication of a quality status, such as a “NO” indication128, which indicates that the NHRQI sub-assembly108is not fully assembled and thus cannot provide time in temperature history of the carton106with which it is associated.

Similarly, as indicated by reference number129, it is undesirable for a package101to be associated with a NHRQI sub-assembly103, without that NHRQI sub-assembly103having been supplied with an HRCM. In such a case, as seen in enlargement circle D inFIG.1C, NHRQI sub-assembly103preferably displays pre-supply visible state I. Barcode reader113, upon reading barcodes110in pre-supply visible state I, preferably provides information to quality indication computer115which enables quality indication computer115to provide an immediate indication of a quality status, such as a “NO” indication130, which indicates that the NHRQI sub-assembly103is not fully assembled and thus cannot provide time in temperature history of the package101with which it is associated.

In a preferred embodiment of the present invention, each HRQI assembly100and105, or in the undesirable case wherein the HRCM was not supplied to an NHRQI sub-assembly103or108, each NHRQI sub-assembly103and108, is inspected prior to being associated with a package101or carton106, respectively. Preferably, a conventional barcode reader, such as barcode reader113, reads barcodes110and111on each HRQI assembly100and105or NHRQI sub-assembly103and108substantially immediately prior to the association of the same with a package101or carton106. Barcode reader113, upon reading barcodes110and111on HRQI assembly100and105or NHRQI sub-assembly103and108, preferably provides information to a quality indication computer115which enables quality indication computer115to provide an immediate indication of a quality status of the HRQI assembly100and105or NHRQI sub-assembly103and108read by barcode reader113.

If, as a result of the reading by the conventional barcode reader, an indication is provided that the HRQI assembly100and105or NHRQI sub-assembly103and108is unfit for use, then the HRQI assembly100and105or NHRQI sub-assembly103and108is preferably discarded and is not associated with a package101or carton106. Examples of an HRQI assembly100and105or NHRQI sub-assembly103and108that is unfit for use include an HRQI assembly100and105or NHRQI sub-assembly103and108that is in pre-supply visible state I or VI, that is in visible state V or X, or that is unreadable by a typical barcode reader113.

It is appreciated that whereas machine reading of the NHRQI sub-assemblies103and108and HRQI assemblies100and105provides an indication of whether or not a given event has occurred, the indication of a quality status by the quality indication computer115provides an indication of whether and to what extent that event has affected the quality of a given product with which NHRQI sub-assembly103, NHRQI sub-assembly108, HRQI assembly100or HRQI assembly105is associated. It is appreciated that there may be a great variation in the effect of a given event depending on the type of product. Thus, for example, exposure to 30 degrees Celsius for a short period of time may cause a live attenuated influenza vaccine to be rendered unfit for use but may not appreciably affect the quality or usability of ibuprofen tablets.

As seen inFIG.1D, as indicated by reference numeral131, a user employing an imager-equipped telephone, such as, inter alia, a smartphone running a barcode-reading application, or other suitable mobile communicator132, for example during an inspection of a pharmacy refrigerator, may image HRQI assembly100and communicate the image information to a suitably programmed quality indication computer133. Quality indication computer133may be different from computer115or identical to computer115, and is capable of reading the barcodes110from the image information generated by mobile communicator132and providing to the user, via SMS or any other suitable communication methodology, an immediate indication of a quality status, such as a GOOD QUALITY indication134. This quality status indicates that the product is safe for use. Alternatively, if the user employs a barcode reader-equipped communicator, the communicator can provide to the computer115an output resulting from reading the barcode110.

In a preferred embodiment of the present invention, quality indication computer133preferably maintains or communicates with a database which preferably includes at least an event description table, associating various visible states of HRQI assemblies101and105with various events, such as injection of ink and exposure to a temperature in exceedance of a particular temperature threshold for a particular time duration, and a product status table, associating various events with product types, product descriptions, and product quality statuses.

It is appreciated that quality indication computers115and133may provide reports to various interested entities, such as the manufacturer or distributor of the products, health authorities and other governmental or private entities, to enable real-time monitoring of the quality of products offered for use. Quality indication computers115and133may have a user identification functionality, such as a caller ID functionality, so as to be able to identify a user requesting information, classify the user, for example as a pharmacist, a manufacturer's QA inspector and a health inspector, and provide an appropriate quality indication output. Additionally or alternatively, quality indication computers115and133may send messages to pharmacy or supply-chain management regarding remedial steps to be taken, such as refrigeration maintenance or repair instructions.

As described hereinabove and as seen inFIG.1D, HRQI assembly100may indicate an exceedance of the upper temperature threshold for at least the second over-temperature cumulative time duration. Thus, upon exceedance of the second over-temperature cumulative time duration, HRQI assembly100assumes visible state III, as seen at reference numeral135inFIG.1D.

Accordingly, upon inspection, such as a periodic inspection at a medical facility, an inspector using barcode reader113may read HQRI assemblies100. Barcode reader113, upon reading HRQI assembly100with barcodes110in visible state III, as seen in enlargement circle A ofFIG.1D, provides information to quality indication computer115which enables quality indication computer115to provide an immediate indication of a quality status, such as a “W” indication136. This “W” indication136indicates that, although the package101to which HRQI assembly100is attached is still suitable for use, the upper temperature threshold has been exceeded.

Additionally or alternatively, as seen at reference numeral140inFIG.1D, a medical practitioner may conduct a final inspection of HRQI assembly100immediately prior to removing contents of package101therefrom. For example, a nurse may use a suitable mobile communicator142, such as, inter alia, a smartphone running a barcode-reading application, or any suitable conventional barcode reader, to scan HRQI assembly100prior to withdrawing a vaccine from package101with which HRQI assembly100is associated, such as a vial. As seen in enlargement circle B ofFIG.1D, in the illustrated example, the barcode110of HRQI assembly100is in its visible state V. Mobile communicator142or barcode reader113, upon reading HQRI assembly with barcodes110in visible state V, provides information to quality indication computer133which enables quality indication computer133to provide an immediate indication of a quality status, such as a BAD: FROZE indication144, to the medical practitioner. This BAD: FROZE indication144indicates that the package101to which it was attached is not usable, since the package101was exposed to a temperature below the lower temperature threshold for the under-temperature time duration.

In another embodiment of the present invention, an additional inspection may be carried out automatically at a pharmacy checkout, where the HRQI assembly100is read by a checkout scanner. It is appreciated that further inspections may be carried out, either manually or automatically, at suitable times and locations.

It is appreciated that HRQI assembly100may also include other product quality related indications, such as an indication of the elapse of a relatively long period of time at an acceptable storage temperature. Additionally, the HRQI assembly100may be used to indicate events which occur following the release or purchase of a product.

In a preferred embodiment of the present invention, as seen inFIG.1E, at least one of package101and carton106are associated with an additional label150and155, respectively. Additional labels150and155preferably include indicia157and159, respectively, which may be machine-readable, human sensible, or both machine-readable and human sensible. Indicia157and159preferably provide product information relating to package101and carton106, respectively, such as any or all of, inter alia, product type, manufacturing date, packaging location and quality assurance (QA) inspector identification. In a preferred embodiment of the present invention, each of indicia157and159are machine-readable indicia, such as, inter alia, a bar code or a QR code.

Preferably, additional label150is in close physical proximity to HRQI assembly100and additional label155on package101is in close physical proximity to HRQI assembly105on carton106. Thus, in a preferred embodiment of the present invention, HRQI assembly100and additional label150can be read substantially simultaneously by either or both of a human user and a machine reader, such as barcode reader113or mobile communicator142. Similarly, HRQI assembly105and additional label155can be read substantially simultaneously by either or both of a human user and a machine reader, such as barcode reader113or mobile communicator142.

Thus, in a preferred embodiment of the present invention, quality indication computer115receives outputs from both HRQI assembly100or105and corresponding additional label150or155. Preferably, quality indication computer115relates the output from HRQI assembly100or105with the product output from additional label150or155. In other words, output from a scan of HRQI assembly100or105and additional label150or155is provided to quality indication computer115, and quality indication computer115preferably bases the quality indication output on outputs from both HRQI assembly100or105and corresponding additional label150or155.

For example, if the product output from additional label150or155indicates that package101or carton106is subject to a manufacturer recall, quality indication computer115preferably provides an output indicating that the contents of package101or carton106should not be used, even if output from HRQI assembly100or105indicates that package101or carton106has not been exposed to temperatures either above an upper temperature threshold temperature or below a lower temperature threshold temperature. Conversely, if the output from HRQI assembly100or105indicates that package101or carton106has been exposed to temperatures either above an upper temperature threshold temperature for a predetermined time duration or below a lower temperature threshold temperature for a predetermined time duration, quality indication computer115preferably provides an output indicating that the contents of package101or carton106should not be used, even if the product output from additional label150or155indicates that package101or carton106is acceptable for use.

Additionally, in a preferred embodiment of the present invention, quality indication computer115maintains and updates the decision table which provides product quality status outputs based on the output indications provided by the indicator reader and the additional parameters. In such an embodiment, if, for example, a predetermined number or percentage of packages101or cartons106from a particular group, such as for example a batch, a lot, a manufacturing facility, a storage facility or a transportation line, are found to have been exposed to temperatures either above an upper temperature threshold temperature for a predetermined time duration or below a lower temperature threshold for a predetermined time duration, then entries on the decision table for all packages101or cartons106from that group are updated. For example, entries on the decision table for all packages101or cartons106from that group may be modified to include a warning regarding possible unacceptable temperature exposure, and/or include a request for an investigation into temperature history of the batch.

Reference is now made toFIG.2, which is a simplified illustration of a heat responsive coloring material supplier (HRCMS)190, which is an example of one or both of HRCMSs102and107ofFIGS.1A-1E, and toFIGS.3A-3D, which together are a simplified illustration of a preferred method of construction of a heat responsive quality indicator (HRQI)200, which is an embodiment of one or both of HRQI assemblies100and105ofFIGS.1A-1E.

HRQI assembly200preferably includes a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly202including at least one coloring material reservoir210, at least one indicator template212and at least one coloring material diffuser220. HRQI assembly200preferably additionally includes a quality parameter responsive coloring material (QPRCM)240. In a preferred embodiment of the present invention, QPRCM240is an HRCM, which is flowable at a temperature exceeding an upper temperature threshold, as indicated by waved lines in corresponding figures. QPRCM240is characterized by a viscosity and a melting point such that QPRCM240is flowable through or on coloring material diffuser220at temperatures above an upper temperature threshold and is not flowable through or on coloring material diffuser220at temperatures below the upper temperature threshold. Additionally, QPRCM240is preferably characterized by a color that is readily distinguishable from a color of coloring material diffuser220.

QPRCM240, when supplied to coloring material diffuser220of NHRQI sub-assembly202, preferably converts NHRQI sub-assembly202to HRQI assembly200, which is responsive to changes in temperature over time in exceedance of the upper temperature threshold, for changing an appearance of HRQI assembly200. Thus, HRQI assembly200is formed by supplying QPRCM240to NHRQI sub-assembly202, preferably by injecting QPRCM240into NHRQI sub-assembly202.

When QPRCM240is flowable, QPRCM240preferably diffuses through coloring material diffuser220. Conversely, when QPRCM240is not flowable, QPRCM240preferably does not diffuse through coloring material diffuser220. Preferably, HRQI assembly200includes a quantity of QPRCM240sufficient to saturate the entirety or nearly the entirety of coloring material diffuser220following an exposure of HRQI assembly200to the upper temperature threshold for predetermined cumulative time duration.

It is further appreciated that QPRCM240may additionally or alternatively be embodied as a coloring material that is responsive to at least one alternative or additional quality parameter, including, inter alia, moisture, force, pressure, pH and elapsed time. In such a case, HRQI assembly200is preferably embodied as at least, inter alia, a moisture responsive quality indicator, a force responsive quality indicator, a pressure responsive quality indicator, a pH responsive quality indicator and an elapsed time responsive quality indicator, respectively.

In one embodiment of the present invention, (not shown), QPRCM240is supplied directly to coloring material diffuser220. In such an embodiment, coloring material reservoir210may be obviated.

In another embodiment of the present invention, as seen particularly inFIGS.2-3D, QPRCM240is supplied indirectly to coloring material diffuser220. In such an embodiment, QPRCM240is preferably supplied to coloring material reservoir210, and coloring material reservoir210supplies QPRCM240to coloring material diffuser220.

In a preferred embodiment of the present invention, coloring material diffuser220is embodied as filter paper, such as Whatman No. 3 filter paper commercially available from Whatman International [CAT #: 1003917]. Additionally, coloring material reservoir210is preferably embodied as a pad, for example, K-R; 210/34/28, commercially available from Noam-Urim of Kibbutz Urim, Israel, and QPRCM240is preferably embodied as a coloring agent, such as Sudan Black, a black color dye [CAS: 4197-25-5], combined at a ratio of 1.4 grams per 1 kilogram in Decyl Decanoate [CAS: 1654-86-0].

Preferably, indicator template212includes a transparent substrate on which is formed non-transparent printing. In a preferred embodiment of the present invention, all areas on the transparent substrate which are desired to be opaque, including both a background and areas in which features will be printed, are printed with white ink, and a plurality of features, such as bars forming part of barcodes corresponding to barcodes110or111ofFIGS.1A-1E, are preferably printed with black ink over the white ink as desired.

In another embodiment of the present invention, a background area of indicator template212is printed with white ink; however, the white ink is not deposited in the areas in which the plurality of features are formed, and the plurality of features are preferably printed with black ink.

More generally, in all embodiments of the present invention, the background area of indicator template212and the plurality of features of indicator template212are printed in such colors as to define high contrast therebetween.

Indicator template212preferably further includes at least one transparent area248, indicated by dotted lines inFIGS.3A-3D. It is appreciated that the dotted lines indicating transparent area or areas248are drawn for ease of understanding, and preferably transparent area or areas248are not readily distinguishable from surrounding areas of indicator template212. In a preferred embodiment of the present invention, transparent area or areas248are not printed, i.e., preferably no material is deposited on transparent area or areas248. For the purposes of the present specification and claims, the term “transparent area” is defined so as to include within its scope areas that are either transparent or translucent.

Preferably, coloring material diffuser220is visible through the entirety of each of transparent areas248. Thus, a color visible in each of transparent areas248is determined by a color of a portion of coloring material diffuser220located therebehind. In a preferred embodiment of the present invention, each of transparent areas248is initially white in color, and assumes a black color upon a coloring of coloring material diffuser220by QPRCM240.

In a preferred embodiment of the present invention, indicator template212additionally includes at least one area252upon which is deposited a cold responsive coloring material254, such as a thermochromic coloring material, such as irreversible thermochromic ink commercially available from CTI Technology, Colorado Springs, USA. It is appreciated that although, for ease of understanding, dashed lines inFIGS.3A-3Dindicate area252, preferably area252is not readily distinguishable from surrounding areas of indicator template212.

It is appreciated that as used herein, “cold responsive” is used to indicate an element or system that changes as a result of cold, wherein “cold” is used to indicate a temperature below a lower temperature threshold, such as a temperature at which cold responsive coloring material254typically changes color.

In a preferred embodiment of the present invention, cold responsive coloring material254is initially characterized by a first color, and irreversibly assumes a second color, which is different from the first color, upon exposure to a temperature below a lower temperature threshold for example, below 2 degrees Celsius, for an under-temperature time duration. As described hereinabove, in one embodiment of the present invention, the under-temperature time duration is very short, preferably less than 60 seconds, more preferably less than 30 seconds, more preferably less than 15 seconds, even more preferably less than 10 seconds and most preferably less than 5 seconds. In another embodiment of the present invention, the under-temperature time duration is relatively long, and may be, for example, 5 minutes, 10 minutes, 20 minutes, 30 minutes or 45 minutes.

Thus, if the under-temperature time duration is very short, then cold responsive coloring material254preferably assumes the second color substantially immediately upon being exposed to a temperature below the lower temperature threshold. In contrast, if the under-temperature time duration is relatively long, for example 30 minutes, then cold responsive coloring material254assumes the second color only upon an exposure to a temperature less than the lower temperature threshold for at least 30 minutes.

It is appreciated that the first color and the second color assumed by cold responsive coloring material254may be any suitable colors which are discernable from one another. In one embodiment of the present invention, the first and second colors are readily discernable from one another by a human. Additionally or alternatively, the first and second colors are readily discernable from one another by a machine. For example, in one embodiment of the present invention, cold responsive coloring material254characterized by the first color is colorless and transparent, and cold responsive coloring material254characterized by the second color is blue.

In the example illustrated inFIGS.2-3D, indicator templates212are embodied as a plurality of barcodes258, such as barcodes110or111, including a first barcode260, a second barcode262, a third barcode264, a fourth barcode266and a fifth barcode268, which are preferably different from each other and arranged in a stacked arrangement. As indicated by dotted lines, formed within barcodes258are transparent areas248, including a transparent area270, a transparent area272and a transparent area274.

As described hereinabove, coloring material diffuser220is preferably visible through the entirety of each of transparent areas248. More particularly, a portion280of coloring material diffuser220is preferably visible through transparent area270, a portion282of coloring material diffuser220is preferably visible through transparent area272and a portion284of coloring material diffuser220is preferably visible through transparent area274. Thus, it is appreciated that a color visible in each of transparent areas270,272and274is determined by a color of each of portions280,282and284, respectively. It is appreciated that although, for ease of understanding, dotted lines inFIGS.3A-3Dindicate each of portions280,282and284, preferably portions280,282and284are not readily distinguishable from surrounding areas of coloring material diffuser220.

Preferably, each of transparent areas270,272and274is formed within at least two of barcodes258and forms a readable portion thereof. In the illustrated embodiment ofFIGS.3A-4D, transparent area270forms part of barcodes260and262, transparent area272forms part of barcodes262and264, and transparent area274forms part of barcodes264and266. Each of transparent areas248preferably has the same width as a single barcode bar. Alternatively, the width of any of the transparent areas270,272and274may be different from the width of a single barcode bar. Additionally, the width of the portion of a transparent area248which forms part of one of barcodes258may be different from the width of the portion of the same transparent area248which forms part of another of barcodes258.

Preferably, all of barcodes258include at least a portion of area252within which is located cold responsive coloring material254, and the at least portion of area252forms a readable portion of barcodes258. Accordingly, area252forms part of each of barcodes260,262,264,266and268. Area252preferably has the same width as a single barcode bar. Alternatively, the width of at least a portion of area252may be different from the width of a single barcode bar.

It is appreciated that barcodes260,262,264,266and268may be arranged in any suitable order with respect to one another. Similarly, transparent areas270,272and274may be arranged in any suitable order with respect to one another. Furthermore, it is appreciated that at least one of barcodes260,262,264,266and268and/or transparent areas270,272and274may be obviated from indicator template212and HRQI assembly200. Similarly, one or more additional barcodes and/or transparent areas may be added to indicator template212and HRQI assembly200.

In a preferred embodiment of the present invention, a different single one of barcodes258is machine-readable at each of visible states I, II, III, IV and V. For example, in the example illustrated inFIGS.2-4D, barcode260is read as 7290003804191 at pre-supply visible state I, barcode262is read as 7290003804108 at post-supply visible state II, barcode264is read as 7290003804122 in visible state III, barcode266is read as 7290003804115 in visible state IV and barcode268is read as 7290003804139 in visible state V. Preferably, each of barcodes258is machine-readable only in the single one of visible states I, II, III, IV and V, as listed above. In one embodiment of the present invention, at least some of the characters associated with a numeric or alphanumeric code are a quality code.

As seen particularly inFIGS.3A-3D, when coloring material diffuser220is in an uncolored state, meaning that QPRCM240has not been supplied to coloring material diffuser220, coloring material diffuser220causes each of transparent areas270,272and274to appear white in color. The white appearance of transparent area270preferably allows barcode260to be machine-readable, while the white appearance of transparent areas270,272and274preferably causes barcodes262,264and266to be non-machine-readable. Additionally, as long as NHRQI sub-assembly202has not been exposed to a temperature less than the lower temperature threshold, cold responsive coloring material254is preferably characterized by the first color thereof, for example colorless and transparent, and area252does not interfere with the readability of any of barcodes260,262,264and266, while the first color of area252preferably prevents barcode268from being read. Thus, when coloring material diffuser220is in an uncolored state and NHRQI sub-assembly202has not been exposed to a temperature less than the lower temperature threshold, NHRQI sub-assembly202is preferably in pre-supply visible state I, wherein only barcode260is in a machine-readable state.

As seen inFIG.3A, a container290, such as, inter alia, package101or carton106, is ready to be associated with an HRQI assembly200. It is appreciated that container290is typically a product package, and may be embodied as, inter alia, an individual product package, such as a vial, a box of product packages, a pallet of product packages or a shipping container of product packages. In a preferred embodiment of the present invention, a type of container290with which an HRQI assembly200is associated, and more particularly a number of individual products contained by the container290associated with HRQI assembly200, is at least partially determined by a relationship between a cost of monitoring container290, a temperature-sensitivity of a product within container290and a financial value of a product within container290.

Preferably, as further seen inFIG.3A, QPRCM240has not yet been supplied to NHRQI sub-assembly202, and therefore NHRQI sub-assembly202is preferably not yet associated with container290. As described hereinabove, prior to a supply of QPRCM240to NHRQI sub-assembly202, NHRQI sub-assembly202has not been exposed to a temperature less than the lower temperature threshold and is preferably in pre-supply visible state I.

Preferably, in visible state I, barcode260is typically readable by a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, and barcodes262,264,266and268are preferably not readable by a barcode reader. Thus, the NHRQI sub-assembly202is in pre-supply visible state I and presents a single machine-readable barcode260, typically readable by a conventional barcode reader as 7290003804191.

NHRQI sub-assembly202is preferably embodied as a self-adhesive label. Typically, after fabrication of NHRQI sub-assemblies202and before QPRCM240is supplied thereto, NHRQI sub-assemblies202are stored on a roll liner292. NHRQI sub-assembly202includes a back portion294, on a rear side (not shown) of which is preferably an adhesive (not shown). The adhesive preferably serves to affix NHRQI sub-assembly202to roll liner292. Typically, following the production of HRQI assembly200, the adhesive on NHRQI sub-assembly202is also used to affix HRQI assembly200to container290.

As seen particularly inFIGS.2and3B, HRCMS190preferably includes a coloring material supplier298, such as injection module104ofFIG.1A, which includes at least one injector302, such as a needle assembly. In a preferred embodiment of the present invention, coloring material supplier298includes a heating assembly303, such as a resistive heating assembly. If an ambient temperature of coloring material supplier298is below the upper temperature threshold of QPRCM240while coloring material supplier298supplies QPRCM240to NHRQI sub-assembly202, heating assembly303provides heat to QPRCM240during the supply thereof to NHRQI sub-assembly202, thereby maintaining QPRCM240at a temperature at which QPRCM240is flowable during the supply thereof to NHRQI sub-assembly202.

Typically, coloring material supplier298supplies QPRCM240to NHRQI sub-assembly202while NHRQI sub-assembly202is affixed to roll liner292. In the embodiment shown inFIGS.2-3D, coloring material supplier298supplies QPRCM240to coloring material reservoir210, and coloring material reservoir210then supplies QPRCM240to coloring material diffuser220. In another embodiment of the present invention, coloring material supplier298supplies QPRCM240directly to coloring material diffuser220, and coloring material reservoir210may be obviated.

In a preferred embodiment of the present invention, QPRCM240is supplied to NHRQI sub-assembly202immediately prior to the association of HRQI assembly200with container290. In other words, QPRCM240is preferably supplied to NHRQI sub-assemblies202as NHRQI sub-assemblies202are being positioned for imminent association with containers290. Thus, in the illustrated embodiment shown inFIG.2, as roll liner292is unspooled to make NHRQI sub-assemblies202available for affixation to containers290, QPRCM240is supplied to NHRQI sub-assemblies202.

Preferably, an aperture304is formed in back portion294of NHRQI sub-assembly202. As seen particularly inFIG.3B, QPRCM240is preferably supplied by injector302to NHRQI sub-assembly202through aperture304. In the illustrated embodiment of the present invention, aperture304enables fluid communication between injector302and coloring material reservoir210, which in turn is in fluid communication with coloring material diffuser220. In another embodiment of the present invention, in which coloring material reservoir210may be obviated, aperture304enables fluid communication directly between injector302and coloring material diffuser220.

Preferably, a plurality of apertures314are formed on roll liner292, and each of apertures314is generally aligned with one of apertures304. It is appreciated that apertures304and314may be formed either during respective fabrications of NHRQI sub-assembly202and roll liner292, or as part of the supply of QPRCM240to NHRQI sub-assembly202. Alternatively, one of plurality of apertures304and314may be formed during a respective fabrication of NHRQI sub-assembly202and roll liner292, and the other of plurality of apertures304and314may be formed as part of the supply of QPRCM240to NHRQI sub-assembly202. Typically, in an embodiment wherein at least one of plurality of apertures304and314is formed as part of the supply of QPRCM240to NHRQI sub-assembly202, the at least one of plurality of apertures304and314is formed by injector302.

As described above, in the embodiment illustrated inFIGS.2and3B, QPRCM240is supplied to NHRQI sub-assembly202via aperture304on back portion294of NHRQI sub-assembly202prior to, preferably immediately prior to, associating HRQI assembly200with container290. In an alternative embodiment of the present invention, QPRCM240is supplied to NHRQI sub-assembly202after associating NHRQI sub-assembly202with container290. In an embodiment wherein the supply of QPRCM240to NHRQI sub-assembly202occurs after associating NHRQI sub-assembly202with container290, coloring material supplier298and apertures314may be obviated, and aperture304may be obviated or located elsewhere on NHRQI sub-assembly202.

In an embodiment wherein QPRCM240is supplied to NHRQI sub-assembly202following the association of NHRQI sub-assembly202with container290, for example, an injector may supply QPRCM240to NHRQI sub-assembly202through an aperture formed in a front surface or a side surface of NHRQI sub-assembly202.

Turning now particularly toFIG.3C, it is seen that immediately following a supply of QPRCM240to NHRQI sub-assembly202, portion280of coloring material diffuser220preferably becomes colored with QPRCM240, and thus the color visible through transparent area270is determined by the color of QPRCM240. In the example shown inFIGS.2-3D, as seen particularly inFIG.3C, immediately following a supply of QPRCM240to NHRQI sub-assembly202, transparent area270shows a black color, and HRQI assembly200thus preferably assumes post-supply visible state II immediately following a supply of QPRCM240to NHRQI sub-assembly202.

It is appreciated that the coloring of portion280by QPRCM240, and thus the changing of the color visible through transparent area270, changes an appearance of HRQI assembly200, and more particularly, changes an appearance of barcode260and of barcode262.

In post-supply visible state II, transparent area270shows a color similar to the color of bars of barcodes258, while transparent areas272and274remain uncolored. Therefore, barcodes260,264and266are preferably unreadable by a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, and only barcode262is readable by a conventional barcode reader. Additionally, at post-supply visible state II, HRQI assembly200has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material254is preferably characterized by the first color thereof, for example colorless and transparent, and area252does not interfere with the readability of any of barcodes260,262,264and266, while the first color of area252preferably prevents barcode268from being read. Thus, HRQI assembly200in post-supply visible state II presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode262having numerical sequence 7290003804108.

It is appreciated that once HQRI assembly200assumes visible state II, HRQI assembly200preferably cannot thereafter revert to visible state I.

Preferably, QPRCM240is supplied in a flowable state, as indicated by waved lines inFIGS.3B &3C, to NHRQI sub-assembly202. In order to maintain a flowable state thereof, QPRCM240is typically supplied to NHRQI sub-assembly202at a temperature exceeding the upper temperature threshold. However, as seen particularly in enlargement circle B ofFIG.2and inFIG.3D, following supply of QPRCM240to NHRQI sub-assembly202, HRQI assembly200is cooled to, and maintained at, a temperature which does not exceed the upper temperature threshold, such that QPRCM240is not flowable, as indicated by interlocking lines in enlargement circle B ofFIG.2and inFIG.3D.

In one embodiment of the present invention, HRCMS190includes at least one cooling system330. Preferably, following a supply of QPRCM240to NHRQI sub-assembly202, HRQI assembly200is brought into thermal contact with cooling system330, thereby rapidly reducing the temperature of HRQI assembly200to a temperature below the upper temperature threshold, so that QPRCM240is not flowable. It is appreciated that cooling system330preferably does not cool HRQI assembly200to a temperature below the lower temperature threshold, and thus cold responsive coloring material254does not change color in response to temperature conditions within cooling system330.

In another embodiment of the present invention, cooling system330may be obviated, and following the supply of QPRCM240to NHRQI sub-assembly202, HRQI assembly200may be cooled to a temperature below the upper temperature threshold, such that QPRCM240is no longer flowable, after being associated with container290. In this embodiment, cooling of HRQI assembly200is preferably effected by thermal contact with container290which, at the time of the association of HRQI assembly200therewith, is at a temperature below the upper temperature threshold. Alternatively, HRQI assembly200may be cooled by placing HQRI assembly200and the associated container290in a cold storage environment, such as a refrigerator. It is appreciated that the temperature of HRQI assembly200and associated container290is preferably not less than the lower temperature threshold, and thus cold responsive coloring material254does not change color in response to temperature conditions of container290at the time of association of HQRI assembly200with container290.

As described hereinabove with reference toFIGS.1A-1E, NHRQI sub-assembly202is preferably embodied as a self-adhesive label, and the association of HRQI assembly200with container290is preferably embodied as an affixation of HRQI assembly200to container290, and more particularly as an adherence of HRQI assembly200to container290. It is noted that the adhesive on the rear side of back portion294of HRQI assembly200preferably serves to affix HRQI assembly200to container290, and that the adhesion of HRQI assembly200to container290preferably serves to seal aperture304, preventing an egress of QPRCM240therefrom.

It is appreciated that in an embodiment wherein QPRCM240is supplied to NHRQI sub-assembly202after associating NHRQI sub-assembly202with container290, cooling system330is typically not included in HRCMS190. Instead, HRQI assembly200is cooled only after being associated with container290. Similarly, in such an embodiment, if an aperture is included on a front or a side surface of NHRQI sub-assembly202, the aperture may be sealed with a suitable sealant, preventing an egress of QPRCM240therefrom.

As illustrated inFIGS.3A &3B, in one embodiment of the present invention, NHRQI sub-assembly202is not yet associated with container290. Similarly, as illustrated inFIG.3C, immediately after the supply of QPRCM240to HRQI assembly200, HRQI assembly200is preferably still not associated with container290.

As illustrated inFIG.2, in one embodiment of the present invention, HRQI assembly200is cooled to a temperature below the upper temperature threshold before being associated with container290, preferably by cooling system330. In an alternative embodiment, HRQI assembly200may be cooled by placing HQRI assembly200and associated container290in a cold storage environment, such as a refrigerator. Thus, the lowering of the temperature of QPRCM240and the association of HRQI assembly200with container290are separate steps.

However, in another embodiment of the present invention, as illustrated inFIG.3D, HRQI assembly200is cooled to a temperature below the upper temperature threshold only after being associated with container290. As described hereinabove, in this embodiment, cooling of HRQI assembly200is preferably effected by thermal contact with container290which, at the time of the association of HRQI assembly200therewith, is at a temperature below the upper temperature threshold. Thus, the lowering of the temperature of QPRCM240and the association of HRQI assembly200with container290are achieved in a single step.

In a preferred embodiment of the present invention, HRCMS190further includes a barcode reader340, which preferably reads barcodes258substantially immediately prior to an association of HRQI assembly200or NHQRI sub-assembly202with container290. Barcode reader340, upon reading barcodes258, preferably provides information to a quality indication computer, such as quality indication computer115, which enables the quality indication computer to provide an immediate indication of a quality status of the HRQI assembly200or NHQRI sub-assembly202read by barcode reader340.

If barcode reader340provides an indication that an HRQI assembly200, or in an undesirable case wherein QPRCM240was not supplied to an NHRQI sub-assembly202, an NHRQI sub-assembly202, is unfit for use, then the HRQI assembly200or NHRQI sub-assembly202is preferably discarded and is not associated with a container290. Examples of an HRQI assembly200or NHRQI sub-assembly202that is unfit for use include an HRQI assembly200or NHRQI sub-assembly202that is in pre-supply visible state I, that is in visible state V, or that is unreadable by a typical barcode reader, for example, due to damage to barcodes258.

In another preferred embodiment of the present invention (not shown) barcode reader340is obviated, and is replaced with a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, which is not part of HRCMS190.

In a preferred embodiment of the present invention, HRCMS190further includes a container association module360. If an indication is provided, for example by barcode reader340or barcode reader113, that an HRQI assembly200is fit for use, then container association module360preferably associates that HRQI assembly200with a container290. In a preferred embodiment of the present invention, container association module360positions HRQI assembly200relative to container290such that the adhesive on the rear side of HRQI assembly200contacts container290, thereby affixing HRQI assembly200to container290.

In the embodiment illustrated inFIG.2, barcode reader340is shown as being part of container association module360. Alternatively, barcode reader340may be separate from container association module360.

Reference is now made toFIGS.4A-4D, which are simplified illustrations of typical operative use cases of HRQI assembly200.

It is appreciated that in the operative states shown inFIGS.4A-4C, HRQI assembly200has not been exposed to a temperature below the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material254is preferably characterized by the first color thereof, for example colorless and transparent, and area252does not interfere with the readability of any of barcodes260,262,264and266, while the first color of area252preferably prevents barcode268from being read.

It is further appreciated that although, for ease of understanding, dotted lines inFIGS.4A-4Dindicate each of transparent areas248and portions280,282and284, preferably transparent areas248and portions280,282and284are not readily distinguishable from surrounding areas of indicator template212and coloring material diffuser220, respectively. Similarly, for ease of understanding, dashed lines inFIGS.4A-4Dindicate area252; however, area252may not be readily distinguishable from surrounding areas of indicator template212.

Following the supply of QPRCM240to NHRQI sub-assembly202and when a temperature of HRQI assembly200exceeds the upper temperature threshold, QPRCM240assumes a flowable state, as indicated by waved lines inFIG.4A. In an embodiment wherein HRQI assembly200includes coloring material reservoir210, upon assuming a flowable state, QPRCM240is released from coloring material reservoir210and begins to diffuse through coloring material diffuser220. In an embodiment wherein HRQI assembly200does not include coloring material reservoir210, upon assuming a flowable state, QPRCM240begins to diffuse through coloring material diffuser220.

It is also appreciated that the respective first and second over-temperature cumulative time durations from the start of diffusion of QPRCM240along coloring material diffuser220until each of portions282and284of coloring material diffuser220become colored is defined, for example, by a length of coloring material diffuser220between portion280and each of portions282and284. Additionally, these time durations are typically a function of a composition of QPRCM240, as well as a function of a material from which coloring material diffuser220is made and a thickness thereof. For example, properties of QPRCM240, coloring material diffuser220, and transparent areas272and274, such as composition and position thereof, are chosen such that that the respective first and second over-temperature cumulative time durations from the start of diffusion of QPRCM240along coloring material diffuser220until QPRCM240colors portions282and284of coloring material diffuser220, which are visible through respective transparent areas272and274, is one hour and four hours, respectively. However, it is appreciated that properties of QPRCM240and coloring material diffuser220, as well as locations of transparent areas272and274, may be chosen such that each of the first and second over-temperature cumulative time durations, from the start of diffusion of QPRCM240along coloring material diffuser220until QPRCM240colors portions282and284of coloring material diffuser220, which are visible through respective transparent areas272and274, may be any suitable respective time duration.

Typically, the first and second over-temperature cumulative time durations, as well as the upper and lower temperature thresholds, are chosen based on the requirements of contents of container290. For example, an HRQI assembly200for association with a flu vaccine may have a lower temperature limit of 2 degrees Celsius, while an HRQI assembly200for association with a COVID-19 vaccine may have a lower temperature limit of −70 degrees Celsius. Similarly, an HRQI assembly200for association with a package of frozen meat may have respective first and second over-temperature cumulative time durations of one and four hours, while an HRQI assembly200for association with a package of fresh meat may have respective first and second over-temperature cumulative time durations of 30 minutes and one hour.

Turning particularly toFIG.4A, it is seen that when a temperature of container290, and of HRQI assembly200associated therewith, exceeds the upper temperature threshold for less than the first over-temperature cumulative time duration, QPRCM240begins to diffuse through coloring material diffuser220beyond portion280in a direction toward portion282. However, as long as a temperature of container290and of HRQI assembly200associated therewith does not exceed the upper temperature threshold for at least the first over-temperature cumulative time duration, QPRCM240preferably does not color portion282.

Thus, as long as a temperature of container290and of HRQI assembly200associated therewith does not exceed the upper temperature threshold for at least the first over-temperature cumulative time duration, neither portion282nor portion284of coloring material diffuser220become colored, and thus neither transparent area272nor transparent area274appear colored, and HRQI assembly200remains in visible state II, in which preferably only barcode262is in a readable state.

In contrast, as seen particularly toFIG.4B, when a temperature of container290and of HRQI assembly200associated therewith exceeds the upper temperature threshold for at least the first over-temperature cumulative time duration, QPRCM240diffuses through portions of coloring material diffuser220, including portion282.

Thus, when a temperature of container290and of HRQI assembly200associated therewith exceeds the upper temperature threshold for at least the first over-temperature cumulative time duration, the color visible through transparent area272is determined by the color of QPRCM240. As seen particularly inFIG.4B, upon a coloring of portion282by black QPRCM240, transparent area272shows a black color, and HRQI assembly200thus preferably assumes visible state III.

It is appreciated that the coloring of portion282by QPRCM240, and thus the changing of the color visible through transparent area272, changes an appearance of HRQI assembly200, and more particularly, changes an appearance of barcode262and of barcode264.

In visible state III, transparent areas270and272show a color similar to the color of bars of barcodes258, while transparent area274remains uncolored. Therefore, barcodes260,262and266are preferably unreadable by a conventional barcode reader, while barcode264is readable by a conventional barcode reader. Additionally, in visible state III, HRQI assembly200has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material254is preferably characterized by the first color thereof, for example colorless and transparent, and area252does not interfere with the readability of any of barcodes260,262,264and266, while the first color of area252preferably prevents barcode268from being read. Thus, HRQI assembly200in visible state III presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode264having numerical sequence 7290003804122.

It is appreciated that once HRQI assembly200assumes visible state III, HRQI assembly200preferably cannot thereafter revert to either of states I or II, notwithstanding that the temperature of HRQI assembly200and associated container290subsequently drops below the upper temperature threshold.

It is additionally appreciated that once having been supplied to NHRQI sub-assembly202, QPRCM240is operative to assume a non-flowable state upon HRQI assembly200being exposed to a temperature below the upper temperature threshold, regardless of a visible state then displayed by HRQI assembly200. Similarly, once having been supplied to NHRQI sub-assembly202, QPRCM240is operative to assume a flowable state upon HRQI assembly200being exposed to a temperature exceeding the upper temperature threshold, regardless of a visible state then displayed by HRQI assembly200.

Turning now particularly toFIG.4C, it is seen that following an elapse of an additional time duration at a temperature exceeding the upper temperature threshold, such that the total cumulative elapsed time is at least the second over-temperature cumulative time duration, QPRCM240diffuses further through coloring material diffuser220, including through portion284.

Thus, when a temperature of container290and of HRQI assembly200associated therewith exceeds the upper temperature threshold for at least the second over-temperature cumulative time duration, the color visible through transparent area274is determined by the color of QPRCM240. As seen particularly inFIG.4C, upon a coloring of portion284by black QPRCM240, transparent area274shows a black color, and HRQI assembly200thus preferably assumes visible state IV.

It is appreciated that the coloring of portion284by QPRCM240, and thus the changing of the color visible through transparent area274, changes an appearance of HRQI assembly200, and more particularly, changes an appearance of barcode264and of barcode266.

In visible state IV, each of transparent areas270,272and274shows a color similar to the color of bars of barcodes258. Therefore, barcodes260,262and264are preferably unreadable by a conventional barcode reader, while barcode266is readable by a conventional barcode reader. Additionally, in visible state IV, HRQI assembly200has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material254is preferably characterized by the first color thereof, for example colorless and transparent, and area252does not interfere with the readability of any of barcodes260,262,264and266, while the first color of area252preferably prevents barcode268from being read. Thus, upon exposure of container290and of HRQI assembly200associated thereto to a temperature exceeding the upper temperature threshold for at least the second over-temperature cumulative time duration, HRQI assembly200assumes visible state IV. In visible state IV, HRQI assembly200preferably presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode266having numerical sequence 7290003804115.

It is appreciated that once HRQI assembly200has assumed visible state IV, HRQI assembly200preferably cannot thereafter revert to any of states I, II and III, notwithstanding that the temperature of HRQI assembly200and associated container290subsequently drops below the upper temperature threshold.

Turning now particularly toFIG.4D, it is seen that when a temperature of container290and of HRQI assembly200associated therewith falls below the lower temperature threshold for at least the under-temperature time duration, cold responsive coloring material254irreversibly assumes the second color, and HRQI assembly200assumes visible state V.

It is appreciated that the assumption of the second color by cold responsive coloring material254changes an appearance of HRQI assembly200, and more particularly, changes an appearance of barcodes260,262,264,266and268.

It is appreciated that once cold responsive coloring material254assumes the second color, area252preferably prevents any of barcodes260,262,264and266from being read, while the second color of area252preferably allows barcode268to be read. It is appreciated that in visible state V, transparent areas248may show any color, since the second color of cold responsive coloring material254in area252preferably prevents barcodes260,262,264and266from being read regardless of a color visible through any of transparent areas248.

Thus, upon exposure of container290and of HRQI assembly200associated therewith to a temperature below the lower temperature threshold for at least the under-temperature time duration, HRQI assembly200assumes visible state V. In visible state V, HRQI assembly200preferably presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode268having numerical sequence 7290003804139.

It is appreciated that once HRQI assembly200assumes visible state V, HRQI assembly200preferably cannot thereafter revert to any of states I, II, III and IV, notwithstanding that the temperature of HRQI assembly200and associated container290subsequently exceeds the lower temperature threshold, or even the upper temperature threshold.

It is noted that while it is typically undesirable to associate container290to NHRQI sub-assembly202to which QPRCM240has not been supplied, in the illustrated embodiment of the present invention, NHRQI sub-assembly202without QPRCM240may be operative to assume visible state V.

Reference is now made toFIG.5, which is a simplified illustration of a heat responsive coloring material supplier (HRCMS)490, which is an example of one or both of HRCMSs102and107ofFIGS.1A-1E, and toFIGS.6A-6D, which together are a simplified illustration of a preferred method of construction of a heat responsive quality indicator (HRQI)500, which is an embodiment of one or both of HRQI assemblies100and105ofFIGS.1A-1E.

HRQI assembly500preferably includes a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly502including at least one coloring material reservoir510, at least one indicator template512and at least one coloring material diffuser520. HRQI assembly500preferably additionally includes a quality parameter responsive coloring material (QPRCM)540. In a preferred embodiment of the present invention, QPRCM540is a HRCM, which is flowable at a temperature exceeding an upper temperature threshold, as indicated by waved lines in corresponding figures.

QPRCM540is characterized by a viscosity and a melting point such that QPRCM540is flowable through or on coloring material diffuser520at temperatures above an upper temperature threshold and is not flowable through or on coloring material diffuser520at temperatures below the upper temperature threshold. Additionally, QPRCM540is preferably characterized by a color that is readily distinguishable from a color of coloring material diffuser520.

QPRCM540, when supplied to coloring material diffuser520of NHRQI sub-assembly502, preferably converts NHRQI sub-assembly502to HRQI assembly500, which is responsive to changes in temperature over time in exceedance of the upper temperature threshold, for changing an appearance of HRQI assembly500. Thus, HRQI assembly500is formed by supplying QPRCM540to NHRQI sub-assembly502, preferably by injecting QPRCM540into NHRQI sub-assembly502.

When QPRCM540is flowable, QPRCM540preferably diffuses through coloring material diffuser520. Conversely, when QPRCM540is not flowable, QPRCM540preferably does not diffuse through coloring material diffuser520. Preferably, HRQI assembly500includes a quantity of QPRCM540sufficient to saturate the entirety or nearly the entirety of coloring material diffuser520following an exposure of HRQI assembly500to the upper temperature threshold for a predetermined cumulative time duration.

It is further appreciated that QPRCM540may additionally or alternatively be embodied as a coloring material that is responsive to at least one alternative or additional quality parameter, including, inter alia, moisture, force, pressure, pH and elapsed time. In such a case, HRQI assembly500is preferably embodied as at least, inter alia, a moisture responsive quality indicator, a force responsive quality indicator, a pressure responsive quality indicator, a pH responsive quality indicator and an elapsed time responsive quality indicator, respectively.

In one embodiment of the present invention, (not shown), QPRCM540is supplied directly to coloring material diffuser520. In such an embodiment, coloring material reservoir510may be obviated.

In another embodiment of the present invention, as seen particularly inFIGS.5-6D, QPRCM540is supplied indirectly to coloring material diffuser520. In such an embodiment, QPRCM540is preferably supplied to coloring material reservoir510, and coloring material reservoir510supplies QPRCM540to coloring material diffuser520.

In a preferred embodiment of the present invention, coloring material diffuser520is embodied as filter paper, such as Whatman No. 3 filter paper commercially available from Whatman International [CAT #: 1003917]. Additionally, coloring material reservoir510is preferably embodied as a pad, for example, K-R; 210/34/28, commercially available from Noam-Urim of Kibbutz Urim, Israel, and QPRCM540is preferably embodied as a coloring agent, such as Sudan Black, a black color dye [CAS: 4197-25-5], combined at a ratio of 1.4 grams per 1 kilogram in Decyl Decanoate [CAS: 1654-86-0].

Preferably, indicator template512includes a transparent substrate on which is formed non-transparent printing. In a preferred embodiment of the present invention, all areas on the transparent substrate which are desired to be opaque, including both a background and areas in which features will be printed, are printed with white ink, and a plurality of features, such as bars forming part of barcodes corresponding to barcodes110or111ofFIGS.1A-1E, are preferably printed with black ink over the white ink as desired.

In another embodiment of the present invention, a background area of indicator template512is printed with white ink; however, the white ink is not deposited in the areas in which the plurality of features are formed, and the plurality of features are preferably printed with black ink.

More generally, in all embodiments of the present invention, the background area of indicator template512and the plurality of features of indicator template512are printed in such colors as to define high contrast therebetween.

Indicator template512preferably further includes at least one transparent area548, indicated by dotted lines inFIGS.6A-6D. It is appreciated that the dotted lines indicating transparent area or areas548are drawn for ease of understanding, and preferably transparent area or areas548are not readily distinguishable from surrounding areas of indicator template512. In a preferred embodiment of the present invention, transparent area or areas548are not printed, i.e., preferably no material is deposited on transparent area or areas548. For the purposes of the present specification and claims, the term “transparent area” is defined so as to include within its scope areas that are either transparent or translucent.

Preferably, coloring material diffuser520is visible through the entirety of each of transparent areas548. Thus, a color visible in each of transparent areas548is determined by a color of a portion of coloring material diffuser520located therebehind. In a preferred embodiment of the present invention, each of transparent areas548is initially white in color, and assumes a black color upon a coloring of coloring material diffuser520by QPRCM540.

In a preferred embodiment of the present invention, indicator template512additionally includes at least one area552upon which is deposited a cold responsive coloring material554, such as a thermochromic coloring material, such as irreversible thermochromic ink commercially available from CTI Technology, Colorado Springs, USA. Alternatively, area552and cold responsive coloring material554may be embodied as a commercially available cold responsive label, such as a Model 54000 Freeze Check™ temperature indicator commercially available from DeltaTrak Inc., Pleasanton, USA. It is appreciated that although, for ease of understanding, dashed lines inFIGS.6A-6Dindicate area552, preferably area552is not readily distinguishable from surrounding areas of indicator template512.

It is appreciated that as used herein, “cold responsive” is used to indicate an element or system that changes as a result of cold, wherein “cold” is used to indicate a temperature below a lower temperature threshold, such as a temperature at which cold responsive coloring material554typically changes color.

In a preferred embodiment of the present invention, cold responsive coloring material554is initially characterized by a first color, and irreversibly assumes a second color, which is different from the first color, upon exposure to a temperature below a lower temperature threshold, for example, below 2 degrees Celsius, for an under-temperature time duration. As described hereinabove, in one embodiment of the present invention, the under-temperature time duration is very short, preferably less than 60 seconds, more preferably less than 30 seconds, more preferably less than 15 seconds, even more preferably less than 10 seconds and most preferably less than 5 seconds. In another embodiment of the present invention, the under-temperature time duration is relatively long, and may be, for example, 5 minutes, 10 minutes, 20 minutes, 30 minutes or 45 minutes.

Thus, if the under-temperature time duration is very short, then cold responsive coloring material554preferably assumes the second color substantially immediately upon being exposed to a temperature below the lower temperature threshold. In contrast, if the under-temperature time duration is relatively long, for example 30 minutes, then cold responsive coloring material554assumes the second color only upon an exposure to a temperature less than the lower temperature threshold for at least 30 minutes.

It is appreciated that the first color and the second color assumed by cold responsive coloring material554may be any suitable colors which are discernable from one another. In one embodiment of the present invention, the first and second colors are readily discernable from one another by a human. Additionally or alternatively, the first and second colors are readily discernable from one another by a machine. For example, in one embodiment of the present invention, cold responsive coloring material554characterized by the first color is colorless and transparent, and cold responsive coloring material554characterized by the second color is blue. In another embodiment of the present invention, cold responsive coloring material554characterized by the first color is green, and cold responsive coloring material554characterized by the second color is colorless and transparent.

It is appreciated that while the embodiment illustrated inFIGS.5-6Dincludes cold responsive coloring material554, in another embodiment of the present invention, HRQI assembly500does not include cold responsive coloring material554.

In the example illustrated inFIGS.5-6D, indicator templates512includes a plurality of barcodes558, such as barcodes110or111, including a first barcode560, a second barcode562, a third barcode564, a fourth barcode566and a fifth barcode568, which are preferably different from each other and arranged in a stacked arrangement. As indicated by dotted lines, formed within barcodes558are transparent areas548, including a transparent area570, a transparent area572, a transparent area574and a transparent area576. In the example illustrated inFIGS.5-6D, indicator templates512further includes human sensible indicia, including area552and a transparent area578.

It is appreciated that human sensible indica corresponding to at least one of area552and transparent area578may also be included in the embodiment described hereinabove with reference toFIGS.2-4D.

As described hereinabove, coloring material diffuser520is preferably visible through the entirety of each of transparent areas548. More particularly, a portion580of coloring material diffuser520is preferably visible through transparent area570, a portion582of coloring material diffuser520is preferably visible through transparent area572, a portion584of coloring material diffuser520is preferably visible through transparent area574and a portion586of coloring material diffuser520is preferably visible through transparent areas576and578. Thus, it is appreciated that a color visible in each of transparent areas570,572,574and576is determined by a color of each of portions580,582,584and586, respectively, and that a color visible in transparent area578is determined by a color of portion586. It is appreciated that although, for ease of understanding, dotted lines inFIGS.6A-6Dindicate each of portions580,582,584and586, preferably portions580,582,584, and586are not readily distinguishable from surrounding areas of coloring material diffuser520.

Preferably, each of transparent areas570,572,574and576is formed within at least two of barcodes558and forms a readable portion thereof. In the illustrated embodiment ofFIGS.6A-7E, transparent area570forms part of barcodes560and562, transparent area572forms part of barcodes562and564, transparent area574forms part of barcodes564and566and transparent area576forms part of barcodes566and568. Each of transparent areas548preferably has the same width as a single barcode bar. Alternatively, the width of any of the transparent areas570,572,574and576may be different from the width of a single barcode bar. Additionally, the width of the portion of a transparent area548which forms part of one of barcodes558may be different from the width of the portion of the same transparent area548which forms part of another of barcodes558.

It is appreciated that barcodes560,562,564,566and568may be arranged in any suitable order with respect to one another. Similarly, transparent areas570,572,574and576may be arranged in any suitable order with respect to one another. Furthermore, it is appreciated that at least one of barcodes560,562,564,566and568and/or transparent areas570,572,574,576and578may be obviated from indicator template512and HRQI assembly500. Similarly, one or more additional barcodes and/or transparent areas may be added to indicator template512and HRQI assembly500.

In a preferred embodiment of the present invention, a different single one of barcodes558is machine-readable at each of visible states I, II, III, IIIa, and IV. For example, in the example illustrated inFIGS.5-6D, barcode560is read as 7290003804191 at pre-supply visible state I, barcode562is read as 7290003804108 at post-supply visible state II, barcode564is read as 7290003804122 in visible state III, barcode566is read as 7290003804115 in a visible state IIIa and barcode568is read as 7290003804139 in visible state IV. Preferably, each of barcodes558is machine-readable only in the single one of visible states I, II, III, IIIa and IV listed above.

As seen particularly inFIGS.6A-6D, when coloring material diffuser520is in an uncolored state, meaning that QPRCM540has not been supplied to coloring material diffuser520, coloring material diffuser520causes each of transparent areas570,572,574,576and578to appear white in color. The white appearance of transparent area570preferably allows barcode560to be machine-readable, while the white appearance of transparent areas570,572,574and576preferably causes barcodes562,564,566and568to be non-machine-readable. Thus, when coloring material diffuser520is in an uncolored state and NHRQI sub-assembly502has not been exposed to a temperature less than the lower temperature threshold, NHRQI sub-assembly502is preferably in pre-supply visible state I, wherein only barcode560is in a machine-readable state.

Additionally, as long as NHRQI sub-assembly502has not been exposed to a temperature less than the lower temperature threshold, cold responsive coloring material554is preferably characterized by the first color thereof, for example colorless and transparent, and area552provides an indication that a temperature of NHRQI sub-assembly502has not fallen below the lower temperature threshold.

In the embodiment illustrated inFIGS.5-6D, area552and cold responsive coloring material554thereon preferably provide a human sensible indication of whether or not a temperature of NHRQI sub-assembly502has fallen below the lower temperature threshold for the under-temperature time duration. In a preferred embodiment of the present invention, NHRQI sub-assembly502includes explanatory features, such as text and/or graphics, explaining at least one visible appearance of area552. For example, in the illustrated embodiment, NHRQI sub-assembly502includes a message588“DISCARD IF DARKENED→” adjacent to area552, thereby indicating to a user that if cold responsive coloring material554is characterized by the first color thereof, a temperature of NHRQI sub-assembly502has not fallen below the lower temperature threshold for the under-temperature time duration, but if cold responsive coloring material554is characterized by the second color thereof, a temperature of NHRQI sub-assembly502has fallen below the lower temperature threshold for the under-temperature time duration.

Typically, if QPRCM540has not yet been supplied to NHRQI sub-assembly502, a characterization of cold responsive coloring material554by the second color thereof indicates to a user that NHRQI sub-assembly502should not be associated with a product package and should be discarded. Similarly, if QPRCM540has been supplied to NHRQI sub-assembly502, thus forming HRQI assembly500, and HRQI assembly500has been associated with a product package, a characterization of cold responsive coloring material554by the second color thereof indicates to a user that the product package with which HRQI assembly500is associated should be discarded.

It is appreciated that in the embodiment illustrated inFIGS.5-6D, area552and cold responsive coloring material554thereon preferably additionally provide a machine-sensible indication of whether or not a temperature of NHRQI sub-assembly502has fallen below the lower temperature threshold for the under-temperature time duration. Preferably, a system such as a suitably programmed machine vision system is operative to assess a color visible in area552and provide a suitable indication based thereon.

As seen inFIG.6A, a container590, such as, inter alia, package101or carton106, is ready to be associated with an HRQI assembly500. It is appreciated that container590is typically a product package, and may be embodied as, inter alia, an individual product package, a box of product packages, a pallet of product packages or a shipping container of product packages. In a preferred embodiment of the present invention, a type of container590with which an HRQI assembly500is associated, and more particularly a number of individual products contained by the container590associated with HRQI assembly500, is at least partially determined by a relationship between a cost of monitoring container590, a temperature-sensitivity of a product within container590and a financial value of a product within container590.

Preferably, as further seen inFIG.6A, QPRCM540has not yet been supplied to NHRQI sub-assembly502, and therefore NHRQI sub-assembly502is preferably not yet associated with container590. As described hereinabove, prior to a supply of QPRCM540to NHRQI sub-assembly502, NHRQI sub-assembly502has not been exposed to a temperature less than the lower temperature threshold and is preferably in pre-supply visible state I.

Preferably, in visible state I, barcode560is typically readable by a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, and barcodes562,564,566and568are preferably not readable by a barcode reader. Thus, the NHRQI sub-assembly502is in pre-supply visible state I and presents a single machine-readable barcode560, typically readable by a conventional barcode reader as 7290003804191.

NHRQI sub-assembly502is preferably embodied as a self-adhesive label. Typically, after fabrication of NHRQI sub-assemblies502and before QPRCM540is supplied thereto, NHRQI sub-assemblies502are stored on a roll liner592. NHRQI sub-assembly502includes a back portion594, on a rear side (not shown) of which is preferably an adhesive (not shown). The adhesive preferably serves to affix NHRQI sub-assembly502to roll liner592. Typically, following the production of HRQI assembly500, the adhesive on NHRQI sub-assembly502is also used to affix HRQI assembly500to container590.

As seen particularly inFIGS.5and6B, HRCMS490preferably includes a coloring material supplier598, such as injection module104ofFIG.1A, which includes at least one injector602, such as a needle assembly. In a preferred embodiment of the present invention, coloring material supplier598includes a heating assembly603, such as a resistive heating assembly. If an ambient temperature of coloring material supplier598is below the upper temperature threshold of QPRCM540while coloring material supplier598supplies QPRCM540to NHRQI sub-assembly502, heating assembly603provides heat to QPRCM540during the supply thereof to NHRQI sub-assembly502, thereby maintaining QPRCM540at a temperature at which QPRCM540is flowable during the supply thereof to NHRQI sub-assembly502.

Typically, coloring material supplier598supplies QPRCM540to NHRQI sub-assembly502while NHRQI sub-assembly502is affixed to roll liner592. In the embodiment shown inFIGS.5-6D, coloring material supplier598supplies QPRCM540to coloring material reservoir510, and coloring material reservoir510then supplies QPRCM540to coloring material diffuser520. In another embodiment of the present invention, coloring material supplier598supplies QPRCM540directly to coloring material diffuser520, and coloring material reservoir510may be obviated.

In a preferred embodiment of the present invention, QPRCM540is supplied to NHRQI sub-assembly502immediately prior to the association of HRQI assembly500with container590. In other words, QPRCM540is preferably supplied to NHRQI sub-assemblies502as NHRQI sub-assemblies502are being positioned for imminent association with containers590. Thus, in the illustrated embodiment shown inFIG.5, as roll liner592is unspooled to make NHRQI sub-assemblies502available for affixation to containers590, QPRCM540is supplied to NHRQI sub-assemblies502.

Preferably, an aperture604is formed in back portion594of NHRQI sub-assembly502. As seen particularly inFIG.6B, QPRCM540is preferably supplied by injector602to NHRQI sub-assembly502through aperture604. In the illustrated embodiment of the present invention, aperture604enables fluid communication between injector602and coloring material reservoir510, which in turn is in fluid communication with coloring material diffuser520. In another embodiment of the present invention, in which coloring material reservoir510may be obviated, aperture604enables fluid communication directly between injector602and coloring material diffuser520.

Preferably, a plurality of apertures614are formed on roll liner592, and each of apertures614is generally aligned with one of apertures604. It is appreciated that apertures604and614may be formed either during respective fabrications of NHRQI sub-assembly502and roll liner592, or as part of the supply of QPRCM540to NHRQI sub-assembly502. Alternatively, one of plurality of apertures604and614may be formed during a respective fabrication of NHRQI sub-assembly502and roll liner592, and the other of plurality of apertures604and614may be formed as part of the supply of QPRCM540to NHRQI sub-assembly502. Typically, in an embodiment wherein at least one of plurality of apertures604and614is formed as part of the supply of QPRCM540to NHRQI sub-assembly502, the at least one of plurality of apertures604and614is formed by injector602.

As described above, in the embodiment illustrated inFIGS.5and6B, QPRCM540is supplied to NHRQI sub-assembly502via aperture604shown on back portion594of NHRQI sub-assembly502prior to, preferably immediately prior to, associating HRQI assembly500with container590. In an alternative embodiment of the present invention, QPRCM540is supplied to NHRQI sub-assembly502after associating NHRQI sub-assembly502with container590. In an embodiment wherein the supply of QPRCM540to NHRQI sub-assembly502occurs after associating NHRQI sub-assembly502with container590, coloring material supplier598and apertures614may be obviated, and aperture604may be obviated or located elsewhere on NHRQI sub-assembly502.

In an embodiment wherein QPRCM540is supplied to NHRQI sub-assembly502following the association of NHRQI sub-assembly502with container590, for example, an injector may supply QPRCM540to NHRQI sub-assembly502through an aperture formed in a front surface or a side surface of NHRQI sub-assembly502.

In a preferred embodiment of the present invention, HRQI assembly500also includes explanatory features, such as text and/or graphics, explaining at least one visible appearance of transparent area578. For example, in the illustrated embodiment, HRQI assembly500includes a message628, with the text “DISCARD IF DARKENED→”, adjacent to transparent area578.

Turning now particularly toFIG.6C, it is seen that immediately following a supply of QPRCM540to NHRQI sub-assembly502, portion580of coloring material diffuser520preferably becomes colored with QPRCM540, and thus the color visible through transparent area570is determined by the color of QPRCM540. In the example shown inFIGS.5-6D, as seen particularly inFIG.6C, immediately following a supply of QPRCM540to NHRQI sub-assembly502, transparent area570shows a black color, and HRQI assembly500thus preferably assumes post-supply visible state II immediately following a supply of QPRCM540to NHRQI sub-assembly502.

It is appreciated that the coloring of portion580by QPRCM540, and thus the changing of the color visible through transparent area570, changes an appearance of HRQI assembly500, and more particularly, changes an appearance of barcode560and of barcode562.

In post-supply visible state II, transparent area570shows a color similar to the color of bars of barcodes558, while transparent areas572,574,576and578remain uncolored. Therefore, barcodes560,564,566and568are preferably unreadable by a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, and only barcode562is readable by a conventional barcode reader. Thus, HRQI assembly500in post-supply visible state II presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode562having numerical sequence 7290003804108. Additionally, at post-supply visible state II, HRQI assembly500has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material554is preferably characterized by the first color thereof, for example colorless and transparent, such that area552provides an indication that a temperature of NHRQI sub-assembly502, and thus a temperature of HRQI assembly500, has not fallen below the lower temperature threshold.

It is appreciated that once HQRI assembly500assumes visible state II, HRQI assembly500preferably cannot thereafter revert to visible state I.

Preferably, QPRCM540is supplied in a flowable state, as indicated by waved lines inFIGS.6B &6C, to NHRQI sub-assembly502. In order to maintain a flowable state thereof, QPRCM540is typically supplied to NHRQI sub-assembly502at a temperature exceeding the upper temperature threshold. However, as seen particularly in enlargement circle B ofFIG.5and inFIG.6D, following supply of QPRCM540to NHRQI sub-assembly502, HRQI assembly500is cooled to, and maintained at, a temperature which does not exceed the upper temperature threshold, such that QPRCM540is no longer flowable, as indicated by interlocking lines in enlargement circle B ofFIG.5and inFIG.6D.

In one embodiment of the present invention, HRCMS490includes at least one cooling system630. Preferably, following a supply of QPRCM540to NHRQI sub-assembly502, HRQI assembly500is brought into thermal contact with cooling system630, thereby rapidly reducing the temperature of HRQI assembly500to a temperature below the upper temperature threshold, so that QPRCM540is no longer flowable. It is appreciated that cooling system630preferably does not cool HRQI assembly500to a temperature below the lower temperature threshold, and thus cold responsive coloring material554does not change color in response to temperature conditions within cooling system630.

In another embodiment of the present invention, cooling system630may be obviated, and following the supply of QPRCM540to NHRQI sub-assembly502, HRQI assembly500may be cooled to a temperature below the upper temperature threshold, such that QPRCM540is no longer flowable, after being associated with container590. In this embodiment, cooling of HRQI assembly500is preferably effected by thermal contact with container590which, at the time of the association of HRQI assembly500therewith, is at a temperature below the upper temperature threshold. Alternatively, HRQI assembly500may be cooled by placing HQRI assembly500and the associated container590in a cold storage environment, such as a refrigerator. It is appreciated that the temperature of HQRI assembly500and associated container590is preferably not less than the lower temperature threshold, and thus cold responsive coloring material554does not change color in response to temperature conditions of container590at the time of association of HQRI assembly500with container590.

As described hereinabove with reference toFIGS.1A-1E, NHRQI sub-assembly502is preferably embodied as a self-adhesive label, and the association of HRQI assembly500with container590is preferably embodied as an affixation of HRQI assembly500to container590, and more particularly as an adherence of HRQI assembly500to container590. It is noted that the adhesive on the rear side of back portion594of HRQI assembly500preferably serves to affix HRQI assembly500to container590, and that the adhesion of HRQI assembly500to container590preferably serves to seal aperture604, preventing an egress of QPRCM540therefrom.

It is appreciated that in an embodiment wherein QPRCM540is supplied to NHRQI sub-assembly502after associating NHRQI sub-assembly502with container590, cooling system630is typically not included in HRCMS490. Instead, HRQI assembly500is cooled only after being associated with container590. Similarly, in such an embodiment, if an aperture is included on a front or a side surface of NHRQI sub-assembly502, the aperture may be sealed with a suitable sealant, preventing an egress of QPRCM540therefrom.

As illustrated inFIGS.6A &6B, in one embodiment of the present invention, NHRQI sub-assembly502is not yet associated with container590. Similarly, as illustrated inFIG.6C, immediately after the supply of QPRCM540to HRQI assembly500, HRQI assembly500is preferably still not associated with container590.

As illustrated inFIG.5, in one embodiment of the present invention, HRQI assembly500is cooled to a temperature below the upper temperature threshold before being associated with container590, preferably by cooling system630. In an alternative embodiment, HRQI assembly500may be cooled by placing HQRI assembly500and associated container590in a cold storage environment, such as a refrigerator. Thus, the lowering of the temperature of QPRCM540and the association of HRQI assembly500with container590are separate steps.

However, in another embodiment of the present invention, as illustrated inFIG.6D, HRQI assembly500is cooled to a temperature below the upper temperature threshold only after being associated with container590. As described hereinabove, in this embodiment, cooling of HRQI assembly500is preferably effected by thermal contact with container590which, at the time of the association of HRQI assembly500therewith, is at a temperature below the upper temperature threshold. Thus, the lowering of the temperature of QPRCM540and the association of HRQI assembly500with container590are achieved in a single step.

In a preferred embodiment of the present invention, HRCMS490further includes a barcode reader640, which preferably reads barcodes558substantially immediately prior to an association of HRQI assembly500or NHQRI sub-assembly502with container590. Barcode reader640, upon reading barcodes558, preferably provides information to a quality indication computer, such as quality indication computer115, which enables the quality indication computer to provide an immediate indication of a quality status of the HRQI assembly500or NHQRI sub-assembly502read by barcode reader640.

If barcode reader640provides an indication that an HRQI assembly500, or in an undesirable case wherein QPRCM540was not supplied to an NHRQI sub-assembly502, an NHRQI sub-assembly502, is unfit for use, then the HRQI assembly500or NHRQI sub-assembly502is preferably discarded and is not associated with a container590. Examples of an HRQI assembly500or NHRQI sub-assembly502that is unfit for use include an HRQI assembly500or NHRQI sub-assembly502that is in pre-supply visible state I, that is in visible state V, or that is unreadable by a typical barcode reader, for example, due to damage to barcodes558.

In another preferred embodiment of the present invention (not shown) barcode reader640is obviated, and is replaced with a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, which is not part of HRCMS490.

In a preferred embodiment of the present invention, HRCMS490further includes a container association module660. If an indication is provided, for example by barcode reader640or barcode reader113, that an HRQI assembly500is fit for use, then container association module660preferably associates that HRQI assembly500with a container590. In a preferred embodiment of the present invention, container association module660positions HRQI assembly500relative to container590such that the adhesive on the rear side of HRQI assembly500contacts container590, thereby affixing HRQI assembly500to container590.

In the embodiment illustrated inFIG.5, barcode reader640is shown as being part of container association module660. Alternatively, barcode reader640may be separate from container association module660.

Reference is now made toFIGS.7A-7E, which are simplified illustrations of typical operative use cases of HRQI assembly500.

It is appreciated that in the operative states shown inFIGS.7A-7D, HRQI assembly500has not been exposed to a temperature below the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material554is preferably characterized by the first color thereof, for example colorless and transparent.

It is further appreciated that although, for ease of understanding, dotted lines inFIGS.7A-7Eindicate each of transparent areas548and portions580,582,584and586, preferably transparent areas548and portions580,582,584and586are not readily distinguishable from surrounding areas of indicator template512and coloring material diffuser520, respectively. Similarly, for ease of understanding, dashed lines inFIGS.7A-7Eindicate areas552and578; however, areas552and578may not be readily distinguishable from surrounding areas of indicator template512.

Following the supply of QPRCM540to NHRQI sub-assembly502and when a temperature of HRQI assembly500exceeds the upper temperature threshold, QPRCM540assumes a flowable state, as indicated by waved lines inFIG.7A. In an embodiment wherein HRQI assembly500includes coloring material reservoir510, upon assuming a flowable state, QPRCM540is released from coloring material reservoir510and begins to diffuse through coloring material diffuser520. In an embodiment wherein HRQI assembly500does not include coloring material reservoir510, upon assuming a flowable state, QPRCM540begins to diffuse through coloring material diffuser520. It is appreciated that respective first, second and third over-temperature cumulative time durations from the start of diffusion of QPRCM540along coloring material diffuser520until respective portions582,584and586of coloring material diffuser520become colored is defined, for example, by a length of coloring material diffuser520between portion580and each of portions582,584and586. Additionally, these time durations are typically a function of a composition of QPRCM540, as well as a function of a material from which coloring material diffuser520is made and a thickness thereof.

For example, properties of QPRCM540, coloring material diffuser520, and transparent areas572,574,576and578, such as composition and position thereof, may be chosen such that that the respective first, second and third over-temperature cumulative time durations from the start of diffusion of QPRCM540along coloring material diffuser520until QPRCM540colors portions582,584and586of coloring material diffuser520, which are visible through respective transparent areas572,574,576and578is one hour, two hours and four hours, respectively. However, it is appreciated that properties of QPRCM540and coloring material diffuser520, as well as locations of transparent areas572,574,576and578, may be chosen such that each of the first, second and third over-temperature cumulative time durations, from the start of diffusion of QPRCM540along coloring material diffuser520until QPRCM540colors portions582,586, and584of coloring material diffuser520, which are visible through respective transparent areas572,574,576and578, may be any suitable respective time duration.

Typically, the first, second and third over-temperature cumulative time durations, as well as the upper and lower temperature thresholds, are chosen based on the requirements of contents of container590. For example, an HRQI assembly500for association with a flu vaccine may have a lower temperature limit of 2 degrees Celsius, while an HRQI assembly500for association with a COVID-19 vaccine may have a lower temperature limit of −70 degrees Celsius. Similarly, an HRQI assembly500for association with a package of frozen meat may have respective first, second and third over-temperature cumulative time durations of one hour, two hours and four hours, while an HRQI assembly500for association with a package of fresh meat may have respective first, second and third over-temperature cumulative time durations of 30 minutes, 45 minutes and one hour.

Turning particularly toFIG.7A, it is seen that when a temperature of container590, and of HRQI assembly500associated therewith, exceeds the upper temperature threshold for less than the first over-temperature cumulative time duration, QPRCM540begins to diffuse through coloring material diffuser520beyond portion580in a direction toward portion582. However, as long as a temperature of container590and of HRQI assembly500associated therewith does not exceed the upper temperature threshold for at least the first over-temperature cumulative time duration, QPRCM540preferably does not color portion582.

Thus, as long as a temperature of container590and of HRQI assembly500associated therewith does not exceed the upper temperature threshold for at least the first over-temperature cumulative time duration, none of portions582,584and586become colored, and thus none of transparent areas572,574,576and578appear colored, and HRQI assembly500remains in visible state II, in which preferably only barcode562is in a readable state.

In contrast, as seen particularly toFIG.7B, when a temperature of container590and of HRQI assembly500associated therewith exceeds the upper temperature threshold for at least the first over-temperature cumulative time duration, QPRCM540diffuses through portions of coloring material diffuser520, including portion582.

Thus, when a temperature of container590and of HRQI assembly500associated therewith exceeds the upper temperature threshold for at least the first over-temperature cumulative time duration, the color visible through transparent area572is determined by the color of QPRCM540. As seen particularly inFIG.7B, upon a coloring of portion582by black QPRCM540, transparent area572shows a black color, and HRQI assembly500thus preferably assumes visible state III.

It is appreciated that the coloring of portion582by QPRCM540, and thus the changing of the color visible through transparent area572, changes an appearance of HRQI assembly500, and more particularly, changes an appearance of barcode562and of barcode564.

In visible state III, transparent areas570and572show a color similar to the color of bars of barcodes558, while transparent areas574,576and578remain uncolored. Therefore, barcodes560,562,566and568are preferably unreadable by a conventional barcode reader, while barcode564is readable by a conventional barcode reader. Thus, HRQI assembly500in visible state III presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode564having numerical sequence 7290003804122.

Additionally, in visible state III, HRQI assembly500has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material554is preferably characterized by the first color thereof, for example colorless and transparent, and area552provides an indication that a temperature of NHRQI sub-assembly502, and thus a temperature of HRQI assembly500, has not fallen below the lower temperature threshold.

It is appreciated that once HRQI assembly500assumes visible state III, HRQI assembly500preferably cannot thereafter revert to either of states I or II, notwithstanding that the temperature of HRQI assembly500and associated container590subsequently drops below the upper temperature threshold.

It is additionally appreciated that once having been supplied to NHRQI sub-assembly502, QPRCM540is operative to assume a non-flowable state upon HRQI assembly500being exposed to a temperature below the upper temperature threshold, regardless of a visible state then displayed by HRQI assembly500. Similarly, once having been supplied to NHRQI sub-assembly502, QPRCM540is operative to assume a flowable state upon HRQI assembly500being exposed to a temperature exceeding the upper temperature threshold, regardless of a visible state then displayed by HRQI assembly500.

Turning now particularly toFIG.7C, it is seen that following an elapse of an additional time duration at a temperature exceeding the upper temperature threshold, such that the total cumulative elapsed time is at least the second over-temperature cumulative time duration, QPRCM540diffuses further through coloring material diffuser520, including through portion584.

Thus, when a temperature of container590and of HRQI assembly500associated therewith exceeds the upper temperature threshold for at least the second over-temperature cumulative time duration, the color visible through transparent area574is determined by the color of QPRCM540. As seen particularly inFIG.7C, upon a coloring of portion584by black QPRCM540, transparent area574shows a black color, and HRQI assembly500thus preferably assumes visible state IIIa.

It is appreciated that the coloring of portion584by QPRCM540, and thus the changing of the color visible through transparent area574, changes an appearance of HRQI assembly500, and more particularly, changes an appearance of barcode564and of barcode566.

In visible state IIIa, transparent areas570,572and574show a color similar to the color of bars of barcodes558, while transparent areas576and578remain uncolored. Therefore, barcodes560,562,564and568are preferably unreadable by a conventional barcode reader, while barcode566is readable by a conventional barcode reader. Thus, HRQI assembly500in visible state IIIa presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode566having numerical sequence 7290003804115.

Additionally, in visible state IIIa, HRQI assembly500has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material554is preferably characterized by the first color thereof, for example colorless and transparent, and area552provides an indication that a temperature of NHRQI sub-assembly502, and thus a temperature of HRQI assembly500, has not fallen below the lower temperature threshold.

It is appreciated that once HRQI assembly500assumes visible state IIIa, HRQI assembly500preferably cannot thereafter revert to any of states I, II and III, notwithstanding that the temperature of HRQI assembly500and associated container590subsequently drops below the upper temperature threshold.

Turning now particularly toFIG.7D, it is seen that following an elapse of an additional time duration at a temperature exceeding the upper temperature threshold, such that the total cumulative elapsed time is at least the third over-temperature cumulative time duration, QPRCM540diffuses further through coloring material diffuser520, including through portion586.

Thus, when a temperature of container590and of HRQI assembly500associated therewith exceeds the upper temperature threshold for at least the third over-temperature cumulative time duration, the color visible through transparent areas576and578is determined by the color of QPRCM540. As seen particularly inFIG.7D, upon a coloring of portion586by black QPRCM540, transparent areas576and578each show a black color, and HRQI assembly500thus preferably assumes visible state IV.

It is appreciated that the coloring of portion586by QPRCM540, and thus the changing of the color visible through transparent areas576and578, changes an appearance of HRQI assembly500, and more particularly, changes an appearance of barcode566, barcode568, and of the human sensible indicium of transparent area578.

In visible state IV, each of transparent areas570,572,574and576shows a color similar to the color of bars of barcodes558. Therefore, barcodes560,562,564and566are preferably unreadable by a conventional barcode reader, while barcode568is readable by a conventional barcode reader. Thus, upon exposure of container590and of HRQI assembly500associated thereto to a temperature exceeding the upper temperature threshold for at least the third over-temperature cumulative time duration, HRQI assembly500assumes visible state IV. In visible state IV, HRQI assembly500preferably presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode568having numerical sequence 7290003804139.

Additionally, in visible state IV, transparent area578provides a human sensible indication that a temperature of HRQI assembly500has exceeded the upper temperature threshold for the third over-temperature cumulative time duration. As noted above, in a preferred embodiment of the present invention, HRQI assembly500includes explanatory features, such as text and/or graphics, explaining at least one visible appearance of transparent area578. For example, in the illustrated embodiment, HRQI assembly500includes message628, with the text “DISCARD IF DARKENED→”, adjacent to transparent area578. Thus, message628indicates to a user that if a color visible through transparent area578, as determined by a color of portion586of coloring material diffuser520, is similar to a background color of indicator template512, then a temperature of HRQI assembly500has not exceeded the upper temperature threshold for the third over-temperature cumulative time duration. Similarly, message628indicates to a user that if a color visible through transparent area578is not the same as the background color of indicator template512, such as the color of QPRCM540, then a temperature of HRQI assembly500has exceeded the upper temperature threshold for the third over-temperature cumulative time duration and container590with which HRQI assembly500is associated should be discarded.

In a preferred embodiment of the present invention, as described above, if either one or both of areas552and578indicates an unsuitable environment experienced by HRQI assembly500, then the product being monitored by HRQI assembly500is not fit for use. Preferably, information is included with HRQI assembly500, either as instructions separate from HRQI assembly500or as instructions forming part of HRQI assembly500, indicating to a user and/or a machine reading HRQI assembly500that HRQI assembly500is not fit for use if either one or both of areas552and578indicates that HRQI assembly500has experienced an unsuitable environment for an unsuitable amount of time.

It is appreciated that in the embodiment illustrated inFIGS.5-7E, transparent area578preferably additionally provides a machine-sensible indication of whether or not a temperature of HRQI assembly500has exceeded the upper temperature threshold for the third over-temperature cumulative time duration. Preferably, a system such as a suitably programmed machine vision system is operative to assess a color visible in transparent area578and provide a suitable indication based thereon.

Additionally, in visible state IV, HRQI assembly500has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material554is preferably characterized by the first color thereof, for example colorless and transparent, and area552provides an indication that a temperature of NHRQI sub-assembly502, and thus a temperature of HRQI assembly500, has not fallen below the lower temperature threshold.

It is appreciated that once HRQI assembly500assumes visible state IV, HRQI assembly500preferably cannot thereafter revert to any of states I, II, III and IIIa, notwithstanding that the temperature of HRQI assembly500and associated container590subsequently drops below the upper temperature threshold.

Turning now particularly toFIG.7E, it is seen that when a temperature of container590and of HRQI assembly500associated therewith falls below the lower temperature threshold for at least the under-temperature time duration, cold responsive coloring material554irreversibly assumes the second color, and HRQI assembly500assumes visible state V.

It is appreciated that the assumption of the second color by cold responsive coloring material554changes an appearance of HRQI assembly500, and more particularly, changes an appearance of the human sensible indicium of area552. As described hereinabove, cold responsive coloring material554is characterized by the second color thereof, thus providing a human sensible indication that a temperature of NHRQI sub-assembly502, and thus a temperature of HRQI assembly500, has fallen below the lower temperature threshold for the under-temperature time duration and container590with which HRQI assembly500is associated should be discarded.

It is noted that in the embodiment illustrated inFIGS.7A-7E, the color assumed by cold responsive coloring material554does not typically affect an appearance or readability of any of barcodes560,562,564,566and568. Additionally, in visible state V, transparent areas548may show any color, since, regardless of a color visible through any of transparent areas548, the second color of cold responsive coloring material554in area552preferably provides an indication that a temperature of NHRQI sub-assembly502, and thus a temperature of HRQI assembly500, has fallen below the lower temperature threshold for the under-temperature time duration.

As described hereinabove with reference toFIGS.5-6D, area552preferably additionally may provide a machine-sensible indication of whether or not a temperature of NHRQI sub-assembly502, and thus a temperature of HRQI assembly500, has fallen below the lower temperature threshold for the under-temperature time duration. Preferably, a system such as a suitably programmed machine vision system is operative to assess a color visible in area552and provide a suitable indication based thereon. More specifically, in visible state V, cold responsive coloring material554is characterized by the second color thereof, which preferably indicates to the suitably programmed machine vision system that a temperature of NHRQI sub-assembly502, and thus a temperature of HRQI assembly500, has fallen below the lower temperature threshold for the under-temperature time duration.

Thus, upon exposure of container590and of HRQI assembly500associated therewith to a temperature below the lower temperature threshold for at least the under-temperature time duration, HRQI assembly500assumes visible state V, in which a human- and machine-sensible indication is provided that a temperature of NHRQI sub-assembly502, and thus a temperature of HRQI assembly500, has fallen below the lower temperature threshold for the under-temperature time duration.

It is appreciated that once HRQI assembly500assumes visible state V, HRQI assembly500preferably cannot thereafter revert to any of states I, II, III, IIIa and IV, notwithstanding that the temperature of HRQI assembly500and associated container590subsequently exceeds the lower temperature threshold, or even the upper temperature threshold.

It is noted that while it is typically undesirable to associate container590to NHRQI sub-assembly502to which QPRCM540has not been supplied, in the illustrated embodiment of the present invention, NHRQI sub-assembly502without QPRCM540may be operative to assume visible state V when a temperature thereof has fallen below the lower temperature threshold for the under-temperature time duration.

Reference is now made toFIG.8, which is a simplified illustration of a heat responsive coloring material supplier (HRCMS)790, which is an example of one or both of HRCMSs102and107ofFIGS.1A-1E, and toFIGS.9A-9D, which together are a simplified illustration of a preferred method of construction of a heat responsive quality indicator (HRQI)800, which is an embodiment of one or both of HRQI assemblies100and105ofFIGS.1A-1E.

HRQI assembly800preferably includes a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly802including at least a first coloring material reservoir808and a second coloring material reservoir810, at least one indicator template812and at least one coloring material diffuser820.

HRQI assembly800preferably additionally includes a first quality parameter responsive coloring material (QPRCM)840and a second QPRCM842. In a preferred embodiment of the present invention, each of first and second QPRCMs840and842is an HRCM, which is flowable at a temperature exceeding a first and second upper temperature threshold, respectively, as indicated by waved lines in corresponding figures.

First QPRCM840is characterized by a viscosity and melting point such that first QPRCM840is flowable through or on coloring material diffuser820at temperatures above a first upper temperature threshold and is not flowable through or on coloring material diffuser820at temperatures below the first upper temperature threshold. Similarly, second QPRCM842is characterized by a viscosity and melting point such that second QPRCM842is flowable through or on coloring material diffuser820at temperatures above a second upper temperature threshold and is not flowable through or on coloring material diffuser820at temperatures below the second upper temperature threshold. Both first QPRCM840and second QPRCM842are preferably characterized by a color that is readily distinguishable from a color of coloring material diffuser820.

In a preferred embodiment of the present invention, first QPRCM840and second QPRCM842, when supplied to coloring material diffuser820of NHRQI sub-assembly802, preferably convert NHRQI sub-assembly802to HRQI assembly800, which is responsive to changes in temperature over time in exceedance of the first upper temperature threshold and the second upper temperature threshold, for changing an appearance of HRQI assembly800. Thus, HRQI assembly800is formed by supplying first QPRCM840and second QPRCM842to NHRQI sub-assembly802, preferably by injecting first QPRCM840and second QPRCM842into NHRQI sub-assembly802.

When first QPRCM840is flowable, first QPRCM840preferably diffuses through coloring material diffuser820. Conversely, when first QPRCM840is not flowable, first QPRCM840preferably does not diffuse through coloring material diffuser820. Similarly, when second QPRCM842is flowable, second QPRCM842preferably diffuses through coloring material diffuser820. Conversely, when second QPRCM842is not flowable, second QPRCM842preferably does not diffuse through coloring material diffuser820.

It is further appreciated that at least one of first and second QPRCMs840and842may additionally or alternatively be embodied as a coloring material that is responsive to at least one alternative or additional quality parameter, including, inter alia, moisture, force, pressure, pH and elapsed time. In such a case, HRQI assembly800is preferably embodied as at least, inter alia, a moisture responsive quality indicator, a force responsive quality indicator, a pressure responsive quality indicator, a pH responsive quality indicator and an elapsed time responsive quality indicator, respectively.

In one embodiment of the present invention, (not shown), at least one of first QPRCM840and second QPRCM842is supplied directly to coloring material diffuser820. In such an embodiment, at least one of corresponding first coloring material reservoir808and second coloring material reservoir810may be obviated.

In another embodiment of the present invention, as seen particularly inFIGS.8-9D, both first QPRCM840and second QPRCM842are supplied indirectly to coloring material diffuser820. In such an embodiment, first QPRCM840and second QPRCM842are preferably supplied to first coloring material reservoir808and second coloring material reservoir810, respectively, and first coloring material reservoir808supplies first QPRCM840to coloring material diffuser820and second coloring material reservoir810supplies second QPRCM842to coloring material diffuser820.

In a preferred embodiment of the present invention, coloring material diffuser820is embodied as filter paper, such as Whatman No. 3 filter paper commercially available from Whatman International [CAT #: 1003917]. Additionally, first and second coloring material reservoirs808and810are preferably each embodied as a pad, for example, K-R; 210/34/28, commercially available from Noam-Urim of Kibbutz Urim, Israel, first QPRCM840is preferably embodied as a coloring agent, such as Sudan Black, a black color dye [CAS: 4197-25-5], combined at a ratio of 1.4 grams per 1 kilogram in Decyl Decanoate [CAS: 1654-86-0], and second QPRCM842is preferably embodied as a coloring agent, such as Sudan Black, a black color dye [CAS: 4197-25-5], combined at a ratio of 1.4 grams per 1 kilogram in Butyl Stearate [CAS: 123-95-5].

Preferably, indicator template812includes a transparent substrate on which is formed non-transparent printing. In a preferred embodiment of the present invention, all areas on the transparent substrate which are desired to be opaque, including both a background and areas in which features will be printed, are printed with white ink, and a plurality of features, such as bars forming part of barcodes corresponding to barcodes110or111ofFIGS.1A-1E, are preferably printed with black ink over the white ink as desired.

In another embodiment of the present invention, a background area of indicator template812is printed with white ink; however, the white ink is not deposited in the areas in which the plurality of features are formed, and the plurality of features are preferably printed with black ink.

More generally, in all embodiments of the present invention, the background area of indicator template812and the plurality of features of indicator template812are printed in such colors as to define high contrast therebetween.

Indicator template812preferably further includes at least one transparent area848, indicated by dotted lines inFIGS.9A-9D. It is appreciated that the dotted lines indicating transparent area or areas848are drawn for ease of understanding, and preferably transparent area or areas848are not readily distinguishable from surrounding areas of indicator template812. In a preferred embodiment of the present invention, transparent area or areas848are not printed, i.e., preferably no material is deposited on transparent area or areas848. For the purposes of the present specification and claims, the term “transparent area” is defined so as to include within its scope areas that are either transparent or translucent.

Preferably, coloring material diffuser820is visible through the entirety of each of transparent areas848. Thus, a color visible in each of transparent areas848is determined by a color of a portion of coloring material diffuser820located therebehind. In a preferred embodiment of the present invention, each of transparent areas848is initially white in color, and assumes a black color upon a coloring of coloring material diffuser820by either first QPRCM840or second QPRCM842.

In a preferred embodiment of the present invention, indicator template812additionally includes at least one area852upon which is deposited a cold responsive coloring material854, such as a thermochromic coloring material, such as irreversible thermochromic ink commercially available from CTI Technology, Colorado Springs, USA. It is appreciated that although, for ease of understanding, dashed lines inFIGS.9A-9Dindicate area852, preferably area852is not readily distinguishable from surrounding areas of indicator template812.

It is appreciated that as used herein, “cold responsive” is used to indicate an element or system that changes as a result of cold, wherein “cold” is used to indicate a temperature below a lower temperature threshold, such as a temperature at which cold responsive coloring material854typically changes color.

In a preferred embodiment of the present invention, cold responsive coloring material854is initially characterized by a first color, and irreversibly assumes a second color, which is different from the first color, upon exposure to a temperature below a lower temperature threshold for example, below 2 degrees Celsius, for an under-temperature time duration. As described hereinabove, in one embodiment of the present invention, the under-temperature time duration is very short, preferably less than 60 seconds, more preferably less than 30 seconds, more preferably less than 15 seconds, even more preferably less than 10 seconds and most preferably less than 5 seconds. In another embodiment of the present invention, the under-temperature time duration is relatively long, and may be, for example, 5 minutes, 10 minutes, 20 minutes, 30 minutes or 45 minutes.

Thus, if the under-temperature time duration is very short, then cold responsive coloring material854preferably assumes the second color substantially immediately upon being exposed to a temperature below the lower temperature threshold. In contrast, if the under-temperature time duration is relatively long, for example 30 minutes, then cold responsive coloring material854assumes the second color only upon an exposure to a temperature less than the lower temperature threshold for at least 30 minutes.

It is appreciated that the first color and the second color assumed by cold responsive coloring material854may be any suitable colors which are discernable from one another. In one embodiment of the present invention, the first and second colors are readily discernable from one another by a human. Additionally or alternatively, the first and second colors are readily discernable from one another by a machine. For example, in one embodiment of the present invention, cold responsive coloring material854characterized by the first color is colorless and transparent, and cold responsive coloring material854characterized by the second color is blue.

In the example illustrated inFIGS.8-9D, indicator templates812are embodied as a plurality of barcodes858, such as barcodes110or111, including a first barcode860, a second barcode862, a third barcode864, a fourth barcode866and a fifth barcode868, which are preferably different from each other and arranged in a stacked arrangement. As indicated by dotted lines, formed within barcodes858are transparent areas848, including a transparent area870, a transparent area871, a transparent area872and a set of transparent areas874.

As described hereinabove, coloring material diffuser820is preferably visible through the entirety of each of transparent areas848. More particularly, a portion880of coloring material diffuser820is preferably visible through transparent area870, a portion881of coloring material diffuser820is preferably visible through transparent area871, a portion882of coloring material diffuser820is preferably visible through transparent area872and a portion884of coloring material diffuser820is preferably visible through transparent areas874. Thus, it is appreciated that a color visible in each of transparent areas870,871,872and874is determined by a color of each of portions880,881,882and884, respectively. It is appreciated that although, for ease of understanding, dotted lines inFIGS.9A-9Dindicate each of portions880,881,882and884, preferably portions880,881,882and884are not readily distinguishable from surrounding areas of coloring material diffuser820.

Preferably, each of transparent areas870,871,872and874is formed within at least two of barcodes858and forms a readable portion thereof. In the illustrated embodiment ofFIGS.9A-10E, transparent area870forms part of barcodes860and862, transparent area871forms part of barcodes860and862, transparent area872forms part of barcodes862and864, and transparent areas874form part of barcodes862,864and866. Each of transparent areas848preferably has the same width as a single barcode bar. Alternatively, the width of any of the transparent areas870,872and874may be different from the width of a single barcode bar. Additionally, the width of the portion of a transparent area848which forms part of one of barcodes858may be different from the width of the portion of the same transparent area848which forms part of another of barcodes858.

Preferably, all of barcodes858include at least a portion of area852within which is located cold responsive coloring material854, and the at least portion of area852forms a readable portion of barcodes858. Accordingly, area852forms part of each of barcodes860,862,864,866and868. Area852preferably has the same width as a single barcode bar. Alternatively, the width of at least a portion of area852may be different from the width of a single barcode bar.

It is appreciated that barcodes860,862,864,866and868may be arranged in any suitable order with respect to one another. Similarly, transparent areas870,871,872and874may be arranged in any suitable order with respect to one another. Furthermore, it is appreciated that at least one of barcodes860,862,864,866and868and/or transparent areas870,871,872and874may be obviated from indicator template812and HRQI assembly800. Similarly, one or more additional barcodes and/or transparent areas may be added to indicator template812and HRQI assembly800.

In a preferred embodiment of the present invention, a different single one of barcodes858is machine-readable at each of visible states I, II, III, IV and V. For example, in the example illustrated inFIGS.8-9D, barcode860is read as 7290003804191 at pre-supply visible state I, barcode862is read as 7290003804108 at post-supply visible state II, barcode864is read as 7290003804122 in visible state III, barcode866is read as 7290003804115 in visible state IV and barcode868is read as 7290003804139 in visible state V. Preferably, each of barcodes858is machine-readable only in the single one of visible states I, II, III, IV and V, as listed above. In one embodiment of the present invention, at least some of the characters associated with a numeric or alphanumeric code are a quality code.

As seen particularly inFIGS.9A-9D, when coloring material diffuser820is in an uncolored state, meaning that neither first QPRCM840nor second QPRCM842has been supplied to coloring material diffuser820, coloring material diffuser820causes each of transparent areas870,871,872and874to appear white in color. The white appearance of transparent areas870and871preferably allow barcode860to be machine-readable, while the white appearance of transparent areas870,871,872and874preferably causes barcodes862,864and866to be non-machine-readable. Additionally, as long as NHRQI sub-assembly802has not been exposed to a temperature less than the lower temperature threshold, cold responsive coloring material854is preferably characterized by the first color thereof, for example colorless and transparent, and area852does not interfere with the readability of any of barcodes860,862,864and866, while the first color of area852preferably prevents barcode868from being read. Thus, when coloring material diffuser820is in an uncolored state and NHRQI sub-assembly802has not been exposed to a temperature less than the lower temperature threshold, NHRQI sub-assembly802is preferably in pre-supply visible state I, wherein only barcode860is in a machine-readable state.

As seen inFIG.9A, a container890, such as, inter alia, package101or carton106, is ready to be associated with an HRQI assembly800. It is appreciated that container890is typically a product package, and may be embodied as, inter alia, an individual product package, such as a vial, a box of product packages, a pallet of product packages or a shipping container of product packages. In a preferred embodiment of the present invention, a type of container890with which an HRQI assembly800is associated, and more particularly a number of individual products contained by the container890associated with HRQI assembly800, is at least partially determined by a relationship between a cost of monitoring container890, a temperature-sensitivity of a product within container890and a financial value of a product within container890.

Preferably, as further seen inFIG.9A, neither first QPRCM840nor second QPRCM842has yet been supplied to NHRQI sub-assembly802, and therefore NHRQI sub-assembly802is preferably not yet associated with container890. As described hereinabove, prior to a supply of first QPRCM840and second QPRCM842to NHRQI sub-assembly802, NHRQI sub-assembly802has not been exposed to a temperature less than the lower temperature threshold and is preferably in pre-supply visible state I.

Preferably, in visible state I, barcode860is typically readable by a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, and barcodes862,864,866and868are preferably not readable by a barcode reader. Thus, the NHRQI sub-assembly802is in pre-supply visible state I and presents a single machine-readable barcode860, typically readable by a conventional barcode reader as 7290003804191.

NHRQI sub-assembly802is preferably embodied as a self-adhesive label. Typically, after fabrication of NHRQI sub-assemblies802and before first QPRCM840and second QPRCM842are supplied thereto, NHRQI sub-assemblies802are stored on a roll liner892. NHRQI sub-assembly802includes a back portion894, on a rear side (not shown) of which is preferably an adhesive (not shown). The adhesive preferably serves to affix NHRQI sub-assembly802to roll liner892. Typically, following the production of HRQI assembly800, the adhesive on NHRQI sub-assembly802is also used to affix HRQI assembly800to container890.

As seen particularly inFIGS.8and9B, HRCMS790preferably includes a coloring material supplier898, such as injection module104ofFIG.1A, which includes at least a first injector901and a second injector902, such as a first and second needle assembly, respectively. In a preferred embodiment of the present invention, coloring material supplier898includes a heating assembly903, such as a resistive heating assembly. If an ambient temperature of coloring material supplier898is below the first upper temperature threshold of first QPRCM840while coloring material supplier898supplies first QPRCM840to NHRQI sub-assembly802, heating assembly903provides heat to first QPRCM840during the supply thereof to NHRQI sub-assembly802, thereby maintaining first QPRCM840at a temperature at which first QPRCM840is flowable during the supply thereof to NHRQI sub-assembly802. Similarly, if an ambient temperature of coloring material supplier898is below the second upper temperature threshold of second QPRCM842while coloring material supplier898supplies second QPRCM842to NHRQI sub-assembly802, heating assembly903provides heat to second QPRCM842during the supply thereof to NHRQI sub-assembly802, thereby maintaining second QPRCM842at a temperature at which second QPRCM842is flowable during the supply thereof to NHRQI sub-assembly802.

For example, if the first upper temperature threshold of first QPRCM840is 8 degrees Celsius and the second upper temperature threshold of second QPRCM842is 30 degrees Celsius and HRQI assembly800is being assembled in an area having an ambient temperature of 10 degrees Celsius, first QPRCM840is preferably flowable at the ambient temperature, while second QPRCM842is preferably not flowable at the ambient temperature. Therefore, in this example, heating assembly903preferably warms second QPRCM842in coloring material supplier898to a temperature of at least 30 degrees Celsius, thereby maintaining second QPRCM842at a temperature in which second QPRCM842is in a flowable state.

Typically, coloring material supplier898supplies both first and second QPRCMs840and842to NHRQI sub-assembly802while NHRQI sub-assembly802is affixed to roll liner892. In the embodiment shown inFIGS.8-9D, coloring material supplier898supplies first and second QPRCMs840and842to first and second coloring material reservoirs808and810, respectively, and coloring material reservoir808and810then respectively supply first and second QPRCMs840and842to coloring material diffuser820. In another embodiment of the present invention, coloring material supplier898supplies at least one of first and second QPRCMs840and842directly to coloring material diffuser820, and at least one of corresponding first coloring material reservoir808and second coloring material reservoir810may be obviated.

In a preferred embodiment of the present invention, both first QPRCM840and second QPRCM842are supplied to NHRQI sub-assembly802immediately prior to the association of HRQI assembly800with container890. In other words, both first QPRCM840and second QPRCM842are preferably supplied to NHRQI sub-assemblies802as NHRQI sub-assemblies802are being positioned for imminent association with containers890. Thus, in the illustrated embodiment shown inFIG.8, as roll liner892is unspooled to make NHRQI sub-assemblies802available for affixation to containers890, both first QPRCM840and second QPRCM842are supplied to NHRQI sub-assemblies802.

Preferably, a first aperture904and a second aperture906are each formed in back portion894of NHRQI sub-assembly802. As seen particularly inFIG.9B, first QPRCM840is preferably supplied by first injector901to NHRQI sub-assembly802through first aperture904, and second QPRCM842is preferably supplied by second injector902to NHRQI sub-assembly802through second aperture906. In the illustrated embodiment of the present invention, first and second apertures904and906enable respective fluid communication between each of first and second injectors901and902and corresponding first and second coloring material reservoirs808and810, which in turn are each in fluid communication with coloring material diffuser820. In another embodiment of the present invention, in which at least one of first and second coloring material reservoirs808and810may be obviated, at least one of first and second apertures904and906enables fluid communication directly between respective first and second injectors901and902and coloring material diffuser820.

Preferably, a plurality of pairs of apertures914and916are formed on roll liner892, and each of pairs of apertures914and916is generally aligned with corresponding ones of apertures904and906. It is appreciated that apertures904,906,914and916may be formed either during respective fabrications of NHRQI sub-assembly802and roll liner892, or as part of the supply of first and second QPRCMs840and842to NHRQI sub-assembly802. Alternatively, some of apertures904,906,914and916may be formed during a respective fabrication of NHRQI sub-assembly802and roll liner892, and the others of plurality of apertures904,906,914and916may be formed as part of the supply of first and second QPRCMs840and842to NHRQI sub-assembly802. Typically, in an embodiment wherein at least one of plurality of apertures904,906,914and916is formed as part of the supply of first and second QPRCMs840and842to NHRQI sub-assembly802, the at least one of plurality of apertures904,906,914and916is formed by corresponding injector901or902.

As described above, in the embodiment illustrated inFIGS.8and9B, first and second QPRCMs840and842are supplied to NHRQI sub-assembly802via respective apertures904and906on back portion894of NHRQI sub-assembly802prior to, preferably immediately prior to, associating HRQI assembly800with container890. In an alternative embodiment of the present invention, at least one of first QPRCM840and second QPRCM842is supplied to NHRQI sub-assembly802after associating NHRQI sub-assembly802with container890. In an embodiment wherein the supply of at least one of first QPRCM840second QPRCM842to NHRQI sub-assembly802occurs after associating NHRQI sub-assembly802with container890, at least one of injectors901and902, as well as at least one of apertures914and916, may be obviated, and at least one of apertures904and906may be obviated or located elsewhere on NHRQI sub-assembly802.

In an embodiment wherein at least one of first QPRCM840and second QPRCM842is supplied to NHRQI sub-assembly802following the association of NHRQI sub-assembly802with container890, for example, an injector may supply at least one of first QPRCM840and second QPRCM842to NHRQI sub-assembly802through at least one aperture formed in a front surface or a side surface of NHRQI sub-assembly802.

Turning now particularly toFIG.9C, it is seen that immediately following a supply of first and second QPRCMs840and842to NHRQI sub-assembly802, portions880and881of coloring material diffuser820preferably become colored with first QPRCM840and second QPRCM842, respectively, and thus the color visible through each of transparent areas870and871is determined by the color of first QPRCM840and second QPRCM842, respectively. In the example shown inFIGS.8-9D, as seen particularly inFIG.9C, immediately following a supply of first and second QPRCMs840and842to NHRQI sub-assembly802, transparent areas870and871both show a black color, and HRQI assembly800thus preferably assumes post-supply visible state II immediately following a supply of first and second QPRCMs840and842to NHRQI sub-assembly802.

It is appreciated that the coloring of portions880and881by first QPRCM840and second QPRCM842, respectively, and thus the changing of the color visible through transparent areas870and871, changes an appearance of HRQI assembly800, and more particularly, changes an appearance of barcode860and of barcode862. It is appreciated that if only one of first QPRCM840and second QPRCM842is provided to HRQI assembly800, then only one of portions880and881becomes colored, and HRQI assembly800assumes a state in which it does not display any machine-readable barcodes. As described hereinbelow, a state in which HRQI assembly800does not display any machine-readable barcodes preferably provides an indication that HRQI assembly800is not fit for use and should not be associated with container890.

In another embodiment of the present invention (not shown), separate visible states are provided for each of first and second QPRCMs840and842. In such an embodiment, HRQI assembly800preferably assumes a first post-supply visible state following a supply of first QPRCM840and a second post-supply visible state following a supply of second QPRCM842.

In post-supply visible state II, transparent areas870and871each show a color similar to the color of bars of barcodes858, while transparent areas872and874remain uncolored. Therefore, barcodes860,864and866are preferably unreadable by a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, and only barcode862is readable by a conventional barcode reader. Additionally, at post-supply visible state II, HRQI assembly800has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material854is preferably characterized by the first color thereof, for example colorless and transparent, and area852does not interfere with the readability of any of barcodes860,862,864and866, while the first color of area852preferably prevents barcode868from being read. Thus, HRQI assembly800in post-supply visible state II presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode862having numerical sequence 7290003804108.

It is appreciated that once HQRI assembly800assumes visible state II, HRQI assembly800preferably cannot thereafter revert to visible state I.

Preferably, each of first and second QPRCMs840and842is supplied in a flowable state, as indicated by waved lines inFIGS.9B &9C, to NHRQI sub-assembly802. In order to maintain a flowable state thereof, first QPRCM840is typically supplied to NHRQI sub-assembly802at a temperature exceeding the first upper temperature threshold, and second QPRCM842is supplied to NHRQI sub-assembly802at a temperature exceeding the second upper temperature threshold. However, as seen particularly in enlargement circle B ofFIG.8and inFIG.9D, following supply of first and second QPRCMs840and842to NHRQI sub-assembly802, HRQI assembly800is cooled to, and maintained at, a temperature which does not exceed either the first or second upper temperature thresholds, such that both first and second QPRCMs840and842are not flowable, as indicated by interlocking lines in enlargement circle B ofFIG.8and inFIG.9D.

In one embodiment of the present invention, HRCMS790includes at least one cooling system930. Preferably, following a supply of first and second QPRCMs840and842to NHRQI sub-assembly802, HRQI assembly800is brought into thermal contact with cooling system930, thereby rapidly reducing the temperature of HRQI assembly800to a temperature below both the first and second upper temperature thresholds, so that first and second QPRCMs840and842are not flowable. It is appreciated that cooling system930preferably does not cool HRQI assembly800to a temperature below the lower temperature threshold, and thus cold responsive coloring material854does not change color in response to temperature conditions within cooling system930.

In another embodiment of the present invention, cooling system930may be obviated, and following the supply of first and second QPRCMs840and842to NHRQI sub-assembly802, HRQI assembly800may be cooled to a temperature below the first and second upper temperature thresholds, such that first and second QPRCMs840and842are no longer flowable, after being associated with container890. In this embodiment, cooling of HRQI assembly800is preferably effected by thermal contact with container890which, at the time of the association of HRQI assembly800therewith, is at a temperature below the first and second upper temperature thresholds. Alternatively, HRQI assembly800may be cooled by placing HQRI assembly800and the associated container890in a cold storage environment, such as a refrigerator. It is appreciated that the temperature of HRQI assembly800and associated container890is preferably not less than the lower temperature threshold, and thus cold responsive coloring material854does not change color in response to temperature conditions of container890at the time of association of HQRI assembly800with container890.

As described hereinabove with reference toFIGS.1A-1E, NHRQI sub-assembly802is preferably embodied as a self-adhesive label, and the association of HRQI assembly800with container890is preferably embodied as an affixation of HRQI assembly800to container890, and more particularly as an adherence of HRQI assembly800to container890. It is noted that the adhesive on the rear side of back portion894of HRQI assembly800preferably serves to affix HRQI assembly800to container890, and that the adhesion of HRQI assembly800to container890preferably serves to seal apertures904and906, preventing an egress of first and second QPRCMs840and842therefrom.

It is appreciated that in an embodiment wherein first and second QPRCMs840and842are supplied to NHRQI sub-assembly802after associating NHRQI sub-assembly802with container890, cooling system930is typically not included in HRCMS790. Instead, HRQI assembly800is cooled only after being associated with container890. Similarly, in such an embodiment, if one or more apertures are included on a front or a side surface of NHRQI sub-assembly802, the apertures may be sealed with a suitable sealant, preventing an egress of first and second QPRCMs840and842therefrom.

As illustrated inFIGS.9A &9B, in one embodiment of the present invention, NHRQI sub-assembly802is not yet associated with container890. Similarly, as illustrated inFIG.9C, immediately after the supply of first and second QPRCMs840and842to HRQI assembly800, HRQI assembly800is preferably still not associated with container890.

As illustrated inFIG.8, in one embodiment of the present invention, HRQI assembly800is cooled to a temperature below the first and second upper temperature thresholds before being associated with container890, preferably by cooling system930. In an alternative embodiment, HRQI assembly800may be cooled by placing HQRI assembly800and associated container890in a cold storage environment, such as a refrigerator. Thus, the lowering of the temperatures of first and second QPRCMs840and842and the association of HRQI assembly800with container890are separate steps.

However, in another embodiment of the present invention, as illustrated inFIG.9D, HRQI assembly800is cooled to a temperature below the first and second upper temperature thresholds only after being associated with container890. As described hereinabove, in this embodiment, cooling of HRQI assembly800is preferably effected by thermal contact with container890which, at the time of the association of HRQI assembly800therewith, is at a temperature below both the first and second upper temperature thresholds. Thus, the lowering of the temperatures of first and second QPRCMs840and842and the association of HRQI assembly800with container890are achieved in a single step.

In a preferred embodiment of the present invention, HRCMS790further includes a barcode reader940, which preferably reads barcodes858substantially immediately prior to an association of HRQI assembly800or NHQRI sub-assembly802with container890. Barcode reader940, upon reading barcodes858, preferably provides information to a quality indication computer, such as quality indication computer115, which enables the quality indication computer to provide an immediate indication of a quality status of the HRQI assembly800or NHQRI sub-assembly802read by barcode reader940.

If barcode reader940provides an indication that an HRQI assembly800, or in an undesirable case wherein first and second QPRCMs840and842were not supplied to an NHRQI sub-assembly802, an NHRQI sub-assembly802, is unfit for use, then the HRQI assembly800or NHRQI sub-assembly802is preferably discarded and is not associated with a container890. Examples of an HRQI assembly800or NHRQI sub-assembly802that is unfit for use include an HRQI assembly800or NHRQI sub-assembly802that is in pre-supply visible state I, that is in visible state V, or that is unreadable by a typical barcode reader, for example, due to damage to barcodes858or to a supply of only one of QPRCMs840and842.

In another preferred embodiment of the present invention (not shown) barcode reader940is obviated, and is replaced with a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, which is not part of HRCMS790.

In a preferred embodiment of the present invention, HRCMS790further includes a container association module960. If an indication is provided, for example by barcode reader940or barcode reader113, that an HRQI assembly800is fit for use, then container association module960preferably associates that HRQI assembly800with a container890. In a preferred embodiment of the present invention, container association module960positions HRQI assembly800relative to container890such that the adhesive on the rear side of HRQI assembly800contacts container890, thereby affixing HRQI assembly800to container890.

In the embodiment illustrated inFIG.8, barcode reader940is shown as being part of container association module960. Alternatively, barcode reader940may be separate from container association module960.

Reference is now made toFIGS.10A-10E, which are simplified illustrations of typical operative use cases of HRQI assembly800.

It is appreciated that in the operative states shown inFIGS.10A-10DHRQI assembly800has not been exposed to a temperature below the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material854is preferably characterized by the first color thereof, for example colorless and transparent, and area852does not interfere with the readability of any of barcodes860,862,864and866, while the first color of area852preferably prevents barcode868from being read.

It is further appreciated that although, for ease of understanding, dotted lines inFIGS.10A-10Eindicate each of transparent areas848and portions880,881,882and884, preferably transparent areas848and portions880,881,882and884are not readily distinguishable from surrounding areas of indicator template812and coloring material diffuser820, respectively. Similarly, for ease of understanding, dashed lines inFIGS.10A-10Eindicate area852; however, area852may not be readily distinguishable from surrounding areas of indicator template812.

Following the supply of first and second QPRCMs840and842to NHRQI sub-assembly802and when a temperature of HRQI assembly800exceeds the first upper temperature threshold, first QPRCM840assumes a flowable state, as indicated by waved lines inFIG.10A. However, as long as a temperature of HRQI assembly800does not exceed the second upper temperature threshold, second QPRCM842remains in a non-flowable state, as indicated by interlocking lines inFIG.10A.

In an embodiment wherein HRQI assembly800includes coloring material reservoir808, upon assuming a flowable state, first QPRCM840is released from coloring material reservoir808and begins to diffuse through coloring material diffuser820. In an embodiment wherein HRQI assembly800does not include coloring material reservoir808, upon assuming a flowable state, first QPRCM840begins to diffuse through coloring material diffuser820.

It is also appreciated that the respective first and second over-temperature cumulative time durations from the start of diffusion of first QPRCM840along coloring material diffuser820until each of portions882and884of coloring material diffuser820become colored is defined, for example, by a length of coloring material diffuser820between portion880and each of portions882and884. Additionally, these time durations are typically a function of a composition of first QPRCM840, as well as a function of a material from which coloring material diffuser820is made and a thickness thereof.

Similarly, an additional over-temperature cumulative time duration from the start of diffusion of second QPRCM842along coloring material diffuser820until portion884of coloring material diffuser820becomes colored is defined, for example, by a length of coloring material diffuser820between portion881and portion884. Additionally, this time duration is typically a function of a composition of second QPRCM842, as well as a function of a material from which coloring material diffuser820is made and a thickness thereof.

It is noted that preferably, the first and second over-temperature cumulative time duration provide indications of times spent above a first temperature threshold, while the additional over-temperature cumulative time duration provides an indication of a time spent above a second temperature threshold, where the first temperature threshold and the second temperature thresholds are characterized by different temperatures. Thus, as used herein, “additional over-temperature cumulative time duration” typically provides an indication of exceedance of a different temperature than an indication of exceedance of a temperature indicated by both the “first over-temperature cumulative time duration” and the “second over-temperature cumulative time duration.” It is further appreciated that HRQI800may include any suitable number of transparent areas, placed to allow indications of any suitable number of time durations spent either above the first or second temperature thresholds.

In one example, which should not be construed to be limiting, properties of first QPRCM840, coloring material diffuser820, and transparent areas872and874, such as composition and position thereof, are chosen such that that the respective first and second over-temperature cumulative time durations from the start of diffusion of first QPRCM840along coloring material diffuser820until QPRCM840colors portions882and884of coloring material diffuser820, which are visible through respective transparent areas872and874, is two hours and four hours, respectively. Similarly, for example, properties of second QPRCM842, coloring material diffuser820, and transparent areas874, such as composition and position thereof, are chosen such that that the additional over-temperature cumulative time duration from the start of diffusion of second QPRCM842along coloring material diffuser820until second QPRCM842colors portion884of coloring material diffuser820, which is visible through transparent areas874, is 30 minutes.

However, it is appreciated that properties of first QPRCM840and coloring material diffuser820, as well as locations of transparent areas872and874, may be chosen such that each of the first and second over-temperature cumulative time durations, from the start of diffusion of first QPRCM840along coloring material diffuser820until first QPRCM840colors portions882and884of coloring material diffuser820, which are visible through respective transparent areas872and874, may be any suitable respective time duration. Similarly, properties of second QPRCM842and coloring material diffuser820, as well as location of transparent areas874, may be chosen such that the additional over-temperature cumulative time duration, from the start of diffusion of second QPRCM842along coloring material diffuser820until second QPRCM842colors portion884of coloring material diffuser820, which is visible through transparent areas874, may be any suitable time duration.

As is known in the art, product quality is often sensitive to different temperatures to varying extents. Specifically, a slightly elevated temperature may degrade the quality of a product more slowly than an extremely elevated temperature.

For example, if a vial of vaccine whose recommended storage temperature, in order to maintain the quality thereof, is 2 degrees Celsius, an exposure of the vial to a temperature of 8 degrees Celsius may only render the vial of vaccine unfit for use after a cumulative exposure of 4 hours. However, an exposure of the vial to a temperature of 30 degrees Celsius may cause the quality of the vaccine to reach an unusable state after a cumulative exposure of only 30 minutes. Additionally, even a very short exposure, such as an exposure of 2 seconds, of the vial to a temperature of 0 degrees Celsius, may cause the quality of the vaccine to reach an unusable state.

Typically, the first over-temperature cumulative time duration, the second over-temperature cumulative time duration and the additional over-temperature cumulative time duration, as well as the first upper temperature threshold, the second upper temperature threshold and the lower temperature threshold, are chosen based on the requirements of contents of container890.

For example, an HRQI assembly800for association with a flu vaccine may have a lower temperature limit of 2 degrees Celsius, while an HRQI assembly800for association with a COVID-19 vaccine may have a lower temperature limit of −70 degrees Celsius. Similarly, an HRQI assembly800for association with a package of frozen meat may have respective first and second over-temperature cumulative time durations of two and four hours for a first upper temperature threshold of 8 degrees Celsius and an additional over-temperature cumulative time duration of 30 minutes for a second upper temperature threshold of 30 degrees Celsius, while an HRQI assembly800for association with a package of fresh meat may have respective first and second over-temperature cumulative time durations of 30 minutes and one hour for a first upper temperature threshold of 10 degrees Celsius, and an additional over-temperature cumulative time duration of 15 minutes for a second upper temperature threshold of 30 degrees Celsius.

Turning particularly toFIG.10A, it is seen that when a temperature of container890, and of HRQI assembly800associated therewith, exceeds the first upper temperature threshold for less than the first over-temperature cumulative time duration, but does not exceed the second upper temperature threshold, first QPRCM840begins to diffuse through coloring material diffuser820beyond portion880in a direction toward portion882, while second QPRCM842remains in a non-flowable state. However, as long as a temperature of container890and of HRQI assembly800associated therewith does not exceed the first upper temperature threshold for at least the first over-temperature cumulative time duration, first QPRCM840preferably does not color portion882. Thus, as long as a temperature of container890and of HRQI assembly800associated therewith does not exceed either the first upper temperature threshold for at least the first over-temperature cumulative time duration or the second over-temperature threshold for at least the additional over-temperature cumulative time duration, neither portion882nor portion884of coloring material diffuser820become colored, and thus neither transparent area872nor transparent areas874appear colored, and HRQI assembly800remains in visible state II, in which preferably only barcode862is in a readable state.

In contrast, as seen particularly toFIG.10B, when a temperature of container890and of HRQI assembly800associated therewith exceeds the first upper temperature threshold, for at least the first over-temperature cumulative time duration, but does not exceed the second upper temperature threshold, first QPRCM840diffuses through portions of coloring material diffuser820, including portion882, while second QPRCM842remains in a non-flowable state.

Thus, when a temperature of container890and of HRQI assembly800associated therewith exceeds the first upper temperature threshold for at least the first over-temperature cumulative time duration, the color visible through transparent area872is determined by the color of first QPRCM840. As seen particularly inFIG.10B, upon a coloring of portion882by black first QPRCM840, transparent area872shows a black color, and HRQI assembly800thus preferably assumes visible state III.

It is appreciated that the coloring of portion882by first QPRCM840, and thus the changing of the color visible through transparent area872, changes an appearance of HRQI assembly800, and more particularly, changes an appearance of barcode862and of barcode864.

In visible state III, transparent areas870,871and872show a color similar to the color of bars of barcodes858, while transparent areas874remain uncolored. Therefore, barcodes860,862and866are preferably unreadable by a conventional barcode reader, while barcode864is readable by a conventional barcode reader. Additionally, in visible state III, HRQI assembly800has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material854is preferably characterized by the first color thereof, for example colorless and transparent, and area852does not interfere with the readability of any of barcodes860,862,864and866, while the first color of area852preferably prevents barcode868from being read. Thus, HRQI assembly800in visible state III presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode864having numerical sequence 7290003804122.

It is appreciated that once HQRI assembly800assumes visible state III, HRQI assembly800preferably cannot thereafter revert to either of states I or II, notwithstanding that the temperature of HRQI assembly800and associated container890subsequently drops below the first upper temperature threshold.

It is additionally appreciated that once having been supplied to NHRQI sub-assembly802, first QPRCM840is operative to assume a non-flowable state upon HRQI assembly800being exposed to a temperature below the first upper temperature threshold, regardless of a visible state then displayed by HRQI assembly800. Similarly, once having been supplied to NHRQI sub-assembly802, first QPRCM840is operative to assume a flowable state upon HRQI assembly800being exposed to a temperature exceeding the first upper temperature threshold, regardless of a visible state then displayed by HRQI assembly800.

It is appreciated that HRQI assembly800is also operative to assume visible state III if second QPRCM842begins to diffuse beyond portion881, but does not reach portion884.

Turning now particularly toFIG.10C, it is seen that following an elapse of an additional time duration at a temperature exceeding the first upper temperature threshold, such that the total cumulative elapsed time is at least the second over-temperature cumulative time duration, first QPRCM840diffuses further through coloring material diffuser820, including through portion884.

Thus, when a temperature of container890and of HRQI assembly800associated therewith exceeds the first upper temperature threshold for at least the second over-temperature cumulative time duration, the color visible through transparent areas874is determined by the color of first QPRCM840. As seen particularly inFIG.10C, upon a coloring of portion884by black first QPRCM840, transparent areas874show a black color, and HRQI assembly800thus preferably assumes visible state IV.

It is appreciated that the coloring of portion884by first QPRCM840, and thus the changing of the color visible through transparent areas874, changes an appearance of HRQI assembly800, and more particularly, changes an appearance of barcodes862,864and866.

As seen inFIG.10C, in a first version of visible state IV, each of transparent areas870,871,872and874shows a color similar to the color of bars of barcodes858. Therefore, barcodes860,862and864are preferably unreadable by a conventional barcode reader, while barcode866is readable by a conventional barcode reader. Additionally, in visible state IV, HRQI assembly800has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material854is preferably characterized by the first color thereof, for example colorless and transparent, and area852does not interfere with the readability of any of barcodes860,862,864and866, while the first color of area852preferably prevents barcode868from being read. Thus, upon exposure of container890and of HRQI assembly800associated thereto to a temperature exceeding the first upper temperature threshold for at least the second over-temperature cumulative time duration, HRQI assembly800assumes visible state IV. In visible state IV, HRQI assembly800preferably presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode866having numerical sequence 7290003804115.

It is appreciated that once HRQI assembly800has assumed visible state IV, HRQI assembly800preferably cannot thereafter revert to any of states I, II and III, notwithstanding that the temperature of HRQI assembly800and associated container890subsequently drops below the first upper temperature threshold.

Similarly, as seen particularly inFIG.10D, when a temperature of container890, and of HRQI assembly800associated therewith, exceeds the second upper temperature threshold for at least the additional over-temperature cumulative time duration, second QPRCM842diffuses through coloring material diffuser820beyond portion881, including through portion884.

Thus, the color visible through transparent areas874is determined by the color of second QPRCM842. In the example shown inFIGS.10A-10E, as seen particularly inFIG.10D, upon a coloring of portion884by second QPRCM842, transparent areas874show a black color, and HRQI assembly800thus preferably assumes visible state IV.

It is appreciated that the coloring of portion884by second QPRCM842, and thus the changing of the color visible through transparent areas874, changes an appearance of HRQI assembly800, and more particularly, changes an appearance of barcodes862,864and866.

In the second version of visible state IV, each of transparent areas870,871and874shows a color similar to the color of bars of barcodes858, and transparent area872remains uncolored. Therefore, barcodes860,862and864are preferably unreadable by a conventional barcode reader, while barcode866is readable by a conventional barcode reader. Additionally, in visible state IV, HRQI assembly800has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material854is preferably characterized by the first color thereof, for example colorless and transparent, and area852does not interfere with the readability of any of barcodes860,862,864and866, while the first color of area852preferably prevents barcode868from being read. Thus, upon exposure of container890and of HRQI assembly800associated thereto to a temperature exceeding the second upper temperature threshold for at least the additional over-temperature cumulative time duration, HRQI assembly800assumes visible state IV. As described hereinabove with reference toFIG.10C, in visible state IV, HRQI assembly800preferably presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode866having numerical sequence 7290003804115.

As noted above with reference toFIG.10C, it is appreciated that once HRQI assembly800has assumed visible state IV, HRQI assembly800preferably cannot thereafter assume any of states I, II and III, notwithstanding that the temperature of HRQI assembly800and associated container890subsequently drops below the second upper temperature threshold or exceeds either the first or second upper temperature thresholds for additional amounts of time.

Turning now particularly toFIG.10E, it is seen that when a temperature of container890and of HRQI assembly800associated therewith falls below the lower temperature threshold for at least the under-temperature time duration, cold responsive coloring material854irreversibly assumes the second color, and HRQI assembly800assumes visible state V.

It is appreciated that the assumption of the second color by cold responsive coloring material854changes an appearance of HRQI assembly800, and more particularly, changes an appearance of barcodes860,862,864,866and868.

It is appreciated that once cold responsive coloring material854assumes the second color, area852preferably prevents any of barcodes860,862,864and866from being read, while the second color of area852preferably allows barcode868to be read. It is appreciated that in visible state V, transparent areas848may show any color, since the second color of cold responsive coloring material854in area852preferably prevents barcodes860,862,864and866from being read regardless of a color visible through any of transparent areas848.

Thus, upon exposure of container890and of HRQI assembly800associated therewith to a temperature below the lower temperature threshold for at least the under-temperature time duration, HRQI assembly800assumes visible state V. In visible state V, HRQI assembly800preferably presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode868having numerical sequence 7290003804139.

It is appreciated that once HRQI assembly800has assumed visible state V, HRQI assembly800preferably cannot thereafter assume any of states I, II, III and IV, notwithstanding that the temperature of HRQI assembly800and associated container890subsequently exceeds the lower temperature threshold, or even either the first or second upper temperature thresholds.

It is noted that while it is typically undesirable to associate container890to NHRQI sub-assembly802to which one or both of first and second QPRCMs840and842have not been supplied, in the illustrated embodiment of the present invention, NHRQI sub-assembly802without either or both of first and second QPRCMs840and842may be operative to assume visible state V.

Alternatively, HRQI assembly800may include, instead of NHRQI sub-assembly802, an initial heat responsive quality indicator (IHRQI) sub-assembly (not shown), similar to NHRQI sub-assembly802, including at least one coloring material diffuser, such as a coloring material diffuser820and at least one indicator template, such as an indicator template812. In contrast to sub-assembly NHRQI802, in this alternative embodiment, the IHRQI sub-assembly also includes at least a first heat responsive coloring material (HRCM), corresponding to second QPRCM842, which is flowable at a first temperature exceeding a first upper temperature threshold. It is appreciated that unlike second QPRCM842, which is preferably injected into NHRQI sub-assembly802, the first HRCM may be supplied to the IHRQI sub-assembly in any suitable manner.

In this embodiment, HRQI assembly800further includes a second HRCM, corresponding to first QPRCM840, which, when supplied to the coloring material diffuser of the IHRQI sub-assembly, preferably by injection, preferably converts the IHRQI sub-assembly to HRQI assembly800. Thus, in this embodiment, HRQI assembly800is formed by supplying the second HRCM to the IHRQI sub-assembly, preferably by injecting the second HRCM into the IHRQI sub-assembly.

Typically, in this embodiment, the first upper temperature threshold of HRQI800is higher than the second upper temperature threshold of HRQI800. For example, the first upper temperature threshold may be 45 degrees Celsius, and the second upper temperature threshold may be 8 degrees Celsius. In contrast to the embodiment shown inFIGS.8-10E, in this embodiment, the first HRCM is supplied to the IHRQI sub-assembly at the time of manufacture of the IHRQI sub-assembly, because the first upper temperature threshold of the first HRCM is typically a temperature higher than ambient temperatures normally experienced during standard storage, shipping and handling of the IHRQI sub-assembly, and thus maintaining the IHRQI sub-assembly at temperatures below the first upper temperature threshold is typically neither difficult nor expensive. However, since temperatures normally experienced during standard storage, shipping and handling of the IHRQI assembly may often exceed the second upper temperature threshold of the second HRCM, the second HRCM is injected into the IHRQI sub-assembly substantially immediately prior to an association of HRQI assembly800of this embodiment with a container, thereby reducing the effort and cost associated with maintaining the IHRQI sub-assembly at a temperature below the second upper temperature threshold.

Reference is now made toFIG.11, which is a simplified illustration of a heat responsive coloring material supplier (HRCMS)1090, which is an example of one or both of HRCMSs102and107ofFIGS.1A-1E, and toFIGS.12A-12D, which together are a simplified illustration of a preferred method of construction of a heat responsive quality indicator (HRQI)1100, which is an embodiment of one or both of HRQI assemblies100and105ofFIGS.1A-1E.

HRQI assembly1100preferably includes a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly1102including at least a first coloring material reservoir1108and a second coloring material reservoir1110, at least one indicator template1112and at least one coloring material diffuser1120.

HRQI assembly1100preferably additionally includes a first quality parameter responsive coloring material (QPRCM)1140and a second QPRCM1142. In a preferred embodiment of the present invention, each of first and second QPRCMs1140and1142is an HRCM, which is flowable at a temperature exceeding a first and second upper temperature threshold, respectively, as indicated by waved lines in corresponding figures. First QPRCM1140is characterized by a viscosity and melting point such that first QPRCM1140is flowable through or on coloring material diffuser1120at temperatures above a first upper temperature threshold and is not flowable through or on coloring material diffuser1120at temperatures below the first upper temperature threshold. Similarly, second QPRCM1142is characterized by a viscosity and melting point such that second QPRCM1142is flowable through or on coloring material diffuser820at temperatures above a second upper temperature threshold and is not flowable through or on coloring material diffuser1120at temperatures below the second upper temperature threshold. Both first QPRCM1140and second QPRCM1142are preferably characterized by a color that is readily distinguishable from a color of coloring material diffuser1120.

First QPRCM1140and second QPRCM1142, when supplied to coloring material diffuser1120of NHRQI sub-assembly1102, preferably convert NHRQI sub-assembly1102to HRQI assembly1100, which is responsive to changes in temperature over time in exceedance of the first upper temperature threshold and the second upper temperature threshold, for changing an appearance of HRQI assembly1100. Thus, HRQI assembly1100is formed by supplying first QPRCM1140and second QPRCM1142to NHRQI sub-assembly1102, and more preferably by injecting first QPRCM1140and second QPRCM1142into NHRQI sub-assembly1102.

When first QPRCM1140is flowable, first QPRCM1140preferably diffuses through coloring material diffuser1120. Conversely, when first QPRCM1140is not flowable, first QPRCM1140preferably does not diffuse through coloring material diffuser1120. Similarly, when second QPRCM1142is flowable, second QPRCM1142preferably diffuses through coloring material diffuser1120. Conversely, when second QPRCM1142is not flowable, second QPRCM1142preferably does not diffuse through coloring material diffuser1120.

It is further appreciated that at least one of QPRCMs1140and1142may additionally or alternatively be embodied as a coloring material that is responsive to at least one alternative or additional quality parameter, including, inter alia, moisture, force, pressure, pH and elapsed time. In such a case, HRQI assembly1100is preferably embodied as at least, inter alia, a moisture responsive quality indicator, a force responsive quality indicator, a pressure responsive quality indicator, a pH responsive quality indicator and an elapsed time responsive quality indicator, respectively.

In one embodiment of the present invention, (not shown), at least one of first QPRCM1140and second QPRCM1142is supplied directly to coloring material diffuser1120. In such an embodiment, at least one of corresponding first coloring material reservoir1108and second coloring material reservoir1110may be obviated.

In another embodiment of the present invention, as seen particularly inFIGS.11-12D, both first QPRCM1140and second QPRCM1142are supplied indirectly to coloring material diffuser1120. In such an embodiment, first QPRCM1140and second QPRCM1142are preferably supplied to first coloring material reservoir1108and second coloring material reservoir1110, respectively, and first coloring material reservoir1108supplies first QPRCM1140to coloring material diffuser1120and second coloring material reservoir1110supplies second QPRCM1142to coloring material diffuser1120.

In a preferred embodiment of the present invention, coloring material diffuser1120is embodied as filter paper, such as Whatman No. 3 filter paper commercially available from Whatman International [CAT #: 1003917]. Additionally, coloring material reservoirs1108and1110are each preferably embodied as a pad, for example, K-R; 210/34/28, commercially available from Noam-Urim of Kibbutz Urim, Israel, first QPRCM1140is preferably embodied as a coloring agent, such as Sudan Black, a black color dye [CAS: 4197-25-5], combined at a ratio of 1.4 grams per 1 kilogram in Decyl Decanoate [CAS: 1654-86-0], and second QPRCM1142is preferably embodied as a coloring agent, such as Sudan Black, a black color dye [CAS: 4197-25-5], combined at a ratio of 1.4 grams per 1 kilogram in Butyl Stearate [CAS: 123-95-5].

Preferably, indicator template1112includes a transparent substrate on which is formed non-transparent printing. In a preferred embodiment of the present invention, all areas on the transparent substrate which are desired to be opaque, including both a background and areas in which features will be printed, are printed with white ink, and a plurality of features, such as bars forming part of barcodes corresponding to barcodes110or111ofFIGS.1A-1E, are preferably printed with black ink over the white ink as desired.

In another embodiment of the present invention, a background area of indicator template1112is printed with white ink; however, the white ink is not deposited in the areas in which the plurality of features are formed, and the plurality of features are preferably printed with black ink.

More generally, in all embodiments of the present invention, the background area of indicator template1112and the plurality of features of indicator template1112are printed in such colors as to define high contrast therebetween.

Indicator template1112preferably further includes at least one transparent area1148, indicated by dotted lines inFIGS.12A-12D. It is appreciated that the dotted lines indicating transparent area or areas1148are drawn for ease of understanding, and preferably transparent area or areas1148are not readily distinguishable from surrounding areas of indicator template1112. In a preferred embodiment of the present invention, transparent area or areas1148are not printed, i.e., preferably no material is deposited on transparent area or areas1148. For the purposes of the present specification and claims, the term “transparent area” is defined so as to include within its scope areas that are either transparent or translucent.

Preferably, coloring material diffuser1120is visible through the entirety of each of transparent areas1148. Thus, a color visible in each of transparent areas1148is determined by a color of a portion of coloring material diffuser1120located therebehind. In a preferred embodiment of the present invention, each of transparent areas1148is initially white in color, and assumes a black color upon a coloring of coloring material diffuser1120by either first QPRCM1140or second QPRCM1142.

In a preferred embodiment of the present invention, indicator template1112additionally includes at least one area1152upon which is deposited a cold responsive coloring material1154, such as a thermochromic coloring material, such as irreversible thermochromic ink commercially available from CTI Technology, Colorado Springs, USA. Alternatively, area1152and cold responsive coloring material1154may be embodied as a commercially available cold responsive label, such as a Model 54000 Freeze Check™ temperature indicator commercially available from DeltaTrak Inc., Pleasanton, USA. It is appreciated that although, for ease of understanding, dashed lines inFIGS.12A-12Dindicate area1152, preferably area1152is not readily distinguishable from surrounding areas of indicator template1112.

It is appreciated that as used herein, “cold responsive” is used to indicate an element or system that changes as a result of cold, wherein “cold” is used to indicate a temperature below a lower temperature threshold, such as a temperature at which cold responsive coloring material1154typically changes color.

In a preferred embodiment of the present invention, cold responsive coloring material1154is initially characterized by a first color, and irreversibly assumes a second color, which is different from the first color, upon exposure to a temperature below a lower temperature threshold, for example, below 2 degrees Celsius, for an under-temperature time duration. As described hereinabove, in one embodiment of the present invention, the under-temperature time duration is very short, preferably less than 60 seconds, more preferably less than 30 seconds, more preferably less than 15 seconds, even more preferably less than 10 seconds and most preferably less than 5 seconds. In another embodiment of the present invention, the under-temperature time duration is relatively long, and may be, for example, 5 minutes, 10 minutes, 20 minutes, 30 minutes or 45 minutes.

Thus, if the under-temperature time duration is very short, then cold responsive coloring material1154preferably assumes the second color substantially immediately upon being exposed to a temperature below the lower temperature threshold. In contrast, if the under-temperature time duration is relatively long, for example 30 minutes, then cold responsive coloring material1154assumes the second color only upon an exposure to a temperature less than the lower temperature threshold for at least 30 minutes.

It is appreciated that the first color and the second color assumed by cold responsive coloring material1154may be any suitable colors which are discernable from one another. In one embodiment of the present invention, the first and second colors are readily discernable from one another by a human. Additionally or alternatively, the first and second colors are readily discernable from one another by a machine. For example, in one embodiment of the present invention, cold responsive coloring material1154characterized by the first color is colorless and transparent, and cold responsive coloring material1154characterized by the second color is blue. In another embodiment of the present invention, cold responsive coloring material1154characterized by the first color is green, and cold responsive coloring material1154characterized by the second color is colorless and transparent.

It is appreciated that while the embodiment illustrated inFIGS.11-12Dincludes cold responsive coloring material1154, in another embodiment of the present invention, HRQI assembly1100does not include cold responsive coloring material1154.

In the example illustrated inFIGS.11-12D, indicator templates1112includes a plurality of barcodes1158, such as barcodes110or111, including a first barcode1160, a second barcode1162, a third barcode1164, a fourth barcode1166and a fifth barcode1168, which are preferably different from each other and arranged in a stacked arrangement. As indicated by dotted lines, formed within barcodes1158are transparent areas1148, including a transparent area1170, a transparent area1171, a transparent area1172, a transparent area1174and a transparent area1176. In the example illustrated inFIGS.11-12D, indicator templates1112further includes human sensible indicia, including area1152and a transparent area1178.

It is appreciated that human sensible indica corresponding to at least one of area1152and transparent area1178may also be included in the embodiment described hereinabove with reference toFIGS.8-10E.

As described hereinabove, coloring material diffuser1120is preferably visible through the entirety of each of transparent areas1148. More particularly, a portion1180of coloring material diffuser1120is preferably visible through transparent area1170, a portion1181of coloring material diffuser1120is preferably visible through transparent area1171, a portion1182of coloring material diffuser1120is preferably visible through transparent area1172, a portion1184of coloring material diffuser1120is preferably visible through transparent area1174and a portion1186of coloring material diffuser1120is preferably visible through transparent areas1176and1178. Thus, it is appreciated that a color visible in each of transparent areas1170,1171,1172,1174and1176is determined by a color of each of portions1180,1181,1182,1184and1186, respectively, and that a color visible in transparent area1178is determined by a color of portion1186. It is appreciated that although, for ease of understanding, dotted lines inFIGS.12A-12Dindicate each of portions1180,1181,1182,1184and1186, preferably portions1180,1181,1182,1184and1186are not readily distinguishable from surrounding areas of coloring material diffuser1120.

Preferably, each of transparent areas1170,1171,1172,1174and1176is formed within at least two of barcodes1158and forms a readable portion thereof. In the illustrated embodiment ofFIGS.12A-13F, transparent areas1170and1171each form part of barcodes1160and1162, transparent area1172forms part of barcodes1162and1164, transparent area1174forms part of barcodes1164and1166and transparent area1176forms part of barcodes1162,1164,1166and1168. Each of transparent areas1148preferably has the same width as a single barcode bar. Alternatively, the width of any of the transparent areas1170,1171,1172,1174and1176may be different from the width of a single barcode bar. Additionally, the width of the portion of a transparent area1148which forms part of one of barcodes1158may be different from the width of the portion of the same transparent area1148which forms part of another of barcodes1158.

It is appreciated that barcodes1160,1162,1164,1166and1168may be arranged in any suitable order with respect to one another. Similarly, transparent areas1170,1171,1172,1174and1176may be arranged in any suitable order with respect to one another. Furthermore, it is appreciated that at least one of barcodes1160,1162,1164,1166and1168and/or transparent areas1170,1171,1172,1174,1176and1178may be obviated from indicator template1112and HRQI assembly1100. Similarly, one or more additional barcodes and/or transparent areas may be added to indicator template1112and HRQI assembly1100.

In a preferred embodiment of the present invention, a different single one of barcodes1158is machine-readable at each of visible states I, II, III, IIIa, and IV. For example, in the example illustrated inFIGS.11-12D, barcode1160is read as 7290003804191 at pre-supply visible state I, barcode1162is read as 7290003804108 at post-supply visible state II, barcode1164is read as 7290003804122 in visible state III, barcode1166is read as 7290003804115 in a visible state IIIa and barcode1168is read as 7290003804139 in visible state IV. Preferably, each of barcodes1158is machine-readable only in the single one of visible states I, II, III, IIIa and IV listed above.

As seen particularly inFIGS.12A-12D, when coloring material diffuser1120is in an uncolored state, meaning that neither first QPRCM1140nor second QPRCM1142has been supplied to coloring material diffuser1120, coloring material diffuser1120causes each of transparent areas1170,1171,1172,1174,1176and1178to appear white in color. The white appearance of transparent areas1170and1171preferably allows barcode1160to be machine-readable, while the white appearance of transparent areas1170,1171,1172,1174and1176preferably causes barcodes1162,1164,1166and1168to be non-machine-readable. Thus, when coloring material diffuser1120is in an uncolored state and NHRQI sub-assembly1102has not been exposed to a temperature less than the lower temperature threshold, NHRQI sub-assembly1102is preferably in pre-supply visible state I, wherein only barcode1160is in a machine-readable state.

Additionally, as long as NHRQI sub-assembly1102has not been exposed to a temperature less than the lower temperature threshold, cold responsive coloring material1154is preferably characterized by the first color thereof, for example colorless and transparent, and area1152provides an indication that a temperature of NHRQI sub-assembly1102has not fallen below the lower temperature threshold.

In the embodiment illustrated inFIGS.11-12D, area1152and cold responsive coloring material1154thereon preferably provide a human sensible indication of whether or not a temperature of NHRQI sub-assembly1102has fallen below the lower temperature threshold for the under-temperature time duration. In a preferred embodiment of the present invention, NHRQI sub-assembly1102includes explanatory features, such as text and/or graphics, explaining at least one visible appearance of area1152. For example, in the illustrated embodiment, NHRQI sub-assembly1102includes a message1188“DISCARD IF DARKENED→” adjacent to area1152, thereby indicating to a user that if cold responsive coloring material1154is characterized by the first color thereof, a temperature of NHRQI sub-assembly1102has not fallen below the lower temperature threshold for the under-temperature time duration, but if cold responsive coloring material1154is characterized by the second color thereof, a temperature of NHRQI sub-assembly1102has fallen below the lower temperature threshold for the under-temperature time duration.

Typically, if first and second QPRCMs1140and1142have not yet been supplied to NHRQI sub-assembly1102, a characterization of cold responsive coloring material1154by the second color thereof indicates to a user that NHRQI sub-assembly1102should not be associated with a product package and should be discarded. Similarly, if first and second QPRCMs1140and1142have been supplied to NHRQI sub-assembly1102, thus forming HRQI assembly1100, and HRQI assembly1100has been associated with a product package, a characterization of cold responsive coloring material1154by the second color thereof indicates to a user that the product package with which HRQI assembly1100is associated should be discarded.

It is appreciated that in the embodiment illustrated inFIGS.11-12D, area1152and cold responsive coloring material1154thereon preferably additionally provide a machine-sensible indication of whether or not a temperature of NHRQI sub-assembly1102has fallen below the lower temperature threshold for the under-temperature time duration. Preferably, a system such as a suitably programmed machine vision system is operative to assess a color visible in area1152and provide a suitable indication based thereon.

As seen inFIG.12A, a container1190, such as, inter alia, package101or carton106, is ready to be associated with an HRQI assembly1100. It is appreciated that container1190is typically a product package, and may be embodied as, inter alia, an individual product package, a box of product packages, a pallet of product packages or a shipping container of product packages. In a preferred embodiment of the present invention, a type of container1190with which an HRQI assembly1100is associated, and more particularly a number of individual products contained by the container1190associated with HRQI assembly1100, is at least partially determined by a relationship between a cost of monitoring container1190, a temperature-sensitivity of a product within container1190and a financial value of a product within container1190.

Preferably, as further seen inFIG.12A, first and second QPRCMs1140and1142have not yet been supplied to NHRQI sub-assembly1102, and therefore NHRQI sub-assembly1102is preferably not yet associated with container1190. As described hereinabove, prior to a supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102, NHRQI sub-assembly1102has not been exposed to a temperature less than the lower temperature threshold and is preferably in pre-supply visible state I.

Preferably, in visible state I, barcode1160is typically readable by a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, and barcodes1162,1164,1166and1168are preferably not readable by a barcode reader. Thus, the NHRQI sub-assembly1102is in pre-supply visible state I and presents a single machine-readable barcode1160, typically readable by a conventional barcode reader as 7290003804191.

NHRQI sub-assembly1102is preferably embodied as a self-adhesive label. Typically, after fabrication of NHRQI sub-assemblies1102and before first and second QPRCMs1140and1142are supplied thereto, NHRQI sub-assemblies1102are stored on a roll liner1192. NHRQI sub-assembly1102includes a back portion1194, on a rear side (not shown) of which is preferably an adhesive (not shown). The adhesive preferably serves to affix NHRQI sub-assembly1102to roll liner1192. Typically, following the production of HRQI assembly1100, the adhesive on NHRQI sub-assembly1102is also used to affix HRQI assembly1100to container1190.

As seen particularly inFIGS.11and12B, HRCMS1090preferably includes a coloring material supplier1198, such as injection module104ofFIG.1A, which includes at least a first injector1201and a second injector1202, such as a first and second needle assembly, respectively. In a preferred embodiment of the present invention, coloring material supplier1198includes a heating assembly1203, such as a resistive heating assembly. If an ambient temperature of coloring material supplier1198is below the first upper temperature threshold of first QPRCM1140while coloring material supplier1198supplies first QPRCM1140to NHRQI sub-assembly1102, heating assembly1203provides heat to first QPRCM1140during the supply thereof to NHRQI sub-assembly1102, thereby maintaining first QPRCM1140at a temperature at which first QPRCM1140is flowable during the supply thereof to NHRQI sub-assembly1102. Similarly, if an ambient temperature of coloring material supplier1198is below the second upper temperature threshold of second QPRCM1142while coloring material supplier1198supplies second QPRCM1142to NHRQI sub-assembly1102, heating assembly1203provides heat to second QPRCM1142during the supply thereof to NHRQI sub-assembly1102, thereby maintaining second QPRCM1142at a temperature at which second QPRCM1142is flowable during the supply thereof to NHRQI sub-assembly1102.

Typically, coloring material supplier1198supplies both first and second QPRCMs1140and1142to NHRQI sub-assembly1102while NHRQI sub-assembly1102is affixed to roll liner1192. In the embodiment shown inFIGS.11-12D, coloring material supplier1198supplies first and second QPRCMs1140and1142to first and second coloring material reservoirs1108and1110, respectively, and coloring material reservoir1108and1110then respectively supply first and second QPRCMs1140and1142to coloring material diffuser1120. In another embodiment of the present invention, coloring material supplier1198supplies at least one of first and second QPRCMs1140and1142directly to coloring material diffuser1120, and at least one of corresponding first coloring material reservoir1108and second coloring material reservoir1110may be obviated.

In a preferred embodiment of the present invention, both first QPRCM1140and second QPRCM1142are supplied to NHRQI sub-assembly1102immediately prior to the association of HRQI assembly1100with container1190. In other words, both first QPRCM1140and second QPRCM1142are preferably supplied to NHRQI sub-assemblies1102as NHRQI sub-assemblies1102are being positioned for imminent association with containers1190. Thus, in the illustrated embodiment shown inFIG.11, as roll liner1192is unspooled to make NHRQI sub-assemblies1102available for affixation to containers1190, both first QPRCM1140and second QPRCM1142are supplied to NHRQI sub-assemblies1102.

Preferably, a first aperture1204and a second aperture1206are each formed in back portion1194of NHRQI sub-assembly1102. As seen particularly inFIG.12B, first QPRCM1140is preferably supplied by first injector1201to NHRQI sub-assembly1102through first aperture1204, and second QPRCM1142is preferably supplied by second injector1202to NHRQI sub-assembly1102through second aperture1206. In the illustrated embodiment of the present invention, first and second apertures1204and1206enable respective fluid communication between each of first and second injectors1201and1202and corresponding first and second coloring material reservoirs1108and1110, which in turn are each in fluid communication with coloring material diffuser1120. In another embodiment of the present invention, in which at least one of first and second coloring material reservoirs1108and1110may be obviated, at least one of first and second apertures1204and1206enables fluid communication directly between respective first and second injectors1201and1202and coloring material diffuser1120.

Preferably, a plurality of pairs of apertures1214and1216are formed on roll liner1192, and each of pairs of apertures1214and1216is generally aligned with corresponding ones of apertures1204and1206. It is appreciated that apertures1204,1206,1214and1216may be formed either during respective fabrications of NHRQI sub-assembly1102and roll liner1192, or as part of the supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102. Alternatively, some of apertures1204,1206,1214and1216may be formed during a respective fabrication of NHRQI sub-assembly1102and roll liner1192, and the others of plurality of apertures1204,1206,1214and1216may be formed as part of the supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102. Typically, in an embodiment wherein at least one of plurality of apertures1204,1206,1214and1216is formed as part of the supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102, the at least one of plurality of apertures1204,1206,1214and1216is formed by corresponding injector1201or1202.

As described above, in the embodiment illustrated inFIGS.11and12B, first and second QPRCMs1140and1142are supplied to NHRQI sub-assembly1102via respective first and second apertures1204and1206shown on back portion1194of NHRQI sub-assembly1102prior to, preferably immediately prior to, associating HRQI assembly1100with container1190. In an alternative embodiment of the present invention, at least one of first and second QPRCMs1140and1142are supplied to NHRQI sub-assembly1102after associating NHRQI sub-assembly1102with container1190. In an embodiment wherein the supply of at least one of first and second QPRCMs1140and1142to NHRQI sub-assembly1102occurs after associating NHRQI sub-assembly1102with container1190, coloring material supplier1198and at least one of apertures1214and1216may be obviated, and at least one of apertures1204and1206may be obviated or located elsewhere on NHRQI sub-assembly1102.

In an embodiment wherein at least one of first and second QPRCMs1140and1142is supplied to NHRQI sub-assembly1102following the association of NHRQI sub-assembly1102with container1190, for example, an injector may supply at least one of first and second QPRCMs1140and1142to NHRQI sub-assembly1102through at least one aperture formed in a front surface or a side surface of NHRQI sub-assembly1102.

In a preferred embodiment of the present invention, HRQI assembly1100also includes explanatory features, such as text and/or graphics, explaining at least one visible appearance of transparent area1178. For example, in the illustrated embodiment, HRQI assembly1100includes a message1228, with the text “DISCARD IF DARKENED→”, adjacent to transparent area1178.

Turning now particularly toFIG.12C, it is seen that immediately following a supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102, portions1180and1181of coloring material diffuser1120preferably become colored with first QPRCM1140and second QPRCM1142, respectively, and thus the color visible through each of transparent areas1170and1171is determined by the color of first QPRCM1140and second QPRCM1142, respectively. In the example shown inFIGS.11-12D, as seen particularly inFIG.12C, immediately following a supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102, transparent areas1170and1171both show a black color, and HRQI assembly1100thus preferably assumes post-supply visible state II immediately following a supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102.

It is appreciated that the coloring of portions1180and1181by first and second QPRCMs1140and1142, respectively, and thus the changing of the color visible through transparent areas1170and1171, changes an appearance of HRQI assembly1100, and more particularly, changes an appearance of barcode1160and of barcode1162. It is appreciated that if only one of first QPRCM1140and second QPRCM1142is provided to HRQI assembly1100, then only one of portions1180and1181becomes colored, and HRQI assembly1100assumes a state in which it does not display any machine-readable barcodes. As described hereinbelow, a state in which HRQI assembly1100does not display any machine-readable barcodes preferably provides an indication that HRQI assembly1100is not fit for use and should not be associated with container1190.

In another embodiment of the present invention (not shown), separate visible states are provided for each of first and second QPRCMs1140and1142. In such an embodiment, HRQI assembly1100preferably assumes a first post-supply visible state following a supply of first QPRCM1140and a second post-supply visible state following a supply of second QPRCM1142.

In post-supply visible state II, transparent areas1170and1171each show a color similar to the color of bars of barcodes1158, while transparent areas1172,1174,1176and1178remain uncolored. Therefore, barcodes1160,1164,1166and1168are preferably unreadable by a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, and only barcode1162is readable by a conventional barcode reader. Thus, HRQI assembly1100in post-supply visible state II presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode1162having numerical sequence 7290003804108.

Additionally, at post-supply visible state II, HRQI assembly1100has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material1154is preferably characterized by the first color thereof, for example colorless and transparent, such that area1152provides an indication that a temperature of NHRQI sub-assembly1102, and thus a temperature of HRQI assembly1100, has not fallen below the lower temperature threshold.

It is appreciated that once HQRI assembly1100assumes visible state II, HRQI assembly1100preferably cannot thereafter revert to visible state I.

Preferably, each of first and second QPRCMs1140and1142is supplied in a flowable state, as indicated by waved lines inFIGS.12B &12C, to NHRQI sub-assembly1102. In order to maintain a flowable state thereof, first QPRCM1140is typically supplied to NHRQI sub-assembly1102at a temperature exceeding the first upper temperature threshold, and second QPRCM1142is typically supplied to NHRQI sub-assembly1102at a temperature exceeding the second upper temperature threshold. However, as seen particularly in enlargement circle B ofFIG.11and inFIG.12D, following supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102, HRQI assembly1100is cooled to, and maintained at, a temperature which does not exceed either the first or second upper temperature thresholds, such that both first and second QPRCMs1140are not flowable, as indicated by interlocking lines in enlargement circle B ofFIG.11and inFIG.12D.

In one embodiment of the present invention, HRCMS1090includes at least one cooling system1230. Preferably, following a supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102, HRQI assembly1100is brought into thermal contact with cooling system1230, thereby rapidly reducing the temperature of HRQI assembly1100to a temperature below both the first and second upper temperature thresholds, so that first and second QPRCMs1140and1142are no longer flowable. It is appreciated that cooling system1230preferably does not cool HRQI assembly1100to a temperature below the lower temperature threshold, and thus cold responsive coloring material1154does not change color in response to temperature conditions within cooling system1230.

In another embodiment of the present invention, cooling system1230may be obviated, and following the supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102, HRQI assembly1100may be cooled to a temperature below the first and second upper temperature thresholds, such that first and second QPRCMs1140and1142are no longer flowable, after being associated with container1190. In this embodiment, cooling of HRQI assembly1100is preferably effected by thermal contact with container1190which, at the time of the association of HRQI assembly1100therewith, is at a temperature below the first and second upper temperature thresholds. Alternatively, HRQI assembly1100may be cooled by placing HQRI assembly1100and the associated container1190in a cold storage environment, such as a refrigerator. It is appreciated that the temperature of HQRI assembly1100and associated container1190is preferably not less than the lower temperature threshold, and thus cold responsive coloring material1154does not change color in response to temperature conditions of container1190at the time of association of HQRI assembly1100with container1190.

As described hereinabove with reference toFIGS.1A-1E, NHRQI sub-assembly1102is preferably embodied as a self-adhesive label, and the association of HRQI assembly1100with container1190is preferably embodied as an affixation of HRQI assembly1100to container1190, and more particularly as an adherence of HRQI assembly1100to container1190. It is noted that the adhesive on the rear side of back portion1194of HRQI assembly1100preferably serves to affix HRQI assembly1100to container1190, and that the adhesion of HRQI assembly1100to container1190preferably serves to seal apertures1204and1206, preventing an egress of first and second QPRCMs1140and1142therefrom.

It is appreciated that in an embodiment wherein first and second QPRCMs1140and1142are supplied to NHRQI sub-assembly1102after associating NHRQI sub-assembly1102with container1190, cooling system1230is typically not included in HRCMS1090. Instead, HRQI assembly1100is cooled only after being associated with container1190. Similarly, in such an embodiment, if an aperture is included on a front or a side surface of NHRQI sub-assembly1102, the aperture may be sealed with a suitable sealant, preventing an egress of first and second QPRCMs1140and1142therefrom.

As illustrated inFIGS.12A &12B, in one embodiment of the present invention, NHRQI sub-assembly1102is not yet associated with container1190. Similarly, as illustrated inFIG.12C, immediately after the supply of first and second QPRCMs1140and1142to HRQI assembly1100, HRQI assembly1100is preferably still not associated with container1190.

As illustrated inFIG.11, in one embodiment of the present invention, HRQI assembly1100is cooled to a temperature below the first and second upper temperature thresholds before being associated with container1190, preferably by cooling system1230. In an alternative embodiment, HRQI assembly1100may be cooled by placing HQRI assembly1100and associated container1190in a cold storage environment, such as a refrigerator. Thus, the lowering of the temperatures of first and second QPRCMs1140and1142and the association of HRQI assembly1100with container1190are separate steps.

However, in another embodiment of the present invention, as illustrated inFIG.12D, HRQI assembly1100is cooled to a temperature below the first and second upper temperature thresholds only after being associated with container1190. As described hereinabove, in this embodiment, cooling of HRQI assembly1100is preferably effected by thermal contact with container1190which, at the time of the association of HRQI assembly1100therewith, is at a temperature below the first and second upper temperature thresholds. Thus, the lowering of the temperatures of first and second QPRCMs1140and1142and the association of HRQI assembly1100with container1190are achieved in a single step.

In a preferred embodiment of the present invention, HRCMS1090further includes a barcode reader1240, which preferably reads barcodes1158substantially immediately prior to an association of HRQI assembly1100or NHQRI sub-assembly1102with container1190. Barcode reader1240, upon reading barcodes1158, preferably provides information to a quality indication computer, such as quality indication computer115, which enables the quality indication computer to provide an immediate indication of a quality status of the HRQI assembly1100or NHQRI sub-assembly1102read by barcode reader1240.

If barcode reader1240provides an indication that HRQI assembly1100, or, in an undesirable case wherein one or both of first and second QPRCMs1140and1142were not supplied to NHRQI sub-assembly1102, NHRQI sub-assembly1102, is unfit for use, then the HRQI assembly1100or NHRQI sub-assembly1102is preferably discarded and is not associated with a container1190. Examples of an HRQI assembly1100or NHRQI sub-assembly1102that is unfit for use include an HRQI assembly1100or NHRQI sub-assembly1102that is in pre-supply visible state I, that is in visible state V, or that is unreadable by a typical barcode reader, for example, due to damage to barcodes1158or to a supply of only one of QPRCMs1140and1142.

In another preferred embodiment of the present invention (not shown) barcode reader1240is obviated, and is replaced with a conventional barcode reader, such as barcode reader113, mobile communicator132or mobile communicator142ofFIGS.1A-1E, which is not part of HRCMS1090.

In a preferred embodiment of the present invention, HRCMS1090further includes a container association module1260. If an indication is provided, for example by barcode reader1240or barcode reader113, that an HRQI assembly1100is fit for use, then container association module1260preferably associates that HRQI assembly1100with a container1190. In a preferred embodiment of the present invention, container association module1260positions HRQI assembly1100relative to container1190such that the adhesive on the rear side of HRQI assembly1100contacts container1190, thereby affixing HRQI assembly1100to container1190.

In the embodiment illustrated inFIG.11, barcode reader1240is shown as being part of container association module1260. Alternatively, barcode reader1240may be separate from container association module1260.

Reference is now made toFIGS.13A-13F, which are simplified illustrations of typical operative use cases of HRQI assembly1100.

It is appreciated that in the operative states shown inFIGS.13A-13E, HRQI assembly1100has not been exposed to a temperature below the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material1154is preferably characterized by the first color thereof, for example colorless and transparent.

It is further appreciated that although, for ease of understanding, dotted lines inFIGS.13A-13Findicate each of transparent areas1148and portions1180,1181,1182,1184and1186, preferably transparent areas1148and portions1180,1181,1182,1184and1186are not readily distinguishable from surrounding areas of indicator template1112and coloring material diffuser1120, respectively. Similarly, for ease of understanding, dashed lines inFIGS.13A-13Findicate area1152and transparent area1178; however, area1152and transparent area1178may not be readily distinguishable from surrounding areas of indicator template1112.

Following the supply of first and second QPRCMs1140and1142to NHRQI sub-assembly1102, and when a temperature of HRQI assembly1100exceeds the first upper temperature threshold, first QPRCM1140assumes a flowable state, as indicated by waved lines inFIG.13A. In an embodiment wherein HRQI assembly1100includes first coloring material reservoir1108, upon assuming a flowable state, first QPRCM1140is released from first coloring material reservoir1108and begins to diffuse through coloring material diffuser1120. In an embodiment wherein HRQI assembly1100does not include first coloring material reservoir1108, upon assuming a flowable state, first QPRCM1140begins to diffuse through coloring material diffuser1120.

It is appreciated that respective first, second and third over-temperature cumulative time durations from the start of diffusion of first QPRCM1140along coloring material diffuser1120until respective portions1182,1184and1186of coloring material diffuser1120become colored is defined, for example, by a length of coloring material diffuser1120between portion1180and each of portions1182,1184and1186. Additionally, these time durations are typically a function of a composition of first QPRCM1140, as well as a function of a material from which coloring material diffuser1120is made and a thickness thereof.

Similarly, an additional over-temperature cumulative time duration from the start of diffusion of second QPRCM1142along coloring material diffuser1120until portion1186of coloring material diffuser1120becomes colored is defined, for example, by a length of coloring material diffuser1120between portion1181and portion1186. Additionally, this time duration is typically a function of a composition of second QPRCM1142, as well as a function of a material from which coloring material diffuser1120is made and a thickness thereof.

It is noted that preferably, the first, second and third over-temperature cumulative time duration provide indications of times spent above a first temperature threshold, while the additional over-temperature cumulative time duration provides an indication of a time spent above a second temperature threshold, where the first temperature threshold and the second temperature thresholds are characterized by different temperatures. Thus, as used herein, “additional over-temperature cumulative time duration” typically provides an indication of exceedance of a different temperature than an indication of exceedance of a temperature indicated by the “first over-temperature cumulative time duration,” the “second over-temperature cumulative time duration” and the “third over-temperature cumulative time duration.” It is further appreciated that HRQI1100may include any suitable number of transparent areas, placed to allow indications of any suitable number of time durations spent either above the first or second temperature thresholds.

In one example, which should not be construed to be limiting, properties of first QPRCM1140, coloring material diffuser1120, and transparent areas1172and1174, such as composition and position thereof, are chosen such that that the respective first and second over-temperature cumulative time durations from the start of diffusion of first QPRCM1140along coloring material diffuser1120until first QPRCM1140colors portions1182and1184coloring material diffuser1120, which are visible through respective transparent areas1172and1174, are one hour and two hours, respectively. Additionally, in this example, properties of transparent area1176, such as position thereof, are chosen such that that the third over-temperature cumulative time duration from the start of diffusion of first QPRCM1140along coloring material diffuser1120until first QPRCM1140colors portion1186of coloring material diffuser1120, which is visible through respective transparent areas1176and1178, is four hours. Similarly, for example, properties of second QPRCM1142, coloring material diffuser1120, and transparent areas1176and1178, such as composition and position thereof, are chosen such that that the additional over-temperature cumulative time duration from the start of diffusion of second QPRCM1142along coloring material diffuser1120until second QPRCM1142colors portion1186of coloring material diffuser1120, which is visible through transparent areas1176and1178, is 30 minutes.

However, it is appreciated that properties of first QPRCM1140and coloring material diffuser1120, as well as locations of transparent areas1172,1174,1176and1178, may be chosen such that each of the first, second and third over-temperature cumulative time durations, from the start of diffusion of first QPRCM1140along coloring material diffuser1120until first QPRCM1140colors portions1182,1184and1186of coloring material diffuser1120, may be any suitable respective time duration. Similarly, properties of second QPRCM1142and coloring material diffuser1120, as well as location of transparent areas1176and1178, may be chosen such that the additional over-temperature cumulative time duration, from the start of diffusion of second QPRCM1142along coloring material diffuser1120until second QPRCM1142colors portion1186of coloring material diffuser1120, may be any suitable time duration.

As discussed hereinabove, product quality is often sensitive to different temperatures to varying extents. Specifically, a slightly elevated temperature may degrade the quality of a product more slowly than an extremely elevated temperature.

For example, if a vial of vaccine whose recommended storage temperature, in order to maintain the quality thereof, is 2 degrees Celsius, an exposure of the vial to a temperature of 8 degrees Celsius may only render the vial of vaccine unfit for use after a cumulative exposure of 4 hours. However, an exposure of the vial to a temperature of 30 degrees Celsius may cause the quality of the vaccine to reach an unusable state after a cumulative exposure of only 30 minutes. Additionally, even a very short exposure, such as an exposure of 2 seconds, of the vial to a temperature of 0 degrees Celsius, may cause the quality of the vaccine to reach an unusable state.

Typically, the first, second and third over-temperature cumulative time durations, the additional over-temperature cumulative time duration, as well as the first upper temperature threshold, second upper temperature threshold and lower temperature threshold, are chosen based on the requirements of contents of container1190. For example, an HRQI assembly1100for association with a flu vaccine may have a lower temperature limit of 2 degrees Celsius, while an HRQI assembly1100for association with a COVID-19 vaccine may have a lower temperature limit of −70 degrees Celsius. Similarly, an HRQI assembly1100for association with a package of frozen meat may have respective first, second and third over-temperature cumulative time durations of one hour, two hours and four hours for a first upper temperature limit of 8 degrees Celsius, and an additional over-temperature cumulative time duration of 30 minutes for a second upper temperature limit of 30 degrees Celsius, while an HRQI assembly1100for association with a package of fresh meat may have respective first, second and third over-temperature cumulative time durations of 30 minutes, 45 minutes and one hour for a first upper temperature limit of 10 degrees Celsius, and an additional over-temperature cumulative time duration of 15 minutes for a second upper temperature limit of 30 degrees Celsius.

Turning particularly toFIG.13A, it is seen that when a temperature of container1190, and of HRQI assembly1100associated therewith, exceeds the first upper temperature threshold, but not the second upper temperature threshold, for less than the first over-temperature cumulative time duration, first QPRCM1140begins to diffuse through coloring material diffuser1120beyond portion1180in a direction toward portion1182, while second QPRCM1142remains in a non-flowable state. However, as long as a temperature of container1190and of HRQI assembly1100associated therewith does not exceed the first upper temperature threshold for at least the first over-temperature cumulative time duration, first QPRCM1140preferably does not color portion1182.

Thus, as long as a temperature of container1190and of HRQI assembly1100associated therewith does not exceed the first upper temperature threshold for at least the first over-temperature cumulative time duration, and does not exceed the second upper temperature threshold for the additional over-temperature cumulative time duration, none of portions1182,1184and1186become colored, and thus none of transparent areas1172,1174,1176and1178appear colored, and HRQI assembly1100remains in visible state II, in which preferably only barcode1162is in a readable state.

In contrast, as seen particularly toFIG.13B, when a temperature of container1190and of HRQI assembly1100associated therewith exceeds the first upper temperature threshold, but not the second upper temperature threshold, for at least the first over-temperature cumulative time duration, first QPRCM1140diffuses through portions of coloring material diffuser1120, including portion1182, while second QPRCM1142remains in a non-flowable state.

Thus, when a temperature of container1190and of HRQI assembly1100associated therewith exceeds the first upper temperature threshold, but not the second upper temperature threshold, for at least the first over-temperature cumulative time duration, the color visible through transparent area1172is determined by the color of first QPRCM1140. As seen particularly inFIG.13B, upon a coloring of portion1182by black QPRCM1140, transparent area1172shows a black color, and HRQI assembly1100thus preferably assumes visible state III.

It is appreciated that the coloring of portion1182by first QPRCM1140, and thus the changing of the color visible through transparent area1172, changes an appearance of HRQI assembly1100, and more particularly, changes an appearance of barcode1162and of barcode1164.

In visible state III, transparent areas1170,1171and1172show a color similar to the color of bars of barcodes1158, while transparent areas1174,1176and1178remain uncolored. Therefore, barcodes1160,1162,1166and1168are preferably unreadable by a conventional barcode reader, while barcode1164is readable by a conventional barcode reader. Thus, HRQI assembly1100in visible state III presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode1164having numerical sequence 7290003804122.

Additionally, in visible state III, HRQI assembly1100has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material1154is preferably characterized by the first color thereof, for example colorless and transparent, and area1152provides an indication that a temperature of NHRQI sub-assembly1102, and thus a temperature of HRQI assembly1100, has not fallen below the lower temperature threshold.

It is appreciated that once HRQI assembly1100assumes visible state III, HRQI assembly1100preferably cannot thereafter revert to either of states I or II, notwithstanding that the temperature of HRQI assembly1100and associated container1190subsequently drops below the first upper temperature threshold.

It is additionally appreciated that once having been supplied to NHRQI sub-assembly1102, first QPRCM1140is operative to assume a non-flowable state upon HRQI assembly1100being exposed to a temperature below the first upper temperature threshold, regardless of a visible state then displayed by HRQI assembly1100. Similarly, once having been supplied to NHRQI sub-assembly1102, first QPRCM1140is operative to assume a flowable state upon HRQI assembly1100being exposed to a temperature exceeding the first upper temperature threshold, regardless of a visible state then displayed by HRQI assembly1100.

It is appreciated that once HQRI assembly has assumed visible state III, HRQI assembly1100will continue to display visible state III even if the second upper temperature threshold is exceeded and second QPRCM1142begins to diffuse beyond portion1181, as long as the second upper temperature threshold has not been exceeded for the additional over-temperature cumulative time duration and second QPRCM1142does not reach portion1186.

Turning now particularly toFIG.13C, it is seen that following an elapse of an additional time duration at a temperature exceeding the first upper temperature threshold, such that the total cumulative elapsed time is at least the second over-temperature cumulative time duration, first QPRCM1140diffuses further through coloring material diffuser1120, including through portion1184.

Thus, when a temperature of container1190and of HRQI assembly1100associated therewith exceeds the first upper temperature threshold for at least the second over-temperature cumulative time duration, but does not exceed the second upper temperature threshold for at least the additional over-temperature cumulative time duration, the color visible through transparent area1174is determined by the color of first QPRCM1140. As seen particularly inFIG.13C, upon a coloring of portion1184by black first QPRCM1140, transparent area1174shows a black color, and HRQI assembly1100thus preferably assumes visible state IIIa.

It is appreciated that the coloring of portion1184by first QPRCM1140, and thus the changing of the color visible through transparent area1174, changes an appearance of HRQI assembly1100, and more particularly, changes an appearance of barcode1164and of barcode1166.

In visible state IIIa, transparent areas1170,1171,1172and1174show a color similar to the color of bars of barcodes1158, while transparent areas1176and1178remains uncolored. Therefore, barcodes1160,1162,1164and1168are preferably unreadable by a conventional barcode reader, while barcode1166is readable by a conventional barcode reader. Thus, HRQI assembly1100in visible state IIIa presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode1166having numerical sequence 7290003804115.

Additionally, in visible state IIIa, HRQI assembly1100has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material1154is preferably characterized by the first color thereof, for example colorless and transparent, and area1152provides an indication that a temperature of NHRQI sub-assembly1102, and thus a temperature of HRQI assembly1100, has not fallen below the lower temperature threshold.

It is appreciated that once HRQI assembly1100assumes visible state IIIa, HRQI assembly1100preferably cannot thereafter revert to any of states I, II and III, notwithstanding that the temperature of HRQI assembly1100and associated container1190subsequently drops below the first upper temperature threshold.

It is appreciated that once HQRI assembly has assumed visible state IIIa, HRQI assembly1100will continue to display visible state IIIa even if the second upper temperature threshold is exceeded and second QPRCM1142begins to diffuse beyond portion1181, as long as the second upper temperature threshold has not been exceeded for the additional over-temperature cumulative time duration and second QPRCM1142does not reach portion1186.

Turning now particularly toFIG.13D, it is seen that following an elapse of an additional time duration at a temperature exceeding the first upper temperature threshold, such that the total cumulative elapsed time is at least the third over-temperature cumulative time duration, first QPRCM1140diffuses further through coloring material diffuser1120, including through portion1186.

Thus, when a temperature of container1190and of HRQI assembly1100associated therewith exceeds the first upper temperature threshold for at least the third over-temperature cumulative time duration, the color visible through transparent areas1176and1178is determined by the color of first QPRCM1140. As seen particularly inFIG.13D, upon a coloring of portion1186by black first QPRCM1140, transparent areas1176and1178each show a black color, and HRQI assembly1100thus preferably assumes visible state IV.

It is appreciated that the coloring of portion1186by first QPRCM1140, and thus the changing of the color visible through transparent areas1176and1178, changes an appearance of HRQI assembly1100, and more particularly, changes an appearance of barcodes1162,1164,1166, barcode1168, and of the human sensible indicium of transparent area1178.

In visible state IV each of transparent areas1170,1171,1172,1174and1176shows a color similar to the color of bars of barcodes1158. Therefore, barcodes1160,1162,1164and1166are preferably unreadable by a conventional barcode reader, while barcode1168is readable by a conventional barcode reader. Thus, upon exposure of container1190and of HRQI assembly1100associated thereto to a temperature exceeding the first upper temperature threshold for at least the third over-temperature cumulative time duration, HRQI assembly1100assumes visible state IV. In visible state IV, HRQI assembly1100preferably presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode1168having numerical sequence 7290003804139.

Additionally, in visible state IV, transparent area1178provides a human sensible indication that a temperature of HRQI assembly1100has exceeded either the first upper temperature threshold for the third over-temperature cumulative time duration or the second upper temperature threshold for the additional over-temperature cumulative time duration. As noted above, in a preferred embodiment of the present invention, HRQI assembly1100includes explanatory features, such as text and/or graphics, explaining at least one visible appearance of transparent area1178. For example, in the illustrated embodiment, HRQI assembly1100includes message1228, with the text “DISCARD IF DARKENED→”, adjacent to transparent area1178.

Thus, message1228indicates to a user that if a color visible through transparent area1178, as determined by a color of portion1186of coloring material diffuser1120, is similar to a background color of indicator template1112, then a temperature of HRQI assembly1100has not exceeded either the first upper temperature threshold for the third over-temperature cumulative time duration or the second upper temperature threshold for the additional over-temperature cumulative time duration. Similarly, message1228indicates to a user that if a color visible through transparent area1178is not the same as the background color of indicator template1112, such as the color of first QPRCM1140or second QPRCM1142, then a temperature of HRQI assembly1100has exceeded either the first upper temperature threshold for the third over-temperature cumulative time duration or the second upper temperature threshold for the additional over-temperature cumulative time duration, and container1190with which HRQI assembly1100is associated should be discarded.

In a preferred embodiment of the present invention, as described above, if either one or both of areas1152and1178indicates an unsuitable environment experienced by HRQI assembly1100, then the product being monitored by HRQI assembly1100is not fit for use. Preferably, information is included with HRQI assembly1100, either as instructions separate from HRQI assembly1100or as instructions forming part of HRQI assembly1100, indicating to a user and/or a machine reading HRQI assembly1100that HRQI assembly1100is not fit for use if either one or both of areas1152and1178indicates that HRQI assembly1100has experienced an unsuitable environment for an unsuitable amount of time.

It is appreciated that in the embodiment illustrated inFIGS.11-13F, transparent area1178preferably additionally provides a machine-sensible indication of whether or not a temperature of HRQI assembly1100has exceeded either the first upper temperature threshold for the third over-temperature cumulative time duration or the second upper temperature threshold for the additional over-temperature cumulative time duration. Preferably, a system such as a suitably programmed machine vision system is operative to assess a color visible in transparent area1178and provide a suitable indication based thereon.

Additionally, in visible state IV, HRQI assembly1100has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material1154is preferably characterized by the first color thereof, for example colorless and transparent, and area1152provides an indication that a temperature of NHRQI sub-assembly1102, and thus a temperature of HRQI assembly1100, has not fallen below the lower temperature threshold.

It is appreciated that once HRQI assembly1100assumes visible state IV, HRQI assembly1100preferably cannot thereafter assume any of states I, II, III and IIIa, notwithstanding that the temperature of HRQI assembly1100and associated container1190subsequently drops below the first upper temperature threshold.

Similarly, as seen particularly toFIG.13E, when a temperature of container1190, and of HRQI assembly1100associated therewith, exceeds the second upper temperature threshold for at least the additional over-temperature cumulative time duration, second QPRCM1142diffuses through coloring material diffuser1120beyond portion1181, including through portion1186.

Thus, the color visible through transparent areas1176and1178is determined by the color of second QPRCM1142. In the example shown inFIGS.13A-13F, as seen particularly inFIG.13E, upon a coloring of portion1186by second QPRCM1142, transparent areas1176and1178show a black color, and HRQI assembly1100thus preferably assumes visible state IV.

It is appreciated that the coloring of portion1186by second QPRCM1140, and thus the changing of the color visible through transparent areas1176and1178, changes an appearance of HRQI assembly1100, and more particularly, changes an appearance of barcodes1162,1164,1166and1168, and of the human sensible indicium of transparent area1178.

In visible state IV, each of transparent areas1170,1171,1172,1174and1176shows a color similar to the color of bars of barcodes1158. Therefore, barcodes1160,1162,1164and1166are preferably unreadable by a conventional barcode reader, while barcode1168is readable by a conventional barcode reader. Thus, upon exposure of container1190and of HRQI assembly1100associated thereto to a temperature exceeding the second upper temperature threshold for at least the additional over-temperature cumulative time duration, HRQI assembly1100assumes visible state IV. As described hereinabove with reference toFIG.13D, in visible state IV, HRQI assembly1100preferably presents a single machine-readable barcode typically readable by a conventional barcode reader, here exemplified as barcode1168having numerical sequence 7290003804139.

Additionally, in visible state IV, transparent area1178provides a human sensible indication that a temperature of HRQI assembly1100has exceeded either the second upper temperature threshold for the additional over-temperature cumulative time duration or the first upper temperature threshold for the third over-temperature cumulative time duration.

Additionally, in visible state IV, HRQI assembly1100has preferably not been exposed to a temperature less than the lower temperature threshold for at least the under-temperature time duration. Therefore, cold responsive coloring material1154is preferably characterized by the first color thereof, for example colorless and transparent, and area1152provides an indication that a temperature of NHRQI sub-assembly1102, and thus a temperature of HRQI assembly1100, has not fallen below the lower temperature threshold.

As noted above with reference toFIG.13D, once HRQI assembly1100assumes visible state IV, HRQI assembly1100preferably cannot thereafter assume any of states I, II, III and IIIa, notwithstanding that the temperature of HRQI assembly1100and associated container1190subsequently drops below the second or first upper temperature threshold.

Turning now particularly toFIG.13F, it is seen that when a temperature of container1190and of HRQI assembly1100associated therewith falls below the lower temperature threshold for at least the under-temperature time duration, cold responsive coloring material1154irreversibly assumes the second color, and HRQI assembly1100assumes visible state V.

It is appreciated that the assumption of the second color by cold responsive coloring material1154changes an appearance of HRQI assembly1100, and more particularly, changes an appearance of the human sensible indicium of area1152. As described hereinabove, cold responsive coloring material1154is characterized by the second color thereof, thus providing a human sensible indication that a temperature of NHRQI sub-assembly1102, and thus a temperature of HRQI assembly1100, has fallen below the lower temperature threshold for the under-temperature time duration and container1190with which HRQI assembly1100is associated should be discarded.

It is noted that in the embodiment illustrated inFIGS.13A-13F, the color assumed by cold responsive coloring material1154does not typically affect an appearance or readability of any of barcodes1160,1162,1164,1166and1168. Additionally, in visible state V, transparent areas1148may show any color, since, regardless of a color visible through any of transparent areas1148, the second color of cold responsive coloring material1154in area1152preferably provides an indication that a temperature of NHRQI sub-assembly1102, and thus a temperature of HRQI assembly1100, has fallen below the lower temperature threshold for the under-temperature time duration.

As described hereinabove with reference toFIGS.11-12D, area1152preferably additionally may provide a machine-sensible indication of whether or not a temperature of NHRQI sub-assembly1102, and thus a temperature of HRQI assembly1100, has fallen below the lower temperature threshold for the under-temperature time duration. Preferably, a system such as a suitably programmed machine vision system is operative to assess a color visible in area1152and provide a suitable indication based thereon. More specifically, in visible state V cold responsive coloring material1154is characterized by the second color thereof, which preferably indicates to the suitably programmed machine vision system that a temperature of NHRQI sub-assembly1102, and thus a temperature of HRQI assembly1100, has fallen below the lower temperature threshold for the under-temperature time duration.

Thus, upon exposure of container1190and of HRQI assembly1100associated therewith to a temperature below the lower temperature threshold for at least the under-temperature time duration, HRQI assembly1100assumes visible state V, in which a human- and machine-sensible indication is provided that a temperature of NHRQI sub-assembly1102, and thus a temperature of HRQI assembly1100, has fallen below the lower temperature threshold for the under-temperature time duration.

It is appreciated that once HRQI assembly1100assumes visible state V, HRQI assembly1100preferably cannot thereafter revert to any of states I, II, III, IIIa and IV, notwithstanding that the temperature of HRQI assembly1100and associated container1190subsequently exceeds the lower temperature threshold, or even the first or second upper temperature thresholds.

It is noted that while it is typically undesirable to associate container1190to NHRQI sub-assembly1102to which first and second QPRCMs1140and1142have not been supplied, in the illustrated embodiment of the present invention, NHRQI sub-assembly1102without one or both of first and second QPRCMs140and1142may be operative to assume visible state V when a temperature thereof has fallen below the lower temperature threshold for the under-temperature time duration.

Alternatively, HRQI assembly1100may include, instead of NHRQI sub-assembly1102, an initial heat responsive quality indicator (IHRQI) sub-assembly (not shown), similar to NHRQI sub-assembly1102, including at least one coloring material diffuser, such as a coloring material diffuser1120and at least one indicator template, such as an indicator template1112. In contrast to NHRQI sub-assembly1102, in this alternative embodiment, the IHRQI sub-assembly also includes at least a first heat responsive coloring material (HRCM), corresponding to second QPRCM1142, which is flowable at a first temperature exceeding a first upper temperature threshold. It is appreciated that unlike second QPRCM1142, which is preferably injected into NHRQI sub-assembly1102, the first HRCM may be supplied to the IHRQI sub-assembly in any suitable manner.

In this embodiment, HRQI assembly1100further includes a second HRCM, corresponding to first QPRCM1140, which, when supplied to the coloring material diffuser of the IHRQI sub-assembly, preferably by injection, preferably converts the IHRQI sub-assembly to HRQI assembly1100. Thus, in this embodiment, HRQI assembly1100is formed by supplying the second HRCM to the IHRQI sub-assembly, preferably by injecting the second HRCM into the IHRQI sub-assembly.

Typically, in this embodiment, the first upper temperature threshold of HRQI1100is higher than the second upper temperature threshold of HRQI1100. For example, the first upper temperature threshold may be 45 degrees Celsius, and the second upper temperature threshold may be 8 degrees Celsius. In contrast to the embodiment shown inFIGS.11-13F, in this embodiment, the first HRCM is supplied to the IHRQI sub-assembly at the time of manufacture of the IHRQI sub-assembly, because the first upper temperature threshold of the first HRCM is typically a temperature higher than ambient temperatures normally experienced during standard storage, shipping and handling of the IHRQI sub-assembly, and thus maintaining the IHRQI sub-assembly at temperatures below the first upper temperature threshold is typically neither difficult nor expensive. However, since temperatures normally experienced during standard storage, shipping and handling of the IHRQI assembly may often exceed the second upper temperature threshold of the second HRCM, the second HRCM is injected into the IHRQI sub-assembly substantially immediately prior to an association of HRQI assembly1100of this embodiment with a container, thereby reducing the effort and cost associated with maintaining the IHRQI sub-assembly at a temperature below the second upper temperature threshold.

Reference is now made toFIGS.14,15A &15B, of whichFIGS.15A &15Bare simplified illustrations of typical operative use cases of an HRQI assembly1400andFIG.14is a simplified illustration of a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly1402from which HRQI assembly1400is constructed. It is appreciated that HRQI assembly1400is preferably constructed in a similar manner to HRQI assembly800, as described hereinabove with reference toFIGS.8-9D, and features of HRQI assembly1400which are the same as corresponding features of HRQI assembly800are indicated with corresponding reference numbers.

It is further appreciated that NHRQI sub-assembly1402is preferably operative to assume visible state I corresponding to visible state I assumed by NHRQI sub-assembly802, and HRQI assembly1400is preferably operative to assume visible states II, III, IV and V corresponding to the visible states II, III, IV and V which are operative to be assumed by HRQI assembly800. However, while in the embodiment shown inFIGS.8-10Eof the present invention visible state III assumed by HRQI assembly800is preferably associated with only a warning regarding use of a product in container890, visible state III assumed by HRQI assembly1400, seen inFIG.15A, is preferably associated with an indication that container890should be discarded. For the sake of conciseness, HRQI assembly1400is not illustrated having assumed visible states II or V, although it is noted that HRQI assembly1400is preferably operative to assume these states.

As seen inFIGS.14-15B, HRQI assembly1400preferably includes an NHRQI sub-assembly1402including at a first coloring material reservoir1408and a second coloring material reservoir1410, at least one indicator template1412, a first coloring material diffuser1420and a second coloring material diffuser1422. Preferably first coloring material diffuser1420is in liquid communication with first coloring material reservoir1408, and a second coloring material diffuser1422is in liquid communication with second coloring material reservoir1410.

In the illustrated embodiment shown inFIGS.14-15B, first coloring material reservoir1408is supplied with a first quality parameter responsive coloring material (QPRCM)1440, and second coloring material reservoir1410is supplied with a second quality parameter responsive coloring material (QPRCM)1444. In another embodiment of the present invention, at least one of first and second QPRCMs1440and1442is supplied directly to the corresponding at least one of first and second coloring material diffusers1420and1422, and the corresponding at least one of first and second coloring material reservoirs1408and1410may be obviated. In a preferred embodiment of the present invention, each of first and second QPRCMs1440and1442is an HRCM, which is flowable at a temperature exceeding a first and second upper temperature threshold, respectively, as indicated by waved lines in corresponding figures.

In a preferred embodiment of the present invention, HRQI assembly1400is formed by supplying first QPRCM1440and second QPRCM1442to NHRQI sub-assembly1402, and more preferably by injecting first QPRCM1440and second QPRCM1442into NHRQI sub-assembly1402.

First QPRCM1440is characterized by a viscosity and melting point such that first QPRCM1440is flowable through or on first coloring material diffuser1420at temperatures above a first upper temperature threshold and is not flowable through or on first coloring material diffuser1420at temperatures below the first upper temperature threshold. Similarly, second QPRCM1442is characterized by a viscosity and melting point such that second QPRCM1442is flowable through or on second coloring material diffuser1422at temperatures above a second upper temperature threshold and is not flowable through or on second coloring material diffuser1422at temperatures below the second upper temperature threshold. Both first QPRCM1440and second QPRCM1442are preferably characterized by respective colors that are readily distinguishable from a color of each of respective first and second coloring material diffusers1420and1422.

It is appreciated that in the embodiment shown inFIGS.14-15B, HRQI assembly1400includes both first and second coloring material diffusers1420and1422, which are preferably not in liquid communication with one another. Therefore, portion884of second coloring material diffuser1422is preferably operative to be colored only by second QPRCM1442, and not by first QPRCM1440. This is in contrast with the embodiment illustrated inFIGS.8-10Eand described hereinabove, which includes a single coloring material diffuser820, thereby allowing portion884of coloring material diffuser820to be colored by either one or both of first and second QPRCMs840and842.

Unlike in the embodiment illustrated inFIGS.8-10E, in the embodiment illustrated inFIGS.14-15B, visible state IV can only be assumed when a temperature of container890and of HRQI assembly1400associated therewith exceeds the second upper temperature threshold for at least the additional over-temperature cumulative time duration, thereby causing portion884to become colored by second QPRCM1442.

Alternatively, HRQI assembly1400may include, instead of NHRQI sub-assembly1402, an initial heat responsive quality indicator (IHRQI) sub-assembly (not shown), similar to NHRQI sub-assembly1402, including at least a first coloring material diffuser, such as a coloring material diffuser1422, at least a second coloring material diffuser, such as a coloring material diffuser1420, and at least one indicator template, such as an indicator template1412. In contrast to NHRQI sub-assembly1402, in this alternative embodiment, the IHRQI sub-assembly also includes at least a first heat responsive coloring material (HRCM), corresponding to second QPRCM1442, which is flowable at a first temperature exceeding a first upper temperature threshold. It is appreciated that unlike second QPRCM1442, which is preferably injected into NHRQI sub-assembly1402, the first HRCM may be supplied to the IHRQI sub-assembly in any suitable manner.

In this embodiment, HRQI assembly1400further includes a second HRCM, corresponding to first QPRCM1440, which, when supplied to the coloring material diffuser of the IHRQI sub-assembly, preferably by injection, preferably converts the IHRQI sub-assembly to HRQI assembly1400. Thus, in this embodiment, HRQI assembly1400is formed by supplying the second HRCM to the IHRQI sub-assembly, preferably by injecting the second HRCM into the IHRQI sub-assembly.

Typically, in this embodiment, the first upper temperature threshold of HRQI1400is higher than the second upper temperature threshold of HRQI1400. For example, the first upper temperature threshold may be 45 degrees Celsius, and the second upper temperature threshold may be 8 degrees Celsius. In contrast to the embodiment shown inFIGS.14-15B, in this embodiment, the first HRCM is supplied to the IHRQI sub-assembly at the time of manufacture of the IHRQI sub-assembly, because the first upper temperature threshold of the first HRCM is typically a temperature higher than ambient temperatures normally experienced during standard storage, shipping and handling of the IHRQI sub-assembly, and thus maintaining the IHRQI sub-assembly at temperatures below the first upper temperature threshold is typically neither difficult nor expensive. However, since temperatures normally experienced during standard storage, shipping and handling of the IHRQI assembly may often exceed the second upper temperature threshold of the second HRCM, the second HRCM is injected into the IHRQI sub-assembly substantially immediately prior to an association of HRQI assembly1400of this embodiment with a container, thereby reducing the effort and cost associated with maintaining the IHRQI sub-assembly at a temperature below the second upper temperature threshold.

Reference is now made toFIGS.16,17A &17B, of whichFIGS.17A &17Bare simplified illustrations of typical operative use cases of an HRQI assembly1700andFIG.16is a simplified illustration of a shelf-stable, non-heat responsive quality indicator (NHRQI) sub-assembly1702from which HRQI assembly1700is constructed. It is appreciated that HRQI assembly1700is preferably constructed in a similar manner to HRQI assembly1100, as described hereinabove with reference toFIGS.11-12D, and features of HRQI assembly1700which are the same as corresponding features of HRQI assembly1100are indicated with corresponding reference numbers.

It is further appreciated that NHRQI sub-assembly1702is preferably operative to assume visible state I corresponding to visible state I assumed by NHRQI sub-assembly1102, and HRQI assembly1700is preferably operative to assume visible states II, III, IIIa, IV and V, corresponding to the visible states II, III, IIIa, IV and V which are operative to be assumed by HRQI assembly1100. However, while in the embodiment illustrated inFIGS.11-13Fof the present invention visible state IIIa assumed by HRQI assembly1100is preferably associated with only a warning regarding use of a product in container1190, while the visible state IIIa assumed by HRQI assembly1700, seen inFIG.17A, is preferably associated with an indication that container1190should be discarded. For the sake of conciseness, HRQI assembly1700is not illustrated having assumed any of visible states II, IIIa and V, although it is noted that HRQI assembly1700is preferably operative to assume these states.

As seen inFIGS.16-17B, HRQI assembly1700preferably includes an NHRQI sub-assembly1702including at a first coloring material reservoir1708and a second coloring material reservoir1710, at least one indicator template1712, a first coloring material diffuser1720and a second coloring material diffuser1722. Preferably first coloring material diffuser1720is in liquid communication with first coloring material reservoir1708, and a second coloring material diffuser1722is in liquid communication with second coloring material reservoir1710.

In the embodiment illustrated inFIGS.16-17B, first coloring material reservoir1708is supplied with a first quality parameter responsive coloring material (QPRCM)1740, and in second coloring material reservoir1710is supplied with a second quality parameter responsive coloring material (QPRCM)1742. In another embodiment of the present invention, at least one of first and second QPRCMs1740and1742is supplied directly to the corresponding at least one of first and second coloring material diffusers1720and1722, and the corresponding at least one of first and second coloring material reservoirs1708and1710may be obviated. In a preferred embodiment of the present invention, each of first and second QPRCMs1740and1742is an HRCM, which is flowable at a temperature exceeding a first and second upper temperature threshold, respectively, as indicated by waved lines in corresponding figures.

In a preferred embodiment of the present invention, HRQI assembly1700is formed by supplying first QPRCM1740and second QPRCM1742to NHRQI sub-assembly1702, and more preferably by injecting first QPRCM1740and second QPRCM1742into NHRQI sub-assembly1702.

First QPRCM1740is characterized by a viscosity and melting point such that first QPRCM1740is flowable through or on first coloring material diffuser1720at temperatures above a first upper temperature threshold and is not flowable through or on first coloring material diffuser1720at temperatures below the first upper temperature threshold. Similarly, second QPRCM1742is characterized by a viscosity and melting point such that second QPRCM1742is flowable through or on second coloring material diffuser1722at temperatures above a second upper temperature threshold and is not flowable through or on second coloring material diffuser1722at temperatures below the second upper temperature threshold. Both first QPRCM1740and second QPRCM1742are preferably characterized by respective colors that are readily distinguishable from a color of each of respective first and second coloring material diffusers1720and1722.

It is appreciated that in the embodiment shown inFIGS.16-17B, HRQI assembly1700includes both first and second coloring material diffusers1720and1722, which are preferably not in liquid communication with one another. Therefore, portion1186of second coloring material diffuser1722is preferably operative to be colored only by second QPRCM1742, and not by first QPRCM1740. This is in contrast with the embodiment shown inFIGS.11-13Fand described hereinabove, which includes a single coloring material diffuser1120, thereby allowing portion1186of coloring material diffuser1120to be colored by either one or both of first and second QPRCMs1140and1142.

Unlike in the embodiment shown inFIGS.11-13F, in the embodiment shown inFIGS.16-17B, visible state IV can only be assumed when a temperature of container1190and of HRQI assembly1700associated therewith exceeds the second upper temperature threshold for at least the additional over-temperature cumulative time duration, thereby causing portion1186to become colored by second QPRCM1742.

Alternatively, HRQI assembly1700may include, instead of NHRQI sub-assembly1702, an initial heat responsive quality indicator (IHRQI) sub-assembly (not shown), similar to NHRQI sub-assembly1702, including at least a first coloring material diffuser, such as a coloring material diffuser1722, at least a second coloring material diffuser, such as a coloring material diffuser1720, and at least one indicator template, such as an indicator template1712. In contrast to NHRQI sub-assembly1702, in this alternative embodiment, the IHRQI sub-assembly also includes at least a first heat responsive coloring material (HRCM), corresponding to second QPRCM1742, which is flowable at a first temperature exceeding a first upper temperature threshold. It is appreciated that unlike second QPRCM1742, which is preferably injected into NHRQI sub-assembly1702, the first HRCM may be supplied to the IHRQI sub-assembly in any suitable manner.

In this embodiment, HRQI assembly1700further includes a second HRCM, corresponding to first QPRCM1740, which, when supplied to the coloring material diffuser of the IHRQI sub-assembly, preferably by injection, preferably converts the IHRQI sub-assembly to HRQI assembly1700. Thus, in this embodiment, HRQI assembly1700is formed by supplying the second HRCM to the IHRQI sub-assembly, preferably by injecting the second HRCM into the IHRQI sub-assembly.

Typically, in this embodiment, the first upper temperature threshold of HRQI1700is higher than the second upper temperature threshold of HRQI1700. For example, the first upper temperature threshold may be 45 degrees Celsius, and the second upper temperature threshold may be 8 degrees Celsius. In contrast to the embodiment shown inFIGS.16-17B, in this embodiment, the first HRCM is supplied to the IHRQI sub-assembly at the time of manufacture of the IHRQI sub-assembly, because the first upper temperature threshold of the first HRCM is typically a temperature higher than ambient temperatures normally experienced during standard storage, shipping and handling of the IHRQI sub-assembly, and thus maintaining the IHRQI sub-assembly at temperatures below the first upper temperature threshold is typically neither difficult nor expensive. However, since temperatures normally experienced during standard storage, shipping and handling of the IHRQI assembly may often exceed the second upper temperature threshold of the second HRCM, the second HRCM is injected into the IHRQI sub-assembly substantially immediately prior to an association of HRQI assembly1700of this embodiment with a container, thereby reducing the effort and cost associated with maintaining the IHRQI sub-assembly at a temperature below the second upper temperature threshold.

It is noted that some visible states are associated with the terms “first,” “second” and “third” herein. Such ordinal terms are used for convenience only, and do not imply a particular order of assumption of such states. Similarly, such ordinal terms do not imply a dependency between states. Thus, in some embodiments of the present invention an HRQI assembly may be operative to assume, for example, only a second state and not a first state, or only a first and third state, but not a second state.

It is noted that some thresholds are associated with the terms “first,” “second” and “third” herein. Such ordinal terms are used for convenience only, and do not imply a particular order of such thresholds. Similarly, such ordinal terms do not imply any relationship between thresholds.

It is additionally noted that the term “temperature threshold” as used herein may be embodied as a range of temperatures rather than as a single temperature value. For example, the term “upper temperature threshold” as used herein is typically embodied as a range of temperatures. Typically, the upper temperature threshold includes a first temperature value at which the QPRCM changes from a non-flowable state to a flowable state, and a second temperature value, most typically different from the first temperature value, at which the QPRCM changes from a flowable state to a non-flowable state.

It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and sub-combinations of various features of the invention and modifications thereof which may occur to persons skilled in the art upon reading the foregoing description and which are not in the prior art.