Patent Description:
The present invention pertains to the art of testing the integrity of seals associated with various packaging or containers. Particularly, the present invention is directed to using a dynamic vacuum decay method and control system for detecting a leak in a package.

Flexible package leak testing is often performed using the vacuum decay test method. Vacuum is drawn on a package in a test chamber and the vacuum level is monitored. For flexible packaging the use of a flexible membrane is often used. Testing low headspace packaging is often challenging, as the air within a low volume package can be evacuated before a leak can be detected.

In order to detect leaks in a low volume flexible package, the test must be performed such that the internal volume of the package is not completely evacuated before the test measurement occurs. If vacuum is not pulled effectively on the test chamber, it is possible that all air could be evacuated from a package and the defect could go undetected. Thus, large leaks in a low headspace package may not be detected.

With reference to <FIG>, the traditional vacuum decay pulls vacuum until a timer has been triggered or a vacuum level has been reached. In test methods that use a specific timer, a package that is defective can bleed all the air out during the evacuation cycle (<FIG>, correct positive) and there is no more air to leak out. A package that may be non-leaking but requires more time for the test chamber to be evacuated would not reach vacuum in the allotted time, and may even be detected as a leak (<FIG>, false negative). Non-dynamic filling based on a timer is not reliable in pulling vacuum to the target vacuum level and detecting critical leaks while passing good samples.

The general approach of pulling vacuum until the target vacuum level is reached is also not reliable as the large leaks will have leaked the air out during the evacuation cycle while also slowing down the evacuation process. Once the target vacuum level is reached, the defect has no air remaining inside and there is no leak that can be measured.

<CIT>, regarded as the closest prior art, discloses a method and a test system for leak testing of liquid and non-liquid filled rigid and semi-rigid non-porous containers. The container is enclosed in a conforming test chamber and subjected to vacuum while the pressure within the chamber is monitored by an absolute pressure transducer, alone or in combination with a second differential transducer, to determine if leaks are present in the container. The test system remains under low pressure or vacuum conditions while leak tests are not actively in progress such that the system is maintained at an at-rest low vacuum condition to minimize pressure sensor drift and to eliminate build-up of vapours or gases within test system between tests that may hinder the speed and sensitivity of the leak tests. In the method of testing for package leaks in the test system the package is placed in the test chamber and air is evacuated from the test chamber by a vacuum source. Then, as the test system approaches a target pressure, a trigger pressure is detected, wherein the trigger pressure is higher than the target pressure. Then, the test chamber is isolated from the vacuum source and subsequently the test detecting the presence or absence of a leak in the package based on pressure measurements in the test system is initiated and performed via monitoring both the absolute and the differential pressures.

Embodiments of the present invention are directed to a vacuum leak test operated using a vacuum decay control system and a test chamber. The present invention is directed to a method and testing apparatus for detecting even sub-visible leaks in non-porous containers including, but not limited to, chemical and/or medicinal containing vials, pouches, blister packs, ampoules, syringes, injection cartridges and ophthalmic packages. In a method of the invention, a partially or completely filled container is placed within a leak-tight and sealed test chamber. After the container is placed within the test chamber and the chamber sealed, a vacuum is pulled within the system plus the chamber by a vacuum pump, with the vacuum level being monitored through a series of sequential test periods using a pressure transducer. In order to improve leak detection and minimize incorrect test results, methods of the present invention provide a dynamic vacuum decay test method wherein vacuum decay in the test chamber is dynamically controlled using a timer in cooperation with a pressure feedback control system, such that isolation of the test chamber from the vacuum source is delayed based upon detection of a predetermined pressure level in conjunction with the timer.

In one embodiment of the present invention, a method of testing for package leaks by a test system that includes a vacuum source, a test chamber in which a package is received for testing, and a valve for selectively isolating the test chamber from the vacuum source, comprises placing a package in the test chamber, drawing a vacuum on the test chamber by the vacuum source, detecting a predetermined pressure level in the test system, based upon the detection of the predetermined pressure level, determining when to stop drawing the vacuum on the test chamber, isolating the test chamber from the vacuum source based upon the determination, and subsequently detecting the presence or absence of a leak in the package based on pressure measurements in the test chamber.

The method comprises determining when to stop drawing the vacuum by initiating a timer, and wherein the test chamber is isolated from the vacuum source after expiration of the timer. By way of example and not limitation, the timer may expire after <NUM> second. The test system includes a microcontroller to monitor the pressure level and initiate the timer, wherein the microcontroller dynamically determines when to initiate the timer based on the measured pressure level. In some embodiments, the predetermined pressure level may be 700mbar.

In some embodiments the test chamber may be, for example, a rigid test chamber or a flexible test chamber, and the container may be, for example, a flexible package, non-porous vial, ampoules injection cartridge, ophthalmic product package, syringe, pouch, blister package, and medicinal packaging.

In another embodiment of the present invention, a method of testing completely or partially liquid product filled or dry product filled rigid and semi-rigid nonporous containers for leaks, including headspace gas leaks and/or vapor leaks derived from package contents, using at least one pressure transducer in a testing system that includes a vacuum source and wherein the testing system may be selective isolated from a test chamber in which a container is received for testing, comprises the steps of step A) placing a container in an airtight test chamber and sealing the chamber, step B) maintaining a controlled vacuum pressure within the testing system prior to communicating the testing system to the test chamber, step C) initiating a test by connecting the testing system to the test chamber and drawing a vacuum on the test chamber utilizing the vacuum source, step D) upon reaching a target first determined pressure, initiating a delay timer in the testing system, step E) upon expiration of the delay timer, closing the vacuum source from the test chamber; and subsequently, and step F) monitoring any decay in the vacuum created in the test chamber using the pressure transducer to detect any increase in pressure within the test chamber such that increases in pressure may reflect a leak in the container.

In some embodiments, step C may be performed such that in a first period of time, if a first predetermined pressure is not achieved, the test is aborted but, if achieved, the test continues to step D. Further, for example, step C may be performed such if the first predetermined pressure is achieved, the test continues for a second period of time and if a second predetermined pressure is not achieved, the test is aborted; otherwise the test continues to step D.

In other embodiments, step C may be performed in at least two steps, such in a first period of time, the testing system in the controlled state is isolated from the vacuum source, then the testing system is connected to the test chamber while monitoring the pressure within the test chamber using the pressure transducer and aborting the testing if a first predetermined pressure is exceeded within a first predetermined period of time from the start of the test; otherwise the test continues by opening the vacuum source to the testing system and allowing the vacuum source to reduce the pressure in the test chamber to a predetermined vacuum utilizing the vacuum source while monitoring the pressure within the test chamber using the pressure transducer For example, in step C, the test is aborted if a second predetermined pressure is not achieved within a second predetermined period of time, following the first period from the start of the test.

Some embodiments of a method of present invention may include the additional steps of closing the testing system to the test chamber while maintaining a vacuum pressure within the testing system and venting the test chamber if the first predetermined pressure is not reached within the first predetermined period of time. Further, the method may include the additional steps of closing the testing system to the test chamber while maintaining a vacuum pressure within the testing system and venting the test chamber after the monitoring of step F.

In some embodiments, for example, the predetermined pressure level may be 700mbar, and/or the timer expires after <NUM> second. Additionally, the test system includes a microcontroller to monitor the pressure level measured by the pressure transducer and initiate the timer. For example, the microcontroller may dynamically determine when to initiate the timer based on the measured pressure level.

Yet another embodiment of the present invention includes a system for testing for package leaks. The system comprises a vacuum source connected to a test chamber via a conduit, a pressure regulator connected in the conduit between the vacuum source and the test chamber, a first valve connected in the conduit between the pressure regulator and the test chamber for selectively isolating the vacuum source from the conduit, a second valve connected in the conduit between the first valve and the test chamber for isolating the test chamber from the conduit, a pressure transducer connected to the conduit between the first valve and the second valve for measuring pressure in the test system, and a timer that is initiated when the pressure transducer detects a target vacuum level, wherein the first valve is closed to isolate the vacuum source from the conduit upon expiration of the timer.

It is an object of the present invention to provide a vacuum leak test operated using a vacuum decay control system and a test chamber. The leak test method may be deployed by a test controller system. The test controller can operate with a rigid test chamber or a flexible test chamber, although the use of a flexible test chamber is advantageous. The target vacuum level, the trigger vacuum level, and the timers associated with the test may vary, but generally would not need modification due to the intelligent dynamic vacuum system. Embodiments of the leak test method consistent with the present invention may be deployed in conjunction with other vacuum test solutions.

It is an object of the present invention to provide distinct advantages and improvements to the vacuum decay leak detection of a wide variety of containers, and more particularly to the testing of containers filled with either dry product or liquid product such as non-porous vials, ampoules, injection cartridges, ophthalmic product packages, syringes, pouches, blister packages and other packages containing critical medicinal and/or chemical products. The use of the intelligent dynamic vacuum leak detection method of the present invention applies to the testing of containers using a method of dynamically controlling and measuring vacuum decay within a test chamber in which a container being tested is sealed and wherein as a vacuum is being pulled with the test chamber the pressure levels are continuously monitored, such that pressure conditions within the test chamber over a period of time are used to indicate passage or failure of a container being tested.

The above and other aspects and features will become apparent from the following description with reference to the following figures, wherein like reference numerals refer to like parts throughout the various figures unless otherwise specified, and wherein:.

The test system can either be at atmospheric pressure or at a controlled pressure. In the example depicted in <FIG>, the test system is at a controlled vacuum of 500mbar. The test chamber is closed. Once the test is initiated, vacuum is being drawn on the test chamber. When the vacuum is initially drawn on the chamber the vacuum reading remains stable between the target vacuum level and atmospheric pressure. As the vacuum level is being drawn on the chamber the test system is initially removing air volume and not building a vacuum level, and the vacuum remains at the vacuum plateau until air is evacuated. Once the air volume has generally been evacuated, the vacuum level will build quickly. On approaching the target vacuum level, the test system triggers a vacuum trigger, initiating an evacuation delay timer, upon passing through a specific pressure threshold, in this case the trigger pressure is 700mbar and the timer is set to <NUM> second. Once the vacuum level passes through the trigger point, the timer will determine when to stop pulling vacuum on the chamber.

With reference to <FIG>, a test system <NUM> in accordance with an embodiment of the present invention includes a vacuum source <NUM> and a test chamber <NUM> connected by a vacuum conduit <NUM>. A vacuum regulator <NUM> is placed in the vacuum conduit <NUM> between the vacuum source <NUM> and a first valve <NUM> in the vacuum conduit <NUM>. A second valve <NUM> is placed in the vacuum conduit <NUM> between the first valve <NUM> and the test chamber <NUM>. A pressure transducer <NUM> is placed in communication with the vacuum conduit between the first valve <NUM> and the second valve <NUM>. A third valve <NUM> for venting test system <NUM> is placed in communication with the vacuum conduit <NUM> between the first valve <NUM> and the second valve <NUM>.

A computer including a timer (not shown) provides control signals to the vacuum source <NUM>, the vacuum regulator <NUM>, the first valve <NUM>, the second valve <NUM>, and the third valve <NUM>, and receives a pressure signal from the pressure transducer <NUM> indicating pressure conditions in the test chamber <NUM>.

With reference to <FIG>, an example operation of the test system <NUM> is described. At time T0, the test system is at a controlled vacuum of <NUM> mbar, first valve <NUM> is open, second valve <NUM> is closed, and third valve <NUM> is closed. Once the test is initiated at time T1, the second valve <NUM> is opened and a regulated vacuum begins to be drawn on the test chamber <NUM> by vacuum source <NUM> via vacuum regulator <NUM> through vacuum conduit <NUM>. When the vacuum is initially drawn on the test chamber <NUM>, the vacuum reading remains stable between a target vacuum level and atmospheric pressure. As the vacuum level is being drawn on the test chamber <NUM>, the test system <NUM> is initially removing air volume and not building a vacuum level, and the vacuum remains at a vacuum plateau until air is evacuated. Once the air volume has generally been evacuated, the vacuum level builds quickly. As the test system <NUM> approaches the target vacuum level, a specific pressure threshold designated a vacuum trigger is detected by the pressure transducer <NUM> at time T2, at which point a delay timer is initiated in the control computer. For example and without limitation, in this example the trigger pressure is <NUM> mbar and the timer is set to <NUM> second. Once the vacuum level passes through the trigger point, the timer will determine when to close first valve <NUM> at time T3 to isolate the vacuum source <NUM> from the test chamber <NUM>, and thereby stop pulling vacuum on the chamber. The pressure transducer <NUM> then monitors the pressure in the test system to determine the existence of a leak in the package under test. Upon completion of the test, or otherwise aborting the test, the third valve <NUM> is opened to vent the test system <NUM> at time T4.

With reference to <FIG>, a test system <NUM> in accordance with the alternative embodiment of the present invention includes a vacuum source <NUM> and a test chamber <NUM> connected by a vacuum conduit <NUM>. The vacuum regulator <NUM> is disposed in the vacuum conduit <NUM> between the vacuum source <NUM> and a first valve <NUM> in the vacuum conduit <NUM>. A second valve <NUM> is placed in the vacuum conduit <NUM> between the first valve <NUM> and the test chamber <NUM>. A pressure transducer <NUM> is placed in communication with the vacuum conduit between the first valve <NUM> and the second valve <NUM>. A third valve <NUM> for venting test system <NUM> is placed in communication with the vacuum conduit <NUM> between the first valve <NUM> and the second valve <NUM>. In the alternative embodiment, a fourth valve <NUM> is introduced to bypass the vacuum regulator <NUM> for enhanced vacuum flow.

Still referring to <FIG>, the alternative embodiment is distinguished from the embodiment shown in <FIG> by proving an additional unregulated vacuum supply. A bypass conduit <NUM> is provided to bypass the vacuum regulator <NUM> and the first valve <NUM> by connecting the vacuum source <NUM> from point A of the vacuum conduit <NUM> to point B of the vacuum conduit <NUM> without passing through the vacuum regulator <NUM> and the first valve <NUM>. A fourth valve <NUM> is placed in the bypass conduit <NUM> for controlling the bypass vacuum supply from point A to point B. Accordingly, the bypass conduit <NUM> provides an unregulated vacuum supply from point A to point B when the fourth valve <NUM> is open.

A microcomputer including a timer (not shown) provides control signals to the vacuum source <NUM>, the vacuum regulator <NUM>, the first valve <NUM>, the second valve <NUM>, the third valve <NUM>, and the fourth valve <NUM>, and receives a pressure signal from the pressure transducer <NUM> indicating pressure conditions in the test chamber <NUM>.

With reference to <FIG>, an example operation of the test system <NUM> is described. At time T0, the test system is at a controlled vacuum of 500mbar, the first valve <NUM> and the fourth <NUM> are open, and the second valve <NUM> and third valve <NUM> are closed. Once the test is initiated at time T1, the second valve <NUM> is opened and a vacuum begins to be drawn on the test chamber <NUM> by vacuum source <NUM>. A regulated vacuum is drawn through the first valve <NUM> via vacuum regulator <NUM>, and an unregulated vacuum is drawn through the fourth valve <NUM>. When the vacuum is initially drawn on the test chamber <NUM>, the vacuum reading remains stable between a target vacuum level and atmospheric pressure. As the vacuum level is being drawn on the test chamber <NUM>, the test system <NUM> is initially removing air volume and not building a vacuum level, and the vacuum remains at a vacuum plateau until air is evacuated. Once the air volume has generally been evacuated, the vacuum level builds quickly. As the test system <NUM> approaches the target vacuum level, a specific pressure threshold designated a vacuum trigger is detected by the pressure transducer <NUM> at time T2, at which point a delay timer is initiated in the control computer and the fourth valve <NUM> offering the unregulated vacuum is closed. For example and without limitation, in this example the trigger pressure is <NUM> mbar and the timer is set to <NUM> second. Once the vacuum level passes through the trigger point, the first valve <NUM> offering regulated vacuum remains open, and the timer will determine the first valve <NUM> is closed at time T3 to isolate the vacuum source <NUM> from the test chamber <NUM>, and thereby stop pulling vacuum on the chamber. The pressure transducer <NUM> then monitors the pressure in the test system to determine the existence of a leak in the package under test. Upon completion of the test, or otherwise aborting the test, the third valve <NUM> is opened to vent the test system <NUM>.

With reference to <FIG>, when testing a package that has a large leak with the dynamic vacuum mode, the vacuum level in the test chamber will pass the trigger point, and upon the timer stopping the evacuation of the test chamber, a large leak in the package-under-test will cause a spike in pressure (<FIG>, correct positive). The method reliably draws vacuum on pouches regardless of the time it takes to evacuate the general volume of the test chamber. A package that may be non-leaking but requires more time for the test chamber to be evacuated would not be detected as a leak (<FIG>, correct negative).

With reference to <FIG>, a flow diagram is depicted to illustrate a dynamic vacuum decay leak detection method consistent with the present invention. Referring to <FIG>, and <FIG> and <NUM>, a controlled vacuum level is established in the test system at step <NUM>, prior to communicating the test system to the test chamber. Here, the first valve to selectively isolate the vacuum source is open, and the second valve to selectively isolate the test chamber from the test system is closed, such that the test chamber is isolated from the test system. At step <NUM>, the second valve is opened such that the vacuum source of the test system is in communication with the test chamber, and the test system begins to pull vacuum on the test chamber. At step <NUM>, a predetermined vacuum trigger is detected as vacuum in the test chamber begins to build, measured by the pressure transducer, and the detection of this vacuum trigger is fed back to a control system. Based on the detected vacuum trigger, the control system initiates the timer. By way of example and not limitation, the timer may be set to expire after <NUM> second. When the timer expires at step <NUM>, the first valve is closed to isolate the vacuum source from the test chamber. At step <NUM>, pressure between the test system and the test chamber is equalized, and pressure in the test system is monitored by the pressure transducer to determine the presence of a leak in the package under test. At step <NUM>, the third valve is opened to vent the test system.

The present invention allows for a variety of package shapes and sizes to be placed into the test chamber with the same test parameters, and regardless of test chamber volume surrounding the package, it can provide an accurate vacuum evacuation. In doing so, large leaks can be detected on packages with low headspace and little volume surrounding the package. Simultaneously, a larger package format may be tested that requires a longer time to evacuate, and the system would dynamically be able to reach the appropriate vacuum level.

Embodiments of the present invention are directed to a vacuum leak test operated using a vacuum decay control system and a test chamber. The leak test method may be deployed by a test controller system. The test controller can operate with a rigid test chamber or a flexible test chamber, although the use of a flexible test chamber is advantageous. The target vacuum level, the trigger vacuum level, and the timers associated with the test may vary, but generally would not need modification due to the intelligent dynamic vacuum system. Embodiments of the leak test method consistent with the present invention may be deployed in conjunction with other vacuum test solutions.

The present invention offers distinct advantages to the vacuum decay leak detection of a wide variety of containers, and more particularly to the testing of containers filled with either dry product or liquid product such as non-porous vials, ampoules, injection cartridges, ophthalmic product packages, syringes, pouches, blister packages and other packages containing critical medicinal and/or chemical products. The use of the intelligent dynamic vacuum leak detection method of the present invention applies to the testing of containers using a method of dynamically controlling and measuring vacuum decay within a test chamber in which a container being tested is sealed and wherein as a vacuum is being pulled with the test chamber the pressure levels are continuously monitored, such that pressure conditions within the test chamber over a period of time are used to indicate passage or failure of a container being tested.

Claim 1:
A method of testing for package leaks by a test system (<NUM>; <NUM>) that includes a vacuum source (<NUM>; <NUM>), a test chamber (<NUM>; <NUM>) in which a package is received for testing, and a valve (<NUM>; <NUM>) for selectively isolating the test chamber (<NUM>; <NUM>) from the vacuum source (<NUM>; <NUM>), the method comprising:
placing a package in a test chamber (<NUM>; <NUM>);
evacuating air from the test chamber (<NUM>; <NUM>) by a vacuum source (<NUM>; <NUM>);
detecting a trigger pressure as the test system (<NUM>; <NUM>) approaches a target pressure, wherein the trigger pressure is higher than the target pressure;
initiating a timer by a computer upon detecting the trigger pressure;
isolating the test chamber (<NUM>; <NUM>) from the vacuum source (<NUM>; <NUM>) upon expiration of the timer; and
subsequently initiating a test detecting the presence or absence of a leak in the package based on pressure measurements in the test system (<NUM>; <NUM>).