Patent Description:
As is known, primary containers for pharmaceutical or veterinary use are moved in bulk or are aggregated, in a ready to use state where the containers have been aggregated and sterilized. For this purpose, primary container are placed in secondary container, wherein the primary containers are placed separated and next to each other.

In the present description and in the attached claims, the term "primary container" is meant to indicate containers made of glass or polymer, such as, but not exclusively, vials and cartridges with or without a closure system and syringes both with or without a needle shield, a needle safety device or a luer lock cap.

In the present discussion specific reference will be made to containers for pharmaceutical and veterinary use, however, the principles of the present invention can be applied in the same way also to other fields, as will become obvious to those skilled in the art. Moreover, the present invention is not related to a specific type, size, or shape of a glass container.

It is known to aggregate the primary containers in a so-called nest and tub configuration, wherein the primary containers are arranged in a nest and the nest is in turn arranged inside a tub.

This configuration is particularly adapted to handle the primary containers throughout the various operations to which the primary containers are subjected, such as treatment step (filling, capping, manual or automated inspection operations) or for performing various combination, washing, sterilization, inspection operations, etc..

In these types of operations, it is important to create a complete traceability of the origin of each container.

It is known in the prior art the serialization concept, namely to apply to the primary container a machine or human readable code in order to provide a unique identity to the primary container, in the same way as a fingerprint.

As an example, the readable code marking of the containers can be marked on the container, by means of a printing unit, which is able to print a specific mark on each container.

Besides the serialization concept, it is known in the packaging field to apply an aggregation concept, which is used to create a "parent and child" relationship between different packaging levels, in order to simplify the management of the process in the supply chain.

As an example, a pallet can have a unique identifier, two shipper (children), and each shipper can have two tubs (children of shipper). Therefore, in this example, the aggregation of unique identifier comprises seven unique identifiers in three "parent and child" levels.

In this way, by means of a scanning of one of the readable code, it is possible to provide the identity of the parents and children of all the levels.

Although the systems of the prior art are widely used and appreciated, they are not devoid of drawbacks.

First of all, the systems used by the prior art do not permit to overcome the challenges connected to the orientation of the nest in the tub. As a matter of fact, a nest may contain a plurality of containers in specific positions. Therefore, the automatic systems have to locate the machine-readable code of each container to map the location and orientation of each container.

Furthermore, the readability of the machine-readable code of each container is not so simple, in view of the possible orientation of the container in the nest.

<CIT> discloses a container unit according to the preamble of claim <NUM>.

The object of the present invention is therefore to solve at least some of the drawbacks and limitations cited with reference to the prior art.

A first task of the present invention is to simplify the readability of the machine-readable code of the containers, in particular in the filling machine.

A second task is to overcome the machine nest orientation challenges mentioned above.

Another task is to improve the ability to pass product and supplier data to the filling machine / line to increase product traceability.

The object is at least partially achieved by a container unit according to claim <NUM>, an apparatus for managing containers according to claim <NUM>, and by a method for managing containers according to claim <NUM>.

Further features and advantages of the invention will become more apparent from the description of a preferred but non-exclusive embodiment of a method and a apparatus for managing containers according to the invention, illustrated by way of non-limiting example in the accompanying drawings, in which :.

The elements or parts of elements that the embodiments described in the following have in common will be indicated by the same reference numerals.

<FIG> shows a container unit <NUM> for handling containers <NUM> according to the present invention.

The container unit <NUM> comprises a support surface <NUM> arranged with a plurality of seats <NUM>, each of the seats <NUM> being adapted to contain a container <NUM>.

Each container <NUM> is provided with a container data carrier <NUM> adapted to contain a unique identifier of the container <NUM>.

The container unit <NUM> comprises at least one container unit data carrier <NUM> adapted to contain data of the containers <NUM> contained in the seats <NUM>, said data comprising the unique identifiers of each container <NUM>, and the position of each container <NUM> in the seats <NUM>.

According to a possible embodiment, the at least one container unit data carrier <NUM> may be provided on a bottom wall <NUM> of the container unit <NUM>. Preferably, as it can be seen in <FIG>, the at least one container unit data carrier <NUM> may be provided on the bottom wall <NUM> in a central position with respect to the perimeter of the bottom wall <NUM>.

The at least one container unit data carrier <NUM> is adapted to be read and written with data.

In particular, the at least one container unit data carrier <NUM> may be a bi-dimensional barcode, an electronic chip or a memory device. Preferably, the at least one container unit data carrier <NUM> may be a RFID or NFC type chip. Moreover, the container unit data carrier <NUM> may be any information carrier allowing the modification of its information content.

According to a possible embodiment, the container unit <NUM> may comprise at least one container (<NUM>) The container data carrier <NUM> may be adapted to contain data comprising the unique identifier of the container <NUM>, and the position of each container <NUM> in the seats <NUM>.

The specifications of the unique identity may be based upon agreed specifications, published guidance documents, international specifications or regulatory requirements.

According to a possible embodiment, the unique identifier can be delivered for example by the computerised control systems <NUM>, data carriers, or can be received or uploaded from an external system (not shown).

According to a possible embodiment, the container data carrier <NUM> may be for example a bi dimensional bar code, in particular a QR code.

The container data carrier <NUM> may be applied to each container <NUM> via a marking process as for example laser, inkjet or other related marking process, which are able to provide variable data strings and two dimensional barcode images. According to alternative embodiments, the container data carrier <NUM> can also be added to the container <NUM> via a third-party component such as an electronic or semiconductor based data carrier which becomes associated with the container <NUM>, for example during the manufacturing process.

As mentioned above, the containers <NUM> may be manufactured from glass, plastic, rubber, be multi-material assemblies or other suitable materials and may contain a container data carrier <NUM> as part of a component or an assembly.

Advantageously, container data carrier <NUM> may be adapted to be machine-readable using camera systems, electronic readers (RFID or NFC) or other reading devices which may be needed to ensure automatic readability within a production environment.

The unique identity contained in the container data carrier <NUM> may be stored in the computer control system <NUM> as a digital data string, electronic files along with any specific data in order to create a parent and child relationship between the different aggregation levels.

According to the invention, the container unit <NUM> comprises a nest locator <NUM> provided on its surface, adapted to be the reference for mapping the position of the containers <NUM> in the seats <NUM>. The nest locator <NUM> may be a machine-readable code.

According to a possible embodiment, the nest locator may be a bi-dimensional bar code, and/or a text component so as to be machine and/or human readable.

According to a possible embodiment, the tray <NUM> may comprise side walls <NUM> and a bottom wall <NUM>.

The container unit data carrier <NUM> may be provided on said support element <NUM> or on said tray <NUM>.

The container unit data carrier <NUM> should be placed in a position that facilitates the readability whilst at the same time not affecting the operation or sterility of any machines that are using the apparatus according to the present invention. Equally, the position of the container unit data carrier <NUM> may be defined by different stakeholders whilst still enabling compliance with the process requirements.

The container unit data carrier <NUM> is used as a method to facilitate the transfer data between different machines.

According to a possible embodiment, the container unit data carrier <NUM> may be adapted to be read and written with data sets in a defined method. As an example, the container unit data carrier may be adapted to contain data relating to: manufacturer, production date, batch number, supplier code, production time, unique identifier position, number of objects, line number, nest locator, object type, object dimension, container unique identifier code.

According to a possible embodiment, the support element <NUM> may comprise the nest locator <NUM>.

As mentioned above, the containers (<NUM>) may be made of glass or polymer. Moreover, the containers <NUM> may be a vial or a cartridge with or without a closure system, or a syringe with or without a needle shield, a needle safety device or a luer lock cap.

<FIG> shows an embodiment of an apparatus for managing containers <NUM> according to the present invention. The apparatus <NUM> comprises:.

According to a possible embodiment, the nest locator <NUM> may be adapted to be used by the a computerized control system <NUM> as a zero point, using a matrix method where the seats <NUM> are divided in columns and rows, in which the nest locator <NUM> is adapted to define a first column and a first row, each seat <NUM> being defined by a row number, and a column number.

This method is the preferred method as most of the machines using ready to use configuration, process the nest in rows. The activity required for each unique identifier / container is completed by the machine / process before indexing to the next row.

According to an alternative embodiment, the computerized control system <NUM> is adapted to define the position of the seats <NUM> by counting the seats <NUM> starting from the seat <NUM> nearest to the nest locator <NUM>, counting from one side to the other along a row, and when the row has been completed, the sequence continued with a next row.

With reference to the example of <FIG>, the position of the container may be defined as a unique position number when the count is made from the position of the nest locator <NUM> which is located on the top lefthand corner of the nest. In this case the positions will be counted as a sequence moving left to right along the first row. When row has been completed the sequence will be continued in the same manner within row two - moving left to right. This method defines each position as a unique number.

According to a possible embodiment, the nest locator <NUM> may contain a bi-dimensional barcode, although it may be also located in an image by means of its color, shape or a different visual mark.

In an alternative embodiment, the nest locator <NUM> may contain a bi-dimensional barcode and a text component. In this way, the nest locator may be both machine and human readable as a fail-safe prevent errors and facilitate human intervention when needed or to indicate the correct "zero position" when the nest may be printed with more than one "nest locator". As a matter of fact, in some manufacturing line the nest may be rotated during the process.

According to a possible embodiment, the tray may comprise a second nest locator <NUM>, adapted to be used as an end point.

The apparatus <NUM> may comprise a first camera reader <NUM> operatively connected to the computerized control system <NUM>, adapted to read a nest locator <NUM> provided on said container unit <NUM>, in order to map the position of the containers <NUM>.

According to a possible embodiment, the apparatus may comprise a second camera reader <NUM> operatively connected to the computerized control system <NUM> adapted to read the unique identifier of the containers <NUM>.

According to a possible embodiment, the container data carrier <NUM> of each container <NUM> may comprise a RFID chip. In this case, the second camera reader <NUM>, operatively connected to the computerized control system may be substituted or complemented by a device able to read and/or write the RFID chip. Regardless of the type of reader used to read and possibly read/write the information carried by the container data carrier <NUM>, at least one reader may be used to locate and/or identify both the nest locator and the container data carrier <NUM>.

The configuration of the apparatus depends on the product type, the packaging and the manufacturing specifications required. In particular, it may be integrated within the container manufacturing lines, or be designed as a separate product management station running in parallel to the manufacturing line.

When the apparatus is designed as a separate product management station, the product will be moved from one line to another once the relevant process steps have been completed.

The apparatus of the present invention is adapted to manage higher levels of aggregation as part of the process such as container unit <NUM> to shipper and shipper to pallet etc., in line with customer or industry wide specifications. The higher level of aggregation will use the same method of creating an electronic association between the higher levels of packing using data carriers.

As an example, the shipper may be provided with a specific unique identifier, that can be associated with the container unit data carrier of the associated tray, nest locator, and the containers unique identifier.

The apparatus according to the present invention may operate as a standalone unit or be integrated with an automated production process, such as a container manufacturing line. In this regard, the computerized controlled system <NUM> of the apparatus may be a standalone system, or may be integrated as a software in the main computerized control system of the manufacturing line.

In particular, the main computerized control system of the manufacturing line may be adapted to continue to work in conjunction with the process management system. During the process, embedded software systems and algorithms, specifically designed for the process will manage and coordinate process and share data in both directions across the different levels and pieces of equipment.

During the manufacturing process, data may be added to the container data carrier, and/or to the container unit data carrier associated with the tray, and they may be adapted to be stored in the computerized control system of the apparatus or in the main computerized control system of the manufacturing line. As an example, this data can be the batch number, the identity, the unique identifier, the position, status changes and aggregation relationships.

According to a possible embodiment, the container data carrier <NUM> and the container unit data carrier <NUM> are not adapted to physically contain all the necessary data, but they may be associated with a memory, for example on the computerized controlled system, wherein these data are available. In this specific case, the container data carrier <NUM> and the container unit data carrier <NUM> may be for example an optical code such as a barcode or a QR code.

According to a possible embodiment, the data may be generated, uploaded and stored in a corporate level system <NUM>, designed to be the overall data management and control system. The corporate level system may be designed to enable data sharing with other computer systems. Data sharing can be done via a variety of file formats and this may include, but is not limited to XML, JSON, EPCIS messaging etc..

Corporate level system <NUM> may be structured in a manner which facilitates compliance with any relevant international standards and mandates which may be required by external authorities. This may include access controls and other security features to ensure data integrity and security.

The status, readability, image, unique identifier or any other relevant parameters may be updated in the corporate level system <NUM> and stored for later usage.

Any changes of status at any point in the process may be added to the existing data managed or may be stored so that it is possible to see a full history of the product during its lifetime. This data may be uploaded or transferred to external computer systems.

Additional functionality may be added to the corporate level system <NUM> to enable external messaging, alerts and notifications, reporting, tracking and tracing shipments etc..

As mentioned above, the apparatus may be adapted to create an electronic relationship between the components, nest, tub, shippers, or higher aggregation levels within the bulk container manufacturing process or the ready to use process, which delivers pre-sterilized products direct to aseptic process machines, line or systems.

In the case of bulk packaging, the apparatus may be adapted to create a specific electronic relationship between the unique identifier of the container and the different levels of the packaging hierarchy such as container <NUM> to container unit <NUM>, container unit <NUM> to shipper, shipper to pallet, etc. The access to the aggregation structure may be delivered for example via URL access, system integration and data exchange or a data carrier.

It will be now described a possible method for managing containers with an apparatus according to the present invention.

The method in its essential form comprises the steps of:.

According to a possible embodiment, depicted in <FIG>, the nest locator <NUM> may be used as a zero point in the removing operation, using a matrix method where the seats are divided in columns and rows, in which the nest locator <NUM> is adapted to define a first column and a first row. In this method each seat will be defined by row number, and a column number.

According to an alternative embodiment, the position of the seats <NUM> are defined by counting the seats <NUM> starting from the seat <NUM> nearest to the nest locator <NUM>, counting from one side to the other along a row, and when the row has been completed, the sequence continued with a next row.

According to a possible embodiment, after step c) the support element <NUM> may be provided inside the tray <NUM>, and support element <NUM> and tray <NUM> may be sealed together.

Moreover, the method may comprise other steps such as:.

The advantages that can be achieved with the present invention are clear.

First of all, the apparatus and the method of the present invention make it possible to simplify readability of the container unique identifier passing through the filling machine.

Furthermore, it is possible to overcome the machine nest orientation challenges by defining a zero point on the nest.

Once again, it is possible to pass product and supplier data to the filling line to increase product traceability.

Moreover, the aggregation process will create an electronic association between the nest, each individual UID/container, its position in the nest and any production data associated with manufacturing process.

The nest and tub aggregation process may be part of ready to use manufacturing process which requires the process steps to be carried out in a clean room of a designated class. All the components associated with the system are maintained within a specific set environmental conditions temperature which follow internal norms or standards such as International Standards Organization (ISO). This may be done as a complete unit or as separate components within the manufacturing line.

Claim 1:
Container unit (<NUM>) for handling containers (<NUM>), suitable to be aggregated in a so-called nest and tub configuration, wherein
the container unit (<NUM>) is a nest configured to be arranged inside a tub, wherein the container unit (<NUM>) comprises:
- a support surface (<NUM>) arranged with a plurality of seats (<NUM>), each of said seats (<NUM>) being adapted to contain a container (<NUM>), each container (<NUM>) being provided with a container data carrier (<NUM>) adapted to contain a unique identifier of the container (<NUM>);
- at least one container unit data carrier (<NUM>) adapted to contain data of the containers (<NUM>) contained in the seats (<NUM>), said data comprising the unique identifiers of each container (<NUM>), and the position of each container (<NUM>) in the seats (<NUM>);
characterised by comprising a nest locator (<NUM>) provided on the surface of the container unit (<NUM>) and adapted to be the reference for mapping the position of the containers (<NUM>) in the seats (<NUM>).