RU2843263C9 - System and method for monitoring data relating to processing of medical containers - Google Patents

Abstract

FIELD: medicine; physics.

SUBSTANCE: invention relates to a system for tracking data relating to the processing of a plurality of medical containers (100) configured to be placed in first layer (1, 2) of a package comprising: at least one marking (103) made on and/or in the material of each medical container (100) and representing the corresponding unique article identifier (UAI) for each corresponding medical container, remotely readable and writable electronic component (21) located on and/or in package first layer, wherein said remotely readable and writable electronic component is configured to store the UAI of each medical container located in the first layer of the package, and configured to write and/or read data related to the processing of the medical containers.

EFFECT: system and method for monitoring data relating to the processing of medical containers are disclosed.

13 cl, 5 dwg

Description

Field of technology

The invention relates to a system and method for tracking data related to the processing of one or more medical containers, such as syringes, test tubes or cartridges.

State of the art

Often, medical containers need to be transported from one facility to another if they are manufactured at one facility and filled at another facility, or, less commonly, if they are manufactured and filled at the same facility and must be delivered to another facility after filling.

For such transportation, the containers are usually placed in a package containing a grouping tray or nest, hereinafter referred to as "nest", a packaging cuvette, hereinafter referred to as "cuvette", and preferably a sealing lid and a plastic bag, hereinafter referred to as "sealable bag", to ensure sterility. The combination of nest and cuvette, and optionally the sealing lid and sealable bag, will hereinafter be referred to as "package", while the term "cuvette" will refer to the empty cuvette.

The nest may have different shapes depending on the type of containers to be accommodated. It may have openings that may be coaxially surrounded by tubes to receive cylindrical container bodies with flanges, the flanges resting on the upper ends of the tubes. Alternatively, the nest may have special openings to accommodate cartridges that will contact the bottom of the cuvette. In another embodiment, the nest may have tubes with closed bottoms to receive containers without flanges; the nest may also be made of an elastic material and have openings in which the containers are held by friction.

The nest is therefore designed to conveniently store and transport several containers at the same time without the risk of contamination or destruction. In addition, this storage and transport means can be used and reused, starting from the manufacture of containers to their final filling and storage in the pharmaceutical industry.

The cuvette comprises a peripheral outer flange, located at the level of its upper opening, for sealing the sealing lid. The cuvette also comprises a peripheral inner flange, located below the outer flange, for supporting the nest. In use, the nest is placed in the cuvette, which is closed with a hermetic lid, and the whole is placed in a sealable bag and sterilized. Groups of packages can then be stacked upside down in a box, such as a cardboard or plastic box, with an intermediate sheet placed between two groups of packages, a group being a row of several packages.

When received at the destination, the bags are removed from the box and turned upside down, the sealed bag is opened, the tray is removed from the sealed bag and opened. The nests are then removed from it and the containers can be filled and/or processed.

An important aspect related to the manufacture, transport and filling of medical containers, hereinafter referred to as "processing", is the traceability of the medical containers, i.e. the ability to identify each of the medical containers throughout the entire processing process - from their manufacture at the manufacturing plant, including their packing in a nest and then in a cuvette, to their filling and further processing, usually at the manufacturer's end user. It may also be preferable to trace the medical containers all the way to their final use, such as for an injection into a patient, and even to their disposal.

Solutions for tracking medical containers have been proposed.

The first solution is to label the medical containers with a data tag or label. Each data tag is different from one container to another, allowing each container to be individually tracked.

The user can ensure traceability at the container level, for example, by using color coding, which can be quite difficult to implement, and/or by performing labor-intensive manual procedures during line cleaning or manual verification of containers. In particular, color coding can only be applied to the outside diameter of the container, close to the flange, and is very likely to degrade during sterilization operations.

In addition, the container markings are not visible when said container is packed in a ditch or nest, wherein such nest is typically used as a transport device when handling containers by the consumer. Consequently, the consumer cannot see the markings and cannot identify the containers, which greatly limits container tracking and may lead to errors in container filling when a given composition is poured into the wrong container.

The second solution is to mark the nest in which the medical containers are located, while the said containers are not marked.

However, before the containers are placed in the nest, traceability at the container level is not possible. In addition, when the consumer removes the medical containers from the nest to perform quality control of said containers and fill them with the composition, the possibility of tracking the containers is lost. As a result, the consumer cannot guarantee that the correct container has been filled with the right composition, which may lead to serious consequences for the patient to be treated with this composition.

Disclosure of the essence of the invention

The technical problem to which the invention is directed is to create a system for tracking data related to the processing of one or more medical containers designed to be placed in a nest of packaging, which allows for the effective tracking of each of the said medical containers along the entire process chain, starting from the moment of their manufacture by the manufacturer, including their packaging in the nest and then in the cuvette, their filling and further processing, as a rule, at the end user of the manufacturer, and also, as a rule, during the use of the medical containers, for example, for the introduction of a pharmaceutical composition, and their disposal.

For this purpose, the object of the invention is a system for tracking data related to the processing of a plurality of medical containers designed to be placed in a first layer of packaging, comprising:

- at least one marking made on and/or in the material of each medical container and representing the corresponding unique product identifier (UPI) for each corresponding medical container,

- a remotely readable and writable electronic component located on and/or in the first layer of the packaging, wherein said remotely readable and writable electronic component is designed with the ability to store the UII of each medical container located in the first layer of the packaging, and with the ability to record and/or read data related to the processing of medical containers.

The packaging, especially for medical containers, may comprise a plurality of layers separating the containers from the environment. Some of said layers may be designed to form a barrier for air, liquids and/or any contaminants that may affect the sterility of the containers. Some of said layers may be designed to protect the medical containers from impacts and/or vibrations that may affect their integrity. In this text, the "first layer" means the layer of the packaging that is closer to the medical containers. In particular, said first layer is in contact with the environment surrounding the medical containers. Said first layer is also one of the first layers, in chronological order, used in the packaging process.

The expression "contained on and/or in" means that the component may be included in the first layer of the packaging and/or attached to it by any suitable means (e.g. by overmolding, labelling, gluing, assembly using mechanical fastening means such as clips, screws, etc.).

The data tracking system of the invention ensures full traceability of a container with a medicinal product from the first stages of the process to the pharmaceutical consumer at the stage of final packaging by combining the marking of medical containers, wherein said marking of each medical container includes a unique product identifier (UPI), with a remotely readable and writable electronic component built into the socket.

The marking of medical containers is applied to the material or inside the mass of material of said medical containers during their manufacture. Preferably, the marking of medical containers is performed inside the mass of material of said medical containers. This marking is reliable and can be applied as early as possible during the manufacturing process of medical containers.

In this text, the term "mass of material" refers to the material of which the body or lid of the medical container is composed. The material may be glass, plastic, rubber or thermoplastic elastomer.

In this text, the term “robust” means that the marking will be resistant to any stage of the manufacturing process of medical containers.

Thus, the proposed data tracking system combines container traceability without the limitations associated with visual reading, since said containers are virtually integrated in a remotely readable and writable electronic component of the socket. In addition, the UID of the socket is accessible without the limitations of visual reading, since it can be read using wireless technology of a remotely readable and writable electronic component, such as an RFID tag.

In accordance with other additional features of the data tracking system:

- the first layer of packaging is a nest or cuvette, preferably a nest,

- the remotely readable and writable electronic component contains a corresponding unique product identifier (UPI) related to the first layer of packaging,

- the data tracking system further comprises a data storage system configured to store data related to the processing of a medical container, wherein said data is associated with the UII of each medical container and, optionally, with the UII of the first layer of packaging,

- at least one marking is optical, preferably at least one marking is selected from the group consisting of: a one-dimensional marking such as a barcode, a two-dimensional marking such as a data matrix or QR code, and text;

the remotely readable and writable electronic component is selected from the group comprising: an RFID tag, an ultra-wideband real-time location system (RTLS), a Wi-Fi-enabled module, a Bluetooth-enabled module, a ZigBee-enabled module and an infrared-enabled module, wherein preferably the remotely readable and writable electronic component is an RFID tag that comprises an RFID chip and an antenna connected to the chip.

Another object of the invention is a method for tracking data related to the processing of a plurality of medical containers configured to be placed in a first layer of packaging, said method comprising the steps of:

a) take material for processing of many medical containers,

b) carry out markings on and/or in the material of each medical container at the first stages of manufacturing the medical containers, whereby said markings encode the corresponding unique product identifier (UPI) for each corresponding medical container;

and additionally, at each stage of manufacturing medical containers, the following stage is performed:

(c) record data relating to the manufacturing stages of the medical containers and/or individual physical data of each medical container in a data storage system, whereby said recorded data is linked to the UII of each relevant medical container.

In accordance with other optional features of the data tracking method, the method additionally includes the steps of:

d) place medical containers provided with markings in the first layer of packaging containing a remotely readable and writable electronic component,

e) record the UII of each medical container in a remotely readable and writable electronic component contained on and/or in the first layer of the packaging,

and additionally includes at each stage of processing the first layer of packaging a stage at which:

f) record data relating to each said processing step of the first layer of packaging in a data storage system and, optionally, in a remotely readable and writable electronic component contained in the first layer of packaging,

- marking of medical containers is carried out by gluing a label, enamel sintering, inkjet printing, laser marking such as picosecond laser marking or femtosecond laser marking, pulsed inkjet printing or dot impact marking,

- the stages of manufacturing a medical container may include at least one of the following stages:

i) cutting, washing and shaping glass rods used as starting material for medical containers;

ii) molding of plastic used as a starting material for a medical container;

iii) printing of the scale on the medical container;

iv) placing the needle on the medical container;

v) washing the medical container;

vi) siliconization of medical container;

vii) placing the tip cap on the medical container;

viii) visual inspection of the medical container,

- the data recorded in step c) and/or f) are selected from the following: setting, date, station identifier, ambient temperature and/or raw material batch number;

- the data storage system comprises at least one computer server and/or at least one storage device,

the steps of processing the first layer of packaging may include at least one of the following:

- sterilization of the first layer of packaging and each of the medical containers located in the first layer of packaging;

- sealing of each of the medical containers;

- storage of the first layer of packaging for intermediate storage and/or transportation.

In some embodiments, the first layer of packaging is a nest, and processing the first layer of packaging further includes at least one of the following steps:

- filling each medical container located in the first layer of packaging with a pharmaceutical composition;

- moving the first layer of packaging to the inspection location, where it is possible to inspect each of the medical containers.

Brief description of the drawings

Additional features and advantages of the invention will be disclosed in the following description given with reference to the attached drawings, in which:

Fig. 1 shows a partial section of a package for medical containers containing a nest and a cuvette;

Fig. 2 illustrates a typical workflow for processing medical containers;

Fig. 3A shows a medical container with a bar code applied to the tip cap;

Fig. 3B shows a medical container containing a QR code applied to the body of the medical container;

Fig. 4 shows a partial view of the socket containing the RFID tag and the temperature sensor;

Fig. 5 shows a typical workflow for processing medical containers at a manufacturing plant.

Implementation of the invention

The invention relates to a system for tracking data related to the processing of at least one medical container designed to be placed in a first layer of packaging.

The medical container may be a syringe, a vial, or a cartridge. The medical container may include a cylindrical member and a cap that covers the tip of the cylindrical member.

The first layer of the packaging may be a nest designed to hold at least one medical container in a certain position and/or orientation, or a cuvette containing such a nest. According to a preferred embodiment, the first layer is a nest.

Fig. 1 shows an embodiment of such packaging.

The package includes a cuvette 1, which is typically made of plastic and is intended to accommodate a plurality of medical containers 100. The cuvette contains a bottom 10, a peripheral wall 11 extending from the bottom to the upper opening 12 of the cuvette. A peripheral flange 13 extends outward from the upper part of the peripheral wall 11. The peripheral flange is configured to be sealed on a sealing lid (not shown) for hermetically sealing the cuvette.

Advantageously, the medical containers 100 can be arranged vertically in the cuvette, i.e. the longitudinal axis of the cylindrical body of the medical container runs in the vertical direction (which is the direction of gravity), while the opening of the cylindrical body is directed toward the upper part of the cuvette. Thus, in this orientation, the medical containers can be filled with a pharmaceutical composition, remaining in the cuvette, thereby minimizing manipulations with the medical containers.

For this purpose, medical containers 100 can be placed in a socket 2, which contains a plurality of guide openings 20, made with the possibility of receiving the corresponding medical container and holding it in the vertical direction. Cuvette 1 contains a peripheral inner edge 14, made with the possibility of supporting the socket 2.

In other embodiments (not shown), the medical containers may be positioned in the cuvette in a different orientation, such as in a horizontal direction, but this orientation is less preferred because it does not allow the medical containers to be filled directly into the cuvette.

The term "processing" refers to the steps associated with the medical containers from their manufacture by the manufacturer and placement in the first layer of packaging to the final packaging by the consumer after the medical containers have been inspected by the consumer. The first part M of the processing, called "manufacturer processing", may be performed by the manufacturer, and the second part C of the processing, called "consumer processing", may be performed by the consumer or by a plurality of consumers in succession. The processing also includes the transport T of the first layer of packaging with the medical containers from the manufacturer to the consumer (see Fig. 2). The steps performed in manufacturer processing and the steps performed in consumer processing are described in more detail in the following text.

The present invention aims to provide clear and complete traceability of medical containers from their manufacture by the manufacturer and packaging in the first layer to the consumer at the stage of final packaging and even further to the disposal of the medical containers.

For this purpose, the invention proposes a data tracking system that combines at least one medical container marked with an identifier specific to said at least one medical container with a remotely readable and writable electronic component embedded in a first layer of packaging intended to accommodate these marked medical containers.

In more detail, the data tracking system comprises at least one marking associated with each medical container, wherein said marking is applied to each medical container during the production process of said medical container, as well as a remotely readable and writable electronic component embedded in the first layer of the packaging.

Fig. 3A and 3B show embodiments of a medical container 100, which comprises a cylindrical body 101 and a cap 102 covering the tip of the cylindrical body.

Each medical container is provided with the appropriate marking 103. This marking is the corresponding unique product identifier (UPI), which allows the identification of the corresponding medical container among others. Thus, each container contains a unique and corresponding UII, which contains information specific to this container and can thus be tracked throughout the processing of medical containers.

Preferably, the marking is selected from the group comprising a one-dimensional (1D) marking, a two-dimensional (2D) marking, or text. Preferably, the marking 103 is selected from the group comprising a bar code (see Fig. 3A), a data matrix, a QR code (see Fig. 3B), or text. Preferably, the marking is a data matrix. The data matrix is a high-density, two-dimensional bar code symbology that allows a large amount of information or data to be integrated into a small area, such as on a cylindrical body of a medical container. The data matrix is thus particularly suitable for marking medical containers.

The marking type may preferably be selected from the following: labeling, enamel sintering, inkjet printing, laser marking such as picosecond laser marking or femtosecond laser marking, pulse inkjet printing or dot impact marking.

This marking may be applied to the surface of the material of the medical container or to the mass of the material of the medical container. Preferably, the marking is embedded in the mass of the material of the medical container. If the medical container comprises a cylindrical body 101 and a cap 102 covering the tip of the cylindrical body, the marking may be made on or in the material of the cap 102 (see Fig. 3A) and/or on or in the material of the cylindrical element 101 (see Fig. 3B).

An electronic remotely readable and writable component located on and/or in the first layer of the packaging is designed with the ability to record and read data related to the processing of medical containers intended for placement in it. The said remotely readable and writable electronic component may also contain a corresponding unique device identifier (UDI) related to the first layer of the packaging.

The remotely readable and writable electronic component may be selected from a group comprising an RFID tag, an ultra-wideband real-time location system (RTLS), a Wi-Fi-enabled module, a Bluetooth™-enabled module, a ZigBee™-enabled module, an infrared module. The remotely readable and writable electronic component is preferably an RFID tag. Said RFID tag comprises an RFID chip and an antenna connected to the chip. The RFID tag is known per se and may be used, for example, in the form of a self-adhesive label that may be glued to an article, or in the form of a self-supporting device that may be embedded in an object, in particular the first layer of the packaging according to the present invention, for example by overlay molding.

According to an embodiment, a remotely readable and writable electronic component is embedded in the first layer of the packaging. By an electronic component embedded in the first layer of the packaging, it is to be understood that the socket completely or at least partially covers the electronic component, so that the electronic component is protected from the external environment and therefore cannot be damaged or removed. In this way, the remotely readable and writable electronic component cannot be physically accessible, which prevents any damage that may occur as a result of processing steps, especially during the transport of the socket containing the medical containers from the manufacturer to the consumer or during sterilization processes, such as ethylene oxide sterilization or steam sterilization.

According to an embodiment, the remotely readable and writable electronic component is connected to a processor and/or at least one sensor, which are also integrated into the first layer of the packaging. The sensor can be selected from one or more of the following elements: a temperature sensor, a pressure sensor, a humidity sensor and a motion sensor. The remotely readable and writable electronic component can be further connected to a battery for powering the above-mentioned elements and a memory for storing data. The remotely readable and writable electronic component can be further connected to a GPS (global positioning system) module for determining the location of the nest during the processing of medical containers.

The sensors are designed to receive physical data related to their respective function, such as temperature, pressure, humidity and movement data, and to output a corresponding signal to the processor during the processing of medical containers. After processing the signal, the data can be stored in memory and/or transmitted to a data storage system.

Fig. 4 shows an embodiment of a socket 2 containing an RFID tag 21 and a temperature sensor 22. The RFID tag and the temperature sensor can be included in the socket material, for example, by overlay molding in the plastic material of the socket, or attached to the upper or lower surface of the socket, for example, by means of glue.

According to a preferred embodiment, the data tracking system further comprises a data storage system that can store data related to the UII of each medical container, to the UII of the nest, and/or data recorded in a remotely readable and writable electronic device.

The data storage system preferably comprises a computer server and/or a storage device. Advantageously, the data storage system may comprise several computer servers and/or several storage devices.

In the case of a drive, the manufacturer can transfer the manufacturer's processing data to the drive and provide the drive to the consumer. The consumer can therefore access the drive and view the data, allowing him to verify that the manufacturer's processing complies with the standards.

In the case of a computer server, the producer may transmit the producer's processing data to the server. The consumer may then access the server and view the data, in particular to check for compliance. The consumer may also transmit the consumer's processing data to the server.

The data access provided by the producer to the consumer can be full, meaning that the consumer can access all the data stored in the data storage system, or partial, meaning that the consumer can access only a part of the data stored in the data storage system.

Moreover, in addition to viewing the data, the consumer can use this data and incorporate it into the consumer's workflow steps.

According to the first embodiment, the computer server is shared between the producer and the consumer. The producer and the customer can exchange data with each other.

According to the second embodiment, the producer can access the first server, called the producer server, and the consumer can access the second server, called the consumer server. The producer can transmit the producer's processing data to the producer's server and transmit this data or a part of it to the consumer's server. The consumer can then access the consumer's server to view this data. The consumer can transmit the consumer's processing data to the consumer's server and transmit this data or a part of it to the producer's server.

An example of a computer server would be a cloud-type server.

The invention also relates to a method for tracking data related to the processing of a plurality of medical containers configured to be placed in a nest, said method comprising the following steps (see Fig. 5):

a) stage M1: take material for processing of a plurality of medical containers,

b) step M2: marking is applied to the material of each medical container and/or inside it during the first stages of manufacturing the medical containers, whereby said marking encodes the corresponding unique device identifier (UDI) for each corresponding medical container;

and additionally, at each stage of manufacturing medical containers, the following stage is performed:

c) step M3: recording data relating to the stages of production of medical containers and/or individual physical data of each medical container in the data storage system, whereby said recorded data is linked to the UII of each corresponding medical container.

As explained above, step M2 can be carried out by labeling, enamel sintering, inkjet printing, laser marking such as picosecond laser marking or femtosecond laser marking, pulsed inkjet printing or dot impact marking, preferably laser marking.

An additional comparison step may be performed before step M3. Said comparison step compares the data associated with the UID of each medical container with a reference identifier to ensure that the medical container being compared is the one being sought, for example, specified in the production order. If the result of the comparison step is negative, another comparison step may be performed. If the comparison step is positive, step c) may be performed.

Stage M3 can be performed at each stage of the manufacturing of medical containers. Thus, stage M3 can be performed either at the beginning, or in the middle, or at the end of the manufacturing stage.

At stage M3, any data related to the manufacturing stages and the UII of the medical container can be recorded in the data storage system. These data can be settings, date, location identifier, ambient temperature, batch number of the source material, and also, preferably, dimensional and cosmetic defects issued by the inspection chamber during mass processing, the type of devices used, etc.

The method according to the invention may further comprise the following steps (see Fig. 5):

d) step M4: placing the medical containers with markings in the socket containing the remotely readable and writable electronic component,

e) stage M5: recording the UII of each medical container in a remotely readable and writable electronic component contained in the socket.

The method according to the invention may additionally include at each stage of processing the nest the following stage:

f) step M6: recording data relating to each mentioned processing step of the socket in a data storage system and, optionally, in a remotely readable and writable electronic component contained in the socket.

In the method according to the invention, the steps of manufacturing the medical containers may include at least one of the following steps: cutting, washing, forming glass rods or molding plastic materials, which are used as the starting material for the medical container, printing a scale, such as a scale for measuring volume, annealing the glass rods, washing the medical containers, siliconizing, attaching a tip including a needle to the cylindrical body of the medical containers, installing the tip cap on the needle and visually inspecting the medical container. The result of these steps is obtaining cylindrical bodies for medical containers, optionally containing a flange and a tip, as well as, optionally, a printed scale for measuring volume. The obtained medical containers are ready for placement in the nest.

Although the marking of the medical container may be applied prior to any of the manufacturing steps, said marking is preferably performed after the annealing step.

Preferably, the marking representing the UII can be applied to and/or into, preferably into, the material of the medical container. Preferably, the marking is performed as quickly as possible during the manufacturing process, taking into account possible technical limitations (e.g., the heat resistance of the marking). For example, when marking is performed with a femtosecond laser, the marking is performed after annealing, since marking with a femtosecond laser does not withstand the annealing temperature. However, in the case of enamel sintering, the marking can be performed before annealing.

According to a preferred embodiment, the laser marking is performed by a laser in the material of the medical container using a femtosecond laser. When the medical container is intended to be connected to a needle, the marking is performed after annealing, but before the needle is attached, mainly because the marking is performed as early as possible in this way, which allows the transformations of the container to be monitored as early as possible.

During the forming and annealing stages, the data recorded in the data storage system and associated with the cylindrical body UIS may include:

- data related to the forming station: machine settings, dimensional control, date, production station ID, ambient temperature, batch number of the starting material;

- data related to the annealing stage: temperature profile of the annealing furnace, date, etc.;

- data related to needle attachment/intermediate packaging: type of adhesive used, key input variables of the gluing process, results of cosmetic and dimensional inspection.

After these initial manufacturing steps, the medical containers are washed with an appropriate liquid, such as water, in a cleaning step. Preferably, this is water used in water for injection (WFI), which is commonly used in the food, chemical, and pharmaceutical industries. Water for injection is purified water that is free of particles and bacteria.

The cleaned medical containers are then siliconized.

In more detail, the interior of the cylindrical bodies of medical containers is siliconized, which consists of applying a thin film of silicone to at least the inner surface of the cylindrical body.

A tip cap can then be placed on the tip of the medical containers to cover the needle.

During these stages of production, data recorded in the data storage system may include:

- data related to the production station: type of equipment used and preferably their settings for cleaning, sterilization and/or assembly, date, production station identifier, ambient temperature, batch number of starting material;

- data related to the cleaning stage: type of cleaning liquid used, temperature of the cleaning liquid, cleaning time, number of cleaning cycles;

- data related to the siliconization stage: type of silicone used, siliconization temperature, silicone consumption, siliconization time.

Step M4 of the method according to the invention includes placing medical containers made with markings in a nest.

The socket comprises at least one remotely readable and writable electronic component. The remotely readable and writable electronic component is preferably integrated into the socket, which prevents wear thereof.

Preferably, the remotely readable and writable electronic component may also comprise a remotely readable and writable electronic component associated with the socket.

At stage M5, i.e. when all medical containers are placed in the slot, the reader/writer writes all UIIs associated with each of the medical containers into a remotely readable and writable electronic component built into the slot.

Then, during each stage of processing of the nest, stage M6 can be performed. Thus, stage M6 can occur either at the beginning, or in the middle, or at the end of the stage of processing of the nest. During stage M6, the data related to the stages of processing of the nest can be transferred from the storage device to the remotely readable and writable electronic component of the nest. Thus, the nest can contain all the information related to the processing of the medical containers up to their packing in said nest. These data can also be transferred to another storage device, different from the one used previously.

The nest processing steps may include at least one of the following steps:

- sterilization of the nest and each of the medical containers located in the nest;

- filling each medical container placed in the nest with a pharmaceutical composition;

- sealing of each of the medical containers;

- transporting the nest to the inspection site, where each of the medical containers can be inspected;

- storing the nest in a cuvette for intermediate storage and/or transportation.

The above mentioned stages can be implemented both by the manufacturer and by the consumer.

Preferably, the nest can be placed in a cuvette, and the upper opening of the cuvette containing the nest is covered with a film to close the cuvette. The film can be made of any suitable material that has good mechanical strength and sealing properties. Polyethylene film is particularly suitable for this purpose, especially Tyvek® film, which is a non-woven synthetic material made from polyethylene fibers.

The cuvettes are placed in one or more sealable bags, which are then sealed. The sealable bags are then placed in cases containing labels, and the cases are placed on pallets.

Typically, data associated with the first layer processing steps of packaging may include:

- data related to the packaging station: type of devices used and, preferably, their settings for performing the placement of containers in a nest, the placement of a nest in a cuvette and the placement of a cuvette in a sealed bag, date, identification of the production station, ambient temperature, batch number of the starting material;

- data relating to the placement of containers in the nest: nest characteristics;

- data relating to the placement of the nest in the cuvette: cuvette characteristics, film characteristics such as the material from which the film is made;

- data relating to the placement of the cuvette in the sealed bag: characteristics of the sealed bag.

The trays can then be moved into a sterilization chamber for sterilization. Sterilization is preferably carried out with ethylene oxide or steam.

If there are sensors in the first layer of packaging, they can record physical data related to the sterilization of medical containers. These physical data, called sensor data, include, for example, temperature, humidity, pressure and exposure time. These data, called sensor data, can be transmitted from a remotely readable and writable electronic component to a memory device.

At any time during the processing stage of the first layer of packaging, the data contained in the tag of the remotely readable and writable electronic component of the first layer of packaging may be transferred from the remotely readable and writable electronic component to the storage device.

This data may include:

- UII of the first layer of packaging and/or

- UII of medical containers contained in the first layer of packaging, and/or

- data on the stages of production of medical containers; and/or

- data regarding the stages of processing the first layer of packaging.

Thus, the manufacturer and the consumer may have access to some or all of the above data, and thus they can fully trace the medical containers and the first layer of packaging throughout the entire processing at the manufacturer.

In the case of first-layer packaging sensors, they can record physical data related to the delivery of medical containers from the manufacturer to the consumer, i.e. during transportation from the manufacturer to the consumer. Such physical data include, for example, temperature, humidity and vibration.

The consumer can conduct quality checks before filling the medical containers. Containers that pass the tests can proceed to the filling stage, while those that fail the tests are rejected.

Quality assurance process data includes data related to tests performed by the customer to determine whether medical containers meet standards.

The consumer can proceed to unpack the cuvette to fill the containers with the pharmaceutical composition. The nest containing the medical containers can be placed directly into the filling chain.

Data related to these stages may include:

- data related to the filling station: type of devices used and, preferably, their settings for filling, date, filling station identifier, ambient temperature;

- data regarding the pharmaceutical composition: type of pharmaceutical composition, temperature, pressure, viscosity.

The consumer can remove the filled medical containers from the nest, perform a visual quality control of the medical containers and put the checked medical containers back into the nest.

The dual marking of both the medical containers and the corresponding first layer of packaging in accordance with the invention is particularly useful here, since it allows the traceability of the medical containers and their corresponding first layer of packaging to be maintained when said medical containers are separated from the first layer of packaging.

Containers that pass visual inspection can be placed back in the nest, while those that fail the inspection are rejected.

Data related to this stage may include:

- updated status of medical containers (accepted/rejected),

- data from visual tests carried out by the consumer to determine whether medical containers comply with standards.

Medical containers that have passed visual testing may be stored in cold conditions prior to use or transportation.

For storage, the medical containers may be transferred from the slot to another slot, referred to as a "second slot," which may also contain a remotely readable and writable electronic component (e.g., an RFID tag) configured to store the UID of the medical containers and to record and/or read data related to the processing of the medical containers.

If nest sensors are present, they can record physical data related to the storage of medical containers in cold conditions. These sensor data include, for example, temperature, humidity, pressure and storage date.

The trays containing the nests can be transported to a secondary packaging facility.

When nest sensors are present, they can record physical data related to the transport of medical containers when the cuvettes are outside the cold chain. Such sensor data includes, for example: temperature, humidity and pressure.

If necessary, sensor data is transferred from a remotely readable and writable electronic component to a storage device.

The medical containers can then be removed from the nests and packed into secondary packaging.

Claims (36)

1. A system for tracking data related to the processing of a plurality of medical containers (100) configured to be placed in a first layer (1, 2) of packaging, comprising: - at least one marking (103) made on and/or in the material of each medical container (100) and representing the corresponding unique product identifier (UPI) for each corresponding medical container, - a remotely readable and writable electronic component (21) located on and/or in the first layer of the packaging, wherein said remotely readable and writable electronic component is designed with the ability to store the UII of each medical container located in the first layer of the packaging, and with the ability to record and/or read data related to the processing of medical containers. 2. The system according to claim 1, wherein the first layer of packaging is a nest (2) or a cuvette (1), preferably a nest. 3. The system according to claim 1 or 2, wherein the remotely readable and writable electronic component contains a corresponding unique product identifier (UPI) related to the first layer of packaging. 4. The system of claim 3, further comprising a data storage system configured to store data relating to the processing of a medical container, wherein said data is associated with the UII of each medical container and, optionally, with the UII of the first layer of packaging. 5. The system according to any one of claims 1 to 4, wherein at least one marking (103) is optical, preferably at least one marking is selected from the group comprising a one-dimensional marking such as a barcode, a two-dimensional marking such as a data matrix or QR code, and text. 6. The system according to any one of claims 1 to 5, wherein the remotely readable and writable electronic component is selected from the group comprising an RFID tag, an ultra-wideband real-time location system (RTLS), a Wi-Fi-enabled module, a Bluetooth-enabled module, a ZigBee-enabled module, and an infrared-enabled module, wherein the remotely readable and writable electronic component is preferably an RFID tag that comprises an RFID chip and an antenna connected to the chip. 7. A method for tracking data related to the processing of a plurality of medical containers configured to be placed in a first layer of packaging, said method comprising the steps of: a) take material for processing of many medical containers, b) carry out markings on and/or in the material of each medical container at the first stages of manufacturing the medical containers, whereby said markings encode the corresponding unique product identifier (UPI) for each corresponding medical container; in addition, at each stage of manufacturing medical containers, the following steps are performed: c) record data relating to the stages of manufacture of medical containers and/or individual physical data of each medical container in a data storage system, whereby said recorded data is linked to the UII of each relevant medical container, d) place medical containers provided with markings in the first layer of packaging containing a remotely readable and writable electronic component, e) record the UII of each medical container in a remotely readable and writable electronic component contained on and/or in the first layer of the packaging, wherein the method additionally includes, at each stage of processing the first layer of packaging, a stage in which: f) record data relating to each said processing step of the first layer of packaging in a data storage system and, optionally, in a remotely readable and writable electronic component contained in the first layer of packaging. 8. The method according to claim 7, wherein the marking of the medical containers is carried out by gluing a label, sintering enamel, inkjet printing, laser marking such as picosecond laser marking or femtosecond laser marking, pulsed inkjet printing or dot impact marking. 9. The method according to any one of paragraphs. 7, 8, in which the steps of manufacturing the medical container include at least one of the following steps: i) cutting, washing and shaping of glass rods used as starting material for medical container; ii) molding of plastic used as a starting material for a medical container; iii) printing of the scale on the medical container; iv) placing the needle on the medical container; v) washing the medical container; vi) siliconization of medical container; vii) placing the tip cap on the medical container; viii) visual inspection of the medical container. 10. The method according to any one of claims 7 to 9, wherein the data recorded in step c) and/or f) are settings, date, station identifier, ambient temperature, batch number of the starting material, control results. 11. The method according to any one of paragraphs. 7-10, in which the data storage system comprises at least one computer server and/or at least one storage device. 12. The method according to any one of paragraphs 8-11, further comprising at least one of the following steps of processing the first layer of packaging: - sterilization of the first layer of packaging and each of the medical containers located in the first layer of packaging; - sealing of each of the medical containers; - storage of the first layer of packaging for intermediate storage and/or transportation. 13. The method according to claim 12, wherein the first layer of packaging is a nest, and the processing of the first layer of packaging further includes at least one of the following steps: - filling each medical container located in the first layer of packaging with a pharmaceutical composition; - moving the first layer of packaging to the inspection location, where it is possible to inspect each of the medical containers.