Track & Trace Solutions From The IMA Group

As you know, there has been a high increase in the falsification or counterfeiting of pharmaceutical products that represents an important economic problem, not to speak of risks linked to our health.

All the pharmaceutical products distributed in France after 31 December 2010 will have to bear a Data Matrix (2D) barcode containing the production batch number, expiry date, production facility address and full product identification data.

Generally speaking, measures have already been taken to activate traceability solutions, called Track & Trace, to complete and check the process of the pharmaceutical production chain, specifically:

• Installation of a 2D code marking system (DataMatrixECC200) in every packaging line. This system must be capable of operating in real time.
• Installation of a special system in all the packaging lines capable of verifying in real time whether the 2D code is correct or not.
• Installation of a software operating system capable of procuring, managing and storing the 2D codes that identify the packages (cartons). This system is installed in all the packaging lines.
• Installation of a centralized system to manage the 2D codes, capable of collecting and managing data from all the production lines and making them usable for wholesalers and/or pharmaceutical labs.
• Installation of a 2D code verification system for all packages that certifies the authenticity of the package. This system will be installed at the wholesalers' facility and/or at the pharmaceutical labs.

Track & Trace encoding and reading applications must take into account standards that are being gradually adopted by other countries.

We have defined three implementation stages, drawn up according to client demands.

Stage 1: coding (the 2D codes) on all cartons and data collection inside a specific database, available at all production lines (minimum condition).

Stage 2: the same procedure will be applied to the downstream machines (bundling machine, case packer and palletizer). For instance, the bundle's code must be the same as the one that is on the carton and so on. Data collection must refer to every single production line.

Stage 3: data management and interaction between the production lines and ERP operating systems, such as SAP and others.

At this point in time, France is required to comply with first stage only.

There are many measures to be taken in the pharmaceutical labs that mainly concern simple production lines, among which:

• The installation of a 2D code printer;
• The 2D code print check, as well as the creation and management of the 2D codes.

As far as big production lines are concerned, the activity consists in implementing the interaction with the ERP operating systems.

The foregoing identification systems are not part of the IMA Group production range, although they are directly linked to the products we offer.

What does the IMA Group propose to its clients?
The IMA Group produces packaging machines and units. Our scope is to integrate the technology required for the Track & Trace process into our machines.

As concerns the cartoning sector, IMA Safe is capable of supplying:

• All-purpose external carton conveyor, model AD153TT, standalone, versatile and reliable. It is fitted with a checking system that can be paired with any cartoning machine (IMA or other ones). You may either install 2D code printers of everyday use, inkjet coding units or Wolke units (HP), or the like, on both sides of the carton. Moreover, we can install a 2D code checking system on the carton as well as the system that checks for the actual rejection of the carton. This unit is equipped with an electronic device that checks for the carton's correct position and may be installed both on new machines and existing ones (Retrofit).
• All-purpose external carton conveyor, model AD153TT, not standalone but just as versatile and reliable as the foregoing, and that can be paired only with IMA cartoning machines. You may either install 2D code printers of everyday use, inkjet coding units or Wolke units (HP), or the like, on both sides of the carton. Moreover, we can install a 2D code checking system on the carton as well as the system that checks for the actual rejection of the carton. This unit is equipped with an electronic device that checks for the carton's correct position and may be installed both on new machines and existing ones (Retrofit).
• Integrated and customized module, to be paired with the A81, GIANT and DYNAMICA cartoning machines, which allows conveying the carton for the 2D coding (as specified for the AD153TT), the checking and expelling of the carton by toothed belt in lieu of the flat belt. This unit is suitable for new machine applications and for clients who prefer conveying the cartons through toothed belts. Devices that check that the carton flaps have been closed correctly may also be installed.

IMA Safe Line has developed applications, for the printing of codes and/or labels and for cameras that check Tracking & Tracing data on the end packages before shipment, for all the machines at the end of the production line, i.e. downstream of the cartoning machines (bundling machines, wrapping machines, case packers and palletizers). These changes were necessary to extend the checks all the way to the final packaging stage.

The foregoing changes may be carried out both on new machines and existing ones (Retrofit).

IMA Safe and IMA Safe Line are always in touch and actively collaborate with the most important suppliers of Track & Trace systems to integrate 2D code printers, collect and store data, with the aim of finding the most appropriate and GMP-oriented solutions.

Antares Vision is one of IMA's privileged suppliers thanks to the experience it has acquired at the following levels: product presence control, code control through camera and print quality control through OCV/OCR.

The Antares Vision system for the Track & Trace process is totally modular. It may be applied, fully complying with the specific regulations of the affected country, to check and trace the 2D code all the way to the pallet. This system permits managing production line data through a central operating system to trace the package at all times. Antares Vision devices dialog directly with the coding systems (HP type) to take-on-charge the code information from the printer to the camera (intelligent).

IMA Life has just developed certain labeling machine applications. The request that clients make most often is that of applying the 2D code to the labels and this is why IMA Life has come up with different solutions for the Track & Trace process.

The most recent labeling machine, model SENSITIVE TE 3T, features the application of labels on three of the carton's sides. In actual fact, this machine is capable of applying two tamper-proof security seals on the two sides of the carton and an optical label on the top side. The advantage of this machine, many of which have already been successfully inserted in production lines, is its compact and ergonomic design that allows it to be easily accessed and quickly cleaned. Among its features, do not forget the safe transferal of the carton, the expulsion of the non-conforming product and the tool-free size changeover. The SENSITIVE TE 3T guarantees a production speed of up to 400 cartons/minute.

Thanks to the mobility of the operating units, the following components may be installed on this machine:

• Different 2D code printer models;
• A camera for reading and checking data (batch, expiry date, progressive 2D) to track any product on which a label has been fixed.

The application for printing and checking the 2D code is available both for the labels and the cartons. The label RFID code reader is also available.

IMA Life has provided a number of solutions to leading, worldwide multinational pharmaceutical enterprises, and many more can be created and customized according to market production requirements or trends.

SOURCE: IMA S.p.A.