Fighting Piracy - Over the past couple of years, there have been many ongoing discussions throughout the world on how to combat the problems of counterfeiting in the pharmaceutical industry. Several solutions have been developed and applied, e.g. hologram labels, tamper-evident labeling as well as many others. In addition to these familiar technologies, many governments worldwide have passed legislation requiring the unique marking of each individual unit of sale. In 2006, for example, the California Pedigree Law was announced.

Other states and countries followed - but most of the timelines and the work involved for the industry were underestimated so introduction has been postponed in many cases. Nonetheless, Turkey kept to its schedule and was the first country to implement legislation governing the tracking and tracing of pharmaceutical products from the manufacturer to the pharmacy. It came into effect on Jan. 1. Other countries will soon follow suit - mostly with different approaches. At present, there are three different fields of application:

1. Codification regulations, such as the French CIP13
2. Label tracking, such as the Belgium barcoding system
3. Unique serialization numbering, such as in Turkey

Track & Trace by Uhlmann offers pharmaceutical manufacturers solutions to comply with these legal requirements.

How the Code Is Applied to the Carton

When it comes to the identification of pharmaceutical products, Uhlmann primarily favors 2D codes. However, solutions on the basis of RFID technology or other codes are also part of the company's repertoire. No matter what type of code is required, there is a common denominator: Track & Trace by Uhlmann is always an integral solution that includes all the necessary components.
2D codes contain a serial number (e.g. numbers according to the EPCglobal definition) and encoded data such as batch number and expiry date. Laser or ink-jet systems integrated by Uhlmann VisioTec apply the codes to the carton. A code reader or camera system then verifies and scans the code. The data are stored in the Uhlmann line tracking database. This procedure fulfils the requirements of the Turkish serialization law, for example, by uniquely identifying the smallest sales unit.

How the Packaging Process Continues

In order to ensure easy identification during dispatch and further distribution, Uhlmann's system also identifies further packaging units such as packaging cases and pallets. A camera installed in the case packer, for example, reads the 2D codes of each carton put into a shipping case. This data is passed on to the Uhlmann tracking database. The data of the 2D code now to be applied to the shipping case is linked with the information from the 2D codes on the cartons already stored in the database. This principle is known as the parent/child relationship or aggregation and can be repeated with further downstream machines. If necessary, additional code label printing systems have to be integrated in the line. At the end of the line, the shipping cases reach a pallet that is already marked with a barcode. The information of the 2D codes on the shipping cases is linked with the data on the pallet barcodes. To enable this, one camera records the 2D codes at the product in feed and a second scans the barcode on the pallet. The two sets of information are then linked in the database. In addition, Uhlmann also offers standalone units and solutions for manual case packaging stations as well as manual palletizing as such processes are quite frequently used in the industry.
The full production chain is then complete. Thanks to the seamless identification and linking of the different information in the Uhlmann tracking database, the manufacturer can subsequently check every step. Furthermore, the code enables him to clearly prove whether the product is original or counterfeit.

How Additional Benefits Are Achieved

Uhlmann has taken its system one step further. It is possible to apply a code to the blister using Track & Trace. A printing system applies a unique code to the lidding material and this is recorded by a camera. True to the principle of parent/child relationship, the information on the blisters and the carton are linked in the database.
But what are the benefits of applying Track & Trace at an earlier stage of the packaging process? Production data - such as sealing pressure, sealing temperature, type of forming material and forming material batch - can be checked at a later date. No matter which type of code is used and scanned, this offers additional reliability. Moreover, in the case of a product recall, for example, it is a simple exercise to identify foregoing errors with the help of the blister code. All blisters with the same parameter settings can be clearly identified.
This solution also offers advantages during the packaging process: e.g. during in-process control (IPC). On the one hand, the manufacturer benefits from the additional information because all production parameters are to be found on the blister. On the other hand, during IPC, faulty packs can be identified quickly and reliably. Validation is also simplified. For instance, when defining the parameter range of the sealing temperature, blisters are produced using different temperatures and subsequently tested for tightness. As the codes on the tightly sealed blisters include information on the sealing temperature, the test engineer can quickly establish which temperatures guarantee reliable production.
The unique identification of blisters likewise pays off in the case of late stage customization. Application of the 2D codes avoids any mix-up of otherwise unmarked blisters.

How Existing Machines Are Upgraded

For existing production lines, Uhlmann offers a solution with a downstream printing system and camera in each case. Compared to integration of Track & Trace in existing machines, this solution offers additional benefits in terms of validation. For example, a standalone unit is installed at the end of the cartoner. This applies a code to each carton and subsequently verifies it.