Counterfeit pharmaceuticals are a growing threat to patients and the pharmaceutical industry alike – also in Germany. Currently, initiatives and public authorities worldwide are working on guidelines and regulations with the aim to standardize processes for traceability and to protect pharmaceutical products. One attempt is the EU Directive 2011/62/EU, which stipulates the introduction of encoded packages with a unique serial number for prescription drugs. The “unique identifying feature” and a “tamper-proof seal” will be defined country-specifically in line with EU guidelines. But how can manufacturers implement these requirements?
To jointly elaborate a solution, many market players in Germany founded the association “securPharm e.V.”. The association develops technical and organizational solutions according to the EU order within a pilot project for this purpose, the data matrix code was determined data carrier, which has to contain a unique product number and serial number for end-to-end verification. As serial numbers must be randomized for tamper-proof allocation, secure and reliable software is essential.
Flexible concept for maximum safety
The Bosch CPS module (Carton Printing System) is a stand-alone solution and the currently most flexible serialization system on the market. After the tracking data is printed onto the package, it is automatically verified by the camera system. All relevant production data are managed in real time using our software.
In addition to printing and verifying, the modular and scalable concept allows setting up of a complete system including a central control unit with functional features such as checkweigher and labeler. The CPS can be equipped and updated with various software systems any time to guarantee a secure allocation of serials numbers. Additionally, the CPS can be equipped with a Tamper Evident-functionality. As for the CPS 1900 with Tamper Evident function, transparent standard labels are placed on the folding carton; verification is accomplished by a sensor.
Thereby, the Bosch CPS module enables manufacturers to meet the market requirements and legal standards for marking and serialization of folding cartons in the pharmaceutical industry worldwide.
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