Augsburg manufacturer BÖWE SYSTEC is applying its extensive Track & Trace know-how to the pharmaceutical industry. Its new serialisation solution will have its debut on the booth at ACHEMA 2018 from June 11 to 15 in Frankfurt am Main (Hall 1.1, Booth E14).
Designed to halt the life-threatening trade in illegal medicines, the EU’s Falsified Medicines Directive (FMD) comes into force on February 2, 2019 and makes reliable serialisation and marking systems an absolute requirement. From then on, all medicines must bear a unique code and serial number to ensure that they can be tracked throughout the entire production process right up to the final customer. BÖWE SYSTEC has developed a modular stand-alone solution that is specifically designed to meet these requirements and that combines all the necessary functions in a single system:
• Automatic serialization by imprinting a unique data matrix code on unprinted folded boxes
• Verification of already printed packaging
• Automatic decommissioning
• Target/actual comparison of batch (total control)
• Print quality check or sample removal for hand scanning
With the ability to adjust its speed as needed, the serialization system can process every conceivable type of packaging reliably and, above all, securely right from the smallest 25 x 25 x 40 mm folded box up to exceptionally large medicine packages measuring as much as 250 x 250 x 400 mm.
Naturally, when providing protection against falsified medicines, security is the top priority. Revision-proof management of serial numbers can very quickly become highly complex and there is a substantial risk of duplication. As a Track & Trace specialist, BÖWE SYSTEC is able to draw on over 30 years of experience in this field and to guarantee processing that can be proven to be 100 percent secure. BÖWE SYSTEC’s well-thought-out software ensures end-to-end serialization consistency right up to the final stage in the process. Seamless item tracking using the latest topCam reading and sensor technology allows the position of every unit to be known at all times. Furthermore, immediate real time data comparisons both within and between production sites ensure that no serial number can be issued more than once anywhere in the world and also totally fault-free compliance with global pharmaceutical guidelines such as FMD, GMP or GAMP5.
The serialisation module does not just offer secure implementation of the pharmaceutical directive in a single system. It also combines the highest degree of flexibility with extraordinary ease of handling. Product handling, coding and inspection by camera are all managed via a single individually configurable software interface that can be adapted to cope with third-party systems and that is available for three levels of coverage: machine, site, multi-site.
In March, PharmLog, a pharmaceutical logistics company based in Bönen, took delivery of the first system.