Modular software solution for the serialization with China Codes (EDMC) in practice

Future-oriented investment by mid-size north German company

This was the challenge facing managers at Schaper & Brümmer who have now converted one of their eight packaging lines as a pilot installation. “Serialization for the Chinese market was not just a new undertaking for us, but also a key investment in the future and made us one of the first mid-size phytopharmaceutical manufacturers to take this step. Working together with our trusted partners, we were able to bring this project to a successful conclusion. Thanks to the versatile software solution provided by Atlantic Zeiser in particular, we will be able to fulfil new and changing requirements in future too and so can safeguard our market position,” says Dr. Martin Tegtmeier, head of manufacturing at Schaper & Brümmer.

The family-run business from the north German state of Lower Saxony exports its plant-based medicines to more than 40 countries and generates 45 percent of its total turnover from foreign business. China, for which it received a marketing back in 1994 as one of the first western phytopharmaceutical manufacturers to be granted this approval, has since emerged as one of the company’s most important export markets for such products as the common-cold treatment Esberitox and menopause preparation Remifemin. “To be able to continue serving the Chinese market after January 1, 2016, we had to start production in 2015. We ruled out the use of a packaging service provider owing to insufficient free capacities for the large batch sizes we need. We therefore decided to convert an existing packaging line, an investment with a high six-figure volume and a project start date of January 2014,” Tegtmeier recalls.

Process and needs analysis by an in-house project team

To produce an initial plant concept, an interdisciplinary team of IT, production, purchasing and sales specialists discussed the fundamental issues. They were joined by those responsible for compliance with drug-related legislation. In parallel the project team acquired relevant expert knowledge about serialization for China, appropriate coding and camera technologies, tamper-proof packaging and IT issues. This was collated in the user requirement specification
(URS), which stipulated the criteria that were to be met by external services and suppliers and the conditions that had to be ensured internally – both in normal situations and in exceptional circumstances or in the event of a malfunction.

Conversion of high-performance line only possible with MEDTRACKER

The existing packaging line was equipped with a track & trace unit that prints serialization numbers on the individual packs, verifies the codes and automatically rejects units that are unusable – because of inadequate print quality for example. A case packer was incorporated in the packaging line as an additional hardware component. It places the previously bundled individual packs in cases and records the codes on the individual packs with a camera system. The new hardware components supplied by different third parties are actuated by higher-level software that ensures audit-proof generation, printing, management and storage of the serialization codes – a task that could only be adequately solved by Atlantic Zeiser with its special MEDTRACKER serialization software.

“We were converting a high-performance line set to produce 240 packs per minute – that is four packs per second. The required control software therefore had to be capable of processing very large quantities of data in an extremely short time. A further challenge was the integration of hardware components supplied by other manufacturers in the plant concept. This aspect, together with the high data processing performance we needed, could be satisfied only by MEDTRACKER software from Atlantic Zeiser,” says Tegtmeier.

Expanded packaging line is met with great response

As an active member of the Bonn-based Federal Association of Pharmaceutical Manufacturers (Bundesverband der Arzneimittelhersteller – BAH), Schaper & Brümmer has shared its experience during the project with other pharma companies interested in serialization for China and has demonstrated the converted packaging line in Salzgitter by way of example. “Because of the complexity of the requirements, which has to be incorporated with extremely individual, company-specific needs, we would strongly recommend getting to grips with the subject as early as possible,” sums up Tegtmeier. He has already been approached several times about performing serialization on behalf of other manufacturers. But for now the company is working flat out on its own production for China with two shifts in operation. Aside from that, the managers of Schaper & Brümmer are thinking about converting a further packaging line. “We would definitely work with Atlantic Zeiser again.”

Would you like to learn more about how Atlantic Zeiser can support you to serializing packaging with modular software architecture MEDTRACKER?

Contact us and we would be happy to schedule a free consultation!

Lisa Romahn