CASE STUDY: The language of serialisation

This case study deals with the issues surrounding serialisation with Chinese codes and how MEDTRACKER control software can help.

The companies

Headquartered in Emmingen-Liptingen, Germany, Atlantic Zeiser develops innovative and practice-proven systems, including hardware and software components. Its product portfolio includes sophisticated serialisation, personalisation, customisation and track & trace solutions.

Schaper & Brümmer, headquartered in Salzgitter-Ringelheim, Germany, is a mid-sized pharmaceutical company that produces non-prescription, naturally-based medication for the modern market.

The challenge

As one of the first manufacturers of phytopharmaceuticals in Germany, Schaper & Brümmer exports its plant-based medicines to more than 40 countries and generates 45% of its total turnover from foreign business.

After receiving marketing authorisation in 1994 for the Chinese market, this export region has become one of the company’s most important for phytopharmaceuticals — including products such as the common-cold treatment Esberitox and menopause preparation Remifimin.

The rules that have been introduced progressively since 2013 for specified preparations now apply to all medicines sold on the Chinese market: they must be provided with the special Electronic Drug Monitoring Code (EDMC) to meet Chinese requirements. The coding system stipulates serialisation and aggregation and thus ensures transparency and traceability — and therefore drug security — in the supply chain. The requirements of the Chinese code go right to the heart of companies’ existing processes and are far from easy to implement.

“To be able to continue serving the Chinese market after 1 January 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,” recalled Dr Martin Tegtmeier, head of manufacturing at Schaper & Brümmer.

The solution

The MEDTRACKER software solution from Atlantic Zeiser has a modular structure, can be implemented in existing or new facilities and is a flexible and audit-proof solution for generating, distributing, printing, aggregating and tracking codes for all current international regulations. Additionally, it includes a full track & trace capability for e-pedigree applications, as needed for the US for instance.

Should the range of requirements change, the software can be adapted. In this way — if configured accordingly — it can cover the requirements of different markets, while forthcoming, as yet unknown, criteria can be implemented in a straightforward way without the need to purchase new software. Furthermore, the modular design of Atlantic Zeiser’s MEDTRACKER also allows the implementation of track & trace for parts of a line, entire lines, production facilities or whole companies — overall, therefore, it is a solution that can expand to accommodate growing requirements.

“This was an important consideration when we decided in favour of the MEDTRACKER solution. Actually, apart from serialisation in China, similar programmes are currently being launched and rolled out all over the world. Given that we export to more than 40 countries, we will undoubtedly have to respond to further regulations in our target markets,” explained Tegtmeier. “Although, as a manufacturer of non-prescription medicines, we are currently exempt from the delegated regulation concerning the falsified medicines directive that will be transposed into national law in Europe in the coming years, it looks almost certain that we will have to address this issue in future. Thanks to the MEDTRACKER solution from Atlantic Zeiser, we are prepared for it when it comes.”

The process

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. Their aim was to define actual requirements, to analyse existing and planned processes and, on this basis, to determine overall plant effectiveness with a focus on the desired availability, performance and quality of the envisaged plant.

In parallel the project team acquired relevant expert knowledge about serialisation 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.

In describing the advantages of this in-house approach Tegtmeier stated: “We were able to make informed and therefore better decisions during the implementation phase. In addition, as those responsible for compliance with drug-related legislation, we have retained relevant knowledge internally even after the project’s completion and can act accordingly if needed.”

The existing packaging line was equipped with a track & trace unit that prints serialisation numbers on individual packs, verifies 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.

Thereafter an aggregation code is printed and automatically applied to the case. Aggregation at pallet level is performed manually. 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 serialisation codes.

“We were converting a high-performance line set to produce 240 packs per minute — that is four packs per second. The requisite control software therefore had to be capable of processing very large quantities of data in an extremely short time,” Tegtmeier emphasized. “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.”

The benefits

“Serialisation 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,” Tegtmeier said. “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 the future too and so can safeguard our market position.”

As an active member of the Bonn-based Federal Association of Pharmaceutical Manufacturers, Schaper & Brümmer has shared its experience during the project with other companies interested in serialisation for the Chinese market and has used its converted packaging line in Salzgitter as an example. “Because of the complexity of the requirements, which must be incorporated with extremely individual, company-specific needs, we would strongly recommend getting to grips with the subject as early as possible,” summarises Tegtmeier.