Proposed serialisation requirements for drugs could add up to a logistical nightmare for European pharmaceutical companies if they decide upon a serialisation infrastructure that does not match forthcoming tasks. Atlantic Zeiser’s MEDTRACKER software is a flexible, secure and easy-to-implement solution to this potential problem.

The pharmaceutical industry is contemplating the implications of the likely introduction of an EU-wide serialisation requirement for drug packages by 2018. Other countries and regions are developing their own specialised strategies, while some markets, such as China and Turkey, already have theirs in place. Small and mid-size manufacturers in particular, as well as their packaging service providers, are facing massive challenges in the search for suitable software. How can one integrate existing hardware components and ensure maximum data security? Can a fast-growing and currently inestimable data volume feasibly be managed? And what action is being taken to accommodate future requirements efficiently?

As a leading supplier of sophisticated product individualisation and track-and-trace solutions, Atlantic Zeiser has developed some modular, easy-to-implement software for the forthcoming range of tasks. MEDTRACKER generates, distributes, prints, aggregates and tracks codes for all international regulations, and includes full track-and-trace capability for e-pedigree applications.

"We expect 80% of all drug packages sold worldwide to be subject to mandatory serialisation within the next seven to ten years," says Helmut Schneider, group product manager of packaging at Atlantic Zeiser. "Pharmaceutical companies and packaging service providers are therefore eager to integrate future-proof software without having to invest in new machinery."

The software architecture of MEDTRACKER has been developed to be adaptable to existing, even heterogeneous, third-party hardware. Thanks to an extensive interface library, the product can be integrated in all conventional business and process management systems. If required, it can even take charge of all process management tasks. The modularity achieved by the flexible architecture, moreover, enables seamless expansion.

Simple code aggregation

The modular design also enables a single product to handle the implementation of track-and-trace for parts of lines, entire lines, production sites or whole enterprises. Unlike conventional software, MEDTRACKER is a generic database application in which every function is dynamically programmed. An almost unlimited number of process steps, available machines, and exchangeable and alternative processes can be defined in order to achieve highest possible production flexibility, in combination with fast and versatile job assignment. MEDTRACKER integrates the new processes of serialisation and verification into users’ existing – often fully automated – workflows. This capability can be combined with manual handling routines, including aggregation and re-aggregation, typically in the shipping warehouse.

Proven high-security architecture

Atlantic Zeiser draws on its wealth of in-house expertise to ensure the highest standards of data security. Many of MEDTRACKER’s fundamental components have been successfully deployed in sensitive industrial sectors by the company over the last decade, but for the first time an extended suite of applications is available to the pharmaceutical segment.

The software embraces effective, continuously refined defensive measures against criminal hacking. In addition, data is exchanged between production operations and facilities in an encrypted format, which has by no means been standard practice in the pharmaceutical segment until now.

All product and logistic information is collected and stored for each medicine package. Proven and defined access mechanisms ensure the system can be audited easily and, thanks to its real-time capability, MEDTRACKER also complies with the extremely short response times demanded by packaging lines, which sets it apart from classic database applications.

Atlantic Zeiser is headquartered in Germany and has ten subsidiaries in the key growth markets of Europe, the US and Asia. Sales and service offices in more than 50 countries ensure close proximity to customers all over the world.