Addressing the challenges of serialisation

Soon-to-be-enforced EU serialisation requirements present a number of challenges on the software side. One solution has recently been announced by track and trace systems specialist Atlantic Zeiser.

From 2017, all drug packages entering circulation in the EU must be unmistakably identified and seamlessly traceable.

THE pharmaceutical industry is contemplating the implications of the likely introduction of an EU-wide serialisation requirement for drug packages by 2017.

Small and mid-size pharmaceutical manufacturers in particular, but also their packaging service providers, are facing massive challenges in the search for suitable software solutions. How are existing hardware components to be integrated? How can maximum data security be ensured? Can a fast-growing and currently inestimable data volume be feasibly managed? And what action is being taken to accommodate future requirements efficiently as well?
As a supplier of sophisticated individualisation and track & trace systems, Atlantic Zeiser is presenting what it describes as a modular, easy-to-implement software solution for the forthcoming range of tasks at Interpack 2014. Medtracker, it says, is a flexible solution for generating, distributing, printing, aggregating and tracking codes for all international regulations – and includes a full track & trace capability for e-pedigree applications. “We expect 80 percent of all drug packages sold worldwide to be subject to mandatory serialisation within the next seven years,” says Helmut Schneider, Group Product Manager Packaging at Atlantic Zeiser. “Pharmaceutical companies and packaging service providers are therefore eager to integrate future-proof software solutions without needing to invest in new machinery.” Atlantic Zeiser has developed the software architecture of Medtracker to be fully compatible with existing, even heterogeneous third-party hardware. Thanks to an extensive interface library, Medtracker can be integrated in all conventional business and process management solutions. If required, it can even take charge of all process management tasks. The modularity achieved by the flexible architecture, moreover, facilitates seamless expansion.

Code aggregation
The modular design also allows the implementation of track & trace for parts of a line, entire lines, production sites or whole enterprises – with a single product. Unlike conventional software, Medtracker is a generic database application in which all functionalities are dynamically programmed. Not only can this innovative software solution collect and aggregate data on the usual three levels of the packaging hierarchy (individual product, secondary packaging and pallet), but the customer can also simply insert any number of additional levels, such as bundles, containers etc. Medtracker integrates the new processes of serialisation and verification into users’ existing, often fully automated workflows. This functionality can be combined with manual handling routines, including aggregation and re-aggregation, typically in the shipping warehouse.

High-security architecture
To ensure the highest standards of data security, Atlantic Zeiser draws on its wealth of in-house expertise. The company has already been integrating many of the new software solution’s fundamental components for more than ten years in security-conscious industrial sectors. Medtracker is now making an extended suite of applications available to the pharmaceutical segment as well for the first time. The software embraces effective, continuously refined defense measures against criminal hacking by outsiders. In addition, data are exchanged between production operations and facilities in an encrypted format as a general rule, which has by no means been standard practice in the pharmaceutical segment thus far. All product and logistic information is collected and stored for each individual medicine package. Proven and defined access mechanisms ensure the system’s auditability. 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.