Software facilitates safe and simple serialisation with existing machinery

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? Atlantic Zeiser is presenting a modular, easy-to-implement software solution for the forthcoming range of tasks at interpack.

MEDTRACKER is a flexible solution for generating, distributing, printing, aggregating and tracking codes for all international regulations and includes a full track and trace capability for e-pedigree applications. Atlantic Zeiser has developed the 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.

The modular design also allows the implementation of track and 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 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 and often fully automated workflows. This functionality can be combined with manual handling routines, including aggregation and re-aggregation, typically in the shipping warehouse.

Atlantic Zeiser has been integrating many of the software solution’s fundamental components in security-conscious industrial sectors for more than ten years and is now making an extended suite of applications available to the pharmaceutical segment for the first time. MEDTRACKER 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. 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.

Hall 16/Stand A47, interpack 2014, 8–14 May, Messe Düsseldorf, Germany.

Atlantic Zeiser, www.atlanticzeiser.com.