EPM Magazine February 9, 2015
Serialisation – a learning curve, or dangerous high speed bend?
Carton printers and pharmaceutical packers are required to handle secure and complex data files to provide individualised cartons. Jim Kaye from Atlantic Zeiser UK looks at the challenges of serialisation.
The realisation of different national and international requirements for serialisation and track & trace is still one of the biggest challenges in the pharmaceutical industry. Different coding philosophies, specific requirements for aggregation and data handling in different areas of the world, need to be integrated into the packaging process from each single step to the management of the whole production process. Along with the appropriate equipment for encoding, verification and aggregation, the integration of appropriate software-systems that interplay with machinery and integrate into the existing IT-infrastructure is one of the most important aspects for the successful implementation of serialisation.
Machinery may need additional equipment to handle variable data, and variable data is rarely a part of the typical pharmaceutical companies IT infrastructure, so a Data Hub that can liaise between machine production requirements and overall management or ERP controls can be essential once you have more than one line running serialisation. Especially the administration and assignment of codes across multiple production lines or plants running the same products. Something many pharmaceutical companies are not yet prepared for. Moreover the multitude of different regulations for serialisation from Europe over China to America tremendously complicates the situation.
Many pharmaceutical companies have realized that the successful implementation of serialisation mainly depends on the IT-infrastructure. The innovative software solution MEDTRACKER from Atlantic Zeiser for instance can be combined with existing machinery and is able to interact with all common Enterprise-Resource-Planning-Systems.