Cracking the code on serialisation
About the blogger: Heidi Vanheerswynghels is a strategic account manager at Videojet Technologies Inc., a manufacturer of marking and coding systems. She leads a defined group of the company’s global pharmaceutical key accounts and carries responsibility for all medical and pharmaceutical business in EMEA.
In 2011, the anti-piracy consortium Business Action to Stop Counterfeiting Piracy (BASCAP) of the International Chamber of Commerce estimated that the annual cost of counterfeiting and piracy was $775 billion (£463 billion/€561 billion) and is expected to reach $1.7 trillion (£1 trillion/€1.2 trillion) by 2015. BASCAP points out that the costs of counterfeiting extend far beyond the lost revenue opportunity to include the impact on consumer safety, lost government revenues and an estimated destruction of 2.5 million jobs globally. The pharmaceutical industry is a frequent target of counterfeiting and according to the 2011 Report on EU customs enforcement of intellectual property rights (IPR), medicines represented the single highest product category detained by EU customs agencies for suspected IPR infringement.
Combating the proliferation of counterfeit drugs is a complex topic, yet serialisation of the individual unit of sale remains a critical tool in the fight to protect consumers and IPR holders. Its effectiveness against these threats is evident in the recent passage of regulations across the globe mandating serialisation, including DRC-54, The System for National Control of Medicines in Brazil, the EU Falsified Medicines Directive and the recently passed Drug Quality and Security Act in the US.
Serialisation has clear implications for the integration of data and physical product flows both at the packaging lines and downstream in the supply chain. And while the complexities of generating unique codes, managing aggregations and supporting downstream product movement and authentication receive significant attention, it is easy to overlook the role that coding and marking need to play in an effective serialisation programme. Data matrix codes have become the predominant ‘code carrier’ for the majority of pharmaceutical regulations. Besides the obvious advantages of machine readability with low-cost optical imagers, Data matrix codes have a high data carrying capacity and embedded error correction, which allows for some code damage while maintaining readability.
While most coding and marking suppliers have Data matrix marking capability, packaging professionals need to consider a broader set of supplier capabilities to identify the right coding and marking partner for their serialisation needs. At the packaging line, the success of any serialisation project requires the integration of software, printers, cameras and material handling. Identifying a coding and marking supplier with a track record of working with serialisation software providers to successfully communicate unique code data between the software system and the printer has obvious benefits.
Another critical element is the printing technology breadth of the chosen coding and marking partner. Pharmaceutical manufacturers often produce a range of products utilising different packaging substrates that require specific printing technologies. Opting for a partner with a range of printing technologies ensures that the packaging professional can evaluate options and consider future packaging line requirements including throughput and substrate flexibility.
Lastly, the ideal coding and marking partner should be proactive in offering suggestions on the proper integration of the printing solution with the material handling solution. The interaction of these two elements can be overlooked with implications on code quality, throughput and the overall efficiency of the packaging processes.
Pharmaceutical packaging teams are now literally racing against the clock to get serialisation systems in place before the legislated deadlines. And while these projects are complex, these teams can eliminate one dimension of complexity by teaming with a qualified coding and marking supplier. Properly-integrated printers, generating high quality Data matrix codes, are a foundational element to any successful serialisation programme.