Serialisation and the ‘batch of one’: the solution to continuous manufacturing?

Craig Stobie, head – global Life Sciences team, Domino Printing Sciences considers the correlation between the trend from batch to continuous manufacturing and the move from batch traceability to item serialisation

Craig Stobie, head – global Life Sciences team at Domino

Earlier this month, MIT Professor Tim Jamison shared his concern that despite continuous manufacturing being the future for pharma, a lack of scientific knowledge will hold the industry back from adopting continuous processes. While continuous manufacturing has been on the pharma agenda for at least two decades, the requirement for traceability by batch has always been one of the stumbling blocks.

However, the pharma industry is now facing arguably the biggest challenge it has ever faced – moving from batch to item-level serialisation – as called for by the EU Falsified Medicines Directive (FMD), Europe’s response to the global threat of counterfeiting. As manufacturers are now implementing line systems to enable item-level products to be identified and tracked at any point of the supply chain, this could signal the beginning of a new, continuous future for pharma.

From 2018, each pack will effectively become a ‘batch of one’, uniquely identifiable by a 2D data matrix code and human readable text. While pharmaceutical manufacturing has up to this point enabled faulty products to be identified by batch, item-level serialisation will enable issues to be identified right down to the specific pack itself.

But how can this element of quality control work within continuous pharmaceutical lines? Item-level serialisation will behave in the same way as a time code on food products, so perhaps the answer lies in Good Manufacturing Practice (GMP) protocols. Echoing the processes used in the food industry, faulty products within a continuous line could be dealt with by isolating products coded between a time scale either side of the faulty product – enabling continuous lines to work efficiently and for quality control processes to keep patient safety at its heart.

And although Professor Jamison has concerns about the lack of talent in the industry to implement such technologies, all is not lost. The pharma industry will be changing radically within the next three years and manufacturers are already refitting their lines to integrate serialisation into current processes to keep systems up and running at the levels of Overall Equipment Effectiveness (OEE) they have achieved up to this point. They will be all too familiar with such overhaul, e.g. high start-up costs, new training and initial labour that will result in increased speeds, higher quality print and more secure products in the long run.

Whatever the challenges that manufacturers will face over the next few years as the industry evolves, the new processes will be far more efficient than batch manufacturing we have been used to. So I can’t help but wonder – could item-level serialisation be the push pharma needs to have the confidence to go continuous?

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