As we get closer to the deadline for the European Falsified Medicines Directive and the need for companies to be fully ready for serialisation, Markus Rosenkranz, leader Serialisation Solutions, Rockwell Automation EMEA, discusses how best to meet the interoperability challenges head on and drive return on investment.
Chess Piece
The need for pharmaceutical companies to introduce serialisation technologies into drugs manufacture and distribution to meet existing, incoming and future compliance requirements is well documented.
It’s difficult to overstate the scale of damage caused by drugs counterfeiting; the human cost in lives lost and the suffering associated is incalculable. Widely reported cases blaming counterfeits include contaminated blood-thinner medication, home Botox kits, erectile dysfunction pills, and medicines used to battle malaria, tuberculosis and other life-threatening diseases.
Trusted pharmaceutical brands have suffered in public perception, and the combined financial effect on the industry is estimated at around $75 billion per year.
A reliable method to prove the authenticity of drugs sold around the world has been a priority for governments and international regulatory bodies for several years, and although there is some way to go before a harmonised global standard is possible, many regions are well on the way to requiring pharmaceutical companies to provide track-and-trace coding on packaging in order to be licensed.
A number of companies that operate internationally have advanced strategies and are compliant in regions already requiring various levels of track-and-trace labelling, such as the US (since November 2017) or are on course for forthcoming EU (February 2019) legislation. Many more however, are faced with a steep learning curve or implementation challenges to remaining compliant; not least overcoming the significant interoperability challenges of an extensive supply chain.
Meeting the serialisation challenge
While the regulations make it clear that serialisation is the solution to protect the supply chain from rogue elements and counterfeit products, it is not prescriptive about how the requisite technology should be implemented. Moreover, there is no universally adopted data format for capturing the aggregated track-and-trace information produced by serialisation to make it available to partners along the supply chain.
At the manufacturing level, the new regulations require that every stage of the end-of-line packaging process has tracking capability. This includes machines, printers, labellers and associated vision systems, including barcode scanners. Every stage in the finished goods packaging process must provide a unique serial number to the product barcode or RFID tag.
For some products, this might include five levels of what is known as parent-child aggregation, with serial numbers applied from the unit or dose level all the way up to the pallet level. For example, the pallet serial number is a ‘parent’ and must be paired to the unique case serial numbers it contains — the ‘children’. Similarly, the case serial number is a ‘parent’ of the cartons (‘children’) it contains and so on.
Interoperability
One problem for many pharmaceutical producers at the manufacturing stage is that, historically, many have installed ‘black-box’ automation solutions for their packaging lines. Black-box solutions often contain unique or customised machines, customised software drivers, proprietary networks and unique application software.
Applying such complex individual identifiers retrospectively is a huge undertaking that requires high speed data handling capability. Moreover, the re-engineering (and potentially reverse-engineering) required to re-programme and update such a system to the new requirements, where it is even possible to do so, often involves a prohibitive amount of downtime.
The resulting system, if it reached the required compliances of today would still be very difficult to adapt again for new regulations in the future, and may struggle to manage any regional variations to requirements to produce drugs for different markets.
In addition to all of this, such systems are unlikely to be able to take advantage of some of the benefits and potential return on investment (ROI) of moving to a serialisation solution, such as the kind of the Industrial Internet of Things (IIoT) gains in productivity and efficiency possible in a modern, connected enterprise.
Return on investment
Serialisation legislation requires investment from up and down the supply chain, and a significant investment from manufacturers. Importantly though, as with any such investment, manufacturers should also seek a return on investment (ROI) — beyond the indirect contribution to a beneficial reduction in counterfeiting. The latest serialisation methods can help achieve a rapid ROI by making the interoperability between device-level machines and enterprise level information and business systems. This in turn offers manufacturers the opportunity to harvest data that can help increase throughput, aid long-term profitability and further adapt their solutions to future regulation changes.
A serialisation solution that includes an integration gateway with preconfigured channels for order creation and the export of EPCIS data that is simple to integrate into the existing system can greatly reduce the up-front engineering cost and reduce the time to achieving ROI.
Sustainability for pharmaceutical manufacturers in the face of changing regulations now hinges upon not just meeting the serialisation challenge but leveraging the required improvement in data handling capabilities to safeguard their business in the digital era. The good news is that through serialisation adoption, and particularly when coupled with the best MES technology now available to manufacturers, this is entirely possible. Moreover, by partnering with the right vendor to implement the right solution and lean on the recent and relevant experience they can bring to the factory, drugs producers can benefit from the advantages already being enjoyed by early adopters.