UK pilot shows serialisation and authentication in harmony

A pilot project that demonstrates the potential of pharmaceutical serialisation, tracking and authentication of drugs as they travel through the supply chain has been completed by SecureTrace, a consortium of UK companies.

The pilot was carried out using a high-speed packaging line located at a facility in Hull operated by pharmaceutical company Reckitt Benckiser.

The pilot is designed as a showcase for a multilayered approach to preventing pharmaceutical counterfeiting and diversion, based on serialisation and tracking using on-pack 2D datamatrix codes and radiofrequency identification (RFID) at the carton level, and the use of laser surface authentication and forensic signature inks for authentication.

SecureTrace notes that the process begins when pharmaceuticals are imprinted with unique and secure 2D barcodes featuring authenticating markers in the ink. A unique natural fingerprint is also generated using laser surface authentication, a technology which generates a unique signature for each pack based on the natural variation on the surface of the paperboard.

Pack data is aggregated to cartons and pallets, and barcodes and RFID labels are then applied to cartons. The information is stored in a master database.

Importantly, the pilot used an authentic Reckitt Benckiser product format that was packaged in test boxes and cartons at full production line speeds for authentication at key points in the supply chain.

Once the pharmaceuticals left the packaging facility, handheld field readers provided authentication and verification as the product travelled throughout the supply chain to its point of dispensation, according to the consortium.

Suzy Firkin of Authentix, the company which led the project, told SecuringPharma.com that the aim of the project was to demonstrate in a practical manner how serialisation and authentication can be combined effectively.

This combination, alongside the routine use of tamper evident seals, lies at the heart of the European Commission's draft Directive on falsified medicinal products which is currently being deliberated at the European Parliament level.

"Serialisation is a great thing to implement, but on its own cannot provide a complete answer for preventing pharmaceutical counterfeiting and diversion," she said.

The pilot clearly demonstrates the feasibility of running a number of different technologies alongside each other, she added. A company might need only two or three of them to serve their own product's requirements, but the pilot provides a working example of their use in practice.

SecureTrace is also keen to show that its system is in alignment with other industry projects, including the serialisation pilot recently-completed by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the BRIDGE traceability project.

SecureTrace's pilot takes that work further, however, by exploring the inclusion of additional authentication technologies that do not impact on the packaging design and the practical integration of technology at the production line and in the supply chain.

"European countries have taken a fragmented approach to tracking drugs while the US has struggled to establish a workable pedigree system," commented Jim Rittenburg, vice president of healthcare at Authentix and lead partner for SecureTrace.

"SecureTrace establishes a clear and workable strategy that has been developed and executed by all players involved in the process," he added.

UK solution

The SecureTrace pilot was part-funded by the UK government's Technology Strategy Board, which supports projects that combine manufacturing, research and technology partners.

"It was important for us to demonstrate that UK-based companies have all the expertise required to implement this type of programme," commented Firkin.

The next stage for the consortium will be to communicate the findings of the pilot to a wider audience, she said.

For logistical reasons open days at the Hull facility have been ruled out, but SecureTrace is planning to present the pilot at conferences and will schedule workshops to provide an extended demonstration of the integration of the technologies.

The 10 companies involved in the pilot are as follows: