Unique single-solution product delivering serialisation and data management, incorporating number generation, coding, vision, data storage, management and reporting – at line, site and company level
Internal view of SerialTrac
Domino Printing Sciences has launched SerialTrac – a complete compliance solution that the Cambridge firm says meets all the requirements of current and impending pharmaceutical serialisation legislation.
SerialTrac has been designed to allow turnkey installation on primary packaging lines. It is equipped to handle both internally- and externally-generated serial numbers and also offers aggregation functionality as standard, including post-manufacture rework and repacking – essential to any pharmaceutical manufacturing process. Its patented data compression techniques reduce the reliance on large, cumbersome and expensive databases. A high degree of standardisation means that Domino is able to offer SerialTrac as a cost-effective, scalable compliance tool which can be rapidly installed.
With the Delegated Acts associated with the EU Falsified Medicines Directive (FMD) now in the public domain, item-level serialisation in the EU will be a reality in less than three years’ time (February 2019). Domino estimates that a significant proportion of manufacturers will be hard-pressed to meet that deadline, but for some at least, the solution may be SerialTrac.
The impact of the FMD and other serialisation schemes around the world should not be underestimated for any branch of the industry
Jim Orford, Commercial Programme Manager for SerialTrac at Domino, says the product has been engineered with a specific section of the market in mind. 'The impact of the FMD and other serialisation schemes around the world should not be under-estimated for any branch of the industry but Domino recognises that small to medium-sized businesses are particularly hard hit,' he says.
'Typically these manufacturers do not have the infrastructure or resources readily available to create a bespoke solution or to integrate with an ERP system – yet they face exactly the same complexity challenges as operations ten times their size.'
One such pharmaceutical SME is currently evaluating the SerialTrac system and is expected to place an order in the near future.
Throughout the serialisation process, Domino has repeatedly stated that no single supplier can provide a complete solution addressing all the core disciplines, which include code generation and management, code application and verification, pack handling, reject and data storage, management and reporting.
Domino’s response to this problem, and the culmination of more than three years’ work for the team involved, is SerialTrac, which is produced under the Domino brand by a consortium of companies with complementary expertise. The result is a proven, ‘out of the box’ serialisation product that combines best in class technological solutions for all aspects of serialisation, synchronised in a single product from a single supplier.
Most serialisation projects to date have been out of necessity based on a bespoke solution, but with SerialTrac, Domino has taken a different approach, recognising that the higher the degree of customisation, the greater the complexity. To this end, SerialTrac is not an application-specific solution; rather, Domino has created a master specification that covers the widest possible range of user requirements.
Secure code generation and management functionality is based on the Codentify traceability solution, which is widely proven in the tobacco sector for fraud prevention and fiscal recovery. At its heart is a powerful algorithm featuring assymetric encryption that generates random codes from a virtually infinite number of combinations.
Craig Stobie, Director – Global Sector Management and Development at Domino, says: 'Over the years of our involvement with Codentify, we have come to recognise just how formidable a serialisation solution it really is – and hence its potential for the pharmaceutical sector. However, code generation and management is just one of the many functions of SerialTrac.
'We have drawn on Domino’s extensive experience in the pharmaceutical sector to develop SerialTrac as a product that is native to the industry, conforming with all the very particular requirements and processes that are unique to pharma.'
'It is a three-year project coming to fruition; we've augmented for the pharmaceutical sector a system that's already been running for 15 years in the tobacco industry.'
Installation on a typical line can be completed with minimal impact to any production environment
Installation on a typical line can be completed with minimal impact to any production environment; this compares favourably with the install requirements for bespoke systems, which are proving lengthy for many of the contractors currently at work in the field, Domino says. The interface with the customer’s IT structure is restricted: a link with the local ERP system is created solely to enable SerialTrac to request only the essential Master Data required to build the specific attributes of the product in question.
'In bringing SerialTrac to market we have sought at all times to look at the challenge from the perspective of the customer, rather than that of a vendor,' says Orford. 'While Domino’s global expertise in coding and marking for patient safety is second to none, this is just one aspect of successful serialisation. We decided at the outset of the project that highly-qualified partners and local support would be essential and I’m pleased to say that the enthusiastic feedback from prospective customers so far appears to validate this approach.'
SerialTrac will be available to order in Spain from May 2016 and in the UK from July, ahead of a wider rollout. Integration, installation and technical support will be provided by Domino’s local partners Invescontrol and Olmec respectively.
To support the product and continued growth across the business, Domino will be increasing its workforce by 10–15% in the near future, Bond added.