As the EU FMD deadline edges closer, manufacturers will need to implement new systems to guarantee the continued sales of prescription and some over-the-counter medicines within the European market
With just three years remaining to implement serialisation systems before the EU Falsified Medicines Directive comes into force, one of the main concerns at Hispack 2015 centred around the possible reduction of Overall Equipment Effectiveness (OEE) due to the complexities of moving from batch to item-level serialisation. Leading coding and marking specialist Domino Printing Sciences’ presence at Hispack 2015 focused on reassuring manufacturers that rather than impacting production, serialisation can have a positive effect on performance.
Present on-stand throughout the packaging show, Domino was showcasing its market-leading coding and marking equipment including the G320i OEM integrated into an Invescontrol serialisation handling module, developed to print long-lasting, durable codes at high speeds and therefore increase line-effectiveness within serialisation systems.
In his address in Barcelona on Thursday 23 April, EU Life Sciences sector manager Bart Vansteenkiste presented the latest serialisation updates in the pharmaceutical sector, focusing on the threat counterfeit medicines has on global health. 'The impact of counterfeit medicines is widespread,' Vansteenkiste said. 'In the last five years 30 million counterfeit medicines have been seized across European borders. Worldwide sales of counterfeit medicines top €57bn annually, while almost two thirds of drugs purchased online are fake.'
With potential downtime a reality, these manufacturers know that by introducing the right coding equipment now, it could potentially save them a lot in time and money and improve line efficiency speed
Vansteenkiste stressed that as the deadline edges closer, manufacturers will need to implement new systems to guarantee the continued sales of prescription and some over-the-counter medicines within the European market. 'By the end of the year it’s expected the final delegated acts will be published, including the products that must comply,' said Vansteenkiste. He also mentioned that 'although the quality of the code within the manufacturing plant will be key, it will also be mandated in the legislation that the code quality must remain throughout the lifespan of the product'. This means that any printed code must be extremely robust and contrast must be maintained.
'Although this is a while away, manufacturers have started to implement complex serialisation systems to their lines – in fact more than 60% of pharmaceutical companies have pilot projects in place,' he added. 'With potential downtime a reality, these manufacturers know that by introducing the right coding equipment now, it could potentially save them a lot in time and money and improve line efficiency speed.'
Vansteenkiste also explained how Domino is supporting its customers through its Partner Programme, which demonstrates legislative compliance through compatibility of its products and solutions with other suppliers.
'Domino’s Partner Programme helps manufacturers to comply with legislation through a consolidated programme of expertise that connects manufacturers and industry bodies,' said Vansteenkiste. 'Our partnerships with suppliers reassure our customers that our equipment is compliant not only with serialisation requirements, but with other systems required for an end-to-end serialisation solution.'
Domino’s latest coding technologies have been key in assisting pharmaceutical manufacturers move from batch to item-level serialisation. Domino provides a range of equipment for superior quality and high reliability coding in the Life Sciences sector, like the D- and F-Series scribing and fibre lasers, the G-Series Thermal Ink Jet for fast production environments and the thermal transfer overprint for printing onto flexible packaging films and labels.