Nicola Rapley, Global Marketing Manager for Pharmaceutical and Medical Devices at Videojet Technologies, looks at coding and marking technology in the generics market…
The use of generic drugs has never been more prevalent. With the expiration of more and more patents from the so-called blockbuster drugs, pharma manufacturers are able to reproduce these expensive branded products and market them at a far lower cost, as the product itself has been developed, formulated and approved already. A report by IMS
Health, Global Medicines Use in 2020: Outlook and Implications, highlights that by 2020 the global volume of medicines used will reach 4.5 trillion doses. Generics will play a key role in this rise, with an overall annualised growth rate of 10.6%, and with an aging population and rising healthcare costs to consider, it isn’t hard to see why. As an example of the huge volumes used, in the US alone generic drugs are expected to be used to fill 91-92% of all dispensed prescriptions by 2020.
This is good news for the manufacturers of generic drugs in terms of volume sales, as it is volume they need to remain profitable, but pharma manufacturers must all adhere to the strict and vast array of regulatory requirements – such as serialisation and track and trace – regardless of their size, which in turn has cost implications on a production line. Margins are much tighter in the generics market, with high demand in terms of production schedules, therefore every second of productivity that can be gained is vital to the bottom line. Unscheduled downtime and product wastage due to poor coding is highly undesirable.
Uptime, reliability and legibility are key, and many pharma manufacturers will lean towards Thermal inkjet (TIJ) or Laser marking systems due to their suitability to the ‘clean’ manufacturing environment.
Thermal inkjet systems available on the market today give a high-quality, high-resolution print at up to 600x600dpi and are simple to use and simple to maintain. Systems are capable of printing multiple linear and 2D bar codes,
including DataMatrix, QR, GS1, PPN and HIBC, at speeds of up to 300-metres per minute (984ft/min). On certain systems, up to six printheads can be added (with any four printing simultaneously), enabling electronic changeover between batches that require different print locations or packaging. Removing the requirement for manual print-head setup to change print locations means that changeover times can be reduced significantly, leading to higher throughput levels for the manufacturer. The risk of operator errors occurring due to manual intervention is also taken out of the equation. New inks are in development constantly, such as Flex Solvent. This new solvent ink for TIJ applications opens up new opportunities to mark more durable codes on non-porous substrates that were previously difficult to mark, such as bi-axially oriented polypropylene (BOPP), for example.
Laser coders are also popular due to their ability to code continuously with very little maintenance. Given the clean environments synonymous with the pharma industry, lenses can often be left for significant amounts of time before cleaning is required, reducing downtime. Laser is considered to be a completely clean technology as there are absolutely no consumables to take into consideration. A new CO2 laser is due to enter the market this year which, as a result of listening closely to customers’ challenges and requirements, has been developed to increase throughput capabilities. It will feature rapid data processing capabilities that will allow the system to produce complex codes at speeds not seen from a 30W laser in pharma production.
It is impossible to achieve high levels of productivity if the coder on the line is not efficient and implementing these systems effectively needs to be a swift and organised process. Many generics manufacturers are small to medium sized enterprises, who must take on the challenges of serialisation, for example, internally in order to comply with regulations such as the Drug Supply Chain Security Act (DSCSA) for the US market and the Falsified Medicines Directive (FMD) in Europe. The legislation applies to all pharma manufacturers, so the necessary steps must be taken to ensure compliance with the timelines as set out.
Profit margins, as we have mentioned, are tight, and to add additional equipment to facilitate new regulations adds to production costs – therefore, optimising production lines is a priority. Finding a partner who is able to support that process from start to finish has significant benefits, as the smoother the transition, the less downtime will be experienced. Having the backing of a global service network is something to be mindful of, as is finding a partner who has significant experience in implementing serialisation solutions and the structure in place to deliver to requirements – from a single coding unit to a turnkey project.