Pharmaceutical manufacturers and packagers could be facing increased costs due to re-engineering of production lines to satisfy newly upgraded European Union Falsified Medicines Directives (FMD). Printing and packaging systems that carry out coding, and its related post-print inspection, offline as an independent process might make it easier for manufacturers to meet the new compliance requirements in a cost effective and timely fashion.
The FMD was instituted to reduce the number of “falsified and counterfeit medications from infiltrating the legal pharmaceutical supply chain”. It was initially implemented in 2011. Beginning soon any manufacturer not meeting the new requirements could be forced to withdraw its products from the market.
One of the primary new regulatory requirements is that each pharmaceutical package needs to have a “machine readable 2D Datamatrix encoded” serialized number printed on the package. In addition to needing such a unique serial number, the packages have to comply with all normal expiration date and batch number regulations. The increased coding, or labeling, requirements mean many manufacturers will need to upgrade, and update, their printing and coding devices. The print professionals at Griffin-Rutgers understand that a change to a high speed Datamatrix code printer could be initially complex and costly to implement into a fully automated packaging line.
It’s estimated that many of the systems in the EU will be rendered obsolete by the FMD requirements. What will likely happen is that the pharmaceutical manufacturers will be forced to upgrade their systems to meet the requirements for the specialized coding and associated image verification.
Griffin-Rutgers print professionals understand that retrofitting coding systems could be a primary option as a way to meet the upgraded standards. This could mean significantly upgrading the packaging line coding station with a new digitally based coder. Such an upgrade could also require the integration of a new serialized data interface capable of generating and tracking appropriate code information. As previously mentioned above, coding packaging materials off line is very possibly a less expensive, and faster to implement, alternative.
Using a continuous ink jet printer is not ideal because such systems cannot typically meet the challenge of producing a readable, and appropriately graded 2D code. Additionally, as part of the FMD updates, the codes must be checked by an inspection system as a way to assure the unique number encrypted in the code has been printed, is readable, and is correct. Vision system reliability performance can be significantly impacted by the quality of the printed code and any 2D code that is blurry or too far out of position could be rendered unreadable.
Thermal inkjet printers, which print at much greater dot resolution than continuous inkjets, can produce a clearer code image and more dependably readable 2D code on a pharmaceutical package. Thermal inkjet printers are also much less expensive to purchase and easier to maintain than continuous inkjets making them possibly the obvious technology choice to meet the new standards. Such high resolution coders are much more easily integrated with off line feeding/transport, coding units that are easy to install, simple to maintain and can produce at high enough throughput speeds to support several separate packaging lines from a single off line unit.
Pharmaceutical manufacturers and packagers in the United States are also faced with coming new regulations and standards that must be met for regulatory compliance dealing with product and public safety. The print professionals from Griffin-Rutgers can provide a variety of solutions to suit specific needs, and can assist with almost any coding problem or task.
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