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Ability to meet & exceed all current global and national track and trace regulations:
The development of unit-dose packaging means that Tjoapack can meet and exceed all current requirements for Track and Trace regulations – even those that go no further than item (small pack/carton), case and/or pallet level. In fact, most healthcare systems that regulate for Track & Trace at all require only one level of coding or marking at this time, though most plan to go further; usually the chosen level is the patient pack - item (patient pack/carton) level - and most regulations or recommendations have not linked (aggregated) one level of packaging to the next - as yet, but they will. The US is trying hard with its e-pedigree requirements in states such as Florida and more recently California and in Europe EFPIA, Turkey and other countries are in the process of implementing mandates.
In Europe, EFPIA has a vision of a more complete system of Track and Trace to include coding, marking and authentication but again traceability at this stage is only envisaged to go down to item (patient pack/carton) rather than individual blister strip or pouch. Such an approach has potentially large implications for re-packing of product - which is perfectly legal in Europe – and for counterfeiting of drugs by substitution or diversion unless you can identify any drug right down to the individual dose (at whatever level of packaging that may be). This critical for patient safety, patient records, reimbursement and of course complete traceability. The vision is to build out from item (patient pack) level to case and pallet and also implement a complete authentication system via a complete infrastructure following a major trial will be announced in 2008.
Understanding and using data carriers both printed and RFID:
One of the most significant recent developments within the pharmaceutical market has been to adoption and use of 2-D bar codes such as Data Matrix, QR or RSS (Databar) bar code formats. These ‘complex’ or ‘composite’ codes allow a significant amount of data to be carried by a very small printed code (much smaller than a linear bar code) in a physically small space (very important on small pharmaceutical packs, vials, ampoules, small jars and pots and blister strips). Though some of these codes were heavily promoted as offering the ‘best’ solution when batch level identification was the ‘flavour-of-the-month’, codes such as RSS, but these turned out to be difficult to print at production line speeds and even more difficult to read and verify on the fly (moving on a production line) uniquely, because of their complexity; something that Data Matrix for instance excels at. In addition, codes such as Data Matrix are extremely robust something that other 2-D codes and all linear bar codes are not.
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Recent requirements for printing and encoding unique data into codes on the pharmaceutical production line (California, EFPIA) have led many companies to review their whole production line packaging processes. Most have found that they have little or no experience, skills or understanding of what is required to print unique codes with multiple data pieces and structures that also need to be read and verified at production line speeds to meet the planned regulations.
Some companies even believe they can simply buy a software solution and ‘fit’ it onto an existing line – all have found it is not that simple, software, hardware, devices and data need to be integrated to strict compliance standards and this is not simple process for the inexperienced.
Complex data carrier printing on line
has become second-nature at Tjoapack:
The development, adoption, printing and verification of 2-D bar codes such as Data Matrix have become second nature to Tjoapack. For many years the need to identify pharmaceutical products right down to the unit of dose, often the individual blister pouch has been part of Tjoapack’s daily work. This is not just the blister strip or item level (patient pack/carton) that is also undertaken as part of the process, but also carton, case and pallet to ensure complete traceability within a true unit-dose system as used in Holland but also other complex codes such as RSS (Databar). Work has often involved multiple coding solutions at various packaging levels mixing human readable (alphanumeric, linear bar codes, 2D bar codes and more recently RFID tags all integrated across a range of packaging.
Growing Use of Unit-Dose:
Packing and coding drugs to the unit-dose level of identification has only been essential (regulated) in a limited number of markets as yet, these include Scandinavian countries, Holland, Belgium, Spain, Portugal in Europe and it is companies such as Tjoapack who have led the development of their use and application. In these healthcare systems unit-dose dispensing is seen as the cornerstone of individual patient safety systems and that being able to identify at pack (item) or batch level is seen insufficient to meet true patient safety requirements - even though it may be fine for bars of chocolate or a tin of beans - it is not pharmaceuticals.
Implementation of processes on-line, complex and difficult for the inexperienced
One of the complications for pharmaceuticals as they need to learn and implement these new processes onto their existing production lines is not just printing and verification but is to link or aggregate one packaging level to another, as required by a number of mandates and pedigree schemes. Therefore, simply putting a code on a pack with a simple piece of data is not enough, you will now need to add product data to expiry date, batch/lot number and then add a unique serialised code to meet many recent mandates such as Turkey.
You will need to put this data into a carrier such as a Data Matrix format, print it onto a pack and verify that the quality and content of the code meets the regulatory and compliance needs of the process. Once you have mastered the ability to undertake this process at a single level of packaging you then need add a whole new level of complexity to the process.
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