Pharmaceutical marking approach improves traceability

The technique will allow faster identification and resolution of any manufacturing quality problems, but will also prove invaluable as an anti-counterfeit measure because the specific coding and validation systems are almost impossible to copy.

Currently, most components within diagnostic kits, medical devices and other healthcare products and equipment are ’stamped’ with a lot code at the point of manufacture. However, these codes are of limited use for quality improvement unless products are produced in very small batches.

As a result, regulatory bodies across the world are now putting manufacturers under increasing pressure to invest in much more sophisticated traceability systems, while manufacturers are looking for effective ways to prevent the growing problem of counterfeiting of pharmaceuticals and other healthcare products.

The approach being developed by Innomech will enable manufacturers to mark products with a code that is either unique to the item or shared by only a small number of items produced together.

The codemark is an unobtrusive two-dimensional dot matrix identifier that is linked to a look-up database. In effect, the matrix code acts as a ’key’ to access much more detailed information, such as the specific batch codes of raw materials used during production, the time of manufacture and the production line. A version of the database could be accessible online for anyone to verify the item is genuine.

The codes can be printed or laser etched onto products, applied to virtually any substrate and can even be added onto the surface of pharmaceutical capsules or coated tablets. Matrix codes can be as small as 2 x 2mm holding the code for up to 10 billion numbers. The codes can be read by widely available readers or, in many cases, from a picture taken with even the simplest camera phone.

For example, a doctor in Africa about to dispense a treatment course for malaria could take a picture of the product packaging code, send it by SMS to a centralised online database and within seconds have an auto-response to confirm the validity of the product and be sure he or she is not dispensing an ineffective or even potentially fatal counterfeit product.

’Innomech is now working with several clients to help adjust their manufacturing processes to incorporate this new approach and enable products to be much more easily marked than has previously been possible,’ said Steve Robertson, managing director of Innomech.