As the biologics market continues to grow exponentially, the limitations of today’s thermal packaging utilizing phase change materials could have a considerable impact on the timely delivery of safe and effective medication. Gelled PCM eliminate these limitations and offer a more dependable future for the biopharma industry.
Falsified and counterfeit medicines are a chronic problem for the pharmaceutical sector, with a third of all shipments in the worst affected parts of the world estimated to contain fake medicines. Highly portable and often extremely valuable, medicines continue to be a favorite with those determined to fake products or subvert the system for illegitimate gain. Faced with this continued global threat, legislatures around the world are responding by tightening the supply chain to stamp out illicit goods.
The true extent of the counterfeiting is unknown, since no global study has ever been carried out, but according to WHO estimates, up to 15% of all medicines are counterfeit.
In recent years the production of, and trade in, falsified medicines – both research based and generic – has grown to become a global illegal business. At the borders of the EU alone over 30 million counterfeit medicines have been seized during the last five years, and the statistics regarding medicines supplied online are equally disturbing: according to the European Alliance for Safe Medicines, 62% of medicines purchased online are fake or substandard.
In numerous pharma companies, the following problem is being posed: shrinking lot sizes are constantly worsening the ratio of packaging system set-up time to running time. By Dr. Ralph Blum, Mediseal GmbH, Schloss Holte
Two years ago, Elaiapharm undertook the packaging of an important new solid dose product (Cipralex, an antidepressant) to be launched across a large number of international markets. The product itself is an ODT – orally dispersible tablet – formulation packed in child resistant cold form blisters.
At the end of the packaging process, the packaged syringes should meet the requirements for sterile devices in the operating room. Therefore, the finished blisters are autoclaved at 121 °C (2 bar) for 15 minutes. Only minimal deformation of the blisters is tolerated, so that the syringes can be used in the operating room without problems after this thermal treatment.