The November 2017 deadline for including unique product identifiers on prescription drugs is putting a strain on multiple parts of the industry, much of which is ill-prepared to meet the target. Here, we look to the experience of a company that is ahead of the curve for lessons on how to manage and ease the transition to serialization.
The Indian vaccine manufacturer Serum Institute of India has a vision – to continually increase the production of affordable, high-quality vaccines. The founder and owner Dr. Cyrus S. Poonawalla believes that every child in the world should be granted access to inexpensive bacterial and viral vaccines against Tetanus, Influenza or MMR (mumps, measles and rubella), to name just a few.
With 840 million inhabitants, and two-thirds of global pharmaceutical sales, the US and Europe are also a lucrative target for drug crime. New sales channels such as the internet as well as global and more complex manufacturing and distribution channels make it increasingly easier for pharmaceutical counterfeiters to market counterfeits directly or to infiltrate the supply chain.
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.
Volumetric feeding by means of a flowmeter, a method that has become established at Pharmatis, was also implemented in this project; the configuration was taken over by the Mediseal HMI. The feeding system is highly flexible and can be adapted to a wide range of products.