Wernher von Braun, the father of modern rocketry famously stated, “one test is worth a thousand expert opinions.” The FDA has put their own regulatory spin on this axiom: “if you didn’t document it; it didn’t happen.” This extends beyond the drug therapies themselves to the packaging and logistics practices that are used to distribute them; what the FDA refers to as the “holding” of a drug.
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.
Specializing in sterile manufacturing, Excelvision, based in Annonay, France, provides contract manufacturing services for liquid eye drop plastic vials to numerous companies. However, to increase production and capitalize on additional contract manufacturing opportunities, Excelvision enlised Bosch Packaging Systems AG, based in Beringen, Switzerland, to install a fully automated packaging line. With significantly higher output capabilities, Excelvision expects to increase production by nearly five-fold. The new line also gives the company greater flexibility to meet the diverse requirements of its customers.
Falsified medicines are fake medicines that pass themselves off as real, authorized medicines. They may contain ineffective or incorrect doses of active ingredients and pose a major threat to public health and safety. As falsifications become more sophisticated, the risk of falsified medicines reaching patients in the EU increases every year. Not only do falsified medicines present an incalculable health risk for patients, they also damage the corporate image of pharmaceutical manufacturers and can lead to large financial losses.