Modeling tool helps companies right size equipment for efficiency and savings.
As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs. One option is to leverage the advanced aseptic manufacturing of blow-fill-seal (B/F/S) technology, which has the potential to address the challenges of traditional glass filling as well as the global distribution of biologics.
he Serum Bio Pharma Park in Pune is the first of its kind in the country and was designed in strict compliance with cGMP (current Good Manufacturing Practice) standards.
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.