Posts Tagged ‘Isolator Systems’

5 questions to Matthias Angelmaier – Product manager barrier systems and isolator technology

Today, the processing of highly potent pharmaceuticals is becoming increasingly important. However, this is not the only trend that has an impact on the pharmaceutical industry. In this interview, Matthias Angelmaier, global product manager for barrier systems and isolator technology, not only gives answers to current trends and development opportunities, but also provides exciting insights behind the scenes of a product manager.

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Requalification – GMP-requirements for the pharmaceutical industry are valid worldwide

The initial achieved qualification status has to be maintained durably. For this purpose, relevant influencing factors on General Manufacturing Process (GMP) have to be checked periodically. The regulatory requirement of requalification is mandatory worldwide. Prominent superordinate regulations are the GMP guidelines of the US and the EU as well as the guidelines of PIC/S. …more




Article in Pharmaceutical Processing by Bosch’s Jürgen Metzger: The Fine Art Of Transferring Products Into Barrier Systems

Pharmaceutical manufacturing processes are becoming more complex and guidelines stricter. Accordingly, the focus in aseptic operations is of course protecting the aseptic interior of a barrier system against the environment and vice versa also protecting operators from highly potent pharmaceuticals. This requires suitable barrier technologies. One of the first steps is the categorization of the actual pharmaceutical product, followed by …more


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