Posts Tagged ‘Isolator Systems’




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




Mini White Paper: The Ongoing RABS vs. Isolator Question

Isolator

by Christian Lavarreda

Over fifteen years have now passed since the Isolation Technology Task Force of the Parenteral Drug Association (PDA) published the influential Technical Report No. 34 (TR 34), “Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products,” yet considerable confusion still surrounds the terms barrier, Restricted Access Barrier System (RABS), and isolator and their respective suitability and favorability in pharmaceutical fill-finish operations. …more


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