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Sealing Technology for Active Pharmaceutical Ingredients Manufacture

New developments in perfluoroelastomers are setting the standard for sealing in the manufacture and storage of active pharmaceutical ingredients. This article reviews the growing popularity of these elastomers and their application in total containment systems.

Primary pharmaceutical manufacturers are faced with a problem - how to handle active pharmaceutical ingredients (APIs) and intermediates without risk to the health of their workers arising from processing leaks or breaches in containment during manufacture? Moreover, to meet good manufacturing practice (GMP) regulations for API manufacture, manufacturing operations should not compromise API integrity through poor hygiene standards and cross contamination. To overcome these issues seals are used in pumps, valves and pipe work on the plant and in intermediate bulk containers (IBCs) used for the transportation of raw materials and intermediates.


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By David Holt, International Business Manager at Precision Polymer Engineering Ltd

David Holt is International Business Manager at high performance seals and mouldings specialist, Precision Polymer Engineering Ltd. He is responsible for developing global markets for PPE's perfluoroelastomer, Perlast®, in the chemical, pharmaceutical and semiconductor industries. David joined Precision Polymer Engineering in 1998 and is a member of the Chartered Institute of Marketing and the Institute of Incorporated Engineers.

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