The need for cleanliness and biocompatibility is paramount for the Bioprocessing industries. An increased focus on the potential risk of leachables in recent times has increased the pressure on polymer converters to go to extreme lengths to minimise leachables from their products. How this can be achieved in mixing elastomeric materials for BioPharmaceutical sealing applications is discussed. This is extended to downstream processing such as moulding and subsequent finishing and handling of elastomeric components. A brief review of the current test requirements, and test methods employed, is given and how this is achieved through careful operational practices in both mixing of the elastomeric material, and subsequent processing, supported by data gathered in manufacture.
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