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Article: Part 2, Bio-Process Systems Alliance Component Quality Test Matrices

BioProcess International
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Description

By BPSA Guidelines and Standards Committee

For each single-use system subcomponent class — whether filter capsules, films and containers, tubing, and connectors and fittings — BPSA member manufacturers identified consensus quality tests. The matrices describe test methods in common language and list consensus reference documents along with testing frequency: at initial qualification, periodically, on sample lots, or (in the case of filter integrity testing) continually. The matrices also compare different test references used for specific test methods.

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