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Tag: CCS

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Explore Annex 1 PUPSIT requirements, causes of filter damage, and how proactive integrity testing strengthens sterility assurance in aseptic processing....
Explore HEPA filter types used in pharmaceutical cleanrooms. Understand H13 vs H14, ULPA, gel-sealed filters, and Annex 1 testing requirements....
Growth Promotion Testing (GPT) verifies culture media performance to support microbial growth in pharmaceutical microbiology applications....
Learn how to build a risk-based Contamination Control Strategy (CCS) that meets Annex 1 (2022) expectations. Discover the key elements,...
Discover the key updates in USP–NF PF 51(2), including revisions to chromatography, analytical instrument qualification, microbial contamination control, solubility measurements,...
Differentiate contamination, cross-contamination, and mix-ups in pharma manufacturing. Discover their causes, impacts, and prevention strategies to ensure GMP compliance....

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