ISO 13408-2 PDF
I.S. EN ISO () (English): Aseptic processing of health care products – Part 2: Filtration [Authority: The European Union Per. BS EN ISO specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in. ANSI/AAMI/ISO (R)/A ANSI/AAMI/ISO ANSI/AAMI/ISO (R) ANSI/AAMI/ISO (R).
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EN ISO 13408-2
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BS EN ISO 13408-2:2018
BS EN ISO – Aseptic processing of health care products. Sterilizing filtration
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An alternative to terminal sterilization, asseptic processing enables the sterility of pre-sterilized components and products during assembly allowing the final product to be sterile in its final container resulting in an terminally sterilized product. Quality control, Quality assurance systems, Personnel, Environment workingBiological filters, Medical equipment, Verification, Filtration, Filters, Sterile equipment, Production, Sterilization hygieneQuality management.
The process include the filtration, lyophilization drying processclean-in-place technology CIPsterilization in place SIP and isolator system used to maintain aseptic conditions.
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