Найдено: 19
Overview ISO 13408-1:2023 - Aseptic processing of health care products - Part 1: General requirements defines the general requirements and guidance for establishing, validating and controlling asepti…
Overview ISO 13408-7:2012 - Aseptic processing of health care products, Part 7 - provides requirements and guidance for alternative process simulations used to qualify aseptic processing of medical d…
Overview ISO 13408-2:2018 - "Aseptic processing of health care products - Part 2: Sterilizing filtration" specifies requirements and guidance for sterilizing filtration as an integral element of asep…
Overview ISO 13408-3:2006 - "Aseptic processing of health care products - Part 3: Lyophilization" provides requirements and guidance for controlling and validating lyophilization (freeze-drying) when…
Overview ISO 13408-4:2005 - "Aseptic processing of health care products - Part 4: Clean‑in‑place technologies" specifies requirements and guidance for clean‑in‑place (CIP) processes applied to produc…
Overview ISO 13408-5:2006 - "Aseptic processing of health care products - Part 5: Sterilization in place" provides general requirements and guidance for sterilization in place (SIP) of product-contac…
Overview ISO 13408-6:2021 - Aseptic processing of health care products - Part 6: Isolator systems specifies requirements and guidance for the specification, selection, qualification, bio‑decontaminat…