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Overview EN ISO 13408-1:2024 (ISO 13408-1:2023) specifies the general requirements and guidance for the development, validation and routine control of aseptic processing of health care products. Publ…
Overview EN ISO 13408-6:2021 (ISO 13408-6:2021) provides requirements and guidance for isolator systems used in the aseptic processing of health care products, including the processing of cell‑based…
Overview EN ISO 13408-2:2018 - "Aseptic processing of health care products - Part 2: Sterilizing filtration" specifies requirements and guidance for the use of sterilizing filtration within aseptic p…
Overview EN ISO 13408-7:2015 (ISO 13408-7:2012) addresses aseptic processing for medical devices and combination products when terminal sterilization is not possible and the conventional media-fill a…
Overview EN ISO 13408-3:2011 - Aseptic processing of health care products, Part 3: Lyophilization (freeze-drying) - is the CEN-adopted version of ISO 13408-3:2006. The standard specifies requirements…
Overview EN ISO 13408-5:2011 (ISO 13408-5:2006 adopted by CEN) defines general requirements and guidance for sterilization in place (SIP) of product-contact surfaces used in the aseptic manufacture o…
Overview EN ISO 13408-4:2011 (ISO 13408-4:2005) specifies general requirements and guidance for clean‑in‑place (CIP) technologies used in the aseptic manufacture of sterile health care products. The…
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…
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 13408-4:2005 - "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 13408-3:2006 - "Aseptic processing of health care products - Part 3: Lyophilization" provides requirements and guidance for controlling and validating lyophilization (freeze-drying) when…
Overview ISO 13408-2:2018 - "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 13408-7:2012 - 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 13408-1:2023 - Aseptic processing of health care products - Part 1: General requirements defines the general requirements and guidance for establishing, validating and controlling asepti…