ISO-13408-2 › Aseptic processing of health care products - Part 2: Sterilizing filtration
The following bibliographic material is provided to assist you with your purchasing decision:
ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.
ISO 13408-2:2018 is not applicable to removal of viruses.
Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).
ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.
ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-D4169Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM-F1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Document Number
ISO 13408-2:2018
Revision Level
2ND EDITION
Status
Current
Publication Date
Jan. 1, 2018
Committee Number
ISO/TC 198