This part of YY/T 0567 specifies the requirements for sterilization and filtration in the aseptic processing of medical products. This section also provides filter users with guidance on the establishment, validation, and routine operation of sterile filtration processes for the aseptic processing of medical products. This section does not apply to virus removal. Sterile filtration is not suitable for liquids containing active ingredient particles larger than the filter pore size (such as whole-cell vaccines).
YY/T 0567.2-2005 history
2021YY/T 0567.2-2021 Aseptic processing of health care products - Part 2: filtration
2005YY/T 0567.2-2005 Aseptic processing of health care products - Part 2: filtration