YY/T 0567.2-2021 Aseptic processing of health care products—Part 2:Sterilizing filtration

Scope

This part of YY/T 0567 specifies the terms and definitions of sterile filtration, quality system elements, determination of the characteristics of sterile filters, determination of process and equipment characteristics, definition of fluids, process definition, validation, routine monitoring and control, release of sterile filtration products, and maintaining the effectiveness of the process.
This part is applicable to the establishment, validation, and routine operation of the sterile filtration process in medical device production.
This part is not applicable to the removal of viruses. Sterile filtration is not applicable to fluids containing active ingredients with particle sizes larger than the pore size of the filter (e.g., whole-cell bacterial vaccines).
This part is not applicable to high-efficiency air filters (HEPA).
This part does not specifically address the requirements for the development, validation, and routine control of the process for removing pathogens such as spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease.

Development Information

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