Standard No.:	YY/T 0567.2-2021
English Name:	Aseptic processing of health care products-Part 2:Sterilizing filtration
Chinese Name:	医疗保健产品的无菌加工 第2部分：除菌过滤
Chinese Classification:	C47    Public medical equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.080.01 11.080.01    Sterilization and disinfection in general 11.080.01
Issued by:	National Medical Products Adminstration
Issued on:	2021-03-09
Implemented on:	2022-4-1
Status:	valid
Superseding:	YY/T 0567.2-2005 Aseptic processing of health care products - Part 2: Filtration
Language:	English
File Format:	PDF
Word Count:	14500 words
Price(USD):	435.0
Delivery:	via email in 1 business day

Aseptic processing of health care products- Part 2: Sterilizing filtration 1 Scope This part of YY/T 0567 specifies the terms and definitions, quality system elements, sterilizing filter characterization, process and equipment characterization, fluid definition, process definition, validation, routine monitoring and control, product release from sterilizing filtration and maintaining process effectiveness of sterilizing filtration. It is applicable to the set‑up, validation and routine operation of a sterilizing filtration process during medical devices production. This document 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). This part is not applicable to high efficiency particulate air (HEPA) filters. This document 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. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated reference, only the edition cited applies. For undated references, the latest edition (including any amendments) applies. GB 18278.1 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18278.1-2015, ISO 17665-1: 2006, IDT) GB 18279.1 Sterilization of health-care products—Ethylene oxide—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18279.1-2015, ISO 11135-1: 2007, IDT) GB/T 18279.2 Sterilization of health care products—Part 2: Guidance on the application of GB 18279.1(GB/T 18279.2-2015, ISO/TS 11135-2: 2008, IDT) GB 18280.1 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (GB 18280.1-2015, ISO 11137-1: 2006, IDT) GB/T 19971 Sterilization of health care products - Vocabulary (GB/T 19971-2015, ISO/TS 11139:2006, IDT) YY/T 0287 Medical devices-Quality management systems-Requirements for regulatory purposes (YY/T 0287-2017, ISO 13485:2016, IDT) YY/T 0567.5 Aseptic processing of health care products - Part 5: Sterilization in place (YY/T 0567.5-2011, ISO 13408-5:2006, IDT) ISO 13408-1:2008 Aseptic processing of health care products—Part 1: General requirements ISO 13408-1: 2008/Amd.1: 2013 Aseptic processing of health care products—Part 1: General requirements—Amendment 1 3 Terms and definitions For the purposes of this document, the terms and definitions given in GB/T 19971 and the following apply. 3.1 bacterial challenge test test performed to evaluate the capability of a filter (3.5) to retain organisms from liquid bacterial suspension under defined conditions 3.2 bioburden population of viable microorganisms (3.9) on or in product and/or sterile barrier system [GB/T 19971-2015, 2.2] Note: For the purposes of this document, the definition of bioburden is the population of viable microorganisms in a fluid (3.6) prior to sterilizing filtration (3.11). 3.3 chemical compatibility capability of process fluids (3.6) and filter (3.5) materials to be used together, under the specified process conditions, without adverse effects on either the fluids or filter materials 3.4 extractable substance that can be released from a filter (3.5) or material using extraction solvents and/or extraction conditions that are expected to be at least as aggressive as the normal use conditions Note: GB/T 16886.12-2017, 3.8, modified 3.5 filter construct of porous material through which a fluid (3.6) is passed to remove viable and/or non‑ viable particles 3.6 fluid substance that continually deforms (flows) under applied shear force Example: Liquid, gas, vapour or plasma. Note: The filtrate of the fluid subjected to the sterilizing filtration (3.11) process might be the product to be produced, a part of the formulation, a gas used to provide overpressure or a process gas released into the aseptic processing area (e.g. gases released from air actuated valves). 3.7 filter integrity test non‑destructive physical test that can be correlated to the bacterial retention capability of a filter assembly 3.8 leachable substance that can be released from a filter (3.5) or filter assembly during normal use conditions 3.9 microorganism an entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses [GB/T 19971-2015, definition 2.26] Note: Viruses are not addressed in this document. 3.10 pore size rating nominal pore size of a filter (3.5) as claimed and stated in the labelling Note: The pore size rating is determined by retention performance with a model particle. The pore size rating is not necessarily the physical diameter of the pores but is a rating based on the size of particles which might not pass through the filter.

1 Scope 2 Normative references 3 Terms and definitions 4 Quality system elements 5 Sterilizing filter characterization 6 Process and equipment characterization 7 Fluid definition 8 Process definition 9 Validation 10 Routine monitoring and control 11 Product release from sterilizing filtration 12 Maintaining process effectiveness Annex A (Informative) Guidance on the application of this document Bibliography