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YY/T 1479-2016Sterility test method for membrane filters (English PDF)

薄膜过滤器的无菌试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 29, 2016

Implementation date

June 1, 2017

Scope

YY/T 1479-2016 is the English-translated version of 薄膜过滤器的无菌试验方法.

YY/T 1479-2016 is the Chinese pharmaceutical industry standard that gives the membrane filtration method of sterility testing, as used in the manufacture, the testing and the other processing of medical products and as the final sterility test of a product.

It sets out the filters and the apparatus, the media and their growth promotion, the volumes filtered and the rinsing, the incubation and the reading of the result, and the controls that make the result valid. Issued on 29 July 2016, it has applied since 1 June 2017.

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Document preview — YY/T 1479-2016

National Standard of the People's Republic of China

Classification: C 47

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 normative reference document
3 Terms and definitions
4 Test conditions
5 Test method for sterility
6 culture and observation
7 judgment
Appendix A (informative) Preparation of media and detection of medium

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies sterile film filtration as used in the production, testing or other treatment of medical products and as a final product Aseptic test method.

NOTE: Filtration of the membrane is not applicable to the twisted or partially oversized membrane filter.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 19973.2-2005 Sterilization methods for medical devices - Part 2. Sterility test for confirmation of sterilization (ISO 11737-2.:1995, IDT)

YY/T 0567.1-2013 Sterile processing of health care products - Part 1. General requirements (ISO 13408-1.:2008 IDT) Pharmacopoeia of the People's Republic of China

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Membrane filter

For the use of liquid impurities, sterilization, microbial limit inspection or sterility inspection and other purposes of the diaphragm, and other pre-installed filter or filter can be installed Of the filter device.

3.2 Sterility test

Under the given culture conditions, the test used to determine whether there is a viable microorganism on the product unit.

4 Test conditions

4.1 Water

Unless otherwise stated, the water involved should comply with the relevant provisions of the Purified Water in the Pharmacopoeia of the People's Republic of China.

4.2 Medium

The preparation of the culture medium and the examination of the culture medium are given in Appendix A.

4.3 Conditions for aseptic testing of film filters

The conditions for aseptic testing should include the following.

a) test in a controlled environment;

For example. in the B-class clean area A-level unidirectional air area, aseptic isolation system; YY/T 0567.1-2013

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB/T 32361-2015|GB/T 11446.10-2013

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