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GB/T 16293-2025: Test method for airborne microbe in clean room(zone) of the pharmaceutical industy
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GB/T 16293-2025: Test method for airborne microbe in clean room(zone) of the pharmaceutical industy

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ICS 13.040.30 CCSC30 National Standards of the People's Republic of China Replaces GB/T 16293-2010 Test methods for airborne bacteria in cleanrooms (areas) of the pharmaceutical industry Published on 2025-10-05 Implemented on 2026-11-01 State Administration for Market Regulation The State Administration for Standardization issued a statement.

Table of contents

Preface III 1.Scope 1 2 Normative References 1 3.Terms and Definitions 1 4.Personnel Requirements 1 5.Main Instruments and Equipment 2 5.1 Sampler 2 5.2 Other Instruments and Equipment 2 6.Culture medium 2 7.Test Conditions 2 8.Test Method 2 8.1 Determine sampling points 2 8.2 Sampling Step 3 8.3 Culture Count 3 8.4 Result Characterization 4 9 Test Report 4 Reference 5

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. This document replaces GB/T 16293-2010 "Test Method for Airborne Bacteria in Cleanrooms (Areas) of Pharmaceutical Industry", and is consistent with GB/T 16293-2010. In comparison, aside from structural adjustments and editorial changes, the main technical changes are as follows. ---Terminology and definitions have been changed (see Chapter 3, Chapter 3 of the.2010 edition); ---Added the working principle of the airborne bacteria sampler (see 5.1); ---Added requirements for culture media (see Chapter 6); ---The requirements for sampling points have been changed (see 8.1, 5.4.1 of the.2010 edition, Appendix A); ---Added minimum sampling volume requirements for different cleanliness levels (see 8.2.2); ---Cultural counts have been changed (see 8.3, 4.10.2 and 4.11 in the.2010 edition); ---The section on "Outcome Assessment" has been removed (see section 5.7 in the.2010 edition); ---The "Daily Monitoring" feature has been removed (see section 5.8 of the.2010 version); ---The section on "Sampling Point Layout in Cleanrooms (Areas)" has been removed (see Appendix A of the.2010 edition); ---The section on "sterilization and preparation of culture media" has been removed (see Appendix B of the.2010 edition). Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Infusion Equipment (SAC/TC106). This document was drafted by. Shandong Provincial Institute for Medical Device and Pharmaceutical Packaging Inspection, China National Institutes for Food and Drug Control, and Beijing Municipal Institute of Medical Devices and Pharmaceuticals. Medical Device Testing and Research Institute (Beijing Medical Biological Protective Equipment Testing and Research Center), Shanghai Institute of Food and Drug Packaging Materials Testing, Liaoning Provincial Institute of Pharmaceutical Research The Institute for Food Inspection and Testing, Zhejiang Provincial Institute for Food and Drug Control, and Hubei Provincial Institute for Medical Device Quality Supervision and Inspection. The main drafters of this document are. Zhang Mengmeng, Wang Wenqing, Luan Yuanyuan, Zhao Yanjun, Wang Lin, Xin Yun, Yi Dawei, Zheng Xiaoling, Li Ling, Chen Fang, and Liu Bin. The release history of this document and the document it replaces is as follows. ---First published in.1996 as GB/T 16293-1996, and revised for the first time in.2010; ---This is the second revision. Test methods for airborne bacteria in cleanrooms (areas) of the pharmaceutical industry

1 Scope

This document describes the test method for airborne bacteria in cleanrooms (areas) of the pharmaceutical industry. This document applies to the airborne bacteria testing of cleanrooms (areas), clean plants, and clean laboratories in the pharmaceutical industry. This document does not apply to online monitoring systems.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document. Pharmacopoeia of the People's Republic of China, 2025 Edition, Part IV

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 airborne microbe Live microorganisms suspended in the air. Note. This document specifically refers to live microorganisms suspended in the air collected through active sampling methods. 3.2 The number of airborne bacterial colonies per unit volume of air. Note. The unit for airborne bacteria concentration is colony forming units per cubic meter (CFU/m3). 3.3 static at-rest The cleanroom or clean area has been built and the equipment is in place, operating in accordance with the agreed method, but no personnel are present. [Source. GB/T 25915.1-2021, 3.3.2] 3.4 Dynamic operational The cleanroom or clean area facilities are operating in accordance with the agreed method, and a specified number of personnel are working in accordance with the agreed method. [Source. GB/T 25915.1-2021, 3.3.3] 4.Personnel Requirements Testing personnel in cleanrooms (areas) should receive training in basic hygiene and microbiology, and should ensure that testing activities are conducted in a manner appropriate to their professional knowledge. Intervention in cleanrooms (areas) is minimized. ...