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GB/T 16294-2025: Test method for settling microbe in clean room (zone) of the pharmaceutical industy
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GB/T 16294-2025: Test method for settling 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 16294-2010 Test methods for settling 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 1 6.Culture medium 1 7.Test Conditions 2 8.Test Method 2 8.1 Determine sampling points 2 8.2 Sampling Step 3 8.3 Culture Count 3 9 Test Report 3 Reference 4

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 16294-2010 "Test Method for Settling Bacteria in Cleanrooms (Areas) of Pharmaceutical Industry", and is consistent with GB/T 16294-2010. 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 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); ---The requirement for "minimum number of petri dishes" has been removed (see 5.4.2 in the.2010 version); ---The requirements for petri dish exposure time have been changed (see 8.2.2, 8.2.3, and 4.4.3 in the.2010 version); ---The culture conditions have been changed (see 8.3.2, 4.4.5 in the.2010 version); ---The "Result Calculation" section has been removed (see section 5.6 of the.2010 edition); ---The section "Outcome Assessment" has been removed (see section 5.7 of 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, Liaoning Provincial Institute for Drug Control, and Shanghai Municipal Institute of Food and Drug Control. Packaging Materials Testing Institute, Beijing Institute for Medical Device Testing (Beijing Medical Biological Protective Equipment Testing and Research Center), China Food and Drug Administration The Institute for Quality Inspection and Testing, Hubei Provincial Institute for Medical Device Quality Supervision and Inspection, and Zhejiang Provincial Institute for Food and Drug Control. The main drafters of this document are. Wang Wenqing, Zhang Mengmeng, Ma Heng, Zhang Yajie, Xin Yun, Wang Lin, Tian Lin, Wang Yeting, Wu Xin, Zhang Jing, and Li Wenli. The release history of this document and the document it replaces is as follows. ---First published in.1996 as GB/T 16294-1996, and revised for the first time in.2010; ---This is the second revision. Test methods for settling bacteria in cleanrooms (areas) of the pharmaceutical industry

1 Scope

This document describes the test method for settling bacteria in cleanrooms (areas) of the pharmaceutical industry. This document applies to the settling bacteria test in cleanrooms (areas), clean plants, and clean laboratories in the pharmaceutical industry.

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 Settling microbes Live microorganisms suspended in the air, collected using a passive sampling method. 3.2 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] 3.3 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. 5.Main Instruments and Equipment Incubators, pressure steam sterilizers, etc., should be calibrated regularly. 6.Culture medium Tryptic soy agar (TSA) medium is generally chosen, and a suitable neutralizing agent can be added if necessary. When monitoring results indicate suspected fungal infection or... ...