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GB/T 16292-2025: Test method for airborne particles in clean room(zone) of the pharmaceutical industry
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GB/T 16292-2025: Test method for airborne particles in clean room(zone) of the pharmaceutical industry

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ICS 13.040.30 CCSC30 National Standards of the People's Republic of China Replaces GB/T 16292-2010 Test methods for suspended particles 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.Working principle and general requirements of the instrument 3 4.1 Working Principle 3 4.2 General requirements for instruments 3 5.Test Preparation 4. 5.1 Personnel 4 5.2 Instruments 4 5.3 Environment 4 6.Grading Test 4 6.1 General Rules 4 6.2 Determine the minimum number of sampling points 4 6.3 Sampling points in large-area cleanrooms (areas) 6 6.4 Determining the location of sampling points 6 6.5 Determine the single sampling quantity and sampling time at each point. 6.6 Sampling Procedures and Precautions 6.7 Result Calculation 7 6.8 Test Report 7 7.Monitoring 8. 7.1 General Rules 8 7.2 Risk Assessment 8 7.3 Development, implementation, and continuous improvement of the monitoring plan 8 7.4 Determine the minimum number of sampling points 8 7.5 Determining the location of sampling points 9 7.6 Countermeasures for Deviations During Monitoring 9 Appendix A (Informative) Considerations for Developing an Environmental Monitoring Plan 10 A.1 Risk Assessment 10 A.2 General Considerations 10 Reference 11

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 16292-2010 "Test Methods for Airborne Particles in Cleanrooms (Areas) of Pharmaceutical Industry", and is consistent with GB/T 16292- Compared to.2010, aside from structural adjustments and editorial changes, the main technical changes are as follows. ---Terminology and definitions have been revised (see Chapter 3, Chapter 3 of the.2010 edition); ---The instrument's working principle and schematic diagram have been added, and the description of the instrument's working principle has been refined (see 4.1, 4.3 in the.2010 version); ---The testing methodology has been changed (see Chapter 6, Chapter 4 in the.2010 edition), and the minimum number of sampling points has been changed (see 6.2, in the.2010 edition). 5.4.1.1), sampling point location (see 6.4, 5.4.1.2 in the.2010 version), and single sampling size (see 6.5, 5.4.3 in the.2010 version), are deleted. In addition to the limitation on the number of samples (see 5.4.2 in the.2010 edition); ---The sampling time at each point has been increased (see 6.5); ---The calculation methods for standard deviation and 95% confidence upper limit have been removed (see sections 6.3 and 6.4 in the.2010 edition), and the unit of particles per cubic meter has been added. The method for calculating concentration (see 6.7.3) has been revised, and the result evaluation (see Chapter 7 of the.2010 edition) has been removed. ---The "Test Report" has been modified (see 6.8, Chapter 8 of the.2010 edition); ---Added "Monitoring" (see Chapter 7); ---The "Sampling Point Layout in Cleanrooms (Areas)" has been removed (see Appendix A 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. China National Institutes for Food and Drug Control, Shandong Provincial Institute for Medical Device and Pharmaceutical Packaging Inspection and Testing, and Shanghai Municipal Institute of Food and Drug Control. Pharmaceutical Packaging Materials Testing Institute, Beijing Institute for Drug Control, Tianjin Institute for Drug Control, Hebei Provincial Institute for Drug and Medical Device Testing The Academy, the Joint Logistics Support Force Drug and Instrument Supervision and Inspection Station, China Academy of Building Research Co., Ltd., and Beijing Institute for Medical Device Testing (Beijing Medical Biological Protective Equipment Testing and Research Center). The main drafters of this document are. Zhao Xia, Xie Langui, Zhang Peng, Sun Huimin, Wei Jiaming, Jiang Zhijie, Li Yang, Gao Yanxia, Ni Ming, Cao Guoqing, and Wang Lin. Yu Xiaohui. The release history of this document and the document it replaces is as follows. ---First published in.1996 as GB/T 16292-1996, and revised for the first time in.2010; ---This is the second revision. Test methods for suspended particles in cleanrooms (areas) of the pharmaceutical industry

1 Scope

This document describes a test method for the concentration of airborne particles in cleanrooms (areas) in the pharmaceutical industry. This document applies to the testing of airborne particles in cleanrooms (areas) 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. GB/T 29024.4 Optical measurement methods for single particles in particle size analysis - Part 4.Light scattering dust particle counters in cleanrooms GB/T 36066 Technical requirements and applications for testing in cleanrooms and related controlled environments

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Cleanroom (zone) A room or area where environmental control and classification of particulate and microbial contamination are implemented. Note. Its building structure, equipment, and use are all designed to reduce the entry, generation, and retention of pollution sources in the area. 3.2 cleanliness The degree of cleanliness is determined by the statistical number of suspended particles of a certain size or larger in a unit volume of air within a clean environment. 3.3 airborne particles Solid and liquid particles ranging in size from 0.1 μm to 100 μm are used for air cleanliness classification. Note. For a suspended particle counting instrument, the area or volume of a particle sphere produces a response value, and different response values are equivalent to different particle diameters. 3.4 particle size The diameter of a sphere, as measured by a particle size analyzer, is equivalent to the response of the measured particle. Note. The diameter given by the light scattering discrete particle counter is the optical equivalent diameter. [Source. GB/T 25915.1-2021, 3.2.2] 3.5 The number of particles per unit volume of air. [Source. GB/T 25915.1-2021, 3.2.3] 3.6 A controlled airflow with stable and parallel velocity across the entire cross-section of the cleanroom or clean area. [Source. GB/T 25915.1-2021, 3.2.7] ...