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

Foreword

This document is drafted in accordance with the rules given in GB/T 1.1-2020, Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents.

This document replaces GB/T 16293-2010, Test method for airborne microbe in clean room (zone) of the pharmaceutical industry. Compared with GB/T 16293-2010, apart from structural adjustments and editorial changes, the main technical changes are as follows:

- the terms and definitions have been changed (see Clause 3; Clause 3 of the 2010 edition);

- the working principle of the airborne microbe sampler has been added (see 5.1);

- requirements for the culture medium have been added (see Clause 6);

- the requirements for sampling points have been changed (see 8.1; 5.4.1 and Annex A of the 2010 edition);

- minimum sample volumes for the different cleanliness classes have been added (see 8.2.2);

- incubation and counting have been changed (see 8.3; 4.10.2 and 4.11 of the 2010 edition);

- "Evaluation of results" has been deleted (see 5.7 of the 2010 edition);

- "Routine monitoring" has been deleted (see 5.8 of the 2010 edition);

- "Layout of sampling points in clean rooms (zones)" has been deleted (see Annex A of the 2010 edition);

- "Sterilization and preparation of culture media" has been deleted (see Annex B of the 2010 edition).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights.

This document was proposed by the National Medical Products Administration and is under the jurisdiction of the National Technical Committee on Medical Infusion Devices of Standardization Administration of China (SAC/TC 106).

Drafting organizations: Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, National Institutes for Food and Drug Control, Beijing Institute of Medical Device Testing (Beijing Medical Biological Protection Equipment Testing Center), Shanghai Institute for Food and Drug Packaging Material Control, Liaoning Institute for Drug Inspection and Testing, Zhejiang Institute for Food and Drug Control, Hubei Medical Devices Quality Supervision and Test Institute.

Main drafters: Zhang Mengmeng, Wang Wenqing, Luan Yuanyuan, Zhao Yanjun, Wang Lin, Xin Yun, Yi Dawei, Zheng Xiaoling, Li Ling, Chen Fang, Liu Bin.

This document and the documents it replaces were issued as follows: first issued in 1996 as GB/T 16293-1996, first revised in 2010; this is the second revision.

1 Scope

This document describes the test method for airborne microbes in clean rooms (zones) of the pharmaceutical industry.

This document applies to the testing of airborne microbes in clean plants, clean laboratories and other clean rooms (zones) of the pharmaceutical industry.

This document does not apply to online monitoring systems.

2 Normative references

The contents of the following documents constitute indispensable provisions of this document through normative references in the text. For dated references, only the edition corresponding to that date applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

Pharmacopoeia of the People's Republic of China, 2025 edition, Volume IV

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

3.1 airborne microbe: viable microorganisms suspended in the air. Note: in this document, specifically the viable microorganisms suspended in the air that are collected by active sampling.

3.2 airborne microbe concentration: the number of airborne microbe colonies per unit volume of air. Note: the unit of airborne microbe concentration is colony-forming units per cubic metre (CFU/m3).

3.3 at-rest: the condition in which the clean room or clean zone is complete, with the equipment installed and operating in a manner agreed upon, but with no personnel present. [Source: GB/T 25915.1-2021, 3.3.2]

3.4 operational: the condition in which the clean room or clean zone is functioning in the specified manner, with equipment operating and with the specified number of personnel present and working in the manner agreed upon. [Source: GB/T 25915.1-2021, 3.3.3]

4 Personnel requirements

Personnel testing clean rooms (zones) shall be trained in the relevant specialist knowledge, such as the basics of hygiene and microbiology, and shall keep the interference of the test activities with the clean room (zone) to a minimum.

6 Culture medium

Tryptic soy agar (TSA) is generally used, with a suitable neutralizer added where necessary. Where fungi are suspected from the monitoring results, or to take account of seasonal effects, sabouraud dextrose agar (SDA) may be added. The media shall comply with the relevant requirements of 9203 of the Pharmacopoeia of the People's Republic of China, 2025 edition, Volume IV.

7 Test conditions

For the qualification of a clean room (zone), tests shall be carried out in both the at-rest and the operational occupancy states. For routine monitoring of a clean room (zone), tests shall be carried out under operational conditions.

At-rest tests of unidirectional flow clean rooms (zones) should start after the purification air-conditioning system has been operating normally for at least 10 min; at-rest tests of non-unidirectional flow clean rooms (zones) should start after it has been operating normally for at least 30 min.