GB/T 16293-2025 Test method for airborne microbe in clean room (zone) of the pharmaceutical industry
1 Scope
This document describes the test method for airborne microbe in clean room (zone) of pharmaceutical industry. This document is applicable to the tests of the airborne microbe in clean room (zone), clean laboratory and similar environment of pharmaceutical industry. This document is not applicable to online monitoring systems.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
Pharmacopoeia of the People’s Republic of China ( Edition 2025, Volume IV)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
airborne microbe
living microorganism suspending in the air
Note: in this document, it specifically refers to living microorganism suspending in the air collected by the active sampling method.
3.2
airborne microbe concentration
number of airborne microbe colonies per unit volume of air
Note: The unit of airborne microbe concentration is colony forming units per cubic meter (CFU/m3).
3.3
at-rest
condition where the clean room or clean zone is complete with 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
condition where equipment in the clean room or clean zone is operating in the specified, with the specified number of personnel working as agreed
[Source: GB/T 25915.1-2021, 3.3.3]
4 Requirements for personnel
The test personnel in the clean room (zone) shall receive training on basic knowledge of hygiene and microbiology, and other related professional knowledge to minimize the intervention of test activities with the clean room (zone).
5 Main instruments and apparatus
5.1 Sampler
Generally, the mesh impacting sampler is used. The operating principle of the mesh impacting sampler is that microbial aerosols, under the suction effect of the sampler fan, are directed towards the surface of the solid culture media according to the principle of inertia. The carrier particles with sufficient momentum move in a straight line along the original direction due to inertia, and do not divert following the direction of fluid rotation. They collide with the surface of the culture media and are collected.
The sampler shall be used according to the instructions and calibrated regularly.
Note: Currently, the samplers used for testing airborne microbes include slit impacting samplers, centrifugal impacting samplers, impact samplers, filtration samplers, etc.
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for personnel
5 Main instruments and apparatus
5.1 Sampler
5.2 Other instruments and apparatus
6 Culture media
7 Test conditions
8 Test methods
8.1 Determination of sampling points
8.2 Sampling procedures
8.3 Culture count
8.4 Result characterization
9 Test report
Bibliography
