GB/T 16294-2025 Test method for settling microbe in clean room (zone)of the pharmaceutical industry
1 Scope
This document describes the test method for settling microbe in clean room (zone) of the pharmaceutical industry. This document is applicable to the tests of the settling microbe in clean room (zone), clean laboratory and similar environment of pharmaceutical industry.
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
settling microbe
living microorganism suspending in the air collected by the passive sampling method
3.2
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]
3.3
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]
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for personnel
5 Main 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
9 Test report
Bibliography
