GB/T 16292-2025 Test method for airborne particles in clean room (zone) of the pharmaceutical industry
1 Scope
This document specifies the test methods for concentration of airborne particles in clean room (zone) of the pharmaceutical industry.
This document applies to tests for airborne particles in clean room (zone) of the pharmaceutical industry.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 29024.4 Determination of particle size distribution - Single particle light interaction methods - Part 4: Light scattering airborne particle counter for clean spaces
GB/T 36066 Cleanrooms and associated controlled environments - Technical requirements and application of testing
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
clean room (zone)
room or zone where environmental control and classification are implemented for dust particle and microbial contamination
Note: Its building structure, equipment and usage are all designed to reduce the entry, generation, and retention of pollution sources within the zone.
3.2
cleanliness
level of cleanliness distinguished by the statistical number of airborne particles with a particle size greater than or equal to a specific value per unit volume of air in a clean environment
3.3
airborne particle
solid or liquid particles which, for purposes of classification of air cleanliness, with the size of 0.1μm to 100μm
Note: For an airborne particle counter, the area or volume of a particle sphere generates a response value, and different response values correspond to different particle diameters.
3.4
particle size
diameter of a sphere that produces a response, by a given particle-sizing instrument, that is equivalent to the response produced by the particle being measured
Note: For discrete-particle light-scattering instruments, the equivalent optical diameter is used.
[Source: GB/T 25915.1-2021, 3.2.2]
3.5
particle concentration
number of particles per unit volume of air
[Source: GB/T 25915.1-2021, 3.2.3]
3.6
unidirectional airflow
controlled airflow through the entire cross-section of a clean room or a clean zone with a steady velocity and airstreams that are considered to be parallel
[Source: GB/T 25915.1-2021, 3.2.7]
3.7
non-unidirectional airflow
air distribution where the supply air entering the clean room or clean zone mixes with the internal air by means of induction
[Source: GB/T 25915.1-2021, 3.2.8]
3.8
as-built
condition where the clean room or clean zone is complete with all services connected and functioning but with no equipment, furniture, materials or personnel present
[Source: GB/T 25915.1-2021, 3.3.1]
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Operating principle and general requirements of instrument
4.1 Operating principle
4.2 General requirements of instrument
5 Test preparation
5.1 Personnel
5.2 Instrument
5.3 Environment
6 Classification test
6.1 General
6.2 Determination of the minimum number of sampling points
6.3 Sampling points for large-area clean room (zone)
6.4 Determination of positions of sampling points
6.5 Determination of the single sampling quantity and the sampling time of each point
6.6 Sampling procedures and precautions
6.7 Results calculation
6.8 Test report
7 Monitoring
7.1 General
7.2 Risk assessment
7.3 Development, implementation and continuous improvement of monitoring plan
7.4 Determination of the minimum number of sampling points
7.5 Determination of positions of sampling points
7.6 Measures for deviations arising during the monitoring
Annex A (Informative) Considerations for developing an environmental monitoring plan
A.1 Risk assessment
A.2 General considerations
Bibliography
