GB/T 16292-2010 Translated English of Chinese Standard. (GBT 16292-2010, GB/T16292-2010, GBT16292-2010): Test method for airborne particles in cleanroom (zone) of the pharmaceutical industryhttps://www.chinesestandard.net, 2019 M02 2 - 17 pages This Standard specifies the test method for airborne particle contamination. This Standard is applicable to the verification of airborne particle testing and environment in cleanroom and clean areas in the pharmaceutical industry, sterile rooms or local air purification areas (including clean bench). This Standard cannot be used to characterize physical, chemical, or reflective, or reproducible properties of airborne particles. |
Contents
| 3 | |
Scope | 4 |
Test methods | 6 |
Test rules | 8 |
Calculation of results | 10 |
Result evaluation | 12 |
Annex A normative Sampling point layout in cleanroom zone | 14 |
Common terms and phrases
according to formula air cleanliness level air conditioning system air purification area airborne particle concentration airborne particle counts airborne particle sampling airborne particle testing Annex as-bulit or at-rest at-rest test Average airborne particle calculated according CGMP clean bench Cleanliness level 100 cubic meter grain/m3 cubic meter particles/m3 evenly arranged Figure A.3 flow cleanroom zone GB/T grain per cubic Horizontal unidirectional laser particle counter local air purification Maximum allowable number method for airborne minimum number Minimum sampling amount Minimum sampling point non-unidirectional flow cleanroom number of airborne number of operational number of sampling one-way flow table operational-state testing particle size greater particles in cleanroom pharmaceutical industry pieces/m3 Maximum allowable production operator evacuates purified air conditioning relative humidity requirements for airborne rest test pieces/m3 sampling nozzle sampling point layout self-cleaning suspended particle t-distribution coefficient test instrument test method test pieces/m3 Maximum test report total number unidirectional airflow unidirectional flow cleanroom upper confidence limit