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 industry
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.
Calculation of results
Annex A normative Sampling point layout in cleanroom zone
according to formula air conditioning system air purification area airborne particle concentration airborne particle counts airborne particle sampling airborne particle testing Annex as-bulit or at-rest Average airborne particle calculated according CGMP clean bench Cleanliness level 100 counter The airborne cubic meter grain/m3 cubic meter particles/m3 evenly arranged Figure A.1 Figure A.2 flow cleanroom zone GB/T grain per cubic 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 and location number of airborne number of sampling one-way flow table operational-state testing particle sampling points particle size greater particles in cleanroom pharmaceutical industry production operator evacuates purified air conditioning relative humidity requirements for airborne rest test pieces/m3 sampling nozzle sampling point layout scattering particle counter self-cleaning suspended particle t-distribution coefficient test instrument test method test pieces/m3 Maximum test report unidirectional airflow unidirectional flow cleanroom upper confidence limit Vertical unidirectional