GB/T 16292-2010: Test method for airborne particles in clean room (zone) of the pharmaceutical industry

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Scope

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.
NOTE. Within the sampling particle size range, the actual particle concentration is unpredictable and
significantly changes with time as the sampling amount increases.

Basic Data

Standard ID	GB/T 16292-2010 (GB/T16292-2010)
Description (Translated English)	Test method for airborne particles in clean room (zone) of the pharmaceutical industry
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	13.040.30
Word Count Estimation	13,117
Date of Issue	2010-09-02
Date of Implementation	2011-02-01
Older Standard (superseded by this standard)	GB/T 16292-1996
Quoted Standard	YY 0033-2000
Adopted Standard	ISO 14644-1
Regulation (derived from)	National Standard Announcement 2010 No.4 (Total No.159)
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies test methods of air pollution particulates. This standard applies to the pharmaceutical industry clean room and clean area, verify sterile room or local air purification area (including clean bench) air particulates and environmental testing. This standard can not be used to characterize the physical, chemistry, reproductive characteristics reflected rays can be learned, or airborne particles.