GB/T 16293-2010

Active

Test method for airborne microbe in clean room(zone) of the pharmaceutical industry

医药工业洁净室(区)浮游菌的测试方法

Standard Type
GBT
ICS
13.040.30
CCS
C30
Status
Active
Issue Date
2010-09-02
Implementation
2011-02-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the test methods for determining the concentration of airborne viable microorganisms (floating bacteria) in clean rooms and controlled zones used in the pharmaceutical industry. It is applied during facility qualification, routine environmental monitoring, and validation of aseptic processing areas to ensure compliance with cleanliness classifications and contamination control requirements.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.