GB/T 16292-2010

Active

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

医药工业洁净室(区)悬浮粒子的测试方法

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 method for determining the concentration of airborne particles in clean rooms and clean zones used in the pharmaceutical industry. It is applied to classify and monitor air cleanliness during manufacturing, filling, and packaging processes for sterile drugs and other pharmaceutical products. The method ensures compliance with cleanliness grade limits, such as ISO Class 5 or Class 7, for quality control and regulatory validation.

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.