GB/T 16294-2025

Upcoming

Test method for settling microbe in clean room(zone)of the pharmaceutical industy

医药工业洁净室(区)沉降菌的测试方法

Standard Type
GBT
ICS
13.040.30
CCS
C30
Status
Upcoming
Issue Date
2025-10-05
Implementation
2026-11-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies the test methods for determining the number of settling microbes in clean rooms and controlled zones within the pharmaceutical industry. It is applied during facility qualification, routine environmental monitoring, and validation of aseptic processing areas to ensure microbial contamination levels meet regulatory cleanliness classifications. The standard is critical for maintaining product sterility and compliance with Good Manufacturing Practice (GMP) requirements in pharmaceutical manufacturing environments.

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.