GB/T 42398-2023

Active

Technical specifications of cleanroom design for cell culture

细胞培养洁净室设计技术规范

Standard Type
GBT
ICS
13.040.35
CCS
C70
Status
Active
Issue Date
2023-03-17
Implementation
2023-10-01
Centralized Committee
国家标准委
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

GB/T 42398-2023 specifies design requirements for cleanrooms used in cell culture processes, including air cleanliness, temperature, humidity, and pressure differentials. It applies to the construction and operation of facilities in biomedical research, pharmaceutical production, and biotechnology industries where sterile environments are critical for cell growth and contamination control. The standard ensures consistent environmental conditions for cell-based experiments, vaccine development, and therapeutic cell manufacturing.

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.