GB/T 43459-2023
ActiveTechnical specification for cell culture operations in cleanroom and relevant controlled environment
洁净室及受控环境中细胞培养操作技术规范
Application Summary AI generated
This standard specifies technical requirements for cell culture operations conducted within cleanrooms and other controlled environments, covering facility design, personnel behavior, material flow, and contamination control. It is applied in pharmaceutical, biotechnology, and medical device industries where aseptic cell culture processes are performed, such as in the production of cell therapies, vaccines, or diagnostic reagents. The standard ensures consistent environmental conditions to maintain cell viability, prevent cross-contamination, and support regulatory compliance in Good Manufacturing Practice (GMP) settings.
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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.