General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest
GB/T 42398-2023
Introduction
The GB/T 42398-2023 Technical Specification for Design of Cell Culture Cleanrooms is a comprehensive guideline that provides technical requirements and recommendations for the design of cleanrooms specifically used for cell culture. This standard aims to ensure the sterility and cleanliness of the environment, which is crucial for successful cell culture processes.
The specification covers various aspects of cleanroom design, including architectural design, layout, and construction materials. It also includes guidelines for the selection and installation of equipment, such as HVAC systems, air filters, and sterilization systems. Additionally, the standard provides recommendations for environmental monitoring, maintenance, and validation procedures to ensure the continuous quality of the cleanroom.
By adhering to the guidelines outlined in the GB/T 42398-2023, cleanroom designers and operators can establish a controlled and contamination-free environment that is conducive to cell growth and viability. This standard is applicable to research laboratories, pharmaceutical companies, and other facilities involved in cell culture activities.
Overall, the GB/T 42398-2023 Technical Specification for Design of Cell Culture Cleanrooms serves as a valuable resource for professionals in the field, promoting standardized practices and ensuring the quality and integrity of cell culture processes.
GB/T 42398-2023 history
2023GB/T 42398-2023 Technical specifications for cell culture clean room design