GB/T 42398-2023 Active National standards

GB/T 42398-2023 Technical specifications of cleanroom design for cell culture

Publish Date: 2023-03-17 Implement Date: 2023-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 42398-2023

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Industrial dust and gas prevention and control technology

ICS Name: Clean rooms (sterile rooms) and related controlled environments

Publish Date: 2023-03-17

Implement Date: 2023-10-01

Pages: 12 pages

Scope

This document specifies the general requirements for the design of cell culture cleanrooms, including ventilation and purification, enclosure structures, electrical and information systems, water supply and drainage, gas pipelines, and safety requirements. This document is applicable to the design of cleanrooms used for cell culture in human applications. Other cell culture cleanrooms should refer to this document for guidance.

Development Information

Word Count: 26 Thousand words Pages: 12 pages

Referenced Standards

GB 5749-1985 Sanitary standard for drinking water GB 5749-2006 Standards for drinking water quality GB 5749-2022 Standards for drinking water quality GB 17945-2000 Fire emergency luminaries GB 17945-2010 Fire emergency lighting and evacuate indicating system GB 17945-2024 Fire emergency lighting and evacuate indicating system GB/T 29469-2012 Cleanrooms and associated controlled environments—Evaluation of performance and rationality GB/T 29469-2024 Cleanrooms and associated controlled environments—Evaluation of performance and rationality GB/T 36372-2018 Cleanrooms and associated controlled environments—General technical requirements of combined envelope structure GB 50016-2014 Code for fire protection design of buildings GB 50457-2019 Standard for design of pharmaceutical industry clean room GB 50472-2008 Code for design of electronic industry clean room GB 50591-2010 Code for construction and acceptance of cleanroom

Related Standards

GB/T 25915.1-2010 Replaced

GB/T 25915.1-2010 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness

Publish Date: 2011-01-14

GB/T 25915.2-2010 Replaced

GB/T 25915.2-2010 Cleanrooms and associated controlled environments—Part 2:Specifications for testing and monitoring to prove continued compliance with GB/T 25915.1

Publish Date: 2011-01-14

GB/T 25915.3-2010 Replaced

GB/T 25915.3-2010 Cleanrooms and associated controlled environments—Part 3:Test methods

Publish Date: 2011-01-14

GB/T 25915.4-2010 Active

GB/T 25915.4-2010 Cleanrooms and associated controlled environments—Part 4:Design,construction and start-up

Publish Date: 2011-01-14

GB/T 25915.5-2010 Active

GB/T 25915.5-2010 Cleanrooms and associated controlled environments—Part 5:Operations

Publish Date: 2011-01-14

GB/T 25915.7-2010 Active

GB/T 25915.7-2010 Cleanrooms and associated controlled environments—Part 7:Separative devices (clean air hoods,gloveboxes,isolators and minienvironments)

Publish Date: 2011-01-14