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The national standard "Construction and Acceptance Criteria for Clean Rooms in the Pharmaceutical Industry", which was co-edited by TIANS, has been officially released
source:Marketing
date:2025-05-23

Recently, the national standard Code for Construction and Acceptance of Cleanrooms for Pharmaceutical Industry (GB/T 51466-2025), co-compiled by TIANS Group, has been published on the official website of the Ministry of Housing and Urban-Rural Development (www.mohurd.gov.cn). Organized and published by the Institute of Standards and Quotas of the Ministry of Housing and Urban-Rural Development through China Planning Press Co., Ltd., the standard will be officially implemented on September 1, 2025. Ms. Zhou Lanxia, Director and President of the Group and Dean of the Chemical and Pharmaceutical Design Institute; Mr. Pan Houchang, Chief Engineer of the Chemical and Pharmaceutical Design Institute; Mr. Wang Lubo, Deputy Chief Engineer of the Chemical and Pharmaceutical Design Institute; and Mr. Liu Zhefeng, Deputy Chief Engineer of the Process Technology Center, participated in the compilation and review of this standard as contributors and reviewers.

This standard provides comprehensive and detailed regulations for the construction and acceptance of cleanrooms in the pharmaceutical industry, covering aspects such as architectural finishes, purification HVAC, process piping, water supply and drainage, equipment installation, fire protection and safety facilities, electrical systems, instrumentation, and communication. The formal implementation of the standard will promote the standardization of construction and acceptance practices in the pharmaceutical industry, ensure that facility facilities meet pharmaceutical production requirements, safeguard drug quality and safety, and advance the technological level and healthy development of the pharmaceutical industry.

As an engineering design group dedicated to empowering the industrialization of new technologies, TIANS Group has always been deeply committed to the biopharmaceutical field, actively contributing to the development of standards and specifications in related areas. Currently, TIANS Group has participated in compiling multiple national and local standards in the field of pharmaceutical cleanrooms, such as Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air Cleanliness by Particle Concentration, *Cleanrooms and Associated Controlled Environments—Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1*, and Technical Specification for Cell Culture Operations in Cleanrooms and Controlled Environments.

In the future, TIANS Group will continue to be driven by technology, actively participate in the development of standardized systems, and provide more intellectual support for the standardization and normalization of cutting-edge technologies. The group will also keep collaborating with clients to create high-quality projects for the industry, mastering the future through technology.