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Building a new benchmark for clean room facilities construction
source:TIANS
date:2020-11-12

[Abstract]:

Recently, TIANS group has been awarded the title of member of SAC / tc319, vice president of the group, chief designer, chairman of the biomedical business division, and member of the Technology Committee of TIANS. Ding Zhijie was also employed as a member of the Third Committee on standards.

 

The National Technical Committee for standardization of clean rooms and related controlled environments (SAC / tc319) was approved by the National Standardization Management Committee in January 2008, and the undertaking unit of the secretariat was China Standardization Association. Since its establishment, 10 national standards have been formulated and implemented, and 8 national standards are being formulated. He also represented China in the ISO / TC 209 annual meeting and working group meeting. Its current members include leaders of well-known design institutes, engineering companies and academic institutions, including the Chinese Academy of electronic engineering design and the Academy of Military Medical Sciences of the Chinese people's Liberation Army.

TIANS group is an engineering technology group led by technology. Over the years, we have designed and built a number of industry model projects in the field of chemical and biological drugs. Because of the particularity of pharmaceutical industry, high standard clean room and related controlled environment play a decisive role in drug production quality. Therefore, TIANS group has been committed to participate in the construction of standards and norms in relevant fields. At present, TIANS group has participated in the preparation of two national standards, clean rooms and related controlled environments, Part 1: classification of air cleanliness grades according to particle concentration and clean rooms and related controlled environments Part 2: providing evidence of clean room air cleanliness by particle concentration monitoring, which are organized and drafted by the national Technical Committee for standardization of clean rooms and related controlled environments.

In addition, Ding Zhijie, an expert from the science and Technology Committee of the group, was invited to participate in the review and compilation of the national standard "technical code for design of cell preparation clean room", which fills the gap in the field of quality control in the whole process of cell preparation in China. Recently, a meeting was held in Shanghai Design and Research Institute of TIANS.

 

Clean room technology is very important to industrial production. With the rapid development of economy and society, especially the scientific experiments and high-tech production processes represented by microelectronics, biomedicine and high-precision equipment manufacturing, higher standards have been put forward for the precision, miniaturization, high purity, high quality and high reliability of enterprise products. High quality clean room and related controlled environment are the cornerstone and guarantee for the development of China's high-tech industry. TIANS group will continue to deeply participate in the standardization construction, play more power in the design and construction of relevant clean facilities, and work with the standardization committee to promote the industry to move forward.