GB 50457-2019 (GB 50457-2008) PDF English
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NATIONAL STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
Code for Design of Pharmaceutical Industry
Clean Room
Issued on: NOVEMBER 12, 2008
Implemented on: JUNE 1, 2009
Jointly Issued by Ministry of Housing and Urban-Rural Construction of the People's
Republic of China
General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China
NATIONAL STANDARD
OF THE PEOPLE S REPUBLIC OF CHINA
Code for Design of Pharmaceutical Industry Clean Room
Chief Development Department. China pharmaceutical Association of Engineering Design
Approval Department. Ministry of Housing and Urban-Rural Development of the People's Republic
of China
Implementation Date. June 1, 2009
Beijing 2009
NOTICE
This code is written in Chinese and English. The Chinese text shall be taken as the ruling one in
the event of any inconsistency between the Chinese text and the English text.
Announcement of the Ministry of Housing and Urban-Rural
Development of the People's Republic of China
No. 159
Announcement on Publishing the National Standard "Code for Design of
Pharmaceutical Industry Clean Room"
The standard "Code for Design of Pharmaceutical Industry Clean Room" is approved as a national
standard with the number GB50457-2008, and it is implemented from June 1, 2009. Therein, Articles
(Items) 3.2.1, 3.2.6, 4.2.4, 5.1.2 (1, 2, 3), 5.1.6, 5.1.7, 5.1.8, 5.1.14 (1, 2), 5.2.1 (2), 5.2.2 (1, 2, 5, 7, 8),
5.3.1, 5.3.2, 5.4.3 (1, 2, 4), 6.1.2, 6.1.4, 6.1.9, 6.4.1, 6.4.2, 6.4.3 , 6.4.5, 7.1.1, 7.1.8, 7.2.2, 7.2.3, 7.2.5,
7.2.12 (1, 2), 8.1.6, 8.2.1, 8.2.3, 8.2.4, 8.2.5, 8.2.6, 8.2.8, 8.2.9, 8.3 .8 (1, 4), 9.1.3 , 9.1.4, 9.2.5, 9.2.7,
9.2.8, 9.2.10 (3, 4, 5), 9.2.14, 9.2.15, 9.2.19, 9.3.4, 9.4.3, 9.4.4, 9.5.4, 9.6.1 , 9.6.2, 9.6.3, 9.6.4, 10.3.1,
10.3 .2, 10.3.3, 10.3.4 (1), 10.4.1, 10.4.2, 10.4.3 (2, 3, 4), 10.4.4, 10.4.5, 10.4.6 (1), 11.2.7, 11.2.8,
11.3.3 , 11.3.4, 11.3.5, 11.3 .6, 11.4.3 and 11.4.4 are compulsory provisions and must be enforced
strictly.
Authorized by the Standard Rating Research Institute of the Ministry of Housing and Urban-Rural
Development of the People 's Republic of China, this code is published and distributed by China
Planning Press.
Ministry of Housing and Urban-Rural Development of the People's Republic of China
November 12, 2008
Foreword
This standard, in accordance with the requirements of the document- " Announcement on printing
and distributing 2005 preparation and revision planning (batch 2) of engineering construction standards"
(Jian Biao Han [2005] No. 124), is formulated by SINOPEC Shanghai Engineering Co., Ltd. together
with SINOPHARM Wuhan Pharmaceutical Industry Design Institute and SINOPHARM Chongqing
Pharmaceutical Industry Design Institute.
In the preparation course hereof, the standard is finalized upon referencing the development of
"Good Manufacture Practice" (GMP) and clean technologies at home and abroad and the practice of
engineering construction, as well as widely soliciting the opinions of the concerned.
The provisions printed in bold type are compulsory ones and must be enforced strictly.
The Ministry of Housing and Urban-Rural Development is in charge of the governance and the
interpretation of the compulsory provisions, and SINOPEC Shanghai Engineering Co., Ltd. is in
charge of the interpretation of the concrete technical contents. All relevant organizations are kindly
requested to sum up and accumulate your experiences in actual practices during the process of
implementing this standard. The relevant opinions and advice, whenever necessary, can be posted or
passed on to SINOPEC Shanghai Engineering Co. , Ltd. (No. 769, Zhangyang Road, Pudong New
District, Shanghai 200120, China).
as .
The Chief Development Organization, Participating Organizations and Chief Drafting Staffs are
Chief Development Organization. SINOPEC Shanghai Engineering Co., Ltd .
Participating Organizations. SINOPHARM Wuhan Pharmaceutical Industry Design Institute
SINOPHARM Chongqing Pharmaceutical Industry Design Institute
Chief Drafting Staffs. Miao Dehua, Wang Fuguo, Wang Zhengyang, Wu Tianhe, lLiu LinJ, Chen Yuqi,
Li Ankang, Tang Xiaofang, Gu Jihong, Yu Youcai, Yang Limin, Chen Qinye,
Yang Jun, Yang Yixin, Han Lixun, Huang Jlnfu, Liu Yuan, Wu Xia
Table of Contents
General Provisions ... 1
2 Terms ... 2
3 Environmental Parameters of Production Area ... 5
3.1 General Requirements ...-. 5
3.2 Design Requirements ofEnvironmental Parameters ... 5
4 Plant Location and General Layout... 7
4.1 Plant Location ... 7
4.2 General Layout ... 7
5 Process Design ... 9
5 .1 Process Layout ... 9
5.2 Personnel Cleaning ... 12
5.3 Materials Cleaning ... 13
5.4 Process Water ... 13
6 Process Line ... 16
6.1 General Requirements ... 16
6.2 Pipeline Material, Valve and Fittings ... 16
6.3 Installation and Insulation of Pipes ... 17
6.4 Safety Engineering ... 17
7 Equiptnents ... 19
7 .I General Requirements ... 19
7.2 Design and Selection ... 19
8 Construction ... 21
8.1 General Require1nents ... 21
8.2 Firefighting and Evacuating ... 21
8.3 Indoor Decoration ... 22
9 Air Cleaning ... 25
9.1 General Requiretnents ... 25
9.2 Purified Air Conditioning System ... 25
9.3 Air Pattern and Air Output ... 30
9.4 Air Pipe and Attachment ... 31
9.5 Monitoring and Control ... 32
9.6 Special Requirements of Clean Room Used for Production of Medicine Like Penicillin ... 32
I 0 Water Supply and Drainage ... 34
10.1 General Requirements ... 34
10.2 Water Supply ... 34
10.3 Drainage ... 34
10.4 Fire Fighting Device ... 35
11 Electric ... 3 7
11.1 Electric Power Distribution ... 3 7
11.2 Lighting ... 37
11.3 Communication ... 3 8
11.4 Electrostatic Protection and Grounding ... 39
Appendix A Examples on Air Cleanliness Class of Pharmaceutical Environment ...40
Appendix B Maintenance and Administration of Pharmaceutical Clean Room (Zone) ... 43
Appendix C Validation of Pharmaceutical Clean Room (Zone) ...45
Explanation ofWording in This Code ...47
1 General Provisions
1.0.1 This standard is formulated, with a view to following out the related national guideline/policies
and "Good Manufacture Practice" (GMP), making state-of-art technology, economic application,
safety and stability, and guaranteed quality, satisfying the requirements of energy conservation and
environmental protection.
1.0.2 This standard is applicable to designs of new, extended and rebuilt pharmaceutical industry
clean rooms.
1.0.3 The design of pham1aceutical industry clean room shall provide the necessary conditions for
construction and installation, facilities validation, maintenance administration, overhaul test and safe
operation.
1.0.4 The design of pharmaceutical industry clean room shall meet the provisions of the related
national standards, besides this standard.
2 Terms
2.0.1 Pharmaceutical clean room (zone)
Room or space which the parameters, such as concentration of airborne particles and microorganisms,
temperature, humidity and pressure, are controlled or restricted.
2.0.2 Room for cleaning human body
Room where personnel shall be cleaned by a procedure before entering clean zone...
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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