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Similar standardsGB 50457-2008: Code for design of pharmaceutical industry clean room---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB50457-2008NATIONAL 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 ForewordThis 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 XiaTable of ContentsGeneral 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 Terms2.0.1 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. |