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JB/T 20175-2017 English PDF

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JB/T 20175-2017: Aseptic isolators
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PDF similar to JB/T 20175-2017


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Basic data

Standard ID JB/T 20175-2017 (JB/T20175-2017)
Description (Translated English) Aseptic isolators
Sector / Industry Mechanical & Machinery Industry Standard (Recommended)
Classification of Chinese Standard C92
Word Count Estimation 10,187
Date of Issue 2017-01-09
Date of Implementation 2017-07-01
Regulation (derived from) Ministry of Industry and Information Technology Announcement No.2 of 2017
Issuing agency(ies) Ministry of Industry and Information Technology
Summary This standard specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules, signs, instructions for use, packaging, transportation and storage of sterile isolators.

JB/T 20175-2017: Aseptic isolators

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Sterile isolator) ICS 11.120.30 C92 Record number. 57133-2017 People's Republic of China pharmaceutical machinery industry standards Sterile isolators 2017-01-09 Published 2017-07-01 implementation Ministry of Industry and Information Technology of the People's Republic of China

Foreword

This standard in accordance with GB/T 1.1-2009 "Standardization Guide Part 1. Standard structure and preparation" and GB/T.20001.10- 2014 Rules for the preparation of the standard Part 10. Product Standards "given the formulation of rules. This standard proposed by the China Pharmaceutical Equipment Industry Association. This standard by the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356) centralized. This standard was drafted by. Shanghai East Futong Technology Co., Ltd. Participated in the drafting of this standard. Zhejiang Tailin Biotechnology Co., Ltd., Wenzhou City, Quality and Technical Supervision Inspection and Waugh, Wenzhou Veken Health Experimental Equipment Co., Ltd. The main drafters of this standard. Zheng Xiaodong, Zheng Jinwang, Cheng Jinsheng, Wu Wenlei, Xu Wenchao, Jin Chunfeng, summer letter group, Zhan Xin, Chen Chao. Sterile isolators

1 Scope

This standard specifies the terms and definitions aseptic isolator, classification and marking, requirements, test methods, inspection rules, signs, instructions for use Book, package, transport and storage. This standard applies to aseptic production and sterile inspection using a sterile isolator (hereinafter referred to as "isolator").

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 Packaging - Pictorial signs Mechanical and Electrical Safety Machinery - Electrical Equipment Part 1. General Specifications GB/T 6388 transport packaging shipping symbols GB/T 9969 Industrial Products Manual General The Generation of GB/T 10111 Random Number and Its Application in Product Quality Sampling Inspection GB/T 13306 signs GB/T 13384 mechanical and electrical product packaging General technical conditions GB/T 13554-2008 high efficiency air filter Test methods for suspended particles in the clean room (area) of pharmaceutical industry GB/T 16292-2010 Test methods for airborne bacteria in the clean room (area) of the pharmaceutical industry GB/T 16293-2010 Test methods for settling bacteria in the clean room (area) of pharmaceutical industry GB/T 16294-2010 Metallic cutting machines - Measurement of noise level of sound pressure level GB/T 16769 Industrial machinery - Electrical equipment - Protective earth continuity test code Cleanrooms and related controlled environments Part 7. Isolators Classification of sealed closures and methods of inspection GBZ 2.1 Occupational exposure limits for hazardous agents in the workplace Part 1. Chemical hazardous agents Determination of oxides in the air at workplaces GBZ/T 160.32-2004 Pharmaceutical machinery product model compilation method Drug Production Quality Management Practices (2010 Revision) Ministry of Health of the People's Republic of China Ministry of Health Order No. 79 Pharmacopoeia of the People's Republic of China (2015 Edition) Three National Pharmacopoeia Committees Pharmacopoeia of the People's Republic of China (2015) Four National Pharmacopoeia Committees

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Sterile isolator isolator A device or system in which the internal environment remains sterile and completely isolated from the outside world.

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