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JB/T 20175-2017Aseptic isolators (English PDF)

无菌隔离器

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Issued by

MIIT

Level / Type

Industry · Recommended

Issue date

January 9, 2017

Implementation date

July 1, 2017

Scope

JB/T 20175-2017 is the English-translated version of 无菌隔离器.

JB/T 20175-2017 is the Chinese standard "Aseptic isolators". Its scope clause reads: 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"). Its clauses include terms and definitions.

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Document preview — JB/T 20175-2017

National Standard of the People's Republic of China

Issued by: Ministry of Industry and Information Technology of the People's Republic of China

1 Scope
2 Normative references
3 Terms and definitions
3.1 Sterile isolator isolator

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Cited by

JB/T 20079-2021Liquid filling and stoppering machines for antibiotic vials

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