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GBZ42540-2023: Technical guide for containment of pharmaceutical equipment - Solid preparations
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/Z 42540-2023 | English | 579 |
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Technical guide for containment of pharmaceutical equipment - Solid preparations
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GB/Z 42540-2023
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Basic data | Standard ID | GB/Z 42540-2023 (GB/Z42540-2023) | | Description (Translated English) | Technical guide for containment of pharmaceutical equipment - Solid preparations | | Sector / Industry | National Standard | | Classification of Chinese Standard | C90 | | Classification of International Standard | 11.120.30 | | Word Count Estimation | 28,238 | | Date of Issue | 2023-05-23 | | Date of Implementation | 2023-12-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GBZ42540-2023: Technical guide for containment of pharmaceutical equipment - Solid preparations---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.
GB /Z 42540-2023: Technical Guidelines for Sealing of Pharmaceutical Equipment Solid Preparations
ICS 11:120:30
CCSC90
National Standardization Guidance Technical Document of the People's Republic of China
Pharmaceutical Equipment Containment Technical Guidelines for Solid Preparations
Solid preparations
2023-12-01 implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Abbreviations 1
5 Occupational Exposure Level (OEB) and Implementation Path 1
6 Application of airtight technology 2
7 Evaluation 5
Appendix A (Informative) Sealing Technology 7
Appendix B (Informative) Calculation Example of Leakage Rate of Closed System---Pressure Change Method 18
Appendix C (informative) Particle sealing performance evaluation test for solid preparation equipment 20
Reference 24
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents"
drafting:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed and managed by the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356):
This document was drafted by: Zhejiang Canaan Technology Co:, Ltd:, Tongji University, Sichuan Kelun Pharmaceutical Co:, Ltd:, Shandong Xinma
Pharmaceutical Equipment Co:, Ltd:
The main drafters of this document: Fang Zheng, Xie Nan, Xie Zhongze, Wang Hongmin, Wu Guoqiao, Wu Wutong, Tan Hongbo, Dai Huafeng, Yu Jun, Yang Yulong,
Wang Hui, Huang Yuanyuan, Cai Gen:
Pharmaceutical Equipment Containment Technical Guidelines for Solid Preparations
1 Scope
This document provides the occupational exposure level and sealing technology application of solid preparation equipment with chemical hazard factors occupational exposure control requirements:
and assessment guidelines:
This document is applicable to solid preparation equipment for the production and preparation of pharmaceuticals in a closed manner:
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document:
GB/T 36030 General Technical Requirements for Cleaning in Place and Sterilization of Pharmaceutical Machinery (Equipment)
GB 37823 Emission Standard of Air Pollutants for Pharmaceutical Industry
EJ/T 1096-1999 Classification of airtightness of sealed chambers and its inspection methods
3 Terms and Definitions
The following terms and definitions apply to this document:
3:1
The long-term repeated exposure of workers to one or more occupational harmful factors in the process of occupational activities will not cause discomfort to most of the exposed workers:
Tolerable exposure levels for adverse health effects:
[Source: GB /Z 2:1-2019, 3:5, modified]
3:2
Chemical substances, dust and biological factors present or generated in the workplace:
[Source: GB /Z 2:1-2019, 3:1, modified]
4 Abbreviations
The following abbreviations apply to this document:
5 Occupational Exposure Level (OEB) and the way to achieve it
5:1 Confirmation of OEB and common engineering control measures
Selecting a reasonable OEB grade according to the OEL values of different APIs facilitates the selection of suitable production facilities and operating procedures:
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