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GBZ42540-2023 English PDF

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US$579.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
GBZ42540-2023: Technical guide for containment of pharmaceutical equipment - Solid preparations
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/Z 42540-2023	579	Add to Cart	5 days	Technical guide for containment of pharmaceutical equipment - Solid preparations	Valid

Similar standards

GB/T 36030 JB/T 20032 GB/T 15723 GB/T 15692

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

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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GBZ42540-2023_English be delivered?

Answer: Upon your order, we will start to translate GBZ42540-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GBZ42540-2023_English with my colleagues?

Answer: Yes. The purchased PDF of GBZ42540-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.