JB/T 20206-2022Temperature control units for biopharmaceutical reaction processes (English PDF)
生物制药反应过程温控装置
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Issued by
MIIT
Level / Type
Industry · Recommended
Issue date
April 8, 2022
Implementation date
October 1, 2022
Scope
JB/T 20206-2022 is the English-translated version of 生物制药反应过程温控装置.
JB/T 20206-2022 governs the process temperature control units that use plant utilities to transfer heat in an orderly way to the reaction stages of biopharmaceutical production. It defines the unit independent mode, in which energy is delivered to a single temperature control point, and classifies and models the units before setting requirements and test methods. Because these skids carry pressure-bearing heat exchange parts, they are referred to GB/T 150 in all parts and GB/T 151, to GB/T 12241, GB/T 1226, GB/T 4272 and TSG 21, while water quality follows GB 5749 and electrical safety GB/T 36035. Inspection rules, instruction manuals, packaging, transport and storage round out the document. Issued on 8 April 2022, it has applied since 1 October 2022.
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Document preview — JB/T 20206-2022
National Standard of the People's Republic of China
- ICS
- 11.120.30
- Classification
- C 91
Issued by: Ministry of Industry and Information Technology of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Classification and Model
- 5 requirements
- 6 Test method
- 7 Inspection rules
- 8 Signs, instructions for use, packaging, transportation and storage
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.
1 Scope
This document specifies the classification and model, requirements, test methods, inspection rules and instructions for the use of signs of temperature control devices for biopharmaceutical reaction processes. Instructions, packaging, transportation and storage.
This document is applicable to process temperature control devices that can realize orderly heat transfer and control through public energy in the biopharmaceutical reaction process. (hereinafter referred to as the temperature control device).
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 150 (all parts) pressure vessels
GB/T 151 heat exchanger
GB/T 191 Packaging, storage and transportation icon marks
GB/T 1226 General pressure gauge
GB/T 3768 Acoustic sound pressure method for measuring sound power level and sound energy level of noise sources adopts the simple method of enveloping the measuring surface above the reflecting surface. easy method
GB/T 4272 General Rules for Equipment and Pipeline Insulation Technology
GB 5749 Hygienic Standards for Drinking Water
GB/T 6388 Transport packaging receipt and delivery marks
GB/T 9969 General Rules for Instructions for Use of Industrial Products
GB/T 10111 Generation of Random Numbers and Its Application in Product Quality Sampling Inspection
GB/T 12241 General requirements for safety valves
GB/T 13306 Signage
GB/T 13384 General Technical Specifications for Packaging of Mechanical and Electrical Products
GB/T 36035 General Requirements for Electrical Safety of Pharmaceutical Machinery
JB/T 20188-2017 Pharmaceutical machinery product model compilation method
TSG21 Safety Technical Supervision Regulations for Stationary Pressure Vessels
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Temperature control unit
Integrated controls for precise temperature control during heat transfer.
3.2 Unit independent mode
The mode of orderly energy transfer for only one temperature control point.
......
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
Normative references
- GB/T 151Heat exchangers
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 1226General pressure gauge
- GB/T 4272General principles of thermal insulation technique for equipment and pipes
- GB 5749Standards for drinking water quality
- GB/T 9969General principles for preparation of instructions for use of industrial products
GB/T 150 · GB/T 3768 · GB/T 6388
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Related Standards
GB 5749-2022 — Standards for drinking water quality
GB/T 10111-2008 — Generation of random numbers and procedures applied to sampling inspection for product quality
GB/T 12241-2021 — Safety valves - General requirements
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