Foreword
This document has been drafted in accordance with the provisions of GB/T 1.12020 "Guidelines for Standardization Work Part 1 Structure and Drafting Rules for Standardization Documents".
Please note that some of the contents of this document may involve patents. The issuing body of this document does not assume the responsibility of identifying patents This document is proposed and attributed by the National Technical Committee for Standardization of Pharmaceutical Equipment (SAC/TC 356).
1 Scope
This document specifies the pharmaceutical machinery (equipment) (hereinafter referred to as pharmaceutical equipment) the overall requirements for the selection of materials, material selection steps, material classification, the choice of metal materials, the choice of non-metallic materials and the choice of unknown materials.
This document applies to pharmaceutical equipment where the material, or direct contact with the required process media material selection, also applies to food machinery and equipment.
2 normative reference documents
The following documents constitute the essential provisions of the document through the normative references in the text. Among them, note the date of the reference document, only the date of the corresponding version applies to this document; not attention to the period of reference documents, the latest version (including all the change orders) applies to this document.
GB/T 150.2 Pressure vessel Part 2: Materials
GB/T 4334 Corrosion of metals and alloys Austenitic and ferritic-austenitic (duplex) stainless steel intergranular corrosion test method
GB/T 16886.1 Biological evaluation of medical devices Part 1: Risk management process evaluation and testing
GB/T 24511 stainless steel and heat-resistant steel plates and strips for pressure-bearing equipment
TSG 21-2016 fixed pressure vessel safety and technical supervision procedures
3 Terms and definitions
There are no terms and definitions that need to be defined in this document
4 General requirements
4.1 The quality and specifications of the material should comply with the current national standards, industry standards or relevant technical conditions. 4.2 The performance of the material should meet the working conditions of pharmaceutical equipment (equipment categories, the nature of the material, the level of the pharmaceutical production environment, working temperature, pressure, etc.) requirements.
4.3 The process performance of the material should be suitable for the processing requirements of pharmaceutical equipment.
5 material selection steps
5.1 analysis to determine the main factors affecting the working conditions of pharmaceutical equipment and failure forms
5.2 to determine the main factors and failure forms of the material performance requirements: major categories: metal, non-metallic.
6 Classification of materials
Pharmaceutical equipment commonly used materials are classified in Appendix A.
7 Selection of metal materials
7.1 Stainless steel materials
7.1.1 Pharmaceutical equipment commonly used stainless steel domestic and foreign grade comparison
Pharmaceutical equipment commonly used stainless steel domestic and foreign grade comparison table in Appendix B 7.1.2 Pharmaceutical equipment commonly used stainless steel material chemical composition pharmaceutical equipment commonly used stainless steel material chemical composition in Appendix C.
7.1.3 Mechanical properties
Mechanical properties of the selected materials should meet the design, manufacturing specifications for mechanical property requirements 7.1.4 corrosion resistance requirements
7.1.4.1 Stainless steel materials can be selected according to the stainless steel pitting corrosion resistance index, commonly used stainless steel pitting corrosion resistance index see Appendix D 7.1.4.2 For a specific use selected a specific stainless steel materials, and no relevant historical cases and test data, should be carried out according to GB/T 4334 corrosion test.
7.1.5 The selection of metal materials related specifications
8 selection of non-metallic materials
8.1 Basic requirements
The functional properties of the selected material should meet the relevant requirements of biocompatibility, extractables / precipitates, physical properties and chemical compatibility, and should not affect the material or the required process media. 8.2 Biocompatibility
Polymer materials should be biocompatible with the materials they come in contact with, and should not interfere with their metabolism or ability to survive and reproduce.
8.3 Extractables/precipients
The extractables / precipitates of the selected material should meet the requirements of its intended use
8.7 Selection of non-metallic materials not included in this document
The selection of non-metallic materials not listed in this document should meet the requirements of Chapter 4, and their physical and mechanical properties, chemical properties, biocompatibility and extractables / precipitates should be no less than the selected materials listed in this document, no relevant historical cases and test data, the corresponding tests should be conducted.
9 Unknown material selection
Unknown sources of materials should not be selected
Attachment A (informative) pharmaceutical equipment commonly used materials classification
A.1 Pharmaceutical equipment commonly used materials classification
By nature into metal materials and non-metallic materials. Metallic materials are divided into two categories: ferrous and non-ferrous metals. Non-metallic materials are also divided into organic non-metallic materials, inorganic non-metallic materials.
A.2 Classification of commonly used metal materials for pharmaceutical equipment
A.2.1 Classification of carbon steel is shown in Table A.1.
Appendix B (informative) pharmaceutical equipment commonly used stainless steel material domestic and foreign grade comparison
Pharmaceutical equipment commonly used stainless steel materials at home and abroad, see Table B.1.
Foreword
1 Scope
2 normative reference documents
3 Terms and definitions
4 General requirements
5 material selection steps
6 Classification of materials
7 Selection of metal materials
8 selection of non-metallic materials
9 Unknown material selection
Attachment A (informative) pharmaceutical equipment commonly used materials classification
Appendix B (informative) pharmaceutical equipment commonly used stainless steel material domestic and foreign grade comparison
