GB/T 42354-2023General for selection material of pharmaceutical machinery (English PDF)

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 general requirements for the selection of materials for pharmaceutical machinery (equipment) (hereinafter referred to as pharmaceutical equipment), the steps for material selection, and the classification of materials.

Types, selection of metallic materials, selection of non-metallic materials and selection of unknown materials.

This document is applicable to the selection of materials in direct contact with materials or required process media in pharmaceutical equipment, and is also applicable to food machinery and equipment.

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 150.2 Pressure Vessels Part 2: Materials

GB/T 4334 Corrosion of metals and alloys - Test method for intergranular corrosion of austenitic and ferritic-austenitic (duplex) stainless steels

GB/T 16886.1 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process

GB/T 24511 Stainless steel and heat-resistant steel plates and strips for pressure equipment

TSG21-2016 Safety Technical Supervision Regulations for Stationary Pressure Vessels

3 Terms and Definitions

This document does not have terms and definitions that need to be defined.

4 General requirements

4.1 The quality and specifications of materials shall comply with the current national standards, industry standards or relevant technical conditions.

4.2 The performance of materials should meet the working conditions of pharmaceutical equipment (equipment category, material properties, level of pharmaceutical production environment, working temperature, etc.) degree, pressure, etc.) requirements.

4.3 The technological properties of materials should be suitable for the processing requirements of pharmaceutical equipment.

4.4 Materials that are in direct contact with materials or required process media should be non-toxic, corrosion-resistant, non-shedding, and not compatible with the drugs produced or those that require Chemical reaction or adsorption of the required process medium, effective control of insoluble particles, or release of substances into the drug may affect product quality and cause hazards It should be able to withstand the disinfection and sterilization treatment of high temperature steam or chemical gas. Its sterilization adaptability should meet the relevant requirements of GB/T 16886.1.

4.5 The materials of main pressure components in pressure equipment shall comply with GB/T 150.2, GB/T 24511, TSG21-2016 and other relevant standards. relevant provisions of the standards.

5 Material selection steps

5.1 Analyze and determine the main influencing factors and failure modes in the working conditions of pharmaceutical equipment.

5.2 Determine the main influencing factors and failure mode requirements for material performance.

---Category. metal, non-metal;