General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
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GB/T 42354-2023
Introduction
GB/T 42354-2023 Guidelines for the Selection of Pharmaceutical Machinery (Equipment) Materials is a national standard in China that provides guidance on the appropriate selection of materials used in pharmaceutical machinery and equipment.
This standard aims to ensure the quality and safety of pharmaceutical products by establishing requirements for the materials used in the manufacturing process. It covers a wide range of materials, including metals, polymers, ceramics, and composites, and provides guidelines for their selection based on factors such as chemical compatibility, mechanical properties, and cleanliness.
The standard also emphasizes the importance of compliance with relevant regulations and standards, both national and international, to guarantee the suitability of the selected materials for pharmaceutical applications. It provides information on testing methods and requirements for material performance evaluation, including tests for chemical resistance, durability, and cleanliness.
In addition, GB/T 42354-2023 highlights the need for proper documentation and traceability of materials used in pharmaceutical machinery and equipment. It requires manufacturers to provide detailed information about the materials used, including their composition, processing methods, and any potential risks associated with their use.
Overall, this standard serves as a valuable reference for pharmaceutical machinery manufacturers, suppliers, and users, ensuring the selection of appropriate materials that meet the highest quality and safety standards in the pharmaceutical industry.
GB/T 42354-2023 history
2023GB/T 42354-2023 Pharmaceutical machinery (equipment) material selection guidelines