T/CNPPA 3018-2021 Active Group standards

T/CNPPA 3018-2021 Medicinal glass container classification and application guidelines

Publish Date: 2021-08-02 Implement Date: 2021-08-02 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CNPPA 3018-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: \nLogo, packaging, transportation, storage

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2021-08-02

Implement Date: 2021-08-02

Scope

Main technical content: Pharmaceutical glass containers are commonly used packaging containers that directly contact drugs. This document comprehensively considers the characteristics of pharmaceutical glass, its development trends, and the factors affecting drug quality. It selects five classification methods for pharmaceutical glass containers based on material, performance, molding process, surface treatment after molding, and shape, etc. These classification methods and corresponding application scenarios are based on existing products and knowledge, and may have limitations and irrationalities. They will be adjusted accordingly with the development of technology and industry. This document aims to provide theoretical basis and references for promoting the R&D of pharmaceutical glass products, advancing production technology, and meeting new application needs. When pharmaceutical glass manufacturers design, develop, and name new products and formulate product standards based on this document, they should fully understand and pay attention to the types, characteristics, and requirements of drugs. When pharmaceutical companies select pharmaceutical glass containers through this document, they should comprehensively consider the classification and application of various pharmaceutical glass containers based on the characteristics of drugs, drug production processes, and drug dosage forms, and select suitable product types. While conducting necessary compatibility studies, they should also pay attention to product quality stability and uniformity, such as the fluctuation range of indicators such as the linear thermal expansion coefficient of glass and the content of boron trioxide. After selecting glass containers, pharmaceutical companies should sign quality agreements with pharmaceutical glass manufacturers, which generally include: --- the content of quality audits; --- product standards (including appearance defects, geometric shape, size and deviation, physical