Technical Points Analysis of Self-stability Study on Plastic and Rubber Pharmaceutical Packaging
10.3870/j.issn.1004-0781.2024.11.008
- VernacularTitle:塑料和橡胶类药包材自身稳定性研究技术要点解析
- Author:
Wenli LI
1
;
Jing ZHANG
;
Lili LIU
;
Lei CHEN
;
Kai XU
Author Information
1. 山东省医疗器械和药品包装检验研究院,国家药品监督管理局药品包装材料质量控制实验室,济南 250101
- Keywords:
Pharmaceutical packaging;
Plastic;
Rubber;
Self-stability
- From:
Herald of Medicine
2024;43(11):1750-1753
- CountryChina
- Language:Chinese
-
Abstract:
Objective The purpose,requirements,and techniques of self-stability research for plastic and rubber pharmaceutical packaging materials were analyzed to conduct more research on the self-stability of pharmaceutical packaging materials.Methods Based on the regulatory requirements for bundling review of drug products and pharmaceutical packaging,the existing technical guidelines for the self-stability study of pharmaceutical packaging,as well as associated literature globally,the technical points of self-stability study are discussed.Additionally,the potential changes of self-stability study in the future were also discussed under the most updated framework of guidelines for plastics and elastomers in Chinese Pharmacopeia,as well as the update of relevant ASTM standards.Results Self-stability research for plastic and rubber pharmaceutical packaging materials is a regulatory requirement,which is of great significance.The self-stability requirements may have the possibility of changes according to the update of the national pharmaceutical packaging standard system.Conclusion The study on the self-stability of plastic and rubber pharmaceutical packaging provides good practice in ensuring the safety,effectiveness,and quality controllability of drug products.
