Quality Control and Reasonable Selection of Rubber Closures for Pharmaceutical Packaging
10.3870/j.issn.1004-0781.2024.11.007
- VernacularTitle:药品包装用橡胶密封件的质量控制与合理选用
- Author:
Jun XU
1
;
Wanling LAN
;
Yaju ZHOU
;
Meicheng YANG
;
Lei CHEN
Author Information
1. 上海市食品药品包装材料测试所,上海 201203
- Keywords:
Pharmaceutical packaging;
Rubber closure;
Quality control;
Reasonable selection
- From:
Herald of Medicine
2024;43(11):1745-1749
- CountryChina
- Language:Chinese
-
Abstract:
Objective To enhance the understanding of the quality control of rubber closures and to promote pharmaceutical manufacturers'reasonable selection and effective management of rubber closures.Methods According to the performance needs of drug products for rubber closures,the impacts of the ingredients and manufacturing processes of rubber closures with other possible influence on drug products were analyzed.Complied with the requirements of pharmaceutical lifecycle management,the processes of selection and utilization of rubber closures were divided into three periods,including screening,validation and maintenance,and suggestions on the tasks and goals for these three periods were given.Results Though the actual performance of rubber closures was affected by multiple factors,the processability in the pharmaceutical manufacturing processes and the suitability in the periods of storage,transportation and clinical application could be confirmed by reasonable screening and scientific validation of rubber closures.And by the effective quality control of rubber closures,the suitability could be maintained across the lifecycle of drug products.Conclusion By means of the reasonable selection and effective quality control of rubber closures,it would be benefit for keeping drug safety,efficacy and quality controllability throughout the lifecycle.
