Investigation and Analysis on the Evaluation of Heat Resistance,Freezing Resistance,and Thermal Stability of Glass Containers for Pharmaceutical Packaging
10.3870/j.issn.1004-0781.2024.12.022
- VernacularTitle:药品包装用玻璃容器耐热性和耐冷冻性及热稳定性评价调研分析
- Author:
Ying LI
1
;
Guang YIN
;
Xia ZHAO
Author Information
1. 中国食品药品检定研究院,北京 100050
- Keywords:
Glass containers for pharmaceutical packaging;
Heat resistance;
Freezing resistance;
Thermal stability
- From:
Herald of Medicine
2024;43(12):2009-2013
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a more scientific and reasonable evaluation method for the heat resistance,freezing resistance,and thermal stability of glass containers for pharmaceutical packaging to meet the regulatory needs of drugs in the new situation.Methods A survey was conducted on domestic injection production enterprises in the form of a questionnaire,including the process parameters of cleaning for glass containers for pharmaceutical packaging,terminal sterilization during injection production,and the freeze-drying process flow of freeze-dried formulations.Results The parameters of dry heat sterilization,freeze-drying,and moist heat sterilization used in actual production of injections vary widely,and evaluation through laboratory simulation under single conditions lacks scientific and practical applicability.Conclusions In order to implement the construction of the new standard system for glass packaging materials in 2025 edition of the Chinese Pharmacopoeia,through this investigation,the actual production process parameters of drugs were shown,and it is proposed that specific experimental conditions for heat resistance,freezing resistance,and thermal stability will no longer be limited in the new standard system for use.Suitable experimental conditions can be set by enterprises based on their actual process to evaluate performance.
