Key Points Analysis of Functionality Evaluation Methods for Prefilled Syringe with Luer Conical Fitting
10.3870/j.issn.1004-0781.2025.04.007
- VernacularTitle:鲁尔接头预灌封注射器相关功能性评价方法要点解析
- Author:
Xiaohui YU
1
;
Wenli LI
;
Yiwei ZHAO
;
Bo ZHANG
;
Lei CHEN
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重点实验室,济南 250101
- Publication Type:Journal Article
- Keywords:
Prefilled syringe;
Luer conical fitting;
Functionality;
Evaluation methods
- From:
Herald of Medicine
2025;44(4):542-546
- CountryChina
- Language:Chinese
-
Abstract:
Objective To assist drug and pharmaceutical packaging material manufacturers in understanding and utilizing the functionality evaluation methods for prefilled syringe with Luer conical fittings,thereby scientifically specifying product quality.Methods By comparing the standards status both domestically and internationally,and in conjunction with the product characteristics,production,and actual usage situation of prefilled syringe with Luer conical fittings,the test contents and key points of related functionality evaluation methods were analyzed.Results The functionality evaluation methods for prefilled syringe with Luer conical fittings represent improvements and supplements to domestic standard,appropriate methods should be selected based on the product type.Conclusion Developing functionality evaluation methods for prefilled syringe with Luer conical fittings will provide guidance to standardized quality control for drug and pharmaceutical packaging material manufacturers.It will also better meet the requirements for market regulation,and is an effective way to promote the overall development of the industry.
