Comparison of Domestic and International Standards for Prefilled Syringes
10.3870/j.issn.1004-0781.2025.04.004
- VernacularTitle:预灌封注射器国内外标准的比较
- Author:
Xiaowen BO
1
;
Guangyu SUN
;
Aijuan LIU
;
Yong SHEN
;
Min 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;
YBB standard;
ISO standard;
United States Pharmacopoeia,United States Pharmacopoeia(USP)
- From:
Herald of Medicine
2025;44(4):527-531
- CountryChina
- Language:Chinese
-
Abstract:
Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system.Methods A thorough review of the framework,scope,and quality control key points of the 2015 national pharmaceutical packaging material standards(abbreviated as YBB standards),the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted.Comparative analysis was employed to reveal the similarities and differences among the three,thereby uncovering the unique characteristics of each.Results The YBB standards emphasize quality control for prefilled syringes,offering clear and operational guidelines that provide companies with precise directives for production and testing.However,the scope of these standards is relatively limited.ISO standards apply to a wide range of products,featuring comprehensive coverage and a degree of flexibility.They emphasize the universality of products and compatibility with other international standards,which facilitates global production and trade.USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach.Conclusion By thoroughly studying and drawing upon the quality control philosophies,standard frameworks,and key control points of prefilled syringes from both domestic and international standards,we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.
