高压放电法和微生物挑战法(浸没式)测试西林瓶包装系统密封性
High-voltage leak detection and microbial challenge method(microbial ingress method)for testing the package integrity of injection vials
咸富荣1
作者信息
- 1. 上海市食品药品包装材料测试所 上海 201203
- 折叠
摘要
目的:建立高压放电法和微生物挑战法(浸没式)以测试西林瓶包装系统密封性.方法:采用高压放电法及微生物挑战法(浸没式)检测西林瓶包装系统密封性.结果:微生物挑战法(浸没式)对 1、3、5、10 μm孔径的激光打孔阳性样品的阳性检出率分别为 0%、30%、60%、70%,而高压放电法均为 100%;微生物挑战法(浸没式)阳性率灵敏度和高压放电法灵敏度(检测限)分别为 1.4 μm和 1 μm.后者优于前者.结论:高压放电法及微生物挑战法(浸没式)均可用于评估西林瓶包装系统的密封性.
Abstract
Objective:To establish high-voltage leak detection and microbiological challenge test(microbial ingress method)to determine the package integrity of the injection vial.Methods:The package integrity of the injection vial was determined using the high-voltage leak detection and microbiological challenge test(microbial ingress method).Results:The positive detection rates of 1,3,5 and 10 μm laser-bored hole samples were 0%,30%,60%and 70%by microbiological challenge test(microbial ingress method),respectively and 100%by high-voltage leak detection method.The sensitivity of positive rate was 1.4 μm by the microbial ingress method,and 1 μm by the high-voltage leak detection,and the later was higher than the former.Conclusion:Both the high-voltage leak detection and microbiological challenge test(microbial ingress method)can be used to evaluate the container closure integrity of injection vials.
关键词
高压放电法/微生物挑战法(浸没式)/西林瓶/包装系统密封性Key words
high-voltage leak detection/microbiological challenge test(microbial ingress method)/injection vials/package integrity引用本文复制引用
基金项目
国家药典委Y04药包材密封性完整性指导原则课题(2019)(2019Y04)
出版年
2024
NETL
NSTL
万方数据