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

作　　者：咸富荣 XIAN Furong(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201203

出　　处：《上海医药》2024年第9期131-135,共5页Shanghai Medical & Pharmaceutical Journal

基　　金：国家药典委2019Y04药包材密封性完整性指导原则课题项目(2019Y04)。

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、10μm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1.4μm和1μm。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。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 mm 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 mm by the microbial ingress method,and 1 mm 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 

分 类 号：TB487[一般工业技术—包装工程]