真空衰减法包装系统密封性研究策略

Research Strategy of Testing Package Integrity by Vacuum Decay Method

在药品整个产品生命周期中必须保持包装的容器密封完整性,以确保无菌性和稳定性。真空衰减法作为无损的确定性包装系统密封性检查方法,已广泛应用于包装的选择、生产、组装以及产品生产、货架期稳定性评估等。文章介绍了真空衰减法的基本原理,分析了该方法的优缺点及选择依据,根据相关指导原则和审评要求总结了方法开发及验证的关键因素,改善分析方法的灵敏度,旨在为制药行业提供可靠的包装系统密封性检查方法。

The container closure integrity of a pharmaceutical package must be maintained throughout the product life-cycle to ensure sterility and stability.The vacuum decay method has been extensively applied as a nondestructive,deterministic package integrity test approach for package selection,processing and assembly,product manufacturing and shelf-life stability assessments.This article introduces the basic principles of vacuum decay method,analyzes the advantages,disadvantages and selection basis of this method.According to relevant guidelines and review requirements,it summarizes the key factors for method development and validation,and improves the sensitivity of the analytical method.This article aims to provide reliable package integrity test method for pharmaceutical industry.