Research Strategy of Testing Package Integrity by Vacuum Decay Method
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.
vacuum decay methodpackage integritymethod development and validationsensitivity
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