Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.
Vacuum decay is a test method that has been proven over decades and improved with new technology innovations. The test method is simple in principle and challenges container integrity based on fundamental physical properties. It involves drawing vacuum on a package within a test chamber and monitoring the vacuum level for any decay, which would indicate a leak. The method established itself as a non-destructive replacement to the water bath leak test. It provides significant savings by not wasting product for a leak test, and generates return on investment in under six months for many products.
New product types and packaging configurations, such as highly viscous formulations, pose a threat to traditional leak-testing methods, challenging current practices for container closure integrity testing.
A non-invasive, non-subjective solution that is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system.
This technical report describes a study to evaluate binding affinity of Control Standard Endotoxin (CSE) to different plastic sample collection containers.
This study shows that HVLD can detect leaks down to the Maximum Allowable Leakage Limit (MALL) and arguably makes it one of the most sensitive leak test methods in the market.
The study addresses the common concern that vacuum decay is not a suitable test solution for detecting microleaks in parenteral containers if the product contains large molecule or proteinaceous liquids.