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.
An overview of integrity tests where a high sensitivity are required to prevent the risks of stability failure of highly moisture sensitive drugs (e.g. dry powder for inhalation) or the risk of biological ingress of sterile parenteral drugs.
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.
Vacuum decay is a test method that has been proven over decades and improved with new technology innovations. 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.