Container Closure Integrity Testing Services

The USP <1207> Sterile Product Packaging-Integrity Test chapter revises the test methods recommended for use to detect leaks or loss of integrity in sterile pharmaceutical product containers. In this chapter, traditional microbial immersion and dye ingress methods are classified as probabilistic methods which require a series of sequential events with random outcomes to qualitatively determine if a package has leaked. Due to the risk of false negatives, these probabilistic methods require that both positive and negative controls are used for every measurement test session. The recommendations in the chapter describe and recommend the use of deterministic methods, which predictably and quantitatively measure a physical or chemical endpoint to determine the closure integrity of a container. Laser-based headspace analysis is described as a non-destructive deterministic method that uses laser spectroscopy to detect gas flow through a container defect. Having introduced this method into the pharmaceutical industry, LIGHTHOUSE offers both equipment and measurement services for container closure integrity testing. LIGHTHOUSE supports customers who are preparing to implement deterministic CCI testing methods. Services for CCI Testing include scientific feasiblity studies, test method development, and equipment lease for on-site testing activities.