Regulators recommend the use of deterministic methods to detect leaks or loss of integrity in sterile pharmaceutical product containers. Deterministic methods, like headspace analysis, predictably and quantitatively measure a physical or chemical endpoint to determine the closure integrity of a container.
Having introduced laser-based headspace analysis 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.
The Product Note describes the CCI testing measurement services offered.
Click here to download.