LIGHTHOUSE’s commitment to quality helps to resolve issues during any recalls or investigations.
LIGHTHOUSE has helped sterile pharmaceutical manufacturers worldwide investigate out-of-specification results, customer complaints, and batch recalls for CCI, oxygen, moisture, and other related issues. Our drive to provide the highest quality, non-destructive instruments give you the peace of mind that you do not have to discard an entire batch of product because of a few defective samples. Our analysis of 100% of the batch helps you identify the root cause of a quality issue.
If you have batches of quarantined or recalled product or issues related to CCI, oxygen or moisture, call LIGHTHOUSE, we have dealt with it before.
Out of Specification Results
LIGHTHOUSE provides services and equipment designed to assist you in rapidly identifying the root cause of process upsets. Whether product is under quarantine or recalled from the market we can quickly have benchtop and automated equipment on-site to assess many of the quality parameters including headspace gas composition, headspace gas concentrations and vacuum level.
LIGHTHOUSE’s non-destructive and non-invasive measurement enables monitoring a single sample over the product’s shelf life and through different storage and/or transport conditions. As a result, customer complaints can be investigated to better understand quality issues.
LIGHTHOUSE laser-based headspace inspection enables rapid automated in-line leak detection by monitoring changes in headspace gas composition or changes in total headspace pressure.
Our machinery is designed to assist you with any batch rework due to loss of container closure integrity (CCI) which can occur due to component defects (cracks in glass, out-of-specification vial/stopper dimensions or improper vial/stopper combinations) or process defects (displaced stoppers prior to capping, misaligned tooling, rough handling).