LIGHTHOUSE provides support for analytical method development. Our Application Scientists have expertise in developing CCI, headspace oxygen and water activity testing methods based on headspace analysis.
After method development, we provide method validation documentation and on-site support for seamless protocol execution.
Selecting the right packaging material is crucial for your product. Can your primary packing serve as a oxygen or moisture barrier? Can it assure CCI? Let LIGHTHOUSE perform your packaging studies now, so there are no surprises in the future.
Do you understand the influence of the (packaging) process on your final product? LIGHTHOUSE Analytical Services offers lab and onsite services to assess your process.
EU GMP Annex 1 [8.28]: “… Appropriately qualified, automated methods for stopper height detection should be in place.”
LIGHTHOUSE Analytical Service can determine at what stopper height displacement there is a risk of container closure integrity failure. The data serves as a solid, science-based foundation of establishing the limits of the stopper height sensor. Using headspace analysis as a closure integrity test method enables justification of the set parameters, thereby safeguarding the product quality.
LIGHTHOUSE Analytical Services offers stability studies in many of our applications:
LIGHTHOUSE Analytical Services offers testing to generate appropriate product life cycle packaging data for products requiring cold storage. EU Annex 1 Section 8.25, specifically states:
‘The container closure integrity validation should take into consideration any transportation or shipping requirements that may negatively impact the integrity of the container (e.g. by decompression or extreme temperatures).’
Studies performed at LIGHTHOUSE enables meeting recent regulatory requirements by generating robust packaging data.
LIGHTHOUSE Analytical Services is your partner for outsourced routine CCI testing. Urgent batch investigation for batches in quarantine is also one of our specialties. Our LIGHTHOUSE experts have delivered results in no time, testing products either in the lab or at the client’ site. Our experts can come onsite with the required equipment and perform the testing for you.