Process Science

Robust process development is a key responsibility of any pilot plant and can enable quick and efficient scale-up to commercial manufacturing.

The rapid non-destructive headspace platforms from LIGHTHOUSE have revolutionized process studies by enabling the straightforward analysis of statistical samples sets, or even whole batches.

LIGHTHOUSE provides full insight into process quality and robustness and our automated headspace analysis platforms can be delivered within weeks for project-based process studies in which full batches are inspected..

 

Characterizing N2 Purging Systems for Liquid or Powder Filling Lines

It is critical to limit the exposure of sensitive formulations to oxygen. LIGHTHOUSE headspace analysis platforms can be set up at- or in-line to a filling line to monitor headspace oxygen levels and the performance of nitrogen purging during filling. Real-time feedback can be invaluable for optimizing and validating the N2 purging process.

As with all LIGHTHOUSE systems, the rapid nature of the measurement means statistical sample sets (and even full batches) can be quickly analyzed, and because the measurement method is nondestructive, there is no need to dispose of destroyed product samples.

Characterizing Freeze Dryers and Cappers for CCI

LIGHTHOUSE has characterized over 15 million commercial freezed dried pharmaceutical vials for container closure integrity (CCI) from sterile manufacturing facilities around the world.

Both the freeze drying and capping processes can introduce risk into the container closure integrity of sterile freeze dried product vials. Our container closure integrity inspection applications quantifies this risk and supports your pharmaceutical process development.

Characterizing Freeze Dryers for Moisture Distribution

The use of LIGHTHOUSE platforms for the non-destructive measurement of headspace moisture levels in lyophilized pharmaceutical product enables efficient and insightful lyophilization process studies.

Analyzing statistical sample sets, and even full batches, enables deep insight. This insight includes moisture mapping of the lyo chamber for freeze dryer qualification and full visibility into moisture variability within a batch for lyo cycle optimization and validation.

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Wherever you need support optimizing product and process quality throughout the product lifecycle, LIGHTHOUSE experts are available for you.

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