ANALYTICAL SERVICES

Lab Testing

With over a decade of experience, our laboratories located in Amsterdam, The Netherlands and Charlottesville, VA, US serve clients all over the world to generate data to deliver better and safer drugs to patients.
Explore LIGHTHOUSE Lab Testing Services in Charlottesville and Amsterdam

  • LIGHTHOUSE Analytical Services is an extension of your analytical laboratory allowing you to take full advantage of our laser-based headspace platforms in the format that works best for you.
  • Good science is what we do. Our scientists use our equipment and application knowledge to develop innovative science-based solutions that become best practice in the global pharmaceutical industry.
  • Our Laboratory in Amsterdam has implemented Good Manufacturing Practices (GMPs) and is planning to get inspected by the Dutch Regulator at the end of 2024!

Other equipment installed in our labs...

  • Residual Seal Force Tester
  • Automatic vial crimping platform
  • Storage temperatures ranging from -190C to +40C

Method development and validation

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.

Primary packaging studies

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.

Process studies

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.

  • Characterize, optimize and validate your nitrogen purging line for oxygen sensitive products
  • Freeze dryer set-up and qualification
  • Freeze dryer moisture mapping
  • Seal process studies

 

Qualification of Raised Stopper Limits

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.

 

A row of transparent plastic syringes with grey caps, aligned on a white surface in a well-lit room, ready for lab testing and headspace analysis.

Stability studies

LIGHTHOUSE Analytical Services offers stability studies in many of our applications:

  • Maintenance of container closure integrity (CCI) over shelf life under various storage conditions.
  • Headspace oxygen consumption of oxidizing formulations over shelf life
  • Product degradation due to moisture in lyophilized products
  • Water activity of tablets, pill or capsules
A person in a lab coat and blue gloves holds a small vial containing a white substance, conducting headspace analysis to ensure accurate lab testing.

Cold storage and transport studies

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.

 

Batch testing and batch investigations

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.

Analytical Lab Services

Analytical Lab Services