Lighthouse Case Studies

1. Moisture Headspace Analysis For Efficient Scaleup Of Freeze Drying Capacity And Validation 10/21/2020

   A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations. Activity involved a scale up of freeze-drying capacity from 14 m2 to 28 m2. With the application of non-destructive feadspace moisture analysis small scale proof of concept studies were used to minimize project risk and the number of full-scale runs in the freeze-drying validation process.

2. Ensuring Container Closure Integrity Of A Gene Therapy Cancer Vaccine Needing Deep Cold Storage 7/22/2020

   A gene therapy clinical trial was halted due to CCI issues in deep cold storage. A CCI test method was developed that enabled non-destructive CCI testing of product vials at these cold temperatures. The capability to non-destructively test clinical product in deep cold storage enabled troubleshooting studies leading to corrective actions that assured good CCI.

3. Quality Stability Testing: Oxygen Monitoring During Shelf Life 6/3/2020

   A manufacturer of a syringe product received complaints about discolored product that was nearing the end of shelf life. A root cause investigation was started and product syringes were put on stability. The headspace oxygen levels were monitored over time. The laser-based headspace analysis proved to be a useful tool to check package integrity and for the presence of reactive headspace gases that can degrade the formulation.

4. Filling Line Nitrogen Purge Qualification In Manufacturing 6/3/2020

   A client had an existing filling line and wanted to optimize the nitrogen purge process to decrease headspace oxygen levels to 2%. In addition, frequent line stoppages resulted in a need to identify and reject high oxygen vials that had lost the nitrogen headspace during the stoppage. A purging process qualification study was performed using rapid non-destructive headspace oxygen analysis in an at-line set-up with samples being measured immediately from the line.

5. CCI Test Method Validation For Pre-Filled Syringes 3/18/2020

   Regulators are paying closer attention to the proper design of robust Container Closure Integrity (CCI) studies and the validation of CCI test methods. 

6. Verifying Vacuum Maintenance While Preserving The Product Sample 3/28/2019

   Vacuum in finished sterile product containers is critical for certain pharmaceutical formulations to ensure proper reconstitution before administration to the patient, or to prevent interactions between the formulation and headspace gas. A loss of vacuum can be a clear indicator of a container closure integrity defect or an issue with the original sealing process. Using a LIGHTHOUSE headspace analysis platform for non-destructive headspace pressure determination verifies the maintenance of vacuum while preserving the product sample.

7. Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage 12/28/2018

   A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.

8. Determination Of Moisture Permeation During Product Shelf Life 12/27/2018

   How non-destructive headspace analysis information can be critical for QC groups performing stability studies, or for packaging development groups responsible for choosing the optimal packaging.

9. Lyo Chamber Moisture Mapping 12/27/2018

   Rapid non-destructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.

10. Root Cause Investigation Into A Possible Container Closure Integrity Failure 12/27/2018

    In cases where oxidation of the formulation causes discoloration and eventual degradation of the product, non-destructive headspace analysis tests can give deep insight into the root cause. Since the samples are not destroyed by the headspace analysis, further testing can be done to accurately correlate headspace conditions with other product characteristics.