Lighthouse Case Studies

1. Nitrogen Purging Process Development For Oxygen Sensitive Formulations In Pre-Filled Syringes 6/22/2021

   A new biological product, in pre-filled glass syringes, had demonstrated oxygen sensitivity in stability studies. Therefore, the headspace was purged with nitrogen during filling, and the client wanted to validate the batch production process and assess the nitrogen purge efficiency. In this study we demonstrate by performing a 100% inspection on the engineering batches using non-destructive headspace oxygen analysis you could gather the data needed before a commercial launch.

2. Oxygen Sensitive Product: Comparing Oxygen Testing Methods 3/7/2021

   The accurate determination of oxygen concentration as a critical quality parameter for oxygen-sensitive products is important across the product life cycle activities. Traditional methods for determining headspace oxygen levels in parenteral containers, such as electrochemical methods or gas chromatography, are slow and destructive. This article describes several case studies comparing non-destructive laser-based oxygen headspace analysis with electrochemical oxygen analysis and gas chromatography.

3. Generating Robust Residual Seal Force-CCI Correlation Data To Ensure CCI Of Vials Requiring Deep Cold Storage 3/3/2021

   The increased implementation of deterministic analytical methods for container closure integrity (CCI) testing has enabled deeper insight into the performance of primary packaging with respect to CCI. However, ensuring good CCI of sterile injectable product goes beyond CCI testing during the product life cycle. This case study describes how packaging development and process study data of a pharmaceutical vial product requiring deep cold storage can be combined in a holistic approach.

4. 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 headspace 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.

5. 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.

6. 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.

7. 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.

8. 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. 

9. 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.

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

    A vaccine-focused biotechnology company needed assistance to 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 they needed to identify the root cause.