Lighthouse Application Notes

1. Correlating Stopper Height To Container Closure Integrity 11/21/2023

   Learn how to comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.

2. Collaborative Automated Sample Handler For Headspace Analyzers 8/17/2023

   Discover a collaborative automated sample handler that eliminates manual sample handling, enabling groups to test larger sample sets and collect statistically significant data while freeing up analysts’ time.

3. Headspace Moisture Analysis For Determination Of Residual Moisture Content In Lyophilized Pharmaceutical Products 8/24/2021

   Here, we describe how rapid non-destructive headspace moisture determination enables the generation of insightful data for product life cycle activities.

4. Container Closure Integrity Of Product Requiring Deep Cold Storage At -80°C 7/23/2020

   If CCI is lost during -80°C storage, non-sterile, cold, dense gas from the storage environment (i.e. air from a -80°C freezer or carbon dioxide from dry ice) can leak into the stored vial. It is therefore critical that robust development work is done to understand the CCI performance of any primary packaging components used for product needing deep cold storage and transport temperatures.

5. Formulation Development: Determining Oxygen Sensitivity 6/3/2020

   Pharmaceutical formulations, especially delicate large molecule biopharmaceuticals, may have some level of oxygen-sensitivity leading to degradation of the active pharmaceutical ingredient. Laser-based headspace oxygen analysis enables accurate, efficient determination of oxygen consumption curves. Accurate measurement of the oxidation rate supports the determination of headspace oxygen specifications and end-of-shelf life stability.

6. Non-Invasive Headspace Analysis For Automated Media Fill Microbial Inspection 12/28/2018

   Laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product allows for quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods.

7. Headspace Oxygen Monitoring On A Pre-filled Syringe Line Filling Oxygen-Sensitive Product 12/28/2018

   This application note describes how laser-based headspace analysis is used for the rapid non-destructive determination of headspace oxygen levels in pre-filled syringes. Data is presented demonstrating two major applications of this technique: 1) headspace oxygen monitoring on a pre-filled syringe line filling oxygen-sensitive product, and 2) container closure testing of pre-filled syringes.

8. Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product 12/27/2018

   This app note describes the application of the PULSAR inspection platform to perform 100% headspace oxygen monitoring during the filling of oxygen-sensitive formulations, 100% container closure inspection of suspect batches, moisture inspection of freeze dried product, and automated media fill inspection.

9. Nitrogen Purge Optimization And Validation Of Sterile Liquid Filling Lines 12/27/2018

   Large molecule biopharmaceuticals can be prone to oxidation and to prevent this from occurring, the headspace is often purged with an inert gas during filling to ensure a longer shelf life.

10. In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers 12/27/2018

    Using a high sensitivity detection technique known as Frequency Modulation Spectroscopy (FMS), LIGHTHOUSE rapid non-destructive headspace oxygen inspection can help streamline the monitoring of purge performance on the filling line. This paper demonstrates the correlation of the FMS rapid non-destructive technique for analyzing headspace oxygen levels with the most commonly used conventional destructive techniques for headspace oxygen inspection.