Rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product. A description of industry applications of headspace moisture analysis including freeze drying cycle optimization, lyo chamber moisture distribution mapping, and 100% moisture inspection of commercial freeze-dried product.
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.
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.
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.
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 primary packaging configuration.
Rapid non-destructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.
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.
Application of the LIGHTHOUSE headspace method demonstrates how ability to quickly and accurately determine headspace oxygen levels saves time and enables deep insight into formulation stability. In addition using a non-destructive laser-based headspace analysis saves valuable product samples and avoids clean-up and contamination issues.
This Application 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.
This Application Note describes how laser-based headspace inspection detects vials having raised stopper issues. Data from ‘raised stopper vials’ is presented showing that quantifying the physical headspace conditions also enables science-based process troubleshooting and optimization.
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