Process Monitoring in Pharmaceutical Lyophilization

Many pharmaceutical manufacturing facilities use indirect measurement tools like Pirani or capacitance manometers to monitor the freeze-drying process. While these gauges provide some insight into the overall pressure within the chamber, residual gas analysis (RGA) offers a more comprehensive understanding of the gas composition and can detect trace contaminants. By continuously analyzing the composition of residual gases during freeze-drying, an RGA provides real-time insights into key process variables, including leak detection, endpoint determination, monitoring contaminants and leaks (such as O₂), sterilization/cleaning operations (like H₂O₂), active pharmaceutical ingredient (API) or formulation decomposition, and product meltback or collapse.

To learn more about RGA in pharmaceutical lyophilization and see experimental data from the LyoHUB demonstration facility, download the App Note HERE.

Monitoring Decomposition of Thermally Sensitive Materials during Pharmaceutical Freeze-Drying

Historically, quadrupole mass spectrometry has been used in pharmaceutical freeze-drying to detect leaks and evaluate cycle endpoints. Recently, this technique has become valuable for cycle development and optimizing sensitive formulations. This application note describes how the INFICON Transpector CPM 3 was used to investigate ammonia salt decomposition during freeze-drying. Ammonia and water vapor have overlapping spectra near the principal peak, making it difficult to identify individual species. The high sensitivity and performance of the INFICON Transpector RGA allow off-principal and unique m/z traces to be monitored with high precision leading to the development of stable and effective formulations at the highest speed possible. To learn more about monitoring decomposition of thermally sensitive materials during pharmaceutical lyophilization and see experimental data from the LyoHUB demonstration facility, download the App Note HERE.