Process analytical technology for lyophilization
Maintaining the purity and quality of pharmaceutical products like parenterals during freeze drying can be challenging due to potential contamination with process fluids. Detecting small silicone oil leaks and accurately monitoring moisture content is essential to ensure product safety.
Monitor moisture and detect leaks during freeze drying
The LYOPLUS® by GEA is a specialized mass spectrometer designed for freeze drying applications. It provides essential data from within the freeze dryer, including the detection of very small silicone oil leaks and monitoring moisture content. The system analyzes the gas mix inside the freeze dryer, distinguishing substances like water, solvents, nitrogen, oxygen, and helium. Its advanced software enables the collection and evaluation of measurement data that would be difficult with ordinary equipment. The LYOPLUS® system improves freeze dryer integrity, enhances productivity, and provides a better understanding of the freeze drying process. The system can be implemented into any existing automation environment or operated as a standalone unit, ensuring flexibility and integration with existing systems. It is compliant with 21 CFR Part 11, includes alarms for high silicone oil concentration, and has a multilingual graphical user interface.
Benefits
- Early detection of impurities prevents product contamination
- Provides valuable data for refining drying recipes
- Fully automated for integration into pharmaceutical production
- Enhanced productivity through quick detection times
- Easy integration with existing automation systems