Lyophilization process optimization sensors
In the biopharmaceutical industry, optimizing the lyophilization process is crucial for maintaining product quality and sterility. Accurate monitoring of water vapor mass flow, temperature, and resistance during freeze-drying can help avoid time-consuming manual processes and improve overall efficiency.
Monitor water vapor mass flow accurately
The LyoFlux® 200 TDLAS (Tunable Diode Laser Absorption Spectroscopy) sensor by SP Scientific is a near-infrared (NIR)-based PAT tool designed to enhance and streamline your lyophilization process. This innovative sensor provides real-time, continuous monitoring of critical product attributes like temperature and resistance to vapor flow. Its non-invasive design ensures that product sterility is not compromised, making it ideal for aseptic environments. The LyoFlux 200 TDLAS is suitable for laboratory, pilot, and production scale lyophilization, offering features such as highly sensitive end-point determination for primary and secondary drying, continuous mass balance calculation, and assessment of heat transfer coefficients (Kv) of vials. It simplifies scale-up by determining these coefficients in a single experiment, thus eliminating the need for manual processes. The integration of this technology contributes to improved product quality through a Quality by Design (QbD) approach.
Benefits
- Real-time, continuous monitoring of product attributes
- Maintains aseptic conditions with non-invasive measurements
- Simplifies scale-up with single-experiment Kv determination
- Improves product quality via a QbD approach
- Applicable across laboratory to production scale lyophilization