The goal of the FDA's Process Analytical Technology (PAT) initiative is to understand and better control the manufacturing process. Quality cannot be tested into products...it should be built-in or should be by design.
IMA LIFE Freeze drying solutions is committed to research and engineer in-house and in partnership with specialist technology providers and customers to develop solutions aligned with the PAT initiative: pharmaceutical and biological drugs which are produced through safe, consistent, repeatable, reproducible processes.
Mass flux equipment monitor for in-line measurement of the vapour flow between chamber and condenser during the freeze drying cycle using laser spectroscopy. Enables more rapid technology transfer and enhanced product time-to-market.
The laboratory facilities and equipment, including Lyoflux, as well as the on-site experts can offer customized cycle development studies with the ultimate goal to optimize the freeze drying process.
Process Monitoring & Control
IMA LIFE Freeze drying solutions has developed a non-contact inspection for in-line, high speed and 100% inspection of critical product parameters. NMR based weight checking for liquid applications (already validated), and solid application (being validated).