PAT SUPPORTIVE SOLUTIONS

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.

Lyoflux

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.

Process Optimisation

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).