PAT Supportive Solutions

FDA’s PAT (Process Analytical Technology) initiative
The goal of PAT is to understand and control the manufacturing process, which is consistent with our current drug quality system. Quality cannot be tested into products; ”it should be built-in or should be by design.”

IMA EDWARDS’ strategic R&D plan is to develop, engineer and market products for manufacturing problems that do not have a solution yet; i.e generate products that support the FDA’s PAT initiative.
Two systems are currently being developed:

NCCW: Non-contact inspection for in-line, high speed and 100% inspection of critical product parameters.
NMR for weight checking. Liquid application is validated—solid application is currently being validated.

LYOFLUX: Mass flux equipment for in-line measurement of the vapor flow during the freeze drying cycle.
Laser spectroscopy to measure the mass flux of the vapor transferred between chamber and condenser is currently being developed.