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From: kidl9/14/2018 10:42:05 AM
   of 49402
 
EnWave ships first nine kw REV freeze-dryer

2018-09-12 10:58 ET - News Release

Mr. Brent Charleton reports

ENWAVE ANNOUNCES SHIPMENT OF A PHARMACEUTICAL RADIANT ENERGY VACUUM FREEZE-DRYER FOR MERCK

EnWave Corp. has completed factory acceptance testing and has shipped its first nine-kilowatt Current Good Manufacturing Practice (cGMP) Radiant Energy Vacuum pharmaceutical freeze-dryer designed for Merck, known as MSD outside the United States and Canada. The pharmaceutical REV machine is designed to meet cGMP standards and to rapidly freeze-dry vials containing pharmaceutical products.

Successful completion of factory acceptance testing demonstrates that REV freeze-drying technology met certain throughput and capacity specifications, designated by Merck.

The successful completion of the factory acceptance testing with Merck marks a significant milestone in the scaled-up commercialization of EnWave's proprietary REV technology in the pharmaceutical sector. Following installation, the equipment will undergo site acceptance testing prior to potential processing of pharmaceutical products using the technology.

Continuous processing of discrete dosage units of pharmaceutical products is sought by the pharmaceutical industry as it seeks more flexible and adaptable manufacturing processes. REV freeze-drying provides a potential continuous drying platform to rapidly dry vaccines, monoclonal antibodies, therapeutic proteins, probiotics, enzymes and small molecule therapeutics.
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