Ima Life North America Inc.

David Debo

Ernesto Renzi

Francis W Demarco

Jozef A W M Corver

Arnab Ganguly

Carlo J J M De Best

Francis W DeMarco

A freeze dryer processes aseptic bulk powder products. The freeze dryer freezes the product by mixing an atomized spray of product with sterile liquid nitrogen to produce a frozen powder. The frozen powder is freeze dried in a vessel by dielectrically heating the frozen powder using electromagnetic radiation such as microwave radiation or infrared radiation, and the frozen powder is continuously agitated using a sterilizable apparatus such as a series of vibrating shelves to maintain even heating and to prevent agglomeration.

Bulk freeze drying using spray freezing and agitated drying with dielectric heating

Parameters of a freeze drying process are monitored by measuring trace materials in the vacuum pump exhaust. The measurements are made using techniques such as acousto-optic spectrometry, multipass cavity-enhanced absorption spectrometry (CEAS) and cavity ring-down spectrometry (CRDS). The technique may be used to diagnose problems such as leakage in the freeze drying shelves, leakage in the condensation coils, leaks from atmosphere in the chambers and the presence of residual cleaning materials. The technique may also be used to monitor the presence of water vapor in the exhaust of a secondary drying process.

Monitoring freeze drying with gas measurement on vacuum pump exhaust

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Batavia, NY, United States of America

David Debo