title: Moisture measurement: a new method for monitoring freeze-drying cycles.
abstract: Quality of the final product largely depends on the freeze-drying process. In turn this largely depends on an adequate control of the amount of residual moisture after freeze-drying. Measuring this amount in the chamber of the freeze-dryer to determine the end point of sublimation and the end point of secondary drying provides a reliable control with regard to the methods traditionally used (for example rapid increase in product temperature). The purpose of this study is to evaluate the benefits and disadvantages of the different methods recommended for the monitoring of a freeze-drying cycle. Two systems for the measurement of the moisture in the freeze dryer are evaluated here: the Pirani vacuum gauge, and the moisture sensor. The moisture sensor appears to be the most sensitive and reliable way of determining both the end of sublimation and the end of secondary drying of the full load batch when placed on a freeze-dryer. The immediate benefit for the industry is to allow to scale-up without the risks of under or over estimating the freeze-drying cycle.
authors.affiliation: Centre National de Transfusion Sanguine, Les Ulis, France.
authors.forename: A
authors.initials: A
authors.lastname: Bardat
authors.forename: J
authors.initials: J
authors.lastname: Biguet
authors.forename: E
authors.initials: E
authors.lastname: Chatenet
authors.forename: F
authors.initials: F
authors.lastname: Courteille
mesh_terms: D004867:Equipment Design; D005612:Freeze Drying / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D011312:Pressure; D011786:Quality Control; D012680:Sensitivity and Specificity; D014867:Water / Q000032:analysis
chemical_list: D014867:Water