Humidity Considerations For Cold Shelf Loading
Humidity Considerations For Cold Shelf Loading
3/2/2005
VertMarkets, Inc.
It is common practice during the production of a parenteral drug which is to eventually be freeze dried for the solution first to be formulated and the vials then filled at room temperature. Afterwards the vials are placed onto the shelves of the lyophilizer which are usually at or near room temperature. However, recent changes in Parenteral development processes such as quick freezing have lead to the need for loading pre-frozen product onto shelves which are much colder (-50?C or more) than the room?s ambient temperature. With this development has come the problem of condensation and even frost buildup on the lyophilizer cabinet and shelves and leads to several considerations.
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