Lyophilised factor VIII cryo:precipitate prodn. - using freeze drying appts. equipped for pasteurisation by direct expansion

摘要

Prodn. of lyophilised factor VIII) cryoprecipitate is effected in a specially designed freeze drying appts. in which the heat required to pasteurise the freeze-dried prod. is generated by direct expansion. The drying chamber is evacuated to 5-50 microns and the shelf temp. is maintained within +/- deg.C of the eutectic point using a combination of three condensing units. When drying is complete, sterile N2 is admitted into the chamber and condensing unit 3 is actuated to bring the system into pasteurisation mode, the temp. being increased to 70 deg.C over a programmed time period.