Condensable chemical vapors for sterilization of freeze dryers.
Sterilization of freeze dryers is usually performed by subjecting them to saturated steam under pressure by steam (121 degrees C, 2 bar a., 30 minutes). In order to avoid such stressful conditions, another process was designed on the basis of a strong oxidizing mixture of condensable chemical vapors, consisting of ozone and hydrogen peroxide in acidic conditions. This process works at sub-zero temperatures up to 30 degrees C and under negative pressure. 10(6), inoculum of standard biological indicators as well as wild types of bioburden were easely sterilized from 2 minutes up to 10 minutes. Other parameters were studied, in order to optimize the main process conditions: temperature, pressure, concentration of chemicals, type of micro-organisms and their environmental surroundings.
Bardat
A
A
Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis, France.
Schmitthaeusler
R
R
Renzi
E
E
D005612:Freeze Drying; D013242:Sterilization; D014835:Volatilization