TY - JOUR T1 - Condensable Chemical Vapors for Sterilization of Freeze Dryers JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 83 LP - 88 VL - 50 IS - 2 AU - A. Bardat AU - R. Schmitthaeusler AU - E. Renzi Y1 - 1996/03/01 UR - http://journal.pda.org/content/50/2/83.abstract N2 - Sterilization of freeze dryers is usually performed by subjecting them to saturated steam under pressure by steam (121°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°C and under negative pressure. 106, 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. ER -