Abstract
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.
- Received January 16, 1995.
- Accepted July 24, 1995.
- Copyright © Parenteral Drug Association. All rights reserved.
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