PT  - JOURNAL ARTICLE
AU  - Bardat, A.
AU  - Schmitthaeusler, R.
AU  - Renzi, E.
TI  - Condensable Chemical Vapors for Sterilization of Freeze Dryers
DP  - 1996 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 83--88
VI  - 50
IP  - 2
4099  - http://journal.pda.org/content/50/2/83.short
4100  - http://journal.pda.org/content/50/2/83.full
SO  - PDA J Pharm Sci Technol1996 Mar 01; 50
AB  - 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.