Premium
Chlorine Dioxide Gas Sterilization of Oxygenators in an Industrial Scale Sterilizer: A Successful Model
Author(s) -
Jeng David K.,
Woodworth Archie G.
Publication year - 1990
Publication title -
artificial organs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 76
eISSN - 1525-1594
pISSN - 0160-564X
DOI - 10.1111/j.1525-1594.1990.tb02981.x
Subject(s) - chlorine dioxide , sterilization (economics) , chemistry , glutaraldehyde , chromatography , aeration , chlorine , inorganic chemistry , organic chemistry , monetary economics , economics , foreign exchange market , foreign exchange
Artificial organ oxygenators, with large surface areas and complicated structures, were sterilized using chlorine dioxide gas in an industrial scale sterilizer. Bacillus subtilis var. niger ATCC 9372 biological indicators (BI) (10 6 spores/BI) planted in the artificial organs were reproducibly sterilized in a designed cycle schedule with a 30‐min dwell time with a chlorine dioxide gas concentration of approximately 30 mg/L in 80 to 85% relative humidity at 30d̀C. The D value (time required for 90% spore inactivation under specific conditions) was estimated to be 4.4 min. Chlorine dioxide was not detected after poststerilization aeration. The intravenous median lethal dose (LD50) of chlorine dioxide derivatives, chlorite and chlorate, in rats was found to be 112.8 and 2,228.6 mg/kg, respectively. In an immediate hypersensitivity test, chlorine dioxide gas‐treated ovalbumin and bovine serum albumin, unlike ethylene oxide gas‐treated proteins, did not cause sterilant‐specific IgE‐mediated hypersensitivity reactions in rats. Results of an Ames mutagenicity test on chlorine dioxide and on the extracts of the chlorine dioxide gas‐exposed oxygenators were negative.