Preconditioning for moisture control in ethylene oxide sterilization.
The moisture condition of a product must be controlled to obtain sterility and maintain product viability during ethylene oxide sterilization. A sterilization process in which prehumidification of product is used to provide moisture condition control was shown to be effective in 2 years of production sterilization experience. On-stream process analysis with a gas chromatograph showed that addition of steam to the chamber was unnecessary when properly preconditioned medical devices packaged in corrugated paper-board were sterilized. Reproducible gas-chamber moisture control and microbial sterility assurance were obtained.
D002408:Catheters, Indwelling / Q000592:standards; D002849:Chromatography, Gas; D003257:Consumer Product Safety; D005027:Ethylene Oxide; D006801:Humans; D006813:Humidity; D011786:Quality Control; D013242:Sterilization / Q000295:instrumentation* / Q000379:methods; D013997:Time Factors
D005027:Ethylene Oxide