Murtaugh J B, Whitaker G
Med Instrum. 1983 May-Jun;17(3):211-5.
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.
必须控制产品的湿度条件，以便在环氧乙烷灭菌过程中实现无菌状态并维持产品的活性。在两年的生产灭菌经验中，一种采用产品预加湿来控制湿度条件的灭菌工艺被证明是有效的。当对包装在瓦楞纸板中的经过适当预处理的医疗器械进行灭菌时，使用气相色谱仪进行的在线过程分析表明无需向腔室中添加蒸汽。实现了可重复的气腔湿度控制和微生物无菌保证。
