Johnson J W, Arnold J F, Nail S L, Renzi E
Upjohn Company, Kalamazoo, Michigan.
J Parenter Sci Technol. 1992 Nov-Dec;46(6):215-25.
The feasibility of using vapor hydrogen peroxide (VHP) as an alternative to steam sterilization has been examined using a pilot plant freeze dryer equipped with a prototype vapor generator. Specific objectives of the study discussed in this presentation were to: 1. Identify critical process variables affecting the lethality of VHP to Bacillus stearothermophilus spores, particularly within dead legs in the system. 2. Measure the efficacy of system degassing after sterilization. 3. Determine the effect of repeated sterilization cycles on the integrity of elastomeric components of the freeze dryer. Penetration of adequate concentrations of hydrogen peroxide vapor into small diameter piping, such as tubing connected to pressure gauges, is the most challenging aspect of VHP sterilization of freeze dryers. Prior to equipment modifications, spore strips placed within such dead legs remained positive irrespective of the number of gas/degas pulses and system pressure. Equipment modifications necessary to effect complete kill of biological indicators placed in system dead legs is discussed. Results of this study support the conclusion that vaporized hydrogen peroxide shows promise as an alternative sterilization method for freeze dryers.
使用配备原型蒸汽发生器的中试规模冷冻干燥机，对采用气态过氧化氢（VHP）替代蒸汽灭菌的可行性进行了研究。本报告中讨论的研究具体目标为：1. 确定影响VHP对嗜热脂肪芽孢杆菌孢子致死率的关键工艺变量，尤其是系统死端内的变量。2. 测量灭菌后系统除气的效果。3. 确定重复灭菌循环对冷冻干燥机弹性部件完整性的影响。将足够浓度的过氧化氢蒸汽渗透到小直径管道（如连接压力表的管道）中，是冷冻干燥机VHP灭菌最具挑战性的方面。在设备改造之前，无论气体/除气脉冲次数和系统压力如何，放置在这些死端内的孢子条检测结果均为阳性。讨论了实现系统死端内生物指示剂完全杀灭所需的设备改造。本研究结果支持以下结论：汽化过氧化氢有望成为冷冻干燥机的一种替代灭菌方法。
