脏器制剂生产过程一般较长,原料和成品大多易被微生物所污染,因而常带有较多的细菌和霉菌。为了使脏器制剂能达到药品卫生标准的要求,除了在生产工艺、卫生管理制度等方面加以改进外,对成品进行灭菌处理也是一个有效的措施。由于脏器制剂多数为具有活性的蛋白质类物质,受热易变性、失活,故不宜采用通常所用的加热灭菌法。环氧乙烷是一种气体灭菌剂,是由它的烷基取代作用,对细菌代谢产生 Organ preparation of the production process is generally longer, most of raw materials and finished products easily contaminated by microorganisms, which often bring more bacteria and mold. In order to make the organ preparations meet the requirements of the standards of pharmaceutical hygiene, in addition to the production process, health management system to be improved, the finished product sterilization is also an effective measure. As the majority of organ preparations of active protein substances, heat variability, inactivation, it is not appropriate to use the usual heat sterilization. Ethylene oxide is a gas sterilant that is produced by its alkyl substitution effect on bacterial metabolism