蒸汽灭菌原理.pdfVIP

From PHARMACEUTICAL ENGINEERING, NOVEMBER/DECEMBER 2013, VOL 33, NO 6 ?Copyright ISPE 2013 Steam Sterilization Principles 蒸汽灭菌原理 by Marcel Dion and Wayne Parker This article presents how a good understanding of basic steam sterilization principles can help with avoiding most common mistakes made when using steam autoclaves. 本文论述了良好地理解基本的蒸汽灭菌原理将有助于避免蒸汽灭菌柜使用中出现的大多数常见错误。 Steam sterilization has been used for more than a century to sterilize items that can withstand moisture and high temperature. Steam is water in the vapor state; therefore, it is non-toxic, generally readily available, and relatively easy to control. A good understanding of basic steam sterilization principles and cycles is necessary to avoid mistakes that can lead to non-sterile load items, poor performance of the equipment, personnel injury, lower productivity, higher operation and maintenance costs, and damage to load items. Steam sterilizers are used for numerous applications in the pharmaceutical and medical device industries. The focus of this article is saturated steam applications, such as laboratory media sterilization, decontamination, and general component sterilization. Terminal sterilization of parenteral liquid products or devices containing liquids may require processes using steam-air mixtures or super-heated water-air mixtures. These processes, as well as in-situ sterilization of tanks, filters, etc., are not addressed in this article. 蒸汽灭菌用于耐热耐湿物品的灭菌已有一个多 世纪。蒸汽是水的气态形式；因此，它无毒、易制 取且相对易控制。良好地理解基本的蒸汽灭菌原理 和周期能够避免一些错误，这些错误可能导致装载 物品非无菌、设备性能低、人员伤害、产量低、运 行和维护成本高，以及装载物品的破坏。蒸汽灭菌 广泛应用于制药和医疗器械行业。本文的重点是饱 和蒸汽的应用，如实验室培养基灭菌、净化和一般 器具灭菌。注射剂产品或带液体的器械的最终灭菌 可能需要使用蒸汽-空气混合气，或过热水-空气混合 气。本文不涉及这些过程以及储罐、过滤器等的原 位灭菌。 Steam Sterilization Principles 蒸汽灭菌原理 Six factors are particularly critical to assure successful steam sterilization: 六个确保蒸汽灭菌成功的关键因素是： 1. Time 时间 2. Temperature 温度 3. Moisture 湿度 4. Direct steam contact 直接蒸汽接触 5. Air removal 排气 6. Drying 干燥 1. Time 时