干热灭菌USP.docVIP

Dry heat sterilization is a process utilized for heat-stable items(glass,stainless steel,nonaqueous liquids,powders,etc.)that are unsuited for steam sterilization because of either an absence of water (nonaqueous liquids and powders) or requirments for absolute dryness following processing (product contact parts for nonaqueous products). 干热灭菌是利用热稳定的项目过程（玻璃，不锈钢，非水液体，粉末，等），不适合蒸汽灭菌因为要么没有水（非水液体和粉末）或要求绝对干燥后处理（非水产品接触部分）。Because dry heat relies on air for the transfer of heatto and from the load items，the processing takes longer than a steam process for a comparable size item load 由于干热依靠空气为热转移和负载的物品的处理，要比一个同等规模的项目负荷汽过程较长。Lengthy heating and cooling periods require that the load items be unaffected by heat over a long period of time and also require the use of the overkill method for cycle development and validation 长时间的加热和冷却期间要求负载项目受热在一段长时间，也需要循环发展和验证了过度的使用方法。Dry heat sterilization is typically performed in the range of 160-190 where the objective is sterilization rather than depyrogenation 干热灭菌通常在160-190，目的是杀菌而不是除热原的范围内进行hot air is in direct contact with the load items( whether wrapped or unwrapped)and transfers some of its thermal energy 热空气与负载的物品直接接触（无论是包装或解开）并将其部分热能unlike steam sterilization ,in dry heat sterilization there is no phase change of the heating medium,and thus heat transfer is less efficient 与蒸汽灭菌不同的是，在干燥的加热灭菌中，加热介质没有相变，因而传热效率不高。the items can be stainless steel ,glass ,ceramic ,or other heat stable materials and may be wrapped or coverd with aluminum foil to protect them during pre-and postprocess handling 项目可以是不锈钢，玻璃，陶瓷，或其他耐热材料和可以包裹或覆盖铝箔保护他们在预处理和后处理Dry heat sterilization is commonly used for heat-stable materials 干燥热灭菌是常用的热稳定材料the limited heat transfer capacity of air requires that items in the oven be placed in locations that were confirmed to be acceptable during the validation effort 空气的有限的热传输能力要求在烤箱中的项目被放置在被确认为在验证工作期间被确认的位置manufacturers should exercise caution with varying load sizes because in some instances(resulting from system design and control