无菌及环氧乙烷留残量检测.ppt

无菌及环氧乙烷残留量检测 浙江省医疗器械检验所 虞海莹 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 提纲 1. 1. 常用灭菌方法常用灭菌方法 3. 3. 微生物检验基础知识微生物检验基础知识 4. 4. 医疗器械无菌检查医疗器械无菌检查 2. 2. 环氧乙烷残留量环氧乙烷残留量 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 常用的灭菌方法 v灭菌的方法： 物理方法 干热灭菌 湿热灭菌 射线灭菌 滤过灭菌 化学方法 气体灭菌 药液灭菌 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 干热灭菌法 v 干热灭菌法可用于能耐受较高温度，却不宜被蒸汽穿透 、或者易被湿热破坏的物品的灭菌。 v 分类： 火焰灭菌法：是将待灭菌物品直接置于火焰中烧灼进行灭菌的 方法，灭菌迅速、可靠、简便。 适用于：耐火焰材质的物品如金属、玻璃用具或容器及瓷器 等的灭菌 干热空气灭菌法：是将待灭菌物品置于高温干热空气中灭菌的 方法，需要长时间高热环境才能达到灭菌效果。 适用于：耐高温材质的物品（玻璃、金属制品等）及耐高温 、不允许湿气穿透的油脂类和粉末化学药品。 干热空气灭菌常用：135145灭菌35h；160170灭 菌24h；180200灭菌0.51h。 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 湿热灭菌法 v 湿热灭菌法是通过热蒸汽或沸水使细菌蛋白质变性而杀 灭微生物的方法。 v 分类: 煮沸灭菌 流通蒸汽灭菌 热压灭菌 适用于：耐高温、耐高压蒸气的物品。金属或玻璃容器及用具、瓷 器、橡胶塞、膜滤器等均能采用此法。 常用条件（温度、蒸气表压与时间）为：115（67kPa），30min ；121（97kPa），20min；126（139 kPa），15min。 v 影响湿热灭菌的因素有： 细菌的种类与数量 器械（被灭菌物）性质 灭菌温度、压力与时间 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 射线灭菌法 常用的有： 辐射灭菌法： 原理是射线可直接破坏细菌DNA，导致微生物死亡。辐射灭菌的 特点是不升高灭菌产品的温度，穿透性强。 适用于：羊肠线、高分子材料等医疗器械的灭菌。 紫外线灭菌法： 是利用紫外线作用于菌体核酸蛋白促使其变性，同时空气受紫 外线照射后产生微量臭氧，从而起共同杀菌作用。紫外光波长 190-350nm之间，其中波长为260nm左右，对微生物的生物效应 最大。 适用于：无菌室、某些工作区的空气灭菌、物体表面灭菌。 微波灭菌法： 采用频率300MHz300kMHz的电磁波照射产生热能杀灭微生物的 方法。 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 紫外线照射灭菌时注意的问题 紫外线的杀菌力，随使用时间增加而减退，一般使用时间达到 额定时间70时应更换紫外线灯管，以保证杀菌效果。紫外线 灯平均寿命一般为2000h。 紫外线的杀菌作用随菌种不同而不同，杀霉菌的照射量要比杀 杆菌大40 50倍。 紫外线照射通常按相对湿度为60的基础设计，室内湿度增加 时，照射量应相应增加。 紫外线灭菌效果与照射的时间长短有关，这需要通过验证来确 定照射时间。 紫外照射灯的安装形式及高度，应根据实际情况，参考使用说 明决定 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 滤过除菌法 v 滤过除菌法：指用滤过方法除去活的或死的微生物的方 法，是一种机械除菌方法，供除菌用的滤器，要求能有 效地从溶液中除净微生物，溶液能顺畅地通过，容易清 洗，操作简便。 v 适用于：对热不稳定的药物溶液、气体、水等的除菌。 v 常用除菌滤器（应在无菌操条件下进行）： 0.22m或0.3m的微孔滤膜 G6垂熔玻璃滤器 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 化学灭菌法 v 气体灭菌法：指用化学药品 的气体或蒸气杀灭微生物的方法。 常用气态杀菌剂：为环氧乙烷 、甲醛、丙二醇、臭氧、乳酸、 过氧 乙酸等。 v 药液灭菌法: 药液灭菌法利用 药液杀灭微生物的方法。 常用的有0.1%0.2%苯扎溴铵溶液 ，75%乙醇、2%煤酚皂溶液、1%聚维 酮碘溶液等。 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 小结 v 高压蒸汽灭菌: 工作服、口罩、稀释液等，置高压杀菌锅内， 一般采用121灭菌半小时, 不同的培养基有不同的要求,应分别处 理。 v 火焰灭菌：接种针、接种环等可直接火焰灭菌。 v 高温干燥灭菌：各种玻璃器皿、注射器、吸管等，置于燥箱中 160灭菌2小时。 v 一般消毒: 无菌室内的凳、工作台、试管架、天平、待检物容器 或包装均无法进行灭菌，必须用其他方法进行消毒处理，可采用适 当的消毒液擦拭消毒，工作人员的手也用此法进行消毒。 v 空气的消毒：开启紫外灯照射3060分钟即可。 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 提纲 1. 1. 常用灭菌方法常用灭菌方法 3. 3. 微生物检验基础知识微生物检验基础知识 4. 4. 医疗器械无菌检查医疗器械无菌检查 2. 2. 环氧乙烷残留量环氧乙烷残留量 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 环氧乙烷灭菌相关知识 v 环氧乙烷灭菌利用环氧乙烷在常温下为气态，蒸汽压较大，对灭菌 物品的穿透性强，可以穿透微孔而达到物品的深部，环氧乙烷是一 种非常活泼的灭菌剂，杀菌能力强且广泛，有很强的穿透能力，适 合于包装物品的灭菌，对物品损坏轻微，且费用较低。现大部分的 医疗器械生产企业采用此种方法灭菌。 v 环氧乙烷能够高效地对医疗产品进行灭菌，在杀灭微生物的同时医 疗产品上的环氧乙烷残留也会对使用者和患者的身体带来一定的毒 害。其毒性包括两个方面： 一为环氧乙烷本身的毒性。通过呼吸器官吸入体内刺激呼吸道，引起 恶心、呕吐、头昏、头痛、嗜睡等症状。严重者可引起肺水肿；通过 皮肤、粘膜接触后，引起红肿、水泡及血泡，严重者可出现局部皮肤 烧伤及粘膜组织灼伤，造成毛发脱落；超量进入人体血液内，可致红 细胞溶解，补体灭活和凝血酶破坏引起全身性溶血。 二是灭菌后生成物的毒性。环氧乙烷与氯元素接触产生毒性很大的氯 醇，与水接触形成乙二醇，对环境和种植物的生产起到很大的破坏作 用。 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 环氧乙烷灭菌相关知识 v 医疗器械产品如采用环氧乙烷灭菌，应由有资格的人员负责设备维 护灭菌的确认和常规控制及产品放行工作。应不断提高各类人员对 环氧乙烷残留量造成健康风险的意识， 首先经环氧乙烷灭菌的医疗器械必须按规定进行解析，即纸塑包装灭 菌后解析7天，全塑包装灭菌后解析14天，并经检测确定器械上的环氧 乙烷残留量小于10g/g后出厂； 其次经环氧乙烷灭菌的医疗器械应采用透气性好，有助于消除残留环 氧乙烷的纸塑包装，以最大限度地降低环氧乙烷残留，降低器械使用 的风险； 第三体积越大，环氧乙烷含量绝对就越高；对于医用敷料、无纺布、 合成医用乳胶手套等对环氧乙烷气体有很强的吸附性，吸附在这类产 品上的残留量很难彻底解析，所以对此类产品，不应选用环氧乙烷灭 菌。 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 环氧乙烷残留量测定方法 v 气相色谱法 v 比色分析法 原理：环氧乙烷在酸性条件下水解成乙二醇，乙二醇经高碘酸氧化生 成 甲醛，甲醛与品红-亚硫酸试液反应产生紫红色化合物，通过比色法分 析 可求得环氧乙烷含量。 所用试剂：高碘酸，硫代硫酸钠，无水亚硫酸钠，碱性品红，盐酸， 乙二醇等 浸提方法：分模拟使用浸提法和极限浸提法。 模拟使用浸提法：用0.1mol/L盐酸作为浸提介质,整个或部分与人体接 触的器械在37(人体温度)浸提,不直接与人体接触的器械在25( 室温)浸提.浸提时间应考虑在推荐或预期使用最为严格的时间条件 下进行,但不短于1h.浸提表面为器械与药液或血液接触的表面. 极限浸提法:取样品上有代表性的部位,截为5mm长碎块,称取2.0g置于 容器中,加0.1mol/L盐酸10ml,室温放置1h,作为供试液;对于容器类 样品,可加0.1mol/L盐酸至公称容量,在371下恒温1h. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 环氧乙烷残留量 v 试验步骤 绘制标准曲线：取5支纳氏比色管，分别精确加入 0.1mol/L盐酸2ml,再精确加入0.5m、1.0ml、1.5ml 、 2.0ml 、2.5ml乙二醇标准溶液。另取一支纳氏比色管 ，精确加入0.1mol/L盐酸2ml作为空白对照。于上述各 管中分别加入高碘酸溶液（5g/L)0.4ml，摇匀，放1h， 然后分别滴加硫代硫酸钠溶液（10g/L）至出现的黄色 恰好消失。再分别加入品红-亚硫酸试液0.2ml，用蒸馏 水稀释到10ml，摇匀，35 37 条件下放置1h,于 560nm波长处以空白液作参比，测定吸光度。绘制吸光 度-体积标准曲线。 试验方法：精确量取供试液2.0ml于纳氏比色管中，按上面 的步骤操作，以测得的吸光度从标准曲线上查得试液相 应的体积。 、 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 提纲 1. 1. 常用灭菌方法常用灭菌方法 3. 3. 微生物检验基础知识微生物检验基础知识 4. 4. 医疗器械无菌检查医疗器械无菌检查 2. 2. 环氧乙烷残留量环氧乙烷残留量 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 微生物检验基础知识 无菌技术：是指在微生物试验工作中，控制或防止各类微生物的污染 及 其干扰的一系列操作方法和有关措施，其中包括无菌环境设施、无菌 试 验器材以及无菌操作。 无菌环境设施 无菌室的使用与管理要求 超净工作台的使用与管理要求 生物安全柜 无菌试验器材 无菌操作： 概念：是指在无菌环境条件下，在对无菌制品或无菌器械进行检 验的过程中，能防止微生物污染与干扰的一种常规操作方法。 注意事项。 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 提纲 1. 1. 常用灭菌方法常用灭菌方法 2. 2. 环氧乙烷残留量环氧乙烷残留量 4. 4. 医疗器械无菌检查医疗器械无菌检查 3. 3. 微生物检验基础知识微生物检验基础知识 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 医疗器械无菌检查引用标准 v 中华人民共和国药典2005版 v / 医用输液输血 注射器具检验方法 第部分：生物学试验方法 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 无菌检查法的定义 v 中华人民共和国药典2005版：无菌检查法系用于检查药 典要求无菌的药品，医疗器具，原料，辅料及其他品种 是否无菌的一种方法 v /：本试验系将医疗 器械或其浸提液接种于培养基内，以检验供试品是否有 细菌和真菌污染 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 无菌检查方式 v 直接接种法 v 薄膜过滤法 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 主要设备 v 超净工作台 v 恒温培养箱 v 恒温水浴箱 v 压力蒸汽灭菌器 v 电热干燥箱 v 光学显微镜 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 主要器具 v 试管及试管架 v 酒精灯 v 75乙醇棉 v 灭菌刻度吸管(1ml) v 灭菌平皿（9cm） v 锥形瓶 v 三角烧瓶 v 灭菌剪刀、镊子等 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 主要培养基 v 流体硫乙醇酸盐培养基 v 改良马丁培养基 v 营养琼脂培养基 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 稀释液、冲洗液及其制备方法 v 无菌氯化钠溶液：质量浓度为9g/L的无菌氯化钠溶液 v 蛋白胨水溶液（ 0.1 ） 制备方法： 取蛋白胨1.0g，加水1000ml，微温溶解，滤清， 调节pH值至7.10.2，分装，灭菌。 v pH7.0氯化钠-蛋白胨缓冲液 制备方法： 取磷酸二氢钾3.56g、磷酸氢二钠7.23g、氯化钠 4.30g、蛋白胨1.0g，加水1000ml，微温溶解，滤清，分装，灭 菌 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 培养基要求 v 用于培养需（厌）气菌和真菌的培养基的制备、培养基 灵敏度检查及其他各项要求应符合中国药典（二部） 附录中无菌检查法的规定。 v 培养基可按药典的处方制备，也可使用按该处方生产的 符合规定的脱水培养基。制备后应采用验证合格的灭菌 程序灭菌。制备好的培养基应保存在225、避光的环 境。培养基若保存于非密闭容器中，一般在三周内使用 ;若保存于密闭容器中，一般可在一年内使用。 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 培养基 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 灵敏度试验的菌种 v 金黄色葡萄球菌 v 枯草芽孢杆菌 v 铜绿假单胞菌 v 生孢梭菌 v 白色念珠菌 v 黑曲霉 :中国医学细菌保藏管理中心 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd.Copyright 2004-2011 Aspose Pty Ltd. 器具灭菌 v 与供试液接触的所有器具应采用可靠方法灭菌，通常置 压力蒸气灭菌器内12130min，或置电热干燥箱内 1602h。 Evaluation only.Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile .Created with Aspose.Slides for .NET 3.5 Client P