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Isolator Systems 隔离系统Isolator Systems隔离系统 General Construc.on 总体构造 • Stainless steel 不锈钢• Flexible film plas.c 高柔韧性塑料薄膜• Rigid plas.c 硬质塑料• Coated mild steel 镀层软钢• Aluminium 铝制• “Hastelloy” 镍基合金Isolator Systems隔离系统 Isolator Systems隔离系统 Stainless Steel 不锈钢 • 304 or 316L 304或316L • Argon arc welded 氩弧焊接• Corners 20 mm radius 边角半径大于20毫米• Finish to 0.6 Ra (inside) 抛光光洁度小于0.6（内部）• No ferri.c (mild steel) tooling!无铁酸盐（软钢）加工 Isolator Systems隔离系统 Stainless Steel: 不锈钢 • Sanitary 无菌• Tough 硬度高• Can be fabricated 可铸造• Heavy 较重• Expensive 较贵• Not so user friendly 不大好用 Isolator Systems隔离系统 Isolator Systems隔离系统 Flexible Film: 柔韧性薄膜 • Clear PVC film -‐ 0.30 to 0.50 mm thick 光亮的PVC薄膜—厚度为0.3到0.5毫米• Standard finish – slight “orange-‐peel” 标准抛光—稍有点桔皮质感• Op.cally clear – press-‐polished 透光度高—高光泽度• RF (radio-‐frequency) welded RF（射频）焊接 Isolator Systems隔离系统 Flexible Film (Stainless base tray) 柔韧性薄膜（不锈钢底盘） • Sanitary 无菌• Surprisingly tough -‐ but beware sharps 硬度极高——小心锋利• Can be fabricated 可铸造• Not expensive 成本不高• Easily installed – light weight 易于安装——重量轻• User friendly 易于使用 Isolator Systems隔离系统 Isolator Systems隔离系统 Other Materials其他材料 • Acrylic (perspex) 丙烯酸（塑胶）• Glass fibre 玻璃纤维• Coated mild steel -‐ Corrodes eventually镀层软钢——会昀终被腐蚀• Aluminium – limited 铝——有限• Hastelloy – expensive but used in highly acid environments 镍基合金——昂贵但用于高酸性环境 Isolator Systems隔离系统 Windows 窗口 • Laminated glass – good, heavy, expensive夹层玻璃——优质、沉重、昂贵• Acrylic – OK 丙烯酸-‐可以• Polycarbonate – OK 聚碳酸酯-‐可以 Dependant on applica.on 取决于具体应用Isolator Systems隔离系统 Handling in Isolators 隔离器中的操作 Gauntlets 防护手套• One-‐piece glove and arm 单只手套与手臂套• Latex rubber 胶乳橡胶• Butyl rubber 丁基橡胶• Hypalon 海帕伦Isolator Systems隔离系统 Handling in Isolators 隔离器中的操作 • Sleeve and glove connected at wrist 袖套与手套在腕部连接• May allow the use of various types and sizes of glove 可以使用多种类型和尺寸的手套• May allow change of glove without breaking containment 无需开封即可更换手套 Isolator Systems隔离系统 Isolator Systems隔离系统 Handling in Isolators 隔离器中的操作 • Sleeve and glove connected at wrist 袖套与手套在腕部连接• May allow the use of various types and sizes of glove 可以使用多种类型和尺寸的手套• May allow change of glove without breaking containment 无需开封即可更换手套 Isolator Systems隔离系统 Gloves手套 • Hands are likely to be contaminated手臂可能会被密封• Gloves are used close to the product 手套为靠近产品时使用• Gloves are highly stressed 手套有高度张力• Gloves are hard to leak test 手套测试不易渗漏 Isolator Systems隔离系统 Gloves手套• Compromise – strength versus feel 强度与触感适中• Need correct size for operators 不同操作人员需要不同的尺寸• Need correct material for process 不同工艺需要不同材质• Suggest double glove 建议用双层手套• Can have changeable type 类型可更换 Isolator Systems隔离系统 Gauntlets and sleeves allow operator to lif about 5 Kg over a radius of about 500 mm.通过手套与袖套，操作者可以在大约500毫米的范围内提起约5公斤的物体 The Half-‐Suit半身衣 The half-‐suit allows operator to lif 15 Kg over a radius of about 1,200 mm 穿上半身衣后，操作者可以在1200毫米的范围内提起约15公斤的物体 Isolator Systems隔离系统 Isolator Systems隔离系统 Air Flow Regimes气流机制 Isolators have air flow to remove airborne par8cles隔离器里有气流用于移除空气中的尘埃 HEPA filters on inlet and on exhaust (see later)在入气口和出气口上有高效过滤器（详见下文） Isolator Systems隔离系统 Air Flow Regime Types气流机制类型 Unidirec8onal (not “laminar”)单向（非“层”） • Air flow from ceiling to floor (as far as prac8cal)从顶部到底部的气流（在切实可行的情况下）• Velocity 0.36 to 0.54 m/s 速度为0.36到0.54米/秒 • Gives air change rate of over 1,000 per hour 换气速率为每小时超过1000次21Isolator Systems隔离系统 底部高效过滤器套袖Isolator Systems隔离系统 Turbulent Flow湍流 Must be designed to sweep all parts of isolator volume 必须设计成能够清空隔离器的所有部分No standing vor8ces or stagnant areas没有停滞漩涡或停滞区May be from 20 to 100 air changes per hour 每小时换气率可能是20到100次Isolator Systems隔离系统 “Engineered” Air Flow “工程”气流 • Essen8ally turbulent, but has arrangements for direc8onal flow, e.g. away from cri8cal filling area towards less cri8cal transfer area.实际为湍流，但是有安排地实现定向气流，比如从重要的填充区而出，朝向重要性较低的转移区。 • May use CFD (computa8onal fluid dynamics) to help design and develop the flow paYern.可以使用CFD（计算流体动力学）帮助设计和开发气流模型。Isolator Systems隔离系统 Local Unidirec8onal 局部单向性 Unidirec8onal flow provided over a cri8cal area在重要区域提供的单向气流Overspill air becomes turbulent supply for the rest of isolator 过剩空气成为隔离器其他部分的湍流供应E.g. some hospital pharmacy isolators 比如某些医院药厂的隔离器Isolator Systems隔离系统 Air Pressure Regimes 气压机制 • Posi8ve pressure – Asep8c opera8ons 正气压—无菌操作• Net ou^low protects the product 产品的净出气保护• Nega8ve pressure – toxic / pathogenic opera8ons 负气压——毒性/病原操作• Net inflow protects the operators 操作者的净入气保护HEPA Filters高效过滤器 • Inlet filter provides “steri
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本文标题：隔离器在无菌药品生产中的应用
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