无菌检查隔离器技术资料.docxVIP

TFL/RD7.2.2-01-02无菌检查隔离器Sterile testing Isolator综述summarize1.无菌检查隔离器应用的优势The advantage of the sterile testing isolator application降低被检产品受污染的风险，减少假阳性的出现的几率Reduce the risk of the products contamination and the false positive降低无菌检查厂房背景环境要求，简化人员更衣程，降低了运行成本Reduce the background class,simplify personnel change clothes,reduce the operation cost保护了操作者，提供了可控稳定的检查环境Protect the operator, provides a controllable and stable environment更加符合法律法规要求More in line with the laws and regulations洁净室和隔离器对比表The Contrast table2.无菌检查隔离器功能及结构特点:The function and feature of the sterile testing isolator :将一次测试或多次测试所使用的样品、培养基和设备放置在传递箱中All the necessary samples, media and equipment for one or several tests are placed in the pass box.将传递箱关闭并且密封，对其进行双氧水灭菌循环，该循环必须经过验证The close and seal the pass box and start the validated H2O2 decontamination cycle. 将物品传递至已经过VHP灭菌的主箱体中；在隔离器的操作台中进行样本的备制Introduce the materials into the main chamber which is already decontaminated with VHP; Sample Preparation will be done in the work station. 备制完成的样品罐从传递箱传出Sample canisters can be transferred though the pass box.根据客户操作批次的多少可以选择不同的组合形式According to customer require, we can make the reasonable solution.人体工程学设计使操作舒适隔离器组合形式Ergonomically designed for operation comfort Combining Form单向流速度为0.45±20% m/s Unidirectional airflow at the speed of 0.45±20% m/s通过友好的人机界面使用触摸屏能方便地对隔离器进行操作Touch screen and friendly HIM are designedd for easy operation of the isolator整机图片The whole machine pictures整机参数The complete machineparameter序号SN内容Content参数描述Parametersdescription1整机高度Overall Height2500mm2宽度Width850mm3长度Length根据客户的工艺要求According to customer process require4手套口中心高度Center height of glove port1050mm5重量Weight1.5t(standard)二、技术说明Technical specifications（一）传递窗Pass-box主框架 Main frameA.性能参数Performance parameter序号SN内容Content参数描述Parametersdescription1整体外形尺寸The overall dimensionPASS-BOX：620*750*25002内部尺寸（长*宽*高）Internal dimensions620*600*7003外腔装饰板External cavity decorativeAISI 3044内腔InsideAISI 3045顶部静压箱材质Plenum materialAISI 3046操作平台材质Material of work pl