秤量罩的技术说明1.docVIP

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秤量罩的技术说明1

秤量罩的技术说明environment area of clean and sterile air , through a unidirectional and descendant air filtered flow with lower pressure in the operation area. The possibility of cross contamination with other products is avoided. 秤量罩的作用原理: 通过下沉降式低压气流均流于操作区域,产生一个洁净无菌的局部环境。从而,避免不同药品之间的交叉污染。 The weighing booth is a vertical laminar flow of class M3.5(ISO14644-M5) air , with a vertical return gird on the frontal side and a double stage of pre-filter. Air flow is taken in by the ventilation unit , through grills placed on the backside wall, filtered by mean the pre-filter before been partitially exhaust into the outside environment (after absolute filtration) to create inside negative pressure and partially recycled through the terminal HEPA filters to generate the larminar down-flow. 秤量罩内部是一个垂直层流级别M3.5洁净区域。正侧面有一个竖直的回风格栅和双层预过滤器。风由风机通过后侧面上的风口吸入,通过预过滤器过滤,一部分风直接排至秤量罩外部并形成局部的负压环境,一部分通过顶部的高效处理后送至工作区。通过顶部的过滤装置形成向下的层流。 Weighing booth is the just solution to non-balance of room pressure. 称量罩解决房间压差失衡的问题。 The operation cycle described above assures a slight depression and, therefore, an isolating from the surrounding area. 上述的作用原理,造成一个微向下层流的气流组织,并形成一个局部的隔离区域。 2. 应用和操作 Application and Operation Principle 2.1 Operation Principle Weighing booth is a containment solution for handling and dosing of none sterile products (including medium/low active ingredients ) with the operator integrally within the LAF (laminar air flow). The identified and carefully estimated factors considered as essential, with particular reference to process and safety requirements, are : Protection of the product 保护产品 Protection and safety of the operator 保护操作人员 Protection of the inner environment 保护内部环境 Protection of the external environment 保护外部环境 Ergonomic factors 保护人类环境 2.2 Application 应用 The applications are dosing and weighing of raw material, sampling antibioticos handling, hormones, cytostatics, etc either powders or liquids. 秤量罩应用于原

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