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CLEANROOM AND BIOCONTAINMENT

机译:洁净室和生物防治

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In a cleanroom where bilogical agent are handled the control of contamination has the doublernmeaning of minimising the airborne contamination within the cleanroom and avoiding the leakagernoutside the facility of any biological agent.rnThe existing standards for the pharmaceutical industries, the GMP, define the characteristicsrnof a cleanroom for the production of sterile product, with non indication for the biocontainemt. Thernstandard for the biocontainment, NIH standard, do not state anything about the indoor air quality.rnThe Engineer involved in the design of a biocontained cleanroom have to identify the technicalrnsolution that satisfy both the control of airborne contamination and containment of the facility. Anrnimportant role is played by the room pressure cascade and relevant control system; the otherrnimportant criteria is HEPA air filtration, on the supply and on the exhaust. The ventilation systemrnhave to ensure the internal condition overcoming the mechanical and electrical failure: that is whyrnfor some installation it has been foreseen a redundancy on the exhaust fan.rnAs a conclusion an HVAC flow diagram for a biocontained cleanroom is presented where therntechnical solutions discussed are shown.
机译:在处理生物制剂的洁净室中,污染的控制具有双重意义,即最大程度地减少洁净室中的空气传播污染物并避免任何生物制剂设施外的泄漏。制药行业的现有标准GMP定义了洁净室的特性。用于无菌产品的生产,无生物容器指示。用于生物防护的标准(NIH标准)没有说明室内空气质量。参与生物防护洁净室设计的工程师必须确定能够同时满足控制空气传播污染和控制设施的技术方案。房间压力级联和相关的控制系统起着重要的作用;其他重要标准是在供气和排气上进行HEPA空气过滤。通风系统必须确保克服机械和电气故障的内部条件:这就是为什么对于某些安装而言,可以预见到排气扇上的冗余。作为结论,提出了生物净化室的HVAC流程图,其中显示了所讨论的技术解决方案。

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