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  • 緃uanХ渴┕ぶ行枰獄hu意哪些问ti?
    laiyuan:http://www.jnyhrs.com 浏览:次 发bu日qi:2020-06-23
    一、緃uan导湮露萮e相对shi度
    1、 Temperature and relative humidity of purification workshop
    wu菌医疗qi械在wute殊规定时,通常要求温度在法规标准检ceStandard and Testing18-28℃,shi度在 45%-65%,企业一ban都ke以kong制在要求内。ru在动态jiance中发现da不到要求,ke能是室内有产热大的仪qi设备。
    When there is no special regulation for sterile medical devices, the temperature is generally required to be within the standard and testing 18-28 ℃, and the humidity is 45% - 65%. Generally, enterprises can control within the requirements. If it can not meet the requirements in the dynamic monitoring, it may be that there are instruments and equipment with large heat production in the room.
    二、緃uan导鋐engliang、huan气次数、jing压cha
    2、 Air volume, air change times and static pressure difference of purification workshop
    在洁净室体积萬anǖ那榭鱿拢琱uan气次数由gai室的送fengliangjue定,erjing压cha取jue于房间的送fengliang与huifengliang、排fengliang的cha值。系统总送fengliang、xinfengliang、总排fenglianghe对外压chake以通过diao整feng机pin率转su或总阀门开启度lai实现,ge房间的fenglianghe压力则ke通过diao整分支管lu阀门开度lai实现。
    When the volume of a clean room is determined, the number of air changes is determined by the air supply volume of the room, while the static pressure difference is determined by the difference between the air supply volume, return air volume and exhaust air volume of the room. The total supply air volume, fresh air volume, total exhaust air volume and external pressure difference of the system can be realized by adjusting the fan frequency speed or the opening degree of the main valve, and the air volume and pressure of each room can be realized by adjusting the opening degree of the branch pipeline valve.
    三、緃uan导湫i子、浮you菌、沉降菌
    3、 Suspended particles, floating bacteria and settling bacteria in purification workshop
    ce试条jianru不能man足规定的huan境参数 ( 温shi度、fengsu、huan气次数、jing压cha在规定fan围之内 ) 要求,关键项mu悬浮li子、浮you菌或沉降菌的ce试结果应蕐ou獁uxiao。由于温度、相对shi度、fengsu、huan气次数、jing压cha共同构cheng了洁净室的微气候,是洁净室维hu正常与fu的重要指征,kejiang关键工序关键项muce试修订wei关键工序全性能ce试。
    空气緃uanこ? src=
    If the test conditions fail to meet the requirements of specified environmental parameters (temperature and humidity, wind speed, air change times, static pressure difference within the specified range), the test results of suspended particles, floating bacteria or settling bacteria of key items shall be regarded as invalid. As temperature, relative humidity, wind speed, air change times and static pressure difference constitute the microclimate of the clean room, which is an important indicator of whether the clean room is maintained normally or not, the key process key item test can be revised to the key process full performance test.
    zhi能这样,才能全面、系统jiance生产洁净室,wei确保洁净室性能jiance的数ju科学性、准确性,ce试部门在进行关键项mu悬浮li子、微生物ce试时,应同时进行温度、相对shi度、huan气次数、jing压chadengqian提条jian的ce试。
    Only in this way can the production clean room be monitored comprehensively and systematically. In order to ensure the scientificity and accuracy of the performance monitoring data of the clean room, the testing department should test the temperature, relative humidity, air change times, static pressure difference and other preconditions at the same time when testing the suspended particles and microorganisms of key projects.
    四、緃uan导湮露屈/div>
    4、 Temperature of purification workshop
    洁净室xia季室温超过设计fan围的原因,多是由于开始萬anǖ膅e洁净室祄u誨iao送fengliang即huan气次数时zhizhu重man足洁净度指标,hu视了对ge洁净室热平heng的校核计算。
    The reason why the room temperature of the clean room exceeds the design range in summer is mostly because the air conditioning air supply volume of each clean room, i.e. the air change frequency, which was determined at the beginning, only focused on meeting the cleanliness index, and ignored the check calculation of the heat balance of each clean room.
    因此在生产洁净室的设计ji运行过程中,bi须对洁净室祄u誨iao送feng参数进行实时修正,保证ge个季节生产洁净室的温度都维chi18-28℃。温度he相对shi度主要影响产pin生产工艺ji细菌的繁殖条jian,还能yin发由生产操作人员舒适度对产pin质liang的影响。
    Therefore, in the process of design and operation of the production clean room, the parameters of air conditioning and air supply in the clean room must be corrected in real time to ensure that the temperature of the production clean room in each season is maintained at 18-28 ℃. Temperature and relative humidity mainly affect the production process and bacterial reproduction conditions, and also cause the impact of the comfort of production operators on product quality.
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    This article is organized and released by the air purification project. Do you know something about these contents? For more information, please click: http://www.jnyhrs.com We will have more exciting content for you to see.