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  • 净化厂房施工中需要注意哪些问题?
    来源:http://www.csvchb.com 浏览: 发布日期:2020-06-23
    一、净化车间温度和相对湿度
    1、 Temperature and relative humidity of purification workshop
    无菌医疗器械在无特殊规定时,通常要求温度在法规标准检测Standard and Testing18-28℃,湿度在 45%-65%,企业一般都可以控制在要求内。如在动态监测中发现达不到要求,可能是室内有产热大的仪器设备。
    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、净化车间风量、换气次数、静压差
    2、 Air volume, air change times and static pressure difference of purification workshop
    在洁净室体积确定的情况下,换气次数由该室的送风量决定,而静压差取决于房间的送风量与回风量、排风量的差值。系统总送风量、新风量、总排风量和对外压差可以通过调整风机频率转速或总阀门开启度来实现,各房间的风量和压力则可通过调整分支管路阀门开度来实现。
    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、净化车间悬浮粒子、浮游菌、沉降菌
    3、 Suspended particles, floating bacteria and settling bacteria in purification workshop
    测试条件如不能满足规定的环境参数 ( 温湿度、风速、换气次数、静压差在规定范围之内 ) 要求,关键项目悬浮粒子、浮游菌或沉降菌的测试结果应视为无效。由于温度、相对湿度、风速、换气次数、静压差共同构成了洁净室的微气候,是洁净室维护正常与否的重要指征,可将关键工序关键项目测试修订为关键工序全性能测试。
    空气净化工程
    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.
    只能这样,才能全面、系统监测生产洁净室,为确保洁净室性能监测的数据科学性、准确性,测试部门在进行关键项目悬浮粒子、微生物测试时,应同时进行温度、相对湿度、换气次数、静压差等前提条件的测试。
    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、净化车间温度
    4、 Temperature of purification workshop
    洁净室夏季室温超过设计范围的原因,多是由于开始确定的各洁净室的空调送风量即换气次数时只注重满足洁净度指标,忽视了对各洁净室热平衡的校核计算。
    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及运行过程中,必须对洁净室的空调送风参数进行实时修正,保证各个季节生产洁净室的温度都维持18-28℃。温度和相对湿度主要影响产品生产工艺及细菌的繁殖条件,还能引发由生产操作人员舒适度对产品质量的影响。
    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.csvchb.com We will have more exciting content for you to see.