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  • 凈化廠房施工中需要注意哪些問題?
    來源:http://www.nexregen.com 瀏覽: 發布日期:2020-06-23
    一、凈化車間溫度和相對濕度
    1、 Temperature and relative humidity of purification workshop
    無菌醫療器械在無特殊規定時,通常要求溫度在法規標準檢測Standard and Testing18-28℃,濕度在 45%-65%,企業一般都可以控制在要求內。如在動態監測中發現達不到要求,可能是室內有產熱大的儀器設備。
    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、凈化車間風量、換氣次數、靜壓差
    2、 Air volume, air change times and static pressure difference of purification workshop
    在潔凈室體積確定的情況下,換氣次數由該室的送風量決定,而靜壓差取決于房間的送風量與回風量、排風量的差值。系統總送風量、新風量、總排風量和對外壓差可以通過調整風機頻率轉速或總閥門開啟度來實現,各房間的風量和壓力則可通過調整分支管路閥門開度來實現。
    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、凈化車間懸浮粒子、浮游菌、沉降菌
    3、 Suspended particles, floating bacteria and settling bacteria in purification workshop
    測試條件如不能滿足規定的環境參數 ( 溫濕度、風速、換氣次數、靜壓差在規定范圍之內 ) 要求,關鍵項目懸浮粒子、浮游菌或沉降菌的測試結果應視為無效。由于溫度、相對濕度、風速、換氣次數、靜壓差共同構成了潔凈室的微氣候,是潔凈室維護正常與否的重要指征,可將關鍵工序關鍵項目測試修訂為關鍵工序全性能測試。
    空氣凈化工程
    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.
    只能這樣,才能全面、系統監測生產潔凈室,為確保潔凈室性能監測的數據科學性、準確性,測試部門在進行關鍵項目懸浮粒子、微生物測試時,應同時進行溫度、相對濕度、換氣次數、靜壓差等前提條件的測試。
    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、凈化車間溫度
    4、 Temperature of purification workshop
    潔凈室夏季室溫超過設計范圍的原因,多是由于開始確定的各潔凈室的空調送風量即換氣次數時只注重滿足潔凈度指標,忽視了對各潔凈室熱平衡的校核計算。
    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.
    因此在生產潔凈室的設計及運行過程中,必須對潔凈室的空調送風參數進行實時修正,保證各個季節生產潔凈室的溫度都維持18-28℃。溫度和相對濕度主要影響產品生產工藝及細菌的繁殖條件,還能引發由生產操作人員舒適度對產品質量的影響。
    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.
    本文由空氣凈化工程整理發布,您是不是對這些內容有所了解了呢?更多的內容請點擊:http://www.nexregen.com我們會有更多精彩內容等你查看。
    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.nexregen.com We will have more exciting content for you to see.
    相關標簽: 空氣凈化工程、實驗室裝修、無菌室裝修、
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