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  • 微生物檢查室和無菌室怎麽設置?
    來源:http://www.relexus.com 瀏覽: 發布日期:2020-12-17
    1、微生物檢查室的環境條件
    1. Environmental conditions of microbiological laboratory
    微生物檢查室是用來檢查非規定滅菌製劑及其原料、輔料受微生物汙染程度的場所。微生物檢查指物品中允許含規定合格範圍內的活的微生物。《中國藥典》2010版附錄規定微生物檢查應在環境潔淨度10000級以下,局部潔淨度100級的單向層流空氣區域內進行。
    Microbial examination room is used to check the microbial contamination of non prescribed sterilization preparations and their raw materials and accessories. Microbiological examination means that the articles are allowed to contain living microorganisms within the specified qualified range. According to the appendix of Chinese Pharmacopoeia (2010 Edition), microbiological examination should be carried out in the unidirectional laminar air area with environmental cleanliness below 10000 and local cleanliness of 100.
    大型設備:冰箱、超淨工作台、培養箱、幹燥箱、恒溫水浴鍋、烘箱、純水機、離心機等
    Large scale equipment: refrigerator, super clean table, incubator, drying oven, constant temperature water bath pot, oven, pure water machine, centrifuge, etc
    小型設備:天平、顯微鏡、分光光度計、酸度計、電導儀和濁度儀、折光儀、雜質度過濾機等
    Small equipment: balance, microscope, spectrophotometer, acidity meter, conductivity meter, turbidity meter, refractometer, impurity filter, etc
    其他:玻璃器皿、試劑(營養瓊脂、牛肉膏蛋白腖、氯化鈉、氫氧化鈉)等
    Others: Glassware, reagents (nutrient agar, beef extract peptone, sodium chloride, sodium hydroxide), etc
    微生物檢查室和無菌室的設置
    Setting of microbiological examination room and aseptic room
    2、無菌檢查室的環境條件
    2. Environmental conditions of aseptic examination room
    無菌檢查室是用來檢查注射劑、用於無菌製劑中的原料、輔料的檢驗場所。以無菌保證水平(SAL)表述。因此,無菌室的環境十分關鍵,對樣品的檢測結果的準確性幹擾很大。
    無菌室裝修
    Aseptic examination room is used to check injections, raw materials and excipients in sterile preparations. It was expressed as sterility assurance level (SAL). Therefore, the environment of aseptic room is very important, which greatly interferes with the accuracy of sample test results.
    設備:超淨工作台、集菌儀
    Equipment: ultra clean working table and bacteria collecting instrument
    3、陽性對照室的環境條件
    3. Environmental conditions of positive control room
    陽性對照室是製備陽性對照菌種及轉接種等場所。陽性對照室應為潔淨度局部100級的單向層流空氣區域內,背景環境潔淨度10,000級,室內空氣經過濾裝置處理後直排室外,一般都在生物安全櫃內操作。
    The positive control room is a place to prepare positive control strains and transfer strains. The positive control room should be a unidirectional laminar air area with local cleanliness of 100 grade, and the background environment cleanliness of 10000 level. The indoor air is directly discharged to the outside after being treated by the filter device, and is generally operated in the biological safety cabinet.
    設備:生物安全櫃、混合器
    Equipment: biosesafety cabinet, mixer
    4 無菌室、微生物限度實驗室和陽性對照室的設置管理
    4. Setting and management of aseptic room, microbial limit laboratory and positive control room
    實驗室布局設計應避免交叉汙染,有利於清潔和日常維護。人和物是潔淨區的汙染源,實驗室要分別設置人流和物流的通道,並有明確的標識。3個實驗室要分別設置更衣通道,避免交叉汙染,環境的著裝要與藥品生產相一致,無菌檢查試驗時的潔淨衣都經過高壓滅菌。進入的物流要與人流分開,每個實驗室要都單獨的傳遞窗傳遞試驗樣品和器具,所有樣品都要用75%乙醇擦拭消毒,無菌檢測所用器具等皆需進過滅菌處理送入無菌檢查室;滅菌的效果要進行驗證確認,傳遞窗必須安裝紫外燈,並定期對其消毒效果進行確認評價,及時更換紫外燈。
    The layout design of laboratory should avoid cross contamination, which is conducive to cleaning and routine maintenance. People and things are the biggest pollution source in clean area. The laboratory should set up the channel of people flow and logistics respectively, and have clear identification. The three laboratories should set up changing channels to avoid cross contamination. The environmental clothing should be consistent with the drug production. The clean clothes in the sterility test should be sterilized by high pressure. The incoming logistics should be separated from the flow of people. Each laboratory should have a separate transfer window to transfer test samples and instruments. All samples should be wiped and disinfected with 75% ethanol. All instruments used for sterility test should be sent to the sterile examination room after sterilization treatment; The sterilization effect should be verified and confirmed. The transmission window must be equipped with ultraviolet lamp, and its disinfection effect should be confirmed and evalsuated regularly, and the ultraviolet lamp should be replaced in time.
    陽性對照室中的操作多為有菌操作,其對操作人員及操作環境汙染的可能性更大,建議用生物安全櫃操作。由此認為,無菌室、微生物限度實驗室本身都應當確保檢測環境對實驗樣品不得產生汙染,而影響檢驗數據的準確性。在無菌檢查的同時要同步對檢驗環境進行檢測,潔淨程度仍然滿足潔淨要求。因此,3個實驗室在檢測結束後的清場、清洗等強度不同,但更終都是以滿足10000潔淨要求及100級潔淨要求為可接受的標準。
    The operation in the positive control room is mostly bacterial operation, which is more likely to pollute the operator and the operating environment. It is recommended to use the biological safety cabinet for operation. Therefore, the sterile room and microbial limit laboratory should ensure that the test environment does not pollute the experimental samples, which will affect the accuracy of the test data. At the same time, the test environment should be tested at the same time, and the cleanliness still meets the requirements of cleanliness. Therefore, the intensity of site cleaning and cleaning of the three laboratories are different after testing, but the final acceptable standard is to meet the requirements of 10000 cleanliness and 100 grade cleanliness.