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class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價格要求：</span>面議</p><p><span>所在地：</span>上海市</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關鍵詞：</span>湖北溫度監(jiān)測系統(tǒng)滅菌柜驗證質量保證,滅菌柜驗證</p><p><span>***更新：</span>2021-01-29 09:05:40</p><p><span id="click" >瀏覽次數(shù)：5次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="ynaxu7j" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">旦霆生物科技（上海）有限公司</a></p><p><span>聯(lián)系人：</span>楊玲玲</p><p><span>郵箱: </span>847678360@qq.com</p><p><span>電話: </span>18918043358</p><p><span>傳真: </span>021_</p><p><span>網(wǎng)址: </span></p><p><span>手機: </span>021-59882315</p><p><span>地址: </span>上海市青浦區(qū)華徐公路966號法姬娜大廈B323室，325室</p><p>[當前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="dcebiur" class="page-proshow02"><p class="title">詳細說明</p><div id="raxp2tu" class="box"><p><p> 濕熱滅菌溫度驗證對驗證儀器的基本要求 </p> <p> 測溫編輯記錄儀器 </p> <p> <p> 測溫記錄儀器是整個實驗的大腦。國內(nèi)外諸多公司直接采用PC機開發(fā)，在Windows 系統(tǒng)平臺基礎上開發(fā)自己的多點數(shù)據(jù)記錄、整理、計算、存儲及I/O的接口軟件，其集多功能軟件為一體裝配在計算機中，既便攜帶，又圖文齊備，直觀可靠。 </p> <p> <br /> </p> <p> 輔助校正儀器 </p> <p> <br /> </p> <p> 設計為一臺高精度的恒溫油槽（又稱干井），采用溫控PID調節(jié)控溫精度高，溫度波動范圍設計在±0.05℃。其有斷偶保護功能，上限設計超溫報警功能。升降溫快速、穩(wěn)定，湖北溫度監(jiān)測系統(tǒng)滅菌柜驗證質量保證、可靠。在設定溫度和測量溫度數(shù)字上，分別3又1/2精確顯示，湖北溫度監(jiān)測系統(tǒng)滅菌柜驗證質量保證。 </p> <p> <br /> </p> <p> 在低溫段檢校采取冰點槽（低溫干井）設施，高低溫干井分別檢測電偶的特殊點溫度值誤差和能否用于實驗的合格性進行甄別篩選。它即是本實驗的檢測校正部件，也是實驗室的常備精密溫度源。通常交國家法定技術監(jiān)督部門定期檢校確認合格,在有效期內(nèi)使用，湖北溫度監(jiān)測系統(tǒng)滅菌柜驗證質量保證。 </p> <p> <br /> </p> 著眼質量，靜思細量，旦霆科技為您提供專業(yè)的計算機化系統(tǒng)驗證服務，為您的合規(guī)之路保駕護航！湖北溫度監(jiān)測系統(tǒng)滅菌柜驗證質量保證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北溫度監(jiān)測系統(tǒng)滅菌柜驗證質量保證,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294640087891/7436443.png"></div><p> 滅菌柜驗證目的 </p> <p> 1.安裝檢查主要是確認設備經(jīng)多年的生產(chǎn)運行，安裝狀況是否符合要求，滅菌器有關文件資料是否符合要求。 </p> <p> 2.運行確認主要檢查設備目前運行狀況是否正常，是否滿足正常生產(chǎn)要求。 </p> <p> 3.性能確認主要驗證設備在空載及滿載情況下經(jīng)過高溫滅菌后能否達到規(guī)定的滅菌效果。 </p> <p> 驗證范圍 </p> <p> 1.高壓電熱壓力蒸汽消毒器安裝狀況檢查； </p> <p> 2.高壓電熱壓力蒸汽消毒器運行確認； </p> <p> 3.高壓電熱壓力蒸汽消毒器性能確認，含連續(xù)三次的空載、滿載測試、挑戰(zhàn)性測試湖南倉庫管理系統(tǒng)滅菌柜驗證公司旦霆科技作為國內(nèi)**的綜合性驗證咨詢公司，專業(yè)解答各種設備驗證及偏差處理等相關問題，歡迎您的垂詢！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北溫度監(jiān)測系統(tǒng)滅菌柜驗證質量保證,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295260507813/6024456.png"></div><p> 設計確認 </p> <p> <br /> </p> <p> 在CNAS-GL040:2019的儀器驗證中，將滿足用戶需求作為**重要的指標，因此在儀器購買前，用戶就必須編制儀器采購技術文件（軟件和硬件），提出所需采購儀器設備的使用條件和技術參數(shù)及性能要求，同時還要對供應商進行評價，這與“4Q驗證”中的設計確認相類似，設計確認就是客戶確認儀器能否滿足自己需求的過程。 </p> <p> <br /> </p> <p> 但在實驗室實際的設計確認過程中，實驗室往往對自己的需求并不了解，或沒有明確的技術指標，導致實際的設計確認過程均以儀器供應商提供的技術參數(shù)作為設計確認的依據(jù)，設計確認及用戶需求說明變得可有可無了。實際上實驗室的儀器技術文件不**是確認儀器參數(shù)能否滿足自身需求的文件，同時也是儀器整個生命周期中進行驗證的重要依據(jù)。 </p> <p> <br /> </p><p> 性能確認的目的是驗證設備的穩(wěn)定性。驗證設備穩(wěn)定的方法一般為連續(xù)生產(chǎn)三批，當此三批產(chǎn)品均合格，且合格率、操作參數(shù)均穩(wěn)定時，即認為設備是合格的。同時進一步確認操作參數(shù)。當設備合格后，就可以進入設備管理的下一個階段。如果設備驗證的結果顯示不合格，則按照設備管理中的報廢或降級使用等規(guī)定進行。 </p> <p> 設備使用管理，主要從人、機、料、法、環(huán)五個方面來進行，基本為設備的安裝確認、運行確認和性能確認的綜合。人是指操作者應經(jīng)過培訓，會操作、維護且按照要求進行；機指設備驗證合格后的完好性；料指合格的物料（指使用此設備的物料工藝經(jīng)過驗證且工藝合格）；法指正確的操作、維護方法；環(huán)指設備工作的環(huán)境（安裝過程中應確認）。通過設備使用管理和安裝管理，就可以規(guī)范設備的驗證工作。通過運行確認，確定設備是合格的，設備能夠生產(chǎn)出合格的產(chǎn)品；通過性能確認，確定設備是穩(wěn)定的，設備能夠連續(xù)生產(chǎn)出合格的產(chǎn)品；通過運行確認、性能確認，確定設備的操作、維護方法，在此要求下，能夠使設備維持在驗證時的狀態(tài)。 </p> <p> <br /> 旦霆科技年度營業(yè)額以50%的速度高速增長，逐漸成為為數(shù)不多的中大型儀器設備驗證測試服務的綜合性公司。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北溫度監(jiān)測系統(tǒng)滅菌柜驗證質量保證,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293616376954/1769054.png"></div><p> 滅菌器驗證方案（目錄） </p> <p> 一、概述 </p> <p> 二、驗證目的 </p> <p> 三、驗證范圍 </p> <p> 四、驗證組織與職責 </p> <p> 五、驗證進度計劃 </p> <p> 六、驗證程序 </p> <p> 1.安裝檢查 </p> <p> 1.1安裝檢查所需文件的檢查 </p> <p> 1.2安全情況檢查 </p> <p> 2.運行確認 </p> <p> 3.性能測試 </p> <p> 3.1消毒效果判斷標準 </p> <p> 3.2空載測試 </p> <p> 3.3滿載性能測試 </p> <p> 3.4挑戰(zhàn)性實驗 </p> <p> 七、文件的匯總和審批 </p> <p> 八、再驗證 </p> <p> 滅菌器驗證方案 </p> <p> 一、概述 </p> <p> 滅菌器主要用于生產(chǎn)過程中潔凈工作服、器械、無菌衣、培養(yǎng)基以及廢棄物等的濕熱滅菌，此次驗證的設備為電熱壓力蒸汽消毒器，滅菌器使用飽和蒸汽滅菌，本次驗證的主要是確認在121°C20分鐘的滅菌條件下能否達到滅菌效果。旦霆科技對驗證測試工程師進行培訓拓展及考核晉級，為向客戶提供更專業(yè)的設備驗證檢測服務而不斷邁進。廣東旦霆生物科技有限公司滅菌柜驗證質量保證</p><p style="text-indent:25px">旦霆科技作為專業(yè)的設備驗證及第三方檢測供應商，取得良好的客戶口碑，我們繼續(xù)保持高水準服務全國。湖北溫度監(jiān)測系統(tǒng)滅菌柜驗證質量保證</p><p> 驗證程序 </p> <p> 安全情況檢查 </p> <p> 對腔室內(nèi)膽材料，壓力及溫度只是指示表進行檢查和校驗，檢查電源是否正常，電路線有無裸露，并對安全閥和放氣閥進行檢查，以確保所有的操作均能在安全狀態(tài)下進行。 </p> <p> 運行確認 </p> <p> 在空載情況下檢查設備各部分功能是否正常，蓋子接口無泄漏； </p> <p> 消毒器內(nèi)泄漏試驗：將消毒器蓋子、放氣閥關閉，送氣升至0.11Mpa，關掉電源，10min內(nèi)壓力變化，不得大于0.01Mpa。 </p> <p> 檢查排期暢通情況和儀表顯示情況。 </p> <p> 性能測試 </p> <p> 性能測試標準 </p> <p> 空載測試：檢查滅菌箱腔內(nèi)的熱分布情況，檢查箱腔內(nèi)可能存在的冷點。各留點溫度計在119°C-123°C之間。 </p> <p> </p> <p> <br /> </p> <p> <br /> </p> <p> <br /> 湖北溫度監(jiān)測系統(tǒng)滅菌柜驗證質量保證</p><p> 旦霆生物科技（上海）有限公司是一家為制藥、化工、化妝品、保健食品、制藥設備等行業(yè)提供GXP合規(guī)咨詢、驗證服務以及培訓的綜合性咨詢公司； </p> <p> 旦霆公司長期致力于幫助企業(yè)順利通過FDA EU TGA WHO CFDA等機構的GMP認證檢查； </p> <p> 公司成員多來自于**外資制藥企業(yè)、外資GMP咨詢公司、及國內(nèi)**的第三方檢測公司。 </p> <p> 作為以慈善事業(yè)為使命的旦霆公司堅持以超值的品質為客戶提供服務，同時公司每年利潤的10%捐獻給中國貧困兒童，持久資助中國貧困兒童的教育。 </p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/3064771.html</p></div></div></div></div></div><div id="2h3icjb" class="page-right twoColRt"><div id="w77numd" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="877gipm" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img src="http://tyunfile.71360.com/UpLoadFile/2019/11/1/14/637082168864691056_lgpj_5374157.jpg" alt="福建ZF配件哪家強信息推薦自業(yè)物資供應" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></div><p>福建ZF配件哪家強信息推薦自業(yè)物資供應</p></a></div><div id="gaskmol" class="recomPic likePro"><a 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