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class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295655537110/1711470.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="dnm4i8d" 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(guān)鍵詞：</span>浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障,滅菌柜驗證</p><p><span>***更新：</span>2021-02-02 01:04:57</p><p><span id="click" >瀏覽次數(shù)：0次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="cw9qnzb" 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="e7dxoar" class="page-proshow02"><p class="title">詳細說明</p><div id="lfzv3v8" class="box"><p><p> 滿載性能測試 </p> <p> 裝載類型：比較大裝載、滿載。 </p> <p> 裝載物：廢物 </p> <p> 測試過程：在比較大裝載情況下，取9支經(jīng)過校驗的標準留點溫度計，將一支置于進氣口處，一支置于排氣口處，一支置于滅菌器溫度計測試點旁，其余溫度計置于滅菌腔中（如熱均勻分布圖）。 </p> <p> 目的 </p> <p> 生物指示劑測試：在比較大負載情況下（占滅菌容積的2/3）測試，將高壓物品均勻放置在腔室內(nèi)各處，不接觸腔室內(nèi)壁。在高壓電熱壓力蒸汽消毒器腔體內(nèi)放置生物指示卡，浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障，按照壓力消毒器運行的標準操作程序，浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障，121°C20分鐘運行消毒。滿載測試應(yīng)連續(xù)進行3次，以檢驗其重現(xiàn)性。分析滅菌效果，浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障。 </p> <p> 在滿載情況下驗證121°C20分鐘的滅菌條件能否達到滅菌效果。旦霆科技團隊成員掌握國內(nèi)為GMP、國標、ISO等相關(guān)法規(guī)，可為相關(guān)企業(yè)開展滅菌柜驗證等服務(wù)。浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295655537110/1711470.png"></div><p> 滅菌器驗證程序 </p> <p> 安裝檢查 </p> <p> 1.1 安裝檢查所需文件的檢查： </p> <p> 1.1.1 高壓電熱壓力蒸汽消毒器使用說明書的檢查：檢查是否有儀器的說明書，說明書與儀器是否配套。 </p> <p> 1.1.2 相關(guān)儀器儀表校驗記錄的檢查：檢查校驗記錄是否完整，是否定期進行校驗。 </p> <p> 1.1.3 高壓電熱壓力蒸汽消毒器使用標準操作規(guī)程的檢查：檢查是否具有相應(yīng)的標準操作規(guī)程。 </p> <p> 1.1.4 高壓電熱壓力蒸汽消毒器維修保養(yǎng)記錄的檢查：檢查儀器的維修保養(yǎng)記錄是否齊全，儀器是否定期進行相應(yīng)的維修保養(yǎng)。 </p> <p> 1.1.5 高壓電熱壓力蒸汽消毒器使用記錄的檢查，檢查使用記錄是否完整。 </p> <p> <br /> 浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障旦霆科技不忘初心，持續(xù)資助中國貧困兒童教育的同時，持續(xù)以高性價比為國內(nèi)企業(yè)提供滅菌柜驗證與咨詢服務(wù).</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295736738282/6333870.png"></div><p> 每個行業(yè)公司為啥要校準，測量，檢測，驗證？哪些儀器需要強檢？什么是CNAS認證？ </p> <p> <br /> </p> <p> 為什么要校準，測量，檢測儀器設(shè)備？ </p> <p> <br /> </p> <p> 本質(zhì)原因：全球經(jīng)濟一體化，企業(yè)生產(chǎn)、貿(mào)易、結(jié)算等都需要統(tǒng)一標準。測量儀器用于生產(chǎn)制造的品質(zhì)控制，對它進行校準，滿足了生產(chǎn)制造統(tǒng)一標準的要求。 </p> <p> <br /> </p> <p> 表面原因：客戶審廠需要查看測量儀器是否有校準，審廠一般有ISO、CCC、UL、TUV、以及其它的客戶審廠。 </p> <p> <br /> </p> <p> 全世界的測量儀器都要驗證，所以說，校準是剛需，一年至少一次。 </p> <p> <br /> </p><p> 滅菌柜的原理： </p> <p> <br /> </p> <p> 1 干熱滅菌柜，結(jié)合國外制造經(jīng)驗優(yōu)勢，精心設(shè)計開發(fā)，為國內(nèi)制藥企業(yè)采用，符合GMP改造要求。 </p> <p> <br /> </p> <p> 2 干熱滅菌柜采用PLC控制，具備手/自動功能，觸摸屏人機界面，有雙重加熱保護功能。 </p> <p> <br /> </p> <p> 3 設(shè)計比較高工作溫度可達350℃，設(shè)備空載熱分布可以達到±3℃，高效通過DOP測試，塵埃粒子測試，箱內(nèi)達到百級狀態(tài)。 </p> <p> <br /> </p> <p> 4 干熱滅菌柜設(shè)備采用滿焊結(jié)構(gòu)，內(nèi)部拋光，Ra≤0.4 ，無死角，無銳角。 </p> <p> <br /> </p> <p> 5 裝置上留有GMP驗證接口。 </p> <p> <br /> </p> <p> 6 干熱滅菌柜產(chǎn)品可供用戶選擇，在配置和尺寸方面也可根據(jù)用戶用途、場地、產(chǎn)量等定制。 </p> <p> <br /> 旦霆科技擁有專業(yè)的驗證及檢測服務(wù)團隊、專業(yè)提供滅菌柜驗證等服務(wù)，因為專業(yè)所以值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294414755860/4492022.png"></div><p> 驗證組織和職責 </p> <p> 1.驗證組織 </p> <p> 成立驗證小組，由以下部門及人員參加 </p> <p> 驗證組長 </p> <p> 生產(chǎn)部： </p> <p> 設(shè)備部： </p> <p> 2.職責與分工 </p> <p> 驗證組長：負責驗證方案的起草，并負責組織實施進行壓力消毒器驗證。負責驗證期間各項工作的協(xié)調(diào)。 </p> <p> 生產(chǎn)部：負責按照要求對壓力容器進行操作和日常保養(yǎng)。 </p> <p> 設(shè)備部：負責壓力容器的指導和驗證物品的準備。 </p> <p> 驗證進度計劃 </p> <p> 驗證活動分為2階段完成，規(guī)定日期如下： </p> <p> 階段1：2020年2月2日——2020年3月3日安裝確認 </p> <p> 階段2：2020年3月4日——2020年4月3日運行及性能確認 </p> <p> <br /> 旦霆科技是國內(nèi)業(yè)內(nèi)口碑良好的為制藥及醫(yī)療器械等相關(guān)行業(yè)提供3Q認證服務(wù)的專業(yè)第三方咨詢公司。浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障</p><p style="text-indent:25px">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(shè)備驗證及偏差處理等相關(guān)問題，歡迎您的垂詢！浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障</p><p> 濕熱滅菌溫度驗證對驗證儀器的基本要求 </p> <p> 按前所述溫度驗證程序設(shè)計要求的技術(shù)原則的五方面內(nèi)容，驗證設(shè)備可包括三部分：(1)測溫元件；(2)測溫編輯記錄儀器；(3)輔助校正儀器。 </p> <p> 測溫元件 </p> <p> 測溫元件采用敏感的多枝精密鉑電阻或電偶組成，原理如圖1。接線較長可以**的擺放在滅菌設(shè)備中選定位置，每支的誤差在±0.5℃以下的測試精度范圍。 </p> <p> 校正時，發(fā)生誤差越程件應(yīng)篩選。這是因為誤差越程后在后面的計算中將導致 F0 偏離，容易帶來誤判結(jié)果。 </p> <p> 電偶是溫度到勢能的變換器，而電阻是溫度到阻值的變換器，兩者在輸出的信號上是不同的。從輸出特性靈敏度看精密鉑電阻（RTD）為優(yōu)。從測溫范圍上比較（-180~2000℃），價性比上熱電偶較優(yōu)。 </p> <p> 目前開發(fā)先進的儀器采用無線信號傳送作為測溫元件。測溫記錄儀就近接收發(fā)來的每一個信號，自動完成轉(zhuǎn)換和記錄、存儲，但造價昂貴，特別小氣，保管有特別的要求, 目前針對旋轉(zhuǎn)釜國內(nèi)已有使用。在滅菌釜的實際溫度驗證實驗儀器上，國內(nèi)外已經(jīng)開發(fā)和生產(chǎn)出成熟的部件和比較先進的儀器，如GE.Kaye（US）、raytek（US）、 Sakura 、multi(Japen) 、Schlumbergez(England) 、 Goodwill(中國臺灣固緯)、Validator2000(北京祥鴻) 等溫度驗證儀。浙江ELN系統(tǒng)滅菌柜驗證品質(zhì)保障</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(shè)備等行業(yè)提供GXP合規(guī)咨詢、驗證服務(wù)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(gòu)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(zhì)為客戶提供服務(wù)，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: 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