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class="twoCol"><div id="ku8e3ax" class="page-proshow clearfix"><p class="current"> 當(dāng)前位置:<a href="http://www.cdcfah.com/">首頁?<a href="http://www.cdcfah.com/cp/">產(chǎn)品供應(yīng)</a>?<a href="http://www.cdcfah.com/cp/second-_yyby/">醫(yī)藥健康</a>?<a href="http://www.cdcfah.com/cp/third-yyby_qtflft/">其他未分類</a>?福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù) 創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</p><div id="3cu3zrt" class="leftbox clearfix"><h1>福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù) 創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</h1><div id="vfcjlx7" class="proBig"><div id="8vskbds" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295339033204/3936007.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="crjqxz3" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295339033204/3936007.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="dhjbdaz" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價(jià)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>福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù),滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-02-05 02:04:43</p><p><span id="click" >瀏覽次數(shù)：3次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="87wwdeb" 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(jī): </span>021-59882315</p><p><span>地址: </span>上海市青浦區(qū)華徐公路966號(hào)法姬娜大廈B323室，325室</p><p>[當(dāng)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="zovsz2u" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="ds2hgco" class="box"><p><p> 驗(yàn)證組織和職責(zé) </p> <p> 1.驗(yàn)證組織 </p> <p> 成立驗(yàn)證小組，由以下部門及人員參加 </p> <p> 驗(yàn)證組長 </p> <p> 生產(chǎn)部： </p> <p> 設(shè)備部： </p> <p> 2.職責(zé)與分工 </p> <p> 驗(yàn)證組長：負(fù)責(zé)驗(yàn)證方案的起草，福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù)，并負(fù)責(zé)組織實(shí)施進(jìn)行壓力消毒器驗(yàn)證。負(fù)責(zé)驗(yàn)證期間各項(xiàng)工作的協(xié)調(diào)。 </p> <p> 生產(chǎn)部：負(fù)責(zé)按照要求對(duì)壓力容器進(jìn)行操作和日常保養(yǎng)。 </p> <p> 設(shè)備部：負(fù)責(zé)壓力容器的指導(dǎo)和驗(yàn)證物品的準(zhǔn)備。 </p> <p> 驗(yàn)證進(jìn)度計(jì)劃 </p> <p> 驗(yàn)證活動(dòng)分為2階段完成，福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù)，福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù)，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(rèn) </p> <p> 階段2：2020年3月4日——2020年4月3日運(yùn)行及性能確認(rèn) </p> <p> <br /> 旦霆科技可與客戶開展遠(yuǎn)程技術(shù)交流，解決難題為雙方良好合作打下扎實(shí)基礎(chǔ)，提供滅菌柜驗(yàn)證等技術(shù)服務(wù)。福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù)</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù),滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295339033204/3936007.png"></div><p> 本文件主要依據(jù)ISO/IEC 17025標(biāo)準(zhǔn)和USP1058《分析儀器驗(yàn)證指導(dǎo)原則》編制，同時(shí)參考了我國的《藥品生產(chǎn)質(zhì)量管理規(guī)范 (2010 年修訂 )》等有關(guān)文件，可為實(shí)驗(yàn)室規(guī)范儀器設(shè)備管理提供指導(dǎo)。本文件滿足 ISO/IEC 17025 標(biāo)準(zhǔn)對(duì)儀器設(shè)備的要求，是針對(duì)儀器設(shè)備的更***、具體管理指導(dǎo)性文件。 </p> <p> 本文件對(duì)儀器驗(yàn)證各階段具體實(shí)施提供了指南，注重儀器對(duì)預(yù)期用途的適用性，可用于常規(guī)檢測實(shí)驗(yàn)室對(duì)各類儀器的管理。為給實(shí)驗(yàn)室施證提供具體指導(dǎo)，本文件以目前檢測實(shí)驗(yàn)室中使用較為***的液相色譜儀例，提供了實(shí)施儀器驗(yàn)證的具體范例。北京電子監(jiān)管碼系統(tǒng)滅菌柜驗(yàn)證咨詢旦霆科技在提供高質(zhì)量服務(wù)的同時(shí)為眾多客戶解決項(xiàng)目偏差、驗(yàn)證偏差等問題。以保證3Q認(rèn)證服務(wù)的順利進(jìn)行。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù),滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294640087891/7436443.png"></div><p> 滅菌器驗(yàn)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(yàn)記錄的檢查：檢查校驗(yàn)記錄是否完整，是否定期進(jìn)行校驗(yàn)。 </p> <p> 1.1.3 高壓電熱壓力蒸汽消毒器使用標(biāo)準(zhǔn)操作規(guī)程的檢查：檢查是否具有相應(yīng)的標(biāo)準(zhǔn)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(jìn)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 /> </p><p> 設(shè)備預(yù)確認(rèn)，在設(shè)備管理中，即是檢查設(shè)備的論證選型報(bào)告、購置合同。通過設(shè)備的論證選型，確認(rèn)設(shè)備的合格、廠家選擇的合理、設(shè)備運(yùn)行的經(jīng)濟(jì)。同樣，通過設(shè)備預(yù)確認(rèn)，完善設(shè)備前期管理工作，包括論證選型報(bào)告齊全（設(shè)備選型依據(jù)、原則等）、購置合同完整并整理歸檔保管等。 </p> <p> 設(shè)備安裝確認(rèn)，通過設(shè)備的基礎(chǔ)安裝、安裝環(huán)境、管道色標(biāo)管理等方面進(jìn)行規(guī)范。并填寫設(shè)備開箱驗(yàn)收記錄、安裝驗(yàn)收記錄等，并將隨機(jī)資料收集整理保管。在設(shè)備管理中，針對(duì)設(shè)備安裝的要求包括：設(shè)備開箱驗(yàn)收管理、設(shè)備安裝管理、色標(biāo)管理等。在此需要補(bǔ)充的是：與設(shè)備相關(guān)的儀器儀表應(yīng)經(jīng)過校驗(yàn)確認(rèn)。 </p> <p> <br /> 旦霆科技作為專業(yè)驗(yàn)證檢測供應(yīng)商，具備CMA資質(zhì)，專業(yè)提供滅菌柜驗(yàn)證服務(wù)，是您放心的選擇！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù),滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295583876954/6963779.png"></div><p> 濕熱滅菌溫度驗(yàn)證對(duì)驗(yàn)證儀器的基本要求 </p> <p> 按前所述溫度驗(yàn)證程序設(shè)計(jì)要求的技術(shù)原則的五方面內(nèi)容，驗(yàn)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(shí)，發(fā)生誤差越程件應(yīng)篩選。這是因?yàn)檎`差越程后在后面的計(jì)算中將導(dǎo)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(hào)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(jià)性比上熱電偶較優(yōu)。 </p> <p> 目前開發(fā)先進(jìn)的儀器采用無線信號(hào)傳送作為測溫元件。測溫記錄儀就近接收發(fā)來的每一個(gè)信號(hào)，自動(dòng)完成轉(zhuǎn)換和記錄、存儲(chǔ)，但造價(jià)昂貴，特別小氣，保管有特別的要求, 目前針對(duì)旋轉(zhuǎn)釜國內(nèi)已有使用。在滅菌釜的實(shí)際溫度驗(yàn)證實(shí)驗(yàn)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(jìn)的儀器，如GE.Kaye（US）、raytek（US）、 Sakura 、multi(Japen) 、Schlumbergez(England) 、 Goodwill(中國臺(tái)灣固緯)、Validator2000(北京祥鴻) 等溫度驗(yàn)證儀。旦霆科技擁有專業(yè)的驗(yàn)證及檢測服務(wù)團(tuán)隊(duì)、專業(yè)提供滅菌柜驗(yàn)證等服務(wù)，因?yàn)閷I(yè)所以值得信賴！北京電子監(jiān)管碼系統(tǒng)滅菌柜驗(yàn)證咨詢</p><p style="text-indent:25px">旦霆科技專業(yè)為國內(nèi)制藥行業(yè)提供滅菌柜驗(yàn)證服務(wù)、第三方測試執(zhí)行以及技術(shù)支持。福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù)</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(yàn)的標(biāo)準(zhǔn)留點(diǎn)溫度計(jì)，將一支置于進(jìn)氣口處，一支置于排氣口處，一支置于滅菌器溫度計(jì)測試點(diǎn)旁，其余溫度計(jì)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(fù)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，按照壓力消毒器運(yùn)行的標(biāo)準(zhǔn)操作程序，121°C20分鐘運(yùn)行消毒。滿載測試應(yīng)連續(xù)進(jìn)行3次，以檢驗(yàn)其重現(xiàn)性。分析滅菌效果。 </p> <p> 在滿載情況下驗(yàn)證121°C20分鐘的滅菌條件能否達(dá)到滅菌效果。福建WMS系統(tǒng)滅菌柜驗(yàn)證服務(wù)</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(yàn)證服務(wù)以及培訓(xùn)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(jī)構(gòu)的GMP認(rèn)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(jiān)持以超值的品質(zhì)為客戶提供服務(wù)，同時(shí)公司每年利潤的10%捐獻(xiàn)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/3164522.html</p></div></div></div></div></div><div id="kjln8ol" class="page-right twoColRt"><div id="m3bdvxz" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="c8mov7w" 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(qiáng) 信息推薦自業(yè)物資供應(yīng)" class="vcenter" 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