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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>?湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</p><div id="2ubtdzq" class="leftbox clearfix"><h1>湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</h1><div id="vegyf22" class="proBig"><div id="yliaxel" class="bigimg"><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 id="bz83m8z" 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="nlah8np" 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>湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-13 01:07:09</p><p><span id="click" >瀏覽次數(shù)：2次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="unaxeqx" 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="bjqd3gs" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="37i8s4q" class="box"><p><p> 設(shè)備預(yù)確認(rèn)，在設(shè)備管理中，即是檢查設(shè)備的論證選型報告、購置合同，湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司。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，湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司，湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司。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 /> 旦霆科技嚴(yán)謹(jǐn)?shù)尿?yàn)證P&T&R，嚴(yán)格的方案報告審核制度，降低報告錯誤率，減少客戶工作量。湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295655537110/1711470.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)對儀器設(shè)備的要求，是針對儀器設(shè)備的更***、具體管理指導(dǎo)性文件。 </p> <p> 本文件對儀器驗(yàn)證各階段具體實(shí)施提供了指南，注重儀器對預(yù)期用途的適用性，可用于常規(guī)檢測實(shí)驗(yàn)室對各類儀器的管理。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。安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證旦霆科技不但擁有龐大的驗(yàn)證及檢測團(tuán)隊(duì)，同時配備幾百套驗(yàn)證及檢測儀器，專業(yè)開展滅菌柜驗(yàn)證服務(wù)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295583876954/6963779.png"></div><p> 1. 溫度類：超低溫冰箱（-80℃）、低溫冰箱、陰涼柜、生化培養(yǎng)箱、霉菌培養(yǎng)箱、二氧化碳培養(yǎng)箱、搖床、二氧化碳搖床、穩(wěn)定性試驗(yàn)箱、水浴鍋、滅菌鍋/滅菌器、干熱滅菌柜、烘箱、熱風(fēng)循環(huán)烘箱等等 </p> <p> 2. 凈化環(huán)境類：超凈工作臺（潔凈工作臺）、生物安全柜、隔離器、RABS、層流罩、層流車、通風(fēng)廚等等 </p> <p> 3. 光譜色譜類：高效液相色譜儀、氣相色譜儀、紫外可見分光光度計、紅外分光光度計、原子吸收分光光度計、液質(zhì)聯(lián)用儀等等 </p> <p> 4. 生物/細(xì)胞/蛋白類：細(xì)胞計數(shù)器、PCR儀、酶標(biāo)儀、蛋白純化儀、程序降溫儀、電泳儀、凝膠成像儀、滲透壓儀、流式細(xì)胞儀、臺式離心機(jī)、冷凍離心機(jī)等等 </p> <p> 5. 其它類：電子天平、分析天平、PH計、電導(dǎo)率儀、顯微鏡、菌落計數(shù)器等等 </p> <p> 服務(wù)內(nèi)容：針對以上儀器，旦霆科技可提供計算機(jī)化系統(tǒng)驗(yàn)證（CSV）、風(fēng)險評估（RA）、3Q確認(rèn)（3Q驗(yàn)證）以及相關(guān)測試服務(wù)。 </p> <p> <br /> </p><p> 濕熱滅菌溫度驗(yàn)證對驗(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，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(jìn)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(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(中國臺灣固緯)、Validator2000(北京祥鴻) 等溫度驗(yàn)證儀。旦霆科技服務(wù)面向全國、設(shè)備驗(yàn)證項(xiàng)目均安排項(xiàng)目經(jīng)理，對項(xiàng)目質(zhì)量、質(zhì)量、進(jìn)度及時監(jiān)督。保證項(xiàng)目質(zhì)量！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293616376954/1769054.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 /> 計算機(jī)化系統(tǒng)驗(yàn)證服務(wù)選旦霆科技，服務(wù)專業(yè)到位，值得信賴！湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司</p><p style="text-indent:25px">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)。湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司</p><p> <strong></strong>溫度驗(yàn)證的功能測試步驟 </p> <p> <br /> </p> <p> <br /> </p> <p> 由此技術(shù)設(shè)計要求出發(fā)，演化成為目前國內(nèi)***采用的濕熱溫度驗(yàn)證的大容量注射劑實(shí)驗(yàn)方法和實(shí)驗(yàn)器具,也是溫度驗(yàn)證程序設(shè)計的基本要求。使用其作功能測試步驟及參考設(shè)備如下： </p> <p> <br /> </p> <p> 1. 熱分布測試 </p> <p> <br /> </p> <p> 目的：找出**冷點(diǎn)位置，檢驗(yàn)重現(xiàn)性。步驟：(1)設(shè)備儀器校正；(2)熱電偶分布圖；(3)空載熱分布實(shí)驗(yàn)，3次以上；(4)熱電偶插入圖；(5)裝載（模擬生產(chǎn)裝載比較大，**小量）熱分布實(shí)驗(yàn)，各3次以上。 </p> <p> <br /> </p> <p> 2. 熱穿透測試 </p> <p> <br /> </p> <p> 目的：肯定滅菌過程中被測試各點(diǎn)獲得無菌保證值，特別是**冷點(diǎn)位置的F0 值,監(jiān)測檢驗(yàn)重現(xiàn)性。步驟：(1)設(shè)備校正；(2)模擬生產(chǎn)滅菌裝載；(3)熱電偶裝載圖；(4)同品同規(guī)產(chǎn)品比較大與**小裝載熱穿透實(shí)驗(yàn)，每狀態(tài)3次以上。 </p> <p> <br /> </p> <p> 3. 生物指示劑測試 </p> <p> <br /> </p> <p> 目的：挑戰(zhàn)性模擬生產(chǎn)可能因素造成的微生物污染程度來檢驗(yàn)滅菌可靠性，對驗(yàn)證設(shè)計進(jìn)行檢驗(yàn)。步驟：(1)方案的設(shè)計制定；(2)生物指示劑菌株的選擇，測定D值；(3)標(biāo)定濃度和制定樣品；(4)接種，裝載；(5)低限滅菌(每產(chǎn)品，每規(guī)格每種滅菌程序至少3次以上）；(6)樣品的培養(yǎng)與鑒別；(7)評價結(jié)論（數(shù)據(jù)，樣品分析）。 </p> <p> <br /> </p> <p> 4. 偏差與調(diào)整 </p> <p> <br /> </p> <p> 重新設(shè)計后，重復(fù)上面步驟。 </p> <p> <br /> </p> <p> 5. 填寫驗(yàn)證實(shí)驗(yàn)報告書 </p> <p> <br /> 湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司</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(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/2818556.html</p></div></div></div></div></div><div id="ecprd78" class="page-right twoColRt"><div id="rk2s2oq" class="box01 margin10 clearfix"><h3><a 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