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tcPro"><section class="home-main container clearfix"><div id="jmjvsmy" class="twoCol"><div id="ut7z8bw" class="page-proshow clearfix"><p class="current"> 當(dāng)前位置:<a href="http://www.cdcfah.com/">首頁(yè)?<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(lèi)</a>?湖南LIMS系統(tǒng)滅菌柜驗(yàn)證創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</p><div id="enfhev7" class="leftbox clearfix"><h1>湖南LIMS系統(tǒng)滅菌柜驗(yàn)證創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</h1><div id="en7tdub" class="proBig"><div id="gkhoac8" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294585517579/5207058.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="hk2likh" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294585517579/5207058.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="gkcj77g" 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>湖南LIMS系統(tǒng)滅菌柜驗(yàn)證,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-02-03 04:05:25</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="ae3p8z7" 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(huà): </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="kykrvm3" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="kipr3su" class="box"><p><p> 3Q內(nèi)容 </p> <p> 如果是一套完整的儀器(或設(shè)備)驗(yàn)證方案，將包括4個(gè)部分，即4Q，湖南LIMS系統(tǒng)滅菌柜驗(yàn)證，分別為： </p> <p> DQ，設(shè)計(jì)確認(rèn)(Design Qualification)，確認(rèn)設(shè)備的設(shè)計(jì)符合用戶(hù)需求規(guī)范及相關(guān)法規(guī)。 </p> <p> IQ，安裝確認(rèn)(Installation Qualification)，確認(rèn)儀器文件、部件及安裝過(guò)程。 </p> <p> OQ，運(yùn)行確認(rèn)(Operational Qualification)，確認(rèn)儀器在空轉(zhuǎn)狀態(tài)下，在操作的極限范圍內(nèi)能作正常的運(yùn)轉(zhuǎn)。 </p> <p> PQ，性能確認(rèn)(Performance Qualification)，確認(rèn)儀器載樣運(yùn)行下是否符合標(biāo)準(zhǔn)規(guī)定。 </p> <p> 由于實(shí)驗(yàn)室所用儀器均有儀器廠家研發(fā)設(shè)計(jì)而成，因此DQ(設(shè)計(jì)確認(rèn))在儀器驗(yàn)證中可以不做，所以本文所提3Q，是指以上IQ(安裝確認(rèn))、OQ(運(yùn)行確認(rèn))、PQ(性能確認(rèn))。也就是說(shuō)實(shí)驗(yàn)室儀器驗(yàn)證是從IQ(安裝確認(rèn))做起，湖南LIMS系統(tǒng)滅菌柜驗(yàn)證，再做OQ(運(yùn)行確認(rèn))、PQ(性能確認(rèn))，就完成了一套儀器驗(yàn)證的整套資料，湖南LIMS系統(tǒng)滅菌柜驗(yàn)證。 </p> <p> <br /> 著眼質(zhì)量，靜思細(xì)量，旦霆科技為您提供專(zhuān)業(yè)的計(jì)算機(jī)化系統(tǒng)驗(yàn)證服務(wù)，為您的合規(guī)之路保駕護(hù)航！湖南LIMS系統(tǒng)滅菌柜驗(yàn)證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖南LIMS系統(tǒng)滅菌柜驗(yàn)證,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294585517579/5207058.png"></div><p> 滅菌柜的原理： </p> <p> <br /> </p> <p> 1 干熱滅菌柜，結(jié)合國(guó)外制造經(jīng)驗(yàn)優(yōu)勢(shì)，精心設(shè)計(jì)開(kāi)發(fā)，為國(guó)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(dòng)功能，觸摸屏人機(jī)界面，有雙重加熱保護(hù)功能。 </p> <p> <br /> </p> <p> 3 設(shè)計(jì)比較高工作溫度可達(dá)350℃，設(shè)備空載熱分布可以達(dá)到±3℃，高效通過(guò)DOP測(cè)試，塵埃粒子測(cè)試，箱內(nèi)達(dá)到百級(jí)狀態(tài)。 </p> <p> <br /> </p> <p> 4 干熱滅菌柜設(shè)備采用滿(mǎn)焊結(jié)構(gòu)，內(nèi)部拋光，Ra≤0.4 ，無(wú)死角，無(wú)銳角。 </p> <p> <br /> </p> <p> 5 裝置上留有GMP驗(yàn)證接口。 </p> <p> <br /> </p> <p> 6 干熱滅菌柜產(chǎn)品可供用戶(hù)選擇，在配置和尺寸方面也可根據(jù)用戶(hù)用途、場(chǎng)地、產(chǎn)量等定制。 </p> <p> <br /> 湖南旦霆科技滅菌柜驗(yàn)證驗(yàn)證咨詢(xún)旦霆科技為提升各項(xiàng)目質(zhì)量水平，成立質(zhì)量部門(mén)。為滅菌柜驗(yàn)證等驗(yàn)證及檢測(cè)服務(wù)保駕護(hù)航！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖南LIMS系統(tǒng)滅菌柜驗(yàn)證,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295189746094/9212985.png"></div><p> 滅菌柜驗(yàn)證操作過(guò)程 </p> <p> (1)驗(yàn)證用的儀器，主要由三部分組成：高精度的測(cè)溫探頭、用微機(jī)制成的測(cè)溫和傳送集成系統(tǒng)以及手提電腦。 </p> <p> (2)使用以前當(dāng)然就是要進(jìn)行校正。 </p> <p> (3)校正完了以后就按照布點(diǎn)圖進(jìn)行布點(diǎn)。1)空載熱分布是指柜內(nèi)不放任何玻璃瓶，只放空的滅菌架進(jìn)入腔體；2)滿(mǎn)載熱分布是指按比較大裝載量把玻璃瓶放滿(mǎn)滅菌架中，然后探頭是放于瓶外去測(cè)溫，看瓶外的溫度變化；3)滿(mǎn)載熱穿透的玻璃瓶放置方法和跟滿(mǎn)載熱分布一樣，只是溫度檢測(cè)探頭的位置不一樣，滿(mǎn)載熱穿透是把探頭放置于盛滿(mǎn)藥液或水的瓶子中緊固，用于探測(cè)瓶?jī)?nèi)溫度。 </p> <p> 以上每個(gè)階段都需要進(jìn)行至少連續(xù)運(yùn)行3次。這里需要注意的是不同的規(guī)格都需要按比較大裝載量去放置，而且要按正常滅菌的程序進(jìn)行滅菌，不然就失去驗(yàn)證的意義了，而我們?cè)谶@個(gè)過(guò)程只需要觀察數(shù)據(jù)就可以了。 </p> <p> 還有用生物指示劑進(jìn)行挑戰(zhàn)性試驗(yàn)，生物指示劑的選用可根據(jù)藥典，但應(yīng)強(qiáng)調(diào)所用生物指示劑的耐熱性應(yīng)大于產(chǎn)品中常見(jiàn)污染菌的耐熱性，用量也應(yīng)大于產(chǎn)品中該污染菌的水平，經(jīng)生物指示劑驗(yàn)證后，應(yīng)能證明在設(shè)定的F0值條件下，產(chǎn)品的無(wú)菌保證水平低于10－6。 </p> <p> (4)***驗(yàn)證完要對(duì)溫度探頭進(jìn)行再次校正，驗(yàn)證前后偏差均應(yīng)小于0.5℃為合格。 </p> <p> <br /> </p><p> 設(shè)備的驗(yàn)證可以說(shuō)是每個(gè)行業(yè)在投入到批量生產(chǎn)前都必須要做的，后期也要根據(jù)產(chǎn)品設(shè)備的反饋情況來(lái)進(jìn)行設(shè)備的抽查檢測(cè)，不斷的完善設(shè)備的性能提高用戶(hù)的滿(mǎn)意度，那么具體如何操作***給大家介紹一下。 </p> <p> 檢測(cè)試用預(yù)確認(rèn)、安裝確認(rèn)、運(yùn)行確認(rèn)、性能確認(rèn)組成，所以再驗(yàn)證的范圍很廣 </p> <p> 設(shè)備可以的運(yùn)作通常需要硬件和軟件的配合，硬件按照軟件設(shè)定的程序來(lái)運(yùn)行，硬件問(wèn)題是會(huì)通過(guò)外觀、聲響等表現(xiàn)出來(lái)，容易被人察覺(jué)的。這個(gè)時(shí)候檢查人員需要在設(shè)備的組裝、運(yùn)行、性能等方面來(lái)進(jìn)行觀察。 </p> <p> 任何的設(shè)備在使用的過(guò)程中或多或少都會(huì)消耗和破損，所以這個(gè)設(shè)備的檢查需要根據(jù)使用頻率和強(qiáng)度來(lái)指定維護(hù)的期限，確保不會(huì)出現(xiàn)事故，盡可能的避免不必要的損失。旦霆科技作為專(zhuān)業(yè)驗(yàn)證檢測(cè)供應(yīng)商，具備CMA資質(zhì)，專(zhuān)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="湖南LIMS系統(tǒng)滅菌柜驗(yàn)證,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293110195313/2026151.png"></div><p> 歐盟GMP (WHO附錄4）附錄15：確認(rèn)和驗(yàn)證 </p> <p> 必須制定相關(guān)的驗(yàn)證方案，詳細(xì)說(shuō)明確認(rèn)和驗(yàn)證將如何進(jìn)行。方案應(yīng)當(dāng)經(jīng)過(guò)審核和批準(zhǔn)。驗(yàn)證方案應(yīng)詳細(xì)描述關(guān)鍵步驟和可接受標(biāo)準(zhǔn)。 </p> <p> 應(yīng)按照確認(rèn)和/或驗(yàn)證方案編寫(xiě)驗(yàn)證報(bào)告，匯總獲得的數(shù)據(jù)和結(jié)果、對(duì)觀察到的偏差進(jìn)行評(píng)估、得出必要的結(jié)論，提出必要的糾偏措施。確認(rèn)/驗(yàn)證方案中的計(jì)劃的變更，應(yīng)有相應(yīng)記錄并有適當(dāng)?shù)慕忉尅?</p> <p> 確認(rèn)完成且結(jié)果令人滿(mǎn)意時(shí)，應(yīng)有書(shū)面批準(zhǔn)，同意進(jìn)入下一步的確認(rèn)和驗(yàn)證工作。 </p> <p> <br /> 計(jì)算機(jī)化系統(tǒng)驗(yàn)證服務(wù)選旦霆科技，服務(wù)專(zhuān)業(yè)到位，值得信賴(lài)！湖南旦霆科技滅菌柜驗(yàn)證驗(yàn)證咨詢(xún)</p><p style="text-indent:25px">專(zhuān)業(yè)從事滅菌柜驗(yàn)證、培養(yǎng)箱驗(yàn)證、滅菌隧道驗(yàn)證、GSP冷庫(kù)驗(yàn)證、熱風(fēng)循環(huán)烘箱驗(yàn)證等一些列溫度驗(yàn)證服務(wù)。湖南LIMS系統(tǒng)滅菌柜驗(yàn)證</p><p style="text-indent:25px">設(shè)備管理的含義：設(shè)備管理，是以企業(yè)生產(chǎn)經(jīng)營(yíng)目標(biāo)為依據(jù)，通過(guò)一系列的技術(shù)、經(jīng)濟(jì)、組織措施，對(duì)設(shè)備的規(guī)劃、設(shè)計(jì)、制造、選型、購(gòu)置、安裝、使用、維護(hù)、修理、改造、更新直至報(bào)廢的全過(guò)程進(jìn)行科學(xué)的管理；它包括設(shè)備的物質(zhì)運(yùn)動(dòng)和價(jià)值運(yùn)動(dòng)兩個(gè)方面的管理工作。根據(jù)設(shè)備管理的內(nèi)容，我們一般將其分為三個(gè)階段，即設(shè)備的前期管理、后期管理和設(shè)備管理的過(guò)渡階段。前期管理包括設(shè)備的規(guī)劃、設(shè)計(jì)、制造、選型、購(gòu)置；后期管理包括設(shè)備的使用、維護(hù)、修理、改造、更新直至報(bào)廢；過(guò)渡階段為設(shè)備的驗(yàn)證、初期使用和移交。湖南LIMS系統(tǒng)滅菌柜驗(yàn)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(shè)備等行業(yè)提供GXP合規(guī)咨詢(xún)、驗(yàn)證服務(wù)以及培訓(xùn)的綜合性咨詢(xún)公司； </p> <p> 旦霆公司長(zhǎng)期致力于幫助企業(yè)順利通過(guò)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(lái)自于**外資制藥企業(yè)、外資GMP咨詢(xún)公司、及國(guó)內(nèi)**的第三方檢測(cè)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(hù)提供服務(wù)，同時(shí)公司每年利潤(rùn)的10%捐獻(xiàn)給中國(guó)貧困兒童，持久資助中國(guó)貧困兒童的教育。 </p></p><br /><p>文章來(lái)源地址: http://www.cdcfah.com/cp/3134478.html</p></div></div></div></div></div><div id="3ace4f2" class="page-right twoColRt"><div id="yhjwa73" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="kol2ace" 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" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></div><p>福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)</p></a></div><div id="lanu9oq" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/846569.html"><div><img 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