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"index_article"><a href="http://www.cdcfah.com/xw/"><span>行業(yè)資訊</span></a></li><li id = "index_show"><a href="http://www.cdcfah.com/zh/"><span>展會(huì)信息</span></a></li></ul></div></nav><section class="wrap clearfix"><section class="container clearfix tcPro"><section class="home-main container clearfix"><div id="vsevrdp" class="twoCol"><div id="ehjv7wn" 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>?天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</p><div id="cli8x89" class="leftbox clearfix"><h1>天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</h1><div id="yhzq4eq" class="proBig"><div id="fo8xevm" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293110195313/2026151.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="ycriwsj" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293110195313/2026151.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="hv3qh3l" 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>天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-18 08:04:47</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="qpjfoz2" 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="octeyk8" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="ki88xlm" class="box"><p><p> 壓力消毒器驗(yàn)證報(bào)告 </p> <p> 概述 </p> <p> 本次驗(yàn)證通過(guò)對(duì)高壓滅菌器進(jìn)行安裝確認(rèn)、空載、滿載滅菌效果的確認(rèn)證明在121°C20分鐘的滅菌條件下能達(dá)到滅菌效果。 </p> <p> 驗(yàn)證相關(guān)文件 </p> <p> 文件名稱(chēng)： </p> <p> 壓力容器管理規(guī)程 </p> <p> 計(jì)量器具校驗(yàn)管理規(guī)程 </p> <p> 電熱式蒸汽消毒器操作標(biāo)準(zhǔn)操作程序 </p> <p> 壓力消毒器驗(yàn)證方案 </p> <p> 驗(yàn)證組織和職責(zé) </p> <p> 驗(yàn)證組織 </p> <p> 驗(yàn)證小組，由以下部門(mén)及人員參加 </p> <p> 驗(yàn)證組長(zhǎng) </p> <p> 生產(chǎn)部 </p> <p> 設(shè)備部 </p> <p> 職責(zé)與分工 </p> <p> 驗(yàn)證組長(zhǎng)：負(fù)責(zé)驗(yàn)證方案的起草，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> 綜保部：負(fù)責(zé)壓力容器的指導(dǎo)和驗(yàn)證物品的準(zhǔn)備，天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方。旦霆科技致力于質(zhì)量?jī)?yōu)，天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方，天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方、人員佳、信價(jià)比高的質(zhì)量服務(wù)，為制藥行業(yè)等企業(yè)提供滅菌柜驗(yàn)證及檢測(cè)服務(wù)和咨詢(xún)。天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293110195313/2026151.png"></div><p> 滅菌柜驗(yàn)證目的 </p> <p> 1.安裝檢查主要是確認(rèn)設(shè)備經(jīng)多年的生產(chǎn)運(yùn)行，安裝狀況是否符合要求，滅菌器有關(guān)文件資料是否符合要求。 </p> <p> 2.運(yùn)行確認(rèn) 主要檢查設(shè)備目前運(yùn)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(rèn) 主要驗(yàn)證設(shè)備在空載及滿載情況下經(jīng)過(guò)高溫滅菌后能否達(dá)到規(guī)定的滅菌效果。 </p> <p> 驗(yàn)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(yùn)行確認(rèn)； </p> <p> 3.高壓電熱壓力蒸汽消毒器性能確認(rèn)，含連續(xù)三次的空載、滿載測(cè)試、挑戰(zhàn)性測(cè)試天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方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(wèn)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="天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296076728516/5719741.png"></div><p> 性能確認(rèn)中應(yīng)注意以下幾點(diǎn)： </p> <p> 一、流量、壓力和溫度等檢測(cè)儀器必須經(jīng)過(guò)校驗(yàn)并在校驗(yàn)期內(nèi)； </p> <p> 二、制定詳細(xì)的取樣計(jì)劃、化驗(yàn)方法并得到相關(guān)部門(mén)的批準(zhǔn)； </p> <p> 三、性能確認(rèn)時(shí)至少應(yīng)制定好BPR（Batch Production Record，即空白批記錄），按照方案的要求操作設(shè)備，觀察、調(diào)試和取樣并記錄運(yùn)行參數(shù)； </p> <p> 四、將驗(yàn)證數(shù)據(jù)和結(jié)果直接填入性能確認(rèn)方案的空白記錄部分，或作為其附件。人工記錄和計(jì)算機(jī)打印的數(shù)據(jù)作為原始數(shù)據(jù)，數(shù)據(jù)資料必須注明日期和簽名。 </p> <p> <br /> </p><p> 設(shè)計(jì)確認(rèn) </p> <p> <br /> </p> <p> 在CNAS-GL040:2019的儀器驗(yàn)證中，將滿足用戶需求作為**重要的指標(biāo)，因此在儀器購(gòu)買(mǎi)前，用戶就必須編制儀器采購(gòu)技術(shù)文件（軟件和硬件），提出所需采購(gòu)儀器設(shè)備的使用條件和技術(shù)參數(shù)及性能要求，同時(shí)還要對(duì)供應(yīng)商進(jìn)行評(píng)價(jià)，這與“4Q驗(yàn)證”中的設(shè)計(jì)確認(rèn)相類(lèi)似，設(shè)計(jì)確認(rèn)就是客戶確認(rèn)儀器能否滿足自己需求的過(guò)程。 </p> <p> <br /> </p> <p> 但在實(shí)驗(yàn)室實(shí)際的設(shè)計(jì)確認(rèn)過(guò)程中，實(shí)驗(yàn)室往往對(duì)自己的需求并不了解，或沒(méi)有明確的技術(shù)指標(biāo)，導(dǎo)致實(shí)際的設(shè)計(jì)確認(rèn)過(guò)程均以?xún)x器供應(yīng)商提供的技術(shù)參數(shù)作為設(shè)計(jì)確認(rèn)的依據(jù)，設(shè)計(jì)確認(rèn)及用戶需求說(shuō)明變得可有可無(wú)了。實(shí)際上實(shí)驗(yàn)室的儀器技術(shù)文件不**是確認(rèn)儀器參數(shù)能否滿足自身需求的文件，同時(shí)也是儀器整個(gè)生命周期中進(jìn)行驗(yàn)證的重要依據(jù)。 </p> <p> <br /> 旦霆科技擁有專(zhuān)業(yè)的驗(yàn)證及檢測(cè)服務(wù)團(tuán)隊(duì)、專(zhuān)業(yè)提供滅菌柜驗(yàn)證等服務(wù)，因?yàn)閷?zhuān)業(yè)所以值得信賴(lài)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294585517579/5207058.png"></div><p> 驗(yàn)證程序 </p> <p> 安全情況檢查 </p> <p> 對(duì)腔室內(nèi)膽材料，壓力及溫度只是指示表進(jìn)行檢查和校驗(yàn)，檢查電源是否正常，電路線有無(wú)裸露，并對(duì)安全閥和放氣閥進(jìn)行檢查，以確保所有的操作均能在安全狀態(tài)下進(jìn)行。 </p> <p> 運(yùn)行確認(rèn) </p> <p> 在空載情況下檢查設(shè)備各部分功能是否正常，蓋子接口無(wú)泄漏； </p> <p> 消毒器內(nèi)泄漏試驗(yàn)：將消毒器蓋子、放氣閥關(guān)閉，送氣升至0.11Mpa，關(guān)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(cè)試 </p> <p> 性能測(cè)試標(biāo)準(zhǔn) </p> <p> 空載測(cè)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(diǎn)。各留點(diǎn)溫度計(jì)在119°C-123°C之間。 </p> <p> </p> <p> <br /> </p> <p> <br /> </p> <p> <br /> 旦霆科技將不斷完善，繼續(xù)以高質(zhì)量服務(wù)為客戶提供滅菌柜驗(yàn)證、技術(shù)支持及咨詢(xún)服務(wù)!遼寧BMS系統(tǒng)滅菌柜驗(yàn)證第三方</p><p style="text-indent:25px">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！天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方</p><p style="text-indent:25px">打造一批以為依托的“互聯(lián)網(wǎng)+醫(yī)藥健康”協(xié)作平臺(tái)。這定將給相關(guān)企業(yè)，帶來(lái)非常大的發(fā)展機(jī)遇。2019年醫(yī)藥健康新政頻出，無(wú)論是醫(yī)藥研發(fā)企業(yè)還是生產(chǎn)企業(yè)，都面臨了很多挑戰(zhàn)。根據(jù)GMP驗(yàn)證咨詢(xún)與服務(wù)，計(jì)算機(jī)化系統(tǒng)驗(yàn)證，壓縮空氣檢測(cè)，潔凈室檢測(cè)相關(guān)領(lǐng)域極新技術(shù)發(fā)展趨勢(shì)，《2019年本》在鼓勵(lì)類(lèi)條目中新增了新型技術(shù)開(kāi)發(fā)和應(yīng)用的有關(guān)內(nèi)容。例如，在化學(xué)原料藥領(lǐng)域增加了“連續(xù)反應(yīng)”等技術(shù)，在技術(shù)領(lǐng)域增加了“基因醫(yī)治”和“抗體偶聯(lián)”等技術(shù)，在藥用包裝材料領(lǐng)域增加了“中性硼硅藥用玻璃”等新型材料與技術(shù)的開(kāi)發(fā)應(yīng)用，在醫(yī)藥領(lǐng)域增加了“人工智能輔助醫(yī)藥設(shè)備”等新技術(shù)內(nèi)容?？傮w而言，健康科技行業(yè)前景光明。在過(guò)去五年里，這一行業(yè)的穩(wěn)健增長(zhǎng)已經(jīng)給未上市私營(yíng)有限責(zé)任公司公司帶來(lái)逾270億美元的收入，14家公司的估值超過(guò)10億美元。另外，2019年退出總價(jià)值已經(jīng)超過(guò)2018年，達(dá)到創(chuàng)紀(jì)錄的80億美元，這在很大程度上是因?yàn)閺?qiáng)勁IPO的推動(dòng)。未來(lái)，新的旦霆生物科技（上海）有限公司位于上海市青浦區(qū)徐涇鎮(zhèn)華徐公路966號(hào)323室、325室，成立于2014年04月21日的私營(yíng)/民營(yíng)企業(yè)，目前公司的主要經(jīng)營(yíng)范圍是從事生物科技、計(jì)算機(jī)領(lǐng)域內(nèi)的技術(shù)開(kāi)發(fā)、技術(shù)咨詢(xún),企業(yè)管理咨詢(xún),檢測(cè)領(lǐng)域內(nèi)的技術(shù)咨詢(xún)和技術(shù)服務(wù)?！疽婪毥?jīng)批準(zhǔn)的項(xiàng)目,經(jīng)相關(guān)部門(mén)批準(zhǔn)后方可開(kāi)展經(jīng)營(yíng)活動(dòng)】工商合作模式很有可能將隨著兩票制許可人制度的變革而出現(xiàn)。此外，流通渠道多元化和扁平化，醫(yī)藥流通和零售也將受業(yè)外勢(shì)力的沖擊而改變營(yíng)銷(xiāo)模式。天津SAP系統(tǒng)滅菌柜驗(yàn)證第三方</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/2900097.html</p></div></div></div></div></div><div id="tnz7ek7" class="page-right twoColRt"><div id="vzghioq" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="8lkwi3u" 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) 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