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class="container clearfix tcPro"><section class="home-main container clearfix"><div id="wynnaeb" class="twoCol"><div id="m3sj3w4" 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>?湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢誠信為本旦霆生物科技供應(yīng)</p><div id="eyid8iq" class="leftbox clearfix"><h1>湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢誠信為本旦霆生物科技供應(yīng)</h1><div id="8b4h3ea" class="proBig"><div id="w8o0di7" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295380234375/3887825.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="b0bekov" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295380234375/3887825.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="lwk8ois" 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>湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-06 00:14:34</p><p><span id="click" >瀏覽次數(shù)：15次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="3dpzoos" 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="dddnxwg" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="oq3tbva" class="box"><p><p> PQ測試種類： </p> <p> 微生物測試 </p> <p> 化學(xué)測試 </p> <p> 顆粒度測試 </p> <p> 負(fù)載測試 </p> <p> 產(chǎn)品或placebo性能測試 </p> <p> 驗(yàn)證技術(shù)范圍： </p> <p> HVAC（關(guān)鍵區(qū)域） </p> <p> Cleanroom潔凈室驗(yàn)證 </p> <p> Utilities關(guān)鍵的公用工程系統(tǒng)驗(yàn)證 </p> <p> （PFW,WFI,N2，湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢,壓縮空氣和潔凈蒸汽系統(tǒng)） </p> <p> Process Equipment 工藝設(shè)備驗(yàn)證 </p> <p> Process/Sterilisation Process工藝/消毒工藝驗(yàn)證 </p> <p> Laboratory Equipment 實(shí)驗(yàn)室設(shè)備驗(yàn)證 </p> <p> Analytical Methods 分析方法的驗(yàn)證 </p> <p> Cleaning 清潔驗(yàn)證 </p> <p> Computerised Systems 計算機(jī)系統(tǒng)驗(yàn)證 </p> <p> 關(guān)鍵系統(tǒng)的驗(yàn)證 </p> <p> 系統(tǒng)要求驗(yàn)證 </p> <p> 直接和藥品接觸的系統(tǒng) </p> <p> 接觸原材料的系統(tǒng)，湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢，其ZUI終成為成品或直接和藥品接觸的系統(tǒng) </p> <p> 測量，湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢，監(jiān)控或記錄關(guān)鍵參數(shù)的系統(tǒng) </p> <p> 用于傳達(dá)或維護(hù)關(guān)鍵參數(shù)的系統(tǒng) 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)支持及咨詢服務(wù)!湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295380234375/3887825.png"></div><p> 滅菌柜的作用 </p> <p> 滅菌柜是一種殺菌的裝置，可用于多種領(lǐng)域，比如食品、制藥行業(yè)等。顧名思義，滅菌柜的主要作用便是用于殺菌。殺菌滅菌方法通常有以下五種： </p> <p> 1.煮沸法：煮沸100℃，5分鐘，能殺死一般細(xì)菌的繁殖體。煮沸法可用于飲水和一般器械(刀剪、注射器等)的消毒。 <p> 2.流通蒸汽滅菌法：利用100℃左右的水蒸汽進(jìn)行消毒，一般采用流通蒸汽滅菌器，加熱15到39分鐘，可殺死細(xì)菌繁殖體。消毒物品的包裝不宜過大、過緊以利于蒸汽穿透。 </p> <p> 3.間歇滅菌法：利用反復(fù)多次的流通蒸汽，以達(dá)到滅菌的目的。一般用流通蒸汽滅菌器，100℃加熱15～30分鐘，可殺死其中的繁殖體;但芽胞尚有殘存。取出后放37℃孵箱過夜，使芽胞發(fā)育成繁殖體，次日再蒸一次，如此連續(xù)三次以上。本法適用于不耐高溫的營養(yǎng)物(如血清培養(yǎng)基)的滅菌。 </p> <p> 4.巴氏消毒法：利用熱力殺死液體中的病原菌或一般的雜菌，同時不致嚴(yán)重?fù)p害其質(zhì)量的消耗方法。由巴斯德創(chuàng)用以消毒酒精類，故名。加溫61.1～62.8℃半小時，或71.7℃15～30秒鐘。 </p> <p> 5.高壓蒸汽滅菌法：壓力蒸汽滅菌是在專門的壓力蒸汽滅菌器中進(jìn)行的，是熱力滅菌中使用比較普遍、效果比較可靠的一種方法。其優(yōu)點(diǎn)是穿透力強(qiáng)，滅菌效果可靠，能殺滅所有微生物。 </p> 天津倉庫管理系統(tǒng)滅菌柜驗(yàn)證旦霆科技年度營業(yè)額以50%的速度高速增長，逐漸成為為數(shù)不多的中大型儀器設(shè)備驗(yàn)證測試服務(wù)的綜合性公司。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294441425782/9841184.png"></div><p> 我們大多是參照它來制定評價標(biāo)準(zhǔn)的，筆者參考指南的例子把整個滅菌柜驗(yàn)證簡單歸納為以下幾個方面： </p> <p> <br /> </p> <p> (1)預(yù)確認(rèn)，對滅菌柜的基本功能是否達(dá)到公司的要求進(jìn)行確認(rèn)； </p> <p> <br /> </p> <p> (2)安裝確認(rèn)，包括文件確認(rèn)、圖紙檢查、主要機(jī)械部件檢查、安全系統(tǒng)檢查、公用管道連接檢查、儀器儀表檢查和校正、控制系統(tǒng)硬件部分檢查、控制系統(tǒng)軟件功能實(shí)現(xiàn)檢查、備件備品的檢查等； </p> <p> <br /> </p> <p> (3)運(yùn)行確認(rèn)，包括功能測試和基本性能參數(shù)的確認(rèn)，以及對上述安裝確認(rèn)內(nèi)容的運(yùn)行時動態(tài)確認(rèn)，同時根據(jù)實(shí)際情況修訂操作規(guī)程和對操作人員進(jìn)行實(shí)操培訓(xùn)； </p> <p> <br /> </p> <p> (4)性能確認(rèn)，包括驗(yàn)證儀器的校驗(yàn)、空載熱分布(腔室平均溫度與冷點(diǎn)溫差小于1.5℃)、滿載熱分布(腔室平均溫度與冷點(diǎn)溫差小于1.5℃)、滿載熱穿透的試驗(yàn)以及生物指示劑的挑戰(zhàn)性試驗(yàn)。其中，**主要的衡量標(biāo)準(zhǔn)是滅菌階段冷點(diǎn)和平均溫度之差小于0.5℃和**終F0值大于8。 </p> <p> <br /> </p><p> <strong>濕熱滅菌設(shè)備的溫度驗(yàn)證 </strong> </p> <p> <br /> </p> <p> 溫度驗(yàn)證程序設(shè)計基本要求 </p> <p> <br /> </p> <p> 濕熱滅菌的基本程序設(shè)計基本要求源于US.FDA在上世紀(jì)70年代中期提出的，且在80年代施行的：“關(guān)于大容量注射劑GMP技術(shù)性原則”五個方面要求： </p> <p> <br /> </p> <p> (1)在滅菌工序應(yīng)能確保產(chǎn)品達(dá)到F0 ≥ 8； </p> <p> <br /> </p> <p> (2)滅菌前，待實(shí)驗(yàn)的容器中有比較高帶菌量，污染菌應(yīng)具有**強(qiáng)的耐熱性； </p> <p> <br /> </p> <p> (3)每一個滅菌釜的每種裝載方式及每種規(guī)格容器的驗(yàn)證實(shí)驗(yàn)均至少使用10支熱電偶進(jìn)行熱分布實(shí)驗(yàn)； </p> <p> <br /> </p> <p> (4)用待實(shí)驗(yàn)容器灌注粘度相類似的產(chǎn)品進(jìn)行熱穿透實(shí)驗(yàn)，找出容器中升溫**慢點(diǎn)的位置，至少使用10個容器，每個均加入適當(dāng)?shù)纳镏甘緞┎⑶也逵袩犭娕肌．?dāng)滅菌釜的參數(shù)已經(jīng)達(dá)到熱分布實(shí)驗(yàn)已經(jīng)證實(shí)的可重現(xiàn)狀態(tài)，溫度達(dá)到設(shè)定的滅菌溫度時，開始測定F0 值，直到開始冷卻止； </p> <p> <br /> </p> <p> (5)當(dāng)產(chǎn)品達(dá)到滅菌溫度直到開始冷卻的過程，溫度變化必須保持在 ±0.5℃以內(nèi)。 </p> <p> <br /> 旦霆科技團(tuán)隊(duì)成員掌握國內(nèi)為GMP、國標(biāo)、ISO等相關(guān)法規(guī)，可為相關(guān)企業(yè)開展滅菌柜驗(yàn)證等服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296076728516/5719741.png"></div><p> 滅菌柜的驗(yàn)證 </p> <p> <br /> </p> <p> 評價標(biāo)準(zhǔn)和驗(yàn)證內(nèi)容 </p> <p> <br /> </p> <p> 在1992年版世界衛(wèi)生組織的《規(guī)范》第17章，提到對注射劑的驗(yàn)證要求： </p> <p> <br /> </p> <p> (1)17.32條：所有設(shè)備如滅菌柜、空氣過濾系統(tǒng)、水處理系統(tǒng)（包括蒸餾水機(jī)）均應(yīng)按計劃進(jìn)行驗(yàn)證、維護(hù)和監(jiān)控。 </p> <p> <br /> </p> <p> (2)17.55條：任何滅菌方法在正式采用前，該方法對產(chǎn)品的適用性以及每一裝載方式下被滅菌品的所有部位是否達(dá)到規(guī)定滅菌要求都應(yīng)經(jīng)過驗(yàn)證。應(yīng)定期進(jìn)行再驗(yàn)證，每當(dāng)設(shè)備有重大改變時，也須進(jìn)行再驗(yàn)證。 </p> <p> <br /> </p> <p> 而在98版《藥品GMP檢查指南》中： </p> <p> <br /> </p> <p> (1)3102條：滅菌柜的能力是否與生產(chǎn)相適應(yīng)，是否具有自動監(jiān)測及記錄裝置。 </p> <p> <br /> </p> <p> (2)*5703條：關(guān)鍵設(shè)備及無菌藥品的驗(yàn)證內(nèi)容是否包括滅菌設(shè)備、藥液濾過及灌裝（分裝）系統(tǒng)。 </p> <p> <br /> </p> <p> 由上可見，滅菌工序?qū)τ谧⑸鋭┥a(chǎn)的重要作用以及藥政部門對滅菌柜驗(yàn)證的重視。而對于滅菌柜的驗(yàn)證，美國FDA和歐盟藥品衛(wèi)生組織對于不同的滅菌柜有具體的指引和要求（可以查閱有關(guān)的官方網(wǎng)頁），我國在這方面只有02年版的《藥品驗(yàn)證指南》大容量注射劑章節(jié)中給出對于滅菌柜驗(yàn)證的例子，同時05版的《藥典》中關(guān)于滅菌法部分也給出更詳細(xì)的要求。 </p> <p> <br /> 旦霆科技為制藥行業(yè)等企業(yè)提供驗(yàn)證測試服務(wù)。對耗材供應(yīng)商進(jìn)行年審、為項(xiàng)目進(jìn)行及服務(wù)客戶把好關(guān)！天津倉庫管理系統(tǒng)滅菌柜驗(yàn)證</p><p style="text-indent:25px">旦霆科技為提升各項(xiàng)目質(zhì)量水平，成立質(zhì)量部門。為滅菌柜驗(yàn)證等驗(yàn)證及檢測服務(wù)保駕護(hù)航！湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢</p><p> ***百三十九條企業(yè)的廠房、設(shè)施、設(shè)備和檢驗(yàn)儀器應(yīng)經(jīng)過確認(rèn)，應(yīng)采用經(jīng)過驗(yàn)證的生產(chǎn)工藝、操作規(guī)程和檢驗(yàn)方法進(jìn)行生產(chǎn)、操作和檢驗(yàn)，并保持持續(xù)的驗(yàn)證狀態(tài)。 </p> <p> ***百四十條應(yīng)建立確認(rèn)和驗(yàn)證的文件和記錄，并能以文件和記錄證明達(dá)到以下預(yù)定的目標(biāo)： </p> <p> （一）設(shè)計確認(rèn)（DQ）應(yīng)證明廠房、設(shè)施、設(shè)備的設(shè)計符合預(yù)定用途和本規(guī)范要求； </p> <p> （二）安裝確認(rèn)（IQ）應(yīng)證明廠房、設(shè)施和設(shè)備的建造和安裝符合設(shè)計標(biāo)準(zhǔn)； </p> <p> （三）運(yùn)行確認(rèn)（OQ）應(yīng)證明廠房、設(shè)施和設(shè)備的運(yùn)行符合設(shè)計標(biāo)準(zhǔn)； </p> <p> （四）性能確認(rèn)（PQ）應(yīng)證明廠房、設(shè)施、設(shè)備在正常操作方法和工藝條件下能持續(xù)符合標(biāo)準(zhǔn)。 </p> <p> （五）工藝驗(yàn)證（PV）應(yīng)證明一個生產(chǎn)工藝按規(guī)定的工藝參數(shù)能持續(xù)生產(chǎn)出符合預(yù)定的用途和注冊要求的產(chǎn)品。 </p> <p> <br /> </p> <p> <br /> 湖北WMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢</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/2716522.html</p></div></div></div></div></div><div id="thbq72j" class="page-right twoColRt"><div id="unsncxn" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="8c5b78j" 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="erbw38e" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/846569.html"><div><img src="https://tyunfile.71360.com/WaterMark/UploadFile/nbzxsw/637298235378037109/764794.png" 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