福建ELN系統(tǒng)滅菌柜驗證誠信為先誠信為本旦霆生物科技供應-b2b網(wǎng)站_b2b電子商務平臺【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="驗證組織和職責1，福建ELN系統(tǒng)滅菌柜驗證誠信為先.驗證組織成立驗證小組，福建ELN系統(tǒng)滅菌柜驗證誠信為先，由以下部門及人員參加驗證組長生產(chǎn)部：設備部：2.職責與分工驗證組長：負責驗證方案的起草，并負責組織實施進行壓力消毒器驗證"><meta name="keywords" content="福建ELN系統(tǒng)滅菌柜驗證誠信為先,滅菌柜驗證"><link rel="canonical" href="http://www.cdcfah.com/"/><meta name="applicable-device" content="pc"><link rel="shortcut icon" href="/static/new_net_01/images/favicon.ico"><link rel="stylesheet" href="/static/new_net_01/css/slick.css" /><link rel="stylesheet" href="/static/new_net_01/css/addnew.css"><link rel="stylesheet" href="/static/new_net_01/css/sidenav.css"><link rel="stylesheet" href="/static/new_net_01/css/style.css" /><link rel="stylesheet" href="/static/new_net_01/css/tab.css"><link rel="stylesheet" href="/static/new_net_01/css/404.css"> <meta name="baidu-site-verification" content="OBVzrC9aaQ" /> <meta http-equiv="Cache-Control" content="no-transform" /> <meta 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href="http://www.cdcfah.com/cp/third-yyby_qtflft/">其他未分類</a>?福建ELN系統(tǒng)滅菌柜驗證誠信為先誠信為本旦霆生物科技供應</p><div id="j9tf87p" class="leftbox clearfix"><h1>福建ELN系統(tǒng)滅菌柜驗證誠信為先誠信為本旦霆生物科技供應</h1><div id="vcjlipr" class="proBig"><div id="ofrt7y8" 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="u9x7jbd" 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="ofmt3tn" 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)品關鍵詞：</span>福建ELN系統(tǒng)滅菌柜驗證誠信為先,滅菌柜驗證</p><p><span>***更新：</span>2021-01-21 01:04:55</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="e4me9a8" 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: </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="qrtlaro" class="page-proshow02"><p class="title">詳細說明</p><div id="ek79jv3" class="box"><p><p> 驗證組織和職責 </p> <p> 1，福建ELN系統(tǒng)滅菌柜驗證誠信為先.驗證組織 </p> <p> 成立驗證小組，福建ELN系統(tǒng)滅菌柜驗證誠信為先，由以下部門及人員參加 </p> <p> 驗證組長 </p> <p> 生產(chǎn)部： </p> <p> 設備部： </p> <p> 2.職責與分工 </p> <p> 驗證組長：負責驗證方案的起草，并負責組織實施進行壓力消毒器驗證。負責驗證期間各項工作的協(xié)調(diào)，福建ELN系統(tǒng)滅菌柜驗證誠信為先。 </p> <p> 生產(chǎn)部：負責按照要求對壓力容器進行操作和日常保養(yǎng)。 </p> <p> 設備部：負責壓力容器的指導和驗證物品的準備。 </p> <p> 驗證進度計劃 </p> <p> 驗證活動分為2階段完成，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 </p> <p> 階段2：2020年3月4日——2020年4月3日運行及性能確認 </p> <p> <br /> 旦霆科技致力于質量優(yōu)、人員佳、信價比高的質量服務，為制藥行業(yè)等企業(yè)提供滅菌柜驗證及檢測服務和咨詢。福建ELN系統(tǒng)滅菌柜驗證誠信為先</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建ELN系統(tǒng)滅菌柜驗證誠信為先,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293110195313/2026151.png"></div><p> 本文件主要依據(jù)ISO/IEC 17025標準和USP1058《分析儀器驗證指導原則》編制，同時參考了我國的《藥品生產(chǎn)質量管理規(guī)范 (2010 年修訂 )》等有關文件，可為實驗室規(guī)范儀器設備管理提供指導。本文件滿足 ISO/IEC 17025 標準對儀器設備的要求，是針對儀器設備的更***、具體管理指導性文件。 </p> <p> 本文件對儀器驗證各階段具體實施提供了指南，注重儀器對預期用途的適用性，可用于常規(guī)檢測實驗室對各類儀器的管理。為給實驗室施證提供具體指導，本文件以目前檢測實驗室中使用較為***的液相色譜儀例，提供了實施儀器驗證的具體范例。福建ELN系統(tǒng)滅菌柜驗證誠信為先旦霆科技各類行業(yè)的驗證服務經(jīng)驗，專業(yè)為您提供滅菌柜驗證，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建ELN系統(tǒng)滅菌柜驗證誠信為先,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295380234375/3887825.png"></div><p> 歐盟GMP (WHO附錄4）附錄15：確認和驗證 </p> <p> 必須制定相關的驗證方案，詳細說明確認和驗證將如何進行。方案應當經(jīng)過審核和批準。驗證方案應詳細描述關鍵步驟和可接受標準。 </p> <p> 應按照確認和/或驗證方案編寫驗證報告，匯總獲得的數(shù)據(jù)和結果、對觀察到的偏差進行評估、得出必要的結論，提出必要的糾偏措施。確認/驗證方案中的計劃的變更，應有相應記錄并有適當?shù)慕忉尅?</p> <p> 確認完成且結果令人滿意時，應有書面批準，同意進入下一步的確認和驗證工作。 </p> <p> <br /> </p><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：利用反復多次的流通蒸汽，以達到滅菌的目的。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，同時不致嚴重損害其質量的消耗方法。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)點是穿透力強，滅菌效果可靠，能殺滅所有微生物。 </p> 旦霆科技可提供滅菌柜驗證等驗證服務。廣納良言，吸取客戶有效意見、致力于為客戶更好的服務。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建ELN系統(tǒng)滅菌柜驗證誠信為先,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295260507813/6024456.png"></div><p> ***百四十四條確認和驗證不是一次性的行為。***確認或驗證后，應根據(jù)產(chǎn)品質量回顧分析的情況進行再確認或再驗證。關鍵的生產(chǎn)工藝和操作規(guī)程應定期進行再驗證，確保其能夠達到預期結果。 </p> <p> ***百四十八條確認或驗證應按照預先確定和批準的方案實施，并有記錄。確認或驗證工作完成后，應寫出報告，并經(jīng)審核、批準。確認或驗證的結果和結論（包括評價和建議）應有記錄并存檔。 </p> <p> ***百四十九條應根據(jù)驗證的結果確認工藝規(guī)程和操作規(guī)程。壓縮空氣檢測機構，壓縮空氣微生物檢測，提供CMA/CNAS資質檢測，出具CMA資質認證及報告。上海追溯系統(tǒng)滅菌柜驗證驗證公司</p><p style="text-indent:25px">旦霆科技配備數(shù)十人的驗證及檢測團隊，承接國內(nèi)各類相關企業(yè)的滅菌柜驗證、第三方驗證或檢測及咨詢服務。福建ELN系統(tǒng)滅菌柜驗證誠信為先</p><p> 滅菌器驗證程序 </p> <p> <br /> </p> <p> 安裝檢查 </p> <p> <br /> </p> <p> 1.1 安裝檢查所需文件的檢查： </p> <p> <br /> </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> <br /> </p> <p> 1.1.2 相關儀器儀表校驗記錄的檢查：檢查校驗記錄是否完整，是否定期進行校驗。 </p> <p> <br /> </p> <p> 1.1.3 高壓電熱壓力蒸汽消毒器使用標準操作規(guī)程的檢查：檢查是否具有相應的標準操作規(guī)程。 </p> <p> <br /> </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，儀器是否定期進行相應的維修保養(yǎng)。 </p> <p> <br /> </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> <br /> 福建ELN系統(tǒng)滅菌柜驗證誠信為先</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、制藥設備等行業(yè)提供GXP合規(guī)咨詢、驗證服務以及培訓的綜合性咨詢公司； </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等機構的GMP認證檢查； </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為客戶提供服務，同時公司每年利潤的10%捐獻給中國貧困兒童，持久資助中國貧困兒童的教育。 </p></p><br /><p>文章來源地址: 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