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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>?江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu) 誠信服務(wù) 旦霆生物科技供應(yīng)</p><div id="8wnfhoq" class="leftbox clearfix"><h1>江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu) 誠信服務(wù) 旦霆生物科技供應(yīng)</h1><div id="8xpry2j" class="proBig"><div id="bkhjlsu" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295064267579/4636119.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="8ldfmif" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295064267579/4636119.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="j8b7bya" 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>江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu),滅菌柜驗證</p><p><span>***更新：</span>2021-01-15 03:04:51</p><p><span id="click" >瀏覽次數(shù)：1次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="277k3hj" 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="mb8qkwy" class="page-proshow02"><p class="title">詳細說明</p><div id="kubtamd" class="box"><p><p style="text-indent:25px">設(shè)備運行確認，就是設(shè)備各個功能的依次確認，在設(shè)備管理中，江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu)，為設(shè)備的試機，或試運行。概括來講，設(shè)備主要包括四個方面的功能確認：操作功能、安全功能、警示功能和生產(chǎn)功能。操作功能指設(shè)備的可操作性、操作的方便性，安全功能指設(shè)備有防護人身傷害的功能，警示功能指設(shè)備使用過程中超出規(guī)定限度時的報警功能，生產(chǎn)功能是指設(shè)備能夠生產(chǎn)出合格的產(chǎn)品。當設(shè)備的功能齊全后，方可進行下一步的工作。對部分設(shè)備而言，生產(chǎn)功能試驗須有參數(shù)的確認（如梯度試驗），以及基本確定設(shè)備的操作方法，江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu)、維護方法等，人員應(yīng)經(jīng)過操作，江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu)、維護的基本培訓(xùn)。旦霆科技作為國內(nèi)**大中型規(guī)模綜合性咨詢服務(wù)公司，專業(yè)提供滅菌柜驗證服務(wù)，值得信賴！江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu)</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu),滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295064267579/4636119.png"></div><p> 計算機化系統(tǒng)驗證方案（目錄） </p> <p> 驗證目的 </p> <p> 驗證范圍 </p> <p> 職責(zé)確認 </p> <p> 指導(dǎo)文件確認 </p> <p> 術(shù)語縮寫 </p> <p> 驗證實施前提條件 </p> <p> 人員確認 </p> <p> 風(fēng)險評估 </p> <p> 驗證時間安排 </p> <p> 驗證內(nèi)容 </p> <p> 偏差處理 </p> <p> 風(fēng)險的接收與評審 </p> <p> 確認計劃 </p> <p> 驗證譜圖編制 </p> <p> 審核、結(jié)論 </p> <p> 驗證目的 </p> <p> 某公司質(zhì)量檢驗部現(xiàn)有一臺某型號的紫外分光光度計，與工作站軟件、計算機系統(tǒng)及打印機組成色譜儀計算機化系統(tǒng)。為保證這些系統(tǒng)符合GMP標準，滿足使用要求和分析測試需求，保證數(shù)據(jù)的安全，特制的本驗證方案，以進行計算機化系統(tǒng)驗證。江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu)旦霆科技擁有專業(yè)的驗證及檢測服務(wù)團隊、專業(yè)提供滅菌柜驗證等服務(wù)，因為專業(yè)所以值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu),滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294414755860/4492022.png"></div><p> 再驗證 </p> <p> 儀器儀表每年校正一次。 </p> <p> 任何滅菌條件得改變，包括滅菌的溫度、滅菌時間、壓力等改變均需重新驗證。 </p> <p> 一般情況下驗證小組根據(jù)此次驗證結(jié)果，提出再驗證時間。一般驗證的有效期為一年。 </p> <p> <p> 再驗證 </p> <p> 儀器儀表每年校正一次。 </p> <p> 任何滅菌條件得改變，包括滅菌的溫度、滅菌時間、壓力等改變均需重新驗證。 </p> <p> 一般情況下驗證小組根據(jù)此次驗證結(jié)果，提出再驗證時間。一般驗證的有效期為一年。 </p> <p> 再驗證 </p> <p> 儀器儀表每年校正一次。 </p> <p> 任何滅菌條件得改變，包括滅菌的溫度、滅菌時間、壓力等改變均需重新驗證。 </p> <p> 一般情況下驗證小組根據(jù)此次驗證結(jié)果，提出再驗證時間。一般驗證的有效期為一年。 </p> </p><p> 驗證程序 </p> <p> 安全情況檢查 </p> <p> 對腔室內(nèi)膽材料，壓力及溫度只是指示表進行檢查和校驗，檢查電源是否正常，電路線有無裸露，并對安全閥和放氣閥進行檢查，以確保所有的操作均能在安全狀態(tài)下進行。 </p> <p> 運行確認 </p> <p> 在空載情況下檢查設(shè)備各部分功能是否正常，蓋子接口無泄漏； </p> <p> 消毒器內(nèi)泄漏試驗：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> 性能測試 </p> <p> 性能測試標準 </p> <p> 空載測試：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。各留點溫度計在119°C-123°C之間。 </p> <p> </p> <p> <br /> </p> <p> <br /> </p> <p> <br /> 專業(yè)從事滅菌柜驗證、培養(yǎng)箱驗證、滅菌隧道驗證、GSP冷庫驗證、熱風(fēng)循環(huán)烘箱驗證等一些列溫度驗證服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu),滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293616376954/1769054.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(yīng)根據(jù)產(chǎn)品質(zhì)量回顧分析的情況進行再確認或再驗證。關(guān)鍵的生產(chǎn)工藝和操作規(guī)程應(yīng)定期進行再驗證，確保其能夠達到預(yù)期結(jié)果。 </p> <p> ***百四十八條確認或驗證應(yīng)按照預(yù)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(yīng)寫出報告，并經(jīng)審核、批準。確認或驗證的結(jié)果和結(jié)論（包括評價和建議）應(yīng)有記錄并存檔。 </p> <p> ***百四十九條應(yīng)根據(jù)驗證的結(jié)果確認工藝規(guī)程和操作規(guī)程。旦霆科技服務(wù)面向全國、設(shè)備驗證項目均安排項目經(jīng)理，對項目質(zhì)量、質(zhì)量、進度及時監(jiān)督。保證項目質(zhì)量！江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu)</p><p style="text-indent:25px">旦霆科技配備幾百套驗證及檢測儀器，專業(yè)的驗證及檢測服務(wù)團隊，專業(yè)提供驗證服務(wù)，服務(wù)區(qū)域覆蓋全國。江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu)</p><p> 滅菌柜驗證目的 </p> <p> 1.安裝檢查主要是確認設(shè)備經(jīng)多年的生產(chǎn)運行，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.運行確認主要檢查設(shè)備目前運行狀況是否正常，是否滿足正常生產(chǎn)要求。 </p> <p> 3.性能確認主要驗證設(shè)備在空載及滿載情況下經(jīng)過高溫滅菌后能否達到規(guī)定的滅菌效果。 </p> <p> 驗證范圍 </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行確認； </p> <p> 3.高壓電熱壓力蒸汽消毒器性能確認，含連續(xù)三次的空載、滿載測試、挑戰(zhàn)性測試江蘇追溯系統(tǒng)滅菌柜驗證機構(gòu)</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等機構(gòu)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(zhì)為客戶提供服務(wù)，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: http://www.cdcfah.com/cp/2850552.html</p></div></div></div></div></div><div id="xtvsz83" class="page-right twoColRt"><div id="7xol8hj" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="289mjln" 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配件哪家強信息推薦自業(yè)物資供應(yīng)</p></a></div><div id="b3oieqs" 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" alt="寧波寧海直接考A2有幾個科目真誠推薦寧波助學(xué)商務(wù)信息咨詢供應(yīng)" 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