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style="color: #f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-26 08:05:26</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="o87lvr7" 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="fi3e32d" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="ftfm30g" class="box"><p><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，北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測.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，北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測，北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測.5℃和**終F0值大于8。 </p> <p> <br /> 旦霆科技可提供滅菌柜驗(yàn)證等驗(yàn)證服務(wù)。廣納良言，吸取客戶有效意見、致力于為客戶更好的服務(wù)。北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294414755860/4492022.png"></div><p> 壓力消毒器驗(yàn)證報告 </p> <p> 概述 </p> <p> 本次驗(yàn)證通過對高壓滅菌器進(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： </p> <p> 壓力容器管理規(guī)程 </p> <p> 計量器具校驗(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，由以下部門及人員參加 </p> <p> 驗(yàn)證組長 </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：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)證期間各項工作的協(xié)調(diào)。 </p> <p> 生產(chǎn)部：負(fù)責(zé)按照要求對壓力容器進(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。北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測旦霆科技在提供高質(zhì)量服務(wù)的同時為眾多客戶解決項目偏差、驗(yàn)證偏差等問題。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="北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294992236329/5059315.png"></div><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,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)，其ZUI終成為成品或直接和藥品接觸的系統(tǒng) </p> <p> 測量，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) </p><p> 設(shè)備預(yù)確認(rèn)，在設(shè)備管理中，即是檢查設(shè)備的論證選型報告、購置合同。通過設(shè)備的論證選型，確認(rèn)設(shè)備的合格、廠家選擇的合理、設(shè)備運(yùn)行的經(jīng)濟(jì)。同樣，通過設(shè)備預(yù)確認(rèn)，完善設(shè)備前期管理工作，包括論證選型報告齊全（設(shè)備選型依據(jù)、原則等）、購置合同完整并整理歸檔保管等。 </p> <p> 設(shè)備安裝確認(rèn)，通過設(shè)備的基礎(chǔ)安裝、安裝環(huán)境、管道色標(biāo)管理等方面進(jìn)行規(guī)范。并填寫設(shè)備開箱驗(yàn)收記錄、安裝驗(yàn)收記錄等，并將隨機(jī)資料收集整理保管。在設(shè)備管理中，針對設(shè)備安裝的要求包括：設(shè)備開箱驗(yàn)收管理、設(shè)備安裝管理、色標(biāo)管理等。在此需要補(bǔ)充的是：與設(shè)備相關(guān)的儀器儀表應(yīng)經(jīng)過校驗(yàn)確認(rèn)。 </p> <p> <br /> 專注滅菌柜及培養(yǎng)基制備，專業(yè)，精細(xì)，數(shù)據(jù)可靠。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295785400391/920118.png"></div><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)營目標(biāo)為依據(jù)，通過一系列的技術(shù)、經(jīng)濟(jì)、組織措施，對設(shè)備的規(guī)劃、設(shè)計、制造、選型、購置、安裝、使用、維護(hù)、修理、改造、更新直至報廢的全過程進(jìn)行科學(xué)的管理；它包括設(shè)備的物質(zhì)運(yùn)動和價值運(yùn)動兩個方面的管理工作。根據(jù)設(shè)備管理的內(nèi)容，我們一般將其分為三個階段，即設(shè)備的前期管理、后期管理和設(shè)備管理的過渡階段。前期管理包括設(shè)備的規(guī)劃、設(shè)計、制造、選型、購置；后期管理包括設(shè)備的使用、維護(hù)、修理、改造、更新直至報廢；過渡階段為設(shè)備的驗(yàn)證、初期使用和移交。旦霆科技作為專業(yè)的計算機(jī)化系統(tǒng)驗(yàn)證服務(wù)，配備國外專業(yè)驗(yàn)證及檢測儀器，數(shù)據(jù)真實(shí)、質(zhì)量可靠值得推薦!北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測</p><p style="text-indent:25px">旦霆科技提供技術(shù)咨詢、3Q認(rèn)證、驗(yàn)證及檢測服務(wù)。在您不知道具體項目需求時為您擇優(yōu)推薦！北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測</p><p> 1. 溫度類：超低溫冰箱（-80℃）、低溫冰箱、陰涼柜、生化培養(yǎng)箱、霉菌培養(yǎng)箱、二氧化碳培養(yǎng)箱、搖床、二氧化碳搖床、穩(wěn)定性試驗(yàn)箱、水浴鍋、滅菌鍋/滅菌器、干熱滅菌柜、烘箱、熱風(fēng)循環(huán)烘箱等等 </p> <p> 2. 凈化環(huán)境類：超凈工作臺（潔凈工作臺）、生物安全柜、隔離器、RABS、層流罩、層流車、通風(fēng)廚等等 </p> <p> 3. 光譜色譜類：高效液相色譜儀、氣相色譜儀、紫外可見分光光度計、紅外分光光度計、原子吸收分光光度計、液質(zhì)聯(lián)用儀等等 </p> <p> 4. 生物/細(xì)胞/蛋白類：細(xì)胞計數(shù)器、PCR儀、酶標(biāo)儀、蛋白純化儀、程序降溫儀、電泳儀、凝膠成像儀、滲透壓儀、流式細(xì)胞儀、臺式離心機(jī)、冷凍離心機(jī)等等 </p> <p> 5. 其它類：電子天平、分析天平、PH計、電導(dǎo)率儀、顯微鏡、菌落計數(shù)器等等 </p> <p> 服務(wù)內(nèi)容：針對以上儀器，旦霆科技可提供計算機(jī)化系統(tǒng)驗(yàn)證（CSV）、風(fēng)險評估（RA）、3Q確認(rèn)（3Q驗(yàn)證）以及相關(guān)測試服務(wù)。 </p> <p> <br /> 北京WMS系統(tǒng)滅菌柜驗(yàn)證第三方檢測</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/3016768.html</p></div></div></div></div></div><div id="ad3e9q2" class="page-right twoColRt"><div id="tac77dc" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="udkcr8f" class="recomPic likePro"><a 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