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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="o7vrsgm" class="twoCol"><div id="tufrs2i" 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>?重慶BMS系統(tǒng)滅菌柜驗(yàn)證第三方誠信服務(wù) 旦霆生物科技供應(yīng)</p><div id="0ypvwk3" class="leftbox clearfix"><h1>重慶BMS系統(tǒng)滅菌柜驗(yàn)證第三方誠信服務(wù) 旦霆生物科技供應(yīng)</h1><div id="6abnzb3" class="proBig"><div id="jcyuwnj" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296157607422/4527074.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="tx3narn" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296157607422/4527074.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="vzv8kqr" 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>重慶BMS系統(tǒng)滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-27 06:04:40</p><p><span id="click" >瀏覽次數(shù)：3次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="txofrso" 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="rkb82tp" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="ui8bxjf" 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，重慶BMS系統(tǒng)滅菌柜驗(yàn)證第三方。 </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(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(xiàng)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)，重慶BMS系統(tǒng)滅菌柜驗(yàn)證第三方，重慶BMS系統(tǒng)滅菌柜驗(yàn)證第三方。 </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。旦霆科技配備幾百套驗(yàn)證及檢測儀器，專業(yè)的驗(yàn)證及檢測服務(wù)團(tuán)隊(duì)，專業(yè)提供驗(yàn)證服務(wù)，服務(wù)區(qū)域覆蓋全國。重慶BMS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="重慶BMS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/637335296157607422/4527074.png"></div><p> 運(yùn)行確認(rèn)包括：按照標(biāo)準(zhǔn)、操作運(yùn)行和按規(guī)程進(jìn)行清潔、對操作人員培訓(xùn)、進(jìn)行預(yù)防維護(hù)保養(yǎng)，這些內(nèi)容結(jié)束后，運(yùn)行確認(rèn)才算完成。 </p> <p> 性能確認(rèn)(PQ） </p> <p> 性能確認(rèn)應(yīng)在安裝確認(rèn)和運(yùn)行確認(rèn)完成之后進(jìn)行。 </p> <p> 性能確認(rèn)應(yīng)包括但不限于以下方面： </p> <p> 根據(jù)對生產(chǎn)工藝、系統(tǒng)和設(shè)備的相關(guān)知識(shí)制定性能確認(rèn)方案，使用正常生產(chǎn)的物料、適當(dāng)?shù)奶娲坊蛘吣M產(chǎn)品來進(jìn)行測試； </p> <p> 應(yīng)在一種或幾種條件之下進(jìn)行測試，測試的操作條件應(yīng)包括運(yùn)行操作的上下限。 </p> <p> 雖然性能確認(rèn)有時(shí)被描述為一項(xiàng)**的驗(yàn)證活動(dòng)，但在一些情況下，可以將性能確認(rèn)與運(yùn)行確認(rèn)結(jié)合進(jìn)行。重慶BMS系統(tǒng)滅菌柜驗(yàn)證第三方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！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶BMS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/637335294992236329/5059315.png"></div><p> 性能確認(rèn)的目的是驗(yàn)證設(shè)備的穩(wěn)定性。驗(yàn)證設(shè)備穩(wěn)定的方法一般為連續(xù)生產(chǎn)三批，當(dāng)此三批產(chǎn)品均合格，且合格率、操作參數(shù)均穩(wěn)定時(shí)，即認(rèn)為設(shè)備是合格的。同時(shí)進(jìn)一步確認(rèn)操作參數(shù)。當(dāng)設(shè)備合格后，就可以進(jìn)入設(shè)備管理的下一個(gè)階段。如果設(shè)備驗(yàn)證的結(jié)果顯示不合格，則按照設(shè)備管理中的報(bào)廢或降級(jí)使用等規(guī)定進(jìn)行。 </p> <p> 設(shè)備使用管理，主要從人、機(jī)、料、法、環(huán)五個(gè)方面來進(jìn)行，基本為設(shè)備的安裝確認(rèn)、運(yùn)行確認(rèn)和性能確認(rèn)的綜合。人是指操作者應(yīng)經(jīng)過培訓(xùn)，會(huì)操作、維護(hù)且按照要求進(jìn)行；機(jī)指設(shè)備驗(yàn)證合格后的完好性；料指合格的物料（指使用此設(shè)備的物料工藝經(jīng)過驗(yàn)證且工藝合格）；法指正確的操作、維護(hù)方法；環(huán)指設(shè)備工作的環(huán)境（安裝過程中應(yīng)確認(rèn)）。通過設(shè)備使用管理和安裝管理，就可以規(guī)范設(shè)備的驗(yàn)證工作。通過運(yùn)行確認(rèn)，確定設(shè)備是合格的，設(shè)備能夠生產(chǎn)出合格的產(chǎn)品；通過性能確認(rèn)，確定設(shè)備是穩(wěn)定的，設(shè)備能夠連續(xù)生產(chǎn)出合格的產(chǎn)品；通過運(yùn)行確認(rèn)、性能確認(rèn)，確定設(shè)備的操作、維護(hù)方法，在此要求下，能夠使設(shè)備維持在驗(yàn)證時(shí)的狀態(tài)。 </p> <p> <br /> </p><p> 濕熱滅菌溫度驗(yàn)證對驗(yàn)證儀器的基本要求 </p> <p> 測溫編輯記錄儀器 </p> <p> <p> 測溫記錄儀器是整個(gè)實(shí)驗(yàn)的大腦。國內(nèi)外諸多公司直接采用PC機(jī)開發(fā)，在Windows 系統(tǒng)平臺(tái)基礎(chǔ)上開發(fā)自己的多點(diǎn)數(shù)據(jù)記錄、整理、計(jì)算、存儲(chǔ)及I/O的接口軟件，其集多功能軟件為一體裝配在計(jì)算機(jī)中，既便攜帶，又圖文齊備，直觀可靠。 </p> <p> <br /> </p> <p> 輔助校正儀器 </p> <p> <br /> </p> <p> 設(shè)計(jì)為一臺(tái)高精度的恒溫油槽（又稱干井），采用溫控PID調(diào)節(jié)控溫精度高，溫度波動(dòng)范圍設(shè)計(jì)在±0.05℃。其有斷偶保護(hù)功能，上限設(shè)計(jì)超溫報(bào)警功能。升降溫快速、穩(wěn)定、可靠。在設(shè)定溫度和測量溫度數(shù)字上，分別3又1/2精確顯示。 </p> <p> <br /> </p> <p> 在低溫段檢校采取冰點(diǎn)槽（低溫干井）設(shè)施，高低溫干井分別檢測電偶的特殊點(diǎn)溫度值誤差和能否用于實(shí)驗(yàn)的合格性進(jìn)行甄別篩選。它即是本實(shí)驗(yàn)的檢測校正部件，也是實(shí)驗(yàn)室的常備精密溫度源。通常交國家法定技術(shù)監(jiān)督部門定期檢校確認(rèn)合格,在有效期內(nèi)使用。 </p> <p> <br /> </p> CSV認(rèn)證服務(wù)選旦霆科技，多年的驗(yàn)證服務(wù)經(jīng)驗(yàn)，成熟的驗(yàn)證體系，品質(zhì)優(yōu)先，良心推薦。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶BMS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/637335295785400391/920118.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(jì)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) 旦霆科技對驗(yàn)證測試工程師進(jìn)行培訓(xùn)拓展及考核晉級(jí)，為向客戶提供更專業(yè)的設(shè)備驗(yàn)證檢測服務(wù)而不斷邁進(jìn)。重慶BMS系統(tǒng)滅菌柜驗(yàn)證第三方</p><p style="text-indent:25px">專注滅菌柜及培養(yǎng)基制備，專業(yè)，精細(xì)，數(shù)據(jù)可靠。重慶BMS系統(tǒng)滅菌柜驗(yàn)證第三方</p><p> 性能確認(rèn)中應(yīng)注意以下幾點(diǎn)： </p> <p> 一、流量、壓力和溫度等檢測儀器必須經(jīng)過校驗(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 /> 重慶BMS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、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(shí)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/3031061.html</p></div></div></div></div></div><div id="suqhypl" class="page-right twoColRt"><div id="zc7htul" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="3jug8pl" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img 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