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src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295189746094/9212985.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="coesgmi" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295189746094/9212985.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="eqyy0ms" 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>天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司,滅菌柜驗證</p><p><span>***更新：</span>2021-01-15 01:04:18</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="ic2kig8" 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(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="cesage0" class="page-proshow02"><p class="title">詳細說明</p><div id="82kige0" 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，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(dāng)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、維護方法等，天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司，人員應(yīng)經(jīng)過操作、維護的基本培訓(xùn)。專業(yè)滅菌柜驗證，天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司、培養(yǎng)箱驗證、GSP冷庫驗證，天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司、凍干機、熱風(fēng)循環(huán)烘箱驗證、冰箱驗證等一些列溫度驗證服務(wù)。天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295189746094/9212985.png"></div><p> 設(shè)計確認 </p> <p> <br /> </p> <p> 在CNAS-GL040:2019的儀器驗證中，將滿足用戶需求作為**重要的指標，因此在儀器購買前，用戶就必須編制儀器采購技術(shù)文件（軟件和硬件），提出所需采購儀器設(shè)備的使用條件和技術(shù)參數(shù)及性能要求，同時還要對供應(yīng)商進行評價，這與“4Q驗證”中的設(shè)計確認相類似，設(shè)計確認就是客戶確認儀器能否滿足自己需求的過程。 </p> <p> <br /> </p> <p> 但在實驗室實際的設(shè)計確認過程中，實驗室往往對自己的需求并不了解，或沒有明確的技術(shù)指標，導(dǎo)致實際的設(shè)計確認過程均以儀器供應(yīng)商提供的技術(shù)參數(shù)作為設(shè)計確認的依據(jù)，設(shè)計確認及用戶需求說明變得可有可無了。實際上實驗室的儀器技術(shù)文件不**是確認儀器參數(shù)能否滿足自身需求的文件，同時也是儀器整個生命周期中進行驗證的重要依據(jù)。 </p> <p> <br /> 天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司旦霆科技保證測試驗證數(shù)據(jù)真實、測試人員專業(yè)、性價比高。為客戶提供滅菌柜驗證服務(wù)及技術(shù)咨詢！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294441425782/9841184.png"></div><p> 濕熱滅菌溫度驗證對驗證儀器的基本要求 </p> <p> 按前所述溫度驗證程序設(shè)計要求的技術(shù)原則的五方面內(nèi)容，驗證設(shè)備可包括三部分：(1)測溫元件；(2)測溫編輯記錄儀器；(3)輔助校正儀器。 </p> <p> 測溫元件 </p> <p> 測溫元件采用敏感的多枝精密鉑電阻或電偶組成，原理如圖1。接線較長可以**的擺放在滅菌設(shè)備中選定位置，每支的誤差在±0.5℃以下的測試精度范圍。 </p> <p> 校正時，發(fā)生誤差越程件應(yīng)篩選。這是因為誤差越程后在后面的計算中將導(dǎo)致 F0 偏離，容易帶來誤判結(jié)果。 </p> <p> 電偶是溫度到勢能的變換器，而電阻是溫度到阻值的變換器，兩者在輸出的信號上是不同的。從輸出特性靈敏度看精密鉑電阻（RTD）為優(yōu)。從測溫范圍上比較（-180~2000℃），價性比上熱電偶較優(yōu)。 </p> <p> 目前開發(fā)先進的儀器采用無線信號傳送作為測溫元件。測溫記錄儀就近接收發(fā)來的每一個信號，自動完成轉(zhuǎn)換和記錄、存儲，但造價昂貴，特別小氣，保管有特別的要求, 目前針對旋轉(zhuǎn)釜國內(nèi)已有使用。在滅菌釜的實際溫度驗證實驗儀器上，國內(nèi)外已經(jīng)開發(fā)和生產(chǎn)出成熟的部件和比較先進的儀器，如GE.Kaye（US）、raytek（US）、 Sakura 、multi(Japen) 、Schlumbergez(England) 、 Goodwill(中國臺灣固緯)、Validator2000(北京祥鴻) 等溫度驗證儀。 </p><p> 運行確認包括：按照標準、操作運行和按規(guī)程進行清潔、對操作人員培訓(xùn)、進行預(yù)防維護保養(yǎng)，這些內(nèi)容結(jié)束后，運行確認才算完成。 </p> <p> 性能確認(PQ） </p> <p> 性能確認應(yīng)在安裝確認和運行確認完成之后進行。 </p> <p> 性能確認應(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)知識制定性能確認方案，使用正常生產(chǎn)的物料、適當(dāng)?shù)奶娲坊蛘吣M產(chǎn)品來進行測試； </p> <p> 應(yīng)在一種或幾種條件之下進行測試，測試的操作條件應(yīng)包括運行操作的上下限。 </p> <p> 雖然性能確認有時被描述為一項**的驗證活動，但在一些情況下，可以將性能確認與運行確認結(jié)合進行。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！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295583876954/6963779.png"></div><p> 驗證組織和職責(zé) </p> <p> 1.驗證組織 </p> <p> 成立驗證小組，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(shè)備部： </p> <p> 2.職責(zé)與分工 </p> <p> 驗證組長：負責(zé)驗證方案的起草，并負責(zé)組織實施進行壓力消毒器驗證。負責(zé)驗證期間各項工作的協(xié)調(diào)。 </p> <p> 生產(chǎn)部：負責(zé)按照要求對壓力容器進行操作和日常保養(yǎng)。 </p> <p> 設(shè)備部：負責(zé)壓力容器的指導(dǎo)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 /> 旦霆科技可與客戶開展遠程技術(shù)交流，解決難題為雙方良好合作打下扎實基礎(chǔ)，提供滅菌柜驗證等技術(shù)服務(wù)。天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司</p><p style="text-indent:25px">著眼質(zhì)量，靜思細量，旦霆科技為您提供專業(yè)的計算機化系統(tǒng)驗證服務(wù)，為您的合規(guī)之路保駕護航！天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司</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/細胞/蛋白類：細胞計數(shù)器、PCR儀、酶標儀、蛋白純化儀、程序降溫儀、電泳儀、凝膠成像儀、滲透壓儀、流式細胞儀、臺式離心機、冷凍離心機等等 </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化系統(tǒng)驗證（CSV）、風(fēng)險評估（RA）、3Q確認（3Q驗證）以及相關(guān)測試服務(wù)。 </p> <p> <br /> 天津環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證公司</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> 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