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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="2x2cj2l" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295785400391/920118.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="txj4ga2" 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>四川環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證咨詢,滅菌柜驗證</p><p><span>***更新：</span>2021-01-28 01:04:23</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="82gnent" 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="povugxo" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="x3ri7nc" class="box"><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(jìn)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(jìn)行檢查，以確保所有的操作均能在安全狀態(tài)下進(jìn)行。 </p> <p> 運(yùn)行確認(rèn) </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0，四川環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證咨詢.11Mpa，關(guān)掉電源，10min內(nèi)壓力變化，四川環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證咨詢，四川環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證咨詢，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(biāo)準(zhǔn) </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 /> 旦霆科技積極聽取客戶有效意見，不斷完善質(zhì)量體系及服務(wù)理念，為**提供滅菌柜驗證服務(wù)奠定了基礎(chǔ)。四川環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證咨詢</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="四川環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證咨詢,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295785400391/920118.png"></div><p> 歐盟GMP（WHO附錄4） </p> <p> 設(shè)計確認(rèn)（DQ） </p> <p> 新設(shè)施、系統(tǒng)或設(shè)備驗證的DIYI個步驟為設(shè)計確認(rèn)。 </p> <p> 應(yīng)論證設(shè)計符合GMP要求，并應(yīng)有相應(yīng)的記錄。 </p> <p> 安裝確認(rèn)（IQ） </p> <p> 新的設(shè)施或改建的設(shè)施、系統(tǒng)或設(shè)備需安裝確認(rèn)。 </p> <p> 安裝確認(rèn)應(yīng)包括但不限于以下方面： </p> <p> 根據(jù)ZUI新的工程圖紙和技術(shù)規(guī)格/標(biāo)準(zhǔn)說明書，檢查設(shè)備、管道、共用設(shè)施和儀器安裝； </p> <p> 校驗要求； </p> <p> 收集及整理（歸檔）由供應(yīng)商提供的操作指南、維護(hù)保養(yǎng)手冊； </p> <p> 材質(zhì)證明的確認(rèn)。 </p> <p> 運(yùn)行確認(rèn)（OQ） </p> <p> 安裝確認(rèn)之后，應(yīng)接著進(jìn)行運(yùn)行確認(rèn)。 </p> <p> 運(yùn)行確認(rèn)應(yīng)包括但不限于以下方面： </p> <p> 根據(jù)生產(chǎn)工藝、系統(tǒng)和設(shè)備的相關(guān)知識制定OQ方案并進(jìn)行測試； </p> <p> 測試應(yīng)在一種或一組運(yùn)行條件之下進(jìn)行，包括設(shè)備運(yùn)行的上下限，有時稱這種條件為“ZUI 差條件”。廣東GMP認(rèn)證滅菌柜驗證怎么做旦霆科技針對于中大型驗證均配備項目經(jīng)理，在為提供滅菌柜驗證服務(wù)時及時匯報進(jìn)、嚴(yán)格控制質(zhì)量！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="四川環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證咨詢,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296157607422/4527074.png"></div><p> 滅菌器驗證方案（目錄） </p> <p> 一、概述 </p> <p> 二、驗證目的 </p> <p> 三、驗證范圍 </p> <p> 四、驗證組織與職責(zé) </p> <p> 五、驗證進(jìn)度計劃 </p> <p> 六、驗證程序 </p> <p> 1.安裝檢查 </p> <p> 1.1安裝檢查所需文件的檢查 </p> <p> 1.2安全情況檢查 </p> <p> 2.運(yùn)行確認(rèn) </p> <p> 3.性能測試 </p> <p> 3.1消毒效果判斷標(biāo)準(zhǔn) </p> <p> 3.2空載測試 </p> <p> 3.3滿載性能測試 </p> <p> 3.4挑戰(zhàn)性實驗 </p> <p> 七、文件的匯總和審批 </p> <p> 八、再驗證 </p> <p> 滅菌器驗證方案 </p> <p> 一、概述 </p> <p> 滅菌器主要用于生產(chǎn)過程中潔凈工作服、器械、無菌衣、培養(yǎng)基以及廢棄物等的濕熱滅菌，此次驗證的設(shè)備為電熱壓力蒸汽消毒器，滅菌器使用飽和蒸汽滅菌，本次驗證的主要是確認(rèn)在121°C20分鐘的滅菌條件下能否達(dá)到滅菌效果。 </p><p> 滅菌柜的原理： </p> <p> <br /> </p> <p> 1 干熱滅菌柜，結(jié)合國外制造經(jīng)驗優(yōu)勢，精心設(shè)計開發(fā)，為國內(nèi)制藥企業(yè)采用，符合GMP改造要求。 </p> <p> <br /> </p> <p> 2 干熱滅菌柜采用PLC控制，具備手/自動功能，觸摸屏人機(jī)界面，有雙重加熱保護(hù)功能。 </p> <p> <br /> </p> <p> 3 設(shè)計比較高工作溫度可達(dá)350℃，設(shè)備空載熱分布可以達(dá)到±3℃，高效通過DOP測試，塵埃粒子測試，箱內(nèi)達(dá)到百級狀態(tài)。 </p> <p> <br /> </p> <p> 4 干熱滅菌柜設(shè)備采用滿焊結(jié)構(gòu)，內(nèi)部拋光，Ra≤0.4 ，無死角，無銳角。 </p> <p> <br /> </p> <p> 5 裝置上留有GMP驗證接口。 </p> <p> <br /> </p> <p> 6 干熱滅菌柜產(chǎn)品可供用戶選擇，在配置和尺寸方面也可根據(jù)用戶用途、場地、產(chǎn)量等定制。 </p> <p> <br /> 計算機(jī)化系統(tǒng)驗證服務(wù)選旦霆科技，服務(wù)專業(yè)到位，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="四川環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證咨詢,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296076728516/5719741.png"></div><p> <strong></strong>溫度驗證的功能測試步驟 </p> <p> <br /> </p> <p> <br /> </p> <p> 由此技術(shù)設(shè)計要求出發(fā)，演化成為目前國內(nèi)***采用的濕熱溫度驗證的大容量注射劑實驗方法和實驗器具,也是溫度驗證程序設(shè)計的基本要求。使用其作功能測試步驟及參考設(shè)備如下： </p> <p> <br /> </p> <p> 1. 熱分布測試 </p> <p> <br /> </p> <p> 目的：找出**冷點位置，檢驗重現(xiàn)性。步驟：(1)設(shè)備儀器校正；(2)熱電偶分布圖；(3)空載熱分布實驗，3次以上；(4)熱電偶插入圖；(5)裝載（模擬生產(chǎn)裝載比較大，**小量）熱分布實驗，各3次以上。 </p> <p> <br /> </p> <p> 2. 熱穿透測試 </p> <p> <br /> </p> <p> 目的：肯定滅菌過程中被測試各點獲得無菌保證值，特別是**冷點位置的F0 值,監(jiān)測檢驗重現(xiàn)性。步驟：(1)設(shè)備校正；(2)模擬生產(chǎn)滅菌裝載；(3)熱電偶裝載圖；(4)同品同規(guī)產(chǎn)品比較大與**小裝載熱穿透實驗，每狀態(tài)3次以上。 </p> <p> <br /> </p> <p> 3. 生物指示劑測試 </p> <p> <br /> </p> <p> 目的：挑戰(zhàn)性模擬生產(chǎn)可能因素造成的微生物污染程度來檢驗滅菌可靠性，對驗證設(shè)計進(jìn)行檢驗。步驟：(1)方案的設(shè)計制定；(2)生物指示劑菌株的選擇，測定D值；(3)標(biāo)定濃度和制定樣品；(4)接種，裝載；(5)低限滅菌(每產(chǎn)品，每規(guī)格每種滅菌程序至少3次以上）；(6)樣品的培養(yǎng)與鑒別；(7)評價結(jié)論（數(shù)據(jù)，樣品分析）。 </p> <p> <br /> </p> <p> 4. 偏差與調(diào)整 </p> <p> <br /> </p> <p> 重新設(shè)計后，重復(fù)上面步驟。 </p> <p> <br /> </p> <p> 5. 填寫驗證實驗報告書 </p> <p> <br /> 旦霆科技為制藥行業(yè)等企業(yè)提供驗證測試服務(wù)。對耗材供應(yīng)商進(jìn)行年審、為項目進(jìn)行及服務(wù)客戶把好關(guān)！廣東GMP認(rèn)證滅菌柜驗證怎么做</p><p style="text-indent:25px">旦霆科技團(tuán)隊成員掌握國內(nèi)為GMP、國標(biāo)、ISO等相關(guān)法規(guī)，可為相關(guān)企業(yè)開展滅菌柜驗證等服務(wù)。四川環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證咨詢</p><p style="text-indent:25px">設(shè)備運(yùn)行確認(rèn)，就是設(shè)備各個功能的依次確認(rèn)，在設(shè)備管理中，為設(shè)備的試機(jī)，或試運(yùn)行。概括來講，設(shè)備主要包括四個方面的功能確認(rèn)：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(hù)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(jìn)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(rèn)（如梯度試驗），以及基本確定設(shè)備的操作方法、維護(hù)方法等，人員應(yīng)經(jīng)過操作、維護(hù)的基本培訓(xùn)。四川環(huán)境監(jiān)測系統(tǒng)滅菌柜驗證驗證咨詢</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(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/3038963.html</p></div></div></div></div></div><div id="ti8ieam" class="page-right twoColRt"><div id="vzqpy2z" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="znzl3lc" 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(qiáng) 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(qiáng) 信息推薦自業(yè)物資供應(yīng)</p></a></div><div id="jnevo83" 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)" class="vcenter" 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