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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>福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-30 01:04:37</p><p><span id="click" >瀏覽次數(shù)：2次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="827d7zl" 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="w8nhteg" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="drsyjah" class="box"><p><p> 滅菌柜驗(yàn)證操作過程 </p> <p> (1)驗(yàn)證用的儀器，主要由三部分組成：高精度的測溫探頭、用微機(jī)制成的測溫和傳送集成系統(tǒng)以及手提電腦。 </p> <p> (2)使用以前當(dāng)然就是要進(jìn)行校正。 </p> <p> (3)校正完了以后就按照布點(diǎn)圖進(jìn)行布點(diǎn)。1)空載熱分布是指柜內(nèi)不放任何玻璃瓶，只放空的滅菌架進(jìn)入腔體；2)滿載熱分布是指按比較大裝載量把玻璃瓶放滿滅菌架中，然后探頭是放于瓶外去測溫，看瓶外的溫度變化；3)滿載熱穿透的玻璃瓶放置方法和跟滿載熱分布一樣，只是溫度檢測探頭的位置不一樣，滿載熱穿透是把探頭放置于盛滿藥液或水的瓶子中緊固，用于探測瓶內(nèi)溫度，福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證。 </p> <p> 以上每個階段都需要進(jìn)行至少連續(xù)運(yùn)行3次。這里需要注意的是不同的規(guī)格都需要按比較大裝載量去放置，福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證，而且要按正常滅菌的程序進(jìn)行滅菌，不然就失去驗(yàn)證的意義了，而我們在這個過程只需要觀察數(shù)據(jù)就可以了。 </p> <p> 還有用生物指示劑進(jìn)行挑戰(zhàn)性試驗(yàn)，生物指示劑的選用可根據(jù)藥典，但應(yīng)強(qiáng)調(diào)所用生物指示劑的耐熱性應(yīng)大于產(chǎn)品中常見污染菌的耐熱性，用量也應(yīng)大于產(chǎn)品中該污染菌的水平，經(jīng)生物指示劑驗(yàn)證后，應(yīng)能證明在設(shè)定的F0值條件下，產(chǎn)品的無菌保證水平低于10－6。 </p> <p> (4)***驗(yàn)證完要對溫度探頭進(jìn)行再次校正，驗(yàn)證前后偏差均應(yīng)小于0.5℃為合格。 </p> <p> <br /> 旦霆科技可提供滅菌柜驗(yàn)證等驗(yàn)證服務(wù)，福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證。廣納良言，吸取客戶有效意見、致力于為客戶更好的服務(wù)。福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295339033204/3936007.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(yàn)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(yàn)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”。福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證咨詢旦霆科技配備專業(yè)的質(zhì)量部，進(jìn)行驗(yàn)證審核、報告審核等質(zhì)量監(jiān)管，專業(yè)提供儀器驗(yàn)證及咨詢服務(wù)，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294992236329/5059315.png"></div><p> 滅菌器驗(yàn)證程序 </p> <p> <br /> </p> <p> 安裝檢查 </p> <p> <br /> </p> <p> 1.1 安裝檢查所需文件的檢查： </p> <p> <br /> </p> <p> 1.1.1 高壓電熱壓力蒸汽消毒器使用說明書的檢查：檢查是否有儀器的說明書，說明書與儀器是否配套。 </p> <p> <br /> </p> <p> 1.1.2 相關(guān)儀器儀表校驗(yàn)記錄的檢查：檢查校驗(yàn)記錄是否完整，是否定期進(jìn)行校驗(yàn)。 </p> <p> <br /> </p> <p> 1.1.3 高壓電熱壓力蒸汽消毒器使用標(biāo)準(zhǔn)操作規(guī)程的檢查：檢查是否具有相應(yīng)的標(biāo)準(zhǔn)操作規(guī)程。 </p> <p> <br /> </p> <p> 1.1.4 高壓電熱壓力蒸汽消毒器維修保養(yǎng)記錄的檢查：檢查儀器的維修保養(yǎng)記錄是否齊全，儀器是否定期進(jìn)行相應(yīng)的維修保養(yǎng)。 </p> <p> <br /> </p> <p> 1.1.5 高壓電熱壓力蒸汽消毒器使用記錄的檢查，檢查使用記錄是否完整。 </p> <p> <br /> </p> <p> <br /> </p><p> URS容易出現(xiàn)的問題： </p> <p> 使用單位不能提供詳細(xì)具體的URS為設(shè)計單位作為設(shè)計依據(jù)； </p> <p> 不能提出劑型、品種、工藝、產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)或相應(yīng)的操作程序； </p> <p> 對產(chǎn)量、班次、物流控制方面不了解、不專業(yè)和不擅長； </p> <p> 不能按自身的生產(chǎn)工藝需要向制藥裝備廠商提出具體的GMP要求； </p> <p> 不能把GMP的對應(yīng)要求做細(xì)化理解，關(guān)鍵節(jié)點(diǎn)把握不準(zhǔn)確。如潔凈度控制、壓差梯度、氣鎖裝置等； </p> <p> 一份編寫良好的URS用戶需求規(guī)范，不僅考慮工藝要求，而且考慮與GMP的符合性以及驗(yàn)證要求。旦霆科技針對于中大型驗(yàn)證均配備項(xiàng)目經(jīng)理，在為提供滅菌柜驗(yàn)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="福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293616376954/1769054.png"></div><p> 設(shè)備驗(yàn)證合格后，**終確認(rèn)的內(nèi)容有：設(shè)備編號、操作規(guī)程、維護(hù)規(guī)程、點(diǎn)檢卡、潤滑卡、檢修計劃、備品配件臺賬、模具臺賬等。日常使用的包括設(shè)備運(yùn)行（使用）記錄、模具領(lǐng)用記錄、維護(hù)檢修記錄、潤滑記錄、儀器儀表記錄等。并將相關(guān)記錄整理歸檔：調(diào)研報告、合同、開箱驗(yàn)收記錄、裝箱單、安裝驗(yàn)收記錄以及驗(yàn)證報告。驗(yàn)證確認(rèn)的各種內(nèi)容，在設(shè)備管理中應(yīng)有相應(yīng)的規(guī)定。 </p> <p> 備驗(yàn)證合格后即進(jìn)入設(shè)備初期使用階段，設(shè)備初期使用階段故障率較高。依據(jù)設(shè)備失效的浴盆曲線理論，設(shè)備失效狀態(tài)分三個階段：初期的失效高發(fā)期、設(shè)備運(yùn)行的穩(wěn)定期和后期的失效高發(fā)期。因此，設(shè)備移交時間的選擇應(yīng)在驗(yàn)證合格后、運(yùn)行進(jìn)入穩(wěn)定期后進(jìn)行，在設(shè)備管理中，該階段即是常說的磨合期。設(shè)備如果在磨合期前移交，一旦發(fā)生故障，則較難進(jìn)行索賠。因此，設(shè)備初期應(yīng)較多的進(jìn)行運(yùn)行及空白物料試機(jī)，以使設(shè)備盡快進(jìn)入磨合期。在時間分布上，該階段還應(yīng)該在設(shè)備的索賠期限內(nèi)，即設(shè)備索賠期限至少達(dá)到設(shè)備的磨合期。旦霆科技擁有幾百套進(jìn)口及國產(chǎn)儀器，提供專業(yè)滅菌柜驗(yàn)證及檢測服務(wù)，在承接眾多業(yè)務(wù)下保證設(shè)備充足！福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證</p><p style="text-indent:25px">專業(yè)從事滅菌柜驗(yàn)證、培養(yǎng)箱驗(yàn)證、滅菌隧道驗(yàn)證、GSP冷庫驗(yàn)證、熱風(fēng)循環(huán)烘箱驗(yàn)證等一些列溫度驗(yàn)證服務(wù)。福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證</p><p style="text-indent:25px">美國加工產(chǎn)業(yè)與中國有所不同，和美國相比，中國的產(chǎn)業(yè)仍處于初創(chuàng)期。在經(jīng)濟(jì)新常態(tài)下，中國大加工產(chǎn)業(yè)憑借獨(dú)特資源和市場優(yōu)勢，一舉成為資本角逐的重點(diǎn)領(lǐng)域之一。有關(guān)機(jī)構(gòu)預(yù)測，中國加工產(chǎn)業(yè)規(guī)模未來5年年均復(fù)合增長率約為27.26%。國外的谷歌、蘋果等公司，國內(nèi)的阿里巴巴、騰訊、萬科、保利、平安人壽、萬達(dá)等企業(yè)都根據(jù)自身優(yōu)勢扎根大健康領(lǐng)域。拋開服務(wù)型的公共服務(wù)屬性，在市場環(huán)境中，企業(yè)競爭的秘訣是要創(chuàng)造稀缺，結(jié)合消費(fèi)者高、中、低不同等級的需求，并成為難以替代的產(chǎn)品。監(jiān)管體系缺失，山東的疫苗事件中，體現(xiàn)出銷往24個省市的疫苗各方面監(jiān)管力度小。制藥企業(yè)和各大醫(yī)藥機(jī)構(gòu)由不同部門管理，這種分段監(jiān)管方式存在很大的醫(yī)藥健康漏洞。我國經(jīng)濟(jì)進(jìn)入“新常態(tài)”，總體上推動GMP驗(yàn)證咨詢與服務(wù)，計算機(jī)化系統(tǒng)驗(yàn)證，壓縮空氣檢測，潔凈室檢測從粗放式增長向注重質(zhì)量、效率方向轉(zhuǎn)變。民間資本的進(jìn)入也一定程度刺激我國GMP驗(yàn)證咨詢與服務(wù)，計算機(jī)化系統(tǒng)驗(yàn)證，壓縮空氣檢測，潔凈室檢測市場活力。社會對健康類產(chǎn)業(yè)的關(guān)注度越來越高，迫切需要對GMP驗(yàn)證咨詢與服務(wù)，計算機(jī)化系統(tǒng)驗(yàn)證，壓縮空氣檢測，潔凈室檢測的規(guī)模和結(jié)構(gòu)進(jìn)行核算。福建溫度監(jiān)測系統(tǒng)滅菌柜驗(yàn)證質(zhì)量保證</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/3069313.html</p></div></div></div></div></div><div id="h7adsoa" class="page-right twoColRt"><div id="i7negsn" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="cwd3hyp" 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="ecownov" class="recomPic likePro"><a 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