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href="http://www.cdcfah.com/">首頁?<a href="http://www.cdcfah.com/cp/">產(chǎn)品供應</a>?<a href="http://www.cdcfah.com/cp/second-_swfw/">商務服務</a>?<a href="http://www.cdcfah.com/cp/third-swfw_jiancefuwu/">檢測服務</a>?湖北水浴鍋驗證溫度驗證客戶至上誠信服務旦霆生物科技供應</p><div id="mgy7szt" class="leftbox clearfix"><h1>湖北水浴鍋驗證溫度驗證客戶至上誠信服務旦霆生物科技供應</h1><div id="db8gs78" class="proBig"><div id="3i9w3da" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175338989501953/151978.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="fz8vseb" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175338989501953/151978.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="nmolnp2" 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>湖北水浴鍋驗證溫度驗證客戶至上,溫度驗證</p><p><span>***更新：</span>2021-01-24 04:05:33</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="8aewykw" 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="blnzbn3" class="page-proshow02"><p class="title">詳細說明</p><div id="tt3n3o2" class="box"><p><p> 溫度系統(tǒng)驗證-注射劑滅菌器測試方法： </p> <p> 空載溫度分布試驗：將10號探頭置于滅菌柜溫度控制和記錄探頭旁,其余探頭按法規(guī)中表2均勻分布在腔室各處,測溫傳感器均懸空放置,不與金屬表面接觸。開啟滅菌程序,按121C x 12min滅菌程序運行,運行過程中驗證儀記錄各點溫度,連續(xù)運行3次,以檢查其重現(xiàn)性。滿載熱分布試驗：將10號探頭置于滅菌柜溫度控制和記錄探頭旁,其余探頭按法規(guī)中表2均勻分布在腔室各處,測溫傳感器均懸空放置,不與金屬表面接觸。開啟滅菌程序,按121C x 12min滅菌程序運行,運行過程中驗證儀記錄各點溫度,連續(xù)運行3次,以檢查其重現(xiàn)性，湖北水浴鍋驗證溫度驗證客戶至上。見法規(guī)JB/T 20001-2011《注射劑滅菌器》旦霆科技擁有幾百套進口及國產(chǎn)測試驗證儀器，湖北水浴鍋驗證溫度驗證客戶至上，提供專業(yè)溫度驗證，湖北水浴鍋驗證溫度驗證客戶至上、其他驗證及檢測服務，保證設備充足！湖北水浴鍋驗證溫度驗證客戶至上</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北水浴鍋驗證溫度驗證客戶至上,溫度驗證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175338989501953/151978.jpg"></div><p> 溫度系統(tǒng)驗證：2-8℃冰箱測試方法，對測試條件及性能試驗方法需滿足相應條件。 </p> <p> 如試驗條件包括對試驗室；冷藏箱性能試驗環(huán)境溫度和相對濕度要求；溫度控制調(diào)節(jié)；溫度測量等要求。及試驗狀態(tài)、箱體溫度平衡、冷藏箱有效容積測定、性能試驗方法等要求。其中性能試驗方法包括對控溫性能、降溫速度、波動值、均勻性、超溫報警等有明確要求。 </p> <p> 其中環(huán)境溫度試驗應在下列條件下進行: </p> <p> a) 冷卻性能,啟動性試驗:32C士1C和10C士1C; b)降溫速度,波動值,均勻性試驗:32C士1C; c)絕熱性能試驗:32C士1C ; d)噪聲試驗:32°C士1C; e)報警、化霜試驗 :25C士1C; f) 其他試驗:按其試驗要求進行。具體見法規(guī)YYT 0086-2007 藥品冷藏箱中“7試驗方法” </p> <p> <br /> 湖北水浴鍋驗證溫度驗證客戶至上旦霆科技為提升各項目質(zhì)量水平，成立質(zhì)量部門。為溫度驗證等驗證及檢測服務保駕護航！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北水浴鍋驗證溫度驗證客戶至上,溫度驗證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175338989541015/7492176.png"></div><p> 溫度驗證常用法規(guī)有哪些 </p> <p> 溫度系統(tǒng)驗證常用法規(guī)：GBT20154-2014低溫保存箱、YY0027-1990 電熱恒溫培養(yǎng)箱、YY1621-2018 醫(yī)用二氧化碳培養(yǎng)箱、 YYT0086-2007 藥品冷藏箱、 YYT0168-2007 血液冷藏箱、 GBT10586-2006 濕熱試驗箱技術(shù)條件、 GB/T 34399-2017《醫(yī)藥產(chǎn)品冷鏈物流溫控設施設備驗證性能確認技術(shù)規(guī)范》、 GBT29251-2012真空干燥箱、 JBT 20033-2011 熱風循環(huán)烘箱、 JBT20093-2015***玻璃瓶表冷式隧道滅菌干燥機、 GBT30435-2013電熱干燥箱及電熱鼓風干燥箱、 GB8599-2008 大型蒸汽滅菌器技術(shù)要求自動控制型、 JBT 20001-2011 注射劑滅菌器、 JBT20163-2014藥用干熱滅菌器 </p> <p> <br /> </p> <p> <br /> </p><p> <span style="font-size:12px;"> 溫度系統(tǒng)驗證-醫(yī)用生化培養(yǎng)箱溫度測試方法，見法規(guī)YY1641-2018醫(yī)用生化培養(yǎng)箱中5.2.3.1溫度檢測點的布置：</span> </p> <p> 溫度檢測點在3個水平檢測平面上平均分布,每個檢測平面上均有5個檢測點，即共15個檢測點。上層檢測平面到工作空間頂面的距離和下層檢測平面到工作空間底面的距離均為1/10工作空間高度,中間層檢測平面通過工作空間的幾何中心。每個檢測平面上除中心點外,溫度測量點與工作空間內(nèi)側(cè)的距離約為1/10工作空間寬度或深度。溫度檢測點的傳感器探頭應距離擱板15 mm以上,確保傳感器探頭不與擱板或內(nèi)壁等金屬材料接觸。 </p> <p> <br /> 旦霆科技作為專業(yè)驗證檢測供應商，具備CMA資質(zhì)檢測報告國家認可，專業(yè)提供溫度驗證服務，是您放心的選擇。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北水浴鍋驗證溫度驗證客戶至上,溫度驗證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637188431491337890/60026.jpg"></div><p> 溫度系統(tǒng)驗證：-20℃冰箱、-40℃冰箱、-60℃冰箱的測試方法，見法規(guī)GB/T10589-2008低溫試驗箱技術(shù)條件中6.3溫度測試方法： </p> <p> <br /> </p> <p> 測試點的位置及數(shù)量： </p> <p> 1 在試驗箱工作室內(nèi)定出上、中、下三個水平測試面,簡稱上、中、下層。上層與工作室的頂面的距離是工作室高度的1/10,中層通過工作室?guī)缀沃行?，下層在比較低層樣品架上方10 mm處。 </p> <p> 注:工作室具有斜頂或尖頂時,頂面為通過斜面與垂直壁面交線的假想水平面。 </p> <p> 2測試點位于三個測試面上,中心測試點位于工作室?guī)缀沃行?其余測試點到工作室壁的距離為各自邊長的1/10。但對工作室容積不大于1 m3的試驗箱,該距離不小于50 mm. </p> <p> 3 測試點的數(shù)量與工作室容積大小的關(guān)系為: </p> <p> a)工作室容積不大于2 m3時,測試點為9個。 b)工作室容積大于2m3時,測試點為15個。 c)當工作室容積大于50 m3時，應適當增加溫度測試點的數(shù)量。 </p> <p> <br /> </p> <p> <br /> </p> <p> <br /> 旦霆科技作為國內(nèi)**的綜合性驗證咨詢公司，專業(yè)解答各種溫度驗證及偏差處理等相關(guān)問題，歡迎您的垂詢！湖北水浴鍋驗證溫度驗證客戶至上</p><p style="text-indent:25px">旦霆科技擁有先進的驗證理念，成熟的驗證體系，完善的質(zhì)量體系，為您提供專業(yè)、質(zhì)量的溫度驗證服務！湖北水浴鍋驗證溫度驗證客戶至上</p><p> 溫度系統(tǒng)驗證-熱風循環(huán)烘箱用途 </p> <p> 熱風循環(huán)烘箱用于醫(yī)藥、化工、食品、農(nóng)副產(chǎn)品、水產(chǎn)品、輕工等行業(yè)物料的加熱固化、干燥脫水。如原料、中藥飲片、浸膏、粉劑、顆粒、脫水蔬菜等。滅菌隧道、真空干燥箱、電熱鼓風干燥箱、熱風循環(huán)烘箱溫度系統(tǒng)驗證-熱風循環(huán)烘箱箱測試方法，見法規(guī)JB/T20033-2011熱風循環(huán)烘箱，烘箱的空載熱分布試驗采用多點式溫度檢測儀。 A.2烘箱的每個工作腔應布置13個點。工作腔空間的幾何中心是中心點,中心點水平面上設4個點,其余8個試點設在頂角和底層的四角附近。 A.3試點離工作室內(nèi)壁的距離:裝有加熱器的一側(cè),試點距離分風板為150mn；試點距離內(nèi)壁或分風板為100mm。湖北水浴鍋驗證溫度驗證客戶至上</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、制藥設備等行業(yè)提供GXP合規(guī)咨詢、驗證服務以及培訓的綜合性咨詢公司； </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> 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，同時公司每年利潤的10%捐獻給中國貧困兒童，持久資助中國貧困兒童的教育。 </p></p><br /><p>文章來源地址: 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