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class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175339777050781/629819.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="88qsja8" 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>福建凍干機驗證溫度驗證誠信互利,溫度驗證</p><p><span>***更新：</span>2021-01-21 06:04:25</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="edkrtk7" 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="mac8f7g" class="page-proshow02"><p class="title">詳細說明</p><div id="jovse7y" class="box"><p><p> 溫度系統(tǒng)驗證：-80℃冰箱的測試方法 </p> <p> 1溫度均勻性試驗：該試驗在穩(wěn)定狀態(tài)下運行時間不應(yīng)少于24 h。 </p> <p> 2降溫時間試驗:低溫箱放置在試驗室內(nèi),打開門。試驗室溫度調(diào)為25°C,溫控器調(diào)至比較低溫度設(shè)置點，福建凍干機驗證溫度驗證誠信互利，福建凍干機驗證溫度驗證誠信互利,待低溫箱內(nèi)部溫度與環(huán)境達到平衡(溫差士1K)。在低溫箱箱內(nèi)特性點處放置T型熱電偶,關(guān)閉箱門,通電測試，其測定值應(yīng)符合本法規(guī)中5，福建凍干機驗證溫度驗證誠信互利.3.3要求 </p> <p> 3超溫報警性能試驗:在完成儲藏溫度試驗后,從工作溫度范圍任選1個溫度作為工作溫度設(shè)定,報警溫度設(shè)定為工作溫度值士10C,然后調(diào)整工作溫度設(shè)置高于或低于設(shè)定報警溫度,當顯示箱內(nèi)溫度回升或降至報警溫度設(shè)定值時,報警裝置應(yīng)發(fā)出報警信號。具體見法規(guī)GBT20154-2014低溫保存箱中制冷性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，為質(zhì)量提供溫度驗證服務(wù)奠定了基礎(chǔ)。福建凍干機驗證溫度驗證誠信互利</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建凍干機驗證溫度驗證誠信互利,溫度驗證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175339777050781/629819.png"></div><p> 溫度系統(tǒng)驗證-脈動真空滅菌器用途 </p> <p> 溫度系統(tǒng)驗證-脈動真空滅菌器主要用于對空腔物品及器具等進行蒸汽滅菌。在制藥行業(yè)中可對瓶塞、操作工具、大量的工作服等不需降溫防爆的布類物品或藥品進行滅菌，也可用于制藥行業(yè)中生產(chǎn)衛(wèi)生材料、敷料、器械等產(chǎn)品的單位作滅菌設(shè)備，可用于藥材的滅菌、熏蒸和烘干。也可用于食品滅菌。可參考 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藥用干熱滅菌器福建凍干機驗證溫度驗證誠信互利計溫度驗證服務(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="福建凍干機驗證溫度驗證誠信互利,溫度驗證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637188431525859375/4595948.jpg"></div><p> 溫度系統(tǒng)驗證-濕熱試驗箱測試方法，見法規(guī)GB/T 10586-2006 濕熱試驗箱技術(shù)條件， I類(交變)濕熱試驗箱的測試方法： </p> <p> 1 按試驗箱工作室容積的大小,確定溫濕度測試點,安裝溫濕度測試傳感器； 2 測量相對濕度測試點的風速； 3 使工作空間的溫度達到25C土3C,相對濕度保持在45%~75%之間； 4 在1h內(nèi),使工作空間的相對濕度不低于95%； 5 使工作空間的溫濕度按GB/T 2423. 4-1993給定的程序,按“升溫-高溫高濕一降溫一低溫高濕”四個階段連續(xù)變化,并按如下要求進行測試: a) 升溫階段,至少每1 min測量中心點的溫濕度一次; b)在進入高溫高濕階段后,每 1 min測量所有溫濕度點的值一次,在30 min內(nèi)共測30次;在高溫高濕階段結(jié)束,即降溫開始前的30min內(nèi)再測30次。 c)自降溫階段開始，至少每1min測量中心點的溫濕度一次,直到全部測量點的溫度達到25C士3C,相對濕度不低于95%,即進人低溫高濕階段為止; d) 在低溫高濕階段,每1 min測量所有溫濕度點的值一次,共測30次。 </p> <p> <br /> </p><p> <span style="font-size:12px;">溫度系統(tǒng)驗證-冷庫、倉庫、保溫箱、冷藏車；法規(guī)GB/T 34399-2017《醫(yī)藥產(chǎn)品冷鏈物流溫控設(shè)施設(shè)備驗證性能確認技術(shù)規(guī)范》 <p> 規(guī)定了對溫控倉庫、溫控車輛、冷藏箱、保溫箱及溫度監(jiān)測系統(tǒng)性能確認的內(nèi)容要求和合格標準，還對可能造成不同理解的內(nèi)容進行了明確界定,包括: </p> <p> 冷、熱點的確認及監(jiān)測；庫內(nèi)蒸發(fā)器出風口附近5個監(jiān)測點位置的界定；多庫門的開門測試要求；開門測試和保溫測試的操作細節(jié)要求；冷庫和冷藏車的滿載測試要求；溫濕度監(jiān)測系統(tǒng)的核查方法；冷藏箱和保溫箱的靜態(tài)及線路性能確認方法；模擬物的要求；模擬溫度條件的選擇；冷藏箱和保溫箱中途開箱測試的要求等。 </p> <p> <br /> </p> </span> </p> <p> <span style="font-size:12px;"><br /> </span> </p> <p> <br /> </p> <p> <br /> 旦霆科技不但擁有龐大的驗證及檢測團隊，同時配備幾百套驗證及檢測儀器，專業(yè)開展溫度驗證服務(wù)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建凍干機驗證溫度驗證誠信互利,溫度驗證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175338992265625/9753014.png"></div><p> <span style="font-size:12px;"> 溫度系統(tǒng)驗證-血液冷藏箱測試方法如下：</span> </p> <p> <span style="font-size:12px;">1控溫性能：按7.1.2.1規(guī)定的環(huán)境,調(diào)整溫控器至4°C位置,冷藏箱平衡后通電,待達釗穩(wěn)定運行狀態(tài)時,連續(xù)運行24 h以上,測出箱內(nèi)溫度應(yīng)滿足5.3.1的要求。</span> </p> <p> <span style="font-size:12px;"> <p> <span style="font-size:12px;"> 2 降溫速度：按7.1.2.1規(guī)定的環(huán)境,調(diào)整溫控器至4C位置,冷藏箱平衡后通電,測試箱內(nèi)溫度到達4C士1C的時間應(yīng)符合5.3.2的要求。</span> </p> <p> 3波動值：按7.1.2.1規(guī)定的環(huán)境,調(diào)整溫控器至4C位置,冷藏箱平衡后通電,待達到穩(wěn)定運行狀態(tài)后,測出箱內(nèi)中點開機與停機的溫度值應(yīng)符合5.3.3的要求。 </p> <p> 4 均勻性：按7.1.2.1規(guī)定的環(huán)境,調(diào)整溫控器至4C位置,冷藏箱平衡后通電,待達到穩(wěn)定運行狀態(tài)后,測出箱內(nèi)各測量點的平均溫度,應(yīng)滿足5.3.4的要求。 </p> <p> <p> 5超溫報警：按7.1.2.1規(guī)定的環(huán)境,冷藏箱平衡后通電,調(diào)整溫控器使箱內(nèi)溫度顯示分別達到上限6°C和下限2C ,結(jié)果應(yīng)符合5.3.8要求。 </p> <p> 6斷電報警：冷藏箱在通電運行中,斷開主電源,試驗結(jié)果應(yīng)符合5.3. 9要求。具體見法規(guī)YYT 0168-2007 血液冷藏箱溫度7.5 性能試驗方法 </p> <p> <br /> </p> </p> <p> <br /> </p> <p> <span style="font-size:12px;"><br /> </span> </p> <br /> </span> </p> <p> <p> <br /> </p> <p> <br /> </p> </p> <p> <br /> 旦霆科技作為專業(yè)溫度驗證及第三方檢測供應(yīng)商，取得良好的口碑，我們繼續(xù)保持高水準的服務(wù)，服務(wù)全國。福建凍干機驗證溫度驗證誠信互利</p><p style="text-indent:25px">旦霆科技具備新建企業(yè)整場驗證及檢測的實力，可有效開展溫度驗證及相關(guān)驗證或檢測服務(wù)！福建凍干機驗證溫度驗證誠信互利</p><p> 溫度系統(tǒng)驗證-生化培養(yǎng)箱使用環(huán)境要求，見法規(guī)GB/T 28851-2012 生化培養(yǎng)箱技術(shù)條件中3.1環(huán)境條件。 </p> <p> 生化箱應(yīng)在下列條件下使用:a) 室內(nèi)使用;b)溫度為5C~35°C,無劇烈的環(huán)境溫度變化;c) 環(huán)境溫度低于31 °C時比較大相對濕度為80%,環(huán)境溫度為35 C時比較大相對濕度線性降到67%;d)海拔高度不超過2000 m;e)周圍不應(yīng)存在影響生化箱使用的振動、磁場(地磁場除外)以及其他冷熱輻照;f)污染等級2級,周圍無高濃度粉塵或腐蝕性氣體;g)周圍無強烈氣流，當周圍空氣需強流動時，氣流不應(yīng)直接吹到生化箱制冷系統(tǒng)進風口和箱門周圍。福建凍干機驗證溫度驗證誠信互利</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(wù)，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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