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"index_show"><a href="http://www.cdcfah.com/zh/"><span>展會信息</span></a></li></ul></div></nav><section class="wrap clearfix"><section class="container clearfix tcPro"><section class="home-main container clearfix"><div id="febifhj" class="twoCol"><div id="uo2o78o" class="page-proshow clearfix"><p class="current"> 當前位置:<a 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>?福建溫度驗證第三方咨詢誠信服務旦霆生物科技供應</p><div id="crb7lik" class="leftbox clearfix"><h1>福建溫度驗證第三方咨詢誠信服務旦霆生物科技供應</h1><div id="isuhovx" class="proBig"><div id="fzbtv27" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637188431525859375/4595948.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="bac8dv7" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637188431525859375/4595948.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="bfh87k2" 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)品關鍵詞：</span>福建溫度驗證第三方咨詢,溫度驗證</p><p><span>***更新：</span>2021-01-21 07:04:22</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="8zjq8ry" 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="oyv8tfr" class="page-proshow02"><p class="title">詳細說明</p><div id="lug3sk3" class="box"><p><p style="text-indent:25px">溫度系統(tǒng)驗證-醫(yī)藥冷庫主要冷藏儲存在常溫條件下無法保質(zhì)的各類醫(yī)藥產(chǎn)品,在低溫冷藏條件下使藥品不變質(zhì)失效，延長藥品的保質(zhì)期,庫溫一般為-5℃～+8℃。冷藏車倉庫冷庫凍庫低溫倉庫法規(guī)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規(guī)范》布點方式：在倉庫內(nèi)一次性同步布點，確保各測點采集數(shù)據(jù)的同步、有效；每個庫房中均勻性布點數(shù)量不應少于9個，倉間各角及中心位置均應布置測點，福建溫度驗證第三方咨詢，每兩個測點的水平間距不應大于5米，垂直間距不應超過2米；庫房每個作業(yè)出入口及風機出風口區(qū)域至少布置5個測點，庫房中每組貨架或建筑結構的風向死角位置至少應布置3個測點；特殊區(qū)域應布設溫度監(jiān)測點，包括空調(diào)回風位置，福建溫度驗證第三方咨詢、溫度傳感器安裝位置、門、窗、燈等位置；溫度監(jiān)測點均應布設在貨位上或貨物可能存放的位置；旦霆科技取得了客戶的持續(xù)好評，福建溫度驗證第三方咨詢，我們將繼續(xù)以高質(zhì)量服務為客戶提供溫度驗證、技術支持及咨詢服務!福建溫度驗證第三方咨詢</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建溫度驗證第三方咨詢,溫度驗證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637188431525859375/4595948.jpg"></div><p> 溫度系統(tǒng)驗證-注射劑滅菌器試驗條件。 </p> <p> a)環(huán)境溫度:5C ~40C;b)環(huán)境濕度:不大于 85% ;c) 提供的循環(huán)水、冷卻水、蒸汽,壓縮空氣和電源應符合下列要求:循環(huán)水:純化水符合《中華人民共和國藥典》(2010版)二部的要求;冷卻水壓力:0. 15MPa ~0. 5MPa;飽和蒸汽壓力:0.3MPa ~0. 5MPa;壓縮空氣:壓力0. 4MPa ~0. 7MPa,不含液態(tài)水,并濾除所有5μm微粒,且大氣含油量不超過0.5mg/m' ;電源:交流三相380(1土10% )V ,交流單相220(1士10% )V ,50Hz。d) 玻璃輸液瓶:分別符合GB 2639、YBB 00012004、YBB 00022005-2. YBB 00032005、YBB 00292003的規(guī)定。塑料輸液瓶:分別符合YBB 00012002或YBB 00022002的規(guī)定。更多具體見法規(guī)JB/T 20001-2011 注射劑滅菌器福建溫度驗證第三方咨詢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="福建溫度驗證第三方咨詢,溫度驗證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637188431491337890/60026.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 /> </p><p> 溫度系統(tǒng)驗證-電熱干燥箱及電熱鼓風干燥箱布點方法，見法規(guī)GB/T 30435-2013中5.3測試點位置及數(shù)量及使用條件： </p> <p> 工作室容積不大于 2m'的干燥箱應布置9個測試點，一個點布置在工作空間的幾何中心點（o點),其余8個點布置在工作空間的8個頂角上。工作室容積大于2 m'的干燥箱,應在工.作空間幾何中心水平面增加4個測試點。各測試點距工作室內(nèi)壁(加熱器-側除外)的距離，為工作室各白邊長的1/6;測試點距加熱器- -側為邊長的1/5.各試點的位置。使用條件：干燥箱應在下列環(huán)境條件下使用: a)室內(nèi)使用; b)溫度為5 C~35 C; 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) 大氣壓為80 kPa~106 kPa; e)無陽光直接照射或其他熱源直接輻射; f)污染等級2級，周圍無性氣體.高濃度粉塵或腐蝕性氣體; g)周圍無強烈振動和氣流存在。旦霆科技為制藥行業(yè)等企業(yè)提供溫度驗證及驗證測試服務。對耗材供應商進行年審、為項目把好關！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建溫度驗證第三方咨詢,溫度驗證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175339777050781/629819.png"></div><p> 溫度系統(tǒng)驗證-二氧化碳培養(yǎng)箱用途 </p> <p> 二氧化碳培養(yǎng)箱是通過在培養(yǎng)箱箱體內(nèi)模擬形成一個類似細胞/**在生物體內(nèi)的生長環(huán)境，培養(yǎng)箱要求穩(wěn)定的溫度（37°C）、穩(wěn)定的CO2水平（5%）、恒定的酸堿度（pH值：7.2-7.4）、較高的相對飽和濕度（95%），來對細胞/**進行體外培養(yǎng)的一種裝置，是細胞、**、細菌培養(yǎng)的一種先進儀器，是開展免疫學、**學、遺傳學及生物工程所必須的關鍵設備。溫度檢測點的布置：溫度檢測點和工作空間內(nèi)側的距離約為1/10的工作空間寬度、高度或深度,這個距離決定了檢測平面的位置,溫度檢測點在三個水平檢測平面上平均分布.在每個檢測平面上都有9個檢測點,即共27個檢測點。每個檢測平面上溫度檢測點的傳感器探頭應距離擱板15mm以上,確保傳感器探頭不與擱板或內(nèi)壁等金屬材料接觸。旦霆科技專業(yè)提供驗證咨詢、溫度驗證及技術支持，**解答專業(yè)技術問題，歡迎您的垂詢！福建溫度驗證第三方咨詢</p><p style="text-indent:25px">旦霆科技配備專業(yè)的質(zhì)量部，進行驗證審核、報告審核等質(zhì)量監(jiān)管，專業(yè)提供溫度驗證及咨詢服務!福建溫度驗證第三方咨詢</p><p> 溫度系統(tǒng)驗證-滅菌隧道驗證方法 </p> <p> 性能試驗：查驗滅菌機擋風閘門的調(diào)節(jié)功能；查驗滅菌機的冷凝水收集裝置及冷卻介質(zhì)流量的調(diào)節(jié)功能；查驗滅菌機預熱區(qū)、冷卻區(qū)過濾器的結構和質(zhì)量證明書。按照GB/T 16292- -2010 的方法檢測隧道內(nèi)的懸浮粒子是否達到《藥品生產(chǎn)質(zhì)量管理規(guī)范》(2010年修訂)規(guī)定的A級(靜態(tài))要求；查驗高溫區(qū)過濾器的結構和質(zhì)量證明書。按照GB/T 16292- 2010 的方法檢測隧道內(nèi)懸浮粒子是否達到《藥品生產(chǎn)質(zhì)量管理規(guī)范》(2010年修訂)規(guī)定的A級(靜態(tài))要求等。詳見法規(guī)JB/T 20093 -2015***玻璃瓶表冷式隧道滅菌干燥機. 福建溫度驗證第三方咨詢</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: http://www.cdcfah.com/cp/2942861.html</p></div></div></div></div></div><div id="8npeace" class="page-right twoColRt"><div id="8dvxu2n" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="lqifmt7" 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配件哪家強信息推薦自業(yè)物資供應" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></div><p>福建ZF配件哪家強信息推薦自業(yè)物資供應</p></a></div><div id="tn7d9sk" class="recomPic likePro"><a 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