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class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價(jià)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>河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證,溫度驗(yàn)證</p><p><span>***更新：</span>2021-01-15 01:04:18</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="axubnu3" 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(hào)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="pamyary" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="pya8pm8" class="box"><p><p> 溫度系統(tǒng)驗(yàn)證-脈動(dòng)真空滅菌器用途 </p> <p> 溫度系統(tǒng)驗(yàn)證-脈動(dòng)真空滅菌器主要用于對(duì)空腔物品及器具等進(jìn)行蒸汽滅菌。在制藥行業(yè)中可對(duì)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(jìn)行滅菌，也可用于制藥行業(yè)中生產(chǎn)衛(wèi)生材料、敷料，河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證、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(dòng)控制型、 JBT 20001-2011 注射劑滅菌器、 JBT20163-2014藥用干熱滅菌器旦霆科技感恩新老客戶的多年信賴，河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證，河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證，我們將再接再厲，持續(xù)為新老客戶提供質(zhì)量、專業(yè)的溫度驗(yàn)證服務(wù)！河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證,溫度驗(yàn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637188431490947265/9085575.png"></div><p> 溫度系統(tǒng)驗(yàn)證-溫控車輛測(cè)試接受標(biāo)準(zhǔn)，見法規(guī)GB/T 34399-2017《醫(yī)藥產(chǎn)品冷鏈物流溫控設(shè)施設(shè)備驗(yàn)證性能確認(rèn)技術(shù)規(guī)范》中4.2合格判定： </p> <p> 應(yīng)證明車輛滿足相應(yīng)藥品的運(yùn)輸溫度要求。1 車輛空調(diào)系統(tǒng)在既定運(yùn)行條件下，空載和滿載溫度分布測(cè)試結(jié)果證明車廂內(nèi)溫度控制在規(guī)定范圍內(nèi)；2 確定冷點(diǎn)和熱點(diǎn)并在冷、熱點(diǎn)設(shè)置日常監(jiān)測(cè)溫度傳感器； 3 企業(yè)應(yīng)當(dāng)按照國(guó)家有關(guān)規(guī)定，對(duì)溫度記錄儀定期進(jìn)行校準(zhǔn)或者檢定。其比較大允許誤差應(yīng)當(dāng)符合以下要求：測(cè)量范圍在0℃～40℃之間，溫度的比較大允許誤差為±0.5℃；測(cè)量范圍在－25℃～0℃之間，溫度的比較大允許誤差為±1.0℃； 4 溫度傳感器與驗(yàn)證用溫度記錄儀的差值應(yīng)在±1℃以內(nèi)（冷凍運(yùn)輸差值應(yīng)在±2℃以內(nèi)）； 5 確定導(dǎo)致任一測(cè)點(diǎn)超溫的**短開門時(shí)間； 6 確定空調(diào)設(shè)備故障情況下的保溫時(shí)限； 7 冬季和夏季極端溫度條件下均可保證溫度控制符合既定標(biāo)準(zhǔn)； 8 溫度偏差、均勻度、波動(dòng)度應(yīng)不高于±3℃。河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證旦霆科技作為專業(yè)的溫度驗(yàn)證、第三方檢測(cè)供應(yīng)商，配備國(guó)外專業(yè)驗(yàn)證及檢測(cè)儀器,質(zhì)量可靠值得推薦!</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證,溫度驗(yàn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175339008613281/9840885.png"></div><p> 溫度系統(tǒng)驗(yàn)證-注射劑滅菌器試驗(yàn)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(yīng)符合下列要求:循環(huán)水:純化水符合《中華人民共和國(guó)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(guò)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 </p><p> 溫度系統(tǒng)驗(yàn)證-濕熱試驗(yàn)箱測(cè)試方法，見法規(guī)GB/T 10586-2006 濕熱試驗(yàn)箱技術(shù)條件， I類(交變)濕熱試驗(yàn)箱的測(cè)試方法： </p> <p> 1 按試驗(yàn)箱工作室容積的大小,確定溫濕度測(cè)試點(diǎn),安裝溫濕度測(cè)試傳感器； 2 測(cè)量相對(duì)濕度測(cè)試點(diǎn)的風(fēng)速； 3 使工作空間的溫度達(dá)到25C土3C,相對(duì)濕度保持在45%~75%之間； 4 在1h內(nèi),使工作空間的相對(duì)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(gè)階段連續(xù)變化,并按如下要求進(jìn)行測(cè)試: a) 升溫階段,至少每1 min測(cè)量中心點(diǎn)的溫濕度一次; b)在進(jìn)入高溫高濕階段后,每 1 min測(cè)量所有溫濕度點(diǎn)的值一次,在30 min內(nèi)共測(cè)30次;在高溫高濕階段結(jié)束,即降溫開始前的30min內(nèi)再測(cè)30次。 c)自降溫階段開始，至少每1min測(cè)量中心點(diǎn)的溫濕度一次,直到全部測(cè)量點(diǎn)的溫度達(dá)到25C士3C,相對(duì)濕度不低于95%,即進(jìn)人低溫高濕階段為止; d) 在低溫高濕階段,每1 min測(cè)量所有溫濕度點(diǎn)的值一次,共測(cè)30次。 </p> <p> <br /> 旦霆科技擁有先進(jìn)的驗(yàn)證理念，成熟的驗(yàn)證體系，為您提供專業(yè)、質(zhì)量的溫度驗(yàn)證服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證,溫度驗(yàn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637188431034902343/9757862.jpg"></div><p> 溫度系統(tǒng)驗(yàn)證-恒溫恒濕箱/穩(wěn)定性試驗(yàn)箱布點(diǎn)方式，見法規(guī)GB/T 10586-2006 濕熱試驗(yàn)箱技術(shù)條件中測(cè)試點(diǎn)的位置及數(shù)量： </p> <p> 1在試驗(yàn)箱工作室內(nèi)定出上、中、下三個(gè)水平測(cè)試面,簡(jiǎn)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(guò)工作室?guī)缀沃行?，下層在比較低層樣品架.上方10 mm處。（注:工作室具有斜頂或尖項(xiàng)時(shí),頂面為通過(guò)斜面與垂直壁面交線的假想水平面。） 2 測(cè)試點(diǎn)位于三個(gè)測(cè)試面上,中心測(cè)試點(diǎn)位于工作室?guī)缀沃行?其余測(cè)試點(diǎn)到工作室壁的距離為各自邊長(zhǎng)的1/10。但對(duì)工作室容積不大于1 m'的試驗(yàn)箱,該距離不小于50 mm。 3測(cè)試點(diǎn)的數(shù)量與工作室容積大小的關(guān)系為: a)工作室容積不大于2 m'時(shí)，溫度測(cè)試點(diǎn)為9個(gè),相對(duì)濕度測(cè)試點(diǎn)為3個(gè)。 b)工作室容積大于2 m'時(shí),溫度測(cè)試點(diǎn)為15個(gè),相對(duì)濕度測(cè)試點(diǎn)為4個(gè)。 c)當(dāng)工作室容積大于50m3時(shí),溫濕度測(cè)試點(diǎn)的數(shù)量可以適當(dāng)增加。旦霆科技提供技術(shù)咨詢、溫度驗(yàn)證、驗(yàn)證及檢測(cè)服務(wù)。在您不知道具體項(xiàng)目需求時(shí)為您擇優(yōu)推薦！河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證</p><p style="text-indent:25px">旦霆科技為提升各項(xiàng)目質(zhì)量水平，成立質(zhì)量部門。為溫度驗(yàn)證等驗(yàn)證及檢測(cè)服務(wù)保駕護(hù)航！河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)證</p><p style="text-indent:25px">溫度系統(tǒng)驗(yàn)證-藥品冷藏箱主要用于藥品、試劑、疫苗、血液等的冷藏、保存、運(yùn)輸。醫(yī)用冷藏箱低溫保存箱冷藏冷凍箱冷藏箱冷藏車法規(guī)GBT20154-2014低溫保存箱法規(guī)YYT0086-2007 藥品冷藏箱、 1 在車廂內(nèi)一次性同步布點(diǎn)，確保各測(cè)點(diǎn)采集數(shù)據(jù)的同步、有效； 2 每個(gè)冷藏車箱體內(nèi)測(cè)點(diǎn)數(shù)量不應(yīng)少于9個(gè)，每增加20立方米增加9個(gè)測(cè)點(diǎn)，不足20立方米的按20立方米計(jì)算；均勻分布，通常根據(jù)車輛的長(zhǎng)度和有效容積分2或3層布置。 3 特殊區(qū)域應(yīng)布設(shè)溫度監(jiān)測(cè)點(diǎn)，包括空調(diào)送風(fēng)、回風(fēng)位置、溫度傳感器安裝位置、門及可能的送風(fēng)死角等位置。 4 溫度監(jiān)測(cè)點(diǎn)均應(yīng)布設(shè)在貨物可河南倉(cāng)庫(kù)驗(yàn)證溫度驗(yàn)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(zhǎng)期致力于幫助企業(yè)順利通過(guò)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(lái)自于**外資制藥企業(yè)、外資GMP咨詢公司、及國(guó)內(nèi)**的第三方檢測(cè)公司。 </p> <p> 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