安徽庫存管理軟件滅菌柜驗證驗證服務誠信服務旦霆生物科技供應-b2b網站_b2b電子商務平臺【買產品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="第一百三十九條企業(yè)的廠房，安徽庫存管理軟件滅菌柜驗證驗證服務、設施、設備和檢驗儀器應經過確認，應采用經過驗證的生產工藝、操作規(guī)程和檢驗方法進行生產、操作和檢驗，并保持持續(xù)的驗證狀態(tài)。第一百四十條應建立確認和驗證的文件"><meta name="keywords" content="安徽庫存管理軟件滅菌柜驗證驗證服務,滅菌柜驗證"><link rel="canonical" href="http://www.cdcfah.com/"/><meta name="applicable-device" content="pc"><link rel="shortcut icon" href="/static/new_net_01/images/favicon.ico"><link rel="stylesheet" href="/static/new_net_01/css/slick.css" /><link rel="stylesheet" href="/static/new_net_01/css/addnew.css"><link rel="stylesheet" href="/static/new_net_01/css/sidenav.css"><link rel="stylesheet" href="/static/new_net_01/css/style.css" /><link rel="stylesheet" href="/static/new_net_01/css/tab.css"><link rel="stylesheet" href="/static/new_net_01/css/404.css"> <meta name="baidu-site-verification" content="OBVzrC9aaQ" /> <meta http-equiv="Cache-Control" content="no-transform" /> <meta http-equiv="Cache-Control" 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class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294414755860/4492022.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="agoeiwc" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294414755860/4492022.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="saqoo0u" class="content"><p><span>需求數量：</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>產品關鍵詞：</span>安徽庫存管理軟件滅菌柜驗證驗證服務,滅菌柜驗證</p><p><span>***更新：</span>2021-01-16 05:05:24</p><p><span id="click" >瀏覽次數：0次</span></p><a rel="nofollow" class="button">聯系我們</a></div></div><div id="kmc08oe" 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="o2euuao" class="page-proshow02"><p class="title">詳細說明</p><div id="qa008si" class="box"><p><p> ***百三十九條企業(yè)的廠房，安徽庫存管理軟件滅菌柜驗證驗證服務、設施、設備和檢驗儀器應經過確認，應采用經過驗證的生產工藝、操作規(guī)程和檢驗方法進行生產、操作和檢驗，并保持持續(xù)的驗證狀態(tài)。 </p> <p> ***百四十條應建立確認和驗證的文件和記錄，并能以文件和記錄證明達到以下預定的目標： </p> <p> （一）設計確認（DQ）應證明廠房、設施，安徽庫存管理軟件滅菌柜驗證驗證服務、設備的設計符合預定用途和本規(guī)范要求； </p> <p> （二）安裝確認（IQ）應證明廠房，安徽庫存管理軟件滅菌柜驗證驗證服務、設施和設備的建造和安裝符合設計標準； </p> <p> （三）運行確認（OQ）應證明廠房、設施和設備的運行符合設計標準； </p> <p> （四）性能確認（PQ）應證明廠房、設施、設備在正常操作方法和工藝條件下能持續(xù)符合標準。 </p> <p> （五）工藝驗證（PV）應證明一個生產工藝按規(guī)定的工藝參數能持續(xù)生產出符合預定的用途和注冊要求的產品。 </p> <p> <br /> </p> <p> <br /> 旦霆科技成立至今為超過800多家企業(yè)提供GMP咨詢、儀器設備驗證等服務，口碑良好，性價比高！安徽庫存管理軟件滅菌柜驗證驗證服務</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽庫存管理軟件滅菌柜驗證驗證服務,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294414755860/4492022.png"></div><p> 本文件主要依據ISO/IEC 17025標準和USP1058《分析儀器驗證指導原則》編制，同時參考了我國的《藥品生產質量管理規(guī)范 (2010 年修訂 )》等有關文件，可為實驗室規(guī)范儀器設備管理提供指導。本文件滿足 ISO/IEC 17025 標準對儀器設備的要求，是針對儀器設備的更***、具體管理指導性文件。 </p> <p> 本文件對儀器驗證各階段具體實施提供了指南，注重儀器對預期用途的適用性，可用于常規(guī)檢測實驗室對各類儀器的管理。為給實驗室施證提供具體指導，本文件以目前檢測實驗室中使用較為***的液相色譜儀例，提供了實施儀器驗證的具體范例。上海旦霆生物科技有限公司滅菌柜驗證服務旦霆科技布局藥企行業(yè)，目前為20余家相關行業(yè)的公司提供儀器設備驗證及咨詢等服務。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽庫存管理軟件滅菌柜驗證驗證服務,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296157607422/4527074.png"></div><p> 驗證的對象：生產工藝、操作規(guī)程和檢驗方法 </p> <p> 方法：回顧性驗證和同步驗證。 </p> <p> </p> <p> 確認的對象:廠房、設施、設備和檢驗儀器 </p> <p> 方法：前驗證和再驗證 </p> <p> <br /> </p> <p> 用戶需求標準 </p> <p> URS (user requirement specification):是指使用方對廠房、設施、設備和檢驗儀器等硬件設施系統等提出的自己的期望使用需求說明，這個需求綜合自己的使用目的、用途、環(huán)境等提出自己具體的方案，設備供應商依據客戶提供的URS方案進行設備設計（或確認自己已經完成設計的設備能符合需方的要求），待客戶完成DQ（設計確認）后，再進行設備的制造。 </p><p> 滿載測試：滿載測試主要是熱穿透試驗，是在熱分布試驗的基礎上，確定裝載中的“**冷點”，并肯定該點在滅菌過程中獲得的無菌保證值，各留點溫度計在119°C-123°C之間。 </p> <p> 生物指示測試 </p> <p> 121°C壓力蒸汽滅菌化學指示卡的工作原理是卡面指示劑在滅菌過程中的濕熱作用下達到一定溫度和時間后，產生變色反應以顯示滅菌效果，其顏色效應是以壓力蒸汽滅菌的生物指示劑——嗜熱脂肪桿菌芽孢菌片的耐熱參數為數據，以121°C、20分鐘常規(guī)壓力蒸汽滅菌法的滅菌周期為標準而設計的，在飽和蒸汽121（±2）°C滅菌時，指示卡變?yōu)椤皹藴省焙谏幢硎尽胺蠝缇鷹l件”，低于“標準黑色”即表示“不符合滅菌條件”以此判斷滅菌效果。旦霆科技作為國內**的綜合性驗證咨詢公司，專業(yè)解答各種設備驗證及偏差處理等相關問題，歡迎您的垂詢！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽庫存管理軟件滅菌柜驗證驗證服務,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294992236329/5059315.png"></div><p> <strong>濕熱滅菌設備的溫度驗證 </strong> </p> <p> <br /> </p> <p> 溫度驗證程序設計基本要求 </p> <p> <br /> </p> <p> 濕熱滅菌的基本程序設計基本要求源于US.FDA在上世紀70年代中期提出的，且在80年代施行的：“關于大容量注射劑GMP技術性原則”五個方面要求： </p> <p> <br /> </p> <p> (1)在滅菌工序應能確保產品達到F0 ≥ 8； </p> <p> <br /> </p> <p> (2)滅菌前，待實驗的容器中有比較高帶菌量，污染菌應具有**強的耐熱性； </p> <p> <br /> </p> <p> (3)每一個滅菌釜的每種裝載方式及每種規(guī)格容器的驗證實驗均至少使用10支熱電偶進行熱分布實驗； </p> <p> <br /> </p> <p> (4)用待實驗容器灌注粘度相類似的產品進行熱穿透實驗，找出容器中升溫**慢點的位置，至少使用10個容器，每個均加入適當的生物指示劑并且插有熱電偶。當滅菌釜的參數已經達到熱分布實驗已經證實的可重現狀態(tài)，溫度達到設定的滅菌溫度時，開始測定F0 值，直到開始冷卻止； </p> <p> <br /> </p> <p> (5)當產品達到滅菌溫度直到開始冷卻的過程，溫度變化必須保持在 ±0.5℃以內。 </p> <p> <br /> 旦霆科技將不斷完善，繼續(xù)以高質量服務為客戶提供滅菌柜驗證、技術支持及咨詢服務!安徽庫存管理軟件滅菌柜驗證驗證服務</p><p style="text-indent:25px">旦霆科技各類行業(yè)的驗證服務經驗，專業(yè)為您提供滅菌柜驗證，值得信賴！安徽庫存管理軟件滅菌柜驗證驗證服務</p><p> 1. 溫度類：超低溫冰箱（-80℃）、低溫冰箱、陰涼柜、生化培養(yǎng)箱、霉菌培養(yǎng)箱、二氧化碳培養(yǎng)箱、搖床、二氧化碳搖床、穩(wěn)定性試驗箱、水浴鍋、滅菌鍋/滅菌器、干熱滅菌柜、烘箱、熱風循環(huán)烘箱等等 </p> <p> 2. 凈化環(huán)境類：超凈工作臺（潔凈工作臺）、生物安全柜、隔離器、RABS、層流罩、層流車、通風廚等等 </p> <p> 3. 光譜色譜類：高效液相色譜儀、氣相色譜儀、紫外可見分光光度計、紅外分光光度計、原子吸收分光光度計、液質聯用儀等等 </p> <p> 4. 生物/細胞/蛋白類：細胞計數器、PCR儀、酶標儀、蛋白純化儀、程序降溫儀、電泳儀、凝膠成像儀、滲透壓儀、流式細胞儀、臺式離心機、冷凍離心機等等 </p> <p> 5. 其它類：電子天平、分析天平、PH計、電導率儀、顯微鏡、菌落計數器等等 </p> <p> 服務內容：針對以上儀器，旦霆科技可提供計算機化系統驗證（CSV）、風險評估（RA）、3Q確認（3Q驗證）以及相關測試服務。 </p> <p> <br /> 安徽庫存管理軟件滅菌柜驗證驗證服務</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**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/2867906.html</p></div></div></div></div></div><div id="giqmy2i" class="page-right twoColRt"><div id="qqge8ag" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="wmucaq2" 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" 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