湖北倉庫管理軟件滅菌柜驗證公司誠信為本旦霆生物科技供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="再驗證儀器儀表每年校正一次。任何滅菌條件得改變，包括滅菌的溫度、滅菌時間、壓力等改變均需重新驗證。一般情況下驗證小組根據(jù)此次驗證結(jié)果，提出再驗證時間。一般驗證的有效期為一年。再驗證儀器儀表每年校正一次。任何滅菌條件得改變，包括滅菌的溫度、滅"><meta name="keywords" content="湖北倉庫管理軟件滅菌柜驗證公司,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 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href="http://www.cdcfah.com/cp/second-_yyby/">醫(yī)藥健康</a>?<a href="http://www.cdcfah.com/cp/third-yyby_qtflft/">其他未分類</a>?湖北倉庫管理軟件滅菌柜驗證公司誠信為本旦霆生物科技供應(yīng)</p><div id="6ykrtau" class="leftbox clearfix"><h1>湖北倉庫管理軟件滅菌柜驗證公司誠信為本旦霆生物科技供應(yīng)</h1><div id="ryxtqcj" class="proBig"><div id="nro3tno" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295189746094/9212985.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="bqcelnz" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295189746094/9212985.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="uov8ryp" 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>湖北倉庫管理軟件滅菌柜驗證公司,滅菌柜驗證</p><p><span>***更新：</span>2021-01-31 03:05:25</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="od2do8l" 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="7yfhe3w" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="qk3epgd" class="box"><p><p> 再驗證 </p> <p> 儀器儀表每年校正一次。 </p> <p> 任何滅菌條件得改變，包括滅菌的溫度、滅菌時間、壓力等改變均需重新驗證。 </p> <p> 一般情況下驗證小組根據(jù)此次驗證結(jié)果，提出再驗證時間。一般驗證的有效期為一年。 </p> <p> <p> 再驗證 </p> <p> 儀器儀表每年校正一次。 </p> <p> 任何滅菌條件得改變，包括滅菌的溫度、滅菌時間、壓力等改變均需重新驗證。 </p> <p> 一般情況下驗證小組根據(jù)此次驗證結(jié)果，提出再驗證時間。一般驗證的有效期為一年。 </p> <p> 再驗證 </p> <p> 儀器儀表每年校正一次。 </p> <p> 任何滅菌條件得改變，包括滅菌的溫度、滅菌時間、壓力等改變均需重新驗證，湖北倉庫管理軟件滅菌柜驗證公司，湖北倉庫管理軟件滅菌柜驗證公司。 </p> <p> 一般情況下驗證小組根據(jù)此次驗證結(jié)果，提出再驗證時間，湖北倉庫管理軟件滅菌柜驗證公司。一般驗證的有效期為一年。 </p> 旦霆科技是國內(nèi)業(yè)內(nèi)口碑良好的為制藥及醫(yī)療器械等相關(guān)行業(yè)提供3Q認(rèn)證服務(wù)的專業(yè)第三方咨詢公司。湖北倉庫管理軟件滅菌柜驗證公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北倉庫管理軟件滅菌柜驗證公司,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295189746094/9212985.png"></div><p> 驗證的對象：生產(chǎn)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(rèn)的對象:廠房、設(shè)施、設(shè)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(biāo)準(zhǔn) </p> <p> URS (user requirement specification):是指使用方對廠房、設(shè)施、設(shè)備和檢驗儀器等硬件設(shè)施系統(tǒng)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(shè)備供應(yīng)商依據(jù)客戶提供的URS方案進(jìn)行設(shè)備設(shè)計（或確認(rèn)自己已經(jīng)完成設(shè)計的設(shè)備能符合需方的要求），待客戶完成DQ（設(shè)計確認(rèn)）后，再進(jìn)行設(shè)備的制造。湖北倉庫管理軟件滅菌柜驗證公司旦霆科技作為國內(nèi)**大中型規(guī)模綜合性咨詢服務(wù)公司，專業(yè)提供滅菌柜驗證服務(wù)，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北倉庫管理軟件滅菌柜驗證公司,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295857011719/1155457.png"></div><p> 濕熱滅菌溫度驗證對驗證儀器的基本要求 </p> <p> 按前所述溫度驗證程序設(shè)計要求的技術(shù)原則的五方面內(nèi)容，驗證設(shè)備可包括三部分：(1)測溫元件；(2)測溫編輯記錄儀器；(3)輔助校正儀器。 </p> <p> 測溫元件 </p> <p> 測溫元件采用敏感的多枝精密鉑電阻或電偶組成，原理如圖1。接線較長可以**的擺放在滅菌設(shè)備中選定位置，每支的誤差在±0.5℃以下的測試精度范圍。 </p> <p> 校正時，發(fā)生誤差越程件應(yīng)篩選。這是因為誤差越程后在后面的計算中將導(dǎo)致 F0 偏離，容易帶來誤判結(jié)果。 </p> <p> 電偶是溫度到勢能的變換器，而電阻是溫度到阻值的變換器，兩者在輸出的信號上是不同的。從輸出特性靈敏度看精密鉑電阻（RTD）為優(yōu)。從測溫范圍上比較（-180~2000℃），價性比上熱電偶較優(yōu)。 </p> <p> 目前開發(fā)先進(jìn)的儀器采用無線信號傳送作為測溫元件。測溫記錄儀就近接收發(fā)來的每一個信號，自動完成轉(zhuǎn)換和記錄、存儲，但造價昂貴，特別小氣，保管有特別的要求, 目前針對旋轉(zhuǎn)釜國內(nèi)已有使用。在滅菌釜的實際溫度驗證實驗儀器上，國內(nèi)外已經(jīng)開發(fā)和生產(chǎn)出成熟的部件和比較先進(jìn)的儀器，如GE.Kaye（US）、raytek（US）、 Sakura 、multi(Japen) 、Schlumbergez(England) 、 Goodwill(中國臺灣固緯)、Validator2000(北京祥鴻) 等溫度驗證儀。 </p><p> 計算機(jī)化系統(tǒng)驗證方案（目錄） </p> <p> 驗證目的 </p> <p> 驗證范圍 </p> <p> 職責(zé)確認(rèn) </p> <p> 指導(dǎo)文件確認(rèn) </p> <p> 術(shù)語縮寫 </p> <p> 驗證實施前提條件 </p> <p> 人員確認(rèn) </p> <p> 風(fēng)險評估 </p> <p> 驗證時間安排 </p> <p> 驗證內(nèi)容 </p> <p> 偏差處理 </p> <p> 風(fēng)險的接收與評審 </p> <p> 確認(rèn)計劃 </p> <p> 驗證譜圖編制 </p> <p> 審核、結(jié)論 </p> <p> 驗證目的 </p> <p> 某公司質(zhì)量檢驗部現(xiàn)有一臺某型號的紫外分光光度計，與工作站軟件、計算機(jī)系統(tǒng)及打印機(jī)組成色譜儀計算機(jī)化系統(tǒng)。為保證這些系統(tǒng)符合GMP標(biāo)準(zhǔn)，滿足使用要求和分析測試需求，保證數(shù)據(jù)的安全，特制的本驗證方案，以進(jìn)行計算機(jī)化系統(tǒng)驗證。旦霆科技專業(yè)提供計算機(jī)化系統(tǒng)驗證、空調(diào)系統(tǒng)及潔凈室驗證、生產(chǎn)設(shè)備驗證、滅菌柜驗證等驗證咨詢與服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北倉庫管理軟件滅菌柜驗證公司,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295736738282/6333870.png"></div><p> 設(shè)備移交后即進(jìn)入設(shè)備的后期管理階段，該階段是依據(jù)設(shè)備驗證過程中確定的標(biāo)準(zhǔn)、規(guī)定來規(guī)范設(shè)備的運行、使用狀況。當(dāng)出現(xiàn)異常狀況后，則需要從新審核驗證階段確定的規(guī)定，甚至設(shè)備管理規(guī)程，制定新的規(guī)定，或進(jìn)行設(shè)備再驗證，完成設(shè)備管理的PDCA循環(huán)。 </p> <p> 在設(shè)備的后期管理中，同樣與設(shè)備的驗證相關(guān)，此階段的驗證以再驗證為主，當(dāng)懷疑設(shè)備生產(chǎn)不穩(wěn)定時，也可以進(jìn)行再驗證。通過再驗證，證實設(shè)備完好、穩(wěn)定，操作方法、維護(hù)方法正確，參數(shù)恒定。當(dāng)設(shè)備經(jīng)過大修后，亦進(jìn)行再驗證。 </p> <p> <br /> 旦霆科技成員具備多年工作經(jīng)驗、良好的GMP理念、熟悉精通國內(nèi)外相關(guān)法規(guī)，可專業(yè)開展滅菌柜驗證服務(wù)！湖北倉庫管理軟件滅菌柜驗證公司</p><p style="text-indent:25px">旦霆科技針對于中大型驗證均配備項目經(jīng)理，在為提供滅菌柜驗證服務(wù)時及時匯報進(jìn)、嚴(yán)格控制質(zhì)量！湖北倉庫管理軟件滅菌柜驗證公司</p><p> 運行確認(rèn)包括：按照標(biāo)準(zhǔn)、操作運行和按規(guī)程進(jìn)行清潔、對操作人員培訓(xùn)、進(jìn)行預(yù)防維護(hù)保養(yǎng)，這些內(nèi)容結(jié)束后，運行確認(rèn)才算完成。 </p> <p> 性能確認(rèn)(PQ） </p> <p> 性能確認(rèn)應(yīng)在安裝確認(rèn)和運行確認(rèn)完成之后進(jìn)行。 </p> <p> 性能確認(rèn)應(yīng)包括但不限于以下方面： </p> <p> 根據(jù)對生產(chǎn)工藝、系統(tǒng)和設(shè)備的相關(guān)知識制定性能確認(rèn)方案，使用正常生產(chǎn)的物料、適當(dāng)?shù)奶娲坊蛘吣M產(chǎn)品來進(jìn)行測試； </p> <p> 應(yīng)在一種或幾種條件之下進(jìn)行測試，測試的操作條件應(yīng)包括運行操作的上下限。 </p> <p> 雖然性能確認(rèn)有時被描述為一項**的驗證活動，但在一些情況下，可以將性能確認(rèn)與運行確認(rèn)結(jié)合進(jìn)行。湖北倉庫管理軟件滅菌柜驗證公司</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(xùn)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(jī)構(gòu)的GMP認(rèn)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(xiàn)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/3087191.html</p></div></div></div></div></div><div id="7dphoa7" class="page-right twoColRt"><div id="mqsubiu" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="pewifho" class="recomPic likePro"><a 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