河南旦霆科技滅菌柜驗證怎么做創(chuàng)新服務(wù) 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="設(shè)計確認(rèn)（DQ）設(shè)計確認(rèn)是書面確認(rèn)該設(shè)備的設(shè)計能夠滿足用戶需求。質(zhì)量管理人員需要批準(zhǔn)設(shè)計確認(rèn)報告，報告批準(zhǔn)后，對設(shè)計的任何變化需要提出正式的變更申請。安裝確認(rèn)（IQ）安裝確認(rèn)是確認(rèn)所有可能影響產(chǎn)品質(zhì)量的設(shè)施、設(shè)備的各個方面都要符合要求（例如"><meta name="keywords" content="河南旦霆科技滅菌柜驗證怎么做,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" 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class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295785400391/920118.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="bvk8vxj" 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>河南旦霆科技滅菌柜驗證怎么做,滅菌柜驗證</p><p><span>***更新：</span>2021-01-20 06:04:15</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="w3dew84" 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(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="83wsuls" class="page-proshow02"><p class="title">詳細說明</p><div id="2yswikm" class="box"><p><p> 設(shè)計確認(rèn)（DQ） </p> <p> 設(shè)計確認(rèn)是書面確認(rèn)該設(shè)備的設(shè)計能夠滿足用戶需求。質(zhì)量管理人員需要批準(zhǔn)設(shè)計確認(rèn)報告，報告批準(zhǔn)后，對設(shè)計的任何變化需要提出正式的變更申請。 </p> <p> 安裝確認(rèn)（IQ） </p> <p> 安裝確認(rèn)是確認(rèn)所有可能影響產(chǎn)品質(zhì)量的設(shè)施、設(shè)備的各個方面都要符合要求（例如結(jié)構(gòu)、材料）并且正確安裝。安裝確認(rèn)方案應(yīng)確認(rèn)設(shè)計與實際安裝相一致，安裝確認(rèn)方案必須在進行安裝確認(rèn)前批準(zhǔn)，河南旦霆科技滅菌柜驗證怎么做，并且經(jīng)過培訓(xùn)的人員才可以執(zhí)行。 </p> <p> 運行確認(rèn)（OQ） </p> <p> 運行確認(rèn)是確認(rèn)設(shè)備所有可能影響產(chǎn)品質(zhì)量的各個方面都在預(yù)期的范圍之內(nèi)運行。 </p> <p> 所有質(zhì)量關(guān)鍵部件必須根據(jù)預(yù)先審批的測試方案進行測試，測試的方法和范圍將根據(jù)設(shè)備的類型和復(fù)雜程度，以及設(shè)備的關(guān)鍵程度而定，河南旦霆科技滅菌柜驗證怎么做。 </p> <p> 性能確認(rèn)/工藝驗證（PQ/PV） </p> <p> 就生產(chǎn)設(shè)備而言，性能確認(rèn)系指通過設(shè)備整體運行的方法，考察工藝設(shè)備運行的可靠性、主要運行參數(shù)的穩(wěn)定性和運行結(jié)果重現(xiàn)性的一系列活動。故其實際意義即指模擬生產(chǎn)或工藝驗證，通常模擬生產(chǎn)或工藝驗證至少應(yīng)重復(fù)三次。對于比較簡單，河南旦霆科技滅菌柜驗證怎么做、運行較為穩(wěn)定、人員已有一定同類設(shè)備實際運行經(jīng)驗或基于風(fēng)險評估風(fēng)險旦霆科技可與客戶開展遠程技術(shù)交流，解決難題為雙方良好合作打下扎實基礎(chǔ)，提供滅菌柜驗證等技術(shù)服務(wù)。河南旦霆科技滅菌柜驗證怎么做</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南旦霆科技滅菌柜驗證怎么做,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295785400391/920118.png"></div><p> 性能確認(rèn)中應(yīng)注意以下幾點： </p> <p> 一、流量、壓力和溫度等檢測儀器必須經(jīng)過校驗并在校驗期內(nèi)； </p> <p> 二、制定詳細的取樣計劃、化驗方法并得到相關(guān)部門的批準(zhǔn)； </p> <p> 三、性能確認(rèn)時至少應(yīng)制定好BPR（Batch Production Record，即空白批記錄），按照方案的要求操作設(shè)備，觀察、調(diào)試和取樣并記錄運行參數(shù)； </p> <p> 四、將驗證數(shù)據(jù)和結(jié)果直接填入性能確認(rèn)方案的空白記錄部分，或作為其附件。人工記錄和計算機打印的數(shù)據(jù)作為原始數(shù)據(jù)，數(shù)據(jù)資料必須注明日期和簽名。 </p> <p> <br /> 四川溫度監(jiān)測系統(tǒng)滅菌柜驗證第三方檢測旦霆科技作為專業(yè)的設(shè)備驗證及第三方檢測供應(yīng)商，取得良好的客戶口碑，我們繼續(xù)保持高水準(zhǔn)服務(wù)全國。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南旦霆科技滅菌柜驗證怎么做,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294640087891/7436443.png"></div><p> <strong>濕熱滅菌設(shè)備的溫度驗證 </strong> </p> <p> <br /> </p> <p> 溫度驗證程序設(shè)計基本要求 </p> <p> <br /> </p> <p> 濕熱滅菌的基本程序設(shè)計基本要求源于US.FDA在上世紀(jì)70年代中期提出的，且在80年代施行的：“關(guān)于大容量注射劑GMP技術(shù)性原則”五個方面要求： </p> <p> <br /> </p> <p> (1)在滅菌工序應(yīng)能確保產(chǎn)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(yīng)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(chǎn)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(dāng)?shù)纳镏甘緞┎⑶也逵袩犭娕?。?dāng)滅菌釜的參數(shù)已經(jīng)達到熱分布實驗已經(jīng)證實的可重現(xiàn)狀態(tài)，溫度達到設(shè)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(dāng)產(chǎn)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(nèi)。 </p> <p> <br /> </p><p> <strong></strong>溫度驗證的功能測試步驟 </p> <p> <br /> </p> <p> <br /> </p> <p> 由此技術(shù)設(shè)計要求出發(fā)，演化成為目前國內(nèi)***采用的濕熱溫度驗證的大容量注射劑實驗方法和實驗器具,也是溫度驗證程序設(shè)計的基本要求。使用其作功能測試步驟及參考設(shè)備如下： </p> <p> <br /> </p> <p> 1. 熱分布測試 </p> <p> <br /> </p> <p> 目的：找出**冷點位置，檢驗重現(xiàn)性。步驟：(1)設(shè)備儀器校正；(2)熱電偶分布圖；(3)空載熱分布實驗，3次以上；(4)熱電偶插入圖；(5)裝載（模擬生產(chǎn)裝載比較大，**小量）熱分布實驗，各3次以上。 </p> <p> <br /> </p> <p> 2. 熱穿透測試 </p> <p> <br /> </p> <p> 目的：肯定滅菌過程中被測試各點獲得無菌保證值，特別是**冷點位置的F0 值,監(jiān)測檢驗重現(xiàn)性。步驟：(1)設(shè)備校正；(2)模擬生產(chǎn)滅菌裝載；(3)熱電偶裝載圖；(4)同品同規(guī)產(chǎn)品比較大與**小裝載熱穿透實驗，每狀態(tài)3次以上。 </p> <p> <br /> </p> <p> 3. 生物指示劑測試 </p> <p> <br /> </p> <p> 目的：挑戰(zhàn)性模擬生產(chǎn)可能因素造成的微生物污染程度來檢驗滅菌可靠性，對驗證設(shè)計進行檢驗。步驟：(1)方案的設(shè)計制定；(2)生物指示劑菌株的選擇，測定D值；(3)標(biāo)定濃度和制定樣品；(4)接種，裝載；(5)低限滅菌(每產(chǎn)品，每規(guī)格每種滅菌程序至少3次以上）；(6)樣品的培養(yǎng)與鑒別；(7)評價結(jié)論（數(shù)據(jù)，樣品分析）。 </p> <p> <br /> </p> <p> 4. 偏差與調(diào)整 </p> <p> <br /> </p> <p> 重新設(shè)計后，重復(fù)上面步驟。 </p> <p> <br /> </p> <p> 5. 填寫驗證實驗報告書 </p> <p> <br /> 旦霆科技在提供高質(zhì)量服務(wù)的同時為眾多客戶解決項目偏差、驗證偏差等問題。以保證3Q認(rèn)證服務(wù)的順利進行。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南旦霆科技滅菌柜驗證怎么做,滅菌柜驗證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294441425782/9841184.png"></div><p> 滅菌柜的作用 </p> <p> 滅菌柜是一種殺菌的裝置，可用于多種領(lǐng)域，比如食品、制藥行業(yè)等。顧名思義，滅菌柜的主要作用便是用于殺菌。殺菌滅菌方法通常有以下五種： </p> <p> 1.煮沸法：煮沸100℃，5分鐘，能殺死一般細菌的繁殖體。煮沸法可用于飲水和一般器械(刀剪、注射器等)的消毒。 <p> 2.流通蒸汽滅菌法：利用100℃左右的水蒸汽進行消毒，一般采用流通蒸汽滅菌器，加熱15到39分鐘，可殺死細菌繁殖體。消毒物品的包裝不宜過大、過緊以利于蒸汽穿透。 </p> <p> 3.間歇滅菌法：利用反復(fù)多次的流通蒸汽，以達到滅菌的目的。一般用流通蒸汽滅菌器，100℃加熱15～30分鐘，可殺死其中的繁殖體;但芽胞尚有殘存。取出后放37℃孵箱過夜，使芽胞發(fā)育成繁殖體，次日再蒸一次，如此連續(xù)三次以上。本法適用于不耐高溫的營養(yǎng)物(如血清培養(yǎng)基)的滅菌。 </p> <p> 4.巴氏消毒法：利用熱力殺死液體中的病原菌或一般的雜菌，同時不致嚴(yán)重損害其質(zhì)量的消耗方法。由巴斯德創(chuàng)用以消毒酒精類，故名。加溫61.1～62.8℃半小時，或71.7℃15～30秒鐘。 </p> <p> 5.高壓蒸汽滅菌法：壓力蒸汽滅菌是在專門的壓力蒸汽滅菌器中進行的，是熱力滅菌中使用比較普遍、效果比較可靠的一種方法。其優(yōu)點是穿透力強，滅菌效果可靠，能殺滅所有微生物。 </p> 旦霆科技年度營業(yè)額以50%的速度高速增長，逐漸成為為數(shù)不多的中大型儀器設(shè)備驗證測試服務(wù)的綜合性公司。四川溫度監(jiān)測系統(tǒng)滅菌柜驗證第三方檢測</p><p style="text-indent:25px">旦霆科技配備數(shù)十人的驗證及檢測團隊，承接國內(nèi)各類相關(guān)企業(yè)的滅菌柜驗證、第三方驗證或檢測及咨詢服務(wù)。河南旦霆科技滅菌柜驗證怎么做</p><p style="text-indent:25px">從世界范圍來看，美、歐、日等發(fā)達地區(qū)的加工產(chǎn)業(yè)發(fā)展歷史悠久，無論是加工產(chǎn)品制造業(yè)還是加工服務(wù)業(yè)，都處于全球優(yōu)先地位。而泰國、印度等東南亞及南亞地區(qū)，加工產(chǎn)業(yè)雖然起步晚，但是發(fā)展較快，已成為經(jīng)濟社會發(fā)展重要組成部分。服務(wù)型項目新市場加入通常耗資巨大，單一的資本進入往往會形成極大的資本壓力，因此一些重大的服務(wù)型項目往往都會通過數(shù)家有實力的資本進行組合資本。醫(yī)藥健康方面人才培養(yǎng)體制貧乏，經(jīng)調(diào)查，中國的大學(xué)中把物流管理與醫(yī)藥知識結(jié)合的專業(yè)少之又少，單方面精通的人才對于醫(yī)藥冷鏈物流無法完全勝任，通過調(diào)研冷鏈物流企業(yè)，了解到培養(yǎng)物流人員有關(guān)冷鏈物流的相關(guān)知識來勝任冷鏈物流工作的計劃進展緩慢，使得人才成為完善醫(yī)藥健康的重要制約因素。以GMP驗證咨詢與服務(wù)，計算機化系統(tǒng)驗證，壓縮空氣檢測，潔凈室檢測為例，主打運動健康A(chǔ)PP停留在工具層面，缺少完整的消費場景閉環(huán)，較強的工具屬性停留在實現(xiàn)用戶**基礎(chǔ)的功能需求，并未涉及足夠高的用戶使用價值實現(xiàn)，同時缺乏數(shù)字化運營的效能也是運動健康A(chǔ)PP發(fā)展的明顯桎梏，經(jīng)營模式有待進一步探索。河南旦霆科技滅菌柜驗證怎么做</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> 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