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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="383o8dp" 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="wzdeab3" 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>福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu),滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-17 09:04:38</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="ol3f9dk" 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="kxbc3ja" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="gzqxl39" class="box"><p><p> 每個(gè)行業(yè)公司為啥要校準(zhǔn)，測量，檢測，驗(yàn)證？哪些儀器需要強(qiáng)檢？什么是CNAS認(rèn)證？ </p> <p> <br /> </p> <p> 為什么要校準(zhǔn)，測量，檢測儀器設(shè)備？ </p> <p> <br /> </p> <p> 本質(zhì)原因：全球經(jīng)濟(jì)一體化，企業(yè)生產(chǎn)、貿(mào)易、結(jié)算等都需要統(tǒng)一標(biāo)準(zhǔn)。測量儀器用于生產(chǎn)制造的品質(zhì)控制，對(duì)它進(jìn)行校準(zhǔn)，滿足了生產(chǎn)制造統(tǒng)一標(biāo)準(zhǔn)的要求。 </p> <p> <br /> </p> <p> 表面原因：客戶審廠需要查看測量儀器是否有校準(zhǔn)，審廠一般有ISO，福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu)、CCC、UL、TUV、以及其它的客戶審廠。 </p> <p> <br /> </p> <p> 全世界的測量儀器都要驗(yàn)證，所以說，福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu)，福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu)，校準(zhǔn)是剛需，一年至少一次。 </p> <p> <br /> 專業(yè)滅菌柜驗(yàn)證、培養(yǎng)箱驗(yàn)證、GSP冷庫驗(yàn)證、凍干機(jī)、熱風(fēng)循環(huán)烘箱驗(yàn)證、冰箱驗(yàn)證等一些列溫度驗(yàn)證服務(wù)。福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu)</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu),滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295189746094/9212985.png"></div><p> 性能確認(rèn)中應(yīng)注意以下幾點(diǎn)： </p> <p> 一、流量、壓力和溫度等檢測儀器必須經(jīng)過校驗(yàn)并在校驗(yàn)期內(nèi)； </p> <p> 二、制定詳細(xì)的取樣計(jì)劃、化驗(yàn)方法并得到相關(guān)部門的批準(zhǔn)； </p> <p> 三、性能確認(rèn)時(shí)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(yùn)行參數(shù)； </p> <p> 四、將驗(yàn)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(jì)算機(jī)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 /> 福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu)旦霆科技為提升各項(xiàng)目質(zhì)量水平，成立質(zhì)量部門。為滅菌柜驗(yàn)證等驗(yàn)證及檢測服務(wù)保駕護(hù)航！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu),滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295857011719/1155457.png"></div><p> <strong></strong>溫度驗(yàn)證的功能測試步驟 </p> <p> <br /> </p> <p> <br /> </p> <p> 由此技術(shù)設(shè)計(jì)要求出發(fā)，演化成為目前國內(nèi)***采用的濕熱溫度驗(yàn)證的大容量注射劑實(shí)驗(yàn)方法和實(shí)驗(yàn)器具,也是溫度驗(yàn)證程序設(shè)計(jì)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(diǎn)位置，檢驗(yàn)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(shí)驗(yàn)，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(shí)驗(yàn)，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(diǎn)獲得無菌保證值，特別是**冷點(diǎn)位置的F0 值,監(jiān)測檢驗(yàn)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(shí)驗(yàn)，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(yàn)滅菌可靠性，對(duì)驗(yàn)證設(shè)計(jì)進(jìn)行檢驗(yàn)。步驟：(1)方案的設(shè)計(jì)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(píng)價(jià)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(jì)后，重復(fù)上面步驟。 </p> <p> <br /> </p> <p> 5. 填寫驗(yàn)證實(shí)驗(yàn)報(bào)告書 </p> <p> <br /> </p><p> 驗(yàn)證的概念 </p> <p> 1.2010GMP </p> <p> 驗(yàn)證：證明任何操作規(guī)程（或方法）、生產(chǎn)工藝或系統(tǒng)能夠達(dá)到預(yù)期結(jié)果的一系列活動(dòng)。 </p> <p> 確認(rèn)：證明廠房、設(shè)施、設(shè)備能正確運(yùn)行并可達(dá)到預(yù)期結(jié)果的一系列活動(dòng)。 </p> <p> 2.WHO,GMP </p> <p> 驗(yàn)證：證明任一程序、加工、設(shè)備、物料、活動(dòng)或系統(tǒng)能得到預(yù)期結(jié)果，并且有文件記錄的活動(dòng)。 </p> <p> 3.FDA，GMP </p> <p> 驗(yàn)證：是要有足夠的證據(jù)，能證明這一工序?qū)⑹冀K如一地產(chǎn)生出符合預(yù)定質(zhì)量要求的產(chǎn)品，并把這些證據(jù)形成文字。 </p> <p> 2010 GMP 第七章確認(rèn)與驗(yàn)證 </p> <p> ***百三十八條企業(yè)應(yīng)確定需要進(jìn)行的確認(rèn)或驗(yàn)證工作，以證明有關(guān)操作的關(guān)鍵要素能得到有效控制。確認(rèn)或驗(yàn)證的范圍和程度應(yīng)經(jīng)過風(fēng)險(xiǎn)評(píng)估來確定。 </p> <p> <br /> 旦霆科技針對(duì)于中大型驗(yàn)證均配備項(xiàng)目經(jīng)理，在為提供滅菌柜驗(yàn)證服務(wù)時(shí)及時(shí)匯報(bào)進(jìn)、嚴(yán)格控制質(zhì)量！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu),滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296157607422/4527074.png"></div><p> “驗(yàn)證”與“儀器驗(yàn)證” </p> <p> <br /> </p> <p> 要弄清楚儀器驗(yàn)證，首先要清楚兩個(gè)概念，何為驗(yàn)證（Verification），何為儀器驗(yàn)證（Verification of Instruments），根據(jù)ISO/IEC 17025的定義，驗(yàn)證是指通過提供客觀證據(jù)，證明給定項(xiàng)目滿足規(guī)定要求。由此延伸到儀器驗(yàn)證則為對(duì)儀器進(jìn)行核查，通過保留驗(yàn)證過程中產(chǎn)生的資料，證明某個(gè)儀器能滿足用戶的使用需求。 </p> <p> <br /> </p> <p> CNAS-GL040:2019中將儀器驗(yàn)證的定義作了擴(kuò)充，幾乎將儀器的整個(gè)生命周期納入到了儀器驗(yàn)證的活動(dòng)中來，儀器驗(yàn)證的定義有了更豐富的內(nèi)涵———對(duì)儀器在采購、安裝、驗(yàn)收和運(yùn)行階段實(shí)施核查，證明儀器能夠達(dá)到預(yù)期結(jié)果的一系列活動(dòng)。 </p> <p> <br /> 旦霆科技不但擁有龐大的驗(yàn)證及檢測團(tuán)隊(duì)，同時(shí)配備幾百套驗(yàn)證及檢測儀器，專業(yè)開展滅菌柜驗(yàn)證服務(wù)！福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu)</p><p style="text-indent:25px">旦霆科技作為國內(nèi)**的綜合性驗(yàn)證咨詢公司，專業(yè)解答各種設(shè)備驗(yàn)證及偏差處理等相關(guān)問題，歡迎您的垂詢！福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu)</p><p> 壓力消毒器驗(yàn)證報(bào)告 </p> <p> 概述 </p> <p> 本次驗(yàn)證通過對(duì)高壓滅菌器進(jìn)行安裝確認(rèn)、空載、滿載滅菌效果的確認(rèn)證明在121°C20分鐘的滅菌條件下能達(dá)到滅菌效果。 </p> <p> 驗(yàn)證相關(guān)文件 </p> <p> 文件名稱： </p> <p> 壓力容器管理規(guī)程 </p> <p> 計(jì)量器具校驗(yàn)管理規(guī)程 </p> <p> 電熱式蒸汽消毒器操作標(biāo)準(zhǔn)操作程序 </p> <p> 壓力消毒器驗(yàn)證方案 </p> <p> 驗(yàn)證組織和職責(zé) </p> <p> 驗(yàn)證組織 </p> <p> 驗(yàn)證小組，由以下部門及人員參加 </p> <p> 驗(yàn)證組長 </p> <p> 生產(chǎn)部 </p> <p> 設(shè)備部 </p> <p> 職責(zé)與分工 </p> <p> 驗(yàn)證組長：負(fù)責(zé)驗(yàn)證方案的起草，并負(fù)責(zé)組織實(shí)施進(jìn)行壓力消毒器驗(yàn)證。負(fù)責(zé)驗(yàn)證期間各項(xiàng)工作的協(xié)調(diào)。 </p> <p> 生產(chǎn)部：負(fù)責(zé)按照要求對(duì)壓力容器進(jìn)行操作和日常保養(yǎng)。 </p> <p> 綜保部：負(fù)責(zé)壓力容器的指導(dǎo)和驗(yàn)證物品的準(zhǔn)備。福建追溯系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證機(jī)構(gòu)</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(jiān)持以超值的品質(zhì)為客戶提供服務(wù)，同時(shí)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/2886334.html</p></div></div></div></div></div><div id="sfwtk8h" class="page-right twoColRt"><div id="8lceari" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="8qh3rtk" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img 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