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href="http://www.cdcfah.com/cp/third-yyby_qtflft/">其他未分類</a>?重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu) 創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</p><div id="bdfmtpg" class="leftbox clearfix"><h1>重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu) 創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</h1><div id="pqmoqmj" class="proBig"><div id="btp7sry" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295583876954/6963779.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="wzl42ak" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295583876954/6963779.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="wo8d88n" 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>重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu),滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-13 05:07:01</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="vypiu8b" 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="owysikb" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="ljvmtac" class="box"><p><p> 滅菌柜的驗(yàn)證 </p> <p> <br /> </p> <p> 評價(jià)標(biāo)準(zhǔn)和驗(yàn)證內(nèi)容 </p> <p> <br /> </p> <p> 在1992年版世界衛(wèi)生組織的《規(guī)范》第17章，提到對注射劑的驗(yàn)證要求： </p> <p> <br /> </p> <p> (1)17.32條：所有設(shè)備如滅菌柜、空氣過濾系統(tǒng)、水處理系統(tǒng)（包括蒸餾水機(jī)）均應(yīng)按計(jì)劃進(jìn)行驗(yàn)證、維護(hù)和監(jiān)控。 </p> <p> <br /> </p> <p> (2)17.55條：任何滅菌方法在正式采用前，該方法對產(chǎn)品的適用性以及每一裝載方式下被滅菌品的所有部位是否達(dá)到規(guī)定滅菌要求都應(yīng)經(jīng)過驗(yàn)證，重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu)。應(yīng)定期進(jìn)行再驗(yàn)證，每當(dāng)設(shè)備有重大改變時(shí)，也須進(jìn)行再驗(yàn)證。 </p> <p> <br /> </p> <p> 而在98版《藥品GMP檢查指南》中： </p> <p> <br /> </p> <p> (1)3102條：滅菌柜的能力是否與生產(chǎn)相適應(yīng)，是否具有自動(dòng)監(jiān)測及記錄裝置。 </p> <p> <br /> </p> <p> (2)*5703條：關(guān)鍵設(shè)備及無菌藥品的驗(yàn)證內(nèi)容是否包括滅菌設(shè)備、藥液濾過及灌裝（分裝）系統(tǒng)。 </p> <p> <br /> </p> <p> 由上可見，滅菌工序?qū)τ谧⑸鋭┥a(chǎn)的重要作用以及藥政部門對滅菌柜驗(yàn)證的重視。而對于滅菌柜的驗(yàn)證，重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu)，美國FDA和歐盟藥品衛(wèi)生組織對于不同的滅菌柜有具體的指引和要求（可以查閱有關(guān)的官方網(wǎng)頁），我國在這方面只有02年版的《藥品驗(yàn)證指南》大容量注射劑章節(jié)中給出對于滅菌柜驗(yàn)證的例子，重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu)，同時(shí)05版的《藥典》中關(guān)于滅菌法部分也給出更詳細(xì)的要求。 </p> <p> <br /> 著眼質(zhì)量，靜思細(xì)量，旦霆科技為您提供專業(yè)的計(jì)算機(jī)化系統(tǒng)驗(yàn)證服務(wù)，為您的合規(guī)之路保駕護(hù)航！重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu)</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu),滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295583876954/6963779.png"></div><p> ***百三十九條企業(yè)的廠房、設(shè)施、設(shè)備和檢驗(yàn)儀器應(yīng)經(jīng)過確認(rèn)，應(yīng)采用經(jīng)過驗(yàn)證的生產(chǎn)工藝、操作規(guī)程和檢驗(yàn)方法進(jìn)行生產(chǎn)、操作和檢驗(yàn)，并保持持續(xù)的驗(yàn)證狀態(tài)。 </p> <p> ***百四十條應(yīng)建立確認(rèn)和驗(yàn)證的文件和記錄，并能以文件和記錄證明達(dá)到以下預(yù)定的目標(biāo)： </p> <p> （一）設(shè)計(jì)確認(rèn)（DQ）應(yīng)證明廠房、設(shè)施、設(shè)備的設(shè)計(jì)符合預(yù)定用途和本規(guī)范要求； </p> <p> （二）安裝確認(rèn)（IQ）應(yīng)證明廠房、設(shè)施和設(shè)備的建造和安裝符合設(shè)計(jì)標(biāo)準(zhǔn)； </p> <p> （三）運(yùn)行確認(rèn)（OQ）應(yīng)證明廠房、設(shè)施和設(shè)備的運(yùn)行符合設(shè)計(jì)標(biāo)準(zhǔn)； </p> <p> （四）性能確認(rèn)（PQ）應(yīng)證明廠房、設(shè)施、設(shè)備在正常操作方法和工藝條件下能持續(xù)符合標(biāo)準(zhǔn)。 </p> <p> （五）工藝驗(yàn)證（PV）應(yīng)證明一個(gè)生產(chǎn)工藝按規(guī)定的工藝參數(shù)能持續(xù)生產(chǎn)出符合預(yù)定的用途和注冊要求的產(chǎn)品。 </p> <p> <br /> </p> <p> <br /> 重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu)旦霆科技先進(jìn)的進(jìn)口儀器，嚴(yán)謹(jǐn)?shù)馁|(zhì)量管理體系，為制藥企業(yè)量身定制滅菌柜驗(yàn)證、生產(chǎn)設(shè)備驗(yàn)證解決方案。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu),滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295736738282/6333870.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> URS容易出現(xiàn)的問題： </p> <p> 使用單位不能提供詳細(xì)具體的URS為設(shè)計(jì)單位作為設(shè)計(jì)依據(jù)； </p> <p> 不能提出劑型、品種、工藝、產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)或相應(yīng)的操作程序； </p> <p> 對產(chǎn)量、班次、物流控制方面不了解、不專業(yè)和不擅長； </p> <p> 不能按自身的生產(chǎn)工藝需要向制藥裝備廠商提出具體的GMP要求； </p> <p> 不能把GMP的對應(yīng)要求做細(xì)化理解，關(guān)鍵節(jié)點(diǎn)把握不準(zhǔn)確。如潔凈度控制、壓差梯度、氣鎖裝置等； </p> <p> 一份編寫良好的URS用戶需求規(guī)范，不僅考慮工藝要求，而且考慮與GMP的符合性以及驗(yàn)證要求。旦霆科技積極聽取客戶有效意見，不斷完善質(zhì)量體系及服務(wù)理念，為**提供滅菌柜驗(yàn)證服務(wù)奠定了基礎(chǔ)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu),滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295380234375/3887825.png"></div><p> PQ測試種類： </p> <p> 微生物測試 </p> <p> 化學(xué)測試 </p> <p> 顆粒度測試 </p> <p> 負(fù)載測試 </p> <p> 產(chǎn)品或placebo性能測試 </p> <p> 驗(yàn)證技術(shù)范圍： </p> <p> HVAC（關(guān)鍵區(qū)域） </p> <p> Cleanroom潔凈室驗(yàn)證 </p> <p> Utilities關(guān)鍵的公用工程系統(tǒng)驗(yàn)證 </p> <p> （PFW,WFI,N2,壓縮空氣和潔凈蒸汽系統(tǒng)） </p> <p> Process Equipment 工藝設(shè)備驗(yàn)證 </p> <p> Process/Sterilisation Process工藝/消毒工藝驗(yàn)證 </p> <p> Laboratory Equipment 實(shí)驗(yàn)室設(shè)備驗(yàn)證 </p> <p> Analytical Methods 分析方法的驗(yàn)證 </p> <p> Cleaning 清潔驗(yàn)證 </p> <p> Computerised Systems 計(jì)算機(jī)系統(tǒng)驗(yàn)證 </p> <p> 關(guān)鍵系統(tǒng)的驗(yàn)證 </p> <p> 系統(tǒng)要求驗(yàn)證 </p> <p> 直接和藥品接觸的系統(tǒng) </p> <p> 接觸原材料的系統(tǒng)，其ZUI終成為成品或直接和藥品接觸的系統(tǒng) </p> <p> 測量，監(jiān)控或記錄關(guān)鍵參數(shù)的系統(tǒng) </p> <p> 用于傳達(dá)或維護(hù)關(guān)鍵參數(shù)的系統(tǒng) 旦霆科技提供技術(shù)咨詢、3Q認(rèn)證、驗(yàn)證及檢測服務(wù)。在您不知道具體項(xiàng)目需求時(shí)為您擇優(yōu)推薦！重慶實(shí)驗(yàn)室管理軟件滅菌柜驗(yàn)證</p><p style="text-indent:25px">旦霆科技保證測試驗(yàn)證數(shù)據(jù)真實(shí)、測試人員專業(yè)、性價(jià)比高。為客戶提供滅菌柜驗(yàn)證服務(wù)及技術(shù)咨詢！重慶倉庫管理軟件滅菌柜驗(yàn)證機(jī)構(gòu)</p><p style="text-indent:25px">中國加工產(chǎn)業(yè)憑借獨(dú)特資源和市場優(yōu)勢，一舉成為資本角逐的重點(diǎn)領(lǐng)域之一。從世界范圍來看，美、歐、日等發(fā)達(dá)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。如行家預(yù)判，服務(wù)型發(fā)展即將步入黃金時(shí)代，眾多企業(yè)圍繞醫(yī)藥產(chǎn)業(yè)、商業(yè)領(lǐng)域及新興的互聯(lián)網(wǎng)醫(yī)藥等領(lǐng)域正在進(jìn)行廝殺。在我國政策的支持下，在社會(huì)資本的推動(dòng)下以及技術(shù)升級的帶動(dòng)下，互聯(lián)網(wǎng)巨頭、科技巨頭、地產(chǎn)巨頭等企業(yè)紛紛跨界進(jìn)入服務(wù)型。一體化的結(jié)構(gòu)體系難以形成，我國醫(yī)藥、保養(yǎng)正處于初級發(fā)展階段，與體系健全的發(fā)達(dá)地區(qū)相比，冷鏈物流行業(yè)呈現(xiàn)規(guī)模小且分布雜亂的現(xiàn)象。醫(yī)藥行業(yè)上下游未整體規(guī)劃，成為我國冷鏈物流發(fā)展的障礙，從而使得醫(yī)藥冷鏈物流流通效率低下。首先，完善促進(jìn)GMP驗(yàn)證咨詢與服務(wù)，計(jì)算機(jī)化系統(tǒng)驗(yàn)證，壓縮空氣檢測，潔凈室檢測發(fā)展的相關(guān)政策，優(yōu)化產(chǎn)業(yè)發(fā)展環(huán)境。第二，加大對大健康前沿領(lǐng)域支持，技術(shù)帶領(lǐng)健康科技發(fā)展。第三，消滅體制機(jī)制障礙，催生更多GMP驗(yàn)證咨詢與服務(wù)，計(jì)算機(jī)化系統(tǒng)驗(yàn)證，壓縮空氣檢測，潔凈室檢測發(fā)展模式。第四，大力發(fā)展與GMP驗(yàn)證咨詢與服務(wù)，計(jì)算機(jī)化系統(tǒng)驗(yàn)證，壓縮空氣檢測，潔凈室檢測相適應(yīng)的高等教育事業(yè)。重慶倉庫管理軟件滅菌柜驗(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/2824036.html</p></div></div></div></div></div><div id="zcjvcjk" class="page-right twoColRt"><div id="7artf3c" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="ajls39c" 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(qiáng) 信息推薦自業(yè)物資供應(yīng)" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></div><p>福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)</p></a></div><div id="cryamyz" class="recomPic 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