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<div id="qkewoa0" class="MainC fr"> <dl> <dt><span id="0gcgo00" class="STitle fl"><b>技術(shù)文章</b></span><span id="ygos0mm" class="Position fr">您的位置：<a href="/">網(wǎng)站首頁(yè)</a> ><a href="/article.html">技術(shù)文章</a> >《中國(guó)藥典》制藥用水：2025版對(duì)比 2020版</span></dt> <dd> <div id="aug0q80" class="View"> <div id="g0oeyo8" class="PageView"> <h1 id="inside_rnewtil">《中國(guó)藥典》制藥用水：2025版對(duì)比 2020版</h1> <div id="koeggee" class="inside_rnewtime">更新時(shí)間：2025-04-29 點(diǎn)擊次數(shù)：181次</div> <div id="0i0smkw" class="inside_rnewcon"><section style="line-height: 1.6; box-sizing: border-box; text-align: justify; font-size: 16px; color: rgb(62, 62, 62);"><section style="margin: 10px 0px; position: static; box-sizing: border-box;"><section style="text-align: center; color: rgb(0, 0, 0); font-size: 20px; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;">《中國(guó)藥典》制藥用水：2025版對(duì)比 2020版</strong></p></section></section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br/></p><section style="margin-top: 10px; margin-bottom: 10px; position: static; box-sizing: border-box;"><section style="padding: 0.5em; border: 0.1em solid rgb(128, 128, 128); border-radius: 15px; box-sizing: border-box;"><section style="border-color: black; border-width: 3px; padding: 10px; border-radius: 15px; border-style: solid; box-sizing: border-box;"><section style="text-align: center; font-size: 17px; box-sizing: border-box;"><p style="text-align: justify; margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><span style=" font-size: 18px; box-sizing: border-box;">前言</span></strong></p><p style="text-align: justify; margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><span style="font-size: 16px; box-sizing: border-box;"> 制藥用水是制藥生產(chǎn)中至關(guān)重要的一環(huán)，其會(huì)直接影響到藥品安全質(zhì)量與藥品合格率，更是當(dāng)下法規(guī)所一再?gòu)?qiáng)調(diào)的重點(diǎn)，隨著重視程度的不斷增加，作為領(lǐng)域一大重點(diǎn)，法規(guī)要求對(duì)其的要求也將愈發(fā)嚴(yán)格，領(lǐng)域企業(yè)也將面臨更大的挑戰(zhàn)。</span></p></section></section></section></section><section style="margin: 10px 0px; position: static; box-sizing: border-box;"><section style="color: rgb(182, 182, 182); font-size: 14px; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p></section></section><section style="margin: 10px 0px; position: static; box-sizing: border-box;"><section style="color: rgb(182, 182, 182); font-size: 14px; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">關(guān)鍵詞：中國(guó)藥典、制藥用水、制藥用水系統(tǒng)、工藝用水、注射用水、純化水、微生物限度、微生物控制、水系統(tǒng)、潔凈區(qū)、無(wú)菌室、實(shí)驗(yàn)驗(yàn)證、內(nèi)毒素、快檢技術(shù)、藥典規(guī)范、</p></section></section><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p><section style="text-align: left; justify-content: flex-start; display: flex; flex-flow: row; margin: 10px 0px; position: static; box-sizing: border-box;"><section style="display: inline-block; width: 100%; vertical-align: top; align-self: flex-start; flex: 0 0 auto; background-color: rgb(244, 250, 255); padding: 9px; box-sizing: border-box;"><section style="justify-content: flex-start; display: flex; flex-flow: row; position: static; box-sizing: border-box;"><section style="display: inline-block; width: 100%; vertical-align: top; align-self: flex-start; flex: 0 0 auto; border-style: solid; border-width: 1px; border-color: rgb(179, 216, 255); padding: 15px 19px; box-sizing: border-box;"><section style="text-align: justify; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><span style="font-size: 18px; box-sizing: border-box;">一、藥典2025版 VS 2020版目覽表</span></strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"> </p></section><section style="line-height: 0; position: static; box-sizing: border-box;"><section style="max-width: 100%; vertical-align: middle; display: inline-block; line-height: 0; box-sizing: border-box;"><img class="raw-image" style="vertical-align: middle; max-width: 100%; width: 100%; box-sizing: border-box;" data-ratio="0.737037" data-w="1080" _width="100%" data-s="300,640" crossorigin="anonymous" src="https://img53.chem17.com/9/20250429/638815209895986161431.jpg"/></section></section><section style="text-align: justify; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br/></p></section><section style="line-height: 0; position: static; box-sizing: border-box;"><section style="max-width: 100%; vertical-align: middle; display: inline-block; line-height: 0; box-sizing: border-box;"><img class="raw-image" style="vertical-align: middle; max-width: 100%; width: 100%; box-sizing: border-box;" data-ratio="0.4" data-w="1080" _width="100%" data-s="300,640" crossorigin="anonymous" src="https://img53.chem17.com/9/20250429/638815209899892552737.png"/></section></section></section></section><section style="text-align: justify; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p></section><section style="justify-content: flex-start; display: flex; flex-flow: row; margin: 10px 0px; position: static; box-sizing: border-box;"><section style="display: inline-block; width: 100%; vertical-align: top; align-self: flex-start; flex: 0 0 auto; background-color: rgb(243, 250, 255); padding: 9px; box-sizing: border-box;"><section style="justify-content: flex-start; display: flex; flex-flow: row; width: 100%; align-self: flex-start; border-style: solid; border-width: 1px; border-color: rgb(179, 216, 255); padding: 15px 19px; position: static; box-sizing: border-box;"><section style="text-align: justify; width: 100%; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><span style="font-size: 18px; box-sizing: border-box;"><strong style="box-sizing: border-box;">二、聚焦水系統(tǒng)消毒技術(shù)革新與微生物風(fēng)險(xiǎn)管理</strong></span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><span style="font-size: 18px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><br style="box-sizing: border-box;"/></strong></span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;">（一）微生物控制理念升級(jí)：</strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">從傳統(tǒng)的終產(chǎn)品檢測(cè)轉(zhuǎn)向全生命周期動(dòng)態(tài)管理，新增《9209制藥用水微生物監(jiān)測(cè)和控制指導(dǎo)原則》，要求企業(yè)建立微生物趨勢(shì)分析模型，設(shè)定警戒限（歷史均值+2σ）和糾偏限（歷史均值+3σ），連續(xù)超標(biāo)需啟動(dòng)調(diào)查并優(yōu)化消毒策略。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;">（二）消毒技術(shù)規(guī)范化：</strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">明確化學(xué)消毒、熱力消毒、紫外線消毒等主流方法的適用范圍與驗(yàn)證要求，提出消毒劑殘留檢測(cè)標(biāo)準(zhǔn)，要求企業(yè)建立消毒劑殘留數(shù)據(jù)庫(kù)，確保消毒后沖洗流程的有效性。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;">（三）在線監(jiān)測(cè)技術(shù)強(qiáng)制應(yīng)用：</strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">規(guī)定電導(dǎo)率、TOC、微生物負(fù)荷等關(guān)鍵參數(shù)需實(shí)現(xiàn)實(shí)時(shí)監(jiān)控，鼓勵(lì)企業(yè)采用激光誘導(dǎo)熒光、ATP生物發(fā)光等快速檢測(cè)技術(shù)（RMM），將微生物檢測(cè)周期從5天縮短至30分鐘。</p></section></section></section></section><section style="text-align: justify; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p></section><section style="justify-content: flex-start; display: flex; flex-flow: row; margin: 10px 0px; position: static; box-sizing: border-box;"><section style="display: inline-block; width: 100%; vertical-align: top; align-self: flex-start; flex: 0 0 auto; background-color: rgb(243, 250, 255); padding: 9px; box-sizing: border-box;"><section style="justify-content: flex-start; display: flex; flex-flow: row; width: 100%; align-self: flex-start; border-style: solid; border-width: 1px; border-color: rgb(179, 216, 255); padding: 15px 19px; position: static; box-sizing: border-box;"><section style="text-align: justify; width: 100%; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><span style="font-size: 18px; box-sizing: border-box;">三、水系統(tǒng)消毒技術(shù)核心變化解析</span></strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><span style="font-size: 18px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></span></strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><span style="font-size: 17px; box-sizing: border-box;"><strong style="box-sizing: border-box;">（一）微生物監(jiān)測(cè)與風(fēng)險(xiǎn)控制</strong></span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><br style="box-sizing: border-box;"/></strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;">1.取樣策略優(yōu)化：</strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><br style="box-sizing: border-box;"/></strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 2020版：僅要求在儲(chǔ)罐、總送水口、總回水口取樣，微生物限度≤100CFU/ML。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 2025版：強(qiáng)制覆蓋所有使用點(diǎn)（包括高風(fēng)險(xiǎn)點(diǎn)如無(wú)菌制劑配制點(diǎn)），取樣頻率從每周一次提升至每日一次，微生物限度仍為≤100CFU/ML，但明確不得檢出洋蔥伯克霍爾德菌群（Bcc）、銅綠假單胞菌等高風(fēng)險(xiǎn)微生物。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 技術(shù)落地：推薦使用德國(guó)奧克泰士長(zhǎng)期高效無(wú)殘留消毒劑，結(jié)合在線微生物分析儀（實(shí)現(xiàn)實(shí)時(shí)監(jiān)測(cè))。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;">2.生物膜防控：</strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><br style="box-sizing: border-box;"/></strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 2020版：未明確生物膜控制要求。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 2025版：新增生物膜清除與預(yù)防條款，要求采用消毒劑定期清洗（接觸時(shí)間≥2小時(shí)），并通過(guò)結(jié)晶紫染色、ATP熒光檢測(cè)等手段識(shí)別風(fēng)險(xiǎn)區(qū)域。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 典型案例：某制藥企業(yè)采用奧克泰士D-50/500循環(huán)沖洗管道4小時(shí)，成功清除生物膜，微生物負(fù)荷從10?CFU/Ml降至未檢出。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><span style="font-size: 17px; box-sizing: border-box;"><strong style="box-sizing: border-box;">（三）消毒劑殘留與驗(yàn)證</strong></span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><span style="font-size: 17px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><br style="box-sizing: border-box;"/></strong></span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;">1.殘留檢測(cè)方法：</strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 2020版：無(wú)明確要求，企業(yè)多采用目視檢查或pH試紙檢測(cè)。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 2025版：強(qiáng)制要求采用HPLC或GC-MS檢測(cè)殘留，例如過(guò)氧化氫殘留限值≤0.1ppm，采取一定方法快速檢測(cè)。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 技術(shù)難點(diǎn)：殘留檢測(cè)需考慮消毒劑與水質(zhì)的相互作用，例如臭氧消毒后需檢測(cè)溴酸鹽殘留（限值≤0.01mg/L）。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;">2.消毒驗(yàn)證流程：</strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 2020版：僅要求消毒周期驗(yàn)證，未明確挑戰(zhàn)性試驗(yàn)方法。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 2025版：要求開展微生物挑戰(zhàn)試驗(yàn)，接種10?CFU/㎡的標(biāo)準(zhǔn)菌株（如銅綠假單胞菌ATCC 9027），消毒后存活率需≤0.001%。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 案例參考：某注射劑企業(yè)通過(guò)優(yōu)化過(guò)熱水滅菌參數(shù)（121℃、45分鐘），使內(nèi)毒素去除率從90%提升至99.99%，驗(yàn)證周期從每年一次縮短至每季度一次。</p></section></section></section></section><section style="text-align: justify; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p></section><section style="justify-content: flex-start; display: flex; flex-flow: row; margin: 10px 0px; position: static; box-sizing: border-box;"><section style="display: inline-block; width: 100%; vertical-align: top; align-self: flex-start; flex: 0 0 auto; background-color: rgb(243, 250, 255); padding: 9px; box-sizing: border-box;"><section style="justify-content: flex-start; display: flex; flex-flow: row; width: 100%; align-self: flex-start; border-style: solid; border-width: 1px; border-color: rgb(179, 216, 255); padding: 15px 19px; position: static; box-sizing: border-box;"><section style="text-align: justify; width: 100%; box-sizing: border-box;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><span style="font-size: 18px; box-sizing: border-box;"><strong style="box-sizing: border-box;">四、企業(yè)應(yīng)對(duì)策略與技術(shù)升級(jí)路徑</strong></span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><span style="font-size: 17px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><br style="box-sizing: border-box;"/></strong></span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><span style="font-size: 17px; box-sizing: border-box;"><strong style="box-sizing: border-box;">(一)系統(tǒng)設(shè)計(jì)優(yōu)化：</strong></span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 管道材質(zhì)：優(yōu)先采用316L不銹鋼（內(nèi)壁電拋光Ra≤0.28μm），焊接接口需進(jìn)行內(nèi)窺鏡檢測(cè)（缺陷率≤0.1%）；非金屬管道（如PVDF）需通過(guò)溶出物測(cè)試，確保遷移物質(zhì)對(duì)TOC檢測(cè)無(wú)干擾。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 儲(chǔ)罐設(shè)計(jì)：采用常溫循環(huán)（流速≥1.5m/s）或低溫儲(chǔ)存（≤4℃），搭配巴氏滅菌（80℃、30分鐘）防止微生物滋生。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><span style="font-size: 17px; box-sizing: border-box;">（二）消毒技術(shù)選型：</span></strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 高風(fēng)險(xiǎn)場(chǎng)景：無(wú)菌制劑生產(chǎn)推薦采用奧克泰士殺孢子劑進(jìn)行針對(duì)處理，確保生物負(fù)載降低≥3log。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 日常維護(hù)：純化水系統(tǒng)可采用在線電化學(xué)消毒結(jié)合臭氧消毒（濃度0.5-1.0mg/L，接觸時(shí)間≥5分鐘）紫外線消毒（強(qiáng)度≥25mW/cm2），實(shí)現(xiàn)連續(xù)殺菌（在線電化學(xué)消毒逐步替代傳統(tǒng)方式）。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 生物膜清除：使用奧克泰士高濃縮原液循環(huán)沖洗，作用時(shí)間2-4小時(shí)，可有效破壞生物膜結(jié)構(gòu)。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><span style="font-size: 17px; box-sizing: border-box;">（三）在線監(jiān)測(cè)與數(shù)據(jù)管理：</span></strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 關(guān)鍵參數(shù)：電導(dǎo)率（25℃≤5.1μS/cm）、TOC（≤0.5mg/L）、微生物負(fù)荷（≤100CFU/Ml）需實(shí)現(xiàn)實(shí)時(shí)監(jiān)控，數(shù)據(jù)存儲(chǔ)周期≥3年。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 智能預(yù)警：采用在線微生物分析儀，每2秒生成一次檢測(cè)結(jié)果，結(jié)合PLC系統(tǒng)實(shí)現(xiàn)自動(dòng)報(bào)警與消毒程序觸發(fā)。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><br style="box-sizing: border-box;"/></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;"><strong style="box-sizing: border-box;"><span style="font-size: 17px; box-sizing: border-box;">（四）驗(yàn)證與合規(guī)性：</span></strong></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 驗(yàn)證周期：消毒效果驗(yàn)證從每年一次調(diào)整為每季度一次，高風(fēng)險(xiǎn)系統(tǒng)（如注射用水）需每半年進(jìn)行一次全系統(tǒng)再驗(yàn)證。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; box-sizing: border-box;">- 記錄要求：消毒操作需記錄消毒劑名稱、濃度、接觸時(shí)間、殘留檢測(cè)結(jié)果等，電子記錄需符合FDA 21 CFR Part 11要求。</p></section></section></section></section></section></section></section><p><br/></p></div> <div id="yuyyc0m" class="inside_newsthree"> <span><a href="/article.html">返回列表</a><a href="#">返回頂部</a></span> <div class="oq0msee" id="clear" ></div> <div> <p>上一篇 : <a href="/Article-4014833.html">清潔驗(yàn)證雙重困局：TOC殘留測(cè)不準(zhǔn)？孢子殺不死？</a></p> <p>下一篇 : <a href="/Article-4010517.html">制藥企業(yè)潔凈區(qū)滅菌重點(diǎn)與人員規(guī)范解析</a></p></div> </div>  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