醫(yī)療器械生產(chǎn)車間沉降菌超標(biāo)控制辦法-濟(jì)南辰宇環(huán)?？萍加邢薰?/title> <link href="/skins/518065/Css/Style.css" rel="stylesheet" type="text/css" /> <script type="text/javascript" src="/skins/518065/js/jquery-3.6.0.min.js"></script> <link rel="shortcut icon" href="/skins/518065/favicon.ico"> <script type="application/ld+json"> { "@context": "https://ziyuan.baidu.com/contexts/cambrian.jsonld", "@id": "http:///Article-3249444.html", "title": "醫(yī)療器械生產(chǎn)車間沉降菌超標(biāo)控制辦法", "pubDate": "2023-01-17T15:45:33", "upDate": "2023-01-17T15:45:33" }</script> <script language="javaScript" src="/js/JSChat.js"></script><script language="javaScript">function ChatBoxClickGXH() { DoChatBoxClickGXH('https://chat.chem17.com',521593) }</script><script>!window.jQuery && document.write('<script src="https://public.mtnets.com/Plugins/jQuery/2.2.4/jquery-2.2.4.min.js">'+'</scr'+'ipt>');</script><script type="text/javascript" src="https://chat.chem17.com/chat/KFCenterBox/518065"></script><script 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><a href="/article.html">技術(shù)文章</a> >醫(yī)療器械生產(chǎn)車間沉降菌超標(biāo)控制辦法</span></dt> <dd> <div id="rtvpv5r" class="View"> <div id="jzdntlh" class="PageView"> <h1 id="inside_rnewtil">醫(yī)療器械生產(chǎn)車間沉降菌超標(biāo)控制辦法</h1> <div id="55x5bnp" class="inside_rnewtime">更新時間：2023-01-17 點擊次數(shù)：952次</div> <div id="r5j5hv3" class="inside_rnewcon"><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">鍵詞：浮游菌超標(biāo) 制藥廠車間消毒沉降菌控制辦法凈化車間微生物控制</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">建議：凈化車間的微生物控制十分重要，車間的微生物狀況會直接影響產(chǎn)品質(zhì)量。在萬級潔凈區(qū)內(nèi)的關(guān)鍵操作點和潔凈室內(nèi)每周檢測一次沉降菌和浮游菌；在10萬級潔凈區(qū)內(nèi)其檢測頻次為每月檢測一次，30萬級每季度檢測一次沉降菌。在污染情況嚴(yán)重時，需要增加檢測和消毒頻率。</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);"><span style="font-weight: 700; border: 0px; margin: 0px; padding: 0px;">潔凈區(qū)的環(huán)境參數(shù)監(jiān)控是一項工作，以確保所生產(chǎn)的醫(yī)療器械符合法規(guī)和標(biāo)準(zhǔn)要求。</span>實施生產(chǎn)質(zhì)量管理規(guī)范GMP是一項專業(yè)性的系統(tǒng)工程，車間的凈化技術(shù)是控制藥品質(zhì)量的一個重要因素，已經(jīng)成為這一工程的重要組成部分。生物微粒的標(biāo)準(zhǔn)要求(包括浮游菌、沉降菌)在凈化檢測中是最重要的關(guān)鍵指標(biāo)之一，直接影響藥品質(zhì)量。不僅要控制空氣中懸浮狀態(tài)的氣溶膠離子，還要控制微生物數(shù)，潔凈空氣，必須對空間進(jìn)消毒。</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">潔凈室監(jiān)控參數(shù)主要有：溫濕度、壓差、換氣次數(shù)、風(fēng)速、氣流、懸浮粒子、浮游菌、沉降菌、表面微生物與人員微生物等。在藥品生產(chǎn)中，空氣中懸浮粒子可能作為微生物的載體，污染藥品生產(chǎn)過程中的無菌藥品。制藥生產(chǎn)車間消毒相對嚴(yán)格，制藥企業(yè)如何解決浮游菌和沉降菌超標(biāo)。</p><p class="ql-align-center" style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; text-align: center; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);"><img src="https://img62.chem17.com/9/20230117/638095670067346190386.png" style="width:800px;"/><span id="7r5d3bf" class="img-desc" style="border: 0px; margin: 14px auto 20px; padding: 0px; display: block; width: 528px; line-height: 20px !important; color: rgb(145, 145, 145) !important;">奧克泰士制藥廠車間消毒沉降菌控制辦法凈化車間微生物控制</span></p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">十萬級凈化車間的標(biāo)準(zhǔn)是：</p><h1 style="font-size: 1.25em; margin: 0.63em 0px 1.8em; border: 0px; padding: 0px; line-height: 38px; color: rgb(25, 25, 25); counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">1、空氣懸浮粒子濃度≤1000粒/升;</h1><h1 style="font-size: 1.25em; margin: 0.63em 0px 1.8em; border: 0px; padding: 0px; line-height: 38px; color: rgb(25, 25, 25); counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">2、沉降菌總數(shù)≤100cfu/立方米;</h1><h1 style="font-size: 1.25em; margin: 0.63em 0px 1.8em; border: 0px; padding: 0px; line-height: 38px; color: rgb(25, 25, 25); counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">3、浮游菌總數(shù)≤500cfu/立方米;</h1><h1 style="font-size: 1.25em; margin: 0.63em 0px 1.8em; border: 0px; padding: 0px; line-height: 38px; color: rgb(25, 25, 25); counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">4、微生物含量≤0.5%;</h1><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">沉降菌</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">沉降菌是指落在地面或物體表面的灰塵中攜帶的細(xì)菌，一般來說沉淀細(xì)菌監(jiān)測一個月可以做一次，凈化車間需要不斷的監(jiān)控和嚴(yán)格的使用規(guī)范達(dá)到十萬級凈化車間的標(biāo)準(zhǔn)的，讓凈化空間擁有諸多優(yōu)勢安全、節(jié)能、人性化，更好的運(yùn)行，創(chuàng)造良好的生活和工作環(huán)境。</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">浮游菌</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">浮游菌收集懸浮在空氣中的活微生物粒子，通過專門的培養(yǎng)基，在適宜的生長條件下繁殖到可見的菌落數(shù)。測試方法（本方法采用計數(shù)濃度法，即通過收集懸游在空氣中的生物性粒子于專門的培養(yǎng)基，經(jīng)若干時間，在適宜的生長條件下讓其繁殖到可見的菌落進(jìn)行計數(shù)，從而判定潔凈環(huán)境內(nèi)單位體積空氣中的活微生物數(shù)，以此來評定潔凈室(區(qū))的潔凈度。</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">如何解決浮游菌沉降菌超標(biāo)?</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">GMP潔凈區(qū)對微生物的要求，與普通場所消毒不同，潔凈區(qū)需使用“滅菌劑"來嚴(yán)格控制沉降菌和浮游菌。</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">滅菌劑是一種用于消毒要求較高能殺滅包括細(xì)菌芽孢、真菌孢子在內(nèi)的各種微生物的化學(xué)高效消毒劑。在制藥工業(yè)和科學(xué)實驗室使用的滅菌劑也常成為“殺孢子劑"，即能快速殺滅高抗性微生物體—芽孢和霉菌孢子的藥劑。</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">目前國際上常用的滅菌劑有兩種類型，一種是復(fù)合型過氧乙酸（過氧乙酸和過氧化氫復(fù)合，另外一種是復(fù)合型過氧化氫（過氧化氫和銀離子）典型代表為德國Oxytech，屬于基本無腐蝕的生態(tài)型滅菌劑）。</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">兩者都對霉菌和霉菌孢子有極為理想的殺滅效果，兩者的區(qū)別是主要是過氧化氫銀離子是無色無味無毒的，基本無腐蝕，但價格成本高一些；復(fù)合過氧乙酸的成本稍低一些，但過氧乙酸本身具有較大的毒性和刺激性，對金屬等材料的腐蝕性很大。</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">Oxytech奧克泰士</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">奧克泰士進(jìn)口德國，主要成分過氧化氫銀離子。食品級無色無味無毒無殘留型，IFS國際食品標(biāo)準(zhǔn)認(rèn)證，歐盟EMAS檢測認(rèn)證，ISO9001、ISO14001環(huán)境管理體系認(rèn)證等。德國TUV認(rèn)證。是一款高效廣譜的食品級殺孢子劑。不產(chǎn)生微生物耐藥性，無任何毒性殘留，不造成重復(fù)污染等特點。采用的氧化劑為過氧化氫，它與穩(wěn)定劑結(jié)合形成復(fù)合溶液。在GMP中一個生物性潔凈的環(huán)境的非常重要的，奧克泰士相比其他的消毒產(chǎn)品具有更明顯的優(yōu)點。傳統(tǒng)的消毒方法和消毒劑如殺孢子劑不僅時間長而且對人非常危險。奧克泰士的消毒過程是快速、無殘留和安全的，生成產(chǎn)物只有水和氧氣。</p><p style="border: 0px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; font-size: 16px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">潔凈區(qū)要定期使用高效型滅菌劑來處理環(huán)境空間的微生物，在平時可使用臭氧或紫外線作為輔助措施，從而取得對沉降菌和浮游菌達(dá)到控制效果。</p><p style="text-align: center"><img style="max-width:800px;max-height:300%;" 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