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href="/article.html">技術(shù)文章</a> >醫療器械生產(chǎn)車(chē)間沉降菌超標控制辦法</span></dt> <dd> <div id="0eqamyo" class="View"> <div id="qcs0woi" class="PageView"> <h1 id="inside_rnewtil">醫療器械生產(chǎn)車(chē)間沉降菌超標控制辦法</h1> <div id="akyqcoc" class="inside_rnewtime">更新時(shí)間：2023-01-17 點(diǎn)擊次數：729次</div> <div id="0me0gqi" 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：浮游菌超標制藥廠(chǎng)車(chē)間消毒沉降菌控制辦法凈化車(chē)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(chē)間的微生物控制十分重要，車(chē)間的微生物狀況會(huì )直接影響產(chǎn)品質(zhì)量。在萬(wàn)級潔凈區內的關(guān)鍵操作點(diǎn)和潔凈室內每周檢測一次沉降菌和浮游菌；在10萬(wàn)級潔凈區內其檢測頻次為每月檢測一次，30萬(wàn)級每季度檢測一次沉降菌。在污染情況嚴重時(shí)，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;">潔凈區的環(huán)境參數監控是一項工作，以確保所生產(chǎn)的醫療器械符合法規和標準要求。</span>實(shí)施生產(chǎn)質(zhì)量管理規范GMP是一項專(zhuān)業(yè)性的系統工程，車(chē)間的凈化技術(shù)是控制藥品質(zhì)量的一個(gè)重要因素，已經(jīng)成為這一工程的重要組成部分。生物微粒的標準要求(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，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);">潔凈室監控參數主要有：溫濕度、壓差、換氣次數、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(guò)程中的無(wú)菌藥品。制藥生產(chǎn)車(chē)間消毒相對嚴格，制藥企業(yè)如何解決浮游菌和沉降菌超標。</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="4gugkym" 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(chǎng)車(chē)間消毒沉降菌控制辦法凈化車(chē)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(wàn)級凈化車(chē)間的標準是：</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≤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≤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菌，一般來(lái)說(shuō)沉淀細菌監測一個(gè)月可以做一次，凈化車(chē)間需要不斷的監控和嚴格的使用規范達到十萬(wàn)級凈化車(chē)間的標準的，讓凈化空間擁有諸多優(yōu)勢安全、節能、人性化，更好的運行，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(guò)專(zhuān)門(mén)的培養基，在適宜的生長(cháng)條件下繁殖到可見(jiàn)的菌落數。測試方法（本方法采用計數濃度法，即通過(guò)收集懸游在空氣中的生物性粒子于專(zhuān)門(mén)的培養基，經(jīng)若干時(shí)間，在適宜的生長(cháng)條件下讓其繁殖到可見(jiàn)的菌落進(jìn)行計數，從而判定潔凈環(huán)境內單位體積空氣中的活微生物數，以此來(lái)評定潔凈室(區)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?</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潔凈區對微生物的要求，與普通場(chǎng)所消毒不同，潔凈區需使用“滅菌劑"來(lái)嚴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菌芽孢、真菌孢子在內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(shí)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(lèi)型，一種是復合型過(guò)氧乙酸（過(guò)氧乙酸和過(guò)氧化氫復合，另外一種是復合型過(guò)氧化氫（過(guò)氧化氫和銀離子）典型代表為德國Oxytech，屬于基本無(wú)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，兩者的區別是主要是過(guò)氧化氫銀離子是無(wú)色無(wú)味無(wú)毒的，基本無(wú)腐蝕，但價(jià)格成本高一些；復合過(guò)氧乙酸的成本稍低一些，但過(guò)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(guò)氧化氫銀離子。食品級無(wú)色無(wú)味無(wú)毒無(wú)殘留型，IFS國際食品標準認證，歐盟EMAS檢測認證，ISO9001、ISO14001環(huán)境管理體系認證等。德國TUV認證。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(wú)任何毒性殘留，不造成重復污染等特點(diǎn)。采用的氧化劑為過(guò)氧化氫，它與穩定劑結合形成復合溶液。在GMP中一個(gè)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(diǎn)。傳統的消毒方法和消毒劑如殺孢子劑不僅時(shí)間長(cháng)而且對人非常危險。奧克泰士的消毒過(guò)程是快速、無(wú)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);">潔凈區要定期使用高效型滅菌劑來(lái)處理環(huán)境空間的微生物，在平時(shí)可使用臭氧或紫外線(xiàn)作為輔助措施，從而取得對沉降菌和浮游菌達到控制效果。</p><p style="text-align: center"><img style="max-width:800px;max-height:300%;" src="https://img67.chem17.com/9/20230117/638095670835524976436.png" title="1-13 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