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href="/article.html">技術文章</a> >獸藥GMP潔凈室空氣中霉菌超標如何消殺</span></dt> <dd> <div id="ddrv5bl" class="View"> <div id="z5pvzvl" class="PageView"> <h1 id="inside_rnewtil">獸藥GMP潔凈室空氣中霉菌超標如何消殺</h1> <div id="lxnrht5" class="inside_rnewtime">更新時間：2023-05-18 點擊次數(shù)：731次</div> <div id="dbn5rdb" class="inside_rnewcon"><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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的定義：《藥品生產(chǎn)質(zhì)量管理規(guī)范》（Good Manufacturing Practice of Medical Products，GMP）是藥品生產(chǎn)和質(zhì)量管理的基本準則，適用于藥品制劑生產(chǎn)的全過程和原料藥生產(chǎn)中影響成品質(zhì)量的關鍵工序。大力推行藥品GMP，是為了最大限度地避免藥品生產(chǎn)過程中的污染和交叉污染，降低各種差錯的發(fā)生，是提高藥品質(zhì)量的重要措施。</p><p class="ql-align-center" style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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://img64.chem17.com/9/20230518/638200034081573080336.png" style="width:800px;"/></p><p class="ql-align-justify" style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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: justify; 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);">在中國，人藥生產(chǎn)和獸藥生產(chǎn)的GMP是不同的，在獸藥GMP廠房內(nèi)，在生物制品生產(chǎn)過程中污染還是時有發(fā)生的，包括細菌，真菌，支原體污染，獸用生物制品生產(chǎn)過程中污染的途徑有如下幾個方面，細胞及種毒，細菌配養(yǎng)、疫苗生產(chǎn)原料及車間環(huán)境等。</p><p class="ql-align-justify" style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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: justify; 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);">為降低污染和交叉污染的風險，廠房、生產(chǎn)設施和設備應當根據(jù)所生產(chǎn)獸藥的特性、工藝流程及相應潔凈度級別要求做好合理的消毒殺菌工作。</p><p class="ql-align-justify" style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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: justify; 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);">應當根據(jù)獸藥品種、生產(chǎn)操作要求及外部環(huán)境狀況等配置空氣凈化系統(tǒng)，使生產(chǎn)區(qū)有效通風，并有溫度、濕度控制和空氣凈化過濾，保證獸藥的生產(chǎn)環(huán)境符合要求。潔凈區(qū)與非潔凈區(qū)之間、不同級別潔凈區(qū)之間的壓差應當不低于10帕斯卡。必要時，相同潔凈度級別的不同功能區(qū)域（操作間）之間也應當保持適當?shù)膲翰钐荻龋兄甘緣翰畹难b置和（或）設置監(jiān)控系統(tǒng)。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">獸藥生產(chǎn)潔凈室（區(qū)）分為B級、C級和D級4個級別。生產(chǎn)不同類別獸藥的潔凈室（區(qū)）設計應當符合相應的潔凈度要求，包括達到“靜態(tài)"和“動態(tài)"的標準。潔凈區(qū)的內(nèi)表面（墻壁、地面、天棚）應當平整光滑、無裂縫、接口嚴密、無顆粒物脫落，避免積塵，便于有效清潔，必要時應當進行消毒。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">霉菌，是制藥企業(yè)潔凈區(qū)相對來說較難控制的微生物。霉菌的存在勢必會對產(chǎn)品造成不良的影響，那么本文將會提供一種新的消毒技術既可以高效殺滅霉菌抑制其生長繁殖又可以輕松通過驗證，無毒無害無殘留無腐蝕等優(yōu)點。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">許多制藥企業(yè)依舊在沿用酒精對物體表面進行擦拭，酒精對霉菌的抑制效果不是很好。如果采用其它的消毒方法要重新撰寫驗證報告，又要考慮殘留和腐蝕性等諸多因素。酒精在標準實驗室測試可一定程度殺滅霉菌，但現(xiàn)場應用無法保證濃度，且不能噴灑到空氣中消毒，所以酒精也不能作為控制霉菌的有效方式。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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;">空氣中的霉菌應該怎么處理？</span></p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">空氣樣品中的霉菌回收可能是由于多種原因造成的。表面污染物可能會傳播到空氣中，因此污染源可能是人員腳部或車輪帶來的污染。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">監(jiān)測設備和擦拭程序不充分，可能是另一個原因。沒有HEPA過濾廢氣的監(jiān)測設備是污染源。發(fā)生泄漏、HEPA過濾器損壞后，霉菌在墻壁中生長，會導致空氣中會回收到霉菌。需要追蹤霉菌直到其來源，對回收區(qū)域進行霉菌轉(zhuǎn)移通路分析，這一點也很重要。通常，死角區(qū)域、潔凈室和屏障系統(tǒng)的集成，可能會使污染物長時間滯留。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">如果在灌裝區(qū)域（尤其是RAB中）中發(fā)現(xiàn)了霉菌，則說明HEPA之間沒有擴散膜的區(qū)域很難清潔，并且可以容納可能被空氣傳播的污染物。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">最后，根據(jù)回收到的霉菌種類，尤其是繁殖迅速的半知菌，應考慮非生物因素，例如水分、碳源、礦物油等。由于霉菌的抗性較高，能夠通過空氣傳播，那選擇的消毒產(chǎn)品必須能夠殺滅霉菌，且能夠用于空氣消毒。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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;">案例現(xiàn)場狀況：</span></p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">某凈化車間，總面積約500m2，高度7m，經(jīng)檢測空氣中霉菌超標，需進行滅殺工作。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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;">具體實施流程：</span></p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">1. 測算空間大小：500*7=3500m3，需要藥劑量（稀釋后）為：3500*10/1000=35L。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">2. 取3.5L奧克泰士消毒劑，31.5L純凈水，混合稀釋。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">3. 將噴霧設備和藥劑送入車間，確認車間無人后，將藥劑均勻噴灑到空氣中。（時間段：可選擇上班前60-90分鐘或下班后進行）</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">4. 噴霧過程需關閉門窗和通風設備，噴霧完畢后封閉60-90分鐘。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">5. 消殺完成。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">6. <span style="font-weight: 700; border: 0px; margin: 0px; padding: 0px;">效果反饋：</span></p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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);">7. 經(jīng)過奧克泰士處理后霉菌得到了很好的控制，后期每周進行一次消毒工作，車間的霉菌問題得到了解決。</p><p class="ql-align-justify" style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; 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: justify; 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;">針對霉菌，芽孢，支原體、衣原體、噬菌體污染問題，基于國內(nèi)多家客戶的實際情況，為實驗室、科研單位、生產(chǎn)單位、提供精準的支原體、衣原體、噬菌體污染解決方案。</span> 我們提倡生態(tài)環(huán)保的消毒理念，助力中國企業(yè)健康可持續(xù)發(fā)展！</p><p><br/></p></div> <div id="hfvzftr" class="inside_newsthree"> <span><a href="/article.html">返回列表</a><a href="#">返回頂部</a></span> <div class="xnpdfdr" id="clear" ></div> <div> <p>上一篇 : <a 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