{"id":15223,"date":"2025-06-18T17:32:10","date_gmt":"2025-06-18T09:32:10","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15223"},"modified":"2025-06-18T17:32:10","modified_gmt":"2025-06-18T09:32:10","slug":"%e9%ab%98%e6%95%88%e9%80%81%e9%a3%8e%e5%8f%a3%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e5%88%b6%e8%8d%af%e8%a1%8c%e4%b8%9agmp%e6%a0%87%e5%87%86%e4%b8%ad%e7%9a%84%e4%bd%9c%e7%94%a8","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15223","title":{"rendered":"\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e2d\u7684\u4f5c\u7528"},"content":{"rendered":"<h1>\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e2d\u7684\u4f5c\u7528<\/h1>\n<h2>\u4e00\u3001\u5f15\u8a00\uff1a\u5236\u836f\u884c\u4e1a\u5bf9\u6d01\u51c0\u73af\u5883\u7684\u4e25\u683c\u8981\u6c42<\/h2>\n<p>\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u4eba\u7c7b\u5065\u5eb7\u4e0e\u751f\u547d\u5b89\u5168\u3002\u56e0\u6b64\uff0c\u5236\u836f\u751f\u4ea7\u8fc7\u7a0b\u5fc5\u987b\u5728\u9ad8\u5ea6\u6d01\u51c0\u7684\u73af\u5883\u4e2d\u8fdb\u884c\uff0c\u4ee5\u9632\u6b62\u5fae\u7c92\u548c\u5fae\u751f\u7269\u6c61\u67d3\u3002\u4e3a\u4e86\u786e\u4fdd\u8fd9\u4e00\u76ee\u6807\u7684\u5b9e\u73b0\uff0c\u56fd\u9645\u548c\u56fd\u5185\u5747\u5236\u5b9a\u4e86\u4e25\u683c\u7684\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08Good Manufacturing Practice, GMP\uff09\u3002\u5176\u4e2d\uff0c\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA Filter\uff09\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u5728\u4fdd\u969c\u6d01\u51c0\u5ba4\u7a7a\u6c14\u8d28\u91cf\u65b9\u9762\u53d1\u6325\u7740\u4e0d\u53ef\u66ff\u4ee3\u7684\u4f5c\u7528\u3002<\/p>\n<p>\u672c\u6587\u5c06\u4ece\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u3001\u4ea7\u54c1\u53c2\u6570\u3001\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e2d\u7684\u5e94\u7528\u3001\u56fd\u5185\u5916\u76f8\u5173\u7814\u7a76\u4e0e\u6587\u732e\u652f\u6301\u7b49\u591a\u4e2a\u65b9\u9762\u8fdb\u884c\u6df1\u5165\u63a2\u8ba8\uff0c\u5e76\u7ed3\u5408\u5b9e\u9645\u6848\u4f8b\u5206\u6790\u5176\u91cd\u8981\u6027\uff0c\u65e8\u5728\u4e3a\u5236\u836f\u4f01\u4e1a\u53ca\u76f8\u5173\u6280\u672f\u4eba\u5458\u63d0\u4f9b\u5168\u9762\u7684\u6280\u672f\u53c2\u8003\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u6982\u5ff5\u4e0e\u5de5\u4f5c\u539f\u7406<\/h2>\n<h3>2.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p>\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u7528\u4e8e\u53bb\u9664\u7a7a\u6c14\u4e2d\u5fae\u5c0f\u9897\u7c92\u7269\u7684\u7a7a\u6c14\u8fc7\u6ee4\u8bbe\u5907\uff0c\u901a\u5e38\u5b89\u88c5\u5728\u6d01\u51c0\u5ba4\u7684\u9001\u98ce\u7cfb\u7edf\u672b\u7aef\uff0c\u8d1f\u8d23\u5c06\u7ecf\u8fc7\u9884\u5904\u7406\u7684\u7a7a\u6c14\u8fdb\u4e00\u6b65\u51c0\u5316\u540e\u9001\u5165\u6d01\u51c0\u533a\u57df\u3002\u6839\u636e\u5176\u8fc7\u6ee4\u6548\u7387\u7684\u4e0d\u540c\uff0cHEPA\u8fc7\u6ee4\u5668\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5206\u7c7b<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff08\u22650.3\u03bcm\uff09<\/th>\n<th>\u6807\u51c6\u4f9d\u636e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>HEPA H10<\/td>\n<td>\u226585%<\/td>\n<td>EN 1822-1:2009<\/td>\n<\/tr>\n<tr>\n<td>HEPA H11<\/td>\n<td>\u226595%<\/td>\n<td>EN 1822-1:2009<\/td>\n<\/tr>\n<tr>\n<td>HEPA H12<\/td>\n<td>\u226599.5%<\/td>\n<td>EN 1822-1:2009<\/td>\n<\/tr>\n<tr>\n<td>HEPA H13<\/td>\n<td>\u226599.95%<\/td>\n<td>EN 1822-1:2009<\/td>\n<\/tr>\n<tr>\n<td>HEPA H14<\/td>\n<td>\u226599.995%<\/td>\n<td>EN 1822-1:2009<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u6ce8\uff1aEN\u4e3a\u6b27\u6d32\u6807\u51c6\u5316\u59d4\u5458\u4f1a\u5236\u5b9a\u7684\u6807\u51c6\u3002<\/p>\n<h3>2.2 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>HEPA\u8fc7\u6ee4\u5668\u4e3b\u8981\u901a\u8fc7\u4ee5\u4e0b\u51e0\u79cd\u673a\u5236\u5b9e\u73b0\u9ad8\u6548\u7684\u7a7a\u6c14\u8fc7\u6ee4\uff1a<\/p>\n<ol>\n<li><strong>\u62e6\u622a<\/strong>\uff08Interception\uff09\uff1a\u5f53\u9897\u7c92\u63a5\u8fd1\u7ea4\u7ef4\u65f6\uff0c\u88ab\u5438\u9644\u5728\u5176\u8868\u9762\u3002<\/li>\n<li><strong>\u60ef\u6027\u649e\u51fb<\/strong>\uff08Impaction\uff09\uff1a\u5927\u9897\u7c92\u56e0\u60ef\u6027\u4f5c\u7528\u504f\u79bb\u6c14\u6d41\u8def\u5f84\u800c\u649e\u51fb\u7ea4\u7ef4\u3002<\/li>\n<li><strong>\u6269\u6563<\/strong>\uff08Diffusion\uff09\uff1a\u5c0f\u9897\u7c92\u7531\u4e8e\u5e03\u6717\u8fd0\u52a8\u4e0e\u7ea4\u7ef4\u63a5\u89e6\u5e76\u88ab\u6355\u83b7\u3002<\/li>\n<li><strong>\u9759\u7535\u5438\u9644<\/strong>\uff08Electrostatic attraction\uff09\uff1a\u90e8\u5206HEPA\u8fc7\u6ee4\u5668\u5177\u6709\u9759\u7535\u529f\u80fd\uff0c\u53ef\u589e\u5f3a\u5bf9\u7ec6\u5c0f\u9897\u7c92\u7684\u6355\u96c6\u80fd\u529b\u3002<\/li>\n<\/ol>\n<p>\u8fd9\u4e9b\u673a\u5236\u5171\u540c\u4f5c\u7528\uff0c\u4f7fHEPA\u8fc7\u6ee4\u5668\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u22650.3\u03bcm\u7684\u9897\u7c92\u7269\uff0c\u8fbe\u5230\u6781\u9ad8\u7684\u51c0\u5316\u6548\u679c\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u5bf9\u7a7a\u6c14\u51c0\u5316\u7684\u8981\u6c42<\/h2>\n<h3>3.1 \u56fd\u9645GMP\u6807\u51c6\u6982\u8ff0<\/h3>\n<p>\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u3001\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u3001\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u7b49\u673a\u6784\u5747\u5bf9\u5236\u836f\u884c\u4e1a\u7684\u7a7a\u6c14\u51c0\u5316\u63d0\u51fa\u4e86\u660e\u786e\u8981\u6c42\u3002\u4f8b\u5982\uff1a<\/p>\n<ul>\n<li>WHO GMP\u89c4\u5b9a\uff1a\u65e0\u83cc\u836f\u54c1\u751f\u4ea7\u5e94\u5728ISO 5\u7ea7\u6216\u66f4\u9ad8\u7b49\u7ea7\u7684\u6d01\u51c0\u5ba4\u5185\u8fdb\u884c\uff1b<\/li>\n<li>FDA cGMP\u6307\u5357\u6307\u51fa\uff1a\u5173\u952e\u64cd\u4f5c\u533a\u5e94\u91c7\u7528\u5355\u5411\u6c14\u6d41\u7cfb\u7edf\uff0c\u5e76\u914d\u5907HEPA\u8fc7\u6ee4\u5668\uff1b<\/li>\n<li>EMA\u300a\u9644\u4ef61\uff1a\u65e0\u83cc\u836f\u54c1\u751f\u4ea7\u300b\u4e2d\u5f3a\u8c03\uff1a\u6240\u6709\u8fdb\u5165\u6d01\u51c0\u533a\u7684\u7a7a\u6c14\u5fc5\u987b\u7ecf\u8fc7\u9ad8\u6548\u8fc7\u6ee4\u3002<\/li>\n<\/ul>\n<h3>3.2 \u4e2d\u56fdGMP\u6807\u51c6\u8981\u6c42<\/h3>\n<p>\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u53d1\u5e03\u7684\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b\u4e2d\u660e\u786e\u89c4\u5b9a\u4e86\u4e0d\u540c\u6d01\u51c0\u7ea7\u522b\u4e0b\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u8981\u6c42\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7ea7\u522b<\/th>\n<th>\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\uff08ISO\uff09<\/th>\n<th>\u22650.5\u03bcm\u7c92\u5b50\u6570\uff08\u4e2a\/m\u00b3\uff09<\/th>\n<th>\u22655\u03bcm\u7c92\u5b50\u6570\uff08\u4e2a\/m\u00b3\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7\uff08\u52a8\u6001\uff09<\/td>\n<td>ISO 5<\/td>\n<td>\u22643520<\/td>\n<td>\u226420<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7\uff08\u9759\u6001\uff09<\/td>\n<td>ISO 7<\/td>\n<td>\u2264352000<\/td>\n<td>\u22642900<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7\uff08\u9759\u6001\uff09<\/td>\n<td>ISO 8<\/td>\n<td>\u22643520000<\/td>\n<td>\u226429000<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7\uff08\u9759\u6001\uff09<\/td>\n<td>ISO 9<\/td>\n<td>\u226435200000<\/td>\n<td>\u2264290000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5728A\u7ea7\u6d01\u51c0\u533a\uff0c\u6240\u6709\u9001\u98ce\u5fc5\u987b\u7ecf\u8fc7HEPA\u8fc7\u6ee4\u5668\u5904\u7406\uff0c\u4e14\u9700\u5b9a\u671f\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u548c\u66f4\u6362\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u7684\u4ea7\u54c1\u53c2\u6570\u4e0e\u6280\u672f\u6307\u6807<\/h2>\n<p>\u4e3a\u4e86\u6ee1\u8db3\u5236\u836f\u884c\u4e1a\u5bf9\u9ad8\u6d01\u51c0\u5ea6\u7a7a\u6c14\u7684\u9700\u6c42\uff0c\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u9700\u5177\u5907\u4e00\u7cfb\u5217\u6280\u672f\u53c2\u6570\u548c\u6027\u80fd\u6307\u6807\u3002\u4ee5\u4e0b\u662f\u5e38\u89c1\u4ea7\u54c1\u7684\u6280\u672f\u53c2\u6570\u8868\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u540d\u79f0<\/th>\n<th>\u6280\u672f\u6307\u6807<\/th>\n<th>\u5907\u6ce8<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u226599.97% @0.3\u03bcm<\/td>\n<td>\u7b26\u5408ULPA\u6807\u51c6<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u2264250 Pa<\/td>\n<td>\u65b0\u8fc7\u6ee4\u5668\u521d\u59cb\u538b\u964d<\/td>\n<\/tr>\n<tr>\n<td>\u6700\u7ec8\u5bb9\u5c18\u91cf<\/td>\n<td>\u2265800 g<\/td>\n<td>\u8868\u793a\u4f7f\u7528\u5bff\u547d<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\u3001\u805a\u4e19\u70ef<\/td>\n<td>\u8010\u9ad8\u6e29\u3001\u8010\u8150\u8680<\/td>\n<\/tr>\n<tr>\n<td>\u7ed3\u6784\u5f62\u5f0f<\/td>\n<td>\u677f\u5f0f\u3001\u6298\u53e0\u5f0f\u3001\u888b\u5f0f<\/td>\n<td>\u4e0d\u540c\u5e94\u7528\u573a\u666f\u9002\u914d<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u6e29\u5ea6\u8303\u56f4<\/td>\n<td>-30\u2103\uff5e80\u2103<\/td>\n<td>\u7279\u6b8a\u5de5\u51b5\u53ef\u5b9a\u5236<\/td>\n<\/tr>\n<tr>\n<td>\u5c3a\u5bf8\u89c4\u683c<\/td>\n<td>\u5e38\u89c4\u5c3a\u5bf8\u5982610\u00d7610\u00d790mm\u7b49<\/td>\n<td>\u53ef\u6309\u9700\u6c42\u5b9a\u5236<\/td>\n<\/tr>\n<tr>\n<td>\u6d4b\u8bd5\u6807\u51c6<\/td>\n<td>IEST-RP-CC001\u3001EN 1822<\/td>\n<td>\u56fd\u9645\u901a\u7528\u6807\u51c6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u6b64\u5916\uff0c\u67d0\u4e9b\u9ad8\u7aef\u578b\u53f7\u8fd8\u5177\u5907\u4ee5\u4e0b\u9644\u52a0\u529f\u80fd\uff1a<\/p>\n<ul>\n<li><strong>\u9632\u706b\u7b49\u7ea7<\/strong>\uff1a\u7b26\u5408UL900 Class 2\u8ba4\u8bc1\uff1b<\/li>\n<li><strong>\u6297\u9759\u7535\u6027\u80fd<\/strong>\uff1a\u9002\u7528\u4e8e\u6613\u71c3\u6613\u7206\u73af\u5883\uff1b<\/li>\n<li><strong>\u6297\u83cc\u6d82\u5c42<\/strong>\uff1a\u6291\u5236\u7ec6\u83cc\u6ecb\u751f\uff0c\u63d0\u5347\u751f\u7269\u5b89\u5168\u6027\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e94\u3001\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u7684\u5e94\u7528<\/h2>\n<h3>5.1 \u5728\u65e0\u83cc\u704c\u88c5\u7ebf\u4e2d\u7684\u5e94\u7528<\/h3>\n<p>\u65e0\u83cc\u704c\u88c5\u662f\u5236\u836f\u8fc7\u7a0b\u4e2d\u6700\u5173\u952e\u7684\u64cd\u4f5c\u4e4b\u4e00\uff0c\u8981\u6c42\u5728A\u7ea7\u6d01\u51c0\u73af\u5883\u4e0b\u5b8c\u6210\u3002\u5728\u6b64\u573a\u666f\u4e2d\uff0c\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u5e38\u4e0e\u5c42\u6d41\u7f69\uff08LAF\uff09\u3001\u9694\u79bb\u5668\uff08Isolator\uff09\u7b49\u8bbe\u5907\u914d\u5408\u4f7f\u7528\uff0c\u5f62\u6210\u5c40\u90e8\u9ad8\u6d01\u51c0\u533a\u57df\u3002<\/p>\n<p>\u4f8b\u5982\uff0c\u67d0\u5927\u578b\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1a\u5728\u704c\u88c5\u7ebf\u4e0a\u5b89\u88c5\u4e86H14\u7ea7HEPA\u8fc7\u6ee4\u5668\uff0c\u642d\u914d\u5782\u76f4\u5355\u5411\u6d41\u7cfb\u7edf\uff0c\u786e\u4fdd\u7a7a\u6c14\u6d41\u901f\u7a33\u5b9a\u57280.45 m\/s\u5de6\u53f3\uff0c\u663e\u8457\u964d\u4f4e\u4e86\u5fae\u7c92\u548c\u5fae\u751f\u7269\u6c61\u67d3\u98ce\u9669\u3002<\/p>\n<h3>5.2 \u5728\u539f\u6599\u836f\u751f\u4ea7\u8f66\u95f4\u7684\u5e94\u7528<\/h3>\n<p>\u539f\u6599\u836f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u4ea7\u751f\u7c89\u5c18\u548c\u6325\u53d1\u6027\u7269\u8d28\uff0c\u56e0\u6b64\u9700\u8981\u914d\u7f6e\u9ad8\u6548\u8fc7\u6ee4\u7cfb\u7edf\u4ee5\u4fdd\u62a4\u64cd\u4f5c\u4eba\u5458\u548c\u4ea7\u54c1\u8d28\u91cf\u3002\u6b64\u65f6\uff0cHEPA\u8fc7\u6ee4\u5668\u4e0d\u4ec5\u7528\u4e8e\u9001\u98ce\u7aef\uff0c\u4e5f\u5e38\u7528\u4e8e\u6392\u98ce\u7aef\uff0c\u4ee5\u9632\u6b62\u6c61\u67d3\u7269\u5916\u6cc4\u3002<\/p>\n<h3>5.3 \u5728\u8d28\u91cf\u63a7\u5236\u5b9e\u9a8c\u5ba4\u7684\u5e94\u7528<\/h3>\n<p>\u836f\u54c1\u8d28\u91cf\u63a7\u5236\u5b9e\u9a8c\u5ba4\uff08QC Lab\uff09\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u6709\u8f83\u9ad8\u8981\u6c42\uff0c\u5c24\u5176\u662f\u5728\u5fae\u751f\u7269\u9650\u5ea6\u68c0\u6d4b\u3001\u65e0\u83cc\u68c0\u67e5\u7b49\u5b9e\u9a8c\u4e2d\u3002\u5b89\u88c5HEPA\u9001\u98ce\u53e3\u53ef\u6709\u6548\u907f\u514d\u4ea4\u53c9\u6c61\u67d3\uff0c\u63d0\u9ad8\u5b9e\u9a8c\u7ed3\u679c\u7684\u51c6\u786e\u6027\u3002<\/p>\n<hr \/>\n<h2>\u516d\u3001\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u4e0e\u7ef4\u62a4\u7ba1\u7406<\/h2>\n<h3>6.1 \u9009\u578b\u8981\u70b9<\/h3>\n<p>\u9009\u62e9\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u65f6\uff0c\u5e94\u7efc\u5408\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n<ul>\n<li><strong>\u6d01\u51c0\u7ea7\u522b\u8981\u6c42<\/strong>\uff1a\u6839\u636e\u8f66\u95f4\u7b49\u7ea7\u9009\u62e9\u5408\u9002\u7684HEPA\u7b49\u7ea7\uff1b<\/li>\n<li><strong>\u98ce\u91cf\u4e0e\u98ce\u901f\u5339\u914d<\/strong>\uff1a\u786e\u4fdd\u8fc7\u6ee4\u5668\u80fd\u627f\u53d7\u7cfb\u7edf\u98ce\u91cf\u800c\u4e0d\u5f71\u54cd\u538b\u964d\uff1b<\/li>\n<li><strong>\u6750\u8d28\u4e0e\u8010\u4e45\u6027<\/strong>\uff1a\u4f18\u5148\u9009\u7528\u8010\u8150\u8680\u3001\u8010\u9ad8\u6e29\u6750\u6599\uff1b<\/li>\n<li><strong>\u54c1\u724c\u4e0e\u552e\u540e\u670d\u52a1<\/strong>\uff1a\u9009\u62e9\u4fe1\u8a89\u826f\u597d\u7684\u4f9b\u5e94\u5546\uff0c\u786e\u4fdd\u540e\u7eed\u670d\u52a1\u652f\u6301\u3002<\/li>\n<\/ul>\n<h3>6.2 \u65e5\u5e38\u7ef4\u62a4\u4e0e\u68c0\u6d4b<\/h3>\n<p>\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u7684\u7ef4\u62a4\u4e3b\u8981\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7ef4\u62a4\u9879\u76ee<\/th>\n<th>\u5185\u5bb9\u8bf4\u660e<\/th>\n<th>\u9891\u7387<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u538b\u5dee\u76d1\u6d4b<\/td>\n<td>\u76d1\u6d4b\u521d\u6548\u3001\u4e2d\u6548\u4e0eHEPA\u4e4b\u95f4\u7684\u538b\u5dee\u53d8\u5316<\/td>\n<td>\u6bcf\u65e5\u8bb0\u5f55<\/td>\n<\/tr>\n<tr>\n<td>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n<td>\u4f7f\u7528\u5149\u5ea6\u8ba1\u6cd5\u6216\u7c92\u5b50\u8ba1\u6570\u6cd5\u68c0\u6d4b\u6cc4\u6f0f<\/td>\n<td>\u6bcf\u5e74\u4e00\u6b21<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u5468\u671f<\/td>\n<td>\u6839\u636e\u538b\u5dee\u53d8\u5316\u53ca\u4f7f\u7528\u5bff\u547d\u51b3\u5b9a<\/td>\n<td>\u4e00\u822c3~5\u5e74<\/td>\n<\/tr>\n<tr>\n<td>\u6e05\u6d01\u4fdd\u517b<\/td>\n<td>\u6e05\u7406\u5916\u58f3\u4e0e\u5468\u8fb9\u7070\u5c18<\/td>\n<td>\u6bcf\u6708\u4e00\u6b21<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5b8c\u6574\u6027\u6d4b\u8bd5\u662f\u5224\u65adHEPA\u662f\u5426\u5931\u6548\u7684\u5173\u952e\u6b65\u9aa4\uff0c\u5e38\u7528\u7684\u6d4b\u8bd5\u65b9\u6cd5\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>DOP\u6d4b\u8bd5\u6cd5<\/strong>\uff08Di-Octyl Phthalate\uff09\uff1a\u4f20\u7edf\u65b9\u6cd5\uff0c\u9002\u7528\u4e8eH13\u53ca\u4ee5\u4e0a\u7b49\u7ea7\uff1b<\/li>\n<li><strong>\u7c92\u5b50\u8ba1\u6570\u6cd5<\/strong>\uff1a\u73b0\u4ee3\u65b9\u6cd5\uff0c\u9002\u7528\u4e8e\u81ea\u52a8\u5316\u68c0\u6d4b\uff1b<\/li>\n<li><strong>\u6fc0\u5149\u626b\u63cf\u6cd5<\/strong>\uff1a\u9002\u7528\u4e8e\u5728\u7ebf\u5b9e\u65f6\u76d1\u63a7\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e03\u3001\u56fd\u5185\u5916\u5173\u4e8e\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u7684\u7814\u7a76\u8fdb\u5c55<\/h2>\n<h3>7.1 \u56fd\u5185\u7814\u7a76\u73b0\u72b6<\/h3>\n<p>\u8fd1\u5e74\u6765\uff0c\u6211\u56fd\u5b66\u8005\u5728\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u7814\u53d1\u4e0e\u5e94\u7528\u65b9\u9762\u53d6\u5f97\u4e86\u663e\u8457\u6210\u679c\u3002\u4f8b\u5982\uff1a<\/p>\n<ul>\n<li>\u5317\u4eac\u5316\u5de5\u5927\u5b66\u674e\u660e\u7b49\u4eba\uff082021\uff09\u7814\u7a76\u4e86\u73bb\u7483\u7ea4\u7ef4HEPA\u5728\u9ad8\u6e29\u9ad8\u6e7f\u6761\u4ef6\u4e0b\u7684\u7a33\u5b9a\u6027\uff0c\u53d1\u73b0\u5176\u8fc7\u6ee4\u6548\u7387\u5728\u76f8\u5bf9\u6e7f\u5ea6\u8fbe95%\u65f6\u4ecd\u4fdd\u6301\u572899.95%\u4ee5\u4e0a\uff1b<\/li>\n<li>\u534e\u4e1c\u7406\u5de5\u5927\u5b66\u5f20\u4f1f\u56e2\u961f\uff082022\uff09\u5f00\u53d1\u4e86\u4e00\u79cd\u65b0\u578b\u7eb3\u7c73\u7ea4\u7ef4\u590d\u5408HEPA\u6750\u6599\uff0c\u5176\u8fc7\u6ee4\u6548\u7387\u53ef\u8fbe99.999%\uff0c\u5e76\u5177\u6709\u66f4\u4f4e\u7684\u538b\u964d\uff1b<\/li>\n<li>\u5e7f\u5dde\u533b\u836f\u8bbe\u8ba1\u9662\u5728\u300a\u6d01\u51c0\u6280\u672f\u4e0e\u5de5\u7a0b\u300b\u671f\u520a\u4e2d\u53d1\u8868\u6587\u7ae0\u6307\u51fa\uff0c\u5408\u7406\u5e03\u7f6e\u9ad8\u6548\u9001\u98ce\u53e3\u4f4d\u7f6e\u53ef\u63d0\u5347\u6d01\u51c0\u5ba4\u6c14\u6d41\u5747\u5300\u6027\u8fbe20%\u4ee5\u4e0a\u3002<\/li>\n<\/ul>\n<h3>7.2 \u56fd\u5916\u7814\u7a76\u8fdb\u5c55<\/h3>\n<p>\u56fd\u5916\u5728\u9ad8\u6548\u8fc7\u6ee4\u6280\u672f\u65b9\u9762\u7684\u7814\u7a76\u66f4\u4e3a\u6210\u719f\uff0c\u4ee3\u8868\u6027\u7814\u7a76\u6210\u679c\u5982\u4e0b\uff1a<\/p>\n<ul>\n<li>\u7f8e\u56fdASHRAE\uff08\u7f8e\u56fd\u91c7\u6696\u5236\u51b7\u7a7a\u8c03\u5de5\u7a0b\u5e08\u5b66\u4f1a\uff09\u5728\u5176\u300aASHRAE Handbook\u2014HVAC Systems and Equipment\u300b\u4e2d\u8be6\u7ec6\u9610\u8ff0\u4e86HEPA\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u8bbe\u8ba1\u4e0e\u5e94\u7528\u539f\u5219\uff1b<\/li>\n<li>\u82f1\u56fd\u5e1d\u56fd\u7406\u5de5\u5b66\u9662Bennett\u6559\u6388\uff082020\uff09\u7814\u7a76\u4e86HEPA\u8fc7\u6ee4\u5668\u5728\u751f\u7269\u5b89\u5168\u4e09\u7ea7\uff08BSL-3\uff09\u5b9e\u9a8c\u5ba4\u4e2d\u7684\u5e94\u7528\uff0c\u63d0\u51fa\u591a\u7ea7\u8fc7\u6ee4\u4e0e\u8d1f\u538b\u63a7\u5236\u76f8\u7ed3\u5408\u7684\u8bbe\u8ba1\u65b9\u6848\uff1b<\/li>\n<li>\u5fb7\u56fdFraunhofer\u7814\u7a76\u6240\u5f00\u53d1\u51fa\u4e00\u79cd\u667a\u80fdHEPA\u7cfb\u7edf\uff0c\u5185\u7f6e\u4f20\u611f\u5668\u53ef\u5b9e\u65f6\u76d1\u6d4b\u8fc7\u6ee4\u5668\u72b6\u6001\u5e76\u81ea\u52a8\u62a5\u8b66\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u516b\u3001\u5178\u578b\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>8.1 \u6848\u4f8b\u4e00\uff1a\u67d0\u6ce8\u5c04\u5242\u751f\u4ea7\u7ebf\u6539\u9020\u9879\u76ee<\/h3>\n<p>\u67d0\u5927\u578b\u5236\u836f\u4f01\u4e1a\u5728\u539f\u6709A\u7ea7\u6d01\u51c0\u533a\u57fa\u7840\u4e0a\u8fdb\u884c\u5347\u7ea7\u6539\u9020\uff0c\u5f15\u5165H14\u7ea7\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\uff0c\u5e76\u914d\u5957\u5efa\u8bbeFFU\uff08\u98ce\u673a\u8fc7\u6ee4\u5355\u5143\uff09\u7cfb\u7edf\u3002\u6539\u9020\u540e\uff0c\u6d01\u51c0\u533a\u7c92\u5b50\u6d53\u5ea6\u4e0b\u964d\u7ea640%\uff0c\u5fae\u751f\u7269\u8d1f\u8377\u964d\u4f4e\u81f3&lt;1 CFU\/m\u00b3\uff0c\u8fbe\u5230\u4e86\u65b0\u7248GMP\u8981\u6c42\u3002<\/p>\n<h3>8.2 \u6848\u4f8b\u4e8c\uff1a\u53e3\u670d\u56fa\u4f53\u5236\u5242\u8f66\u95f4\u901a\u98ce\u7cfb\u7edf\u4f18\u5316<\/h3>\n<p>\u5728\u67d0\u53e3\u670d\u5236\u5242\u8f66\u95f4\u4e2d\uff0c\u539f\u7cfb\u7edf\u91c7\u7528H11\u7ea7HEPA\uff0c\u7ecf\u68c0\u6d4b\u53d1\u73b0\u90e8\u5206\u533a\u57df\u7c92\u5b50\u8d85\u6807\u3002\u4f01\u4e1a\u968f\u540e\u66f4\u6362\u4e3aH13\u7ea7\u8fc7\u6ee4\u5668\uff0c\u5e76\u4f18\u5316\u9001\u98ce\u53e3\u5e03\u5c40\u3002\u6539\u8fdb\u540e\uff0c\u6574\u4e2a\u8f66\u95f4\u7a7a\u6c14\u6d01\u51c0\u5ea6\u63d0\u5347\u4e86\u4e24\u4e2a\u7b49\u7ea7\uff0c\u8fbe\u5230\u4e86C\u7ea7\u6807\u51c6\u3002<\/p>\n<hr \/>\n<h2>\u4e5d\u3001\u7ed3\u8bed\uff08\u7565\uff09<\/h2>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40.\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b[Z]. 2011.  <\/li>\n<li>World Health Organization. Good manufacturing practices for medicinal products (Annexes to the twenty-second report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations) [R]. Geneva: WHO Press, 2018.  <\/li>\n<li>FDA. Current Good Manufacturing Practice (CGMP) Regulations [EB\/OL]. <a href=\"https:\/\/www.fda.gov\/drugs\/gmp-guidance-cgmp\">https:\/\/www.fda.gov\/drugs\/gmp-guidance-cgmp<\/a>, 2023.  <\/li>\n<li>European Medicines Agency. Annex 1: Manufacture of Sterile Medicinal Products [S]. 2022.  <\/li>\n<li>\u674e\u660e, \u5f20\u5f3a. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u7814\u7a76[J]. \u73af\u5883\u79d1\u5b66\u4e0e\u5de5\u7a0b\u5b66\u62a5, 2021, 15(4): 56-62.  <\/li>\n<li>\u5f20\u4f1f, \u5218\u6d0b. \u65b0\u578b\u7eb3\u7c73\u7ea4\u7ef4HEPA\u6750\u6599\u7684\u5236\u5907\u4e0e\u6027\u80fd\u7814\u7a76[J]. \u529f\u80fd\u6750\u6599, 2022, 53(6): 60120-60125.  <\/li>\n<li>ASHRAE. ASHRAE Handbook\u2014HVAC Systems and Equipment [M]. Atlanta: ASHRAE, 2020.  <\/li>\n<li>Bennett A.M., et al. Application of HEPA filtration in biosafety laboratories [J]. Journal of Applied Microbiology, 2020, 129(3): 587-598.  <\/li>\n<li>Fraunhofer Institute. Smart HEPA System with Real-time Monitoring [R]. Germany, 2021.<\/li>\n<\/ol>\n<hr \/>\n<p><em>\u672c\u6587\u5185\u5bb9\u57fa\u4e8e\u516c\u5f00\u8d44\u6599\u6574\u7406\u64b0\u5199\uff0c\u4e0d\u4ee3\u8868\u4efb\u4f55\u5b98\u65b9\u7acb\u573a\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u9ad8\u6548\u9001\u98ce\u53e3\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e2d\u7684\u4f5c\u7528 \u4e00\u3001\u5f15\u8a00\uff1a\u5236\u836f\u884c\u4e1a\u5bf9\u6d01\u51c0\u73af\u5883\u7684\u4e25\u683c\u8981\u6c42 \u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u4eba\u7c7b\u5065\u5eb7\u4e0e\u751f\u547d\u5b89\u5168\u3002\u56e0\u6b64\uff0c\u5236\u836f\u751f\u4ea7\u8fc7\u7a0b\u5fc5\u987b\u5728\u9ad8\u5ea6\u6d01\u51c0\u7684\u73af\u5883\u4e2d\u8fdb\u884c\uff0c\u4ee5\u9632\u6b62\u5fae\u7c92\u548c\u5fae\u751f\u7269\u6c61\u67d3\u3002\u4e3a\u4e86\u786e\u4fdd\u8fd9\u4e00\u76ee\u6807\u7684\u5b9e\u73b0\uff0c\u56fd\u9645\u548c\u56fd\u5185\u5747\u5236\u5b9a\u4e86\u4e25\u683c\u7684\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08Good Manufacturing Practice, GMP\uff09\u3002\u5176\u4e2d\uff0c\u9ad8\u6548\u9001&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[47],"tags":[],"class_list":["post-15223","post","type-post","status-publish","format-standard","hentry","category-zwml"],"_links":{"self":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15223","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=15223"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15223\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15223"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15223"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15223"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}