{"id":16614,"date":"2025-08-22T16:12:54","date_gmt":"2025-08-22T08:12:54","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16614"},"modified":"2025-08-22T16:12:54","modified_gmt":"2025-08-22T08:12:54","slug":"%e5%a6%82%e4%bd%95%e9%80%89%e6%8b%a9%e9%80%82%e5%90%88gmp%e6%a0%87%e5%87%86%e6%b4%81%e5%87%80%e5%8e%82%e6%88%bf%e7%9a%84hepa%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16614","title":{"rendered":"\u5982\u4f55\u9009\u62e9\u9002\u5408GMP\u6807\u51c6\u6d01\u51c0\u5382\u623f\u7684HEPA\u9ad8\u6548\u8fc7\u6ee4\u5668"},"content":{"rendered":"<h1>\u5982\u4f55\u9009\u62e9\u9002\u5408GMP\u6807\u51c6\u6d01\u51c0\u5382\u623f\u7684HEPA\u9ad8\u6548\u8fc7\u6ee4\u5668<\/h1>\n<p>\u5728\u5236\u836f\u3001\u751f\u7269\u6280\u672f\u3001\u533b\u7597\u5668\u68b0\u7b49\u5bf9\u7a7a\u6c14\u8d28\u91cf\u8981\u6c42\u6781\u9ad8\u7684\u884c\u4e1a\u4e2d\uff0c\u6d01\u51c0\u5382\u623f\u7684\u8bbe\u8ba1\u4e0e\u8fd0\u884c\u5fc5\u987b\u4e25\u683c\u9075\u5faa\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u76f8\u5173\u6807\u51c6\u3002\u5176\u4e2d\uff0c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High Efficiency Particulate Air Filter, HEPA\uff09\u4f5c\u4e3a\u6d01\u51c0\u5ba4\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u7684\u6838\u5fc3\u7ec4\u4ef6\uff0c\u5176\u6027\u80fd\u76f4\u63a5\u5f71\u54cd\u6d01\u51c0\u73af\u5883\u7684\u7a7a\u6c14\u8d28\u91cf\u3001\u5fae\u7c92\u63a7\u5236\u6c34\u5e73\u4ee5\u53ca\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u4e0e\u5408\u89c4\u6027\u3002\u56e0\u6b64\uff0c\u79d1\u5b66\u5408\u7406\u5730\u9009\u62e9\u9002\u5408GMP\u6807\u51c6\u6d01\u51c0\u5382\u623f\u7684HEPA\u8fc7\u6ee4\u5668\uff0c\u662f\u786e\u4fdd\u751f\u4ea7\u73af\u5883\u6301\u7eed\u53d7\u63a7\u7684\u5173\u952e\u73af\u8282\u3002<\/p>\n<p>\u672c\u6587\u5c06\u4eceHEPA\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u3001GMP\u5bf9\u6d01\u51c0\u73af\u5883\u7684\u6280\u672f\u8981\u6c42\u3001HEPA\u8fc7\u6ee4\u5668\u7684\u5173\u952e\u6027\u80fd\u53c2\u6570\u3001\u9009\u578b\u539f\u5219\u3001\u5b89\u88c5\u4e0e\u7ef4\u62a4\u8981\u6c42\u3001\u56fd\u5185\u5916\u6807\u51c6\u5bf9\u6bd4\u4ee5\u53ca\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\u7b49\u591a\u4e2a\u7ef4\u5ea6\uff0c\u7cfb\u7edf\u9610\u8ff0\u5982\u4f55\u4e3aGMP\u6d01\u51c0\u5382\u623f\u9009\u62e9\u5408\u9002\u7684HEPA\u9ad8\u6548\u8fc7\u6ee4\u5668\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001HEPA\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u4e0e\u5206\u7c7b<\/h2>\n<h3>1.1 HEPA\u8fc7\u6ee4\u5668\u7684\u5de5\u4f5c\u539f\u7406<\/h3>\n<p>HEPA\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u80fd\u591f\u9ad8\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u5fae\u7c92\u7684\u7a7a\u6c14\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u5176\u8fc7\u6ee4\u6548\u7387\u901a\u5e38\u5b9a\u4e49\u4e3a\u5bf9\u7c92\u5f84\u22650.3\u5fae\u7c73\uff08\u03bcm\uff09\u7684\u9897\u7c92\u7269\u53bb\u9664\u6548\u7387\u4e0d\u4f4e\u4e8e99.97%\u3002\u6839\u636e\u7f8e\u56fd\u80fd\u6e90\u90e8\uff08DOE\uff09\u6807\u51c6\uff0cHEPA\u8fc7\u6ee4\u5668\u9700\u6ee1\u8db3\u5728\u989d\u5b9a\u98ce\u91cf\u4e0b\u5bf90.3\u03bcm\u9897\u7c92\u7684\u8fc7\u6ee4\u6548\u7387\u226599.97%\u3002<\/p>\n<p>HEPA\u8fc7\u6ee4\u5668\u4e3b\u8981\u901a\u8fc7\u4ee5\u4e0b\u56db\u79cd\u7269\u7406\u673a\u5236\u5b9e\u73b0\u9897\u7c92\u6355\u96c6\uff1a<\/p>\n<ul>\n<li><strong>\u62e6\u622a\u6548\u5e94<\/strong>\uff08Interception\uff09\uff1a\u5f53\u9897\u7c92\u968f\u6c14\u6d41\u8fd0\u52a8\u65f6\uff0c\u9760\u8fd1\u7ea4\u7ef4\u8868\u9762\u5373\u88ab\u5438\u9644\u3002<\/li>\n<li><strong>\u60ef\u6027\u649e\u51fb<\/strong>\uff08Inertial Impaction\uff09\uff1a\u8f83\u5927\u9897\u7c92\u56e0\u60ef\u6027\u65e0\u6cd5\u968f\u6c14\u6d41\u7ed5\u8fc7\u7ea4\u7ef4\uff0c\u76f4\u63a5\u649e\u51fb\u5e76\u88ab\u6355\u83b7\u3002<\/li>\n<li><strong>\u6269\u6563\u6548\u5e94<\/strong>\uff08Diffusion\uff09\uff1a\u6781\u5c0f\u9897\u7c92\uff08&lt;0.1\u03bcm\uff09\u56e0\u5e03\u6717\u8fd0\u52a8\u4e0e\u7ea4\u7ef4\u78b0\u649e\u800c\u88ab\u6355\u83b7\u3002<\/li>\n<li><strong>\u9759\u7535\u5438\u9644<\/strong>\uff08Electrostatic Attraction\uff09\uff1a\u90e8\u5206HEPA\u6ee4\u6750\u5e26\u6709\u9759\u7535\uff0c\u53ef\u589e\u5f3a\u5bf9\u5fae\u5c0f\u9897\u7c92\u7684\u5438\u9644\u80fd\u529b\u3002<\/li>\n<\/ul>\n<blockquote>\n<p>\u6ce8\uff1a0.3\u03bcm\u88ab\u8ba4\u4e3a\u662f\u201c\u6700\u6613\u7a7f\u900f\u7c92\u5f84\u201d\uff08Most Penetrating Particle Size, MPPS\uff09\uff0c\u5373\u5728\u6b64\u7c92\u5f84\u4e0b\u8fc7\u6ee4\u6548\u7387\u6700\u4f4e\uff0c\u56e0\u6b64\u6210\u4e3a\u8861\u91cfHEPA\u6027\u80fd\u7684\u5173\u952e\u6307\u6807\u3002<\/p>\n<\/blockquote>\n<h3>1.2 HEPA\u8fc7\u6ee4\u5668\u7684\u5206\u7c7b<\/h3>\n<p>\u6839\u636e\u56fd\u9645\u6807\u51c6ISO 29463\u548c\u6b27\u6d32\u6807\u51c6EN 1822\uff0cHEPA\u8fc7\u6ee4\u5668\u6309\u8fc7\u6ee4\u6548\u7387\u5206\u4e3a\u591a\u4e2a\u7b49\u7ea7\u3002\u4e0b\u8868\u5217\u51fa\u4e86\u4e3b\u8981\u5206\u7c7b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5206\u7c7b\u6807\u51c6<\/th>\n<th>\u6807\u51c6\u6765\u6e90<\/th>\n<th>\u8fc7\u6ee4\u7b49\u7ea7<\/th>\n<th>\u5bf90.3\u03bcm\u9897\u7c92\u7684\u8fc7\u6ee4\u6548\u7387<\/th>\n<th>\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>EN 1822:2009<\/td>\n<td>\u6b27\u6d32\u6807\u51c6<\/td>\n<td>H13<\/td>\n<td>\u226599.95%<\/td>\n<td>\u6d01\u51c0\u5ba4\u3001\u5236\u836f<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>H14<\/td>\n<td>\u226599.995%<\/td>\n<td>\u9ad8\u7ea7\u522b\u6d01\u51c0\u5ba4\u3001\u65e0\u83cc\u64cd\u4f5c<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>U15<\/td>\n<td>\u226599.9995%<\/td>\n<td>\u8d85\u9ad8\u6d01\u51c0\u73af\u5883\uff08ULPA\uff09<\/td>\n<\/tr>\n<tr>\n<td>ISO 29463<\/td>\n<td>\u56fd\u9645\u6807\u51c6<\/td>\n<td>E10<\/td>\n<td>\u226585%<\/td>\n<td>\u9884\u8fc7\u6ee4\u6216\u4f4e\u7ea7\u522b\u6d01\u51c0\u533a<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>E11<\/td>\n<td>\u226595%<\/td>\n<td>\u4e2d\u7b49\u6d01\u51c0\u533a<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>E12<\/td>\n<td>\u226599.5%<\/td>\n<td>\u9ad8\u7ea7\u522b\u6d01\u51c0\u533a<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>E13<\/td>\n<td>\u226599.95%<\/td>\n<td>\u7b49\u540c\u4e8eH13<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>E14<\/td>\n<td>\u226599.995%<\/td>\n<td>\u7b49\u540c\u4e8eH14<\/td>\n<\/tr>\n<tr>\n<td>\u7f8e\u56fdDOE\u6807\u51c6<\/td>\n<td>DOE-STD-3020-97<\/td>\n<td>HEPA<\/td>\n<td>\u226599.97%<\/td>\n<td>\u6838\u5de5\u4e1a\u3001\u5236\u836f\u3001\u751f\u7269\u5b89\u5168<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u8d44\u6599\u6765\u6e90<\/strong>\uff1aEN 1822:2009\u300aHigh efficiency air filters (EPA, HEPA and ULPA)\u300b\uff1bISO 29463:2011\u300aHigh-efficiency air filters\u300b<\/p>\n<\/blockquote>\n<p>\u5728\u4e2d\u56fd\uff0cGB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u6807\u51c6\u4e5f\u5bf9HEPA\u8fc7\u6ee4\u5668\u8fdb\u884c\u4e86\u89c4\u8303\uff0c\u5176\u5206\u7ea7\u4e0eISO\u6807\u51c6\u57fa\u672c\u4e00\u81f4\u3002\u6839\u636e\u8be5\u6807\u51c6\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u5206\u4e3aA\u3001B\u3001C\u3001D\u56db\u7c7b\uff0c\u5176\u4e2dC\u7c7b\u5bf9\u5e94H13\u7ea7\uff0cD\u7c7b\u5bf9\u5e94H14\u7ea7\uff0c\u9002\u7528\u4e8eGMP A\/B\u7ea7\u6d01\u51c0\u533a\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001GMP\u5bf9\u6d01\u51c0\u5382\u623f\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u8981\u6c42<\/h2>\n<p>\u6839\u636e\u4e2d\u56fd\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u9644\u5f551\u300a\u65e0\u83cc\u836f\u54c1\u300b\u7684\u89c4\u5b9a\uff0c\u6d01\u51c0\u533a\u6309\u7a7a\u6c14\u6d01\u51c0\u5ea6\u5206\u4e3aA\u3001B\u3001C\u3001D\u56db\u4e2a\u7ea7\u522b\uff0c\u5176\u9759\u6001\u4e0e\u52a8\u6001\u4e0b\u7684\u60ac\u6d6e\u7c92\u5b50\u6d53\u5ea6\u9650\u503c\u5982\u4e0b\u8868\u6240\u793a\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7ea7\u522b<\/th>\n<th>\u6700\u5927\u5141\u8bb8\u7c92\u5b50\u6570\uff08\u9759\u6001\uff09<\/th>\n<th>\u6700\u5927\u5141\u8bb8\u7c92\u5b50\u6570\uff08\u52a8\u6001\uff09<\/th>\n<th>\u6362\u6c14\u6b21\u6570\uff08\u6b21\/\u5c0f\u65f6\uff09<\/th>\n<th>\u5178\u578b\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7\uff08\u5c40\u90e8\u767e\u7ea7\uff09<\/td>\n<td>\u22650.5\u03bcm\uff1a3520\u4e2a\/m\u00b3<br \/>\u22655.0\u03bcm\uff1a20\u4e2a\/m\u00b3<\/td>\n<td>\u540c\u9759\u6001<\/td>\n<td>\u226560\uff08\u5355\u5411\u6d41\uff09<\/td>\n<td>\u65e0\u83cc\u704c\u88c5\u3001\u9694\u79bb\u5668\u64cd\u4f5c<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7\uff08\u80cc\u666f\u767e\u7ea7\uff09<\/td>\n<td>\u540cA\u7ea7<\/td>\n<td>\u22650.5\u03bcm\uff1a352000\u4e2a\/m\u00b3<br \/>\u22655.0\u03bcm\uff1a2900\u4e2a\/m\u00b3<\/td>\n<td>40\u201360<\/td>\n<td>\u65e0\u83cc\u5236\u5242\u914d\u5236\u533a<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7\uff08\u4e07\u7ea7\uff09<\/td>\n<td>\u22650.5\u03bcm\uff1a3520000\u4e2a\/m\u00b3<br \/>\u22655.0\u03bcm\uff1a29000\u4e2a\/m\u00b3<\/td>\n<td>\u22650.5\u03bcm\uff1a3520000\u4e2a\/m\u00b3<br \/>\u22655.0\u03bcm\uff1a29000\u4e2a\/m\u00b3<\/td>\n<td>20\u201340<\/td>\n<td>\u975e\u65e0\u83cc\u5236\u5242\u704c\u88c5<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7\uff08\u5341\u4e07\u7ea7\uff09<\/td>\n<td>\u22650.5\u03bcm\uff1a35200000\u4e2a\/m\u00b3<br \/>\u22655.0\u03bcm\uff1a290000\u4e2a\/m\u00b3<\/td>\n<td>\u540c\u9759\u6001<\/td>\n<td>10\u201320<\/td>\n<td>\u539f\u6599\u836f\u5904\u7406\u3001\u5305\u88c5\u533a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u8d44\u6599\u6765\u6e90<\/strong>\uff1a\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\u9644\u5f551<\/p>\n<\/blockquote>\n<p>\u4ece\u4e0a\u8868\u53ef\u89c1\uff0cA\/B\u7ea7\u533a\u57df\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8981\u6c42\u6781\u9ad8\uff0c\u5fc5\u987b\u4f7f\u7528H13\u6216H14\u7ea7HEPA\u8fc7\u6ee4\u5668\uff0c\u4e14\u901a\u5e38\u91c7\u7528\u5355\u5411\u6d41\uff08\u5c42\u6d41\uff09\u8bbe\u8ba1\uff0c\u4ee5\u786e\u4fdd\u5173\u952e\u64cd\u4f5c\u533a\u57df\u7684\u5fae\u7c92\u63a7\u5236\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001HEPA\u8fc7\u6ee4\u5668\u7684\u5173\u952e\u6027\u80fd\u53c2\u6570<\/h2>\n<p>\u5728\u9009\u62e9HEPA\u8fc7\u6ee4\u5668\u65f6\uff0c\u5e94\u7efc\u5408\u8003\u8651\u4ee5\u4e0b\u6280\u672f\u53c2\u6570\uff1a<\/p>\n<h3>3.1 \u8fc7\u6ee4\u6548\u7387\uff08Efficiency\uff09<\/h3>\n<p>\u8fc7\u6ee4\u6548\u7387\u662fHEPA\u8fc7\u6ee4\u5668\u6700\u6838\u5fc3\u7684\u6027\u80fd\u6307\u6807\u3002GMP A\/B\u7ea7\u533a\u57df\u5fc5\u987b\u4f7f\u7528H13\u6216H14\u7ea7\u8fc7\u6ee4\u5668\u3002H14\u7ea7\u8fc7\u6ee4\u5668\u5bf90.3\u03bcm\u9897\u7c92\u7684\u7a7f\u900f\u7387\u4f4e\u4e8e0.005%\uff0c\u9002\u7528\u4e8e\u9ad8\u98ce\u9669\u65e0\u83cc\u64cd\u4f5c\u3002<\/p>\n<h3>3.2 \u521d\u59cb\u963b\u529b\u4e0e\u7ec8\u963b\u529b\uff08Initial and Final Pressure Drop\uff09<\/h3>\n<ul>\n<li><strong>\u521d\u59cb\u963b\u529b<\/strong>\uff1a\u65b0\u6ee4\u5668\u5728\u989d\u5b9a\u98ce\u91cf\u4e0b\u7684\u538b\u964d\uff0c\u901a\u5e38\u4e3a150\u2013250 Pa\u3002<\/li>\n<li><strong>\u7ec8\u963b\u529b<\/strong>\uff1a\u5efa\u8bae\u66f4\u6362\u6ee4\u5668\u65f6\u7684\u538b\u964d\uff0c\u4e00\u822c\u8bbe\u5b9a\u4e3a450\u2013600 Pa\u3002<\/li>\n<\/ul>\n<p>\u8fc7\u9ad8\u963b\u529b\u4f1a\u589e\u52a0\u98ce\u673a\u80fd\u8017\uff0c\u964d\u4f4e\u7cfb\u7edf\u98ce\u91cf\uff0c\u5f71\u54cd\u6d01\u51c0\u5ea6\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/th>\n<th>\u521d\u59cb\u963b\u529b\uff08Pa\uff09<\/th>\n<th>\u7ec8\u963b\u529b\uff08Pa\uff09<\/th>\n<th>\u989d\u5b9a\u98ce\u91cf\uff08m\u00b3\/h\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H13<\/td>\n<td>180\u2013220<\/td>\n<td>450<\/td>\n<td>500\u20131500<\/td>\n<\/tr>\n<tr>\n<td>H14<\/td>\n<td>200\u2013250<\/td>\n<td>500<\/td>\n<td>500\u20131500<\/td>\n<\/tr>\n<tr>\n<td>ULPA (U15)<\/td>\n<td>250\u2013300<\/td>\n<td>600<\/td>\n<td>500\u20131200<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u6570\u636e\u6765\u6e90<\/strong>\uff1aCamfil Farr\u3001AAF International \u4ea7\u54c1\u624b\u518c<\/p>\n<\/blockquote>\n<h3>3.3 \u989d\u5b9a\u98ce\u91cf\u4e0e\u9762\u98ce\u901f<\/h3>\n<p>HEPA\u8fc7\u6ee4\u5668\u7684\u989d\u5b9a\u98ce\u91cf\u9700\u4e0e\u6d01\u51c0\u5ba4\u9001\u98ce\u7cfb\u7edf\u5339\u914d\u3002\u901a\u5e38HEPA\u6ee4\u82af\u7684\u9762\u98ce\u901f\u63a7\u5236\u57280.35\u20130.45 m\/s\u4e4b\u95f4\uff0c\u8fc7\u9ad8\u98ce\u901f\u4f1a\u5bfc\u81f4\u6548\u7387\u4e0b\u964d\u548c\u6ee4\u6750\u7834\u635f\u3002<\/p>\n<h3>3.4 \u6ee4\u6750\u6750\u8d28\u4e0e\u7ed3\u6784<\/h3>\n<ul>\n<li><strong>\u6ee4\u6750<\/strong>\uff1a\u591a\u91c7\u7528\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4\uff08Glass Fiber\uff09\uff0c\u5177\u6709\u9ad8\u6bd4\u8868\u9762\u79ef\u548c\u4f4e\u963b\u529b\u7279\u6027\u3002<\/li>\n<li><strong>\u5206\u9694\u7269<\/strong>\uff1a\u94dd\u7b94\u6216\u70ed\u7194\u80f6\u5206\u9694\uff0c\u786e\u4fdd\u6c14\u6d41\u5747\u5300\u5206\u5e03\u3002<\/li>\n<li><strong>\u8fb9\u6846\u6750\u6599<\/strong>\uff1a\u5e38\u7528\u9540\u950c\u94a2\u677f\u3001\u4e0d\u9508\u94a2\u6216\u94dd\u5408\u91d1\uff0cA\/B\u7ea7\u533a\u57df\u63a8\u8350\u4f7f\u7528\u4e0d\u9508\u94a2\u8fb9\u6846\u4ee5\u9632\u8150\u8680\u548c\u9897\u7c92\u8131\u843d\u3002<\/li>\n<\/ul>\n<h3>3.5 \u6cc4\u6f0f\u68c0\u6d4b\uff08Leak Testing\uff09<\/h3>\n<p>HEPA\u8fc7\u6ee4\u5668\u5b89\u88c5\u540e\u5fc5\u987b\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u5e38\u7528\u65b9\u6cd5\u4e3a<strong>DOP\/PAO\u6c14\u6eb6\u80f6\u626b\u63cf\u6cd5<\/strong>\uff08\u4f9d\u636eISO 14644-3\u548cGB\/T 14295-2019\uff09\u3002\u6d4b\u8bd5\u65f6\u4f7f\u7528\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u4ea7\u751f0.3\u03bcm\u5de6\u53f3\u7684\u9897\u7c92\uff0c\u7528\u5149\u5ea6\u8ba1\u6216\u7c92\u5b50\u8ba1\u6570\u5668\u5728\u4e0b\u6e38\u626b\u63cf\uff0c\u6cc4\u6f0f\u7387\u4e0d\u5f97\u8d85\u8fc70.01%\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001HEPA\u8fc7\u6ee4\u5668\u9009\u578b\u539f\u5219<\/h2>\n<h3>4.1 \u6839\u636e\u6d01\u51c0\u7ea7\u522b\u9009\u62e9\u8fc7\u6ee4\u6548\u7387<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7ea7\u522b<\/th>\n<th>\u63a8\u8350HEPA\u7b49\u7ea7<\/th>\n<th>\u7406\u7531<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7<\/td>\n<td>H14 \u6216 ULPA (U15)<\/td>\n<td>\u5355\u5411\u6d41\u7cfb\u7edf\uff0c\u9700\u6700\u9ad8\u8fc7\u6ee4\u6548\u7387<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7<\/td>\n<td>H13 \u6216 H14<\/td>\n<td>\u80cc\u666f\u73af\u5883\u8981\u6c42\u9ad8\uff0c\u9632\u6b62\u6c61\u67d3A\u533a<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7<\/td>\n<td>H13<\/td>\n<td>\u6ee1\u8db3\u4e07\u7ea7\u6d01\u51c0\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7<\/td>\n<td>H10\u2013H12\uff08\u524d\u7f6e\uff09+ H13<\/td>\n<td>\u53ef\u91c7\u7528\u4e24\u7ea7\u8fc7\u6ee4\uff0c\u5ef6\u957f\u4e3bHEPA\u5bff\u547d<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u53c2\u8003\u6587\u732e<\/strong>\uff1aISPE Baseline Guide: Sterile Product Manufacturing Facilities, Volume 3 (2017)<\/p>\n<\/blockquote>\n<h3>4.2 \u8003\u8651\u5b89\u88c5\u65b9\u5f0f\u4e0e\u7ed3\u6784\u5f62\u5f0f<\/h3>\n<p>HEPA\u8fc7\u6ee4\u5668\u5e38\u89c1\u5b89\u88c5\u5f62\u5f0f\u5305\u62ec\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5b89\u88c5\u65b9\u5f0f<\/th>\n<th>\u9002\u7528\u573a\u666f<\/th>\n<th>\u4f18\u70b9<\/th>\n<th>\u7f3a\u70b9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u9876\u68da\u5b89\u88c5\uff08\u6709\u9694\u677f\uff09<\/td>\n<td>\u6d01\u51c0\u5ba4\u9876\u90e8\u9001\u98ce<\/td>\n<td>\u7ed3\u6784\u7a33\u5b9a\uff0c\u98ce\u91cf\u5927<\/td>\n<td>\u5360\u7528\u7a7a\u95f4\u5927<\/td>\n<\/tr>\n<tr>\n<td>\u6db2\u69fd\u5bc6\u5c01\u5f0f<\/td>\n<td>\u9ad8\u7ea7\u522b\u6d01\u51c0\u5ba4\uff08A\/B\u7ea7\uff09<\/td>\n<td>\u5bc6\u5c01\u6027\u597d\uff0c\u6613\u4e8e\u66f4\u6362<\/td>\n<td>\u6210\u672c\u9ad8\uff0c\u9700\u6db2\u69fd\u6846\u67b6<\/td>\n<\/tr>\n<tr>\n<td>\u65e0\u9694\u677fHEPA<\/td>\n<td>\u7a7a\u95f4\u53d7\u9650\u533a\u57df<\/td>\n<td>\u4f53\u79ef\u5c0f\uff0c\u963b\u529b\u4f4e<\/td>\n<td>\u673a\u68b0\u5f3a\u5ea6\u8f83\u4f4e<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u673a\u8fc7\u6ee4\u5355\u5143\uff08FFU\uff09<\/td>\n<td>\u5c40\u90e8\u5c42\u6d41\u7f69\u3001\u6d01\u51c0\u5de5\u4f5c\u53f0<\/td>\n<td>\u6a21\u5757\u5316\uff0c\u7075\u6d3b\u63a7\u5236<\/td>\n<td>\u7ef4\u62a4\u9891\u7387\u9ad8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u8d44\u6599\u6765\u6e90<\/strong>\uff1aASHRAE Handbook\u2014HVAC Applications (2020)<\/p>\n<\/blockquote>\n<h3>4.3 \u5173\u6ce8\u8010\u6e7f\u6027\u4e0e\u5316\u5b66\u517c\u5bb9\u6027<\/h3>\n<p>\u5728\u5236\u836f\u73af\u5883\u4e2d\uff0c\u6e05\u6d01\u6d88\u6bd2\u5e38\u4f7f\u7528\u4e59\u9187\u3001\u5f02\u4e19\u9187\u6216\u8fc7\u6c27\u5316\u6c22\uff08VHP\uff09\u7b49\u5316\u5b66\u54c1\u3002\u56e0\u6b64\uff0cHEPA\u8fc7\u6ee4\u5668\u5e94\u5177\u5907\u826f\u597d\u7684\u8010\u6e7f\u6027\u548c\u5316\u5b66\u7a33\u5b9a\u6027\u3002\u90e8\u5206\u9ad8\u7aef\u6ee4\u6750\u91c7\u7528\u758f\u6c34\u5904\u7406\uff0c\u9632\u6b62\u6c34\u5206\u5bfc\u81f4\u6ee4\u6750\u584c\u9677\u6216\u5fae\u751f\u7269\u6ecb\u751f\u3002<\/p>\n<h3>4.4 \u9009\u62e9\u5177\u5907\u53ef\u8ffd\u6eaf\u6027\u7684\u4ea7\u54c1<\/h3>\n<p>GMP\u8981\u6c42\u6240\u6709\u5173\u952e\u8bbe\u5907\u5177\u5907\u5b8c\u6574\u7684\u8d28\u91cf\u8ffd\u6eaf\u6587\u4ef6\u3002HEPA\u8fc7\u6ee4\u5668\u5e94\u63d0\u4f9b\uff1a<\/p>\n<ul>\n<li>\u51fa\u5382\u68c0\u6d4b\u62a5\u544a\uff08\u5305\u62ec\u6548\u7387\u3001\u963b\u529b\u3001\u6cc4\u6f0f\u6d4b\u8bd5\uff09<\/li>\n<li>\u6750\u8d28\u8bc1\u660e\uff08\u7b26\u5408FDA\u6216USP Class VI\u6807\u51c6\uff09<\/li>\n<li>\u706d\u83cc\u8bc1\u660e\uff08\u5982\u4f3d\u9a6c\u5c04\u7ebf\u706d\u83cc\uff09<\/li>\n<li>\u6279\u6b21\u7f16\u53f7\u4e0e\u5e8f\u5217\u53f7<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e94\u3001\u56fd\u5185\u5916HEPA\u8fc7\u6ee4\u5668\u6807\u51c6\u5bf9\u6bd4<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u4e2d\u56fd\u6807\u51c6\uff08GB\/T 13554-2020\uff09<\/th>\n<th>\u6b27\u6d32\u6807\u51c6\uff08EN 1822:2009\uff09<\/th>\n<th>\u7f8e\u56fd\u6807\u51c6\uff08DOE-STD-3020\uff09<\/th>\n<th>\u56fd\u9645\u6807\u51c6\uff08ISO 29463\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6d4b\u8bd5\u7c92\u5f84<\/td>\n<td>0.3\u03bcm<\/td>\n<td>MPPS\uff08\u901a\u5e380.1\u20130.3\u03bcm\uff09<\/td>\n<td>0.3\u03bcm<\/td>\n<td>MPPS<\/td>\n<\/tr>\n<tr>\n<td>\u6d4b\u8bd5\u65b9\u6cd5<\/td>\n<td>\u94a0\u7130\u6cd5\u6216\u8ba1\u6570\u6cd5<\/td>\n<td>\u626b\u63cf\u6cd5\uff08\u5c40\u90e8\u6548\u7387\uff09<\/td>\n<td>DOP\u5149\u5ea6\u6cd5<\/td>\n<td>\u8ba1\u6570\u6cd5<\/td>\n<\/tr>\n<tr>\n<td>H13\u7ea7\u6548\u7387<\/td>\n<td>\u226599.99%<\/td>\n<td>\u226599.95%<\/td>\n<td>\u226599.97%<\/td>\n<td>\u226599.95%<\/td>\n<\/tr>\n<tr>\n<td>H14\u7ea7\u6548\u7387<\/td>\n<td>\u226599.999%<\/td>\n<td>\u226599.995%<\/td>\n<td>\u226599.97%\uff08\u4f20\u7edf\uff09<\/td>\n<td>\u226599.995%<\/td>\n<\/tr>\n<tr>\n<td>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n<td>PAO\u626b\u63cf\u6cd5<\/td>\n<td>PAO\/DOP\u626b\u63cf<\/td>\n<td>DOP\u5149\u5ea6\u6cd5<\/td>\n<td>\u5149\u5ea6\u6216\u8ba1\u6570\u626b\u63cf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u8bf4\u660e<\/strong>\uff1a\u4e2d\u56fd\u6807\u51c6GB\/T 13554-2020\u5df2\u4e0e\u56fd\u9645\u63a5\u8f68\uff0c\u4f46\u5728\u5b9e\u9645\u6267\u884c\u4e2d\uff0c\u90e8\u5206\u4f01\u4e1a\u4ecd\u6cbf\u7528\u94a0\u7130\u6cd5\uff0c\u800c\u56fd\u9645\u901a\u884c\u505a\u6cd5\u4e3a\u7c92\u5b50\u8ba1\u6570\u6cd5\u6216\u5149\u5ea6\u6cd5\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u516d\u3001HEPA\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u4e0e\u7ef4\u62a4<\/h2>\n<h3>6.1 \u5b89\u88c5\u8981\u6c42<\/h3>\n<ul>\n<li><strong>\u5bc6\u5c01\u6027<\/strong>\uff1a\u91c7\u7528\u6db2\u69fd\u5bc6\u5c01\u6216\u53cc\u5c42\u5bc6\u5c01\u57ab\uff0c\u9632\u6b62\u672a\u7ecf\u8fc7\u6ee4\u7a7a\u6c14\u6cc4\u6f0f\u3002<\/li>\n<li><strong>\u65b9\u5411\u6807\u8bc6<\/strong>\uff1a\u6ee4\u5668\u5e94\u6807\u6ce8\u6c14\u6d41\u65b9\u5411\uff0c\u4e25\u7981\u53cd\u5411\u5b89\u88c5\u3002<\/li>\n<li><strong>\u652f\u6491\u7ed3\u6784<\/strong>\uff1a\u5b89\u88c5\u6846\u67b6\u5e94\u7262\u56fa\uff0c\u907f\u514d\u632f\u52a8\u5bfc\u81f4\u6ee4\u6750\u7834\u635f\u3002<\/li>\n<\/ul>\n<h3>6.2 \u8fd0\u884c\u7ef4\u62a4<\/h3>\n<ul>\n<li><strong>\u5b9a\u671f\u68c0\u6d4b<\/strong>\uff1a\u6bcf6\u201312\u4e2a\u6708\u8fdb\u884c\u4e00\u6b21\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08PAO\/\u5149\u5ea6\u6cd5\uff09\u3002<\/li>\n<li><strong>\u538b\u5dee\u76d1\u63a7<\/strong>\uff1a\u8bbe\u7f6e\u538b\u5dee\u62a5\u8b66\u88c5\u7f6e\uff0c\u5f53\u963b\u529b\u63a5\u8fd1\u7ec8\u963b\u529b\u65f6\u63d0\u793a\u66f4\u6362\u3002<\/li>\n<li><strong>\u66f4\u6362\u5468\u671f<\/strong>\uff1a\u4e00\u822c\u4e3a3\u20135\u5e74\uff0c\u5177\u4f53\u89c6\u73af\u5883\u5c18\u57c3\u8d1f\u8377\u800c\u5b9a\u3002<\/li>\n<\/ul>\n<h3>6.3 \u5e38\u89c1\u95ee\u9898\u4e0e\u5bf9\u7b56<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u95ee\u9898<\/th>\n<th>\u539f\u56e0<\/th>\n<th>\u89e3\u51b3\u65b9\u6848<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u963b\u529b\u4e0a\u5347\u8fc7\u5feb<\/td>\n<td>\u524d\u7ea7\u8fc7\u6ee4\u5668\u5931\u6548<\/td>\n<td>\u52a0\u5f3aG4\/F8\u521d\u6548\u8fc7\u6ee4\u5668\u7ef4\u62a4<\/td>\n<\/tr>\n<tr>\n<td>\u4e0b\u6e38\u7c92\u5b50\u6570\u8d85\u6807<\/td>\n<td>\u6ee4\u5668\u7834\u635f\u6216\u5bc6\u5c01\u4e0d\u826f<\/td>\n<td>\u7acb\u5373\u505c\u673a\uff0c\u8fdb\u884c\u6cc4\u6f0f\u6d4b\u8bd5<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u6ecb\u751f<\/td>\n<td>\u6ee4\u6750\u53d7\u6f6e\u6216\u6e05\u6d01\u4e0d\u5f53<\/td>\n<td>\u9009\u7528\u758f\u6c34\u6ee4\u6750\uff0c\u5b9a\u671fVHP\u706d\u83cc<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e03\u3001\u56fd\u5185\u5916\u77e5\u540dHEPA\u8fc7\u6ee4\u5668\u5236\u9020\u5546\u5bf9\u6bd4<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u54c1\u724c<\/th>\n<th>\u56fd\u5bb6<\/th>\n<th>\u4ee3\u8868\u4ea7\u54c1<\/th>\n<th>\u7279\u70b9<\/th>\n<th>\u9002\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Camfil<\/td>\n<td>\u745e\u5178<\/td>\n<td>Hi-Flo, Nanofilm<\/td>\n<td>\u4f4e\u963b\u529b\uff0c\u957f\u5bff\u547d<\/td>\n<td>\u5236\u836f\u3001\u533b\u9662<\/td>\n<\/tr>\n<tr>\n<td>AAF International<\/td>\n<td>\u7f8e\u56fd<\/td>\n<td>AAF HEPA<\/td>\n<td>\u5168\u7cfb\u5217H13\u2013H14<\/td>\n<td>\u5de5\u4e1a\u4e0e\u751f\u7269\u5236\u836f<\/td>\n<\/tr>\n<tr>\n<td>Freudenberg<\/td>\n<td>\u5fb7\u56fd<\/td>\n<td>F8, F9 HEPA<\/td>\n<td>\u9ad8\u6548\u4f4e\u8017<\/td>\n<td>\u6b27\u6d32GMP\u9879\u76ee<\/td>\n<\/tr>\n<tr>\n<td>KLC Filter<\/td>\n<td>\u4e2d\u56fd<\/td>\n<td>KLC-H14<\/td>\n<td>\u56fd\u4ea7\u9ad8\u6027\u4ef7\u6bd4<\/td>\n<td>\u56fd\u5185\u5236\u836f\u4f01\u4e1a<\/td>\n<\/tr>\n<tr>\n<td>Nippon Muki<\/td>\n<td>\u65e5\u672c<\/td>\n<td>ULPA\u7cfb\u5217<\/td>\n<td>\u8d85\u9ad8\u6548\uff0c\u4f4e\u53d1\u5c18<\/td>\n<td>\u534a\u5bfc\u4f53\u4e0e\u65e0\u83cc\u5236\u5242<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u6570\u636e\u6765\u6e90<\/strong>\uff1a\u5404\u516c\u53f8\u5b98\u7f51\u4ea7\u54c1\u624b\u518c\u53ca\u300a\u6d01\u51c0\u6280\u672f\u300b\u671f\u520a2023\u5e74\u884c\u4e1a\u62a5\u544a<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u516b\u3001\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>\u6848\u4f8b\u4e00\uff1a\u67d0\u751f\u7269\u5236\u836f\u4f01\u4e1aA\u7ea7\u704c\u88c5\u7ebf<\/h3>\n<ul>\n<li><strong>\u6d01\u51c0\u7ea7\u522b<\/strong>\uff1aA\u7ea7\uff08\u5c40\u90e8\u767e\u7ea7\uff09<\/li>\n<li><strong>\u9001\u98ce\u65b9\u5f0f<\/strong>\uff1a\u5355\u5411\u6d41\u5c42\u6d41\u7f69<\/li>\n<li><strong>HEPA\u9009\u578b<\/strong>\uff1aH14\u7ea7\u65e0\u9694\u677fHEPA\uff0c\u4e0d\u9508\u94a2\u8fb9\u6846\uff0c\u6db2\u69fd\u5bc6\u5c01<\/li>\n<li><strong>\u98ce\u91cf<\/strong>\uff1a1200 m\u00b3\/h\uff0c\u9762\u98ce\u901f0.4 m\/s<\/li>\n<li><strong>\u68c0\u6d4b\u7ed3\u679c<\/strong>\uff1aPAO\u626b\u63cf\u6cc4\u6f0f\u7387&lt;0.005%\uff0c\u7b26\u5408EU GMP Annex 1\u8981\u6c42<\/li>\n<\/ul>\n<h3>\u6848\u4f8b\u4e8c\uff1a\u539f\u6599\u836f\u751f\u4ea7\u8f66\u95f4D\u7ea7\u533a\u57df<\/h3>\n<ul>\n<li><strong>\u6d01\u51c0\u7ea7\u522b<\/strong>\uff1aD\u7ea7<\/li>\n<li><strong>\u7cfb\u7edf\u8bbe\u8ba1<\/strong>\uff1a\u7ec4\u5408\u5f0f\u7a7a\u8c03\u673a\u7ec4+\u4e24\u7ea7\u8fc7\u6ee4<\/li>\n<li><strong>\u8fc7\u6ee4\u914d\u7f6e<\/strong>\uff1aF8\u4e2d\u6548 + H13 HEPA<\/li>\n<li><strong>\u8fd0\u884c\u6548\u679c<\/strong>\uff1a\u7c92\u5b50\u6570\u7a33\u5b9a\u572835200000\u4e2a\/m\u00b3\u4ee5\u4e0b\uff0c\u80fd\u8017\u964d\u4f4e18%<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e5d\u3001HEPA\u8fc7\u6ee4\u5668\u672a\u6765\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<p>\u968f\u7740\u667a\u80fd\u5236\u9020\u4e0e\u7eff\u8272\u5236\u836f\u7684\u63a8\u8fdb\uff0cHEPA\u8fc7\u6ee4\u5668\u6b63\u671d\u7740\u4ee5\u4e0b\u65b9\u5411\u53d1\u5c55\uff1a<\/p>\n<ol>\n<li><strong>\u667a\u80fd\u5316\u76d1\u6d4b<\/strong>\uff1a\u96c6\u6210\u538b\u5dee\u4f20\u611f\u5668\u4e0e\u65e0\u7ebf\u4f20\u8f93\u6a21\u5757\uff0c\u5b9e\u73b0\u8fdc\u7a0b\u76d1\u63a7\u3002<\/li>\n<li><strong>\u73af\u4fdd\u6750\u6599<\/strong>\uff1a\u5f00\u53d1\u53ef\u56de\u6536\u6ee4\u6750\uff0c\u51cf\u5c11\u73bb\u7483\u7ea4\u7ef4\u5e9f\u5f03\u7269\u3002<\/li>\n<li><strong>\u6297\u75c5\u6bd2\u6d82\u5c42<\/strong>\uff1a\u90e8\u5206\u65b0\u578bHEPA\u6ee4\u6750\u6dfb\u52a0\u94f6\u79bb\u5b50\u6216\u5149\u50ac\u5316\u6d82\u5c42\uff0c\u5177\u5907\u6297\u83cc\u6297\u75c5\u6bd2\u529f\u80fd\u3002<\/li>\n<li><strong>\u6570\u5b57\u5316\u8ffd\u6eaf<\/strong>\uff1a\u91c7\u7528RFID\u6807\u7b7e\uff0c\u5b9e\u73b0\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u3002<\/li>\n<\/ol>\n<blockquote>\n<p><strong>\u53c2\u8003\u6587\u732e<\/strong>\uff1aZhang et al., &quot;Development of Antimicrobial HEPA Filters for Pharmaceutical Cleanrooms&quot;, <em>Journal of Aerosol Science<\/em>, 2022.<\/p>\n<\/blockquote>\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\u9644\u5f551\uff1a\u65e0\u83cc\u836f\u54c1. 2011.<\/li>\n<li>GB\/T 13554-2020. \u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b. \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2020.<\/li>\n<li>ISO 29463:2011. <em>High-efficiency air filters (EPA, HEPA and ULPA)<\/em>. International Organization for Standardization.<\/li>\n<li>EN 1822:2009. <em>High efficiency air filters (EPA, HEPA and ULPA)<\/em>. CEN.<\/li>\n<li>ASHRAE. <em>ASHRAE Handbook\u2014HVAC Applications<\/em>. 2020 Edition.<\/li>\n<li>ISPE. <em>Baseline Guide: Sterile Product Manufacturing Facilities, Volume 3<\/em>. 2nd Edition, 2017.<\/li>\n<li>Camfil. <em>HEPA Filter Technical Guide<\/em>. 2023. <a href=\"https:\/\/www.camfil.com\">https:\/\/www.camfil.com<\/a><\/li>\n<li>AAF International. <em>HEPA and ULPA Filters Product Catalog<\/em>. 2022.<\/li>\n<li>\u5f20\u4f1f, \u674e\u5f3a. \u9ad8\u6548\u8fc7\u6ee4\u5668\u5728GMP\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u7814\u7a76. \u300a\u6d01\u51c0\u6280\u672f\u300b, 2021, 39(4): 45\u201350.<\/li>\n<li>Zhang, Y., et al. &quot;Development of Antimicrobial HEPA Filters for Pharmaceutical Cleanrooms&quot;. <em>Journal of Aerosol Science<\/em>, 2022, 160: 106\u2013115.<\/li>\n<li>\u767e\u5ea6\u767e\u79d1. \u201c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u201d. <a href=\"https:\/\/baike.baidu.com\/item\/HEPA%E8%BF%87%E6%BB%A4%E5%99%A8\">https:\/\/baike.baidu.com\/item\/HEPA%E8%BF%87%E6%BB%A4%E5%99%A8<\/a><\/li>\n<li>US Department of Energy. <em>DOE-STD-3020-97: HEPA Filters \u2013 Specifications, Standards, and Testing<\/em>. 1997.<\/li>\n<\/ol>\n<p>\uff08\u5168\u6587\u7ea63800\u5b57\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u5982\u4f55\u9009\u62e9\u9002\u5408GMP\u6807\u51c6\u6d01\u51c0\u5382\u623f\u7684HEPA\u9ad8\u6548\u8fc7\u6ee4\u5668 \u5728\u5236\u836f\u3001\u751f\u7269\u6280\u672f\u3001\u533b\u7597\u5668\u68b0\u7b49\u5bf9\u7a7a\u6c14\u8d28\u91cf\u8981\u6c42\u6781\u9ad8\u7684\u884c\u4e1a\u4e2d\uff0c\u6d01\u51c0\u5382\u623f\u7684\u8bbe\u8ba1\u4e0e\u8fd0\u884c\u5fc5\u987b\u4e25\u683c\u9075\u5faa\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u76f8\u5173\u6807\u51c6\u3002\u5176\u4e2d\uff0c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High Efficiency Particulate Air Filter, HEPA\uff09\u4f5c\u4e3a&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-16614","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\/16614","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=16614"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/16614\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16614"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16614"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16614"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}