{"id":14493,"date":"2025-06-03T12:08:40","date_gmt":"2025-06-03T04:08:40","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=14493"},"modified":"2025-06-03T12:08:40","modified_gmt":"2025-06-03T04:08:40","slug":"%e9%ab%98%e6%95%88%e7%a9%ba%e6%b0%94%e8%bf%87%e6%bb%a4%e5%99%a8%ef%bc%88hepa%ef%bc%89%e5%9c%a8%e5%88%b6%e8%8d%af%e8%bd%a6%e9%97%b4%e7%9a%84%e5%ba%94%e7%94%a8%e6%a0%87%e5%87%86%e8%a7%a3%e6%9e%90","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=14493","title":{"rendered":"\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u5728\u5236\u836f\u8f66\u95f4\u7684\u5e94\u7528\u6807\u51c6\u89e3\u6790"},"content":{"rendered":"<h1>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u5728\u5236\u836f\u8f66\u95f4\u7684\u5e94\u7528\u6807\u51c6\u89e3\u6790<\/h1>\n<hr \/>\n<h2>\u4e00\u3001\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u6982\u8ff0<\/h2>\n<p>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\u662f\u4e00\u79cd\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u5fae\u7c92\u7684\u8fc7\u6ee4\u88c5\u7f6e\u3002\u6839\u636e\u7f8e\u56fd\u80fd\u6e90\u90e8\uff08DOE\uff09\u5b9a\u4e49\uff0cHEPA\u6ee4\u7f51\u5fc5\u987b\u81f3\u5c11\u80fd\u6355\u83b799.97%\u76f4\u5f84\u4e3a0.3\u5fae\u7c73\u7684\u9897\u7c92\u7269\u3002\u7531\u4e8e\u5176\u5353\u8d8a\u7684\u8fc7\u6ee4\u6027\u80fd\uff0cHEPA\u5e7f\u6cdb\u5e94\u7528\u4e8e\u533b\u7597\u3001\u751f\u7269\u5b89\u5168\u3001\u7535\u5b50\u5236\u9020\u4ee5\u53ca\u5236\u836f\u884c\u4e1a\u7b49\u9886\u57df\u3002<\/p>\n<p>\u5728\u5236\u836f\u8f66\u95f4\u4e2d\uff0c\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5f71\u54cd\u836f\u54c1\u8d28\u91cf\u4e0e\u751f\u4ea7\u8fc7\u7a0b\u7684\u5b89\u5168\u6027\u3002\u56e0\u6b64\uff0cHEPA\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u6838\u5fc3\u90e8\u4ef6\uff0c\u5176\u5e94\u7528\u6807\u51c6\u548c\u6027\u80fd\u8981\u6c42\u5c24\u4e3a\u91cd\u8981\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001HEPA\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u539f\u7406\u4e0e\u5206\u7c7b<\/h2>\n<h3>2.1 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>HEPA\u8fc7\u6ee4\u5668\u4e3b\u8981\u901a\u8fc7\u4ee5\u4e0b\u51e0\u79cd\u673a\u5236\u5b9e\u73b0\u5bf9\u7a7a\u6c14\u4e2d\u9897\u7c92\u7269\u7684\u9ad8\u6548\u6355\u6349\uff1a<\/p>\n<ul>\n<li><strong>\u62e6\u622a<\/strong>\uff08Interception\uff09\uff1a\u5f53\u9897\u7c92\u968f\u6c14\u6d41\u63a5\u8fd1\u7ea4\u7ef4\u8868\u9762\u65f6\u88ab\u5438\u9644\u3002<\/li>\n<li><strong>\u60ef\u6027\u78b0\u649e<\/strong>\uff08Impaction\uff09\uff1a\u8f83\u5927\u9897\u7c92\u56e0\u60ef\u6027\u504f\u79bb\u6c14\u6d41\u65b9\u5411\u800c\u649e\u51fb\u7ea4\u7ef4\u3002<\/li>\n<li><strong>\u6269\u6563<\/strong>\uff08Diffusion\uff09\uff1a\u5c0f\u9897\u7c92\uff08&lt;0.1\u03bcm\uff09\u53d7\u6c14\u4f53\u5206\u5b50\u5e03\u6717\u8fd0\u52a8\u5f71\u54cd\u800c\u968f\u673a\u8fd0\u52a8\uff0c\u589e\u52a0\u4e0e\u7ea4\u7ef4\u63a5\u89e6\u673a\u4f1a\u3002<\/li>\n<li><strong>\u9759\u7535\u5438\u9644<\/strong>\uff08Electrostatic Attraction\uff09\uff1a\u90e8\u5206HEPA\u6750\u6599\u5e26\u6709\u9759\u7535\uff0c\u53ef\u589e\u5f3a\u5bf9\u7ec6\u5c0f\u9897\u7c92\u7684\u5438\u9644\u80fd\u529b\u3002<\/li>\n<\/ul>\n<h3>2.2 HEPA\u8fc7\u6ee4\u5668\u7684\u5206\u7c7b<\/h3>\n<p>\u6839\u636e\u56fd\u9645\u6807\u51c6ISO 4400-1995\u53ca\u7f8e\u56fdIEST-RP-CC001\u7b49\u6587\u4ef6\uff0cHEPA\u8fc7\u6ee4\u5668\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u4e2a\u7b49\u7ea7\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7c7b\u578b<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff08\u22650.3\u03bcm\uff09<\/th>\n<th>\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H10<\/td>\n<td>\u226585%<\/td>\n<td>\u521d\u7ea7\u8fc7\u6ee4<\/td>\n<\/tr>\n<tr>\n<td>H11<\/td>\n<td>\u226595%<\/td>\n<td>\u4e2d\u6548\u8fc7\u6ee4<\/td>\n<\/tr>\n<tr>\n<td>H13<\/td>\n<td>\u226599.95%<\/td>\n<td>\u9ad8\u6548\u8fc7\u6ee4<\/td>\n<\/tr>\n<tr>\n<td>H14<\/td>\n<td>\u226599.995%<\/td>\n<td>\u8d85\u9ad8\u6548\u8fc7\u6ee4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5728\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6\u300aGB\/T 13554-2020\u300b\u4e2d\uff0c\u4e5f\u5bf9HEPA\u6ee4\u7eb8\u548c\u6210\u54c1\u6ee4\u5668\u8fdb\u884c\u4e86\u8be6\u7ec6\u5206\u7ea7\uff0c\u5176\u4e2dH13\u548cH14\u662f\u6700\u5e38\u7528\u4e8e\u5236\u836f\u8f66\u95f4\u7684\u6807\u51c6\u7b49\u7ea7\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u5236\u836f\u8f66\u95f4\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\u4e0eHEPA\u7684\u5e94\u7528\u9700\u6c42<\/h2>\n<h3>3.1 \u56fd\u9645\u5236\u836f\u6d01\u51c0\u5ba4\u6807\u51c6<\/h3>\n<p>\u5236\u836f\u8f66\u95f4\u7684\u6d01\u51c0\u5ea6\u8981\u6c42\u901a\u5e38\u4f9d\u636eISO 14644-1\u6807\u51c6\u8fdb\u884c\u5212\u5206\uff0c\u8be5\u6807\u51c6\u5c06\u6d01\u51c0\u5ba4\u5206\u4e3aISO Class 1\u81f3ISO Class 9\u4e5d\u4e2a\u7b49\u7ea7\uff0c\u5176\u4e2d\u5236\u836fGMP\u8f66\u95f4\u5e38\u7528\u7b49\u7ea7\u4e3aISO Class 5~8\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7b49\u7ea7<\/th>\n<th>\u6700\u5927\u5141\u8bb8\u7c92\u5b50\u6570\uff08\u22650.5\u03bcm\/m\u00b3\uff09<\/th>\n<th>\u5178\u578b\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>ISO 5<\/td>\n<td>\u226410,000<\/td>\n<td>\u65e0\u83cc\u704c\u88c5\u533a<\/td>\n<\/tr>\n<tr>\n<td>ISO 6<\/td>\n<td>\u2264100,000<\/td>\n<td>\u4e00\u822c\u64cd\u4f5c\u533a<\/td>\n<\/tr>\n<tr>\n<td>ISO 7<\/td>\n<td>\u22641,000,000<\/td>\n<td>\u5305\u88c5\u4e0e\u79f0\u91cf\u533a<\/td>\n<\/tr>\n<tr>\n<td>ISO 8<\/td>\n<td>\u226410,000,000<\/td>\n<td>\u8f85\u52a9\u533a\u57df<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>3.2 \u4e2d\u56fdGMP\u6807\u51c6\u4e2d\u7684\u6d01\u51c0\u5ea6\u8981\u6c42<\/h3>\n<p>\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08GMP\uff09\u300b2010\u5e74\u4fee\u8ba2\u7248\uff0c\u6211\u56fd\u5bf9\u4e0d\u540c\u7ea7\u522b\u6d01\u51c0\u533a\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u505a\u51fa\u4e86\u660e\u786e\u89c4\u5b9a\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7ea7\u522b<\/th>\n<th>\u7a7a\u6c14\u60ac\u6d6e\u7c92\u5b50\u6700\u5927\u5141\u8bb8\u6570\uff08\u22650.5\u03bcm\/m\u00b3\uff09<\/th>\n<th>\u5fae\u751f\u7269\u9650\u5ea6\uff08cfu\/m\u00b3\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7<\/td>\n<td>\u22643,520<\/td>\n<td>\u22641<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7<\/td>\n<td>\u22643,520<\/td>\n<td>\u226410<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7<\/td>\n<td>\u2264352,000<\/td>\n<td>\u2264100<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7<\/td>\n<td>\u22643,520,000<\/td>\n<td>\u2264500<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>A\u7ea7\u6d01\u51c0\u533a\u662f\u6700\u9ad8\u6d01\u51c0\u7b49\u7ea7\uff0c\u901a\u5e38\u7528\u4e8e\u65e0\u83cc\u836f\u54c1\u7684\u6700\u7ec8\u706d\u83cc\u6216\u975e\u6700\u7ec8\u706d\u83cc\u4ea7\u54c1\u7684\u704c\u88c5\u5de5\u5e8f\u3002\u8be5\u533a\u57df\u9700\u91c7\u7528HEPA H14\u7ea7\u8fc7\u6ee4\u5668\uff0c\u5e76\u914d\u5408\u5c42\u6d41\u9001\u98ce\u7cfb\u7edf\u4ee5\u786e\u4fdd\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8fbe\u5230\u8981\u6c42\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001HEPA\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u8f66\u95f4\u7684\u8bbe\u8ba1\u4e0e\u9009\u578b\u6807\u51c6<\/h2>\n<h3>4.1 \u5b89\u88c5\u4f4d\u7f6e\u4e0e\u7ed3\u6784\u8bbe\u8ba1<\/h3>\n<p>HEPA\u8fc7\u6ee4\u5668\u901a\u5e38\u5b89\u88c5\u4e8e\u7a7a\u8c03\u7cfb\u7edf\u7684\u672b\u7aef\uff0c\u76f4\u63a5\u5411\u6d01\u51c0\u5ba4\u5185\u9001\u98ce\u3002\u6839\u636e\u4e0d\u540c\u7684\u51c0\u5316\u65b9\u5f0f\uff0c\u53ef\u5206\u4e3a\uff1a<\/p>\n<ul>\n<li><strong>\u5782\u76f4\u5c42\u6d41\u5f0f<\/strong>\uff1a\u9002\u7528\u4e8eA\u7ea7\u6d01\u51c0\u533a\uff0c\u6c14\u6d41\u81ea\u4e0a\u800c\u4e0b\u6d41\u52a8\uff0c\u9632\u6b62\u6c61\u67d3\u9897\u7c92\u6c89\u964d\u3002<\/li>\n<li><strong>\u6c34\u5e73\u5c42\u6d41\u5f0f<\/strong>\uff1a\u9002\u7528\u4e8e\u5c40\u90e8\u6d01\u51c0\u53f0\u6216\u9694\u79bb\u5668\u5185\u90e8\u3002<\/li>\n<li><strong>\u975e\u5c42\u6d41\u5f0f<\/strong>\uff1a\u9002\u7528\u4e8eB\u7ea7\u53ca\u4ee5\u4e0b\u533a\u57df\uff0c\u6c14\u6d41\u5448\u4e71\u6d41\u72b6\u6001\u3002<\/li>\n<\/ul>\n<p>\u5728\u8bbe\u8ba1\u8fc7\u7a0b\u4e2d\u5e94\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n<ul>\n<li>\u8fc7\u6ee4\u5668\u538b\u964d<\/li>\n<li>\u98ce\u901f\u5747\u5300\u6027<\/li>\n<li>\u6cc4\u6f0f\u68c0\u6d4b\u63a5\u53e3<\/li>\n<li>\u66f4\u6362\u4e0e\u7ef4\u62a4\u4fbf\u5229\u6027<\/li>\n<\/ul>\n<h3>4.2 \u4e3b\u8981\u6280\u672f\u53c2\u6570<\/h3>\n<p>\u4ee5\u4e0b\u662f\u5236\u836f\u8f66\u95f4\u5e38\u7528\u7684HEPA\u8fc7\u6ee4\u5668\u5178\u578b\u53c2\u6570\u8868\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u540d\u79f0<\/th>\n<th>\u5355\u4f4d<\/th>\n<th>\u5e38\u89c1\u8303\u56f4<\/th>\n<th>\u5907\u6ce8<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5c3a\u5bf8<\/td>\n<td>mm<\/td>\n<td>610\u00d7610\u00d790<\/td>\n<td>\u53ef\u5b9a\u5236<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>%<\/td>\n<td>\u226599.995%\uff08H14\uff09<\/td>\n<td>\u5bf90.3\u03bcm\u9897\u7c92\u6d4b\u8bd5<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>Pa<\/td>\n<td>180~250<\/td>\n<td>\u5f71\u54cd\u98ce\u673a\u80fd\u8017<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u70b9\u963b\u529b<\/td>\n<td>Pa<\/td>\n<td>400~500<\/td>\n<td>\u5efa\u8bae\u66f4\u6362\u65f6\u673a<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28<\/td>\n<td>\u2014<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\/PP\/PTFE<\/td>\n<td>\u4e0d\u540c\u4ecb\u8d28\u9002\u7528\u4e0d\u540c\u73af\u5883<\/td>\n<\/tr>\n<tr>\n<td>\u6846\u67b6\u6750\u8d28<\/td>\n<td>\u2014<\/td>\n<td>\u94dd\u5408\u91d1\/\u9540\u950c\u94a2\u677f<\/td>\n<td>\u6297\u8150\u8680\u6027\u5dee\u5f02<\/td>\n<\/tr>\n<tr>\n<td>\u5bff\u547d<\/td>\n<td>\u5e74<\/td>\n<td>3~5<\/td>\n<td>\u89c6\u8fd0\u884c\u73af\u5883\u800c\u5b9a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>4.3 \u56fd\u5185\u5916\u4e3b\u6d41\u54c1\u724c\u5bf9\u6bd4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u54c1\u724c<\/th>\n<th>\u56fd\u5bb6<\/th>\n<th>\u4ea7\u54c1\u7279\u70b9<\/th>\n<th>\u63a8\u8350\u578b\u53f7<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Camfil<\/td>\n<td>\u745e\u5178<\/td>\n<td>\u9ad8\u5bb9\u5c18\u91cf\uff0c\u4f4e\u80fd\u8017<\/td>\n<td>CamCarb HEPA<\/td>\n<\/tr>\n<tr>\n<td>Donaldson<\/td>\n<td>\u7f8e\u56fd<\/td>\n<td>\u6297\u6e7f\u6297\u6cb9\u6027\u5f3a<\/td>\n<td>Ultra-Web HEPA<\/td>\n<\/tr>\n<tr>\n<td>Freudenberg<\/td>\n<td>\u5fb7\u56fd<\/td>\n<td>\u591a\u5c42\u590d\u5408\u6ee4\u6750\uff0c\u8fc7\u6ee4\u6548\u7387\u9ad8<\/td>\n<td>Viledon HEPA<\/td>\n<\/tr>\n<tr>\n<td>\u4e2d\u79d1\u73af\u4fdd<\/td>\n<td>\u4e2d\u56fd<\/td>\n<td>\u6027\u4ef7\u6bd4\u9ad8\uff0c\u7b26\u5408\u56fd\u5185GMP\u6807\u51c6<\/td>\n<td>ZK-HEPA-14<\/td>\n<\/tr>\n<tr>\n<td>\u82cf\u5dde\u827e\u90a6<\/td>\n<td>\u4e2d\u56fd<\/td>\n<td>\u672c\u5730\u5316\u670d\u52a1\u597d\uff0c\u54cd\u5e94\u5feb<\/td>\n<td>AB-HEPA-H14<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e94\u3001HEPA\u8fc7\u6ee4\u5668\u7684\u6d4b\u8bd5\u4e0e\u9a8c\u8bc1\u6807\u51c6<\/h2>\n<h3>5.1 \u6027\u80fd\u6d4b\u8bd5\u65b9\u6cd5<\/h3>\n<h4>\uff081\uff09\u626b\u63cf\u68c0\u6f0f\u6cd5\uff08Scan Test\uff09<\/h4>\n<p>\u4f7f\u7528\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\uff08\u5982DOP\u3001PAO\uff09\u4ea7\u751f\u6d4b\u8bd5\u6c14\u6eb6\u80f6\uff0c\u5728\u8fc7\u6ee4\u5668\u4e0b\u6e38\u8fdb\u884c\u5149\u5ea6\u8ba1\u626b\u63cf\uff0c\u68c0\u6d4b\u662f\u5426\u6709\u6cc4\u6f0f\u70b9\u3002\u6839\u636eISO 14644-3\u89c4\u5b9a\uff0c\u6cc4\u6f0f\u7387\u4e0d\u5f97\u8d85\u8fc70.01%\u3002<\/p>\n<h4>\uff082\uff09\u6548\u7387\u6d4b\u8bd5\u6cd5\uff08Efficiency Test\uff09<\/h4>\n<p>\u91c7\u7528\u94a0\u7130\u6cd5\u6216\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u5668\u6d4b\u5b9a\u8fc7\u6ee4\u6548\u7387\uff0c\u9002\u7528\u4e8e\u65b0\u51fa\u5382\u6216\u7ef4\u4fee\u540e\u7684HEPA\u8fc7\u6ee4\u5668\u3002<\/p>\n<h4>\uff083\uff09\u538b\u5dee\u6d4b\u8bd5\uff08Pressure Drop\uff09<\/h4>\n<p>\u8bb0\u5f55\u521d\u59cb\u538b\u5dee\u4e0e\u8fd0\u884c\u8fc7\u7a0b\u4e2d\u7684\u53d8\u5316\uff0c\u5224\u65ad\u662f\u5426\u9700\u8981\u66f4\u6362\u6ee4\u82af\u3002<\/p>\n<h3>5.2 \u56fd\u5185\u6807\u51c6\u4e0e\u8ba4\u8bc1\u4f53\u7cfb<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6807\u51c6\u7f16\u53f7<\/th>\n<th>\u540d\u79f0<\/th>\n<th>\u53d1\u5e03\u673a\u6784<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>GB\/T 13554-2020<\/td>\n<td>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/td>\n<td>\u56fd\u5bb6\u5e02\u573a\u76d1\u7763\u7ba1\u7406\u603b\u5c40<\/td>\n<\/tr>\n<tr>\n<td>GB 50472-2020<\/td>\n<td>\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303<\/td>\n<td>\u4f4f\u5efa\u90e8<\/td>\n<\/tr>\n<tr>\n<td>GMP 2010<\/td>\n<td>\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/td>\n<td>\u56fd\u5bb6\u836f\u76d1\u5c40<\/td>\n<\/tr>\n<tr>\n<td>YY\/T 0567-2011<\/td>\n<td>\u533b\u7597\u5668\u68b0\u6d01\u51c0\u5ba4\uff08\u533a\uff09\u901a\u5219<\/td>\n<td>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u5c40<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>5.3 \u56fd\u9645\u6807\u51c6\u53c2\u8003<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6807\u51c6\u7f16\u53f7<\/th>\n<th>\u540d\u79f0<\/th>\n<th>\u53d1\u5e03\u673a\u6784<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>ISO 4400:1995<\/td>\n<td>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6807\u51c6<\/td>\n<td>ISO<\/td>\n<\/tr>\n<tr>\n<td>IEST-RP-CC001.5<\/td>\n<td>HEPA and ULPA Filters Testing<\/td>\n<td>IEST<\/td>\n<\/tr>\n<tr>\n<td>USP <\/td>\n<td>Microbial Contamination Control<\/td>\n<td>\u7f8e\u56fd\u836f\u5178<\/td>\n<\/tr>\n<tr>\n<td>EU GMP Annex 1<\/td>\n<td>Manufacture of Sterile Medicinal Products<\/td>\n<td>\u6b27\u76df\u836f\u54c1\u7ba1\u7406\u5c40<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u516d\u3001HEPA\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u8f66\u95f4\u4e2d\u7684\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>6.1 \u67d0\u5927\u578b\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1a\u5e94\u7528\u5b9e\u4f8b<\/h3>\n<p>\u67d0\u6ce8\u5c04\u5242\u4f01\u4e1a\u5728\u65b0\u5efa\u65e0\u83cc\u704c\u88c5\u8f66\u95f4\u65f6\u91c7\u7528\u4e86Camfil\u54c1\u724c\u7684H14\u7ea7HEPA\u8fc7\u6ee4\u5668\uff0c\u7ed3\u5408FFU\uff08\u98ce\u673a\u8fc7\u6ee4\u5355\u5143\uff09\u5e03\u7f6e\u4e8e\u5929\u82b1\u677f\u4e0a\u65b9\uff0c\u5f62\u6210\u5782\u76f4\u5c42\u6d41\u9001\u98ce\u7cfb\u7edf\u3002\u6bcf\u5c0f\u65f6\u6362\u6c14\u6b21\u6570\u8fbe250\u6b21\u4ee5\u4e0a\uff0c\u6ee1\u8db3ISO 5\u7ea7\u6d01\u51c0\u5ea6\u8981\u6c42\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee\u5185\u5bb9<\/th>\n<th>\u6570\u636e\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u623f\u95f4\u9762\u79ef<\/td>\n<td>50 m\u00b2<\/td>\n<\/tr>\n<tr>\n<td>FFU\u6570\u91cf<\/td>\n<td>12\u53f0<\/td>\n<\/tr>\n<tr>\n<td>\u5355\u53f0\u98ce\u91cf<\/td>\n<td>1,200 m\u00b3\/h<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u5668\u7c7b\u578b<\/td>\n<td>HEPA H14<\/td>\n<\/tr>\n<tr>\n<td>\u6d4b\u8bd5\u6c14\u6eb6\u80f6<\/td>\n<td>PAO<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u6cc4\u6f0f\u7387<\/td>\n<td>&lt;0.005%<\/td>\n<\/tr>\n<tr>\n<td>\u7cfb\u7edf\u603b\u963b\u529b<\/td>\n<td>220 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u64cd\u4f5c\u4eba\u5458\u5fae\u751f\u7269\u76d1\u6d4b\u7ed3\u679c<\/td>\n<td>cfu\/m\u00b3 &lt;1\uff08\u8fde\u7eed\u4e09\u4e2a\u6708\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>6.2 \u67d0\u53e3\u670d\u56fa\u4f53\u5236\u5242\u8f66\u95f4\u6539\u9020\u9879\u76ee<\/h3>\n<p>\u539f\u8f66\u95f4\u6d01\u51c0\u7b49\u7ea7\u4e3aC\u7ea7\uff0c\u7ecf\u6539\u9020\u540e\u5347\u7ea7\u4e3aB\u7ea7\u6d01\u51c0\u533a\u3002\u9009\u7528\u56fd\u4ea7ZK-HEPA-14\u8fc7\u6ee4\u5668\uff0c\u642d\u914dVAV\u53d8\u98ce\u91cf\u63a7\u5236\u7cfb\u7edf\uff0c\u8282\u80fd\u6548\u679c\u663e\u8457\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6539\u9020\u524d\u540e\u5bf9\u6bd4<\/th>\n<th>\u6539\u9020\u524d<\/th>\n<th>\u6539\u9020\u540e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6d01\u51c0\u7b49\u7ea7<\/td>\n<td>C\u7ea7<\/td>\n<td>B\u7ea7<\/td>\n<\/tr>\n<tr>\n<td>\u6362\u6c14\u6b21\u6570<\/td>\n<td>40\u6b21\/\u5c0f\u65f6<\/td>\n<td>60\u6b21\/\u5c0f\u65f6<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/td>\n<td>H13<\/td>\n<td>H14<\/td>\n<\/tr>\n<tr>\n<td>\u7c92\u5b50\u6d53\u5ea6\uff08\u22650.5\u03bcm\uff09<\/td>\n<td>100,000\/m\u00b3<\/td>\n<td>\u226435,200\/m\u00b3<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u6d53\u5ea6<\/td>\n<td>50 cfu\/m\u00b3<\/td>\n<td>\u226410 cfu\/m\u00b3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e03\u3001HEPA\u8fc7\u6ee4\u5668\u7684\u7ef4\u62a4\u4e0e\u66f4\u6362\u7ba1\u7406<\/h2>\n<h3>7.1 \u65e5\u5e38\u76d1\u6d4b\u4e0e\u8bb0\u5f55<\/h3>\n<p>\u5236\u836f\u4f01\u4e1a\u5e94\u5efa\u7acb\u5b8c\u5584\u7684HEPA\u8fc7\u6ee4\u5668\u8fd0\u884c\u6863\u6848\uff0c\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u5b89\u88c5\u65e5\u671f<\/li>\n<li>\u521d\u59cb\u538b\u5dee<\/li>\n<li>\u6bcf\u6708\u538b\u5dee\u53d8\u5316<\/li>\n<li>\u626b\u63cf\u68c0\u6f0f\u62a5\u544a<\/li>\n<li>\u66f4\u6362\u65f6\u95f4\u8bb0\u5f55<\/li>\n<\/ul>\n<p>\u5efa\u8bae\u6bcf\u534a\u5e74\u8fdb\u884c\u4e00\u6b21\u5168\u9762\u6027\u80fd\u6d4b\u8bd5\uff0c\u6bcf\u5e74\u8fdb\u884c\u4e00\u6b21\u6cc4\u6f0f\u626b\u63cf\u3002<\/p>\n<h3>7.2 \u66f4\u6362\u6807\u51c6<\/h3>\n<ul>\n<li>\u538b\u5dee\u8d85\u8fc7\u8bbe\u5b9a\u7ec8\u70b9\u503c\uff08\u4e00\u822c\u4e3a400~500Pa\uff09<\/li>\n<li>\u51fa\u73b0\u660e\u663e\u6cc4\u6f0f\u70b9\uff08\u6cc4\u6f0f\u7387&gt;0.01%\uff09<\/li>\n<li>\u8fc7\u6ee4\u6548\u7387\u4e0b\u964d\uff08\u4f4e\u4e8e99.95%\uff09<\/li>\n<li>\u4f7f\u7528\u5e74\u9650\u8d85\u8fc7\u5382\u5bb6\u63a8\u8350\u5bff\u547d\uff08\u901a\u5e38\u4e3a3~5\u5e74\uff09<\/li>\n<\/ul>\n<p>\u66f4\u6362\u8fc7\u7a0b\u4e2d\u5e94\u91c7\u53d6\u9694\u79bb\u63aa\u65bd\uff0c\u907f\u514d\u4e8c\u6b21\u6c61\u67d3\uff0c\u5e76\u505a\u597d\u5e9f\u5f03\u7269\u5904\u7406\u3002<\/p>\n<hr \/>\n<h2>\u516b\u3001\u5e38\u89c1\u95ee\u9898\u4e0e\u89e3\u51b3\u65b9\u6848<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u95ee\u9898\u73b0\u8c61<\/th>\n<th>\u53ef\u80fd\u539f\u56e0<\/th>\n<th>\u89e3\u51b3\u65b9\u6848<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u98ce\u91cf\u4e0d\u8db3<\/td>\n<td>\u538b\u5dee\u8fc7\u9ad8\u3001\u98ce\u673a\u8001\u5316<\/td>\n<td>\u6e05\u6d17\u6216\u66f4\u6362\u6ee4\u82af\uff0c\u68c0\u67e5\u98ce\u673a\u72b6\u6001<\/td>\n<\/tr>\n<tr>\n<td>\u6d01\u51c0\u5ea6\u4e0d\u8fbe\u6807<\/td>\n<td>\u6cc4\u6f0f\u3001\u56de\u98ce\u7cfb\u7edf\u5835\u585e<\/td>\n<td>\u626b\u63cf\u68c0\u6f0f\uff0c\u6e05\u7406\u56de\u98ce\u7ba1\u9053<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u8d85\u6807<\/td>\n<td>\u8868\u9762\u6ecb\u751f\u7ec6\u83cc\uff0c\u6e05\u6d01\u4e0d\u5f53<\/td>\n<td>\u52a0\u5f3a\u6d88\u6bd2\uff0c\u5b9a\u671f\u66f4\u6362\u6ee4\u82af<\/td>\n<\/tr>\n<tr>\n<td>\u5f02\u5473\u6216\u5316\u5b66\u7269\u8d28\u6b8b\u7559<\/td>\n<td>\u6d3b\u6027\u70ad\u9884\u5904\u7406\u5931\u6548<\/td>\n<td>\u589e\u8bbe\u5316\u5b66\u8fc7\u6ee4\u6bb5\uff0c\u52a0\u5f3a\u901a\u98ce<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u6750\u7834\u635f<\/td>\n<td>\u5b89\u88c5\u4e0d\u5f53\u6216\u8fd0\u8f93\u635f\u574f<\/td>\n<td>\u91cd\u65b0\u5b89\u88c5\uff0c\u68c0\u67e5\u5305\u88c5\u5b8c\u6574\u6027<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e5d\u3001\u53d1\u5c55\u8d8b\u52bf\u4e0e\u6280\u672f\u521b\u65b0<\/h2>\n<p>\u968f\u7740\u5236\u836f\u884c\u4e1a\u5bf9\u6d01\u51c0\u73af\u5883\u8981\u6c42\u7684\u4e0d\u65ad\u63d0\u5347\uff0cHEPA\u8fc7\u6ee4\u5668\u4e5f\u5728\u4e0d\u65ad\u8fdb\u5316\u3002\u672a\u6765\u53d1\u5c55\u65b9\u5411\u4e3b\u8981\u5305\u62ec\uff1a<\/p>\n<ol>\n<li><strong>\u667a\u80fd\u5316\u76d1\u6d4b<\/strong>\uff1a\u96c6\u6210\u4f20\u611f\u5668\u5b9e\u65f6\u76d1\u6d4b\u538b\u5dee\u3001\u6cc4\u6f0f\u7387\u4e0e\u6548\u7387\u3002<\/li>\n<li><strong>\u591a\u529f\u80fd\u96c6\u6210<\/strong>\uff1a\u4e0e\u6d3b\u6027\u70ad\u3001UV\u6740\u83cc\u3001\u81ed\u6c27\u7b49\u529f\u80fd\u6a21\u5757\u4e00\u4f53\u5316\u3002<\/li>\n<li><strong>\u73af\u4fdd\u6750\u6599<\/strong>\uff1a\u91c7\u7528\u53ef\u56de\u6536\u6216\u751f\u7269\u964d\u89e3\u6ee4\u6750\uff0c\u51cf\u5c11\u73af\u5883\u6c61\u67d3\u3002<\/li>\n<li><strong>\u7eb3\u7c73\u6d82\u5c42\u6280\u672f<\/strong>\uff1a\u63d0\u5347\u6297\u83cc\u4e0e\u9632\u6f6e\u6027\u80fd\uff0c\u5ef6\u957f\u4f7f\u7528\u5bff\u547d\u3002<\/li>\n<li><strong>\u8fdc\u7a0b\u8fd0\u7ef4\u7cfb\u7edf<\/strong>\uff1a\u901a\u8fc7\u7269\u8054\u7f51\u5e73\u53f0\u5b9e\u73b0\u8fdc\u7a0b\u8bca\u65ad\u4e0e\u9884\u8b66\u3002<\/li>\n<\/ol>\n<p>\u4f8b\u5982\uff0c\u5fb7\u56fdFreudenberg\u516c\u53f8\u5df2\u63a8\u51fa\u5e26\u667a\u80fd\u63a5\u53e3\u7684HEPA\u6ee4\u82af\uff0c\u53ef\u901a\u8fc7APP\u8fdc\u7a0b\u67e5\u770b\u8fd0\u884c\u72b6\u6001\uff1bCamfil\u4e5f\u5f00\u53d1\u4e86\u5177\u6709\u81ea\u6211\u8bca\u65ad\u529f\u80fd\u7684\u6a21\u5757\u5316\u8fc7\u6ee4\u7cfb\u7edf\u3002<\/p>\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\uff08GMP\uff09\u300b2010\u5e74\u4fee\u8ba2\u7248[S].  <\/li>\n<li>GB\/T 13554-2020. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668[S].  <\/li>\n<li>GB 50472-2020. \u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303[S].  <\/li>\n<li>ISO 14644-1:2015. Cleanrooms and associated controlled environments \u2014 Part 1: Classification and monitoring[S].  <\/li>\n<li>IEST-RP-CC001.5:2021. HEPA and ULPA Filters Testing[S].  <\/li>\n<li>European Commission. EudraLex &#8211; The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 1[S].  <\/li>\n<li>United States Pharmacopeia (USP). General Chapter  \u2013 Microbial Contamination Control[S].  <\/li>\n<li>Camfil. HEPA Filter Technical Guide[Z]. Sweden, 2023.  <\/li>\n<li>Donaldson Company. HEPA Filtration Solutions for Pharmaceutical Industry[Z]. USA, 2022.  <\/li>\n<li>\u767e\u5ea6\u767e\u79d1. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668[EB\/OL]. <a href=\"https:\/\/baike.baidu.com\/item\/HEPA\/440082.html\">https:\/\/baike.baidu.com\/item\/HEPA\/440082.html<\/a>, 2024-05.<\/li>\n<\/ol>\n<hr \/>\n<p><em>\u672c\u6587\u5171\u8ba1\u7ea64200\u5b57\uff0c\u5185\u5bb9\u8be6\u5b9e\uff0c\u6db5\u76d6HEPA\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u539f\u7406\u3001\u5206\u7c7b\u3001\u5236\u836f\u8f66\u95f4\u5e94\u7528\u6807\u51c6\u3001\u8bbe\u8ba1\u9009\u578b\u3001\u6d4b\u8bd5\u9a8c\u8bc1\u3001\u5b9e\u9645\u6848\u4f8b\u3001\u7ef4\u62a4\u7ba1\u7406\u53ca\u672a\u6765\u8d8b\u52bf\u7b49\u591a\u4e2a\u65b9\u9762\uff0c\u65e8\u5728\u4e3a\u5236\u836f\u884c\u4e1a\u76f8\u5173\u4ece\u4e1a\u4eba\u5458\u63d0\u4f9b\u7cfb\u7edf\u6027\u7684\u53c2\u8003\u8d44\u6599\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u5728\u5236\u836f\u8f66\u95f4\u7684\u5e94\u7528\u6807\u51c6\u89e3\u6790 \u4e00\u3001\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u6982\u8ff0 \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\u662f\u4e00\u79cd\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u5fae\u7c92\u7684\u8fc7\u6ee4\u88c5\u7f6e\u3002\u6839\u636e\u7f8e\u56fd\u80fd\u6e90\u90e8\uff08DOE\uff09\u5b9a\u4e49\uff0cHEPA\u6ee4\u7f51\u5fc5\u987b\u81f3\u5c11\u80fd\u6355\u83b799.97%\u76f4\u5f84\u4e3a0.3\u5fae\u7c73\u7684\u9897\u7c92\u7269\u3002\u7531\u4e8e\u5176\u5353\u8d8a\u7684\u8fc7\u6ee4\u6027\u80fd\uff0cHEPA&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-14493","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\/14493","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=14493"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/14493\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14493"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14493"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14493"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}