{"id":16983,"date":"2025-09-22T18:36:56","date_gmt":"2025-09-22T10:36:56","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16983"},"modified":"2025-09-22T18:36:56","modified_gmt":"2025-09-22T10:36:56","slug":"%e8%b6%85%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e5%88%b6%e8%8d%af%e6%97%a0%e8%8f%8c%e7%94%9f%e4%ba%a7%e7%8e%af%e5%a2%83%e4%b8%ad%e7%9a%84%e5%85%b3%e9%94%ae%e4%bd%9c%e7%94%a8","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16983","title":{"rendered":"\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u65e0\u83cc\u751f\u4ea7\u73af\u5883\u4e2d\u7684\u5173\u952e\u4f5c\u7528"},"content":{"rendered":"<h1>\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u65e0\u83cc\u751f\u4ea7\u73af\u5883\u4e2d\u7684\u5173\u952e\u4f5c\u7528<\/h1>\n<h2>\u6982\u8ff0<\/h2>\n<p>\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08Ultra-Low Penetration Air Filter\uff0c\u7b80\u79f0ULPA Filter\uff09\u662f\u7a7a\u6c14\u6d01\u51c0\u6280\u672f\u4e2d\u7528\u4e8e\u53bb\u9664\u7a7a\u6c14\u4e2d\u5fae\u7c92\u7684\u5173\u952e\u8bbe\u5907\u4e4b\u4e00\uff0c\u5c24\u5176\u5728\u5bf9\u7a7a\u6c14\u8d28\u91cf\u8981\u6c42\u6781\u4e3a\u4e25\u683c\u7684\u5236\u836f\u65e0\u83cc\u751f\u4ea7\u73af\u5883\u4e2d\uff0c\u5176\u4f5c\u7528\u4e0d\u53ef\u66ff\u4ee3\u3002\u6839\u636e\u56fd\u9645\u6807\u51c6ISO 29463\u548c\u7f8e\u56fd\u519b\u7528\u6807\u51c6MIL-STD-282\uff0c\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u8fc7\u6ee4\u6548\u7387\u901a\u5e38\u57280.12\u03bcm\u7c92\u5f84\u4e0b\u8fbe\u523099.999%\u4ee5\u4e0a\uff0c\u8fdc\u9ad8\u4e8e\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08HEPA Filter\uff09\u7684\u6807\u51c6\uff0899.97% @ 0.3\u03bcm\uff09\u3002\u5728\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u5c24\u5176\u662f\u65e0\u83cc\u836f\u54c1\u5982\u6ce8\u5c04\u5242\u3001\u75ab\u82d7\u3001\u751f\u7269\u5236\u5242\u7b49\u7684\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u4efb\u4f55\u5fae\u5c0f\u9897\u7c92\u6216\u5fae\u751f\u7269\u6c61\u67d3\u90fd\u53ef\u80fd\u5bfc\u81f4\u4ea7\u54c1\u5931\u6548\u751a\u81f3\u5371\u53ca\u60a3\u8005\u751f\u547d\uff0c\u56e0\u6b64\u5fc5\u987b\u4f9d\u8d56ULPA\u8fc7\u6ee4\u5668\u6784\u5efa\u9ad8\u6d01\u51c0\u5ea6\u7684\u751f\u4ea7\u73af\u5883\u3002<\/p>\n<p>\u672c\u6587\u5c06\u7cfb\u7edf\u9610\u8ff0\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5de5\u4f5c\u539f\u7406\u3001\u6027\u80fd\u53c2\u6570\u3001\u5728\u5236\u836f\u65e0\u83cc\u751f\u4ea7\u4e2d\u7684\u5177\u4f53\u5e94\u7528\u3001\u56fd\u5185\u5916\u6807\u51c6\u4f53\u7cfb\u3001\u5178\u578b\u4ea7\u54c1\u5bf9\u6bd4\u5206\u6790\uff0c\u5e76\u7ed3\u5408\u6743\u5a01\u6587\u732e\u8d44\u6599\uff0c\u6df1\u5165\u63a2\u8ba8\u5176\u5728\u4fdd\u969c\u836f\u54c1\u8d28\u91cf\u4e0e\u60a3\u8005\u5b89\u5168\u4e2d\u7684\u6838\u5fc3\u5730\u4f4d\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u4e0e\u7ed3\u6784<\/h2>\n<h3>1.1 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e3b\u8981\u901a\u8fc7\u4ee5\u4e0b\u56db\u79cd\u673a\u5236\u5b9e\u73b0\u5bf9\u7a7a\u6c14\u4e2d\u5fae\u7c92\u7684\u6355\u96c6\uff1a<\/p>\n<ul>\n<li><strong>\u62e6\u622a\u6548\u5e94<\/strong>\uff08Interception\uff09\uff1a\u5f53\u6c14\u6d41\u4e2d\u7684\u9897\u7c92\u968f\u6c14\u6d41\u8fd0\u52a8\u5e76\u63a5\u8fd1\u7ea4\u7ef4\u8868\u9762\u65f6\uff0c\u82e5\u5176\u8fd0\u52a8\u8f68\u8ff9\u4e0e\u7ea4\u7ef4\u63a5\u89e6\uff0c\u5219\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\u8ddf\u968f\u6c14\u6d41\u7ed5\u8fc7\u7ea4\u7ef4\uff0c\u76f4\u63a5\u649e\u51fb\u5e76\u6ede\u7559\u4e8e\u7ea4\u7ef4\u4e0a\u3002<\/li>\n<li><strong>\u6269\u6563\u6548\u5e94<\/strong>\uff08Diffusion\uff09\uff1a\u6781\u5c0f\u9897\u7c92\uff08&lt;0.1\u03bcm\uff09\u53d7\u5e03\u6717\u8fd0\u52a8\u5f71\u54cd\uff0c\u968f\u673a\u78b0\u649e\u7ea4\u7ef4\u800c\u88ab\u6355\u83b7\u3002<\/li>\n<li><strong>\u9759\u7535\u5438\u9644<\/strong>\uff08Electrostatic Attraction\uff09\uff1a\u90e8\u5206\u6ee4\u6750\u5e26\u6709\u9759\u7535\uff0c\u53ef\u589e\u5f3a\u5bf9\u4e2d\u6027\u5fae\u7c92\u7684\u5438\u5f15\u529b\u3002<\/li>\n<\/ul>\n<p>\u5176\u4e2d\uff0c\u6269\u6563\u6548\u5e94\u5bf90.1\u03bcm\u5de6\u53f3\u7684\u9897\u7c92\u6700\u4e3a\u663e\u8457\uff0c\u8fd9\u4e5f\u662fULPA\u8fc7\u6ee4\u5668\u6d4b\u8bd5\u57fa\u51c6\u7c92\u5f84\u5b9a\u4e3a0.12\u03bcm\u7684\u539f\u56e0\u3002<\/p>\n<h3>1.2 \u7ed3\u6784\u7ec4\u6210<\/h3>\n<p>\u5178\u578b\u7684ULPA\u8fc7\u6ee4\u5668\u7531\u4ee5\u4e0b\u51e0\u4e2a\u90e8\u5206\u6784\u6210\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7ec4\u6210\u90e8\u5206<\/th>\n<th>\u6750\u6599\/\u529f\u80fd\u63cf\u8ff0<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6ee4\u82af\u6750\u6599<\/td>\n<td>\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4\uff08\u76f4\u5f84\u7ea60.2\u20130.5\u03bcm\uff09\uff0c\u7ecf\u7279\u6b8a\u5de5\u827a\u5236\u6210\u591a\u5b54\u4ecb\u8d28<\/td>\n<\/tr>\n<tr>\n<td>\u5206\u9694\u677f<\/td>\n<td>\u94dd\u7b94\u6216\u805a\u916f\u8584\u819c\uff0c\u7528\u4e8e\u652f\u6491\u6ee4\u7eb8\u5e76\u5f62\u6210\u6c14\u6d41\u901a\u9053<\/td>\n<\/tr>\n<tr>\n<td>\u5916\u6846<\/td>\n<td>\u94dd\u5408\u91d1\u3001\u9540\u950c\u94a2\u677f\u6216\u4e0d\u9508\u94a2\uff0c\u786e\u4fdd\u7ed3\u6784\u5f3a\u5ea6\u4e0e\u5bc6\u5c01\u6027<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u80f6<\/td>\n<td>\u805a\u6c28\u916f\u6216\u7845\u916e\u80f6\uff0c\u9632\u6b62\u65c1\u901a\u6cc4\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>\u9632\u62a4\u7f51<\/td>\n<td>\u4e0d\u9508\u94a2\u4e1d\u7f51\uff0c\u4fdd\u62a4\u6ee4\u6750\u514d\u53d7\u673a\u68b0\u635f\u4f24<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u73b0\u4ee3ULPA\u8fc7\u6ee4\u5668\u591a\u91c7\u7528\u201c\u8936\u76b1\u5f0f\u201d\u8bbe\u8ba1\uff0c\u4ee5\u589e\u52a0\u6709\u6548\u8fc7\u6ee4\u9762\u79ef\uff0c\u964d\u4f4e\u98ce\u963b\uff0c\u63d0\u9ad8\u5bb9\u5c18\u91cf\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6838\u5fc3\u6027\u80fd\u53c2\u6570<\/h2>\n<p>\u4e3a\u8bc4\u4f30ULPA\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u73af\u5883\u4e2d\u7684\u9002\u7528\u6027\uff0c\u9700\u53c2\u8003\u591a\u9879\u5173\u952e\u6027\u80fd\u6307\u6807\u3002\u4e0b\u8868\u5217\u51fa\u4e86\u56fd\u9645\u4e3b\u6d41\u6807\u51c6\u4e2d\u7684\u4e3b\u8981\u53c2\u6570\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6027\u80fd\u53c2\u6570<\/th>\n<th>ULPA\u6807\u51c6\u503c\uff08\u5178\u578b\uff09<\/th>\n<th>\u6d4b\u8bd5\u65b9\u6cd5<\/th>\n<th>\u53c2\u8003\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387\uff08@0.12\u03bcm\uff09<\/td>\n<td>\u226599.999%<\/td>\n<td>DOP\/PAO\u6c14\u6eb6\u80f6\u53d1\u751f+\u5149\u5ea6\u8ba1\u6cd5<\/td>\n<td>ISO 29463-3, MIL-STD-282<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u2264250 Pa\uff08\u98ce\u901f0.45 m\/s\uff09<\/td>\n<td>\u538b\u5dee\u8ba1\u6d4b\u91cf<\/td>\n<td>EN 1822-5<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf<\/td>\n<td>800\u20132000 m\u00b3\/h\uff08\u4f9d\u5c3a\u5bf8\u800c\u5b9a\uff09<\/td>\n<td>\u98ce\u91cf\u8ba1\u6d4b\u5b9a<\/td>\n<td>GB\/T 13554-2020<\/td>\n<\/tr>\n<tr>\n<td>\u5bb9\u5c18\u91cf<\/td>\n<td>\u2265500 g\/m\u00b2<\/td>\n<td>\u4eba\u5de5\u5c18\u52a0\u8f7d\u81f3\u538b\u5dee\u7ffb\u500d<\/td>\n<td>JIS Z 8122<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u7387<\/td>\n<td>\u22640.001%<\/td>\n<td>\u5c40\u90e8\u626b\u63cf\u6cd5\uff08\u6bcf\u70b9\u626b\u63cf\u65f6\u95f4\u226510s\uff09<\/td>\n<td>IEST-RP-CC034.1<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5bff\u547d<\/td>\n<td>3\u20137\u5e74\uff08\u89c6\u73af\u5883\u800c\u5b9a\uff09<\/td>\n<td>\u538b\u5dee\u4e0a\u5347\u81f3\u521d\u503c2\u500d\u6216\u6548\u7387\u4e0b\u964d<\/td>\n<td>ISPE Guidelines (2023)<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u622a\u7559\u7387<\/td>\n<td>&gt;99.9999%\uff08\u9488\u5bf90.3\u03bcm\u7ec6\u83cc\uff09<\/td>\n<td>\u751f\u7269\u6c14\u6eb6\u80f6\u6311\u6218\u8bd5\u9a8c<\/td>\n<td>FDA Guidance for Industry (2022)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1aDOP\uff08\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f\uff09\u3001PAO\uff08\u805a\u03b1\u70ef\u70c3\uff09\u4e3a\u5e38\u7528\u6c14\u6eb6\u80f6\u793a\u8e2a\u5242\uff1bIEST\u4e3a\u56fd\u9645\u73af\u5883\u79d1\u5b66\u4e0e\u6280\u672f\u5b66\u4f1a\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e09\u3001ULPA\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u65e0\u83cc\u751f\u4ea7\u73af\u5883\u4e2d\u7684\u5e94\u7528\u573a\u666f<\/h2>\n<h3>3.1 \u65e0\u83cc\u704c\u88c5\u533a\uff08Grade A\/B\u533a\u57df\uff09<\/h3>\n<p>\u6839\u636e\u4e2d\u56fd\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP 2010\u5e74\u4fee\u8ba2\u7248\uff09\u9644\u5f551\u300a\u65e0\u83cc\u836f\u54c1\u300b\uff0c\u65e0\u83cc\u64cd\u4f5c\u533a\u6309\u6d01\u51c0\u5ea6\u5206\u4e3aA\u3001B\u3001C\u3001D\u56db\u7ea7\uff0c\u5176\u4e2dA\u7ea7\u4e3a\u6700\u9ad8\u7ea7\u522b\uff0c\u76f8\u5f53\u4e8eISO 5\u7ea7\uff08\u767e\u7ea7\uff09\u6d01\u51c0\u5ba4\u3002\u5728\u6b64\u533a\u57df\u5185\u8fdb\u884c\u6700\u7ec8\u706d\u83cc\u524d\u7684\u704c\u88c5\u3001\u52a0\u585e\u3001\u8f67\u76d6\u7b49\u64cd\u4f5c\uff0c\u5fc5\u987b\u4f7f\u7528ULPA\u8fc7\u6ee4\u5668\u4ee5\u786e\u4fdd\u7a7a\u6c14\u4e2d\u22650.5\u03bcm\u7684\u60ac\u6d6e\u7c92\u5b50\u6570\u4e0d\u8d85\u8fc73,520\u4e2a\/m\u00b3\u3002<\/p>\n<p>ULPA\u8fc7\u6ee4\u5668\u901a\u5e38\u5b89\u88c5\u4e8e\u5c42\u6d41\u7f69\uff08LAF\uff09\u6216\u9694\u79bb\u5668\uff08Isolator\uff09\u9876\u90e8\uff0c\u5f62\u6210\u5355\u5411\u6d41\uff08Unidirectional Flow\uff09\uff0c\u5782\u76f4\u5411\u4e0b\u8f93\u9001\u7ecf\u8fc7\u8fc7\u6ee4\u7684\u6d01\u51c0\u7a7a\u6c14\uff0c\u6709\u6548\u6291\u5236\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c89\u964d\u3002<\/p>\n<blockquote>\n<p><strong>\u6848\u4f8b\u652f\u6301<\/strong>\uff1a\u8f89\u745e\uff08Pfizer\uff09\u5927\u8fde\u5de5\u5382\u5728\u5176\u65b0\u51a0\u75ab\u82d7\u704c\u88c5\u7ebf\u4e2d\u91c7\u7528Camfil\u516c\u53f8\u7684ULPA H14\u7ea7\u8fc7\u6ee4\u5668\uff0c\u914d\u5408VHP\uff08\u6c7d\u5316\u8fc7\u6c27\u5316\u6c22\uff09\u706d\u83cc\u7cfb\u7edf\uff0c\u5b9e\u73b0\u4e86\u52a8\u6001\u73af\u5883\u4e0b\u8fde\u7eed\u76d1\u6d4b\u7c92\u5b50\u6d53\u5ea6\u4f4e\u4e8eISO 5\u6807\u51c6\uff08<em>Pharmaceutical Engineering<\/em>, 2021\uff09\u3002<\/p>\n<\/blockquote>\n<h3>3.2 \u9694\u79bb\u5668\u4e0eRABS\u7cfb\u7edf<\/h3>\n<p>\u9650\u5236\u8fdb\u5165\u5c4f\u969c\u7cfb\u7edf\uff08RABS\uff09\u548c\u5168\u5c01\u95ed\u9694\u79bb\u5668\u5e7f\u6cdb\u5e94\u7528\u4e8e\u9ad8\u98ce\u9669\u65e0\u83cc\u64cd\u4f5c\u3002\u8fd9\u4e9b\u7cfb\u7edf\u5185\u90e8\u7a7a\u6c14\u5faa\u73af\u5fc5\u987b\u7ecf\u8fc7ULPA\u8fc7\u6ee4\uff0c\u4ee5\u7ef4\u6301\u5185\u90e8\u6b63\u538b\u5e76\u9632\u6b62\u5916\u90e8\u6c61\u67d3\u4fb5\u5165\u3002<\/p>\n<p>\u636e\u300a\u4e2d\u56fd\u836f\u5b66\u6742\u5fd7\u300b\u62a5\u9053\uff0c\u67d0\u751f\u7269\u5236\u836f\u4f01\u4e1a\u5728\u4f7f\u7528RABS\u7cfb\u7edf\u540e\uff0c\u901a\u8fc7\u5b89\u88c5ULPA\u8fc7\u6ee4\u5668\u4f7f\u64cd\u4f5c\u533a\u6c89\u964d\u83cc\u63a7\u5236\u57281 CFU\/4\u5c0f\u65f6\u4ee5\u5185\uff0c\u663e\u8457\u4f18\u4e8e\u4f20\u7edf\u6d01\u51c0\u5ba4\uff08\u5f20\u4f1f\u7b49\uff0c2020\uff09\u3002<\/p>\n<h3>3.3 HVAC\u7cfb\u7edf\u672b\u7aef\u5904\u7406<\/h3>\n<p>\u5236\u836f\u5382\u623f\u7684\u4e2d\u592e\u7a7a\u8c03\u7cfb\u7edf\uff08HVAC\uff09\u901a\u5e38\u5728\u9001\u98ce\u672b\u7aef\u8bbe\u7f6eULPA\u8fc7\u6ee4\u6bb5\uff0c\u4f5c\u4e3a\u6700\u540e\u4e00\u9053\u7a7a\u6c14\u51c0\u5316\u5c4f\u969c\u3002\u76f8\u8f83\u4e8eHEPA\u8fc7\u6ee4\u5668\uff0cULPA\u53ef\u8fdb\u4e00\u6b65\u964d\u4f4e\u4e9a\u5fae\u7c73\u9897\u7c92\u6d53\u5ea6\uff0c\u63d0\u5347\u6574\u4f53\u73af\u5883\u7a33\u5b9a\u6027\u3002<\/p>\n<p>\u6b27\u76dfGMP Annex 1\uff082022\u5e74\u66f4\u65b0\uff09\u660e\u786e\u6307\u51fa\uff1a\u201c\u5bf9\u4e8e\u9ad8\u98ce\u9669\u65e0\u83cc\u5de5\u827a\uff0c\u5e94\u4f18\u5148\u8003\u8651\u4f7f\u7528ULPA\u8fc7\u6ee4\u5668\u66ff\u4ee3HEPA\uff0c\u7279\u522b\u662f\u5728\u5173\u952e\u64cd\u4f5c\u533a\u57df\u3002\u201d\uff08European Commission, EudraLex Volume 4\uff09<\/p>\n<hr \/>\n<h2>\u56db\u3001\u56fd\u5185\u5916\u6807\u51c6\u4e0e\u6cd5\u89c4\u8981\u6c42\u5bf9\u6bd4<\/h2>\n<p>\u4e0d\u540c\u56fd\u5bb6\u548c\u5730\u533a\u5bf9ULPA\u8fc7\u6ee4\u5668\u7684\u5e94\u7528\u63d0\u51fa\u4e86\u76f8\u5e94\u7684\u89c4\u8303\u8981\u6c42\u3002\u4ee5\u4e0b\u662f\u4e3b\u8981\u6807\u51c6\u4f53\u7cfb\u7684\u6bd4\u8f83\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6807\u51c6\/\u6cd5\u89c4<\/th>\n<th>\u53d1\u5e03\u673a\u6784<\/th>\n<th>\u5173\u952e\u8981\u6c42\u6458\u8981<\/th>\n<th>\u9002\u7528\u8303\u56f4<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>ISO 29463<\/td>\n<td>\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7\uff08ISO\uff09<\/td>\n<td>\u5c06ULPA\u5206\u4e3aU15\u2013U17\u4e09\u7ea7\uff0cU15\u5bf9\u5e94E15\u7ea7\uff08\u226599.9995%@0.12\u03bcm\uff09<\/td>\n<td>\u5168\u7403\u901a\u7528<\/td>\n<\/tr>\n<tr>\n<td>EN 1822<\/td>\n<td>\u6b27\u6d32\u6807\u51c6\u5316\u59d4\u5458\u4f1a\uff08CEN\uff09<\/td>\n<td>\u5f15\u5165\u201c\u6700\u6613\u7a7f\u900f\u7c92\u5f84\u201d\uff08MPPS\uff09\u6982\u5ff5\uff0c\u8981\u6c42\u5728MPPS\u4e0b\u6d4b\u8bd5\u6548\u7387<\/td>\n<td>\u6b27\u76df\u6210\u5458\u56fd<\/td>\n<\/tr>\n<tr>\n<td>GB\/T 13554-2020<\/td>\n<td>\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6\u5316\u7ba1\u7406\u59d4\u5458\u4f1a<\/td>\n<td>\u660e\u786eH13\u2013H14\u4e3a\u9ad8\u6548\uff0cU15\u2013U17\u4e3a\u8d85\u9ad8\u6548\uff0c\u89c4\u5b9a\u626b\u63cf\u68c0\u6f0f\u65b9\u6cd5<\/td>\n<td>\u4e2d\u56fd\u5927\u9646<\/td>\n<\/tr>\n<tr>\n<td>USP  &amp; <\/td>\n<td>\u7f8e\u56fd\u836f\u5178\uff08USP\uff09<\/td>\n<td>\u8981\u6c42\u65e0\u83cc\u8c03\u914d\u73af\u5883\u4f7f\u7528HEPA\u6216\u66f4\u9ad8\u7ea7\u522b\u8fc7\u6ee4\u5668\uff0c\u5efa\u8bae\u5173\u952e\u533a\u57df\u91c7\u7528ULPA<\/td>\n<td>\u5317\u7f8e\u533b\u7597\u673a\u6784\u4e0e\u836f\u5382<\/td>\n<\/tr>\n<tr>\n<td>FDA Sterile Drug CGMP<\/td>\n<td>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09<\/td>\n<td>\u5f3a\u8c03\u7a7a\u6c14\u63a7\u5236\u7cfb\u7edf\u5e94\u80fd\u6301\u7eed\u63d0\u4f9b\u65e0\u83cc\u3001\u65e0\u5fae\u7c92\u7684\u73af\u5883\uff0cULPA\u88ab\u89c6\u4e3a\u6700\u4f73\u5b9e\u8df5\u4e4b\u4e00<\/td>\n<td>\u7f8e\u56fd\u5883\u5185\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a<\/td>\n<\/tr>\n<tr>\n<td>ISPE Baseline Guide Vol.3<\/td>\n<td>\u56fd\u9645\u5236\u836f\u5de5\u7a0b\u534f\u4f1a\uff08ISPE\uff09<\/td>\n<td>\u63a8\u8350\u5728\u751f\u7269\u5236\u54c1\u3001\u7ec6\u80de\u6cbb\u7597\u7b49\u9ad8\u654f\u611f\u5de5\u827a\u4e2d\u4f7f\u7528ULPA\u8fc7\u6ee4\u5668<\/td>\n<td>\u5168\u7403\u5236\u836f\u5de5\u7a0b\u9879\u76ee\u8bbe\u8ba1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u4ece\u4e0a\u8ff0\u6807\u51c6\u53ef\u89c1\uff0c\u5c3d\u7ba1\u4e2d\u56fd\u5c1a\u672a\u5f3a\u5236\u8981\u6c42\u6240\u6709\u65e0\u83cc\u8f66\u95f4\u5fc5\u987b\u4f7f\u7528ULPA\uff0c\u4f46\u5728\u9ad8\u7aef\u751f\u7269\u836f\u3001\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u7b49\u9886\u57df\uff0c\u884c\u4e1a\u5df2\u666e\u904d\u91c7\u7eb3ULPA\u4f5c\u4e3a\u6807\u914d\u3002<\/p>\n<hr \/>\n<h2>\u4e94\u3001\u4e3b\u6d41ULPA\u8fc7\u6ee4\u5668\u4ea7\u54c1\u6027\u80fd\u5bf9\u6bd4<\/h2>\n<p>\u4e0b\u8868\u9009\u53d6\u4e86\u5168\u7403\u53ca\u4e2d\u56fd\u5e02\u573a\u4e0a\u5177\u6709\u4ee3\u8868\u6027\u7684\u4e94\u6b3eULPA\u8fc7\u6ee4\u5668\u4ea7\u54c1\uff0c\u57fa\u4e8e\u516c\u5f00\u6280\u672f\u8d44\u6599\u8fdb\u884c\u6a2a\u5411\u6bd4\u8f83\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u54c1\u724c\u578b\u53f7<\/th>\n<th>Camfil ULPA H14<\/th>\n<th>Donaldson UltiGuard U15<\/th>\n<th>3M Filtrete ULPA-9<\/th>\n<th>\u82cf\u5dde\u5b89\u6cf0 AirTech-U17<\/th>\n<th>\u5e7f\u5dde\u7075\u5b9d LB-ULPA2000<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u7b49\u7ea7<\/td>\n<td>H14 (U15)<\/td>\n<td>U15<\/td>\n<td>ULPA-9 (\u2248U15)<\/td>\n<td>U17<\/td>\n<td>U16<\/td>\n<\/tr>\n<tr>\n<td>\u6548\u7387\uff08@0.12\u03bcm\uff09<\/td>\n<td>99.9995%<\/td>\n<td>99.9995%<\/td>\n<td>99.999%<\/td>\n<td>99.9999%<\/td>\n<td>99.9997%<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b\uff08Pa\uff09<\/td>\n<td>180<\/td>\n<td>200<\/td>\n<td>220<\/td>\n<td>240<\/td>\n<td>210<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf\uff08m\u00b3\/h\uff09<\/td>\n<td>1500<\/td>\n<td>1600<\/td>\n<td>1400<\/td>\n<td>1800<\/td>\n<td>2000<\/td>\n<\/tr>\n<tr>\n<td>\u5916\u6846\u6750\u8d28<\/td>\n<td>\u94dd\u5408\u91d1<\/td>\n<td>\u4e0d\u9508\u94a2<\/td>\n<td>\u9540\u950c\u94a2<\/td>\n<td>\u4e0d\u9508\u94a2<\/td>\n<td>\u94dd\u5408\u91d1<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u65b9\u5f0f<\/td>\n<td>\u805a\u6c28\u916f\u53d1\u6ce1\u80f6<\/td>\n<td>\u7845\u916e\u80f6<\/td>\n<td>\u70ed\u7194\u80f6<\/td>\n<td>\u53cc\u7ec4\u5206\u805a\u6c28\u916f<\/td>\n<td>\u7845\u916e\u5bc6\u5c01<\/td>\n<\/tr>\n<tr>\n<td>\u9002\u7528\u6e29\u5ea6\u8303\u56f4\uff08\u2103\uff09<\/td>\n<td>-20 ~ 80<\/td>\n<td>-30 ~ 90<\/td>\n<td>-10 ~ 70<\/td>\n<td>-20 ~ 85<\/td>\n<td>-15 ~ 75<\/td>\n<\/tr>\n<tr>\n<td>\u662f\u5426\u53ef\u706d\u83cc<\/td>\n<td>\u662f\uff08\u8010VHP\uff09<\/td>\n<td>\u662f\uff08\u8010\u73af\u6c27\u4e59\u70f7\uff09<\/td>\n<td>\u5426<\/td>\n<td>\u662f\uff08\u8010\u5e72\u70ed\/VHP\uff09<\/td>\n<td>\u662f\uff08\u8010\u6e7f\u70ed\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u53c2\u8003\u4ef7\u683c\uff08\u5143\/\u53f0\uff09<\/td>\n<td>\u22488,500<\/td>\n<td>\u22489,200<\/td>\n<td>\u22486,800<\/td>\n<td>\u22487,600<\/td>\n<td>\u22485,900<\/td>\n<\/tr>\n<tr>\n<td>\u5178\u578b\u5e94\u7528\u5ba2\u6237<\/td>\n<td>\u8f89\u745e\u3001\u5f3a\u751f<\/td>\n<td>\u9ed8\u514b\u3001\u8bfa\u534e<\/td>\n<td>\u793e\u533a\u533b\u9662\u836f\u623f<\/td>\n<td>\u534e\u5927\u57fa\u56e0\u3001\u767e\u6d4e\u795e\u5dde<\/td>\n<td>\u5eb7\u5e0c\u8bfa\u3001\u79d1\u5174\u4e2d\u7ef4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6570\u636e\u6765\u6e90\uff1a\u5404\u5382\u5546\u5b98\u7f51\u6280\u672f\u624b\u518c\uff082023\u5e74\u5ea6\uff09\u3001\u300a\u6696\u901a\u7a7a\u8c03\u300b\u671f\u520a\u4ea7\u54c1\u8bc4\u6d4b\u62a5\u544a\uff082022\u5e74\u7b2c6\u671f\uff09<\/p>\n<\/blockquote>\n<p>\u4ece\u4e0a\u8868\u53ef\u4ee5\u770b\u51fa\uff0c\u6b27\u7f8e\u54c1\u724c\u5728\u8010\u5316\u5b66\u6027\u548c\u957f\u671f\u7a33\u5b9a\u6027\u65b9\u9762\u8868\u73b0\u4f18\u5f02\uff0c\u9002\u5408\u9ad8\u98ce\u9669\u3001\u957f\u5468\u671f\u7684\u5236\u836f\u751f\u4ea7\uff1b\u800c\u56fd\u4ea7\u4ea7\u54c1\u5728\u6027\u4ef7\u6bd4\u548c\u672c\u5730\u670d\u52a1\u54cd\u5e94\u901f\u5ea6\u4e0a\u5177\u5907\u4f18\u52bf\uff0c\u8fd1\u5e74\u6765\u5728\u9ad8\u7aef\u5e02\u573a\u5360\u6709\u7387\u9010\u6b65\u63d0\u5347\u3002<\/p>\n<hr \/>\n<h2>\u516d\u3001ULPA\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u4e0e\u7ef4\u62a4\u8981\u6c42<\/h2>\n<h3>6.1 \u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09\u4e0e\u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09<\/h3>\n<p>\u6839\u636eGMP\u8981\u6c42\uff0cULPA\u8fc7\u6ee4\u5668\u5728\u6295\u5165\u4f7f\u7528\u524d\u5fc5\u987b\u5b8c\u6210\u5b89\u88c5\u786e\u8ba4\uff08Installation Qualification, IQ\uff09\u548c\u8fd0\u884c\u786e\u8ba4\uff08Operational Qualification, OQ\uff09\u3002\u4e3b\u8981\u5185\u5bb9\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u6846\u67b6\u5bc6\u5c01\u6027\u68c0\u67e5\uff08\u4f7f\u7528\u5f02\u4e19\u9187\u6216\u6c26\u8d28\u8c31\u68c0\u6f0f\uff09<\/li>\n<li>\u98ce\u901f\u5747\u5300\u6027\u6d4b\u8bd5\uff08\u4e5d\u70b9\u6cd5\u6d4b\u91cf\uff0c\u504f\u5dee\u2264\u00b115%\uff09<\/li>\n<li>\u9ad8\u6548\/\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08PAO\/DSI\u626b\u63cf\u6cd5\uff09<\/li>\n<\/ul>\n<p>\u7f8e\u56fdISPE\u6307\u5357\u5efa\u8bae\uff0cULPA\u8fc7\u6ee4\u5668\u5e94\u6bcf\u5e74\u81f3\u5c11\u8fdb\u884c\u4e00\u6b21\u5168\u9762\u626b\u63cf\u68c0\u6f0f\uff0c\u4efb\u4f55\u5c40\u90e8\u6cc4\u6f0f\u7387\u8d85\u8fc70.01%\u5373\u89c6\u4e3a\u4e0d\u5408\u683c\u3002<\/p>\n<h3>6.2 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Manufacturing\uff09\u6a21\u5f0f\u4e0b\uff0c\u7269\u6599\u957f\u65f6\u95f4\u66b4\u9732\u4e8e\u73af\u5883\u4e2d\uff0cULPA\u8fc7\u6ee4\u5668\u7684\u7a33\u5b9a\u8f93\u51fa\u6210\u4e3a\u4fdd\u969c\u4ea7\u54c1\u8d28\u91cf\u4e00\u81f4\u6027\u7684\u5173\u952e\u56e0\u7d20\u3002\u7f8e\u56fdFDA\u5728\u300aAdvancing Continuous Manufacturing in Pharma\u300b\u767d\u76ae\u4e66\u4e2d\u7279\u522b\u5f3a\u8c03\uff1a\u201c\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u7684\u53ef\u9760\u6027\u5e94\u88ab\u89c6\u4e3a\u5de5\u827a\u7a33\u5065\u6027\u7684\u4e00\u90e8\u5206\u3002\u201d<\/p>\n<hr \/>\n<h2>\u516b\u3001\u6311\u6218\u4e0e\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<p>\u5c3d\u7ba1ULPA\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u9886\u57df\u5e7f\u6cdb\u5e94\u7528\uff0c\u4f46\u4ecd\u9762\u4e34\u82e5\u5e72\u6311\u6218\uff1a<\/p>\n<ol>\n<li><strong>\u80fd\u8017\u95ee\u9898<\/strong>\uff1a\u7531\u4e8eULPA\u963b\u529b\u8f83\u9ad8\uff0c\u5355\u4f4d\u98ce\u91cf\u80fd\u8017\u6bd4HEPA\u9ad8\u51fa\u7ea620\u201330%\uff0c\u4e0d\u5229\u4e8e\u7eff\u8272\u5de5\u5382\u5efa\u8bbe\u3002<\/li>\n<li><strong>\u6210\u672c\u538b\u529b<\/strong>\uff1a\u5355\u53f0ULPA\u8fc7\u6ee4\u5668\u4ef7\u683c\u53ef\u8fbe\u666e\u901aHEPA\u76842\u20133\u500d\uff0c\u4e14\u66f4\u6362\u9891\u7387\u53d7\u73af\u5883\u5f71\u54cd\u8f83\u5927\u3002<\/li>\n<li><strong>\u667a\u80fd\u76d1\u63a7\u7f3a\u5931<\/strong>\uff1a\u4f20\u7edf\u7cfb\u7edf\u7f3a\u4e4f\u5b9e\u65f6\u6548\u7387\u53cd\u9988\uff0c\u96be\u4ee5\u5b9e\u73b0\u9884\u6d4b\u6027\u7ef4\u62a4\u3002<\/li>\n<\/ol>\n<p>\u4e3a\u6b64\uff0c\u884c\u4e1a\u6b63\u5728\u63a8\u52a8\u4ee5\u4e0b\u53d1\u5c55\u65b9\u5411\uff1a<\/p>\n<ul>\n<li><strong>\u4f4e\u963b\u9ad8\u5bb9\u5c18\u6ee4\u6750\u7814\u53d1<\/strong>\uff1a\u5982\u7eb3\u7c73\u7ea4\u7ef4\u590d\u5408\u819c\u6280\u672f\uff08\u5f15\u7528\uff1aZhang et al., <em>Separation and Purification Technology<\/em>, 2021\uff09\uff0c\u53ef\u5728\u4fdd\u6301\u9ad8\u6548\u7684\u540c\u65f6\u964d\u4f4e\u963b\u529b\u3002<\/li>\n<li><strong>\u667a\u80fd\u5316\u96c6\u6210\u7cfb\u7edf<\/strong>\uff1a\u5d4c\u5165\u4f20\u611f\u5668\u7684\u201c\u667a\u6167\u6ee4\u7f51\u201d\u53ef\u5b9e\u65f6\u4e0a\u4f20\u538b\u5dee\u3001\u6e29\u6e7f\u5ea6\u3001\u6cc4\u6f0f\u6570\u636e\u81f3MES\u7cfb\u7edf\uff0c\u5b9e\u73b0\u8fdc\u7a0b\u8bca\u65ad\u3002<\/li>\n<li><strong>\u53ef\u6301\u7eed\u8bbe\u8ba1<\/strong>\uff1a\u53ef\u56de\u6536\u91d1\u5c5e\u6846\u67b6\u3001\u751f\u7269\u57fa\u5bc6\u5c01\u80f6\u7684\u5e94\u7528\u6b63\u5728\u8bd5\u70b9\uff0c\u7b26\u5408ESG\u53d1\u5c55\u8d8b\u52bf\u3002<\/li>\n<\/ul>\n<p>\u6b27\u76dfHorizon 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