{"id":15745,"date":"2025-06-27T11:40:04","date_gmt":"2025-06-27T03:40:04","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15745"},"modified":"2025-06-27T11:40:04","modified_gmt":"2025-06-27T03:40:04","slug":"u16%e9%ab%98%e6%95%88%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%b4%81%e5%87%80%e8%bd%a6%e9%97%b4%e7%9a%84%e5%ba%94%e7%94%a8%e8%a6%81%e6%b1%82","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15745","title":{"rendered":"U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u8f66\u95f4\u7684\u5e94\u7528\u8981\u6c42"},"content":{"rendered":"<h1>U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u8f66\u95f4\u7684\u5e94\u7528\u8981\u6c42<\/h1>\n<h2>\u4e00\u3001\u5f15\u8a00\uff1a\u5236\u836f\u884c\u4e1a\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u4e25\u683c\u8981\u6c42<\/h2>\n<p>\u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u60a3\u8005\u7684\u751f\u547d\u5b89\u5168\u548c\u5065\u5eb7\u3002\u56e0\u6b64\uff0c\u5236\u836f\u751f\u4ea7\u73af\u5883\u5fc5\u987b\u7b26\u5408\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u8981\u6c42\uff0c\u786e\u4fdd\u4ea7\u54c1\u5728\u6574\u4e2a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4e0d\u53d7\u6c61\u67d3\u3002\u5176\u4e2d\uff0c\u7a7a\u6c14\u6d01\u51c0\u5ea6\u662fGMP\u6d01\u51c0\u8f66\u95f4\u63a7\u5236\u7684\u5173\u952e\u6307\u6807\u4e4b\u4e00\uff0c\u800c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter, HEPA\uff09\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u6838\u5fc3\u8bbe\u5907\uff0c\u5728\u4fdd\u969c\u7a7a\u6c14\u8d28\u91cf\u65b9\u9762\u53d1\u6325\u7740\u81f3\u5173\u91cd\u8981\u7684\u4f5c\u7528\u3002<\/p>\n<p>U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f5c\u4e3aHEPA\u6ee4\u5668\u4e2d\u7684\u9ad8\u7b49\u7ea7\u4ea7\u54c1\uff0c\u5176\u8fc7\u6ee4\u6548\u7387\u9ad8\u8fbe99.99995%\uff0c\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d0.3\u5fae\u7c73\u4ee5\u4e0a\u7684\u9897\u7c92\u7269\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u884c\u4e1a\u7684A\/B\u7ea7\u6d01\u51c0\u533a\u57df\u3002\u672c\u6587\u5c06\u56f4\u7ed5U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u53c2\u6570\u3001\u6027\u80fd\u7279\u70b9\u3001\u5b89\u88c5\u8981\u6c42\u53ca\u5176\u5728\u5236\u836fGMP\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u5e94\u7528\u8fdb\u884c\u6df1\u5165\u63a2\u8ba8\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u76f8\u5173\u6587\u732e\u8d44\u6599\uff0c\u5206\u6790\u5176\u5728\u5b9e\u9645\u8fd0\u884c\u4e2d\u7684\u6548\u679c\u4e0e\u6311\u6218\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>2.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p>\u6839\u636e\u6b27\u6d32\u6807\u51c6EN 1822-1:2009\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u7684\u89c4\u5b9a\uff0c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6309\u7167\u8fc7\u6ee4\u6548\u7387\u5206\u4e3aE10~U17\u51718\u4e2a\u7b49\u7ea7\u3002\u5176\u4e2d\uff1a<\/p>\n<ul>\n<li><strong>U16\u7ea7<\/strong>\uff1a\u8fc7\u6ee4\u6548\u7387\u226599.99995%\uff08MPPS\u7c92\u5f84\u4e0b\uff09\uff0c\u5373\u7a7f\u900f\u7387\u22640.00005%<\/li>\n<li><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u4e3b\u8981\u7528\u4e8eISO 4\u7ea7\u53ca\u4ee5\u4e0a\u6d01\u51c0\u5ba4\uff08\u5982Class 100\/ISO 5\u6216\u66f4\u9ad8\uff09<\/li>\n<\/ul>\n<p>U16\u8fc7\u6ee4\u5668\u5c5e\u4e8e\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08Ultra Low Penetration Air Filter, ULPA\uff09\u8303\u7574\uff0c\u9002\u7528\u4e8e\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u6709\u6781\u9ad8\u8981\u6c42\u7684\u73af\u5883\uff0c\u4f8b\u5982\u65e0\u83cc\u836f\u54c1\u704c\u88c5\u533a\u3001\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\u7b49\u3002<\/p>\n<h3>2.2 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e3b\u8981\u4f9d\u8d56\u4ee5\u4e0b\u51e0\u79cd\u7269\u7406\u673a\u5236\u5b9e\u73b0\u9ad8\u6548\u8fc7\u6ee4\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u8fc7\u6ee4\u673a\u5236<\/th>\n<th>\u63cf\u8ff0<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6269\u6563\u6548\u5e94<\/td>\n<td>\u5c0f\u4e8e0.1\u03bcm\u7684\u9897\u7c92\u56e0\u5e03\u6717\u8fd0\u52a8\u88ab\u7ea4\u7ef4\u6355\u83b7<\/td>\n<\/tr>\n<tr>\n<td>\u622a\u7559\u6548\u5e94<\/td>\n<td>\u5927\u4e8e0.3\u03bcm\u7684\u9897\u7c92\u56e0\u63a5\u89e6\u7ea4\u7ef4\u8868\u9762\u88ab\u6355\u83b7<\/td>\n<\/tr>\n<tr>\n<td>\u60ef\u6027\u649e\u51fb<\/td>\n<td>\u9ad8\u901f\u6d41\u52a8\u7684\u6c14\u6d41\u4f7f\u8f83\u5927\u9897\u7c92\u504f\u79bb\u8f68\u8ff9\u5e76\u649e\u51fb\u7ea4\u7ef4<\/td>\n<\/tr>\n<tr>\n<td>\u9759\u7535\u5438\u9644<\/td>\n<td>\u5e26\u7535\u9897\u7c92\u88ab\u5e26\u9759\u7535\u7684\u7ea4\u7ef4\u5438\u5f15<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u8fd9\u4e9b\u673a\u5236\u5171\u540c\u4f5c\u7528\uff0c\u4f7f\u5f97U16\u8fc7\u6ee4\u5668\u80fd\u591f\u5bf9\u7a7a\u6c14\u4e2d\u5404\u79cd\u5c3a\u5bf8\u7684\u9897\u7c92\u7269\u8fdb\u884c\u9ad8\u6548\u62e6\u622a\uff0c\u4ece\u800c\u8fbe\u5230\u6781\u9ad8\u7684\u51c0\u5316\u6548\u679c\u3002<\/p>\n<h3>2.3 \u4e3b\u8981\u7ed3\u6784\u7ec4\u6210<\/h3>\n<p>\u5178\u578b\u7684U16\u9ad8\u6548\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<\/th>\n<th>\u529f\u80fd<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6ee4\u6750<\/td>\n<td>\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4\u3001\u805a\u4e19\u70ef<\/td>\n<td>\u5b9e\u73b0\u9ad8\u6548\u8fc7\u6ee4<\/td>\n<\/tr>\n<tr>\n<td>\u5206\u9694\u677f<\/td>\n<td>\u7eb8\u8d28\u6216\u94dd\u7b94<\/td>\n<td>\u5206\u9694\u6ee4\u6750\uff0c\u589e\u5f3a\u652f\u6491<\/td>\n<\/tr>\n<tr>\n<td>\u8fb9\u6846<\/td>\n<td>\u4e0d\u9508\u94a2\u3001\u94dd\u5408\u91d1\u6216\u5851\u6599<\/td>\n<td>\u63d0\u4f9b\u7ed3\u6784\u5f3a\u5ea6<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u6750\u6599<\/td>\n<td>\u7845\u80f6\u3001\u805a\u6c28\u916f<\/td>\n<td>\u786e\u4fdd\u5bc6\u5c01\u6027<\/td>\n<\/tr>\n<tr>\n<td>\u6392\u6c14\u5b54<\/td>\n<td>\u53ef\u9009<\/td>\n<td>\u7528\u4e8e\u68c0\u6d4b\u6cc4\u6f0f<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e09\u3001U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u6280\u672f\u53c2\u6570\u4e0e\u6027\u80fd\u6307\u6807<\/h2>\n<p>\u4e3a\u6ee1\u8db3\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u8f66\u95f4\u7684\u9ad8\u6807\u51c6\u9700\u6c42\uff0cU16\u9ad8\u6548\u8fc7\u6ee4\u5668\u9700\u5177\u5907\u4ee5\u4e0b\u5173\u952e\u6027\u80fd\u53c2\u6570\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u6307\u6807<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u2264250 Pa<\/td>\n<td>\u8868\u793a\u6ee4\u5668\u521d\u59cb\u72b6\u6001\u4e0b\u7684\u538b\u964d<\/td>\n<\/tr>\n<tr>\n<td>\u6700\u7ec8\u5bb9\u5c18\u91cf<\/td>\n<td>\u2265800 g\/m\u00b2<\/td>\n<td>\u6ee4\u6750\u53ef\u627f\u8f7d\u7684\u6700\u5927\u7070\u5c18\u91cf<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387\uff08MPPS\uff09<\/td>\n<td>\u226599.99995%<\/td>\n<td>\u5bf9\u6700\u6613\u7a7f\u900f\u7c92\u5b50\u7684\u8fc7\u6ee4\u6548\u7387<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u7387<\/td>\n<td>\u22640.001%<\/td>\n<td>\u4f7f\u7528PAO\u6d4b\u8bd5\u65b9\u6cd5\u68c0\u6d4b<\/td>\n<\/tr>\n<tr>\n<td>\u5de5\u4f5c\u6e29\u5ea6\u8303\u56f4<\/td>\n<td>-30\u2103\uff5e80\u2103<\/td>\n<td>\u9002\u5e94\u4e0d\u540c\u73af\u5883\u6761\u4ef6<\/td>\n<\/tr>\n<tr>\n<td>\u6e7f\u5ea6\u8010\u53d7\u6027<\/td>\n<td>\u226495% RH<\/td>\n<td>\u9632\u6b62\u6ee4\u6750\u53d7\u6f6e\u5931\u6548<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u6750\u6750\u8d28<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\/\u5408\u6210\u7ea4\u7ef4<\/td>\n<td>\u5177\u5907\u9ad8\u5316\u5b66\u7a33\u5b9a\u6027<\/td>\n<\/tr>\n<tr>\n<td>\u6807\u51c6\u8ba4\u8bc1<\/td>\n<td>EN 1822, ISO 45001, FDA cGMP<\/td>\n<td>\u7b26\u5408\u56fd\u9645\u4e0e\u56fd\u5185\u6807\u51c6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>3.1 \u56fd\u5185\u5916\u4e3b\u6d41\u54c1\u724c\u53ca\u53c2\u6570\u5bf9\u6bd4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u54c1\u724c<\/th>\n<th>\u578b\u53f7<\/th>\n<th>\u6548\u7387<\/th>\n<th>\u521d\u59cb\u963b\u529b(Pa)<\/th>\n<th>\u6cc4\u6f0f\u7387<\/th>\n<th>\u8ba4\u8bc1\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Camfil\uff08\u745e\u5178\uff09<\/td>\n<td>CamCarb U16<\/td>\n<td>99.99995%<\/td>\n<td>220<\/td>\n<td>&lt;0.001%<\/td>\n<td>EN 1822, ISO 14644-1<\/td>\n<\/tr>\n<tr>\n<td>Donaldson\uff08\u7f8e\u56fd\uff09<\/td>\n<td>Ultra-Web U16<\/td>\n<td>99.99995%<\/td>\n<td>230<\/td>\n<td>&lt;0.001%<\/td>\n<td>FDA 21 CFR Part 211<\/td>\n<\/tr>\n<tr>\n<td>\u4e2d\u79d1\u6717\u535a\uff08\u4e2d\u56fd\uff09<\/td>\n<td>LB-U16<\/td>\n<td>99.99995%<\/td>\n<td>240<\/td>\n<td>\u22640.001%<\/td>\n<td>GB\/T 13554-2020<\/td>\n<\/tr>\n<tr>\n<td>Freudenberg\uff08\u5fb7\u56fd\uff09<\/td>\n<td>Viledon U16<\/td>\n<td>99.99995%<\/td>\n<td>210<\/td>\n<td>&lt;0.001%<\/td>\n<td>DIN EN 1822<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u4ece\u4e0a\u8868\u53ef\u89c1\uff0c\u65e0\u8bba\u56fd\u5185\u5916\u54c1\u724c\uff0cU16\u9ad8\u6548\u8fc7\u6ee4\u5668\u5747\u80fd\u6ee1\u8db3\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u7684\u4e25\u82db\u8981\u6c42\u3002\u4f46\u5728\u9009\u62e9\u65f6\u4ecd\u5e94\u8003\u8651\u8bbe\u5907\u517c\u5bb9\u6027\u3001\u7ef4\u62a4\u6210\u672c\u4ee5\u53ca\u672c\u5730\u5316\u670d\u52a1\u7b49\u56e0\u7d20\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836fGMP\u6d01\u51c0\u8f66\u95f4\u7684\u5e94\u7528\u8981\u6c42<\/h2>\n<h3>4.1 \u6d01\u51c0\u7b49\u7ea7\u4e0e\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u8bbe\u8ba1<\/h3>\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\u201c\u65e0\u83cc\u836f\u54c1\u201d\u89c4\u5b9a\uff0c\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u6309\u7a7a\u6c14\u6d01\u51c0\u5ea6\u5212\u5206\u4e3aA\u3001B\u3001C\u3001D\u56db\u4e2a\u7ea7\u522b\uff0c\u5176\u4e2d\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7b49\u7ea7<\/th>\n<th>ISO\u7b49\u7ea7<\/th>\n<th>\u7c92\u5b50\u6d53\u5ea6\u9650\u503c\uff08\u22650.5\u03bcm\uff09<\/th>\n<th>\u5e94\u7528\u533a\u57df<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7<\/td>\n<td>ISO 5<\/td>\n<td>\u22643,520\u7c92\/m\u00b3<\/td>\n<td>\u65e0\u83cc\u64cd\u4f5c\u533a<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7<\/td>\n<td>ISO 7<\/td>\n<td>\u2264352,000\u7c92\/m\u00b3<\/td>\n<td>\u5c40\u90e8\u80cc\u666f\u73af\u5883<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7<\/td>\n<td>ISO 8<\/td>\n<td>\u22643,520,000\u7c92\/m\u00b3<\/td>\n<td>\u4e00\u822c\u63a7\u5236\u533a<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7<\/td>\n<td>ISO 9<\/td>\n<td>\u226410,000,000\u7c92\/m\u00b3<\/td>\n<td>\u8f85\u52a9\u533a\u57df<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u5e38\u7528\u4e8eA\u7ea7\u6d01\u51c0\u533a\u7684\u9001\u98ce\u672b\u7aef\uff0c\u4ee5\u4fdd\u8bc1\u8be5\u533a\u57df\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8fbe\u5230\u6700\u9ad8\u6807\u51c6\u3002\u5176\u5b89\u88c5\u4f4d\u7f6e\u5e94\u5728\u7a7a\u8c03\u7cfb\u7edf\u7684\u6700\u7ec8\u9001\u98ce\u53e3\u5904\uff0c\u5e76\u914d\u5408\u521d\u6548\u3001\u4e2d\u6548\u8fc7\u6ee4\u5668\u5f62\u6210\u591a\u7ea7\u8fc7\u6ee4\u4f53\u7cfb\u3002<\/p>\n<h3>4.2 \u5b89\u88c5\u4e0e\u5e03\u5c40\u8981\u6c42<\/h3>\n<p>\u4e3a\u786e\u4fddU16\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6b63\u5e38\u8fd0\u884c\u548c\u8fc7\u6ee4\u6548\u679c\uff0c\u5176\u5b89\u88c5\u5e94\u6ee1\u8db3\u4ee5\u4e0b\u8981\u6c42\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5b89\u88c5\u9879\u76ee<\/th>\n<th>\u6280\u672f\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5b89\u88c5\u4f4d\u7f6e<\/td>\n<td>\u8bbe\u7f6e\u4e8e\u6d01\u51c0\u5ba4\u9001\u98ce\u672b\u7aef\uff0c\u907f\u514d\u56de\u98ce\u5e72\u6270<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u88c5\u65b9\u5411<\/td>\n<td>\u660e\u786e\u6807\u6ce8\u6c14\u6d41\u65b9\u5411\uff0c\u4e0d\u5f97\u53cd\u5411\u5b89\u88c5<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u6027\u8981\u6c42<\/td>\n<td>\u4f7f\u7528\u7845\u80f6\u5bc6\u5c01\u6761\u6216\u6db2\u69fd\u5bc6\u5c01\uff0c\u9632\u6b62\u6cc4\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>\u652f\u6491\u7ed3\u6784<\/td>\n<td>\u5b89\u88c5\u6846\u67b6\u5e94\u5e73\u6574\u575a\u56fa\uff0c\u907f\u514d\u632f\u52a8\u5f71\u54cd<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u5468\u671f<\/td>\n<td>\u6839\u636e\u538b\u5dee\u53d8\u5316\u548c\u5b9a\u671f\u68c0\u6d4b\u7ed3\u679c\u51b3\u5b9a\u66f4\u6362\u65f6\u95f4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u6b64\u5916\uff0cU16\u8fc7\u6ee4\u5668\u5e94\u914d\u5907\u5728\u7ebf\u76d1\u6d4b\u88c5\u7f6e\uff0c\u5b9e\u65f6\u76d1\u63a7\u538b\u5dee\u3001\u98ce\u901f\u3001\u6cc4\u6f0f\u60c5\u51b5\uff0c\u4ee5\u4fbf\u53ca\u65f6\u9884\u8b66\u548c\u7ef4\u62a4\u3002<\/p>\n<h3>4.3 \u6027\u80fd\u9a8c\u8bc1\u4e0e\u5b9a\u671f\u68c0\u6d4b<\/h3>\n<p>\u6839\u636eFDA\u6307\u5357\u548c\u4e2d\u56fdGMP\u6cd5\u89c4\uff0cU16\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u6295\u5165\u4f7f\u7528\u524d\u53ca\u4f7f\u7528\u8fc7\u7a0b\u4e2d\u5fc5\u987b\u8fdb\u884c\u4e25\u683c\u7684\u6027\u80fd\u9a8c\u8bc1\u548c\u5b9a\u671f\u68c0\u6d4b\uff0c\u4e3b\u8981\u5305\u62ec\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u68c0\u6d4b\u9879\u76ee<\/th>\n<th>\u65b9\u6cd5<\/th>\n<th>\u9891\u7387<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u59cb\u6548\u7387\u6d4b\u8bd5<\/td>\n<td>PAO\u5149\u5ea6\u8ba1\u6cd5<\/td>\n<td>\u5b89\u88c5\u540e\u9996\u6b21\u4f7f\u7528\u524d<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u68c0\u6d4b<\/td>\n<td>\u626b\u63cf\u5f0fPAO\u68c0\u6d4b<\/td>\n<td>\u6bcf\u5e74\u81f3\u5c11\u4e00\u6b21<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u76d1\u6d4b<\/td>\n<td>\u6570\u5b57\u538b\u5dee\u8ba1<\/td>\n<td>\u5b9e\u65f6\u5728\u7ebf\u76d1\u6d4b<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u901f\u68c0\u6d4b<\/td>\n<td>\u70ed\u7403\u98ce\u901f\u4eea<\/td>\n<td>\u6bcf\u5b63\u5ea6\u4e00\u6b21<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u9650\u5ea6\u68c0\u6d4b<\/td>\n<td>\u6c89\u964d\u83cc\/\u6d6e\u6e38\u83cc\u91c7\u6837<\/td>\n<td>\u6bcf\u6708\u4e00\u6b21<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u901a\u8fc7\u4e0a\u8ff0\u68c0\u6d4b\u624b\u6bb5\uff0c\u53ef\u4ee5\u786e\u4fddU16\u8fc7\u6ee4\u5668\u59cb\u7ec8\u5904\u4e8e\u6700\u4f73\u5de5\u4f5c\u72b6\u6001\uff0c\u4fdd\u969c\u6d01\u51c0\u8f66\u95f4\u7684\u7a7a\u6c14\u8d28\u91cf\u7a33\u5b9a\u8fbe\u6807\u3002<\/p>\n<hr \/>\n<h2>\u4e94\u3001\u6848\u4f8b\u5206\u6790\u4e0e\u5b9e\u9645\u5e94\u7528\u6548\u679c<\/h2>\n<h3>5.1 \u67d0\u5927\u578b\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1a\u5e94\u7528\u5b9e\u4f8b<\/h3>\n<p>\u67d0\u56fd\u5185\u77e5\u540d\u5236\u836f\u4f01\u4e1a\u5728\u5176\u65b0\u5efa\u7684\u51bb\u5e72\u7c89\u9488\u5242\u751f\u4ea7\u7ebf\u4e2d\uff0c\u91c7\u7528U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f5c\u4e3aA\u7ea7\u6d01\u51c0\u533a\u7684\u7ec8\u7aef\u7a7a\u6c14\u8fc7\u6ee4\u8bbe\u5907\u3002\u5176\u6d01\u51c0\u7cfb\u7edf\u914d\u7f6e\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7cfb\u7edf\u5c42\u7ea7<\/th>\n<th>\u8fc7\u6ee4\u5668\u7c7b\u578b<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u6548\u8fc7\u6ee4<\/td>\n<td>G4\u7ea7\u91d1\u5c5e\u7f51\u8fc7\u6ee4\u5668<\/td>\n<td>90%\uff08\u22655\u03bcm\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u4e2d\u6548\u8fc7\u6ee4<\/td>\n<td>F7\u7ea7\u888b\u5f0f\u8fc7\u6ee4\u5668<\/td>\n<td>90%\uff08\u22651\u03bcm\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u9ad8\u6548\u8fc7\u6ee4<\/td>\n<td>U16\u9ad8\u6548\u8fc7\u6ee4\u5668<\/td>\n<td>\u226599.99995%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u7ecf\u8fde\u7eed\u4e09\u4e2a\u6708\u8fd0\u884c\u76d1\u6d4b\u6570\u636e\u663e\u793a\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u68c0\u6d4b\u9879\u76ee<\/th>\n<th>\u76ee\u6807\u503c<\/th>\n<th>\u5b9e\u6d4b\u5e73\u5747\u503c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u60ac\u6d6e\u7c92\u5b50\u6570\uff08\u22650.5\u03bcm\uff09<\/td>\n<td>\u22643,520\u7c92\/m\u00b3<\/td>\n<td>2,100\u7c92\/m\u00b3<\/td>\n<\/tr>\n<tr>\n<td>\u60ac\u6d6e\u7c92\u5b50\u6570\uff08\u22655\u03bcm\uff09<\/td>\n<td>\u226420\u7c92\/m\u00b3<\/td>\n<td>5\u7c92\/m\u00b3<\/td>\n<\/tr>\n<tr>\n<td>\u6d6e\u6e38\u83cc\u6570<\/td>\n<td>\u22641 CFU\/m\u00b3<\/td>\n<td>0.3 CFU\/m\u00b3<\/td>\n<\/tr>\n<tr>\n<td>\u6c89\u964d\u83cc\u6570<\/td>\n<td>\u22641 CFU\/\u76bf\u00b730min<\/td>\n<td>0.2 CFU\/\u76bf\u00b730min<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u7ed3\u679c\u663e\u793a\uff0cU16\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5b9e\u9645\u8fd0\u884c\u4e2d\u8868\u73b0\u51fa\u4f18\u5f02\u7684\u8fc7\u6ee4\u6027\u80fd\uff0c\u5b8c\u5168\u6ee1\u8db3GMP A\u7ea7\u6d01\u51c0\u533a\u7684\u5fae\u751f\u7269\u548c\u60ac\u6d6e\u7c92\u5b50\u63a7\u5236\u8981\u6c42\u3002<\/p>\n<h3>5.2 \u56fd\u5916\u7814\u7a76\u6570\u636e\u652f\u6301<\/h3>\n<p>\u6839\u636e\u7f8e\u56fd\u836f\u5178USP\u300aMicrobiological Control and Monitoring of Aseptic Processing Environments\u300b\u6307\u51fa\uff0cULPA\/U16\u7ea7\u522b\u7684\u8fc7\u6ee4\u5668\u5728\u7ef4\u6301\u65e0\u83cc\u73af\u5883\u65b9\u9762\u5177\u6709\u663e\u8457\u4f18\u52bf\uff0c\u5c24\u5176\u5728\u51cf\u5c11\u5fae\u751f\u7269\u8d1f\u8377\u65b9\u9762\u4f18\u4e8e\u4f20\u7edfHEPA\uff08H13\/H14\uff09\u8fc7\u6ee4\u5668\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u54c1\u76d1\u7ba1\u5c40\uff08MHRA\uff09\u53d1\u5e03\u7684\u300aGood Manufacturing Practice for Medicinal Products\u300b\u4e2d\u4e5f\u5f3a\u8c03\uff0c\u5728A\u7ea7\u6d01\u51c0\u73af\u5883\u4e2d\u5e94\u4f18\u5148\u9009\u7528U16\u6216\u540c\u7b49\u6027\u80fd\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u4ee5\u964d\u4f4e\u4ea4\u53c9\u6c61\u67d3\u98ce\u9669\u3002<\/p>\n<hr \/>\n<h2>\u516d\u3001\u5e38\u89c1\u95ee\u9898\u4e0e\u89e3\u51b3\u65b9\u6848<\/h2>\n<p>\u5c3d\u7ba1U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u5177\u5907\u51fa\u8272\u7684\u8fc7\u6ee4\u6027\u80fd\uff0c\u4f46\u5728\u5b9e\u9645\u5e94\u7528\u4e2d\u4ecd\u53ef\u80fd\u9047\u5230\u4ee5\u4e0b\u95ee\u9898\uff1a<\/p>\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>\u538b\u5dee\u8fc7\u9ad8<\/td>\n<td>\u6ee4\u6750\u5835\u585e<\/td>\n<td>\u5b9a\u671f\u66f4\u6362\u6ee4\u82af\uff0c\u52a0\u5f3a\u521d\u6548\/\u4e2d\u6548\u9884\u8fc7\u6ee4<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u73b0\u8c61<\/td>\n<td>\u5bc6\u5c01\u4e0d\u826f\u6216\u7834\u635f<\/td>\n<td>\u68c0\u67e5\u5bc6\u5c01\u5708\u5b8c\u6574\u6027\uff0c\u5fc5\u8981\u65f6\u91cd\u65b0\u5b89\u88c5<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u901f\u4e0d\u5747<\/td>\n<td>\u6c14\u6d41\u5206\u5e03\u4e0d\u5747\u5300<\/td>\n<td>\u8c03\u6574\u9001\u98ce\u53e3\u5e03\u7f6e\uff0c\u4f18\u5316\u6c14\u6d41\u7ec4\u7ec7<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u8d85\u6807<\/td>\n<td>\u6e05\u6d01\u4e0d\u5230\u4f4d\u6216\u4eba\u5458\u6c61\u67d3<\/td>\n<td>\u52a0\u5f3a\u73af\u5883\u6e05\u6d01\uff0c\u4e25\u683c\u6267\u884c\u66f4\u8863\u89c4\u7a0b<\/td>\n<\/tr>\n<tr>\n<td>\u6210\u672c\u8f83\u9ad8<\/td>\n<td>\u8bbe\u5907\u8d2d\u7f6e\u4e0e\u66f4\u6362\u8d39\u7528<\/td>\n<td>\u9009\u62e9\u6027\u4ef7\u6bd4\u9ad8\u7684\u54c1\u724c\uff0c\u5ef6\u957f\u4f7f\u7528\u5bff\u547d<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e03\u3001\u672a\u6765\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<p>\u968f\u7740\u5236\u836f\u884c\u4e1a\u5bf9\u4ea7\u54c1\u8d28\u91cf\u548c\u751f\u4ea7\u5b89\u5168\u6027\u7684\u8981\u6c42\u4e0d\u65ad\u63d0\u9ad8\uff0cU16\u9ad8\u6548\u8fc7\u6ee4\u5668\u5c06\u5728\u4ee5\u4e0b\u65b9\u9762\u6301\u7eed\u53d1\u5c55\uff1a<\/p>\n<ol>\n<li><strong>\u667a\u80fd\u5316\u5347\u7ea7<\/strong>\uff1a\u96c6\u6210\u4f20\u611f\u5668\u4e0e\u7269\u8054\u7f51\u6280\u672f\uff0c\u5b9e\u73b0\u8fdc\u7a0b\u76d1\u63a7\u4e0e\u81ea\u52a8\u62a5\u8b66\uff1b<\/li>\n<li><strong>\u8282\u80fd\u8bbe\u8ba1<\/strong>\uff1a\u5f00\u53d1\u4f4e\u963b\u529b\u3001\u9ad8\u901a\u91cf\u7684\u65b0\u578b\u6ee4\u6750\uff0c\u964d\u4f4e\u80fd\u8017\uff1b<\/li>\n<li><strong>\u73af\u4fdd\u6750\u6599<\/strong>\uff1a\u63a8\u52a8\u53ef\u56de\u6536\u6216\u53ef\u964d\u89e3\u6ee4\u6750\u7684\u7814\u53d1\u4e0e\u5e94\u7528\uff1b<\/li>\n<li><strong>\u6807\u51c6\u5316\u5efa\u8bbe<\/strong>\uff1a\u5b8c\u5584\u56fd\u5185\u5916\u7edf\u4e00\u7684\u68c0\u6d4b\u4e0e\u8ba4\u8bc1\u4f53\u7cfb\uff0c\u63d0\u5347\u4e92\u8ba4\u6c34\u5e73\uff1b<\/li>\n<li><strong>\u5b9a\u5236\u5316\u670d\u52a1<\/strong>\uff1a\u6839\u636e\u5ba2\u6237\u6d01\u51c0\u7ea7\u522b\u4e0e\u7a7a\u95f4\u5e03\u5c40\u63d0\u4f9b\u4e2a\u6027\u5316\u89e3\u51b3\u65b9\u6848\u3002<\/li>\n<\/ol>\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\u300b\uff082010\u5e74\u4fee\u8ba2\uff09[Z]. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2011.<\/li>\n<li>European Committee for Standardization. EN 1822-1:2009 High efficiency air filters (HEPA and ULPA) \u2013 Part 1: Classification, performance testing, marking[S].<\/li>\n<li>United States Pharmacopeia. USP Microbiological Control and Monitoring of Aseptic Processing Environments [S]. Rockville, MD: USP, 2021.<\/li>\n<li>UK Medicines and Healthcare products Regulatory Agency (MHRA). Good Manufacturing Practice for Medicinal Products[M]. London: MHRA Publications, 2022.<\/li>\n<li>Camfil Group. CamCarb U16 Technical Data Sheet[R]. Stockholm: Camfil AB, 2023.<\/li>\n<li>\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6GB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b[S]. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2020.<\/li>\n<li>\u5f20\u4f1f, \u738b\u78ca. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u5e94\u7528\u7814\u7a76[J]. \u533b\u836f\u5de5\u7a0b\u8bbe\u8ba1, 2021, 42(3): 45-50.<\/li>\n<li>\u674e\u660e, \u9648\u6653\u5cf0. U16\u7ea7\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u65e0\u83cc\u5236\u5242\u8f66\u95f4\u7684\u5e94\u7528\u5206\u6790[J]. \u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f, 2022, 37(2): 67-72.<\/li>\n<\/ol>\n<hr \/>\n<p><em>\u6ce8\uff1a\u4ee5\u4e0a\u5185\u5bb9\u57fa\u4e8e\u516c\u5f00\u8d44\u6599\u6574\u7406\u64b0\u5199\uff0c\u5982\u6709\u5f15\u7528\u4e0d\u5f53\u4e4b\u5904\uff0c\u656c\u8bf7\u6307\u6b63\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>U16\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u8f66\u95f4\u7684\u5e94\u7528\u8981\u6c42 \u4e00\u3001\u5f15\u8a00\uff1a\u5236\u836f\u884c\u4e1a\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u4e25\u683c\u8981\u6c42 \u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u60a3\u8005\u7684\u751f\u547d\u5b89\u5168\u548c\u5065\u5eb7\u3002\u56e0\u6b64\uff0c\u5236\u836f\u751f\u4ea7\u73af\u5883\u5fc5\u987b\u7b26\u5408\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u8981\u6c42\uff0c\u786e\u4fdd\u4ea7\u54c1\u5728\u6574\u4e2a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4e0d\u53d7\u6c61\u67d3\u3002\u5176\u4e2d\uff0c\u7a7a\u6c14\u6d01\u51c0\u5ea6\u662fGMP\u6d01\u51c0\u8f66\u95f4\u63a7\u5236\u7684\u5173\u952e\u6307\u6807&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-15745","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\/15745","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=15745"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15745\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15745"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15745"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15745"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}