{"id":15169,"date":"2025-06-18T16:23:21","date_gmt":"2025-06-18T08:23:21","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15169"},"modified":"2025-06-18T16:23:21","modified_gmt":"2025-06-18T08:23:21","slug":"%e7%bb%84%e5%90%88%e5%bc%8f%e4%b8%ad%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%a0%87%e5%87%86%e4%b8%8b%e7%9a%84%e4%bd%bf%e7%94%a8%e8%a7%84%e8%8c%83","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15169","title":{"rendered":"\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e0b\u7684\u4f7f\u7528\u89c4\u8303"},"content":{"rendered":"<h1>\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e0b\u7684\u4f7f\u7528\u89c4\u8303<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5f71\u54cd\u836f\u54c1\u7684\u751f\u4ea7\u8d28\u91cf\u548c\u60a3\u8005\u7684\u5b89\u5168\u3002\u4e3a\u786e\u4fdd\u836f\u54c1\u5728\u6d01\u51c0\u73af\u5883\u4e0b\u751f\u4ea7\uff0c\u5236\u836f\u4f01\u4e1a\u666e\u904d\u91c7\u7528\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u5bf9\u8f66\u95f4\u7a7a\u6c14\u8fdb\u884c\u51c0\u5316\u5904\u7406\u3002\u5176\u4e2d\uff0c<strong>\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668<\/strong>\uff08Combined Medium Efficiency Air Filter\uff09\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u6d01\u51c0\u5ba4\u3001\u65e0\u83cc\u64cd\u4f5c\u533a\u7b49\u5173\u952e\u533a\u57df\u3002\u5176\u4e3b\u8981\u529f\u80fd\u662f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u7684\u5fae\u7c92\u548c\u5fae\u751f\u7269\uff0c\u4ee5\u6ee1\u8db3\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u5bf9\u6d01\u51c0\u5ea6\u7684\u8981\u6c42\u3002<\/p>\n<p>\u672c\u6587\u5c06\u56f4\u7ed5\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u7ed3\u6784\u3001\u6280\u672f\u53c2\u6570\u3001\u6027\u80fd\u7279\u70b9\u53ca\u5176\u5728\u5236\u836fGMP\u73af\u5883\u4e2d\u7684\u5e94\u7528\u89c4\u8303\u8fdb\u884c\u6df1\u5165\u63a2\u8ba8\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u76f8\u5173\u6587\u732e\u8d44\u6599\uff0c\u5206\u6790\u5176\u9009\u578b\u3001\u5b89\u88c5\u3001\u7ef4\u62a4\u53ca\u68c0\u6d4b\u7b49\u65b9\u9762\u7684\u6280\u672f\u8981\u70b9\uff0c\u65e8\u5728\u4e3a\u5236\u836f\u4f01\u4e1a\u63d0\u4f9b\u79d1\u5b66\u5408\u7406\u7684\u7a7a\u6c14\u8fc7\u6ee4\u89e3\u51b3\u65b9\u6848\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>1.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p>\u6839\u636e\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6GB\/T 14295-2008\u300a\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u7684\u89c4\u5b9a\uff0c\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6309\u6548\u7387\u53ef\u5206\u4e3a\u521d\u6548\u3001\u4e2d\u6548\u3001\u9ad8\u4e2d\u6548\u548c\u9ad8\u6548\u8fc7\u6ee4\u5668\u56db\u7c7b\u3002\u5176\u4e2d\uff0c<strong>\u4e2d\u6548\u8fc7\u6ee4\u5668<\/strong>\u4e3b\u8981\u7528\u4e8e\u53bb\u96641\uff5e5 \u03bcm\u7684\u9897\u7c92\u7269\uff0c\u9002\u7528\u4e8e\u7a7a\u8c03\u7cfb\u7edf\u7684\u4e2d\u95f4\u7ea7\u8fc7\u6ee4\uff0c\u5e38\u7528\u4e8e\u533b\u9662\u3001\u5b9e\u9a8c\u5ba4\u3001\u7535\u5b50\u5382\u3001\u5236\u836f\u5382\u7b49\u5bf9\u7a7a\u6c14\u8d28\u91cf\u6709\u4e00\u5b9a\u8981\u6c42\u7684\u573a\u6240\u3002<\/p>\n<p>\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u662f\u6307\u7531\u591a\u4e2a\u4e0d\u540c\u6750\u6599\u6216\u7ed3\u6784\u7684\u8fc7\u6ee4\u5c42\u7ec4\u5408\u800c\u6210\u7684\u4e2d\u6548\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u901a\u5e38\u5305\u62ec\u9884\u8fc7\u6ee4\u5c42\u3001\u4e3b\u8fc7\u6ee4\u5c42\u548c\u652f\u6491\u9aa8\u67b6\u7b49\u90e8\u5206\u3002\u5176\u8bbe\u8ba1\u76ee\u7684\u662f\u901a\u8fc7\u591a\u5c42\u7ed3\u6784\u63d0\u5347\u6574\u4f53\u8fc7\u6ee4\u6548\u7387\u548c\u5bb9\u5c18\u91cf\uff0c\u5ef6\u957f\u4f7f\u7528\u5bff\u547d\uff0c\u964d\u4f4e\u8fd0\u884c\u6210\u672c\u3002<\/p>\n<h3>1.2 \u5e38\u89c1\u7c7b\u578b<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u7c7b\u578b<\/th>\n<th>\u6750\u6599<\/th>\n<th>\u7279\u70b9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u888b\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668<\/td>\n<td>\u5408\u6210\u7ea4\u7ef4\u3001\u73bb\u7ea4<\/td>\n<td>\u5bb9\u5c18\u91cf\u5927\uff0c\u538b\u964d\u4f4e\uff0c\u9002\u5408\u98ce\u91cf\u8f83\u5927\u7684\u7cfb\u7edf<\/td>\n<\/tr>\n<tr>\n<td>\u677f\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668<\/td>\n<td>\u7ea4\u7ef4\u6ee4\u7eb8\u3001\u91d1\u5c5e\u7f51<\/td>\n<td>\u7ed3\u6784\u7d27\u51d1\uff0c\u9002\u7528\u4e8e\u7a7a\u95f4\u53d7\u9650\u573a\u5408<\/td>\n<\/tr>\n<tr>\n<td>\u6298\u53e0\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668<\/td>\n<td>\u6ee4\u7eb8\u3001\u805a\u916f\u7ea4\u7ef4<\/td>\n<td>\u8fc7\u6ee4\u9762\u79ef\u5927\uff0c\u963b\u529b\u5c0f\uff0c\u6548\u7387\u9ad8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e8c\u3001\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u53c2\u6570\u4e0e\u6027\u80fd\u6307\u6807<\/h2>\n<p>\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u4e3b\u8981\u4f9d\u636e\u4ee5\u4e0b\u51e0\u9879\u5173\u952e\u53c2\u6570\u8fdb\u884c\u8bc4\u4f30\uff1a<\/p>\n<h3>2.1 \u521d\u59cb\u6548\u7387\u4e0e\u7ec8\u671f\u6548\u7387<\/h3>\n<p>\u521d\u59cb\u6548\u7387\u6307\u65b0\u8fc7\u6ee4\u5668\u5728\u6807\u51c6\u6d4b\u8bd5\u6761\u4ef6\u4e0b\u7684\u8fc7\u6ee4\u6548\u7387\uff0c\u7ec8\u671f\u6548\u7387\u5219\u662f\u5728\u8fbe\u5230\u7ec8\u963b\u529b\u65f6\u7684\u8fc7\u6ee4\u6548\u7387\u3002\u6839\u636eEN 779:2012\u6807\u51c6\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u521d\u59cb\u6548\u7387\u5e94\u4e0d\u4f4e\u4e8e65%\uff08\u9488\u5bf90.4 \u03bcm\u9897\u7c92\uff09\uff0c\u7ec8\u671f\u6548\u7387\u5e94\u4e0d\u4f4e\u4e8e80%\u3002<\/p>\n<h3>2.2 \u963b\u529b\u7279\u6027<\/h3>\n<p>\u963b\u529b\u662f\u8861\u91cf\u8fc7\u6ee4\u5668\u80fd\u8017\u7684\u91cd\u8981\u6307\u6807\u3002\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u521d\u59cb\u963b\u529b\u5e94\u572880\uff5e150 Pa\u4e4b\u95f4\uff0c\u7ec8\u963b\u529b\u4e0d\u8d85\u8fc7250 Pa\u3002<\/p>\n<h3>2.3 \u5bb9\u5c18\u91cf<\/h3>\n<p>\u5bb9\u5c18\u91cf\u662f\u6307\u8fc7\u6ee4\u5668\u5728\u8fbe\u5230\u7ec8\u963b\u529b\u524d\u80fd\u591f\u5bb9\u7eb3\u7684\u7070\u5c18\u603b\u91cf\uff0c\u5355\u4f4d\u4e3ag\/m\u00b2\u3002\u7ec4\u5408\u5f0f\u7ed3\u6784\u6709\u52a9\u4e8e\u63d0\u9ad8\u5bb9\u5c18\u80fd\u529b\uff0c\u4ece\u800c\u5ef6\u957f\u66f4\u6362\u5468\u671f\u3002<\/p>\n<h3>2.4 \u4f7f\u7528\u5bff\u547d<\/h3>\n<p>\u4f7f\u7528\u5bff\u547d\u53d7\u8fd0\u884c\u73af\u5883\u3001\u6c14\u6d41\u901f\u5ea6\u3001\u9897\u7c92\u6d53\u5ea6\u7b49\u56e0\u7d20\u5f71\u54cd\u3002\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u66f4\u6362\u5468\u671f\u4e3a6\uff5e12\u4e2a\u6708\u3002<\/p>\n<h3>2.5 \u5178\u578b\u6280\u672f\u53c2\u6570\u6c47\u603b\u8868<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u540d\u79f0<\/th>\n<th>\u6807\u51c6\u503c\u8303\u56f4<\/th>\n<th>\u6d4b\u8bd5\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u59cb\u6548\u7387\uff08\u22650.4 \u03bcm\uff09<\/td>\n<td>\u226565%<\/td>\n<td>EN 779:2012<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u671f\u6548\u7387\uff08\u22650.4 \u03bcm\uff09<\/td>\n<td>\u226580%<\/td>\n<td>EN 779:2012<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>80\u2013150 Pa<\/td>\n<td>ASHRAE 52.2<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b<\/td>\n<td>\u2264250 Pa<\/td>\n<td>ASHRAE 52.2<\/td>\n<\/tr>\n<tr>\n<td>\u5bb9\u5c18\u91cf<\/td>\n<td>\u2265500 g\/m\u00b2<\/td>\n<td>ISO 16890<\/td>\n<\/tr>\n<tr>\n<td>\u5de5\u4f5c\u6e29\u5ea6\u8303\u56f4<\/td>\n<td>-10\u2103\uff5e70\u2103<\/td>\n<td>GB\/T 14295-2008<\/td>\n<\/tr>\n<tr>\n<td>\u5de5\u4f5c\u6e7f\u5ea6\u8303\u56f4<\/td>\n<td>\u226490% RH<\/td>\n<td>GB\/T 14295-2008<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e09\u3001\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u5bf9\u7a7a\u6c14\u8fc7\u6ee4\u7684\u8981\u6c42<\/h2>\n<h3>3.1 GMP\u6807\u51c6\u7b80\u4ecb<\/h3>\n<p>\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u662f\u7531\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5236\u5b9a\u5e76\u5f3a\u5236\u6267\u884c\u7684\u836f\u54c1\u751f\u4ea7\u7ba1\u7406\u6cd5\u89c4\uff0c\u5176\u6838\u5fc3\u76ee\u6807\u662f\u4fdd\u969c\u836f\u54c1\u8d28\u91cf\uff0c\u9632\u6b62\u6c61\u67d3\u548c\u4ea4\u53c9\u6c61\u67d3\u3002GMP\u5bf9\u836f\u54c1\u751f\u4ea7\u73af\u5883\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\u63d0\u51fa\u4e86\u660e\u786e\u8981\u6c42\u3002<\/p>\n<p>\u6839\u636e\u4e2d\u56fd\u73b0\u884cGMP\u6807\u51c6\uff08CFDA 2010\u7248\uff09\uff0c\u6d01\u51c0\u533a\u5206\u4e3aA\u3001B\u3001C\u3001D\u56db\u4e2a\u7ea7\u522b\uff0c\u5177\u4f53\u8981\u6c42\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7ea7\u522b<\/th>\n<th>\u5fae\u7c92\u6570\uff08\u22650.5 \u03bcm\uff09\/m\u00b3<\/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\uff08\u9759\u6001\uff09<\/td>\n<td>\u22643,520<\/td>\n<td>\u226410<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7\uff08\u9759\u6001\uff09<\/td>\n<td>\u22643,520<\/td>\n<td>\u226410<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7\uff08\u9759\u6001\uff09<\/td>\n<td>\u2264352,000<\/td>\n<td>\u2264100<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7\uff08\u9759\u6001\uff09<\/td>\n<td>\u22643,520,000<\/td>\n<td>\u2264200<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>3.2 \u4e2d\u6548\u8fc7\u6ee4\u5668\u5728GMP\u4f53\u7cfb\u4e2d\u7684\u5b9a\u4f4d<\/h3>\n<p>\u5728\u5236\u836f\u6d01\u51c0\u7cfb\u7edf\u4e2d\uff0c\u7a7a\u6c14\u5904\u7406\u6d41\u7a0b\u901a\u5e38\u4e3a\uff1a<strong>\u521d\u6548\u2192\u4e2d\u6548\u2192\u9ad8\u6548<\/strong>\u4e09\u7ea7\u8fc7\u6ee4\u3002\u4e2d\u6548\u8fc7\u6ee4\u5668\u4f4d\u4e8e\u521d\u6548\u4e4b\u540e\u3001\u9ad8\u6548\u4e4b\u524d\uff0c\u8d77\u5230\u627f\u4e0a\u542f\u4e0b\u7684\u4f5c\u7528\uff0c\u65e2\u4fdd\u62a4\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e0d\u88ab\u8fc7\u65e9\u5835\u585e\uff0c\u53c8\u63d0\u5347\u6574\u4f53\u7a7a\u6c14\u6d01\u51c0\u5ea6\u3002<\/p>\n<p>\u5728GMP\u6d01\u51c0\u533a\u4e2d\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u4e00\u822c\u7528\u4e8eC\u7ea7\u548cD\u7ea7\u533a\u57df\u7684\u9001\u98ce\u7cfb\u7edf\u4e2d\uff0c\u786e\u4fdd\u8fdb\u5165\u9ad8\u6548\u8fc7\u6ee4\u5668\u524d\u7684\u7a7a\u6c14\u8d28\u91cf\u7a33\u5b9a\u53ef\u63a7\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u7cfb\u7edf\u4e2d\u7684\u5e94\u7528\u89c4\u8303<\/h2>\n<h3>4.1 \u9009\u578b\u539f\u5219<\/h3>\n<p>\u9009\u62e9\u5408\u9002\u7684\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u9700\u7efc\u5408\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n<ul>\n<li><strong>\u7a7a\u6c14\u5904\u7406\u91cf<\/strong>\uff1a\u6839\u636e\u7cfb\u7edf\u98ce\u91cf\u786e\u5b9a\u8fc7\u6ee4\u5668\u5c3a\u5bf8\u3002<\/li>\n<li><strong>\u8fc7\u6ee4\u6548\u7387<\/strong>\uff1a\u5e94\u7b26\u5408GMP\u5bf9\u6d01\u51c0\u7ea7\u522b\u7684\u8981\u6c42\u3002<\/li>\n<li><strong>\u8010\u6e7f\u6027\u4e0e\u8010\u8150\u8680\u6027<\/strong>\uff1a\u5236\u836f\u8f66\u95f4\u5e38\u5b58\u5728\u84b8\u6c7d\u6d88\u6bd2\u8fc7\u7a0b\uff0c\u6750\u6599\u9700\u5177\u5907\u826f\u597d\u7684\u6297\u6e7f\u6027\u548c\u5316\u5b66\u7a33\u5b9a\u6027\u3002<\/li>\n<li><strong>\u66f4\u6362\u5468\u671f\u4e0e\u7ef4\u62a4\u6210\u672c<\/strong>\uff1a\u7ec4\u5408\u5f0f\u7ed3\u6784\u53ef\u5ef6\u957f\u4f7f\u7528\u5bff\u547d\uff0c\u51cf\u5c11\u66f4\u6362\u9891\u7387\u3002<\/li>\n<\/ul>\n<h3>4.2 \u5b89\u88c5\u89c4\u8303<\/h3>\n<p>\u5b89\u88c5\u8fc7\u7a0b\u4e2d\u5e94\u9075\u5faa\u4ee5\u4e0b\u539f\u5219\uff1a<\/p>\n<ul>\n<li>\u5b89\u88c5\u4f4d\u7f6e\u5e94\u8fdc\u79bb\u9ad8\u6e29\u3001\u9ad8\u6e7f\u533a\u57df\uff0c\u907f\u514d\u6ee4\u6750\u8001\u5316\u3002<\/li>\n<li>\u5b89\u88c5\u65b9\u5411\u5e94\u4e0e\u6c14\u6d41\u65b9\u5411\u4e00\u81f4\uff0c\u9632\u6b62\u53cd\u5411\u5b89\u88c5\u5bfc\u81f4\u6548\u7387\u4e0b\u964d\u3002<\/li>\n<li>\u8fc7\u6ee4\u5668\u4e0e\u6846\u67b6\u4e4b\u95f4\u5e94\u5bc6\u5c01\u826f\u597d\uff0c\u9632\u6b62\u65c1\u901a\u6cc4\u6f0f\u3002<\/li>\n<\/ul>\n<h3>4.3 \u8fd0\u884c\u76d1\u6d4b\u4e0e\u66f4\u6362\u6807\u51c6<\/h3>\n<p>\u5b9a\u671f\u76d1\u6d4b\u8fc7\u6ee4\u5668\u7684\u538b\u5dee\u53d8\u5316\uff0c\u5f53\u5b9e\u9645\u963b\u529b\u63a5\u8fd1\u7ec8\u963b\u529b\u65f6\uff0c\u5e94\u53ca\u65f6\u66f4\u6362\u3002\u5efa\u8bae\u5efa\u7acb\u8fc7\u6ee4\u5668\u66f4\u6362\u8bb0\u5f55\u6863\u6848\uff0c\u5305\u62ec\u66f4\u6362\u65f6\u95f4\u3001\u4f7f\u7528\u73af\u5883\u3001\u538b\u5dee\u6570\u636e\u7b49\u4fe1\u606f\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u76d1\u6d4b\u9879\u76ee<\/th>\n<th>\u63a8\u8350\u9891\u7387<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u538b\u5dee\u76d1\u6d4b<\/td>\n<td>\u6bcf\u65e5\u4e00\u6b21<\/td>\n<\/tr>\n<tr>\n<td>\u6548\u7387\u68c0\u6d4b<\/td>\n<td>\u6bcf\u5b63\u5ea6\u4e00\u6b21<\/td>\n<\/tr>\n<tr>\n<td>\u5916\u89c2\u68c0\u67e5<\/td>\n<td>\u6bcf\u6708\u4e00\u6b21<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u68c0\u6d4b<\/td>\n<td>\u6bcf\u534a\u5e74\u4e00\u6b21<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>4.4 \u6e05\u6d17\u4e0e\u6d88\u6bd2\u6ce8\u610f\u4e8b\u9879<\/h3>\n<p>\u867d\u7136\u4e2d\u6548\u8fc7\u6ee4\u5668\u4e00\u822c\u4e0d\u53ef\u6e05\u6d17\uff0c\u4f46\u5728\u67d0\u4e9b\u7279\u6b8a\u60c5\u51b5\u4e0b\uff08\u5982\u5c40\u90e8\u6c61\u67d3\uff09\uff0c\u53ef\u91c7\u7528\u7d2b\u5916\u7ebf\u7167\u5c04\u6216\u81ed\u6c27\u718f\u84b8\u7b49\u65b9\u5f0f\u8fdb\u884c\u8868\u9762\u6d88\u6bd2\uff0c\u4f46\u4e0d\u5f97\u7528\u6c34\u51b2\u6d17\u6216\u6d78\u6ce1\u6ee4\u6750\uff0c\u4ee5\u514d\u7834\u574f\u7ea4\u7ef4\u7ed3\u6784\u3002<\/p>\n<hr \/>\n<h2>\u4e94\u3001\u56fd\u5185\u5916\u7814\u7a76\u4e0e\u5b9e\u8df5\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>5.1 \u56fd\u5185\u7814\u7a76\u8fdb\u5c55<\/h3>\n<p>\u636e\u300a\u4e2d\u56fd\u836f\u623f\u300b\u671f\u520a\u62a5\u9053\uff0c\u56fd\u5185\u591a\u5bb6\u5927\u578b\u5236\u836f\u4f01\u4e1a\u5728\u5b9e\u65bd\u65b0\u7248GMP\u8fc7\u7a0b\u4e2d\uff0c\u9010\u6b65\u6dd8\u6c70\u4f20\u7edf\u677f\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\uff0c\u8f6c\u800c\u91c7\u7528\u888b\u5f0f\u6216\u6298\u53e0\u5f0f\u7ec4\u5408\u4e2d\u6548\u8fc7\u6ee4\u5668\uff0c\u663e\u8457\u63d0\u9ad8\u4e86\u7cfb\u7edf\u7684\u7a33\u5b9a\u6027\u548c\u8fd0\u884c\u7ecf\u6d4e\u6027\u3002<\/p>\n<p>\u4f8b\u5982\uff0c\u6c5f\u82cf\u6052\u745e\u533b\u836f\u6709\u9650\u516c\u53f8\u5728\u5176\u6ce8\u5c04\u5242\u751f\u4ea7\u8f66\u95f4\u6539\u9020\u4e2d\uff0c\u5f15\u5165\u4e86\u65b0\u578b\u590d\u5408\u7ea4\u7ef4\u6750\u6599\u7684\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\uff0c\u7ed3\u679c\u663e\u793a\uff0c\u5728\u76f8\u540c\u98ce\u91cf\u6761\u4ef6\u4e0b\uff0c\u7cfb\u7edf\u963b\u529b\u964d\u4f4e\u4e8615%\uff0c\u5e74\u66f4\u6362\u6b21\u6570\u51cf\u5c11\u4e8620%\u3002<\/p>\n<h3>5.2 \u56fd\u5916\u7ecf\u9a8c\u501f\u9274<\/h3>\n<p>\u7f8e\u56fdFDA\u53d1\u5e03\u7684\u300aGuidance for Industry: Sterile Drug Products Produced by Aseptic Processing\u300b\u4e2d\u6307\u51fa\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u65e0\u83cc\u836f\u54c1\u751f\u4ea7\u4e2d\u5e94\u4f5c\u4e3a\u5173\u952e\u63a7\u5236\u70b9\u4e4b\u4e00\uff0c\u5efa\u8bae\u5b9a\u671f\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u548c\u6548\u7387\u9a8c\u8bc1\u3002<\/p>\n<p>\u6b27\u6d32\u5236\u836f\u5de5\u7a0b\u534f\u4f1a\uff08ISPE\uff09\u5728\u5176\u300aBaseline Guide for HVAC and Utilities\u300b\u4e2d\u5f3a\u8c03\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u5e94\u5e03\u7f6e\u5728\u7a7a\u8c03\u673a\u7ec4\u7684\u6df7\u5408\u6bb5\u540e\u3001\u52a0\u70ed\u6bb5\u524d\uff0c\u4ee5\u4fdd\u8bc1\u6700\u4f73\u7684\u5de5\u4f5c\u72b6\u6001\u3002<\/p>\n<h3>5.3 \u5e94\u7528\u5b9e\u4f8b\u5bf9\u6bd4\u5206\u6790<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u4f20\u7edf\u677f\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668<\/th>\n<th>\u65b0\u578b\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5e73\u5747\u5bff\u547d<\/td>\n<td>6\u4e2a\u6708<\/td>\n<td>12\u4e2a\u6708<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u9891\u7387<\/td>\n<td>\u6bcf\u534a\u5e74\u4e00\u6b21<\/td>\n<td>\u6bcf\u5e74\u4e00\u6b21<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u6548\u7387<\/td>\n<td>60%<\/td>\n<td>75%<\/td>\n<\/tr>\n<tr>\n<td>\u5e73\u5747\u538b\u5dee<\/td>\n<td>120 Pa<\/td>\n<td>90 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u5e74\u7ef4\u62a4\u6210\u672c\uff08\u4e07\u5143\uff09<\/td>\n<td>15<\/td>\n<td>10<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u516d\u3001\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<p>\u968f\u7740\u5236\u836f\u884c\u4e1a\u5bf9\u6d01\u51c0\u5ea6\u8981\u6c42\u7684\u4e0d\u65ad\u63d0\u9ad8\uff0c\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u6b63\u671d\u7740\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u5411\u53d1\u5c55\uff1a<\/p>\n<ol>\n<li><strong>\u9ad8\u6027\u80fd\u6750\u6599\u7814\u53d1<\/strong>\uff1a\u91c7\u7528\u7eb3\u7c73\u7ea4\u7ef4\u3001\u9759\u7535\u589e\u5f3a\u6750\u6599\u7b49\u65b0\u6280\u672f\uff0c\u63d0\u9ad8\u8fc7\u6ee4\u6548\u7387\u3002<\/li>\n<li><strong>\u667a\u80fd\u5316\u76d1\u6d4b\u7cfb\u7edf\u96c6\u6210<\/strong>\uff1a\u5d4c\u5165\u538b\u529b\u4f20\u611f\u5668\u3001RFID\u82af\u7247\u7b49\uff0c\u5b9e\u73b0\u8fdc\u7a0b\u76d1\u63a7\u4e0e\u9884\u8b66\u3002<\/li>\n<li><strong>\u73af\u4fdd\u8282\u80fd\u8bbe\u8ba1<\/strong>\uff1a\u4f18\u5316\u7ed3\u6784\u964d\u4f4e\u963b\u529b\uff0c\u51cf\u5c11\u80fd\u6e90\u6d88\u8017\u3002<\/li>\n<li><strong>\u6a21\u5757\u5316\u4e0e\u6807\u51c6\u5316<\/strong>\uff1a\u4fbf\u4e8e\u5feb\u901f\u66f4\u6362\u4e0e\u7edf\u4e00\u7ba1\u7406\uff0c\u9002\u5e94\u5927\u89c4\u6a21\u5236\u836f\u751f\u4ea7\u7ebf\u9700\u6c42\u3002<\/li>\n<\/ol>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40.\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b[Z]. \u5317\u4eac\uff1a\u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e\uff0c2011.<\/li>\n<li>GB\/T 14295-2008. \u7a7a\u6c14\u8fc7\u6ee4\u5668[S]. \u5317\u4eac\uff1a\u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e\uff0c2008.<\/li>\n<li>EN 779:2012. Particulate air filters for general ventilation \u2013 Determination of the filtration performance[S].<\/li>\n<li>ISO 16890:2016. Air filter for general ventilation \u2013 Testing and classification[S].<\/li>\n<li>FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing [EB\/OL]. <a href=\"https:\/\/www.fda.gov\">https:\/\/www.fda.gov<\/a>, 2004.<\/li>\n<li>ISPE. Baseline Guide for HVAC and Utilities (Volume 4) [M]. 2nd Edition, 2011.<\/li>\n<li>\u9648\u5fd7\u521a, \u738b\u78ca. \u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u7684\u5e94\u7528\u7814\u7a76[J]. \u4e2d\u56fd\u836f\u623f, 2019, 30(12): 1652-1655.<\/li>\n<li>\u5218\u6653\u5cf0. \u5236\u836f\u6d01\u51c0\u7a7a\u8c03\u7cfb\u7edf\u8fc7\u6ee4\u5668\u9009\u578b\u4e0e\u7ef4\u62a4\u7b56\u7565[J]. \u533b\u836f\u5de5\u7a0b\u8bbe\u8ba1, 2020, 41(3): 45-48.<\/li>\n<li>\u767e\u5ea6\u767e\u79d1. \u7a7a\u6c14\u8fc7\u6ee4\u5668 [EB\/OL]. <a href=\"https:\/\/baike.baidu.com\/item\/%E7%A9%BA%E6%B0%94%E8%BF%87%E6%BB%A4%E5%99%A8\/9878448\">https:\/\/baike.baidu.com\/item\/%E7%A9%BA%E6%B0%94%E8%BF%87%E6%BB%A4%E5%99%A8\/9878448<\/a><\/li>\n<li>\u82cf\u5dde\u5b89\u6cf0\u7a7a\u6c14\u6280\u672f\u6709\u9650\u516c\u53f8. \u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u4ea7\u54c1\u624b\u518c[Z]. 2022.<\/li>\n<\/ol>\n<hr \/>\n<p><em>\u672c\u6587\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\uff0c\u5177\u4f53\u5e94\u7528\u8bf7\u7ed3\u5408\u4f01\u4e1a\u5b9e\u9645\u60c5\u51b5\u5e76\u9075\u5faa\u5f53\u5730\u6cd5\u89c4\u8981\u6c42\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e0b\u7684\u4f7f\u7528\u89c4\u8303 \u5f15\u8a00 \u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5f71\u54cd\u836f\u54c1\u7684\u751f\u4ea7\u8d28\u91cf\u548c\u60a3\u8005\u7684\u5b89\u5168\u3002\u4e3a\u786e\u4fdd\u836f\u54c1\u5728\u6d01\u51c0\u73af\u5883\u4e0b\u751f\u4ea7\uff0c\u5236\u836f\u4f01\u4e1a\u666e\u904d\u91c7\u7528\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u5bf9\u8f66\u95f4\u7a7a\u6c14\u8fdb\u884c\u51c0\u5316\u5904\u7406\u3002\u5176\u4e2d\uff0c\u7ec4\u5408\u5f0f\u4e2d\u6548\u8fc7\u6ee4\u5668\uff08Combined Medium Efficiency Air Filter\uff09\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u6d01\u51c0\u5ba4\u3001\u65e0\u83cc\u64cd\u4f5c\u533a\u7b49&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-15169","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\/15169","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=15169"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15169\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15169"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15169"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15169"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}