{"id":15180,"date":"2025-06-18T16:37:38","date_gmt":"2025-06-18T08:37:38","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15180"},"modified":"2025-06-18T16:37:38","modified_gmt":"2025-06-18T08:37:38","slug":"%e4%b8%ad%e6%95%88%e7%a9%ba%e6%b0%94%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e5%88%b6%e8%8d%af%e6%b4%81%e5%87%80%e8%bd%a6%e9%97%b4%e4%b8%ad%e7%9a%84gmp%e5%90%88%e8%a7%84%e6%80%a7%e5%ba%94%e7%94%a8","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15180","title":{"rendered":"\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684GMP\u5408\u89c4\u6027\u5e94\u7528\u5206\u6790"},"content":{"rendered":"<h1>\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684GMP\u5408\u89c4\u6027\u5e94\u7528\u5206\u6790<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u5728\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u6d01\u51c0\u8f66\u95f4\u7684\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u836f\u54c1\u7684\u8d28\u91cf\u4e0e\u5b89\u5168\u3002\u4e3a\u786e\u4fdd\u751f\u4ea7\u73af\u5883\u7b26\u5408\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u8981\u6c42\uff0c\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u6210\u4e3a\u5173\u952e\u63a7\u5236\u73af\u8282\u4e4b\u4e00\u3002\u5176\u4e2d\uff0c\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u5728\u4fdd\u969c\u6d01\u51c0\u5ea6\u3001\u53bb\u9664\u5fae\u7c92\u548c\u5fae\u751f\u7269\u6c61\u67d3\u65b9\u9762\u53d1\u6325\u7740\u4e0d\u53ef\u66ff\u4ee3\u7684\u4f5c\u7528\u3002<\/p>\n<p>\u672c\u6587\u5c06\u56f4\u7ed5\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u3001\u4ea7\u54c1\u53c2\u6570\u3001\u5206\u7c7b\u6807\u51c6\u3001\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u5e94\u7528\u573a\u666f\u53ca\u5176\u5bf9GMP\u5408\u89c4\u6027\u7684\u8d21\u732e\u8fdb\u884c\u7cfb\u7edf\u5206\u6790\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u76f8\u5173\u6587\u732e\u53ca\u884c\u4e1a\u6807\u51c6\uff0c\u63a2\u8ba8\u5176\u9009\u578b\u4e0e\u7ef4\u62a4\u7b56\u7565\uff0c\u65e8\u5728\u4e3a\u5236\u836f\u4f01\u4e1a\u53ca\u76f8\u5173\u6280\u672f\u4eba\u5458\u63d0\u4f9b\u79d1\u5b66\u4f9d\u636e\u548c\u6280\u672f\u652f\u6301\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>1.1 \u5b9a\u4e49\u4e0e\u4f5c\u7528<\/h3>\n<p>\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u662f\u6307\u7528\u4e8e\u53bb\u9664\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u9897\u7c92\u7269\u7684\u4e00\u79cd\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u901a\u5e38\u7528\u4e8e\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e4b\u524d\u4f5c\u4e3a\u4e2d\u95f4\u7ea7\u8fc7\u6ee4\uff0c\u4e3b\u8981\u62e6\u622a5 \u03bcm\u81f31 \u03bcm\u4e4b\u95f4\u7684\u9897\u7c92\u7269\uff0c\u5982\u7070\u5c18\u3001\u82b1\u7c89\u3001\u7ec6\u83cc\u7b49\u3002\u5176\u4e3b\u8981\u4f5c\u7528\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u63d0\u9ad8\u7a7a\u6c14\u6d01\u51c0\u5ea6\uff1b<\/li>\n<li>\u5ef6\u957f\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f7f\u7528\u5bff\u547d\uff1b<\/li>\n<li>\u51cf\u5c11\u8bbe\u5907\u8fd0\u884c\u80fd\u8017\uff1b<\/li>\n<li>\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\u3002<\/li>\n<\/ul>\n<h3>1.2 \u5206\u7c7b\u4e0e\u6807\u51c6<\/h3>\n<p>\u6839\u636e\u56fd\u9645\u6807\u51c6ISO 16890\u548c\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6GB\/T 14295-2019\u300a\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\uff0c\u7a7a\u6c14\u8fc7\u6ee4\u5668\u53ef\u5206\u4e3a\u7c97\u6548\u3001\u4e2d\u6548\u3001\u4e9a\u9ad8\u6548\u548c\u9ad8\u6548\u56db\u4e2a\u7b49\u7ea7\u3002\u4e2d\u6548\u8fc7\u6ee4\u5668\u4e00\u822c\u5206\u4e3aF5~F9\u7ea7\u522b\uff08ISO\u6807\u51c6\uff09\uff0c\u5bf9\u5e94\u4e0d\u540c\u6548\u7387\u7b49\u7ea7\uff0c\u5177\u4f53\u5982\u4e0b\u8868\u6240\u793a\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u8fc7\u6ee4\u7b49\u7ea7<\/th>\n<th>ISO 16890\u6807\u51c6<\/th>\n<th>\u6548\u7387\u8303\u56f4\uff08\u5bf90.4 \u03bcm\u9897\u7c92\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>F5<\/td>\n<td>ePM25 &gt; 50%<\/td>\n<td>50% ~ 65%<\/td>\n<\/tr>\n<tr>\n<td>F6<\/td>\n<td>ePM25 &gt; 65%<\/td>\n<td>65% ~ 80%<\/td>\n<\/tr>\n<tr>\n<td>F7<\/td>\n<td>ePM25 &gt; 80%<\/td>\n<td>80% ~ 90%<\/td>\n<\/tr>\n<tr>\n<td>F8<\/td>\n<td>ePM25 &gt; 90%<\/td>\n<td>90% ~ 95%<\/td>\n<\/tr>\n<tr>\n<td>F9<\/td>\n<td>ePM25 &gt; 95%<\/td>\n<td>&gt; 95%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u8bf4\u660e<\/strong>\uff1aePM25\u6307\u8fc7\u6ee4\u5668\u5bf9\u76f4\u5f84\u5c0f\u4e8e\u7b49\u4e8e2.5\u03bcm\u9897\u7c92\u7684\u5e73\u5747\u6548\u7387\u3002<\/p>\n<\/blockquote>\n<p>\u5728\u4e2d\u56fd\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u4e5f\u5e38\u91c7\u7528\u201c\u4e2d\u65481\u201d\u3001\u201c\u4e2d\u65482\u201d\u3001\u201c\u4e2d\u65483\u201d\u7684\u5206\u7ea7\u65b9\u5f0f\uff0c\u5206\u522b\u5bf9\u5e94\u4e0d\u540c\u7684\u6548\u7387\u7b49\u7ea7\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u4ea7\u54c1\u53c2\u6570\u4e0e\u6027\u80fd\u6307\u6807<\/h2>\n<p>\u4e3a\u4e86\u6ee1\u8db3\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u7684\u9ad8\u6807\u51c6\u8981\u6c42\uff0c\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u8bbe\u8ba1\u4e0e\u5236\u9020\u8fc7\u7a0b\u4e2d\u9700\u6ee1\u8db3\u4e00\u7cfb\u5217\u6280\u672f\u53c2\u6570\uff0c\u4e3b\u8981\u5305\u62ec\u4ee5\u4e0b\u51e0\u9879\uff1a<\/p>\n<h3>2.1 \u4e3b\u8981\u6027\u80fd\u53c2\u6570<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u540d\u79f0<\/th>\n<th>\u63cf\u8ff0<\/th>\n<th>\u5355\u4f4d<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u65b0\u8fc7\u6ee4\u5668\u5728\u989d\u5b9a\u98ce\u91cf\u4e0b\u7684\u538b\u964d<\/td>\n<td>Pa<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b<\/td>\n<td>\u8fc7\u6ee4\u5668\u8fbe\u5230\u66f4\u6362\u6807\u51c6\u65f6\u7684\u538b\u964d<\/td>\n<td>Pa<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf<\/td>\n<td>\u8fc7\u6ee4\u5668\u8bbe\u8ba1\u5de5\u4f5c\u65f6\u7684\u6700\u5927\u98ce\u91cf<\/td>\n<td>m\u00b3\/h<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u6750\u6750\u8d28<\/td>\n<td>\u7ea4\u7ef4\u79cd\u7c7b\uff08\u5982\u73bb\u7483\u7ea4\u7ef4\u3001\u805a\u916f\u7ea4\u7ef4\u3001\u5408\u6210\u6750\u6599\u7b49\uff09<\/td>\n<td>\u2014<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u5bf9\u7279\u5b9a\u7c92\u5f84\u9897\u7c92\u7684\u6355\u96c6\u80fd\u529b<\/td>\n<td>%<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5bff\u547d<\/td>\n<td>\u5728\u89c4\u5b9a\u6761\u4ef6\u4e0b\u8fde\u7eed\u4f7f\u7528\u7684\u65f6\u95f4\u6216\u5904\u7406\u98ce\u91cf<\/td>\n<td>h \/ m\u00b3<\/td>\n<\/tr>\n<tr>\n<td>\u5de5\u4f5c\u6e29\u5ea6\/\u6e7f\u5ea6\u8303\u56f4<\/td>\n<td>\u8bbe\u5907\u53ef\u6b63\u5e38\u8fd0\u884c\u7684\u6e29\u6e7f\u5ea6\u8303\u56f4<\/td>\n<td>\u2103 \/ RH%<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28\u8010\u706b\u6027<\/td>\n<td>\u662f\u5426\u5177\u5907\u963b\u71c3\u6216\u9632\u706b\u6027\u80fd<\/td>\n<td>UL\u8ba4\u8bc1\u7b49<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u68c0\u6d4b\u65b9\u6cd5<\/td>\n<td>\u5982DOP\u6d4b\u8bd5\u3001PAO\u6d4b\u8bd5\u7b49<\/td>\n<td>\u6807\u51c6\u65b9\u6cd5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>2.2 \u5178\u578b\u4ea7\u54c1\u793a\u4f8b\u5bf9\u6bd4<\/h3>\n<p>\u4ee5\u4e0b\u4e3a\u56fd\u5185\u5e38\u89c1\u54c1\u724c\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u90e8\u5206\u6280\u672f\u53c2\u6570\u6bd4\u8f83\uff08\u4ee5\u67d0\u578b\u53f7\u4e3a\u4f8b\uff09\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u54c1\u724c<\/th>\n<th>\u578b\u53f7<\/th>\n<th>\u521d\u59cb\u963b\u529b (Pa)<\/th>\n<th>\u7ec8\u963b\u529b (Pa)<\/th>\n<th>\u989d\u5b9a\u98ce\u91cf (m\u00b3\/h)<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387 (F7)<\/th>\n<th>\u4f7f\u7528\u5bff\u547d (h)<\/th>\n<th>\u6750\u8d28\u7c7b\u578b<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u82cf\u5dde\u5b89\u6cf0<\/td>\n<td>AF-F7-610\u00d7610<\/td>\n<td>80<\/td>\n<td>250<\/td>\n<td>1500<\/td>\n<td>\u226585%<\/td>\n<td>10000<\/td>\n<td>\u5408\u6210\u7ea4\u7ef4+\u73bb\u7ea4<\/td>\n<\/tr>\n<tr>\n<td>\u4e0a\u6d77\u5eb7\u6590\u5c14<\/td>\n<td>KF-ZM-F7<\/td>\n<td>75<\/td>\n<td>220<\/td>\n<td>1400<\/td>\n<td>\u226582%<\/td>\n<td>9000<\/td>\n<td>\u805a\u916f\u7ea4\u7ef4<\/td>\n<\/tr>\n<tr>\n<td>\u5e7f\u4e1c\u4f73\u51c0<\/td>\n<td>JN-MF7-484<\/td>\n<td>85<\/td>\n<td>260<\/td>\n<td>1200<\/td>\n<td>\u226587%<\/td>\n<td>12000<\/td>\n<td>\u590d\u5408\u6ee4\u6750<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e09\u3001GMP\u5bf9\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u7a7a\u6c14\u8d28\u91cf\u7684\u8981\u6c42<\/h2>\n<h3>3.1 GMP\u5bf9\u6d01\u51c0\u5ea6\u7b49\u7ea7\u7684\u89c4\u5b9a<\/h3>\n<p>\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u9644\u5f551\u300a\u65e0\u83cc\u836f\u54c1\u300b\u7684\u89c4\u5b9a\uff0c\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u6839\u636e\u4e0d\u540c\u7528\u9014\u5212\u5206\u4e3aA\u3001B\u3001C\u3001D\u56db\u4e2a\u7b49\u7ea7\uff0c\u5176\u7a7a\u6c14\u6d01\u51c0\u5ea6\u6807\u51c6\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7b49\u7ea7<\/th>\n<th>\u5fae\u7c92\u6570\uff08\u22650.5 \u03bcm\uff09<\/th>\n<th>\u5fae\u7c92\u6570\uff08\u22655 \u03bcm\uff09<\/th>\n<th>\u6d3b\u5fae\u751f\u7269\u9650\u5ea6\uff08\u6c89\u964d\u83cc\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7<\/td>\n<td>\u22643520<\/td>\n<td>\u226420<\/td>\n<td>\u22641 CFU\/\u76bf<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7<\/td>\n<td>\u22643520<\/td>\n<td>\u226420<\/td>\n<td>\u22645 CFU\/\u76bf<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7<\/td>\n<td>\u2264352000<\/td>\n<td>\u22642900<\/td>\n<td>\u226450 CFU\/\u76bf<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7<\/td>\n<td>\u22643520000<\/td>\n<td>\u226429000<\/td>\n<td>\u2264100 CFU\/\u76bf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1aCFU = Colony Forming Units\uff0c\u83cc\u843d\u5f62\u6210\u5355\u4f4d\u3002<\/p>\n<\/blockquote>\n<h3>3.2 GMP\u5bf9\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u603b\u4f53\u8981\u6c42<\/h3>\n<ul>\n<li>\u5fc5\u987b\u914d\u7f6e\u521d\u6548\u3001\u4e2d\u6548\u3001\u9ad8\u6548\u4e09\u7ea7\u8fc7\u6ee4\u7cfb\u7edf\uff1b<\/li>\n<li>\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u5e94\u80fd\u5b9e\u73b0\u8fde\u7eed\u8fd0\u884c\u5e76\u4fdd\u6301\u7a33\u5b9a\uff1b<\/li>\n<li>\u5e94\u5b9a\u671f\u76d1\u6d4b\u7a7a\u6c14\u8d28\u91cf\uff0c\u5305\u62ec\u5c18\u57c3\u7c92\u5b50\u6570\u3001\u5fae\u751f\u7269\u6570\u91cf\u7b49\uff1b<\/li>\n<li>\u8fc7\u6ee4\u5668\u5e94\u5b9a\u671f\u66f4\u6362\u6216\u6e05\u6d17\uff0c\u9632\u6b62\u4e8c\u6b21\u6c61\u67d3\uff1b<\/li>\n<li>\u7cfb\u7edf\u8bbe\u8ba1\u5e94\u907f\u514d\u6b7b\u89d2\u3001\u6da1\u6d41\u533a\u57df\uff0c\u51cf\u5c11\u79ef\u5c18\u98ce\u9669\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u56db\u3001\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u7684\u5e94\u7528\u5206\u6790<\/h2>\n<h3>4.1 \u5e94\u7528\u573a\u666f<\/h3>\n<p>\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u901a\u5e38\u5b89\u88c5\u5728\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e4b\u524d\uff0c\u4f5c\u4e3a\u7b2c\u4e8c\u9053\u9632\u7ebf\uff0c\u4e3b\u8981\u627f\u62c5\u4ee5\u4e0b\u4efb\u52a1\uff1a<\/p>\n<ul>\n<li>\u53bb\u9664\u7a7a\u6c14\u4e2d\u8f83\u5927\u9897\u7c92\uff0c\u4fdd\u62a4\u9ad8\u6548\u8fc7\u6ee4\u5668\uff1b<\/li>\n<li>\u63d0\u9ad8\u6574\u4f53\u51c0\u5316\u6548\u7387\uff1b<\/li>\n<li>\u964d\u4f4e\u9ad8\u6548\u8fc7\u6ee4\u5668\u8d1f\u8377\uff0c\u5ef6\u957f\u5176\u4f7f\u7528\u5bff\u547d\uff1b<\/li>\n<li>\u63a7\u5236\u8f66\u95f4\u5185\u5fae\u751f\u7269\u6d53\u5ea6\u3002<\/li>\n<\/ul>\n<p>\u5178\u578b\u5e94\u7528\u4f4d\u7f6e\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>HVAC\u7cfb\u7edf\uff08\u6696\u901a\u7a7a\u8c03\u7cfb\u7edf\uff09\uff1b<\/li>\n<li>\u5c40\u90e8\u9001\u98ce\u7cfb\u7edf\uff1b<\/li>\n<li>\u5c42\u6d41\u7f69\u9884\u8fc7\u6ee4\u6bb5\uff1b<\/li>\n<li>\u6d01\u51c0\u5ba4\u56de\u98ce\u7cfb\u7edf\u3002<\/li>\n<\/ul>\n<h3>4.2 \u5bf9GMP\u5408\u89c4\u6027\u7684\u8d21\u732e<\/h3>\n<h4>\uff081\uff09\u4fdd\u969c\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8fbe\u6807<\/h4>\n<p>\u4e2d\u6548\u8fc7\u6ee4\u5668\u901a\u8fc7\u6709\u6548\u53bb\u96645 \u03bcm\u4ee5\u4e0b\u7684\u9897\u7c92\u6c61\u67d3\u7269\uff0c\u663e\u8457\u964d\u4f4e\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u9897\u7c92\u7684\u6570\u91cf\uff0c\u4ece\u800c\u6709\u52a9\u4e8e\u7ef4\u6301A\/B\/C\/D\u5404\u7ea7\u6d01\u51c0\u533a\u7684\u5fae\u7c92\u6570\u63a7\u5236\u76ee\u6807\u3002<\/p>\n<h4>\uff082\uff09\u63a7\u5236\u5fae\u751f\u7269\u6c61\u67d3<\/h4>\n<p>\u867d\u7136\u4e2d\u6548\u8fc7\u6ee4\u5668\u672c\u8eab\u4e0d\u5177\u5907\u706d\u83cc\u529f\u80fd\uff0c\u4f46\u5176\u9ad8\u6548\u7684\u9897\u7c92\u53bb\u9664\u80fd\u529b\u53ef\u4ee5\u95f4\u63a5\u63a7\u5236\u7a7a\u6c14\u4e2d\u643a\u5e26\u5fae\u751f\u7269\u7684\u9897\u7c92\u7269\u6570\u91cf\uff0c\u964d\u4f4e\u5fae\u751f\u7269\u6c61\u67d3\u98ce\u9669\u3002<\/p>\n<h4>\uff083\uff09\u63d0\u5347\u7cfb\u7edf\u7a33\u5b9a\u6027\u4e0e\u8282\u80fd\u6548\u679c<\/h4>\n<p>\u5408\u7406\u9009\u62e9\u4e2d\u6548\u8fc7\u6ee4\u5668\u53ef\u964d\u4f4e\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u8d1f\u62c5\uff0c\u63d0\u9ad8\u6574\u4e2a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u7a33\u5b9a\u6027\uff0c\u540c\u65f6\u51cf\u5c11\u98ce\u673a\u529f\u8017\uff0c\u8fbe\u5230\u8282\u80fd\u51cf\u6392\u7684\u76ee\u7684\u3002<\/p>\n<h4>\uff084\uff09\u4fbf\u4e8e\u7ef4\u62a4\u4e0e\u76d1\u63a7<\/h4>\n<p>\u76f8\u6bd4\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u66f4\u6362\u5468\u671f\u66f4\u77ed\uff0c\u7ef4\u62a4\u6210\u672c\u66f4\u4f4e\uff0c\u6709\u5229\u4e8e\u5b9e\u65bd\u5b9a\u671f\u6e05\u6d01\u4e0e\u66f4\u6362\u8ba1\u5212\uff0c\u7b26\u5408GMP\u5bf9\u7cfb\u7edf\u53ef\u8ffd\u6eaf\u6027\u548c\u53ef\u9a8c\u8bc1\u6027\u7684\u8981\u6c42\u3002<\/p>\n<hr \/>\n<h2>\u4e94\u3001\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u4e0e\u7ef4\u62a4\u7b56\u7565<\/h2>\n<h3>5.1 \u9009\u578b\u539f\u5219<\/h3>\n<ul>\n<li>\u6839\u636e\u6d01\u51c0\u533a\u7b49\u7ea7\u786e\u5b9a\u6240\u9700\u8fc7\u6ee4\u6548\u7387\uff1b<\/li>\n<li>\u7ed3\u5408\u98ce\u91cf\u9700\u6c42\u9009\u62e9\u5408\u9002\u7684\u5c3a\u5bf8\u4e0e\u7ed3\u6784\uff1b<\/li>\n<li>\u8003\u8651\u521d\u59cb\u963b\u529b\u4e0e\u7ec8\u963b\u529b\u5bf9\u7cfb\u7edf\u538b\u529b\u7684\u5f71\u54cd\uff1b<\/li>\n<li>\u4f18\u5148\u9009\u7528\u5177\u6709UL\u8ba4\u8bc1\u3001CE\u8ba4\u8bc1\u7684\u4ea7\u54c1\uff1b<\/li>\n<li>\u6ce8\u610f\u6ee4\u6750\u662f\u5426\u9002\u5408\u9ad8\u6e29\u6d88\u6bd2\u6216\u6e7f\u70ed\u73af\u5883\u3002<\/li>\n<\/ul>\n<h3>5.2 \u7ef4\u62a4\u7ba1\u7406\u5efa\u8bae<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u5185\u5bb9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u66f4\u6362\u5468\u671f<\/td>\n<td>\u4e00\u822c\u4e3a6~12\u4e2a\u6708\uff0c\u89c6\u5b9e\u9645\u8fd0\u884c\u6761\u4ef6\u800c\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u6807\u51c6<\/td>\n<td>\u5f53\u963b\u529b\u8fbe\u5230\u7ec8\u963b\u529b\u8bbe\u5b9a\u503c\uff0c\u6216\u6548\u7387\u4e0b\u964d\u8d85\u8fc710%<\/td>\n<\/tr>\n<tr>\n<td>\u6e05\u6d01\u9891\u7387<\/td>\n<td>\u4e0d\u63a8\u8350\u6e05\u6d17\u91cd\u590d\u4f7f\u7528\uff0c\u9664\u975e\u5236\u9020\u5546\u660e\u786e\u5141\u8bb8<\/td>\n<\/tr>\n<tr>\n<td>\u76d1\u6d4b\u9879\u76ee<\/td>\n<td>\u5b9a\u671f\u68c0\u6d4b\u963b\u529b\u53d8\u5316\u3001\u6548\u7387\u8870\u51cf\u3001\u6cc4\u6f0f\u60c5\u51b5<\/td>\n<\/tr>\n<tr>\n<td>\u6587\u6863\u8bb0\u5f55<\/td>\n<td>\u5efa\u7acb\u66f4\u6362\u8bb0\u5f55\u3001\u68c0\u6d4b\u62a5\u544a\u3001\u4f9b\u5e94\u5546\u8d44\u8d28\u8bc1\u660e\u7b49\u5b8c\u6574\u6863\u6848<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u516d\u3001\u56fd\u5185\u5916\u7814\u7a76\u4e0e\u5b9e\u8df5\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>6.1 \u56fd\u5185\u7814\u7a76\u73b0\u72b6<\/h3>\n<p>\u636e\u300a\u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f\u300b\u6742\u5fd7\u62a5\u9053\uff0c\u56fd\u5185\u5236\u836f\u4f01\u4e1a\u5728\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4e2d\u666e\u904d\u91c7\u7528F7~F9\u7ea7\u522b\u7684\u4e2d\u6548\u8fc7\u6ee4\u5668\uff0c\u90e8\u5206\u4f01\u4e1a\u5df2\u5f00\u59cb\u5f15\u5165\u667a\u80fd\u76d1\u6d4b\u7cfb\u7edf\uff0c\u5bf9\u8fc7\u6ee4\u5668\u72b6\u6001\u8fdb\u884c\u5b9e\u65f6\u8ffd\u8e2a\uff0c\u63d0\u5347\u4e86\u7cfb\u7edf\u7684\u81ea\u52a8\u5316\u7ba1\u7406\u6c34\u5e73\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a\u53d1\u5e03\u7684\u300a\u4e2d\u56fd\u836f\u5178\u300b2020\u5e74\u7248\u4e2d\u5bf9\u6d01\u51c0\u5ba4\u7a7a\u6c14\u8d28\u91cf\u63d0\u51fa\u4e86\u66f4\u4e3a\u4e25\u683c\u7684\u8981\u6c42\uff0c\u8fdb\u4e00\u6b65\u63a8\u52a8\u4e86\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u9886\u57df\u7684\u89c4\u8303\u5316\u5e94\u7528\u3002<\/p>\n<h3>6.2 \u56fd\u9645\u7814\u7a76\u8fdb\u5c55<\/h3>\n<p>\u7f8e\u56fdFDA\u5728\u5176\u6307\u5357\u6587\u4ef6\u300aGuideline on Sterile Drug Products Produced by Aseptic Processing\u300b\u4e2d\u6307\u51fa\uff0c\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u5fc5\u987b\u5305\u542b\u591a\u7ea7\u8fc7\u6ee4\u673a\u5236\uff0c\u5176\u4e2d\u4e2d\u6548\u8fc7\u6ee4\u5668\u662f\u4e0d\u53ef\u6216\u7f3a\u7684\u4e00\u73af\uff0c\u5c24\u5176\u5728\u4fdd\u62a4\u9ad8\u6548\u8fc7\u6ee4\u5668\u65b9\u9762\u5177\u6709\u91cd\u8981\u4f5c\u7528\u3002<\/p>\n<p>\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u4e5f\u5728\u5176GMP\u9644\u4ef61\u4e2d\u5f3a\u8c03\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u5e94\u5b9a\u671f\u66f4\u6362\u5e76\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u4ee5\u786e\u4fdd\u5176\u59cb\u7ec8\u5904\u4e8e\u6700\u4f73\u5de5\u4f5c\u72b6\u6001\u3002<\/p>\n<h3>6.3 \u5178\u578b\u5e94\u7528\u6848\u4f8b<\/h3>\n<p>\u67d0\u5927\u578b\u8de8\u56fd\u5236\u836f\u516c\u53f8\u5728\u5176\u6ce8\u5c04\u5242\u751f\u4ea7\u8f66\u95f4\u4e2d\u91c7\u7528\u4e86F8\u7ea7\u522b\u7684\u4e2d\u6548\u8fc7\u6ee4\u5668\uff0c\u5e76\u914d\u5408\u9ad8\u6548\u8fc7\u6ee4\u5668\u6784\u5efa\u4e09\u7ea7\u8fc7\u6ee4\u4f53\u7cfb\u3002\u8be5\u7cfb\u7edf\u81ea\u6295\u5165\u4f7f\u7528\u4ee5\u6765\uff0c\u8f66\u95f4\u7a7a\u6c14\u6d01\u51c0\u5ea6\u59cb\u7ec8\u4fdd\u6301\u5728B\u7ea7\u6c34\u5e73\u4ee5\u4e0a\uff0c\u4e14\u9ad8\u6548\u8fc7\u6ee4\u5668\u66f4\u6362\u5468\u671f\u5ef6\u957f\u4e86\u7ea630%\uff0c\u53d6\u5f97\u4e86\u826f\u597d\u7684\u7ecf\u6d4e\u6548\u76ca\u4e0e\u8d28\u91cf\u4fdd\u969c\u6548\u679c\u3002<\/p>\n<hr \/>\n<h2>\u4e03\u3001\u7ed3\u8bba\u4e0e\u5c55\u671b\uff08\u7565\uff09<\/h2>\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\u300b\uff082010\u5e74\u4fee\u8ba2\uff09[Z]. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2011.  <\/li>\n<li>GB\/T 14295-2019. \u7a7a\u6c14\u8fc7\u6ee4\u5668[S]. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2019.  <\/li>\n<li>ISO 16890-1:2016. Air filter for general ventilation \u2013 Part 1: Technical specifications [S]. Geneva: ISO, 2016.  <\/li>\n<li>FDA. Guideline on Sterile Drug Products Produced by Aseptic Processing [EB\/OL]. <a href=\"https:\/\/www.fda.gov\">https:\/\/www.fda.gov<\/a>, 2004.  <\/li>\n<li>EMA. Annex 1 to the EU GMP Guide: Manufacture of Sterile Medicinal Products [EB\/OL]. <a href=\"https:\/\/www.ema.europa.eu\">https:\/\/www.ema.europa.eu<\/a>, 2020.  <\/li>\n<li>\u674e\u4f1f. \u5236\u836f\u6d01\u51c0\u8f66\u95f4\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u8bbe\u8ba1\u4e0e\u7ba1\u7406[J]. \u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f, 2019(2): 45-50.  <\/li>\n<li>\u738b\u5fd7\u521a. \u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u533b\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u5206\u6790[J]. \u5236\u836f\u5de5\u7a0b, 2020(4): 22-25.  <\/li>\n<li>\u767e\u5ea6\u767e\u79d1. \u7a7a\u6c14\u8fc7\u6ee4\u5668\u8bcd\u6761 [EB\/OL]. <a href=\"https:\/\/baike.baidu.com\/item\/\u7a7a\u6c14\u8fc7\u6ee4\u5668\">https:\/\/baike.baidu.com\/item\/\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/a>, 2023.<\/li>\n<\/ol>\n<hr \/>\n<p><em>\u6ce8\uff1a\u672c\u6587\u7ae0\u5185\u5bb9\u4e3a\u539f\u521b\u64b0\u5199\uff0c\u672a\u590d\u5236\u5176\u4ed6\u6765\u6e90\u5185\u5bb9\uff0c\u5f15\u7528\u8d44\u6599\u5747\u5df2\u6ce8\u660e\u6765\u6e90\u3002\u6b22\u8fce\u8f6c\u53d1\u4e0e\u5f15\u7528\uff0c\u4f46\u8bf7\u6ce8\u660e\u51fa\u5904\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684GMP\u5408\u89c4\u6027\u5e94\u7528\u5206\u6790 \u5f15\u8a00 \u5728\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u6d01\u51c0\u8f66\u95f4\u7684\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u836f\u54c1\u7684\u8d28\u91cf\u4e0e\u5b89\u5168\u3002\u4e3a\u786e\u4fdd\u751f\u4ea7\u73af\u5883\u7b26\u5408\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u8981\u6c42\uff0c\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u6210\u4e3a\u5173\u952e\u63a7\u5236\u73af\u8282\u4e4b\u4e00\u3002\u5176\u4e2d\uff0c\u4e2d\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u5728\u4fdd\u969c\u6d01\u51c0\u5ea6\u3001\u53bb\u9664\u5fae\u7c92\u548c\u5fae\u751f\u7269\u6c61\u67d3\u65b9&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-15180","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\/15180","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=15180"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15180\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15180"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15180"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15180"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}