{"id":15421,"date":"2025-06-20T11:53:55","date_gmt":"2025-06-20T03:53:55","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15421"},"modified":"2025-06-20T11:53:55","modified_gmt":"2025-06-20T03:53:55","slug":"%e9%ab%98%e6%95%88%e7%a9%ba%e6%b0%94%e9%99%a4%e8%8f%8c%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8gmp%e6%b4%81%e5%87%80%e5%8e%82%e6%88%bf%e4%b8%ad%e7%9a%84%e5%ae%89%e8%a3%85%e4%b8%8e%e7%bb%b4%e6%8a%a4","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15421","title":{"rendered":"\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u5728GMP\u6d01\u51c0\u5382\u623f\u4e2d\u7684\u5b89\u88c5\u4e0e\u7ef4\u62a4\u8981\u70b9"},"content":{"rendered":"<h1>\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u5728GMP\u6d01\u51c0\u5382\u623f\u4e2d\u7684\u5b89\u88c5\u4e0e\u7ef4\u62a4\u8981\u70b9<\/h1>\n<h2>\u4e00\u3001\u5f15\u8a00<\/h2>\n<p>\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air, HEPA\uff09\u548c\u8d85\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08Ultra Low Penetration Air, ULPA\uff09\u4f5c\u4e3a\u6d01\u51c0\u5ba4\u7cfb\u7edf\u7684\u6838\u5fc3\u7ec4\u6210\u90e8\u5206\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u3001\u751f\u7269\u6280\u672f\u3001\u533b\u7597\u8bbe\u5907\u3001\u98df\u54c1\u52a0\u5de5\u7b49\u5bf9\u7a7a\u6c14\u8d28\u91cf\u8981\u6c42\u6781\u9ad8\u7684\u9886\u57df\u3002\u5c24\u5176\u662f\u5728\u7b26\u5408\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u6807\u51c6\u7684\u6d01\u51c0\u5382\u623f\u4e2d\uff0c\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u7684\u6027\u80fd\u76f4\u63a5\u5f71\u54cd\u4ea7\u54c1\u7684\u8d28\u91cf\u4e0e\u5b89\u5168\u6027\u3002<\/p>\n<p>\u672c\u6587\u5c06\u4ece\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u51fa\u53d1\uff0c\u8be6\u7ec6\u9610\u8ff0\u5176\u5728GMP\u6d01\u51c0\u5382\u623f\u4e2d\u7684\u5b89\u88c5\u8981\u70b9\u4e0e\u65e5\u5e38\u7ef4\u62a4\u7b56\u7565\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u6743\u5a01\u6587\u732e\u53ca\u884c\u4e1a\u6807\u51c6\uff0c\u63d0\u4f9b\u5b9e\u7528\u7684\u6280\u672f\u53c2\u6570\u4e0e\u64cd\u4f5c\u6307\u5357\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u4e0e\u5206\u7c7b<\/h2>\n<h3>2.1 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>HEPA\/ULPA\u8fc7\u6ee4\u5668\u901a\u8fc7\u7269\u7406\u62e6\u622a\u3001\u60ef\u6027\u649e\u51fb\u3001\u6269\u6563\u6c89\u964d\u548c\u9759\u7535\u5438\u9644\u7b49\u591a\u79cd\u673a\u5236\u6355\u96c6\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u9897\u7c92\u7269\uff0c\u4ece\u800c\u5b9e\u73b0\u9ad8\u6548\u51c0\u5316\u3002\u6839\u636e\u7f8e\u56fd\u80fd\u6e90\u90e8\uff08DOE\uff09\u6807\u51c6\uff0cHEPA\u8fc7\u6ee4\u5668\u5bf90.3 \u03bcm\u7c92\u5f84\u9897\u7c92\u7684\u8fc7\u6ee4\u6548\u7387\u5e94\u4e0d\u4f4e\u4e8e99.97%\uff0c\u800cULPA\u8fc7\u6ee4\u5668\u5219\u5bf90.12 \u03bcm\u9897\u7c92\u7684\u8fc7\u6ee4\u6548\u7387\u8fbe\u523099.999%\u4ee5\u4e0a\u3002<\/p>\n<h3>2.2 \u4e3b\u8981\u5206\u7c7b<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u5206\u7c7b<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387<\/th>\n<th>\u7c92\u5f84\u8303\u56f4<\/th>\n<th>\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>HEPA<\/td>\n<td>\u226599.97%<\/td>\n<td>0.3 \u03bcm<\/td>\n<td>\u6d01\u51c0\u8f66\u95f4\u3001\u533b\u9662\u624b\u672f\u5ba4<\/td>\n<\/tr>\n<tr>\n<td>ULPA<\/td>\n<td>\u226599.999%<\/td>\n<td>0.12 \u03bcm<\/td>\n<td>\u534a\u5bfc\u4f53\u5236\u9020\u3001\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u6570\u636e\u6765\u6e90\uff1aASHRAE Handbook &#8211; HVAC Systems and Equipment (2020)<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e09\u3001GMP\u6d01\u51c0\u5382\u623f\u5bf9\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u7684\u8981\u6c42<\/h2>\n<p>\u6839\u636e\u4e2d\u56fd\u56fd\u5bb6\u836f\u76d1\u5c40\u53d1\u5e03\u7684\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff092010\u5e74\u4fee\u8ba2\u7248\uff0c\u6d01\u51c0\u533a\u6309\u7a7a\u6c14\u6d01\u51c0\u5ea6\u5206\u4e3aA\u7ea7\u3001B\u7ea7\u3001C\u7ea7\u3001D\u7ea7\u56db\u4e2a\u7b49\u7ea7\uff0c\u4e0d\u540c\u7b49\u7ea7\u5bf9\u7a7a\u6c14\u7c92\u5b50\u6570\u548c\u5fae\u751f\u7269\u9650\u5ea6\u6709\u660e\u786e\u9650\u5236\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7b49\u7ea7<\/th>\n<th>ISO\u6807\u51c6<\/th>\n<th>\u7a7a\u6c14\u7c92\u5b50\u9650\u503c\uff08\u22650.5 \u03bcm\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>ISO 5<\/td>\n<td>\u22643520<\/td>\n<td>\u60ac\u6d6e\u83cc\u22641\uff0c\u6c89\u964d\u83cc\u22641<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7<\/td>\n<td>ISO 7<\/td>\n<td>\u226435200<\/td>\n<td>\u60ac\u6d6e\u83cc\u226410\uff0c\u6c89\u964d\u83cc\u22645<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7<\/td>\n<td>ISO 8<\/td>\n<td>\u2264352000<\/td>\n<td>\u60ac\u6d6e\u83cc\u2264100\uff0c\u6c89\u964d\u83cc\u226450<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7<\/td>\n<td>ISO 9<\/td>\n<td>\u22643520000<\/td>\n<td>\u6309\u9700\u8bbe\u5b9a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u6570\u636e\u6765\u6e90\uff1a\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff092010\u5e74\u4fee\u8ba2\u7248<\/p>\n<\/blockquote>\n<p>\u4e3a\u6ee1\u8db3\u4e0a\u8ff0\u6d01\u51c0\u7b49\u7ea7\u8981\u6c42\uff0cGMP\u5382\u623f\u901a\u5e38\u91c7\u7528\u201c\u521d\u6548+\u4e2d\u6548+\u9ad8\u6548\u201d\u7684\u4e09\u7ea7\u8fc7\u6ee4\u7cfb\u7edf\uff0c\u5176\u4e2d\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f4d\u4e8e\u672b\u7aef\u9001\u98ce\u53e3\u4f4d\u7f6e\uff0c\u662f\u4fdd\u969c\u6d01\u51c0\u73af\u5883\u7684\u6700\u540e\u4e00\u9053\u9632\u7ebf\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u4e0e\u4ea7\u54c1\u53c2\u6570<\/h2>\n<h3>4.1 \u9009\u578b\u4f9d\u636e<\/h3>\n<p>\u9009\u62e9\u9ad8\u6548\u8fc7\u6ee4\u5668\u65f6\u5e94\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n<ul>\n<li>\u6d01\u51c0\u7b49\u7ea7\u8981\u6c42<\/li>\n<li>\u5b89\u88c5\u7a7a\u95f4\u5c3a\u5bf8<\/li>\n<li>\u98ce\u91cf\u9700\u6c42<\/li>\n<li>\u521d\u59cb\u538b\u964d\u4e0e\u5bb9\u5c18\u91cf<\/li>\n<li>\u6750\u8d28\u8010\u8150\u8680\u6027<\/li>\n<li>\u662f\u5426\u5177\u5907\u706d\u83cc\u529f\u80fd\uff08\u5982\u9ad8\u6e29\u706d\u83cc\uff09<\/li>\n<\/ul>\n<h3>4.2 \u5e38\u89c1\u4ea7\u54c1\u53c2\u6570\u5bf9\u6bd4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u9879<\/th>\n<th>HEPA H13<\/th>\n<th>HEPA H14<\/th>\n<th>ULPA U15<\/th>\n<th>ULPA U16<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u226599.97%<\/td>\n<td>\u226599.995%<\/td>\n<td>\u226599.999%<\/td>\n<td>\u226599.9995%<\/td>\n<\/tr>\n<tr>\n<td>\u7c92\u5f84\u6d4b\u8bd5\u70b9<\/td>\n<td>0.3 \u03bcm<\/td>\n<td>0.3 \u03bcm<\/td>\n<td>0.12 \u03bcm<\/td>\n<td>0.12 \u03bcm<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>200-250 Pa<\/td>\n<td>250-300 Pa<\/td>\n<td>300-350 Pa<\/td>\n<td>350-400 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u6700\u5927\u98ce\u91cf<\/td>\n<td>1000 m\u00b3\/h<\/td>\n<td>1000-1200 m\u00b3\/h<\/td>\n<td>800-1000 m\u00b3\/h<\/td>\n<td>600-800 m\u00b3\/h<\/td>\n<\/tr>\n<tr>\n<td>\u5bb9\u5c18\u91cf<\/td>\n<td>500-800 g<\/td>\n<td>600-900 g<\/td>\n<td>400-600 g<\/td>\n<td>300-500 g<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\u7eb8\u82af\u4f53<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\u7eb8\u82af\u4f53<\/td>\n<td>\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4\u7eb8<\/td>\n<td>\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4\u7eb8<\/td>\n<\/tr>\n<tr>\n<td>\u706d\u83cc\u65b9\u5f0f<\/td>\n<td>\u53ef\u9009\u9ad8\u6e29\u706d\u83cc<\/td>\n<td>\u53ef\u9009\u9ad8\u6e29\u706d\u83cc<\/td>\n<td>\u53ef\u9009\u5316\u5b66\u718f\u84b8\u6216\u7d2b\u5916<\/td>\n<td>\u53ef\u9009\u5316\u5b66\u718f\u84b8\u6216\u7d2b\u5916<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u6570\u636e\u6765\u6e90\uff1aCamfil Farr\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u624b\u518c\u300b\uff082021\uff09\u3001\u4e2d\u56fd\u5efa\u7b51\u5de5\u4e1a\u51fa\u7248\u793e\u300a\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303\u300bGB50073-2013<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e94\u3001\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u8981\u70b9<\/h2>\n<h3>5.1 \u5b89\u88c5\u524d\u51c6\u5907<\/h3>\n<h4>5.1.1 \u73b0\u573a\u68c0\u67e5<\/h4>\n<ul>\n<li>\u786e\u8ba4\u9001\u98ce\u53e3\u7ed3\u6784\u662f\u5426\u5b8c\u597d\u65e0\u635f<\/li>\n<li>\u6d4b\u91cf\u98ce\u901f\u4e0e\u98ce\u91cf\u662f\u5426\u7b26\u5408\u8bbe\u8ba1\u8981\u6c42<\/li>\n<li>\u68c0\u67e5\u5bc6\u5c01\u6761\u5b8c\u6574\u6027\uff0c\u9632\u6b62\u6f0f\u98ce<\/li>\n<li>\u6838\u5b9e\u8fc7\u6ee4\u5668\u578b\u53f7\u4e0e\u56fe\u7eb8\u4e00\u81f4<\/li>\n<\/ul>\n<h4>5.1.2 \u5b89\u5168\u9632\u62a4<\/h4>\n<ul>\n<li>\u4f69\u6234\u9632\u5c18\u53e3\u7f69\u4e0e\u624b\u5957<\/li>\n<li>\u4f7f\u7528\u65e0\u5c18\u5de5\u5177\u8fdb\u884c\u5b89\u88c5<\/li>\n<li>\u9632\u6b62\u6ee4\u6750\u53d7\u6f6e\u6216\u7834\u635f<\/li>\n<\/ul>\n<h3>5.2 \u5b89\u88c5\u6b65\u9aa4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6b65\u9aa4<\/th>\n<th>\u5185\u5bb9\u63cf\u8ff0<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>1<\/td>\n<td>\u5173\u95ed\u98ce\u673a\u7cfb\u7edf\uff0c\u786e\u4fdd\u65e0\u98ce\u72b6\u6001\u4e0b\u64cd\u4f5c<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>\u6e05\u7406\u9001\u98ce\u53e3\u5185\u90e8\u7070\u5c18\uff0c\u68c0\u67e5\u5bc6\u5c01\u69fd<\/td>\n<\/tr>\n<tr>\n<td>3<\/td>\n<td>\u5c06\u8fc7\u6ee4\u5668\u7f13\u6162\u63d2\u5165\u6846\u67b6\uff0c\u907f\u514d\u78b0\u649e<\/td>\n<\/tr>\n<tr>\n<td>4<\/td>\n<td>\u68c0\u67e5\u56db\u5468\u8fb9\u7f18\u662f\u5426\u8d34\u5408\u7d27\u5bc6<\/td>\n<\/tr>\n<tr>\n<td>5<\/td>\n<td>\u5b89\u88c5\u5b8c\u6bd5\u540e\u8fdb\u884c\u68c0\u6f0f\u6d4b\u8bd5\uff08PAO\u6cd5\u6216\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u5668\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u53c2\u8003\u6587\u732e\uff1aISO 14644-3:2019\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883 \u7b2c3\u90e8\u5206\uff1a\u68c0\u6d4b\u65b9\u6cd5\u300b<\/p>\n<\/blockquote>\n<h3>5.3 \u5e38\u89c1\u5b89\u88c5\u95ee\u9898\u53ca\u89e3\u51b3\u63aa\u65bd<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u95ee\u9898\u73b0\u8c61<\/th>\n<th>\u539f\u56e0\u5206\u6790<\/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>\u5b89\u88c5\u4e0d\u5230\u4f4d\u3001\u6ee4\u7f51\u5835\u585e<\/td>\n<td>\u68c0\u67e5\u5b89\u88c5\u95f4\u9699\uff0c\u66f4\u6362\u65b0\u6ee4\u7f51<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u9732\u62a5\u8b66<\/td>\n<td>\u5bc6\u5c01\u4e0d\u4e25<\/td>\n<td>\u52a0\u5f3a\u5bc6\u5c01\u6761\u3001\u91cd\u65b0\u5b89\u88c5<\/td>\n<\/tr>\n<tr>\n<td>\u5f02\u5e38\u566a\u97f3<\/td>\n<td>\u6ee4\u6750\u53d8\u5f62\u3001\u56fa\u5b9a\u677e\u52a8<\/td>\n<td>\u66f4\u6362\u6ee4\u6750\u3001\u7d27\u56fa\u652f\u67b6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u516d\u3001\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u8fd0\u884c\u7ef4\u62a4<\/h2>\n<h3>6.1 \u65e5\u5e38\u76d1\u6d4b\u4e0e\u8bb0\u5f55<\/h3>\n<ul>\n<li><strong>\u5b9a\u671f\u68c0\u6d4b\u98ce\u901f<\/strong>\uff1a\u5efa\u8bae\u6bcf\u5b63\u5ea6\u4e00\u6b21\uff0c\u4f7f\u7528\u70ed\u7403\u5f0f\u98ce\u901f\u4eea\u6d4b\u91cf\u3002<\/li>\n<li><strong>\u538b\u5dee\u76d1\u6d4b<\/strong>\uff1a\u8bbe\u7f6e\u538b\u5dee\u8868\u5b9e\u65f6\u76d1\u63a7\u521d\u6548\u3001\u4e2d\u6548\u4e0e\u9ad8\u6548\u4e4b\u95f4\u7684\u538b\u529b\u53d8\u5316\u3002<\/li>\n<li><strong>\u7c92\u5b50\u8ba1\u6570<\/strong>\uff1a\u4f7f\u7528\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u5668\u68c0\u6d4b\u6d01\u51c0\u5ea6\uff0c\u9891\u7387\u89c6\u6d01\u51c0\u7b49\u7ea7\u800c\u5b9a\uff08A\/B\u7ea7\u6bcf\u65e5\u4e00\u6b21\uff09\u3002<\/li>\n<li><strong>\u5fae\u751f\u7269\u68c0\u6d4b<\/strong>\uff1a\u91c7\u7528\u6c89\u964d\u83cc\u6cd5\u6216\u6d6e\u6e38\u83cc\u91c7\u6837\u5668\uff0c\u6bcf\u6708\u81f3\u5c11\u4e00\u6b21\u3002<\/li>\n<\/ul>\n<h3>6.2 \u7ef4\u62a4\u5468\u671f\u4e0e\u9879\u76ee<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u5468\u671f<\/th>\n<th>\u5185\u5bb9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5916\u89c2\u68c0\u67e5<\/td>\n<td>\u6bcf\u6708<\/td>\n<td>\u68c0\u67e5\u6ee4\u6750\u662f\u5426\u6709\u7834\u635f\u3001\u6c61\u67d3<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u8bb0\u5f55<\/td>\n<td>\u6bcf\u65e5<\/td>\n<td>\u8bb0\u5f55\u524d\u540e\u538b\u5dee\u53d8\u5316<\/td>\n<\/tr>\n<tr>\n<td>\u68c0\u6f0f\u6d4b\u8bd5<\/td>\n<td>\u6bcf\u5e74<\/td>\n<td>PAO\u6cd5\u6216\u5149\u5ea6\u8ba1\u6cd5\u68c0\u6d4b\u6cc4\u6f0f\u7387<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u5468\u671f<\/td>\n<td>\u89c6\u60c5\u51b5<\/td>\n<td>\u5f53\u538b\u5dee\u8d85\u8fc7\u521d\u59cb\u503c1.5\u500d\u6216\u68c0\u6d4b\u4e0d\u5408\u683c\u65f6\u66f4\u6362<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u53c2\u8003\u6587\u732e\uff1a\u4e2d\u56fd\u533b\u836f\u96c6\u56e2\u8bbe\u8ba1\u9662\uff0c\u300a\u6d01\u51c0\u5382\u623f\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u8bbe\u8ba1\u4e0e\u8fd0\u884c\u7ba1\u7406\u300b\uff082018\uff09<\/p>\n<\/blockquote>\n<h3>6.3 \u6545\u969c\u5904\u7406\u4e0e\u5e94\u6025\u63aa\u65bd<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6545\u969c\u7c7b\u578b<\/th>\n<th>\u8868\u73b0<\/th>\n<th>\u5904\u7406\u65b9\u6cd5<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u9ad8\u6548\u5931\u6548<\/td>\n<td>\u6d01\u51c0\u5ea6\u4e0b\u964d\u3001\u5fae\u751f\u7269\u8d85\u6807<\/td>\n<td>\u7acb\u5373\u505c\u673a\u66f4\u6362\u8fc7\u6ee4\u5668<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u901f\u5f02\u5e38<\/td>\n<td>\u98ce\u53e3\u98ce\u901f\u4f4e\u4e8e\u8bbe\u8ba1\u503c<\/td>\n<td>\u68c0\u67e5\u98ce\u673a\u72b6\u6001\u3001\u66f4\u6362\u524d\u7f6e\u8fc7\u6ee4\u5668<\/td>\n<\/tr>\n<tr>\n<td>\u6f0f\u98ce\u62a5\u8b66<\/td>\n<td>\u68c0\u6d4b\u5230\u7c92\u5b50\u6d53\u5ea6\u7a81\u589e<\/td>\n<td>\u91cd\u65b0\u5bc6\u5c01\u6216\u5c40\u90e8\u4fee\u590d<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e03\u3001\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u4e0e\u518d\u786e\u8ba4<\/h2>\n<h3>7.1 \u9a8c\u8bc1\u5185\u5bb9<\/h3>\n<p>\u6839\u636eICH Q7\u3001FDA cGMP\u4ee5\u53ca\u4e2d\u56fdGMP\u8981\u6c42\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u9700\u8fdb\u884c\u5982\u4e0b\u9a8c\u8bc1\uff1a<\/p>\n<ul>\n<li><strong>\u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09<\/strong>\uff1a\u5305\u62ec\u5b89\u88c5\u4f4d\u7f6e\u3001\u578b\u53f7\u3001\u6570\u91cf\u3001\u5bc6\u5c01\u6027\u7b49\uff1b<\/li>\n<li><strong>\u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09<\/strong>\uff1a\u6d4b\u8bd5\u98ce\u901f\u3001\u98ce\u91cf\u3001\u538b\u5dee\u3001\u6cc4\u9732\u7387\u7b49\uff1b<\/li>\n<li><strong>\u6027\u80fd\u786e\u8ba4\uff08PQ\uff09<\/strong>\uff1a\u6301\u7eed\u76d1\u6d4b\u6d01\u51c0\u5ea6\u4e0e\u5fae\u751f\u7269\u6c34\u5e73\uff0c\u786e\u8ba4\u7cfb\u7edf\u7a33\u5b9a\u6027\u3002<\/li>\n<\/ul>\n<h3>7.2 \u68c0\u6f0f\u6d4b\u8bd5\u65b9\u6cd5<\/h3>\n<p>\u5e38\u7528\u68c0\u6f0f\u65b9\u6cd5\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>PAO\u6cd5\uff08\u805a\u03b1\u70ef\u70c3\u6cd5\uff09<\/strong>\uff1a\u901a\u8fc7\u96fe\u5316PAO\u8bd5\u5242\uff0c\u5728\u4e0b\u6e38\u7aef\u68c0\u6d4b\u6cc4\u6f0f\u6d53\u5ea6\u3002<\/li>\n<li><strong>\u5149\u5ea6\u8ba1\u6cd5<\/strong>\uff1a\u4f7f\u7528\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6d4b\u5b9a\u7a7f\u900f\u7387\uff0c\u5408\u683c\u6807\u51c6\u4e3a\u22640.03%\u3002<\/li>\n<li><strong>\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u5668\u6cd5<\/strong>\uff1a\u9002\u7528\u4e8e\u975e\u6cb9\u6027\u7c92\u5b50\u68c0\u6d4b\uff0c\u7075\u654f\u5ea6\u9ad8\u3002<\/li>\n<\/ul>\n<blockquote>\n<p>\u6ce8\uff1a\u53c2\u8003\u6587\u732e\uff1aFDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004)<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u516b\u3001\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u66f4\u6362\u4e0e\u62a5\u5e9f\u5904\u7406<\/h2>\n<h3>8.1 \u66f4\u6362\u6761\u4ef6<\/h3>\n<ul>\n<li>\u521d\u671f\u538b\u5dee\u589e\u52a0\u81f3\u539f\u503c\u76841.5\u500d\u4ee5\u4e0a\uff1b<\/li>\n<li>\u68c0\u6d4b\u53d1\u73b0\u6cc4\u6f0f\u70b9\u4e14\u65e0\u6cd5\u4fee\u590d\uff1b<\/li>\n<li>\u6d01\u51c0\u5ea6\u6307\u6807\u8fde\u7eed\u591a\u6b21\u4e0d\u5408\u683c\uff1b<\/li>\n<li>\u4f7f\u7528\u5e74\u9650\u8d85\u8fc7\u5382\u5bb6\u63a8\u8350\u671f\u9650\uff08\u4e00\u822c\u4e3a3~5\u5e74\uff09\u3002<\/li>\n<\/ul>\n<h3>8.2 \u62a5\u5e9f\u5904\u7406\u6d41\u7a0b<\/h3>\n<ol>\n<li><strong>\u5173\u95ed\u98ce\u673a\u7cfb\u7edf<\/strong>\uff0c\u786e\u4fdd\u65e0\u98ce\u6d41\u52a8\uff1b<\/li>\n<li><strong>\u7a7f\u6234\u9632\u62a4\u88c5\u5907<\/strong>\uff08\u53e3\u7f69\u3001\u624b\u5957\u3001\u9632\u62a4\u670d\uff09\uff1b<\/li>\n<li><strong>\u62c6\u9664\u65e7\u8fc7\u6ee4\u5668<\/strong>\uff0c\u653e\u5165\u4e13\u7528\u5305\u88c5\u888b\uff1b<\/li>\n<li><strong>\u6d88\u6bd2\u5904\u7406<\/strong>\uff08\u53ef\u91c7\u7528\u73af\u6c27\u4e59\u70f7\u6216\u7d2b\u5916\u7ebf\u7167\u5c04\uff09\uff1b<\/li>\n<li><strong>\u767b\u8bb0\u62a5\u5e9f\u4fe1\u606f<\/strong>\uff0c\u5305\u62ec\u65e5\u671f\u3001\u539f\u56e0\u3001\u4eba\u5458\u7b7e\u5b57\uff1b<\/li>\n<li><strong>\u6309\u7167\u5371\u9669\u5e9f\u5f03\u7269\u5904\u7406\u89c4\u5b9a\u8fdb\u884c\u5904\u7f6e<\/strong>\u3002<\/li>\n<\/ol>\n<blockquote>\n<p>\u6ce8\uff1a\u53c2\u8003\u6587\u732e\uff1a\u56fd\u5bb6\u751f\u6001\u73af\u5883\u90e8\u300a\u5371\u9669\u5e9f\u7269\u540d\u5f55\u300b\uff082021\u5e74\u7248\uff09<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e5d\u3001\u56fd\u5185\u5916\u5178\u578b\u5e94\u7528\u6848\u4f8b<\/h2>\n<h3>9.1 \u4e0a\u6d77\u67d0\u751f\u7269\u533b\u836f\u516c\u53f8\u6d01\u51c0\u8f66\u95f4\u6539\u9020\u9879\u76ee<\/h3>\n<p>\u8be5\u9879\u76ee\u4e3aGMP A\/B\u7ea7\u6d01\u51c0\u533a\u57df\uff0c\u91c7\u7528Camfil H14\u7ea7HEPA\u8fc7\u6ee4\u5668\uff0c\u914d\u5408VHP\uff08\u6c7d\u5316\u8fc7\u6c27\u5316\u6c22\uff09\u706d\u83cc\u7cfb\u7edf\u3002\u5b89\u88c5\u8fc7\u7a0b\u4e2d\u4e25\u683c\u6267\u884cISO\u6807\u51c6\uff0c\u6bcf\u5e74\u8fdb\u884c\u4e24\u6b21PAO\u68c0\u6f0f\u6d4b\u8bd5\uff0c\u6d01\u51c0\u5ea6\u957f\u671f\u7a33\u5b9a\u8fbe\u6807\u3002<\/p>\n<h3>9.2 \u7f8e\u56fd\u8f89\u745e\u5236\u836f\u5de5\u5382HVAC\u7cfb\u7edf\u5347\u7ea7<\/h3>\n<p>\u8f89\u745e\u516c\u53f8\u5728\u5176\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u4e2d\u5f15\u5165ULPA U16\u8fc7\u6ee4\u5668\uff0c\u642d\u914d\u667a\u80fd\u538b\u5dee\u76d1\u6d4b\u7cfb\u7edf\u4e0e\u8fdc\u7a0b\u62a5\u8b66\u5e73\u53f0\uff0c\u5b9e\u73b0\u4e86\u81ea\u52a8\u5316\u7ba1\u7406\u4e0e\u9884\u8b66\u673a\u5236\uff0c\u6709\u6548\u63d0\u5347\u4e86\u7cfb\u7edf\u8fd0\u884c\u53ef\u9760\u6027\u3002<\/p>\n<hr \/>\n<h2>\u5341\u3001\u7ed3\u8bed\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\uff082010\u5e74\u4fee\u8ba2\uff09\u300b[Z]. \u5317\u4eac\uff1a\u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e\uff0c2011.<\/li>\n<li>Camfil Farr. <em>High Efficiency Air Filters Technical Manual<\/em> [M]. Sweden: Camfil Group, 2021.<\/li>\n<li>ASHRAE. <em>ASHRAE Handbook &#8211; HVAC Systems and Equipment<\/em> [M]. Atlanta: ASHRAE Inc., 2020.<\/li>\n<li>\u4e2d\u56fd\u5efa\u7b51\u79d1\u5b66\u7814\u7a76\u9662. GB50073-2013\u300a\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303\u300b[S]. \u5317\u4eac\uff1a\u4e2d\u56fd\u5efa\u7b51\u5de5\u4e1a\u51fa\u7248\u793e\uff0c2013.<\/li>\n<li>ISO. ISO 14644-3:2019 Cleanrooms and associated controlled environments \u2014 Part 3: Test methods [S].<\/li>\n<li>FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing \u2014 Current Good Manufacturing Practice [R]. U.S. Department of Health and Human Services, 2004.<\/li>\n<li>\u56fd\u5bb6\u751f\u6001\u73af\u5883\u90e8. \u300a\u5371\u9669\u5e9f\u7269\u540d\u5f55\uff082021\u5e74\u7248\uff09\u300b[EB\/OL]. <a href=\"http:\/\/www.mee.gov.cn\">http:\/\/www.mee.gov.cn<\/a>, 2021.<\/li>\n<li>\u4e2d\u56fd\u533b\u836f\u96c6\u56e2\u8bbe\u8ba1\u9662. \u300a\u6d01\u51c0\u5382\u623f\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u8bbe\u8ba1\u4e0e\u8fd0\u884c\u7ba1\u7406\u300b[M]. \u5317\u4eac\uff1a\u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e\uff0c2018.<\/li>\n<\/ol>\n<hr \/>\n<p>\u5982\u9700\u83b7\u53d6\u672c\u6587\u6863PDF\u7248\u672c\u6216\u8fdb\u4e00\u6b65\u6280\u672f\u8d44\u6599\uff0c\u8bf7\u8054\u7cfb\u76f8\u5173\u6d01\u51c0\u5de5\u7a0b\u670d\u52a1\u5546\u6216\u53c2\u8003\u5382\u5546\u5b98\u65b9\u6280\u672f\u6587\u6863\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u5728GMP\u6d01\u51c0\u5382\u623f\u4e2d\u7684\u5b89\u88c5\u4e0e\u7ef4\u62a4\u8981\u70b9 \u4e00\u3001\u5f15\u8a00 \u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air, HEPA\uff09\u548c\u8d85\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08Ultra Low Penetration Air, ULPA\uff09\u4f5c\u4e3a\u6d01\u51c0\u5ba4\u7cfb\u7edf\u7684\u6838\u5fc3\u7ec4\u6210\u90e8\u5206\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u3001\u751f\u7269\u6280\u672f\u3001\u533b\u7597\u8bbe\u5907\u3001\u98df\u54c1\u52a0\u5de5\u7b49\u5bf9\u7a7a\u6c14\u8d28\u91cf\u8981\u6c42\u6781\u9ad8\u7684\u9886\u57df\u3002\u5c24\u5176\u662f\u5728\u7b26\u5408\u300a&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-15421","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\/15421","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=15421"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15421\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15421"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15421"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15421"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}