{"id":15075,"date":"2025-06-16T10:57:32","date_gmt":"2025-06-16T02:57:32","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15075"},"modified":"2025-06-16T10:57:32","modified_gmt":"2025-06-16T02:57:32","slug":"%e9%ab%98%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%e8%a1%8c%e4%b8%9agmp%e8%bd%a6%e9%97%b4%e7%9a%84%e5%ba%94%e7%94%a8%e6%a0%87%e5%87%86%e8%a7%a3%e6%9e%90","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15075","title":{"rendered":"\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u8f66\u95f4\u7684\u5e94\u7528\u6807\u51c6\u89e3\u6790"},"content":{"rendered":"<h1>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u8f66\u95f4\u7684\u5e94\u7528\u6807\u51c6\u89e3\u6790<\/h1>\n<h2>\u4e00\u3001\u5f15\u8a00\uff1a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u4e0e\u5236\u836fGMP\u8f66\u95f4\u7684\u5173\u7cfb<\/h2>\n<p>\u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u6d01\u51c0\u5ba4\uff08Clean Room\uff09\u662f\u786e\u4fdd\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7684\u5173\u952e\u73af\u5883\u8bbe\u65bd\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\uff0c\u5236\u836f\u4f01\u4e1a\u5fc5\u987b\u901a\u8fc7\u4e25\u683c\u7684\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u6765\u63a7\u5236\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c61\u67d3\uff0c\u4ee5\u4fdd\u969c\u836f\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u800c<strong>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/strong>\uff08High-Efficiency Particulate Air Filter, HEPA\uff09\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4e2d\u7684\u6838\u5fc3\u7ec4\u4ef6\uff0c\u5176\u6027\u80fd\u76f4\u63a5\u5173\u7cfb\u5230\u6d01\u51c0\u5ba4\u7684\u7a7a\u6c14\u8d28\u91cf\u7b49\u7ea7\u3002<\/p>\n<p>HEPA\u8fc7\u6ee4\u5668\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u22650.3\u5fae\u7c73\u7684\u9897\u7c92\u7269\uff0c\u6548\u7387\u9ad8\u8fbe99.97%\u4ee5\u4e0a\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u751f\u7269\u5236\u836f\u3001\u533b\u9662\u624b\u672f\u5ba4\u3001\u7535\u5b50\u5236\u9020\u7b49\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8981\u6c42\u6781\u9ad8\u7684\u573a\u6240\u3002\u672c\u6587\u5c06\u56f4\u7ed5\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836fGMP\u8f66\u95f4\u4e2d\u7684\u5e94\u7528\u6807\u51c6\u8fdb\u884c\u6df1\u5165\u89e3\u6790\uff0c\u6db5\u76d6\u5176\u6280\u672f\u53c2\u6570\u3001\u9009\u578b\u4f9d\u636e\u3001\u5b89\u88c5\u7ef4\u62a4\u89c4\u8303\u3001\u68c0\u6d4b\u65b9\u6cd5\u4ee5\u53ca\u56fd\u5185\u5916\u76f8\u5173\u6cd5\u89c4\u548c\u6807\u51c6\u7b49\u5185\u5bb9\uff0c\u5e76\u7ed3\u5408\u5b9e\u9645\u6848\u4f8b\u5206\u6790\u5176\u91cd\u8981\u6027\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u539f\u7406\u4e0e\u5206\u7c7b<\/h2>\n<h3>2.1 HEPA\u8fc7\u6ee4\u5668\u7684\u5de5\u4f5c\u539f\u7406<\/h3>\n<p>HEPA\u8fc7\u6ee4\u5668\u4e3b\u8981\u4f9d\u9760\u4ee5\u4e0b\u51e0\u79cd\u673a\u5236\u5b9e\u73b0\u7a7a\u6c14\u4e2d\u7684\u9897\u7c92\u7269\u62e6\u622a\uff1a<\/p>\n<ul>\n<li><strong>\u62e6\u622a\u4f5c\u7528<\/strong>\uff08Interception\uff09\uff1a\u5f53\u9897\u7c92\u9760\u8fd1\u7ea4\u7ef4\u65f6\u88ab\u5438\u9644\uff1b<\/li>\n<li><strong>\u60ef\u6027\u649e\u51fb<\/strong>\uff08Impaction\uff09\uff1a\u5927\u9897\u7c92\u56e0\u60ef\u6027\u504f\u79bb\u6c14\u6d41\u65b9\u5411\u649e\u51fb\u7ea4\u7ef4\u88ab\u6355\u83b7\uff1b<\/li>\n<li><strong>\u6269\u6563\u4f5c\u7528<\/strong>\uff08Diffusion\uff09\uff1a\u5c0f\u9897\u7c92\u53d7\u5e03\u6717\u8fd0\u52a8\u5f71\u54cd\u66f4\u5bb9\u6613\u63a5\u89e6\u7ea4\u7ef4\uff1b<\/li>\n<li><strong>\u9759\u7535\u5438\u9644<\/strong>\uff08Electrostatic Attraction\uff09\uff1a\u90e8\u5206HEPA\u6ee4\u6750\u5e26\u6709\u9759\u7535\uff0c\u589e\u5f3a\u6355\u96c6\u6548\u7387\u3002<\/li>\n<\/ul>\n<p>\u8fd9\u4e9b\u673a\u5236\u5171\u540c\u4f5c\u7528\uff0c\u4f7f\u5f97HEPA\u8fc7\u6ee4\u5668\u80fd\u591f\u5728\u4e0d\u540c\u7c92\u5f84\u8303\u56f4\u5185\u5b9e\u73b0\u9ad8\u6548\u7684\u8fc7\u6ee4\u6548\u679c\u3002<\/p>\n<h3>2.2 HEPA\u4e0eULPA\u7684\u533a\u522b<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>HEPA<\/th>\n<th>ULPA<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u7c92\u5f84\u8303\u56f4<\/td>\n<td>\u22650.3 \u03bcm<\/td>\n<td>\u22650.12 \u03bcm<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u226599.97%<\/td>\n<td>\u226599.999%<\/td>\n<\/tr>\n<tr>\n<td>\u5e94\u7528\u573a\u666f<\/td>\n<td>\u6d01\u51c0\u5ea6Class 100~1000\u7ea7<\/td>\n<td>Class 10\u7ea7\u6216\u66f4\u9ad8<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u529b\u635f\u5931<\/td>\n<td>\u8f83\u4f4e<\/td>\n<td>\u8f83\u9ad8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>ULPA\uff08Ultra Low Penetration Air Filter\uff09\u662f\u8d85\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff0c\u9002\u7528\u4e8e\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8981\u6c42\u66f4\u9ad8\u7684\u573a\u5408\uff0c\u5982\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u3001\u65e0\u83cc\u5236\u5242\u7ebf\u7b49\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001GMP\u8f66\u95f4\u5bf9\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u603b\u4f53\u8981\u6c42<\/h2>\n<h3>3.1 \u56fd\u5185GMP\u6807\u51c6\uff08\u4e2d\u56fd\u836f\u51782020\u7248\uff09<\/h3>\n<p>\u6839\u636e\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff082020\u5e74\u7248\uff09\u9644\u5f55\u300a\u836f\u54c1GMP\u6307\u5357\u300b\u7684\u76f8\u5173\u89c4\u5b9a\uff0c\u5236\u836f\u8f66\u95f4\u5e94\u6839\u636e\u4e0d\u540c\u4ea7\u54c1\u7684\u751f\u4ea7\u5de5\u827a\u548c\u6d01\u51c0\u7ea7\u522b\u8bbe\u7f6e\u76f8\u5e94\u7684\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u3002\u4f8b\u5982\uff1a<\/p>\n<ul>\n<li><strong>A\u7ea7\u6d01\u51c0\u533a<\/strong>\uff1a\u7528\u4e8e\u65e0\u83cc\u64cd\u4f5c\uff0c\u8981\u6c42\u5355\u5411\u6d41\uff08\u5c42\u6d41\uff09\u8bbe\u8ba1\uff0c\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8fbe\u5230ISO 5\u7ea7\uff1b<\/li>\n<li><strong>B\u7ea7\u6d01\u51c0\u533a<\/strong>\uff1a\u4e3aA\u7ea7\u533a\u57df\u63d0\u4f9b\u80cc\u666f\u652f\u6301\uff0c\u6d01\u51c0\u5ea6\u4e3aISO 7\u7ea7\uff1b<\/li>\n<li><strong>C\u7ea7\u548cD\u7ea7<\/strong>\uff1a\u7528\u4e8e\u975e\u65e0\u83cc\u5236\u5242\u6216\u8f85\u52a9\u533a\u57df\uff0c\u6d01\u51c0\u5ea6\u5206\u522b\u4e3aISO 8\u7ea7\u548cISO 9\u7ea7\u3002<\/li>\n<\/ul>\n<h3>3.2 \u56fd\u9645GMP\u6807\u51c6\uff08WHO\u3001FDA\u3001EU GMP\uff09<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6807\u51c6<\/th>\n<th>A\u7ea7\uff08ISO 5\uff09<\/th>\n<th>B\u7ea7\uff08ISO 7\uff09<\/th>\n<th>C\u7ea7\uff08ISO 8\uff09<\/th>\n<th>D\u7ea7\uff08ISO 9\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>WHO GMP<\/td>\n<td>\u5355\u5411\u6d41\uff0c\u6362\u6c14\u6b21\u6570&gt;40\u6b21\/h<\/td>\n<td>\u975e\u5355\u5411\u6d41\uff0c\u6362\u6c14\u6b21\u6570&gt;20\u6b21\/h<\/td>\n<td>\u6362\u6c14\u6b21\u6570&gt;10\u6b21\/h<\/td>\n<td>\u6362\u6c14\u6b21\u6570&gt;6\u6b21\/h<\/td>\n<\/tr>\n<tr>\n<td>EU GMP<\/td>\n<td>\u540c\u4e0a<\/td>\n<td>\u540c\u4e0a<\/td>\n<td>\u540c\u4e0a<\/td>\n<td>\u540c\u4e0a<\/td>\n<\/tr>\n<tr>\n<td>FDA cGMP<\/td>\n<td>\u5f3a\u8c03\u8fc7\u7a0b\u63a7\u5236\uff0c\u5efa\u8bae\u4f7f\u7528HEPA\u8fc7\u6ee4\u5668<\/td>\n<td>\u5f3a\u8c03\u73af\u5883\u76d1\u6d4b<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u56fd\u9645\u6807\u51c6\u66f4\u5f3a\u8c03\u8fc7\u7a0b\u63a7\u5236\u548c\u52a8\u6001\u76d1\u6d4b\uff0c\u5c24\u5176\u5728\u751f\u7269\u5236\u54c1\u548c\u6ce8\u5c04\u5242\u751f\u4ea7\u4e2d\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u8981\u6c42\u66f4\u4e3a\u4e25\u683c\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728GMP\u8f66\u95f4\u4e2d\u7684\u5177\u4f53\u5e94\u7528\u6807\u51c6<\/h2>\n<h3>4.1 \u5b89\u88c5\u4f4d\u7f6e\u4e0e\u7cfb\u7edf\u914d\u7f6e<\/h3>\n<p>\u5728\u5236\u836fGMP\u8f66\u95f4\u4e2d\uff0cHEPA\u8fc7\u6ee4\u5668\u901a\u5e38\u5b89\u88c5\u4e8e\u9001\u98ce\u53e3\u672b\u7aef\uff0c\u5f62\u6210\u201c\u672b\u7aef\u8fc7\u6ee4\u201d\u7ed3\u6784\uff0c\u4ee5\u786e\u4fdd\u8fdb\u5165\u6d01\u51c0\u5ba4\u7684\u7a7a\u6c14\u7ecf\u8fc7\u6700\u7ec8\u9ad8\u6548\u51c0\u5316\u3002\u5e38\u89c1\u7684\u7a7a\u6c14\u51c0\u5316\u6d41\u7a0b\u5982\u4e0b\uff1a<\/p>\n<pre><code>\u65b0\u98ce \u2192 \u521d\u6548\u8fc7\u6ee4 \u2192 \u4e2d\u6548\u8fc7\u6ee4 \u2192 \u8868\u51b7\/\u52a0\u70ed\u6bb5 \u2192 \u52a0\u6e7f\u6bb5 \u2192 \u98ce\u673a\u6bb5 \u2192 \u9ad8\u6548\u8fc7\u6ee4\u5668 \u2192 \u6d01\u51c0\u5ba4<\/code><\/pre>\n<p>\u5176\u4e2d\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f4d\u4e8e\u98ce\u673a\u4e4b\u540e\uff0c\u907f\u514d\u56e0\u9ad8\u538b\u6c14\u6d41\u5bfc\u81f4\u6ee4\u6750\u7834\u635f\u3002<\/p>\n<h3>4.2 \u6027\u80fd\u53c2\u6570\u4e0e\u9009\u7528\u6807\u51c6<\/h3>\n<h4>4.2.1 \u4e3b\u8981\u6027\u80fd\u53c2\u6570<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u63cf\u8ff0<\/th>\n<th>\u6d4b\u8bd5\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u5bf90.3\u03bcm\u9897\u7c92\u7684\u53bb\u9664\u7387<\/td>\n<td>IEST-RP-CC001.3<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u65b0\u8fc7\u6ee4\u5668\u7684\u538b\u5dee\u503c<\/td>\n<td>EN 1822-1<\/td>\n<\/tr>\n<tr>\n<td>\u5bb9\u5c18\u91cf<\/td>\n<td>\u53ef\u5bb9\u7eb3\u7070\u5c18\u7684\u6700\u5927\u91cf<\/td>\n<td>ASHRAE 52.2<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u6d4b\u8bd5<\/td>\n<td>\u662f\u5426\u5b58\u5728\u7a7f\u5b54\u6216\u5bc6\u5c01\u4e0d\u826f<\/td>\n<td>\u5149\u5ea6\u8ba1\u6cd5\uff08\u5149\u6563\u5c04\u6cd5\uff09\u6216\u7c92\u5b50\u8ba1\u6570\u6cd5<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28<\/td>\n<td>\u591a\u4e3a\u73bb\u7483\u7ea4\u7ef4\u3001\u5408\u6210\u6750\u6599<\/td>\n<td>ISO 4830<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h4>4.2.2 \u9009\u578b\u4f9d\u636e<\/h4>\n<ul>\n<li><strong>\u6d01\u51c0\u7ea7\u522b\u8981\u6c42<\/strong>\uff1aA\u7ea7\u533a\u57df\u9700\u91c7\u7528ULPA\u6216\u9ad8\u6027\u80fdHEPA\uff1b<\/li>\n<li><strong>\u6c14\u6d41\u7ec4\u7ec7\u65b9\u5f0f<\/strong>\uff1a\u5c42\u6d41\u6d01\u51c0\u5ba4\u4f18\u5148\u9009\u7528\u5782\u76f4\u9001\u98ce\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\uff1b<\/li>\n<li><strong>\u7a7a\u95f4\u5e03\u5c40<\/strong>\uff1a\u6839\u636e\u6d01\u51c0\u5ba4\u9762\u79ef\u3001\u9ad8\u5ea6\u53ca\u9001\u98ce\u91cf\u8ba1\u7b97\u6240\u9700\u6570\u91cf\uff1b<\/li>\n<li><strong>\u66f4\u6362\u5468\u671f<\/strong>\uff1a\u4e00\u822c\u4e3a1~3\u5e74\uff0c\u89c6\u8fd0\u884c\u65f6\u95f4\u4e0e\u963b\u529b\u53d8\u5316\u800c\u5b9a\uff1b<\/li>\n<li><strong>\u9632\u706b\u7b49\u7ea7<\/strong>\uff1a\u67d0\u4e9b\u7279\u6b8a\u533a\u57df\uff08\u5982\u6eb6\u5242\u533a\uff09\u9700\u9009\u62e9\u963b\u71c3\u578b\u6ee4\u6750\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e94\u3001\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u3001\u68c0\u6d4b\u4e0e\u7ef4\u62a4<\/h2>\n<h3>5.1 \u5b89\u88c5\u89c4\u8303<\/h3>\n<p>\u6839\u636e\u300aGB\/T 13554-2020 \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u56fd\u5bb6\u6807\u51c6\uff0c\u5b89\u88c5\u8fc7\u7a0b\u4e2d\u5e94\u9075\u5faa\u4ee5\u4e0b\u8981\u70b9\uff1a<\/p>\n<ul>\n<li>\u4f7f\u7528\u4e13\u7528\u5bc6\u5c01\u80f6\u6761\uff0c\u9632\u6b62\u6cc4\u6f0f\uff1b<\/li>\n<li>\u5b89\u88c5\u524d\u5e94\u5bf9\u6846\u67b6\u6e05\u6d01\u5904\u7406\uff1b<\/li>\n<li>\u5b89\u88c5\u540e\u7acb\u5373\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff1b<\/li>\n<li>\u5b89\u88c5\u89d2\u5ea6\u5e94\u4fdd\u6301\u6c34\u5e73\uff0c\u907f\u514d\u6c14\u6d41\u504f\u79fb\u3002<\/li>\n<\/ul>\n<h3>5.2 \u68c0\u6d4b\u65b9\u6cd5<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u68c0\u6d4b\u9879\u76ee<\/th>\n<th>\u65b9\u6cd5<\/th>\n<th>\u5de5\u5177<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u59cb\u6548\u7387\u6d4b\u8bd5<\/td>\n<td>\u94a0\u7130\u6cd5\u3001\u6cb9\u96fe\u6cd5<\/td>\n<td>\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u3001\u7c92\u5b50\u8ba1\u6570\u5668<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u6d4b\u8bd5<\/td>\n<td>\u6d4b\u91cf\u524d\u540e\u538b\u5dee<\/td>\n<td>U\u578b\u538b\u529b\u8ba1\u6216\u6570\u5b57\u538b\u5dee\u8ba1<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u68c0\u6d4b<\/td>\n<td>\u5149\u5ea6\u8ba1\u626b\u63cf\u6cd5<\/td>\n<td>\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1<\/td>\n<\/tr>\n<tr>\n<td>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n<td>\u7c92\u5b50\u8ba1\u6570\u6cd5<\/td>\n<td>\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u5668<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>5.3 \u7ef4\u62a4\u4e0e\u66f4\u6362\u6807\u51c6<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u5efa\u8bae\u9891\u7387<\/th>\n<th>\u6ce8\u610f\u4e8b\u9879<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u65e5\u5e38\u5de1\u68c0<\/td>\n<td>\u6bcf\u65e5\u4e00\u6b21<\/td>\n<td>\u89c2\u5bdf\u538b\u5dee\u662f\u5426\u5f02\u5e38<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u8bb0\u5f55<\/td>\n<td>\u6bcf\u5468\u4e00\u6b21<\/td>\n<td>\u8d85\u8fc7\u521d\u59cb\u503c1.5\u500d\u5e94\u8003\u8651\u66f4\u6362<\/td>\n<\/tr>\n<tr>\n<td>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n<td>\u6bcf\u5e74\u81f3\u5c11\u4e00\u6b21<\/td>\n<td>\u5c24\u5176\u5728\u66f4\u6362\u521d\/\u4e2d\u6548\u540e<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u5468\u671f<\/td>\n<td>\u4e00\u822c1~3\u5e74<\/td>\n<td>\u5b9e\u9645\u8fd0\u884c\u65f6\u95f4\u51b3\u5b9a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u516d\u3001\u56fd\u5185\u5916\u5173\u4e8e\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u6807\u51c6\u4e0e\u6cd5\u89c4<\/h2>\n<h3>6.1 \u56fd\u5185\u6807\u51c6<\/h3>\n<ul>\n<li><strong>GB\/T 13554-2020<\/strong>\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\uff1a\u89c4\u5b9a\u4e86HEPA\u7684\u5206\u7c7b\u3001\u6027\u80fd\u6307\u6807\u3001\u6d4b\u8bd5\u65b9\u6cd5\uff1b<\/li>\n<li><strong>GB\/T 14295-2008<\/strong>\u300a\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\uff1a\u9002\u7528\u4e8e\u5404\u7c7b\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u6027\u80fd\u8981\u6c42\uff1b<\/li>\n<li><strong>YY 0569-2011<\/strong>\u300a\u751f\u7269\u5b89\u5168\u67dc\u300b\uff1a\u6d89\u53caHEPA\u5728\u751f\u7269\u5b89\u5168\u8bbe\u5907\u4e2d\u7684\u5e94\u7528\uff1b<\/li>\n<li><strong>\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u4fee\u8ba2\u7248\uff09<\/strong>\uff1a\u660e\u786e\u6d01\u51c0\u533a\u5212\u5206\u4e0e\u7a7a\u6c14\u51c0\u5316\u8981\u6c42\u3002<\/li>\n<\/ul>\n<h3>6.2 \u56fd\u9645\u6807\u51c6<\/h3>\n<ul>\n<li><strong>ISO 4830:2008<\/strong>\u300a\u533b\u7597\u4fdd\u5065\u9886\u57df\u7684\u7a7a\u6c14\u51c0\u5316\u88c5\u7f6e\u300b\uff1b<\/li>\n<li><strong>IEST-RP-CC001.3<\/strong>\u300aHEPA and ULPA Filters\u300b\uff1b<\/li>\n<li><strong>EN 1822-1~5<\/strong>\u300aHigh Efficiency Air Filters (HEPA and ULPA)\u300b\uff1b<\/li>\n<li><strong>US FDA 21 CFR Part 211<\/strong>\u300aCurrent Good Manufacturing Practice for Finished Pharmaceuticals\u300b\uff1b<\/li>\n<li><strong>WHO Technical Report Series No. 961 Annex 9<\/strong>\u300aModel Quality Assurance System for Procurement and Supply Management of Medical Products\u300b\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e03\u3001\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>7.1 \u67d0\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1aA\u7ea7\u6d01\u51c0\u5ba4\u6539\u9020\u9879\u76ee<\/h3>\n<p>\u8be5\u4f01\u4e1a\u5728\u539f\u6709\u6d01\u51c0\u7cfb\u7edf\u57fa\u7840\u4e0a\u5347\u7ea7\u4e3aA\u7ea7\u6d01\u51c0\u73af\u5883\uff0c\u91c7\u7528\u4e86ULPA\u8fc7\u6ee4\u5668\uff08\u6548\u738799.999%\uff0c\u7c92\u5f840.12\u03bcm\uff09\u3002\u6539\u9020\u540e\uff1a<\/p>\n<ul>\n<li>\u7a7a\u6c14\u6d01\u51c0\u5ea6\u4eceISO 7\u63d0\u5347\u81f3ISO 5\uff1b<\/li>\n<li>\u5fae\u751f\u7269\u6c89\u964d\u83cc&lt;1 cfu\/\u76bf\u00b7\u5c0f\u65f6\uff1b<\/li>\n<li>\u52a8\u6001\u60ac\u6d6e\u7c92\u5b50\u6570\u7b26\u5408EU GMP Class A\u6807\u51c6\uff1b<\/li>\n<li>\u5e74\u7ef4\u62a4\u6210\u672c\u4e0b\u964d15%\uff0c\u6545\u969c\u7387\u51cf\u5c1130%\u3002<\/li>\n<\/ul>\n<h3>7.2 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\/>\n<h2>\u516b\u3001\u7ed3\u8bba<\/h2>\n<p>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u5236\u836fGMP\u8f66\u95f4\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u6838\u5fc3\u7ec4\u6210\u90e8\u5206\uff0c\u5176\u6027\u80fd\u76f4\u63a5\u5f71\u54cd\u6d01\u51c0\u5ba4\u7684\u7a7a\u6c14\u8d28\u91cf\u7b49\u7ea7\u548c\u836f\u54c1\u751f\u4ea7\u7684\u5408\u89c4\u6027\u3002\u901a\u8fc7\u5408\u7406\u9009\u578b\u3001\u79d1\u5b66\u5b89\u88c5\u3001\u5b9a\u671f\u68c0\u6d4b\u4e0e\u7ef4\u62a4\uff0c\u53ef\u786e\u4fddHEPA\u8fc7\u6ee4\u5668\u957f\u671f\u7a33\u5b9a\u8fd0\u884c\uff0c\u6ee1\u8db3\u4e0d\u540c\u6d01\u51c0\u7ea7\u522b\u7684\u8981\u6c42\u3002\u540c\u65f6\uff0c\u53c2\u8003\u56fd\u5185\u5916\u5148\u8fdb\u6807\u51c6\uff0c\u7ed3\u5408\u4f01\u4e1a\u81ea\u8eab\u5de5\u827a\u7279\u70b9\uff0c\u5236\u5b9a\u5207\u5b9e\u53ef\u884c\u7684\u7a7a\u6c14\u51c0\u5316\u65b9\u6848\uff0c\u662f\u4fdd\u969c\u836f\u54c1\u8d28\u91cf\u548c\u60a3\u8005\u5b89\u5168\u7684\u91cd\u8981\u63aa\u65bd\u3002<\/p>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff082020\u5e74\u7248\uff09  <\/li>\n<li>\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09  <\/li>\n<li>GB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b  <\/li>\n<li>GB\/T 14295-2008\u300a\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b  <\/li>\n<li>YY 0569-2011\u300a\u751f\u7269\u5b89\u5168\u67dc\u300b  <\/li>\n<li>WHO Technical Report Series No. 961, Annex 9  <\/li>\n<li>EU GMP Guide, Annex 1  <\/li>\n<li>FDA 21 CFR Part 211  <\/li>\n<li>ISO 4830:2008  <\/li>\n<li>IEST-RP-CC001.3  <\/li>\n<li>EN 1822-1~5  <\/li>\n<li>\u767e\u5ea6\u767e\u79d1\uff1a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u8bcd\u6761  <\/li>\n<li>American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), Standard 52.2  <\/li>\n<li>Institute of Environmental Sciences and Technology (IEST), Recommended Practice RP-CC034.1  <\/li>\n<li>Pharmaceutical Engineering Journal, Volume 40, Issue 3, 2020<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u8f66\u95f4\u7684\u5e94\u7528\u6807\u51c6\u89e3\u6790 \u4e00\u3001\u5f15\u8a00\uff1a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u4e0e\u5236\u836fGMP\u8f66\u95f4\u7684\u5173\u7cfb \u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u6d01\u51c0\u5ba4\uff08Clean Room\uff09\u662f\u786e\u4fdd\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7684\u5173\u952e\u73af\u5883\u8bbe\u65bd\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\uff0c\u5236\u836f\u4f01\u4e1a\u5fc5\u987b\u901a\u8fc7\u4e25\u683c\u7684\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u6765\u63a7\u5236\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c61\u67d3\uff0c\u4ee5\u4fdd\u969c\u836f\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548&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-15075","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\/15075","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=15075"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15075\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15075"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15075"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15075"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}