{"id":17131,"date":"2025-10-10T12:33:18","date_gmt":"2025-10-10T04:33:18","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=17131"},"modified":"2025-10-10T12:33:18","modified_gmt":"2025-10-10T04:33:18","slug":"%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e7%94%9f%e7%89%a9%e5%88%b6%e8%8d%af%e6%97%a0%e8%8f%8c%e7%94%9f%e4%ba%a7%e7%8e%af%e5%a2%83%e4%b8%ad%e7%9a%84%e6%80%a7%e8%83%bd%e9%aa%8c%e8%af%81","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=17131","title":{"rendered":"\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u751f\u7269\u5236\u836f\u65e0\u83cc\u751f\u4ea7\u73af\u5883\u4e2d\u7684\u6027\u80fd\u9a8c\u8bc1"},"content":{"rendered":"<h1>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u751f\u7269\u5236\u836f\u65e0\u83cc\u751f\u4ea7\u73af\u5883\u4e2d\u7684\u6027\u80fd\u9a8c\u8bc1<\/h1>\n<h2>\u4e00\u3001\u5f15\u8a00<\/h2>\n<p>\u5728\u73b0\u4ee3\u751f\u7269\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u786e\u4fdd\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u7684\u65e0\u83cc\u6027\u662f\u4fdd\u969c\u4ea7\u54c1\u8d28\u91cf\u548c\u60a3\u8005\u5b89\u5168\u7684\u6838\u5fc3\u8981\u6c42\u3002\u6839\u636e\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff082020\u5e74\u7248\uff09\u53ca\u56fd\u9645\u836f\u54c1\u8ba4\u8bc1\u5408\u4f5c\u7ec4\u7ec7\uff08PIC\/S\uff09\u3001\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u548c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u7684\u76f8\u5173\u6307\u5357\uff0c\u65e0\u83cc\u836f\u54c1\u7684\u751f\u4ea7\u5fc5\u987b\u5728\u53d7\u63a7\u6d01\u51c0\u73af\u5883\u4e2d\u8fdb\u884c\uff0c\u5176\u4e2d\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\u901a\u5e38\u8fbe\u5230ISO 14644-1\u6807\u51c6\u4e2d\u7684ISO 5\u7ea7\uff08\u5373\u4f20\u7edf\u610f\u4e49\u4e0a\u7684\u767e\u7ea7\u6d01\u51c0\u533a\uff09\u3002\u4e3a\u5b9e\u73b0\u8fd9\u4e00\u76ee\u6807\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter, HEPA\uff09\u4f5c\u4e3a\u6d01\u51c0\u5ba4\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u5173\u952e\u7ec4\u4ef6\uff0c\u5176\u6027\u80fd\u76f4\u63a5\u5173\u7cfb\u5230\u5fae\u751f\u7269\u4e0e\u5fae\u7c92\u6c61\u67d3\u7684\u63a7\u5236\u6c34\u5e73\u3002<\/p>\n<p>\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u8fc7\u7269\u7406\u62e6\u622a\u3001\u6269\u6563\u3001\u60ef\u6027\u78b0\u649e\u548c\u9759\u7535\u5438\u9644\u7b49\u673a\u5236\uff0c\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u22650.3 \u03bcm\u7684\u9897\u7c92\u7269\uff0c\u5bf9\u7ec6\u83cc\u3001\u75c5\u6bd2\u53ca\u6c14\u6eb6\u80f6\u5177\u6709\u6781\u9ad8\u7684\u622a\u7559\u6548\u7387\u3002\u7136\u800c\uff0c\u4ec5\u4f9d\u8d56\u8bbe\u5907\u51fa\u5382\u53c2\u6570\u65e0\u6cd5\u4fdd\u8bc1\u5176\u5728\u5b9e\u9645\u8fd0\u884c\u4e2d\u7684\u957f\u671f\u53ef\u9760\u6027\u3002\u56e0\u6b64\uff0c\u5fc5\u987b\u901a\u8fc7\u79d1\u5b66\u3001\u7cfb\u7edf\u7684\u6027\u80fd\u9a8c\u8bc1\u7a0b\u5e8f\uff0c\u786e\u8ba4\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u5185\u6301\u7eed\u6ee1\u8db3\u65e0\u83cc\u751f\u4ea7\u73af\u5883\u7684\u6280\u672f\u8981\u6c42\u3002<\/p>\n<p>\u672c\u6587\u5c06\u56f4\u7ed5\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u751f\u7269\u5236\u836f\u65e0\u83cc\u751f\u4ea7\u73af\u5883\u4e2d\u7684\u6027\u80fd\u9a8c\u8bc1\u5c55\u5f00\u8bba\u8ff0\uff0c\u6db5\u76d6\u5176\u5de5\u4f5c\u539f\u7406\u3001\u5173\u952e\u6027\u80fd\u53c2\u6570\u3001\u9a8c\u8bc1\u9879\u76ee\u3001\u6d4b\u8bd5\u65b9\u6cd5\u3001\u56fd\u5185\u5916\u6807\u51c6\u5bf9\u6bd4\uff0c\u5e76\u7ed3\u5408\u5178\u578b\u5e94\u7528\u573a\u666f\u8fdb\u884c\u5206\u6790\uff0c\u65e8\u5728\u4e3a\u5236\u836f\u4f01\u4e1a\u5efa\u7acb\u5408\u89c4\u3001\u9ad8\u6548\u7684\u9a8c\u8bc1\u4f53\u7cfb\u63d0\u4f9b\u7406\u8bba\u652f\u6301\u4e0e\u5b9e\u8df5\u6307\u5bfc\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u4e0e\u5206\u7c7b<\/h2>\n<h3>\uff08\u4e00\uff09\u5de5\u4f5c\u539f\u7406<\/h3>\n<p>\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e3b\u8981\u91c7\u7528\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4\u6216\u805a\u4e19\u70ef\u7ea4\u7ef4\u4f5c\u4e3a\u6ee4\u6599\uff0c\u4ee5\u968f\u673a\u5806\u53e0\u65b9\u5f0f\u5f62\u6210\u4e09\u7ef4\u7f51\u72b6\u7ed3\u6784\u3002\u5f53\u542b\u6709\u60ac\u6d6e\u9897\u7c92\u7684\u7a7a\u6c14\u901a\u8fc7\u6ee4\u5c42\u65f6\uff0c\u9897\u7c92\u7269\u901a\u8fc7\u4ee5\u4e0b\u56db\u79cd\u673a\u5236\u88ab\u6355\u83b7\uff1a<\/p>\n<ol>\n<li><strong>\u62e6\u622a\u6548\u5e94<\/strong>\uff1a\u5f53\u9897\u7c92\u8fd0\u52a8\u8f68\u8ff9\u9760\u8fd1\u7ea4\u7ef4\u8868\u9762\u65f6\uff0c\u56e0\u8303\u5fb7\u534e\u529b\u4f5c\u7528\u88ab\u5438\u9644\u3002<\/li>\n<li><strong>\u60ef\u6027\u649e\u51fb<\/strong>\uff1a\u8f83\u5927\u9897\u7c92\u56e0\u8d28\u91cf\u5927\uff0c\u5728\u6c14\u6d41\u65b9\u5411\u6539\u53d8\u65f6\u65e0\u6cd5\u53ca\u65f6\u8ddf\u968f\uff0c\u649e\u51fb\u7ea4\u7ef4\u800c\u88ab\u6355\u96c6\u3002<\/li>\n<li><strong>\u6269\u6563\u6548\u5e94<\/strong>\uff1a\u4e9a\u5fae\u7c73\u7ea7\u5c0f\u9897\u7c92\u53d7\u5e03\u6717\u8fd0\u52a8\u5f71\u54cd\uff0c\u968f\u673a\u78b0\u649e\u7ea4\u7ef4\u800c\u6ede\u7559\u3002<\/li>\n<li><strong>\u9759\u7535\u5438\u9644<\/strong>\uff1a\u90e8\u5206\u6ee4\u6750\u5e26\u6709\u9759\u7535\u8377\uff0c\u53ef\u589e\u5f3a\u5bf9\u5e26\u7535\u7c92\u5b50\u7684\u5438\u5f15\u80fd\u529b\u3002<\/li>\n<\/ol>\n<p>\u5176\u4e2d\uff0c\u5bf9\u4e8e\u76f4\u5f84\u7ea60.3 \u03bcm\u7684\u9897\u7c92\uff08\u5373\u6700\u6613\u7a7f\u900f\u7c92\u5f84\uff0cMost Penetrating Particle Size, MPPS\uff09\uff0c\u4e0a\u8ff0\u673a\u5236\u7efc\u5408\u4f5c\u7528\u4e0b\u8fc7\u6ee4\u6548\u7387\u6700\u4f4e\uff0c\u56e0\u6b64\u8be5\u7c92\u5f84\u5e38\u88ab\u7528\u4f5c\u8bc4\u4ef7HEPA\u8fc7\u6ee4\u5668\u6027\u80fd\u7684\u5173\u952e\u6307\u6807\u3002<\/p>\n<h3>\uff08\u4e8c\uff09\u5206\u7c7b\u4e0e\u6807\u51c6<\/h3>\n<p>\u6839\u636e\u56fd\u9645\u7535\u5de5\u59d4\u5458\u4f1aIEC 60335-2-69\u53ca\u6b27\u76dfEN 1822\u6807\u51c6\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u6309\u6548\u7387\u5206\u4e3a\u591a\u4e2a\u7b49\u7ea7\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/th>\n<th>\u6807\u51c6\u4f9d\u636e<\/th>\n<th>\u5bf9MPPS\uff080.3 \u03bcm\uff09\u7684\u8fc7\u6ee4\u6548\u7387<\/th>\n<th>\u5178\u578b\u5e94\u7528<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H13<\/td>\n<td>EN 1822:2019 \/ GB\/T 13554-2020<\/td>\n<td>\u226599.95%<\/td>\n<td>\u6d01\u51c0\u5ba4\u9001\u98ce\u672b\u7aef<\/td>\n<\/tr>\n<tr>\n<td>H14<\/td>\n<td>EN 1822:2019 \/ GB\/T 13554-2020<\/td>\n<td>\u226599.995%<\/td>\n<td>\u65e0\u83cc\u704c\u88c5\u533a\u3001\u9694\u79bb\u5668<\/td>\n<\/tr>\n<tr>\n<td>U15<\/td>\n<td>EN 1822:2019<\/td>\n<td>\u226599.9995%<\/td>\n<td>\u9ad8\u98ce\u9669\u64cd\u4f5c\u533a\u57df<\/td>\n<\/tr>\n<tr>\n<td>U16<\/td>\n<td>EN 1822:2019<\/td>\n<td>\u226599.99995%<\/td>\n<td>\u6781\u9ad8\u6d01\u51c0\u5ea6\u9700\u6c42\u573a\u666f<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u6211\u56fd\u56fd\u5bb6\u6807\u51c6\u300aGB\/T 13554-2020\u300b\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883 \u7b2c3\u90e8\u5206\uff1a\u68c0\u6d4b\u65b9\u6cd5\u300b\uff08\u7b49\u540c\u91c7\u7528ISO 14644-3\uff09\u660e\u786e\u89c4\u5b9a\u4e86HEPA\u8fc7\u6ee4\u5668\u7684\u5206\u7c7b\u3001\u6d4b\u8bd5\u65b9\u6cd5\u53ca\u5b89\u88c5\u540e\u9a8c\u8bc1\u8981\u6c42\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5173\u952e\u6027\u80fd\u53c2\u6570<\/h2>\n<p>\u5728\u751f\u7269\u5236\u836f\u73af\u5883\u4e2d\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u4e0d\u4ec5\u53d6\u51b3\u4e8e\u5176\u521d\u59cb\u6548\u7387\uff0c\u8fd8\u9700\u5173\u6ce8\u5176\u5728\u5b9e\u9645\u8fd0\u884c\u6761\u4ef6\u4e0b\u7684\u7a33\u5b9a\u6027\u4e0e\u8010\u4e45\u6027\u3002\u4ee5\u4e0b\u662f\u8bc4\u4f30\u5176\u6027\u80fd\u7684\u6838\u5fc3\u53c2\u6570\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u540d\u79f0<\/th>\n<th>\u5b9a\u4e49\u8bf4\u660e<\/th>\n<th>\u6d4b\u8bd5\u65b9\u6cd5<\/th>\n<th>\u5408\u683c\u6807\u51c6\uff08\u793a\u4f8b\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u5728\u989d\u5b9a\u98ce\u91cf\u4e0b\uff0c\u65b0\u8fc7\u6ee4\u5668\u4e24\u7aef\u7684\u538b\u529b\u5dee<\/td>\n<td>\u538b\u529b\u8ba1\u6d4b\u91cf<\/td>\n<td>\u2264250 Pa\uff08H14\u578b\uff0c\u98ce\u901f0.45 m\/s\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf<\/td>\n<td>\u8bbe\u8ba1\u5141\u8bb8\u901a\u8fc7\u7684\u6700\u5927\u7a7a\u6c14\u6d41\u91cf<\/td>\n<td>\u98ce\u901f\u4eea+\u622a\u9762\u9762\u79ef\u8ba1\u7b97<\/td>\n<td>\u4f9d\u578b\u53f7\u800c\u5b9a\uff0c\u5e38\u89c1\u4e3a800\u20131200 m\u00b3\/h<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u5bf9\u7279\u5b9a\u7c92\u5f84\u9897\u7c92\uff08\u59820.3 \u03bcm\uff09\u7684\u53bb\u9664\u7387<\/td>\n<td>\u94a0\u7130\u6cd5\/\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u6cd5<\/td>\n<td>H14 \u226599.995%<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u7387<\/td>\n<td>\u5c40\u90e8\u533a\u57df\u662f\u5426\u5b58\u5728\u7a7f\u5b54\u6216\u5bc6\u5c01\u7f3a\u9677\u5bfc\u81f4\u6c14\u6d41\u7ed5\u8fc7\u6ee4\u6750<\/td>\n<td>\u7c92\u5b50\u8ba1\u6570\u626b\u63cf\u6cd5\uff08Scan Test\uff09<\/td>\n<td>\u5355\u70b9\u6cc4\u6f0f \u22640.01% \u626b\u63cf\u603b\u6cc4\u6f0f \u22640.005%<\/td>\n<\/tr>\n<tr>\n<td>\u5bb9\u5c18\u91cf<\/td>\n<td>\u8fc7\u6ee4\u5668\u5728\u538b\u964d\u8fbe\u5230\u7ec8\u963b\u529b\u524d\u53ef\u5bb9\u7eb3\u7684\u7070\u5c18\u603b\u91cf<\/td>\n<td>\u6807\u51c6\u7c89\u5c18\u52a0\u8f7d\u8bd5\u9a8c<\/td>\n<td>\u2265500 g\uff08ASHRAE 52.2\u6807\u51c6\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b<\/td>\n<td>\u8fc7\u6ee4\u5668\u9700\u66f4\u6362\u65f6\u7684\u6700\u5927\u5141\u8bb8\u538b\u964d<\/td>\n<td>\u5b9e\u65f6\u76d1\u6d4b<\/td>\n<td>\u901a\u5e38\u8bbe\u5b9a\u4e3a\u521d\u963b\u529b\u76842\u20133\u500d<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u622a\u7559\u7387<\/td>\n<td>\u5bf9\u7ec6\u83cc\u6c14\u6eb6\u80f6\uff08\u5982\u67af\u8349\u6746\u83cc\u9ed1\u8272\u53d8\u79cd\u82bd\u5b62\uff09\u7684\u53bb\u9664\u80fd\u529b<\/td>\n<td>\u751f\u7269\u6311\u6218\u8bd5\u9a8c<\/td>\n<td>\u2265log\u2084 reduction\uff0899.99%\u4ee5\u4e0a\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u4e0a\u8ff0\u53c2\u6570\u5e94\u7ed3\u5408\u5177\u4f53\u5de5\u827a\u9700\u6c42\u8bbe\u5b9a\u9a8c\u6536\u6807\u51c6\uff0c\u5c24\u5176\u5728A\u7ea7\u6d01\u51c0\u533a\uff08ISO 5\uff09\u4e2d\uff0cH14\u53ca\u4ee5\u4e0a\u7b49\u7ea7\u4e3a\u5f3a\u5236\u8981\u6c42\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u56db\u3001\u6027\u80fd\u9a8c\u8bc1\u7684\u4e3b\u8981\u5185\u5bb9\u4e0e\u6d41\u7a0b<\/h2>\n<p>\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u9a8c\u8bc1\u662f\u4e00\u4e2a\u7cfb\u7edf\u5de5\u7a0b\uff0c\u8d2f\u7a7f\u4e8e\u8bbe\u8ba1\u9009\u578b\u3001\u5b89\u88c5\u8c03\u8bd5\u3001\u8fd0\u884c\u7ef4\u62a4\u548c\u9000\u5f79\u5168\u8fc7\u7a0b\u3002\u4f9d\u636eFDA\u300aGuidance for Industry: Sterile Drug Products Produced by Aseptic Processing\u300b\u53ca\u4e2d\u56fdGMP\uff082010\u5e74\u4fee\u8ba2\uff09\u9644\u5f551\u7684\u8981\u6c42\uff0c\u9a8c\u8bc1\u4e3b\u8981\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u9636\u6bb5\uff1a<\/p>\n<h3>\uff08\u4e00\uff09\u8bbe\u8ba1\u786e\u8ba4\uff08DQ\uff09<\/h3>\n<p>\u5728\u8bbe\u5907\u91c7\u8d2d\u524d\uff0c\u9700\u6839\u636e\u6d01\u51c0\u5ba4\u5e03\u5c40\u3001\u6362\u6c14\u6b21\u6570\u3001\u6e29\u6e7f\u5ea6\u63a7\u5236\u7b49\u56e0\u7d20\u9009\u62e9\u5408\u9002\u89c4\u683c\u7684HEPA\u8fc7\u6ee4\u5668\u3002\u4f8b\u5982\uff0c\u5728\u65e0\u83cc\u704c\u88c5\u7ebf\u7684\u5c42\u6d41\u7f69\uff08LAF\uff09\u4e2d\uff0c\u5e94\u9009\u7528\u65e0\u9694\u677fH14\u578b\u8fc7\u6ee4\u5668\uff0c\u786e\u4fdd\u51fa\u98ce\u9762\u98ce\u901f\u5747\u5300\uff080.36\u20130.54 m\/s\uff09\uff0c\u5e76\u5177\u5907\u4f4e\u6325\u53d1\u6027\u6709\u673a\u7269\uff08VOC\uff09\u91ca\u653e\u7279\u6027\uff0c\u907f\u514d\u5bf9\u4ea7\u54c1\u9020\u6210\u5316\u5b66\u6c61\u67d3\u3002<\/p>\n<h3>\uff08\u4e8c\uff09\u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09<\/h3>\n<p>\u5b89\u88c5\u5b8c\u6210\u540e\u9700\u68c0\u67e5\u4ee5\u4e0b\u5185\u5bb9\uff1a<\/p>\n<ul>\n<li>\u8fc7\u6ee4\u5668\u578b\u53f7\u3001\u5e8f\u5217\u53f7\u4e0e\u8bbe\u8ba1\u6587\u4ef6\u4e00\u81f4\uff1b<\/li>\n<li>\u6846\u67b6\u5bc6\u5c01\u5b8c\u597d\uff0c\u4f7f\u7528\u7845\u916e\u5bc6\u5c01\u80f6\u6216\u6db2\u69fd\u5bc6\u5c01\uff08\u8d1f\u538b\u68c0\u6f0f\u5408\u683c\uff09\uff1b<\/li>\n<li>\u652f\u6491\u7ed3\u6784\u7a33\u56fa\uff0c\u65e0\u53d8\u5f62\uff1b<\/li>\n<li>\u6c14\u6d41\u65b9\u5411\u6b63\u786e\uff0c\u65e0\u53cd\u5439\u98ce\u9669\u3002<\/li>\n<\/ul>\n<p>\u7279\u522b\u5730\uff0c\u91c7\u7528\u6db2\u69fd\u5f0f\u5bc6\u5c01\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u9700\u6ce8\u5165\u4e13\u7528\u5bc6\u5c01\u6cb9\uff08\u5982\u7845\u6cb9\uff09\uff0c\u5e76\u901a\u8fc7\u201c\u6ce1\u6ce1\u6d4b\u8bd5\u201d\u9a8c\u8bc1\u5bc6\u5c01\u6027\u3002<\/p>\n<h3>\uff08\u4e09\uff09\u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09<\/h3>\n<p>\u6b64\u9636\u6bb5\u91cd\u70b9\u6d4b\u8bd5\u8fc7\u6ee4\u5668\u5728\u5b9e\u9645\u5de5\u51b5\u4e0b\u7684\u6027\u80fd\u8868\u73b0\uff0c\u5305\u62ec\uff1a<\/p>\n<h4>1. \u98ce\u901f\u4e0e\u98ce\u91cf\u6d4b\u8bd5<\/h4>\n<p>\u4f7f\u7528\u70ed\u7403\u5f0f\u98ce\u901f\u4eea\u6216\u76ae\u6258\u7ba1\u5728\u51fa\u98ce\u9762\u81f3\u5c11\u53d69\u4e2a\u6d4b\u70b9\uff0c\u8ba1\u7b97\u5e73\u5747\u98ce\u901f\u4e0e\u4e0d\u5747\u5300\u5ea6\u3002\u6839\u636eISO 14644-3\u89c4\u5b9a\uff0c\u5355\u5411\u6d41\u7cfb\u7edf\u98ce\u901f\u4e0d\u5747\u5300\u5ea6\u5e94\u226415%\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u70b9\u7f16\u53f7<\/th>\n<th>\u98ce\u901f\uff08m\/s\uff09<\/th>\n<th>\u504f\u5dee\uff08%\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>1<\/td>\n<td>0.42<\/td>\n<td>-6.7<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>0.45<\/td>\n<td>0.0<\/td>\n<\/tr>\n<tr>\n<td>3<\/td>\n<td>0.47<\/td>\n<td>+4.4<\/td>\n<\/tr>\n<tr>\n<td>&#8230;<\/td>\n<td>&#8230;<\/td>\n<td>&#8230;<\/td>\n<\/tr>\n<tr>\n<td>\u5e73\u5747\u503c<\/td>\n<td>0.45<\/td>\n<td>\u2014<\/td>\n<\/tr>\n<tr>\n<td>\u4e0d\u5747\u5300\u5ea6<\/td>\n<td>\u2014<\/td>\n<td>8.9%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u7ed3\u8bba\uff1a\u7b26\u5408\u226415%\u7684\u6807\u51c6\u3002<\/p>\n<\/blockquote>\n<h4>2. \u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08Integrity Test\uff09<\/h4>\n<p>\u8fd9\u662f\u9a8c\u8bc1\u4e2d\u6700\u5173\u952e\u7684\u4e00\u73af\uff0c\u5e38\u7528\u65b9\u6cd5\u6709\u4e24\u79cd\uff1a<\/p>\n<h5>\uff081\uff09\u5149\u5ea6\u8ba1\u6cd5\uff08Photometric Method\uff09<\/h5>\n<p>\u9002\u7528\u4e8e\u4e0a\u6e38\u6d53\u5ea6\u8f83\u9ad8\u7684\u6d4b\u8bd5\u73af\u5883\uff0c\u5e38\u7528\u6c14\u6eb6\u80f6\u4e3a\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f\uff08DOP\uff09\u3001\u7678\u4e8c\u9178\u4e8c\u5f02\u8f9b\u916f\uff08DEHS\uff09\u6216\u77ff\u7269\u6cb9\u96fe\u3002\u4e0a\u6e38\u53d1\u751f\u6d53\u5ea6\u4e3a10\u2013100 \u03bcg\/L\uff0c\u4f7f\u7528\u5149\u5ea6\u8ba1\u5728\u4e0b\u6e38\u626b\u63cf\uff0c\u68c0\u6d4b\u6cc4\u6f0f\u70b9\u3002<\/p>\n<p>\u516c\u5f0f\uff1a<br \/>\n$$<br \/>\ntext{\u6cc4\u6f0f\u7387} (%) = frac{C<em>{text{downstream}}}{C<\/em>{text{upstream}}} times 100%<br \/>\n$$<\/p>\n<p>\u63a5\u53d7\u6807\u51c6\uff1a\u4efb\u610f\u5355\u70b9\u6cc4\u6f0f \u22640.01%\uff0c\u603b\u626b\u63cf\u6cc4\u6f0f \u22640.005%\u3002<\/p>\n<h5>\uff082\uff09\u7c92\u5b50\u8ba1\u6570\u626b\u63cf\u6cd5\uff08Particle Counting Scan Method\uff09<\/h5>\n<p>\u66f4\u9002\u7528\u4e8e\u9ad8\u6d01\u51c0\u5ea6\u73af\u5883\uff0c\u4f7f\u7528\u51b7\u53d1\u70df\u5668\u4ea7\u751f\u591a\u5206\u6563\u6c14\u6eb6\u80f6\uff08\u5982PSL\u5fae\u7403\uff09\uff0c\u4e0a\u6e38\u6d53\u5ea6\u226520,000 particles\/cm\u00b3\uff08\u9488\u5bf90.3 \u03bcm\u4ee5\u4e0a\u9897\u7c92\uff09\uff0c\u4e0b\u6e38\u7528\u8fdc\u7a0b\u7c92\u5b50\u8ba1\u6570\u5668\u4ee55 cm\/s\u901f\u5ea6\u626b\u63cf\u6574\u4e2a\u8fc7\u6ee4\u5668\u8868\u9762\u53ca\u8fb9\u6846\u3002<\/p>\n<p>\u6839\u636eEU GMP Annex 1\uff082022\u7248\uff09\u5efa\u8bae\uff0c\u626b\u63cf\u63a2\u5934\u5c3a\u5bf8\u4e3a1\u00d710 cm\u00b2\uff0c\u91c7\u6837\u6d41\u91cf\u22651 cfm\uff0828.3 L\/min\uff09\u3002\u82e5\u68c0\u6d4b\u5230\u8d85\u8fc7\u80cc\u666f\u503c10\u500d\u7684\u4fe1\u53f7\uff0c\u5219\u5224\u5b9a\u4e3a\u6cc4\u6f0f\u3002<\/p>\n<h4>3. \u6c14\u6d41\u6d41\u578b\u6d4b\u8bd5\uff08Smoke Test\uff09<\/h4>\n<p>\u901a\u8fc7\u53d1\u70df\u88c5\u7f6e\u89c2\u5bdf\u6c14\u6d41\u662f\u5426\u5448\u5782\u76f4\u5355\u5411\u6d41\uff0c\u662f\u5426\u5b58\u5728\u6da1\u6d41\u3001\u56de\u6d41\u6216\u6b7b\u89d2\u3002\u7406\u60f3\u72b6\u6001\u4e0b\uff0c\u70df\u96fe\u5e94\u5e73\u7a33\u5411\u4e0b\u6d41\u52a8\uff0c\u65e0\u6270\u52a8\u73b0\u8c61\u3002<\/p>\n<hr \/>\n<h2>\u4e94\u3001\u56fd\u5185\u5916\u6cd5\u89c4\u4e0e\u6807\u51c6\u5bf9\u6bd4<\/h2>\n<p>\u4e0d\u540c\u56fd\u5bb6\u548c\u5730\u533a\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u8981\u6c42\u5b58\u5728\u4e00\u5b9a\u5dee\u5f02\uff0c\u4f46\u603b\u4f53\u8d8b\u4e25\u3002\u4e0b\u8868\u5217\u51fa\u4e86\u4e3b\u8981\u6cd5\u89c4\u4f53\u7cfb\u7684\u76f8\u5173\u89c4\u5b9a\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u4e2d\u56fdGMP\uff082010\uff09\u9644\u5f551<\/th>\n<th>EU GMP Annex 1\uff082022\uff09<\/th>\n<th>US FDA Aseptic Guidance\uff082004\uff09<\/th>\n<th>ISO 14644-3:2019<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/td>\n<td>H13\u6216\u66f4\u9ad8<\/td>\n<td>H14\u6216U15<\/td>\n<td>HEPA\uff08\u672a\u660e\u786e\u5206\u7ea7\uff09<\/td>\n<td>\u4f9d\u636eEN 1822\u5206\u7ea7<\/td>\n<\/tr>\n<tr>\n<td>\u5b8c\u6574\u6027\u6d4b\u8bd5\u9891\u7387<\/td>\n<td>\u521d\u6b21\u5b89\u88c5\u53ca\u6bcf\u5e74\u4e00\u6b21<\/td>\n<td>\u5b89\u88c5\u540e\u3001\u7ef4\u4fee\u540e\u3001\u5b9a\u671f\uff08\u22646\u4e2a\u6708\uff09<\/td>\n<td>\u5b89\u88c5\u540e\u53ca\u5b9a\u671f<\/td>\n<td>\u63a8\u8350\u5468\u671f\u6027\u6d4b\u8bd5<\/td>\n<\/tr>\n<tr>\n<td>\u6d4b\u8bd5\u65b9\u6cd5<\/td>\n<td>\u5149\u5ea6\u8ba1\u6cd5\u6216\u7c92\u5b50\u8ba1\u6570\u6cd5<\/td>\n<td>\u7c92\u5b50\u8ba1\u6570\u626b\u63cf\u4e3a\u4e3b<\/td>\n<td>\u53ef\u63a5\u53d7\u5149\u5ea6\u8ba1\u6cd5<\/td>\n<td>\u660e\u786e\u4e24\u79cd\u65b9\u6cd5\u5747\u53ef<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u63a5\u53d7\u6807\u51c6<\/td>\n<td>\u22640.01%<\/td>\n<td>\u22640.01%\uff08\u5355\u70b9\uff09<\/td>\n<td>\u22640.03%\uff08\u5386\u53f2\u6807\u51c6\uff09<\/td>\n<td>\u22640.01%<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u901f\u8981\u6c42\uff08A\u7ea7\u533a\uff09<\/td>\n<td>0.36\u20130.54 m\/s<\/td>\n<td>0.45 m\/s \u00b120%<\/td>\n<td>\u5355\u5411\u6d41\uff0c\u7a33\u5b9a<\/td>\n<td>\u4f9d\u636e\u7528\u9014\u786e\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u751f\u7269\u6311\u6218\u8bd5\u9a8c<\/td>\n<td>\u672a\u5f3a\u5236\u8981\u6c42<\/td>\n<td>\u63a8\u8350\u7528\u4e8e\u9ad8\u98ce\u9669\u533a\u57df<\/td>\n<td>\u53ef\u80fd\u7528\u4e8e\u4e89\u8bae\u60c5\u51b5<\/td>\n<td>\u672a\u5217\u5165\u5e38\u89c4\u6d4b\u8bd5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u4ece\u4e0a\u8868\u53ef\u89c1\uff0c\u6b27\u76df\u6700\u65b0\u7248Annex 1\u663e\u8457\u63d0\u9ad8\u4e86\u5bf9\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u7684\u4e25\u683c\u7a0b\u5ea6\uff0c\u5f3a\u8c03\u57fa\u4e8e\u98ce\u9669\u7684\u5b9a\u671f\u518d\u9a8c\u8bc1\u7b56\u7565\uff0c\u5e76\u63a8\u8350\u4f7f\u7528\u66f4\u7075\u654f\u7684\u7c92\u5b50\u8ba1\u6570\u6cd5\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u4e2d\u56fdGMP\u867d\u5df2\u4e0e\u56fd\u9645\u63a5\u8f68\uff0c\u4f46\u5728\u6d4b\u8bd5\u9891\u7387\u548c\u65b9\u6cd5\u7ec6\u8282\u4e0a\u4ecd\u6709\u63d0\u5347\u7a7a\u95f4\u3002<\/p>\n<hr \/>\n<h2>\u516d\u3001\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>\u6848\u4f8b\u4e00\uff1a\u67d0\u5355\u6297\u836f\u7269\u65e0\u83cc\u704c\u88c5\u7ebfHEPA\u9a8c\u8bc1<\/h3>\n<p>\u67d0\u56fd\u5185\u751f\u7269\u5236\u836f\u4f01\u4e1a\u5728\u5efa\u8bbe\u65b0\u7684\u5355\u514b\u9686\u6297\u4f53\u539f\u6db2\u704c\u88c5\u8f66\u95f4\u65f6\uff0c\u91c7\u7528\u9876\u90e8\u6ee1\u5e03H14\u7ea7\u65e0\u9694\u677f\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u5f62\u6210A\u7ea7\u5c40\u90e8\u4fdd\u62a4\u73af\u5883\u3002\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u53d1\u73b0\uff1a<\/p>\n<ul>\n<li>\u521d\u59cb\u98ce\u901f\u5206\u5e03\u4e0d\u5747\uff0c\u89d2\u843d\u533a\u57df\u504f\u4f4e\u81f30.32 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