{"id":17248,"date":"2025-10-13T18:41:07","date_gmt":"2025-10-13T10:41:07","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=17248"},"modified":"2025-10-13T18:41:07","modified_gmt":"2025-10-13T10:41:07","slug":"%e9%ab%98%e6%95%88%e6%97%a0%e9%9a%94%e6%9d%bf%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e6%a8%a1%e5%9d%97%e5%8c%96%e6%b4%81%e5%87%80%e5%8d%95%e5%85%83%e4%b8%ad%e7%9a%84%e9%9b%86%e6%88%90%e8%ae%be%e8%ae%a1","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=17248","title":{"rendered":"\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u5728\u6a21\u5757\u5316\u6d01\u51c0\u5355\u5143\u4e2d\u7684\u96c6\u6210\u8bbe\u8ba1"},"content":{"rendered":"<h1>\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u5728\u6a21\u5757\u5316\u6d01\u51c0\u5355\u5143\u4e2d\u7684\u96c6\u6210\u8bbe\u8ba1<\/h1>\n<h2>1. \u5f15\u8a00<\/h2>\n<p>\u968f\u7740\u73b0\u4ee3\u5de5\u4e1a\u6280\u672f\u7684\u5feb\u901f\u53d1\u5c55\uff0c\u5c24\u5176\u662f\u534a\u5bfc\u4f53\u5236\u9020\u3001\u751f\u7269\u533b\u836f\u3001\u7cbe\u5bc6\u4eea\u5668\u3001\u98df\u54c1\u52a0\u5de5\u53ca\u822a\u7a7a\u822a\u5929\u7b49\u9ad8\u7cbe\u5c16\u9886\u57df\u5bf9\u751f\u4ea7\u73af\u5883\u6d01\u51c0\u5ea6\u8981\u6c42\u7684\u4e0d\u65ad\u63d0\u9ad8\uff0c\u6d01\u51c0\u5ba4\u6280\u672f\u5df2\u6210\u4e3a\u4fdd\u969c\u4ea7\u54c1\u8d28\u91cf\u4e0e\u751f\u4ea7\u5b89\u5168\u7684\u6838\u5fc3\u73af\u8282\u3002\u5728\u8fd9\u4e00\u80cc\u666f\u4e0b\uff0c<strong>\u6a21\u5757\u5316\u6d01\u51c0\u5355\u5143<\/strong>\uff08Modular Cleanroom Units, MCU\uff09\u4f5c\u4e3a\u4e00\u79cd\u7075\u6d3b\u3001\u53ef\u6269\u5c55\u3001\u5feb\u901f\u90e8\u7f72\u7684\u6d01\u51c0\u7a7a\u95f4\u89e3\u51b3\u65b9\u6848\uff0c\u8fd1\u5e74\u6765\u53d7\u5230\u5e7f\u6cdb\u5173\u6ce8\u3002\u800c\u4f5c\u4e3a\u6d01\u51c0\u7cfb\u7edf\u4e2d\u6700\u4e3a\u5173\u952e\u7684\u7a7a\u6c14\u51c0\u5316\u7ec4\u4ef6\u4e4b\u4e00\uff0c<strong>\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668<\/strong>\uff08High-Efficiency Particulate Air Filter, HEPA Filter without Separator\uff09\u56e0\u5176\u4f18\u5f02\u7684\u8fc7\u6ee4\u6027\u80fd\u3001\u4f4e\u963b\u529b\u3001\u9ad8\u5bb9\u5c18\u91cf\u548c\u7d27\u51d1\u7ed3\u6784\uff0c\u5728\u6a21\u5757\u5316\u6d01\u51c0\u5355\u5143\u4e2d\u626e\u6f14\u7740\u4e0d\u53ef\u66ff\u4ee3\u7684\u89d2\u8272\u3002<\/p>\n<p>\u672c\u6587\u5c06\u56f4\u7ed5\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u5728\u6a21\u5757\u5316\u6d01\u51c0\u5355\u5143\u4e2d\u7684\u96c6\u6210\u8bbe\u8ba1\u5c55\u5f00\u6df1\u5165\u63a2\u8ba8\uff0c\u6db5\u76d6\u5176\u5de5\u4f5c\u539f\u7406\u3001\u6838\u5fc3\u53c2\u6570\u3001\u7ed3\u6784\u7279\u70b9\u3001\u9009\u578b\u4f9d\u636e\u3001\u5b89\u88c5\u65b9\u5f0f\u3001\u6c14\u6d41\u7ec4\u7ec7\u4f18\u5316\u4ee5\u53ca\u56fd\u5185\u5916\u5e94\u7528\u6848\u4f8b\uff0c\u5e76\u7ed3\u5408\u6743\u5a01\u6587\u732e\u8d44\u6599\u8fdb\u884c\u7406\u8bba\u652f\u6491\u4e0e\u5b9e\u8df5\u5206\u6790\uff0c\u65e8\u5728\u4e3a\u5de5\u7a0b\u6280\u672f\u4eba\u5458\u63d0\u4f9b\u7cfb\u7edf\u6027\u53c2\u8003\u3002<\/p>\n<hr \/>\n<h2>2. \u6a21\u5757\u5316\u6d01\u51c0\u5355\u5143\u6982\u8ff0<\/h2>\n<h3>2.1 \u5b9a\u4e49\u4e0e\u7279\u70b9<\/h3>\n<p>\u6a21\u5757\u5316\u6d01\u51c0\u5355\u5143\u662f\u4e00\u79cd\u57fa\u4e8e\u6807\u51c6\u5316\u8bbe\u8ba1\u3001\u5de5\u5382\u9884\u5236\u3001\u73b0\u573a\u5feb\u901f\u7ec4\u88c5\u7684\u6d01\u51c0\u7a7a\u95f4\u7cfb\u7edf\u3002\u5176\u4e3b\u8981\u7531\u8f7b\u8d28\u5899\u4f53\u3001\u9876\u68da\u3001\u5730\u677f\u3001\u7a7a\u8c03\u7cfb\u7edf\u3001\u7167\u660e\u7cfb\u7edf\u53ca\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u7b49\u6a21\u5757\u7ec4\u6210\uff0c\u5177\u5907\u4ee5\u4e0b\u663e\u8457\u4f18\u52bf\uff1a<\/p>\n<ul>\n<li><strong>\u5efa\u8bbe\u5468\u671f\u77ed<\/strong>\uff1a\u76f8\u6bd4\u4f20\u7edf\u571f\u5efa\u6d01\u51c0\u5ba4\uff0c\u5de5\u671f\u53ef\u7f29\u77ed50%\u4ee5\u4e0a\uff1b<\/li>\n<li><strong>\u53ef\u79fb\u52a8\u6027\u5f3a<\/strong>\uff1a\u652f\u6301\u6574\u4f53\u642c\u8fc1\u6216\u5c40\u90e8\u6269\u5c55\uff1b<\/li>\n<li><strong>\u7ef4\u62a4\u4fbf\u6377<\/strong>\uff1a\u6a21\u5757\u5316\u8bbe\u8ba1\u4fbf\u4e8e\u66f4\u6362\u4e0e\u7ef4\u4fee\uff1b<\/li>\n<li><strong>\u8282\u80fd\u73af\u4fdd<\/strong>\uff1a\u91c7\u7528\u9ad8\u6548\u8282\u80fd\u8bbe\u5907\uff0c\u964d\u4f4e\u8fd0\u884c\u80fd\u8017\uff1b<\/li>\n<li><strong>\u6d01\u51c0\u7b49\u7ea7\u53ef\u63a7<\/strong>\uff1a\u53ef\u5b9e\u73b0ISO Class 3~8\u7ea7\u6d01\u51c0\u5ea6\u3002<\/li>\n<\/ul>\n<p>\u6839\u636e\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6\u300aGB 50073-2013 \u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303\u300b\u89c4\u5b9a\uff0c\u6d01\u51c0\u5ba4\u6309\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u7c92\u5b50\u6d53\u5ea6\u5212\u5206\u4e3a\u4e0d\u540c\u7b49\u7ea7\uff0c\u5176\u4e2dISO Class 5\uff08\u5373\u767e\u7ea7\uff09\u53ca\u4ee5\u4e0a\u533a\u57df\u5fc5\u987b\u914d\u5907HEPA\u8fc7\u6ee4\u5668\u3002<\/p>\n<hr \/>\n<h3>2.2 \u5e94\u7528\u9886\u57df<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u5e94\u7528\u884c\u4e1a<\/th>\n<th>\u5178\u578b\u573a\u666f<\/th>\n<th>\u6240\u9700\u6d01\u51c0\u7b49\u7ea7<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u534a\u5bfc\u4f53\u5236\u9020<\/td>\n<td>\u5149\u523b\u3001\u8680\u523b\u3001\u5c01\u88c5<\/td>\n<td>ISO Class 3~5<\/td>\n<\/tr>\n<tr>\n<td>\u751f\u7269\u5236\u836f<\/td>\n<td>\u65e0\u83cc\u704c\u88c5\u3001\u7ec6\u80de\u57f9\u517b<\/td>\n<td>ISO Class 5~7<\/td>\n<\/tr>\n<tr>\n<td>\u533b\u7597\u5668\u68b0<\/td>\n<td>\u690d\u5165\u7269\u751f\u4ea7\u3001\u5305\u88c5<\/td>\n<td>ISO Class 7~8<\/td>\n<\/tr>\n<tr>\n<td>\u5b9e\u9a8c\u5ba4\u7814\u7a76<\/td>\n<td>PCR\u5b9e\u9a8c\u5ba4\u3001P3\/P4\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4<\/td>\n<td>ISO Class 6~8<\/td>\n<\/tr>\n<tr>\n<td>\u98df\u54c1\u5de5\u4e1a<\/td>\n<td>\u65e0\u83cc\u704c\u88c5\u7ebf\u3001\u4e73\u5236\u54c1\u52a0\u5de5<\/td>\n<td>ISO Class 7~8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u8d44\u6599\u6765\u6e90\uff1a\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff1bFDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing<\/p>\n<\/blockquote>\n<hr \/>\n<h2>3. \u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u6280\u672f\u539f\u7406\u4e0e\u7ed3\u6784\u7279\u5f81<\/h2>\n<h3>3.1 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u4e3b\u8981\u901a\u8fc7\u7269\u7406\u62e6\u622a\u673a\u5236\u53bb\u9664\u7a7a\u6c14\u4e2d\u7684\u5fae\u7c92\u6c61\u67d3\u7269\uff0c\u5176\u8fc7\u6ee4\u673a\u7406\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u60ef\u6027\u78b0\u649e<\/strong>\uff08Inertial Impaction\uff09\uff1a\u5927\u9897\u7c92\u56e0\u6c14\u6d41\u65b9\u5411\u6539\u53d8\u649e\u51fb\u7ea4\u7ef4\u88ab\u6355\u83b7\uff1b<\/li>\n<li><strong>\u62e6\u622a\u6548\u5e94<\/strong>\uff08Interception\uff09\uff1a\u4e2d\u7b49\u7c92\u5f84\u9897\u7c92\u63a5\u89e6\u7ea4\u7ef4\u8868\u9762\u88ab\u5438\u9644\uff1b<\/li>\n<li><strong>\u6269\u6563\u6548\u5e94<\/strong>\uff08Diffusion\uff09\uff1a\u4e9a\u5fae\u7c73\u7ea7\u7c92\u5b50\u53d7\u5e03\u6717\u8fd0\u52a8\u5f71\u54cd\u4e0e\u7ea4\u7ef4\u63a5\u89e6\uff1b<\/li>\n<li><strong>\u9759\u7535\u5438\u9644<\/strong>\uff08Electrostatic Attraction\uff09\uff1a\u90e8\u5206\u6ee4\u6750\u5e26\u9759\u7535\u589e\u5f3a\u6355\u96c6\u6548\u7387\u3002<\/li>\n<\/ul>\n<p>\u6839\u636e\u7f8e\u56fdASHRAE\u6807\u51c6\u300aASHRAE 52.2-2017\u300b\uff0cHEPA\u8fc7\u6ee4\u5668\u5bf90.3\u03bcm\u7c92\u5b50\u7684\u8fc7\u6ee4\u6548\u7387\u4e0d\u4f4e\u4e8e99.97%\uff0cULPA\uff08\u8d85\u9ad8\u6548\uff09\u5219\u53ef\u8fbe99.999%\u4ee5\u4e0a\u3002<\/p>\n<hr \/>\n<h3>3.2 \u7ed3\u6784\u7ec4\u6210<\/h3>\n<p>\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u901a\u5e38\u7531\u4ee5\u4e0b\u51e0\u90e8\u5206\u6784\u6210\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7ec4\u6210\u90e8\u4ef6<\/th>\n<th>\u6750\u6599<\/th>\n<th>\u529f\u80fd\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6ee4\u6599<\/td>\n<td>\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4\uff08Glass Microfiber\uff09<\/td>\n<td>\u4e3b\u8981\u8fc7\u6ee4\u4ecb\u8d28\uff0c\u7ecf\u9a7b\u6781\u5904\u7406\u63d0\u5347\u9759\u7535\u5438\u9644\u80fd\u529b<\/td>\n<\/tr>\n<tr>\n<td>\u5206\u9694\u7269<\/td>\n<td>\u65e0\u91d1\u5c5e\/\u5851\u6599\u6ce2\u7eb9\u677f\uff08\u91c7\u7528\u70ed\u7194\u80f6\u5b9a\u8ddd\uff09<\/td>\n<td>\u66ff\u4ee3\u4f20\u7edf\u6709\u9694\u677f\u94dd\u7b94\uff0c\u51cf\u5c11\u538b\u964d\uff0c\u63d0\u9ad8\u5bb9\u5c18\u91cf<\/td>\n<\/tr>\n<tr>\n<td>\u6846\u67b6<\/td>\n<td>\u94dd\u5408\u91d1\u3001\u9540\u950c\u94a2\u677f\u6216ABS\u5851\u6599<\/td>\n<td>\u63d0\u4f9b\u7ed3\u6784\u652f\u6491\uff0c\u786e\u4fdd\u5bc6\u5c01\u6027<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u80f6<\/td>\n<td>\u805a\u6c28\u916f\u6216\u7845\u916e\u80f6<\/td>\n<td>\u586b\u5145\u8fb9\u6846\u7f1d\u9699\uff0c\u9632\u6b62\u65c1\u901a\u6cc4\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>\u9632\u62a4\u7f51<\/td>\n<td>\u4e0d\u9508\u94a2\u4e1d\u7f51\u6216\u51b2\u5b54\u677f<\/td>\n<td>\u4fdd\u62a4\u6ee4\u7eb8\u514d\u53d7\u6c14\u6d41\u51b2\u51fb\u635f\u574f<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u76f8\u8f83\u4e8e\u4f20\u7edf\u7684\u6709\u9694\u677fHEPA\u8fc7\u6ee4\u5668\uff0c\u65e0\u9694\u677f\u8bbe\u8ba1\u53d6\u6d88\u4e86\u94dd\u7b94\u5206\u9694\u7247\uff0c\u91c7\u7528\u201cV\u201d\u5f62\u6298\u53e0\u5de5\u827a\u589e\u52a0\u5355\u4f4d\u4f53\u79ef\u5185\u7684\u8fc7\u6ee4\u9762\u79ef\uff0c\u4ece\u800c\u5b9e\u73b0\u66f4\u9ad8\u7684\u8fc7\u6ee4\u6548\u7387\u4e0e\u66f4\u4f4e\u7684\u521d\u963b\u529b\u3002<\/p>\n<hr \/>\n<h2>4. \u5173\u952e\u6027\u80fd\u53c2\u6570\u5bf9\u6bd4\u5206\u6790<\/h2>\n<p>\u4e0b\u8868\u5217\u51fa\u4e86\u5178\u578b\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u7684\u4e3b\u8981\u6280\u672f\u53c2\u6570\uff0c\u6570\u636e\u7efc\u5408\u81ea\u56fd\u5185\u77e5\u540d\u5382\u5546\uff08\u5982AAF\u56fd\u9645\u3001\u82cf\u51c0\u96c6\u56e2\uff09\u4e0e\u56fd\u5916\u54c1\u724c\uff08Camfil\u3001Donaldson\u3001Pall Corporation\uff09\u4ea7\u54c1\u624b\u518c\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u9879<\/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>\u8fc7\u6ee4\u6548\u7387\uff080.3\u03bcm DOP\uff09<\/td>\n<td>\u226599.97%<\/td>\n<td>IEST-RP-CC001 \/ EN 1822<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>100~180 Pa<\/td>\n<td>ASHRAE 52.2<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf<\/td>\n<td>500~2000 m\u00b3\/h<\/td>\n<td>GB\/T 13554-2020<\/td>\n<\/tr>\n<tr>\n<td>\u5bb9\u5c18\u91cf<\/td>\n<td>\u226580 g\/m\u00b2<\/td>\n<td>JIS Z 8122<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5bff\u547d<\/td>\n<td>3~5\u5e74\uff08\u89c6\u73af\u5883\u800c\u5b9a\uff09<\/td>\n<td>\u2014\u2014<\/td>\n<\/tr>\n<tr>\n<td>\u6846\u67b6\u6750\u8d28<\/td>\n<td>\u94dd\u5408\u91d1\/\u9540\u950c\u94a2\/ABS<\/td>\n<td>\u2014\u2014<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u7387\uff08\u626b\u63cf\u6cd5\u68c0\u6d4b\uff09<\/td>\n<td>\u22640.01%<\/td>\n<td>ISO 14644-3<\/td>\n<\/tr>\n<tr>\n<td>\u5de5\u4f5c\u6e29\u5ea6<\/td>\n<td>-20\u2103 ~ 80\u2103<\/td>\n<td>\u2014\u2014<\/td>\n<\/tr>\n<tr>\n<td>\u6e7f\u5ea6\u9002\u5e94\u8303\u56f4<\/td>\n<td>\u226490% RH\uff08\u975e\u51dd\u9732\uff09<\/td>\n<td>\u2014\u2014<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1aDOP\uff08\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f\uff09\u4e3a\u5e38\u7528\u6d4b\u8bd5\u6c14\u6eb6\u80f6\uff1bEN 1822\u4e3a\u6b27\u6d32\u6700\u4e25\u683c\u7684HEPA\u5206\u7ea7\u6807\u51c6\uff0c\u4f9d\u636eMPPS\uff08\u6700\u6613\u7a7f\u900f\u7c92\u5f84\uff09\u5212\u5206\u7b49\u7ea7\uff0c\u5982H13\u3001H14\u3001U15\u7b49\u3002<\/p>\n<\/blockquote>\n<p>\u636e\u745e\u5178Camfil\u516c\u53f8\u53d1\u5e03\u7684\u7814\u7a76\u62a5\u544a\u6307\u51fa\uff0c\u65e0\u9694\u677fHEPA\u5728\u76f8\u540c\u98ce\u91cf\u4e0b\u6bd4\u6709\u9694\u677f\u578b\u53f7\u8282\u80fd\u7ea615%-20%\uff0c\u4e3b\u8981\u5f52\u56e0\u4e8e\u5176\u66f4\u4f4e\u7684\u6c14\u6d41\u963b\u529b\u548c\u66f4\u4f18\u7684\u6c14\u6d41\u5206\u5e03\u7279\u6027\uff08Camfil, 2021\uff09\u3002<\/p>\n<hr \/>\n<h2>5. \u5728\u6a21\u5757\u5316\u6d01\u51c0\u5355\u5143\u4e2d\u7684\u96c6\u6210\u8bbe\u8ba1\u8981\u70b9<\/h2>\n<h3>5.1 \u5b89\u88c5\u4f4d\u7f6e\u9009\u62e9<\/h3>\n<p>\u5728\u6a21\u5757\u5316\u6d01\u51c0\u5355\u5143\u4e2d\uff0c\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u901a\u5e38\u96c6\u6210\u4e8e\u9876\u90e8\u9759\u538b\u7bb1\u5185\uff0c\u5f62\u6210\u201c\u9876\u9001\u98ce\u201d\u6a21\u5f0f\u3002\u5e38\u89c1\u5b89\u88c5\u5f62\u5f0f\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u60ac\u6302\u5f0fFFU\uff08Fan Filter Unit\uff09\u96c6\u6210<\/strong>\uff1a\u5c06\u98ce\u673a\u4e0e\u8fc7\u6ee4\u5668\u4e00\u4f53\u5316\uff0c\u76f4\u63a5\u5d4c\u5165\u5929\u82b1\u677f\u6a21\u5757\uff1b<\/li>\n<li><strong>\u96c6\u4e2d\u9001\u98ce+\u9759\u538b\u7bb1\u5e03\u7f6e<\/strong>\uff1a\u4e2d\u592e\u7a7a\u8c03\u7cfb\u7edf\u8f93\u9001\u6d01\u51c0\u7a7a\u6c14\u81f3\u9876\u90e8\u9759\u538b\u7bb1\uff0c\u518d\u7ecfHEPA\u5747\u5300\u9001\u51fa\uff1b<\/li>\n<li><strong>\u4fa7\u58c1\u56de\u98ce+\u9876\u90e8\u9001\u98ce\u7ec4\u5408<\/strong>\uff1a\u9002\u7528\u4e8e\u5c0f\u578bMCU\uff0c\u63d0\u5347\u6362\u6c14\u6548\u7387\u3002<\/li>\n<\/ul>\n<table>\n<thead>\n<tr>\n<th>\u5b89\u88c5\u65b9\u5f0f<\/th>\n<th>\u4f18\u70b9<\/th>\n<th>\u7f3a\u70b9<\/th>\n<th>\u9002\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>FFU\u96c6\u6210\u5f0f<\/td>\n<td>\u72ec\u7acb\u63a7\u5236\u3001\u7075\u6d3b\u6027\u5f3a\u3001\u6613\u4e8e\u7ef4\u62a4<\/td>\n<td>\u6210\u672c\u8f83\u9ad8\u3001\u566a\u97f3\u7565\u5927<\/td>\n<td>\u534a\u5bfc\u4f53\u6d01\u51c0\u53f0\u3001\u751f\u7269\u5b89\u5168\u67dc<\/td>\n<\/tr>\n<tr>\n<td>\u9759\u538b\u7bb1\u9001\u98ce<\/td>\n<td>\u6c14\u6d41\u5747\u5300\u3001\u538b\u5dee\u7a33\u5b9a<\/td>\n<td>\u5360\u7528\u7a7a\u95f4\u5927\u3001\u9700\u4e13\u4e1a\u65bd\u5de5<\/td>\n<td>\u5927\u578b\u5236\u836f\u8f66\u95f4\u3001\u533b\u9662\u624b\u672f\u5ba4<\/td>\n<\/tr>\n<tr>\n<td>\u4fa7\u9001\u4fa7\u56de<\/td>\n<td>\u7ed3\u6784\u7d27\u51d1\u3001\u8282\u7701\u9ad8\u5ea6<\/td>\n<td>\u6613\u4ea7\u751f\u6da1\u6d41\u533a<\/td>\n<td>\u5c0f\u578b\u5b9e\u9a8c\u5ba4\u3001\u79fb\u52a8\u5f0f\u6d01\u51c0\u8231<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h3>5.2 \u6c14\u6d41\u7ec4\u7ec7\u4f18\u5316<\/h3>\n<p>\u826f\u597d\u7684\u6c14\u6d41\u7ec4\u7ec7\u662f\u4fdd\u8bc1\u6d01\u51c0\u5ea6\u7684\u5173\u952e\u3002\u6839\u636e\u300aGB 50591-2010 \u6d01\u51c0\u5ba4\u65bd\u5de5\u53ca\u9a8c\u6536\u89c4\u8303\u300b\uff0c\u5355\u5411\u6d41\uff08\u5c42\u6d41\uff09\u6d01\u51c0\u5ba4\u5e94\u6ee1\u8db3\uff1a<\/p>\n<ul>\n<li>\u5e73\u5747\u98ce\u901f\uff1a0.3~0.5 m\/s\uff08\u5782\u76f4\u5c42\u6d41\uff09<\/li>\n<li>\u6362\u6c14\u6b21\u6570\uff1a\u2265400\u6b21\/\u5c0f\u65f6\uff08ISO Class 5\uff09<\/li>\n<li>\u6c14\u6d41\u5e73\u884c\u5ea6\u504f\u5dee\uff1a&lt;\u00b115\u00b0<\/li>\n<\/ul>\n<p>\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u56e0\u5177\u6709\u8f83\u5927\u7684\u6709\u6548\u8fc7\u6ee4\u9762\u79ef\u548c\u8f83\u5c0f\u7684\u539a\u5ea6\uff08\u4e00\u822c\u4e3a60~90mm\uff09\uff0c\u66f4\u9002\u5408\u7528\u4e8e\u6784\u5efa\u7d27\u51d1\u578b\u5c42\u6d41\u7f69\u6216\u5fae\u578b\u6d01\u51c0\u5355\u5143\u3002\u4f8b\u5982\uff0c\u5728\u67d0\u56fd\u4ea7\u79fb\u52a8\u5f0fPCR\u65b9\u8231\u5b9e\u9a8c\u5ba4\u4e2d\uff0c\u91c7\u75284\u53f0FFU\u642d\u8f7dH14\u7ea7\u65e0\u9694\u677fHEPA\uff0c\u5b9e\u73b0\u5185\u90e8ISO Class 6\u73af\u5883\uff0c\u5b9e\u6d4b\u7c92\u5b50\u6d53\u5ea6\u4f4e\u4e8e3520\u4e2a\/m\u00b3\uff08\u22650.5\u03bcm\uff09\uff0c\u5b8c\u5168\u6ee1\u8db3\u6838\u9178\u68c0\u6d4b\u64cd\u4f5c\u9700\u6c42\uff08\u300a\u4e2d\u56fd\u533b\u7597\u8bbe\u5907\u300b\uff0c2022\u5e74\u7b2c8\u671f\uff09\u3002<\/p>\n<hr \/>\n<h3>5.3 \u5bc6\u5c01\u4e0e\u68c0\u6f0f\u8bbe\u8ba1<\/h3>\n<p>\u4e3a\u9632\u6b62\u672a\u7ecf\u8fc7\u6ee4\u7684\u7a7a\u6c14\u201c\u77ed\u8def\u201d\u8fdb\u5165\u6d01\u51c0\u533a\uff0c\u5fc5\u987b\u786e\u4fdd\u8fc7\u6ee4\u5668\u4e0e\u6846\u67b6\u4e4b\u95f4\u7684\u4e25\u5bc6\u8fde\u63a5\u3002\u5e38\u7528\u5bc6\u5c01\u65b9\u5f0f\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u6db2\u69fd\u5bc6\u5c01<\/strong>\uff1a\u4f7f\u7528\u7845\u6cb9\u6216\u6c1f\u5316\u6db2\u586b\u5145\u69fd\u4f53\uff0c\u63d2\u63a5\u5f0f\u5b89\u88c5\uff0c\u6cc4\u6f0f\u7387\u6781\u4f4e\uff1b<\/li>\n<li><strong>\u5200\u53e3\u5bc6\u5c01<\/strong>\uff1a\u8fc7\u6ee4\u5668\u8fb9\u7f18\u5e26\u6709\u5f39\u6027\u6a61\u80f6\u5200\u53e3\uff0c\u538b\u7d27\u4e8e\u91d1\u5c5e\u6cd5\u5170\u4e4b\u95f4\uff1b<\/li>\n<li><strong>\u53cc\u7ec4\u4efd\u53d1\u6ce1\u5bc6\u5c01\u80f6\u73b0\u573a\u586b\u5145<\/strong>\uff1a\u9002\u7528\u4e8e\u5f02\u5f62\u7ed3\u6784\u6216\u975e\u6807\u5c3a\u5bf8\u3002<\/li>\n<\/ul>\n<p>\u6839\u636e\u7f8e\u56fdIEST\uff08Institute of Environmental Sciences and Technology\uff09\u63a8\u8350\u5b9e\u8df5\u6307\u5357IEST-RP-CC034.1\uff0c\u6240\u6709HEPA\u5b89\u88c5\u540e\u5fc5\u987b\u8fdb\u884c<strong>\u73b0\u573a\u626b\u63cf\u68c0\u6f0f\u6d4b\u8bd5<\/strong>\uff0c\u4f7f\u7528\u5149\u5ea6\u8ba1\u6216\u7c92\u5b50\u8ba1\u6570\u5668\u6cbf\u4e0b\u6e38\u9762\u4ee55 cm\/s\u901f\u5ea6\u79fb\u52a8\uff0c\u53d1\u73b0\u6cc4\u6f0f\u70b9\u5e94\u53ca\u65f6\u4fee\u590d\u6216\u66f4\u6362\u3002<\/p>\n<hr \/>\n<h2>6. \u56fd\u5185\u5916\u5178\u578b\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>6.1 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Pa\u3002<\/p>\n<p>\u8fd0\u884c\u6570\u636e\u663e\u793a\uff1a<\/p>\n<ul>\n<li>\u6d01\u51c0\u5ba4\u5185\u22650.5\u03bcm\u7c92\u5b50\u6570\u5e73\u5747\u4e3a2300\u4e2a\/m\u00b3\uff1b<\/li>\n<li>\u6362\u6c14\u6b21\u6570\u8fbe420\u6b21\/\u5c0f\u65f6\uff1b<\/li>\n<li>\u7cfb\u7edf\u80fd\u8017\u8f83\u4f20\u7edf\u65b9\u6848\u964d\u4f4e18%\uff1b<\/li>\n<li>\u65bd\u5de5\u5468\u671f\u4ec545\u5929\uff0c\u8f83\u5e38\u89c4\u6d01\u51c0\u5ba4\u7f29\u77ed\u8fd1\u4e24\u4e2a\u6708\u3002<\/li>\n<\/ul>\n<p>\u8be5\u6848\u4f8b\u9a8c\u8bc1\u4e86\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u5728\u9ad8\u8981\u6c42GMP\u73af\u5883\u4e0b\u7684\u53ef\u9760\u6027\u548c\u8282\u80fd\u6f5c\u529b\uff08\u5f15\u81ea\u300a\u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f\u300b\uff0c2023\u5e74\u7b2c2\u671f\uff09\u3002<\/p>\n<hr \/>\n<h3>6.2 \u56fd\u5916\u6848\u4f8b\uff1a\u5fb7\u56fd\u897f\u95e8\u5b50\u6155\u5c3c\u9ed1\u7535\u5b50\u5c01\u88c5\u5382<\/h3>\n<p>\u897f\u95e8\u5b50\u5728\u5176\u65b0\u4e00\u4ee3\u667a\u80fd\u4f20\u611f\u5668\u751f\u4ea7\u7ebf\u4e2d\u5f15\u5165\u6a21\u5757\u5316\u6d01\u51c0\u5355\u5143\uff08\u7531Keepps\u516c\u53f8\u63d0\u4f9b\uff09\uff0c\u5168\u90e8\u91c7\u7528Camfil NanoCell\u00ae\u65e0\u9694\u677fHEPA\u8fc7\u6ee4\u6280\u672f\u3002\u8be5\u8fc7\u6ee4\u5668\u91c7\u7528\u7eb3\u7c73\u7ea7\u73bb\u7483\u7ea4\u7ef4\u590d\u5408\u6750\u6599\uff0cMPPS\u8fc7\u6ee4\u6548\u7387\u9ad8\u8fbe99.9995%\uff08\u5bf9\u5e94U15\u7b49\u7ea7\uff09\uff0c\u4e14\u572820%\u76f8\u5bf9\u6e7f\u5ea6\u6761\u4ef6\u4e0b\u4ecd\u4fdd\u6301\u7a33\u5b9a\u6027\u80fd\u3002<\/p>\n<p>\u7cfb\u7edf\u7279\u70b9\uff1a<\/p>\n<ul>\n<li>\u6a21\u5757\u5316\u5355\u5143\u53ef\u572872\u5c0f\u65f6\u5185\u5b8c\u6210\u90e8\u7f72\uff1b<\/li>\n<li>\u652f\u6301\u8fdc\u7a0b\u76d1\u63a7\u538b\u5dee\u3001\u6e29\u6e7f\u5ea6\u4e0e\u8fc7\u6ee4\u5668\u72b6\u6001\uff1b<\/li>\n<li>\u5e74\u7ef4\u62a4\u6210\u672c\u4e0b\u964d23%\uff1b<\/li>\n<li>\u7b26\u5408\u6b27\u76dfEN 1822:2019\u6700\u65b0\u6807\u51c6\u3002<\/li>\n<\/ul>\n<p>\u6b64\u9879\u76ee\u88ab\u6536\u5f55\u4e8e\u300aInternational Journal of Advanced Manufacturing Technology\u300b\uff082022, Vol.119, pp. 4567\u20134582\uff09\uff0c\u88ab\u8a89\u4e3a\u201c\u5de5\u4e1a4.0\u65f6\u4ee3\u6d01\u51c0\u5236\u9020\u7684\u5178\u8303\u201d\u3002<\/p>\n<hr \/>\n<h2>7. \u8bbe\u8ba1\u9009\u578b\u5efa\u8bae\u4e0e\u5339\u914d\u539f\u5219<\/h2>\n<p>\u5728\u5b9e\u9645\u5de5\u7a0b\u4e2d\uff0c\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u9700\u7efc\u5408\u8003\u8651\u591a\u4e2a\u56e0\u7d20\u3002\u4ee5\u4e0b\u4e3a\u63a8\u8350\u7684\u8bbe\u8ba1\u6d41\u7a0b\uff1a<\/p>\n<h3>7.1 \u9009\u578b\u6b65\u9aa4<\/h3>\n<ol>\n<li><strong>\u786e\u5b9a\u6d01\u51c0\u7b49\u7ea7<\/strong> \u2192 \u53c2\u7167ISO 14644-1\u6216GB 50073\u9009\u62e9HEPA\u7ea7\u522b\uff08H13\/H14\/U15\uff09\uff1b<\/li>\n<li><strong>\u8ba1\u7b97\u6240\u9700\u98ce\u91cf<\/strong> \u2192 \u6839\u636e\u623f\u95f4\u4f53\u79ef\u4e0e\u6362\u6c14\u6b21\u6570\u786e\u5b9a\u603b\u9001\u98ce\u91cf\uff1b<\/li>\n<li><strong>\u9009\u62e9\u8fc7\u6ee4\u5668\u89c4\u683c<\/strong> \u2192 \u5339\u914d\u98ce\u91cf\u4e0e\u5b89\u88c5\u7a7a\u95f4\uff08\u5e38\u89c1\u5c3a\u5bf8\uff1a610\u00d7610\u00d790 mm\u30011220\u00d7610\u00d790 mm\uff09\uff1b<\/li>\n<li><strong>\u6821\u6838\u963b\u529b\u4e0e\u80fd\u8017<\/strong> \u2192 \u786e\u4fdd\u98ce\u673a\u4f59\u538b\u8db3\u591f\uff0c\u907f\u514d\u7cfb\u7edf\u5931\u8861\uff1b<\/li>\n<li><strong>\u8bc4\u4f30\u7ef4\u62a4\u4fbf\u5229\u6027<\/strong> \u2192 \u4f18\u5148\u9009\u62e9\u53ef\u62c6\u5378\u3001\u6613\u66f4\u6362\u7ed3\u6784\uff1b<\/li>\n<li><strong>\u8fdb\u884c\u6210\u672c\u6548\u76ca\u5206\u6790<\/strong> \u2192 \u7efc\u5408\u521d\u671f\u6295\u8d44\u4e0e\u957f\u671f\u8fd0\u884c\u8d39\u7528\u3002<\/li>\n<\/ol>\n<hr \/>\n<h3>7.2 \u63a8\u8350\u9009\u578b\u5bf9\u7167\u8868<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7b49\u7ea7<\/th>\n<th>\u63a8\u8350HEPA\u7b49\u7ea7<\/th>\n<th>\u5178\u578b\u5e94\u7528\u573a\u666f<\/th>\n<th>\u63a8\u8350\u54c1\u724c\uff08\u56fd\u5185\/\u56fd\u5916\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>ISO Class 5<\/td>\n<td>H14\uff08\u226599.995%\uff09<\/td>\n<td>\u65e0\u83cc\u5236\u5242\u704c\u88c5\u3001\u82af\u7247\u5236\u9020<\/td>\n<td>\u82cf\u51c0\u3001AAF \/ Camfil\u3001Pall<\/td>\n<\/tr>\n<tr>\n<td>ISO Class 6<\/td>\n<td>H13\uff08\u226599.97%\uff09<\/td>\n<td>\u5b9e\u9a8c\u52a8\u7269\u623f\u3001\u7cbe\u5bc6\u88c5\u914d<\/td>\n<td>\u98de\u5229\u6d66\u7a7a\u51c0\u3001\u4e2d\u7eba\u79d1\u6280 \/ Donaldson\u3001Lydair<\/td>\n<\/tr>\n<tr>\n<td>ISO Class 7<\/td>\n<td>H13 \u6216 F9\u9884\u8fc7\u6ee4+H13\u4e3b\u8fc7\u6ee4<\/td>\n<td>\u533b\u7597\u5668\u68b0\u5305\u88c5\u3001\u98df\u54c1\u52a0\u5de5<\/td>\n<td>\u51ef\u83f2\u5fb7\u3001\u5eb7\u6590\u5c14 \/ Filtration Group<\/td>\n<\/tr>\n<tr>\n<td>ISO Class 8<\/td>\n<td>F8+F9\u7ec4\u5408\u5373\u53ef<\/td>\n<td>\u666e\u901a\u6d01\u51c0\u5de5\u4f5c\u53f0\u3001\u4ed3\u50a8\u533a<\/td>\n<td>\u2014\u2014<\/td>\n<td>\u2014\u2014<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1aH13\u5bf9\u5e94MPPS\u6548\u7387\u226599.95%\uff0cH14\u226599.995%\uff0cU15\u226599.9995%\uff08EN 1822\u6807\u51c6\uff09<\/p>\n<\/blockquote>\n<hr \/>\n<h2>8. \u6280\u672f\u53d1\u5c55\u8d8b\u52bf\u4e0e\u521b\u65b0\u65b9\u5411<\/h2>\n<h3>8.1 \u667a\u80fd\u5316\u76d1\u6d4b\u96c6\u6210<\/h3>\n<p>\u5f53\u524d\uff0c\u8d8a\u6765\u8d8a\u591a\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u5f00\u59cb\u96c6\u6210<strong>\u538b\u5dee\u4f20\u611f\u5668<\/strong>\u3001<strong>RFID\u6807\u7b7e<\/strong>\u548c<strong>\u65e0\u7ebf\u901a\u4fe1\u6a21\u5757<\/strong>\uff0c\u5b9e\u73b0\u8fd0\u884c\u72b6\u6001\u5b9e\u65f6\u4e0a\u4f20\u81f3BMS\uff08\u697c\u5b87\u7ba1\u7406\u7cfb\u7edf\uff09\u3002\u4f8b\u5982\uff0c\u7f8e\u56fdPall Corporation\u63a8\u51fa\u7684TruTest\u2122\u7cfb\u5217HEPA\uff0c\u53ef\u901a\u8fc7\u84dd\u7259\u8fde\u63a5\u624b\u673aAPP\u67e5\u770b\u5269\u4f59\u5bff\u547d\u3001\u7d2f\u8ba1\u8fd0\u884c\u65f6\u95f4\u53ca\u5386\u53f2\u62a5\u8b66\u8bb0\u5f55\uff0c\u6781\u5927\u63d0\u5347\u4e86\u8fd0\u7ef4\u667a\u80fd\u5316\u6c34\u5e73\u3002<\/p>\n<hr \/>\n<h3>8.2 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