{"id":17254,"date":"2025-10-13T18:53:02","date_gmt":"2025-10-13T10:53:02","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=17254"},"modified":"2025-10-13T18:53:02","modified_gmt":"2025-10-13T10:53:02","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%e6%97%a0%e8%8f%8c%e7%81%8c%e8%a3%85%e7%ba%bf%e4%b8%ad%e7%9a%84%e5%ae%8c%e6%95%b4%e6%80%a7%e6%b5%8b%e8%af%95","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=17254","title":{"rendered":"\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u65e0\u83cc\u704c\u88c5\u7ebf\u4e2d\u7684\u5b8c\u6574\u6027\u6d4b\u8bd5\u5b9e\u8df5"},"content":{"rendered":"<h1>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u65e0\u83cc\u704c\u88c5\u7ebf\u4e2d\u7684\u5b8c\u6574\u6027\u6d4b\u8bd5\u5b9e\u8df5<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u5c24\u5176\u662f\u65e0\u83cc\u836f\u54c1\u7684\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u73af\u5883\u6d01\u51c0\u5ea6\u76f4\u63a5\u5173\u7cfb\u5230\u4ea7\u54c1\u7684\u8d28\u91cf\u4e0e\u60a3\u8005\u7684\u751f\u547d\u5b89\u5168\u3002\u4e3a\u786e\u4fdd\u65e0\u83cc\u704c\u88c5\u7ebf\u5904\u4e8e\u7b26\u5408GMP\uff08\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff09\u8981\u6c42\u7684\u6d01\u51c0\u73af\u5883\u4e2d\uff0c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter, HEPA Filter\uff09\u4f5c\u4e3a\u5173\u952e\u51c0\u5316\u8bbe\u5907\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u6d01\u51c0\u5ba4\u7684\u9001\u98ce\u7cfb\u7edf\u4e2d\u3002HEPA\u8fc7\u6ee4\u5668\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d0.3\u5fae\u7c73\u4ee5\u4e0a\u7684\u9897\u7c92\u7269\uff0c\u8fc7\u6ee4\u6548\u7387\u901a\u5e38\u8fbe\u523099.97%\u4ee5\u4e0a\uff0c\u662f\u7ef4\u6301A\u7ea7\u6d01\u51c0\u533a\uff08ISO 5\u7ea7\uff09\u73af\u5883\u7684\u6838\u5fc3\u4fdd\u969c\u3002<\/p>\n<p>\u7136\u800c\uff0c\u8fc7\u6ee4\u5668\u5728\u957f\u671f\u8fd0\u884c\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u56e0\u5b89\u88c5\u4e0d\u5f53\u3001\u673a\u68b0\u635f\u4f24\u3001\u8001\u5316\u6216\u5bc6\u5c01\u5931\u6548\u7b49\u539f\u56e0\u5bfc\u81f4\u6027\u80fd\u4e0b\u964d\uff0c\u8fdb\u800c\u5f71\u54cd\u6d01\u51c0\u533a\u7684\u7a7a\u6c14\u8d28\u91cf\u3002\u56e0\u6b64\uff0c\u5bf9\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u8fdb\u884c<strong>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/strong>\uff08Integrity Testing\uff09\uff0c\u6210\u4e3a\u9a8c\u8bc1\u5176\u6301\u7eed\u6709\u6548\u6027\u7684\u5fc5\u8981\u624b\u6bb5\u3002\u672c\u6587\u5c06\u7cfb\u7edf\u9610\u8ff0\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u65e0\u83cc\u704c\u88c5\u7ebf\u4e2d\u7684\u5b8c\u6574\u6027\u6d4b\u8bd5\u5b9e\u8df5\uff0c\u6db5\u76d6\u6d4b\u8bd5\u539f\u7406\u3001\u65b9\u6cd5\u9009\u62e9\u3001\u64cd\u4f5c\u6d41\u7a0b\u3001\u53c2\u6570\u6807\u51c6\u53ca\u56fd\u5185\u5916\u76f8\u5173\u89c4\u8303\u8981\u6c42\uff0c\u5e76\u7ed3\u5408\u5b9e\u9645\u6848\u4f8b\u5206\u6790\u5e38\u89c1\u95ee\u9898\u4e0e\u5e94\u5bf9\u7b56\u7565\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>1.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA Filter\uff09\u662f\u6307\u6309\u7167\u56fd\u9645\u6807\u51c6EN 1822\u6216\u7f8e\u56fd\u519b\u6807MIL-STD-282\u8bbe\u8ba1\u5236\u9020\uff0c\u5bf9\u7c92\u5f84\u22650.3\u03bcm\u7684\u9897\u7c92\u7269\u5177\u6709\u4e0d\u4f4e\u4e8e99.97%\u6355\u96c6\u6548\u7387\u7684\u5e72\u5f0f\u6ee4\u6750\u8fc7\u6ee4\u88c5\u7f6e\u3002\u6839\u636e\u8fc7\u6ee4\u6548\u7387\u548c\u5e94\u7528\u573a\u666f\u7684\u4e0d\u540c\uff0cHEPA\u8fc7\u6ee4\u5668\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5206\u7c7b<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff080.3\u03bcm\uff09<\/th>\n<th>\u5bf9\u5e94\u6807\u51c6<\/th>\n<th>\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H13<\/td>\n<td>\u226599.95%<\/td>\n<td>EN 1822<\/td>\n<td>\u6d01\u51c0\u5ba4\u521d\u6548\u540e\u7aef<\/td>\n<\/tr>\n<tr>\n<td>H14<\/td>\n<td>\u226599.995%<\/td>\n<td>EN 1822<\/td>\n<td>A\/B\u7ea7\u6d01\u51c0\u533a\u4e3b\u8fc7\u6ee4<\/td>\n<\/tr>\n<tr>\n<td>U15<\/td>\n<td>\u226599.9995%<\/td>\n<td>EN 1822<\/td>\n<td>\u9ad8\u98ce\u9669\u65e0\u83cc\u64cd\u4f5c\u533a<\/td>\n<\/tr>\n<tr>\n<td>ULPA\uff08\u8d85\u4f4e\u7a7f\u900f\u7387\uff09<\/td>\n<td>\u226599.999%\uff080.12\u03bcm\uff09<\/td>\n<td>IEST-RP-CC001<\/td>\n<td>\u534a\u5bfc\u4f53\u3001\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5728\u5236\u836f\u884c\u4e1a\uff0c\u5c24\u5176\u662f\u65e0\u83cc\u704c\u88c5\u7ebf\u6240\u5728\u7684A\u7ea7\u6d01\u51c0\u533a\uff0c\u666e\u904d\u91c7\u7528H14\u53ca\u4ee5\u4e0a\u7ea7\u522b\u7684HEPA\u8fc7\u6ee4\u5668\uff0c\u4ee5\u786e\u4fdd\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c61\u67d3\u63a7\u5236\u5728\u53ef\u63a5\u53d7\u6c34\u5e73\u3002<\/p>\n<h3>1.2 \u4e3b\u8981\u7ed3\u6784\u4e0e\u6750\u6599<\/h3>\n<p>\u5178\u578bHEPA\u8fc7\u6ee4\u5668\u7531\u4ee5\u4e0b\u90e8\u5206\u7ec4\u6210\uff1a<\/p>\n<ul>\n<li><strong>\u6ee4\u6599<\/strong>\uff1a\u591a\u91c7\u7528\u73bb\u7483\u7ea4\u7ef4\u6750\u8d28\uff0c\u901a\u8fc7\u968f\u673a\u6392\u5217\u5f62\u6210\u4e09\u7ef4\u7f51\u72b6\u7ed3\u6784\uff0c\u5229\u7528\u62e6\u622a\u3001\u60ef\u6027\u78b0\u649e\u3001\u6269\u6563\u548c\u9759\u7535\u5438\u9644\u7b49\u673a\u5236\u6355\u83b7\u9897\u7c92\u3002<\/li>\n<li><strong>\u5206\u9694\u677f<\/strong>\uff1a\u94dd\u7b94\u6216\u7eb8\u5236\uff0c\u7528\u4e8e\u652f\u6491\u6ee4\u6599\u5e76\u5f62\u6210\u6c14\u6d41\u901a\u9053\u3002<\/li>\n<li><strong>\u8fb9\u6846<\/strong>\uff1a\u91d1\u5c5e\u6216\u5851\u6599\u6750\u8d28\uff0c\u63d0\u4f9b\u7ed3\u6784\u5f3a\u5ea6\u4e0e\u5bc6\u5c01\u9762\u3002<\/li>\n<li><strong>\u5bc6\u5c01\u80f6<\/strong>\uff1a\u805a\u6c28\u916f\u6216\u7845\u916e\u7c7b\uff0c\u786e\u4fdd\u6ee4\u82af\u4e0e\u8fb9\u6846\u4e4b\u95f4\u7684\u6c14\u5bc6\u6027\u3002<\/li>\n<\/ul>\n<h3>1.3 \u5173\u952e\u6027\u80fd\u53c2\u6570<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u5178\u578b\u503c<\/th>\n<th>\u6d4b\u8bd5\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf\uff08m\u00b3\/h\uff09<\/td>\n<td>500\u20132000<\/td>\n<td>ISO 5011<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b\uff08Pa\uff09<\/td>\n<td>180\u2013250<\/td>\n<td>EN 779 \/ ISO 16890<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u8fc7\u6ee4\u6548\u7387\uff080.3\u03bcm\uff09<\/td>\n<td>\u226599.995%\uff08H14\uff09<\/td>\n<td>EN 1822<\/td>\n<\/tr>\n<tr>\n<td>\u6700\u5927\u8010\u538b\u5dee\uff08Pa\uff09<\/td>\n<td>\u2264600<\/td>\n<td>\u5236\u9020\u5546\u89c4\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5bff\u547d\uff08\u5e74\uff09<\/td>\n<td>3\u20135\uff08\u89c6\u73af\u5883\u800c\u5b9a\uff09<\/td>\n<td>GMP\u6307\u5357\u5efa\u8bae<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e8c\u3001\u5b8c\u6574\u6027\u6d4b\u8bd5\u7684\u91cd\u8981\u6027<\/h2>\n<h3>2.1 \u6cd5\u89c4\u4e0e\u6807\u51c6\u8981\u6c42<\/h3>\n<p>\u5168\u7403\u4e3b\u8981\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u5747\u5bf9\u6d01\u51c0\u5ba4HEPA\u7cfb\u7edf\u7684\u5b8c\u6574\u6027\u6d4b\u8bd5\u63d0\u51fa\u660e\u786e\u8981\u6c42\uff1a<\/p>\n<ul>\n<li><strong>\u4e2d\u56fd\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u9644\u5f551<\/strong> \u7b2c\u56db\u5341\u4e09\u6761\u89c4\u5b9a\uff1a\u201c\u6d01\u51c0\u533a\u4f7f\u7528\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e94\u5b9a\u671f\u8fdb\u884c\u68c0\u6f0f\uff0c\u5fc5\u8981\u65f6\u8fdb\u884c\u66f4\u6362\u3002\u201d<\/li>\n<li><strong>\u7f8e\u56fdFDA\u300a\u65e0\u83cc\u5de5\u827a\u6307\u5357\u300b\uff082004\uff09<\/strong> \u660e\u786e\u6307\u51fa\uff1a\u201c\u6240\u6709\u8fdb\u5165\u65e0\u83cc\u64cd\u4f5c\u533a\u7684\u7a7a\u6c14\u5fc5\u987b\u7ecf\u8fc7\u7ecf\u9a8c\u8bc1\u7684HEPA\u8fc7\u6ee4\uff0c\u5e76\u5b9a\u671f\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u3002\u201d<\/li>\n<li><strong>\u6b27\u76dfGMP Annex 1\uff082022\u5e74\u66f4\u65b0\u7248\uff09<\/strong> \u7b2c9.18\u6761\u5f3a\u8c03\uff1a\u201c\u5e94\u5efa\u7acb\u5e76\u6267\u884cHEPA\u8fc7\u6ee4\u5668\u7684\u5b8c\u6574\u6027\u6d4b\u8bd5\u7a0b\u5e8f\uff0c\u6d4b\u8bd5\u9891\u7387\u4e0d\u5f97\u4f4e\u4e8e\u6bcf\u5e74\u4e00\u6b21\uff0c\u9ad8\u98ce\u9669\u533a\u57df\u5e94\u66f4\u9891\u7e41\u3002\u201d<\/li>\n<\/ul>\n<p>\u8fd9\u4e9b\u6cd5\u89c4\u5171\u540c\u6784\u6210\u4e86\u5236\u836f\u4f01\u4e1a\u5b9e\u65bdHEPA\u5b8c\u6574\u6027\u6d4b\u8bd5\u7684\u6cd5\u5f8b\u57fa\u7840\u3002<\/p>\n<h3>2.2 \u98ce\u9669\u9632\u63a7\u610f\u4e49<\/h3>\n<p>\u672a\u901a\u8fc7\u5b8c\u6574\u6027\u6d4b\u8bd5\u7684HEPA\u8fc7\u6ee4\u5668\u53ef\u80fd\u5bfc\u81f4\u4ee5\u4e0b\u98ce\u9669\uff1a<\/p>\n<ul>\n<li>\u5fae\u751f\u7269\u6216\u5fae\u7c92\u7a7f\u900f\uff0c\u6c61\u67d3\u65e0\u83cc\u4ea7\u54c1\uff1b<\/li>\n<li>\u5bfc\u81f4\u65e0\u83cc\u704c\u88c5\u5931\u8d25\uff0c\u5f15\u53d1\u6279\u6b21\u62a5\u5e9f\uff1b<\/li>\n<li>\u589e\u52a0\u65e0\u83cc\u68c0\u67e5\u4e0d\u5408\u683c\u6982\u7387\uff0c\u5f71\u54cd\u4e0a\u5e02\u5ba1\u6279\uff1b<\/li>\n<li>\u89e6\u53d1GMP\u5ba1\u8ba1\u7f3a\u9677\uff0c\u9020\u6210\u505c\u4ea7\u6574\u6539\u3002<\/li>\n<\/ul>\n<p>\u636e\u300a\u4e2d\u56fd\u836f\u4e8b\u300b2021\u5e74\u62a5\u9053\uff0c\u67d0\u5927\u578b\u751f\u7269\u5236\u836f\u4f01\u4e1a\u5728\u5e74\u5ea6\u5ba1\u8ba1\u4e2d\u56e0\u672a\u63d0\u4f9b\u5b8c\u6574\u7684HEPA\u68c0\u6f0f\u8bb0\u5f55\uff0c\u88ab\u5217\u4e3a\u4e25\u91cd\u7f3a\u9677\u9879\uff0c\u76f4\u63a5\u5f71\u54cd\u5176\u65b0\u836f\u7533\u62a5\u8fdb\u7a0b\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u5b8c\u6574\u6027\u6d4b\u8bd5\u65b9\u6cd5<\/h2>\n<p>\u76ee\u524d\u56fd\u9645\u4e0a\u4e3b\u6d41\u7684HEPA\u5b8c\u6574\u6027\u6d4b\u8bd5\u65b9\u6cd5\u5305\u62ec<strong>\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5<\/strong>\u548c<strong>\u6c14\u6eb6\u80f6\u8ba1\u6570\u6cd5<\/strong>\uff08\u5373\u7c92\u5b50\u8ba1\u6570\u6cd5\uff09\uff0c\u5206\u522b\u9002\u7528\u4e8e\u4e0d\u540c\u7b49\u7ea7\u7684\u6d01\u51c0\u73af\u5883\u3002<\/p>\n<h3>3.1 \u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5\uff08Photometer Method\uff09<\/h3>\n<h4>\u539f\u7406<\/h4>\n<p>\u901a\u8fc7\u4e0a\u6e38\u53d1\u751f\u5b9a\u91cf\u6d53\u5ea6\u7684\u6c14\u6eb6\u80f6\uff08\u5e38\u7528DOP\u3001PAO\u6216DEHS\uff09\uff0c\u4f7f\u7528\u5149\u5ea6\u8ba1\u6d4b\u91cf\u4e0a\u4e0b\u6e38\u7684\u5149\u6563\u5c04\u5f3a\u5ea6\uff0c\u8ba1\u7b97\u7a7f\u900f\u7387\uff08Penetration\uff09\uff0c\u5224\u65ad\u662f\u5426\u5b58\u5728\u6cc4\u6f0f\u3002<\/p>\n<h4>\u64cd\u4f5c\u6d41\u7a0b<\/h4>\n<ol>\n<li>\u5728HEPA\u4e0a\u6e38\u6ce8\u5165\u7a33\u5b9a\u6d53\u5ea6\u7684\u6c14\u6eb6\u80f6\uff08\u5982PAO\uff0c\u6d53\u5ea6\u226520\u03bcg\/L\uff09\uff1b<\/li>\n<li>\u4f7f\u7528\u5149\u5ea6\u8ba1\u63a2\u5934\u5728\u4e0b\u6e38\u8ddd\u8fc7\u6ee4\u5668\u8868\u97622\u20135cm\u5904\u4ee5\u22645cm\/s\u901f\u5ea6\u626b\u63cf\uff1b<\/li>\n<li>\u8bb0\u5f55\u6700\u5927\u7a7f\u900f\u7387\uff0c\u82e5\u8d85\u8fc70.01%\uff0c\u5219\u5224\u5b9a\u4e3a\u6cc4\u6f0f\u3002<\/li>\n<\/ol>\n<h4>\u9002\u7528\u8303\u56f4<\/h4>\n<ul>\n<li>\u9002\u7528\u4e8eH13\u7ea7\u8fc7\u6ee4\u5668\uff1b<\/li>\n<li>\u6210\u672c\u8f83\u4f4e\uff0c\u64cd\u4f5c\u7b80\u4fbf\uff1b<\/li>\n<li>\u4e0d\u9002\u7528\u4e8e\u9ad8\u6d01\u51c0\u5ea6\u533a\u57df\uff08\u5982A\u7ea7\u533a\uff09\u7684\u6700\u7ec8\u9a8c\u8bc1\u3002<\/li>\n<\/ul>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u6807\u51c6\u503c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u4e0a\u6e38\u6c14\u6eb6\u80f6\u6d53\u5ea6<\/td>\n<td>\u226520 \u03bcg\/L\uff08PAO\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u901f\u5ea6<\/td>\n<td>\u22645 cm\/s<\/td>\n<\/tr>\n<tr>\n<td>\u63a5\u53d7\u6807\u51c6\uff08\u7a7f\u900f\u7387\uff09<\/td>\n<td>\u22640.01%<\/td>\n<\/tr>\n<tr>\n<td>\u63a2\u5934\u5c3a\u5bf8<\/td>\n<td>1 in\u00b2\uff08\u7ea66.5 cm\u00b2\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u8be5\u65b9\u6cd5\u4f9d\u636eISO 14644-3:2019\u4e2dMAC\uff08Maximum Allowable Concentration\uff09\u539f\u5219\u8bbe\u5b9a\u9650\u503c\u3002<\/p>\n<\/blockquote>\n<h3>3.2 \u6c14\u6eb6\u80f6\u8ba1\u6570\u6cd5\uff08Particle Counting Method\uff09<\/h3>\n<h4>\u539f\u7406<\/h4>\n<p>\u5229\u7528\u7c92\u5b50\u8ba1\u6570\u5668\u6d4b\u91cf\u4e0a\u6e38\u548c\u4e0b\u6e38\u7279\u5b9a\u7c92\u5f84\uff08\u901a\u5e38\u4e3a0.3\u03bcm\u62160.5\u03bcm\uff09\u7684\u7c92\u5b50\u6d53\u5ea6\uff0c\u8ba1\u7b97\u8fc7\u6ee4\u5668\u7684<strong>\u603b\u7a7f\u900f\u7387<\/strong>\uff08Overall Penetration\uff09\u6216<strong>\u5c40\u90e8\u7a7f\u900f\u7387<\/strong>\uff08Local Penetration\uff09\u3002<\/p>\n<h4>\u64cd\u4f5c\u6d41\u7a0b<\/h4>\n<ol>\n<li>\u4e0a\u6e38\u53d1\u751f\u5355\u5206\u6563\u6216\u591a\u5206\u6563\u6c14\u6eb6\u80f6\uff08\u5982PSL\u4e73\u80f6\u7403\u6216DOS\uff09\uff1b<\/li>\n<li>\u4f7f\u7528\u591a\u901a\u9053\u7c92\u5b50\u8ba1\u6570\u5668\u540c\u6b65\u91c7\u96c6\u4e0a\u4e0b\u6e38\u6570\u636e\uff1b<\/li>\n<li>\u8ba1\u7b97\u7a7f\u900f\u7387\uff1a<br \/>\n$$<br \/>\ntext{Penetration (%)} = frac{C<em>{text{downstream}}}{C<\/em>{text{upstream}}} times 100%<br \/>\n$$<\/li>\n<li>\u82e5\u603b\u7a7f\u900f\u7387\u8d85\u8fc70.005%\uff0c\u6216\u5c40\u90e8\u8bfb\u6570\u8d85\u8fc7\u80cc\u666f\u503c10\u500d\uff0c\u5219\u5224\u5b9a\u4e3a\u6cc4\u6f0f\u3002<\/li>\n<\/ol>\n<h4>\u4f18\u52bf\u4e0e\u5c40\u9650<\/h4>\n<ul>\n<li>\u7075\u654f\u5ea6\u9ad8\uff0c\u53ef\u8fbe0.001%\u7ea7\u522b\uff1b<\/li>\n<li>\u9002\u7528\u4e8eU15\u3001ULPA\u7b49\u8d85\u9ad8\u6548\u7387\u8fc7\u6ee4\u5668\uff1b<\/li>\n<li>\u8bbe\u5907\u6602\u8d35\uff0c\u9700\u4e13\u4e1a\u4eba\u5458\u64cd\u4f5c\uff1b<\/li>\n<li>\u6570\u636e\u5904\u7406\u590d\u6742\uff0c\u9700\u914d\u5408\u8f6f\u4ef6\u5206\u6790\u3002<\/li>\n<\/ul>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u6807\u51c6\u503c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u4e0a\u6e38\u7c92\u5b50\u6d53\u5ea6<\/td>\n<td>\u226510\u2075 particles\/ft\u00b3\uff080.3\u03bcm\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u6d4b\u91cf\u7c92\u5f84<\/td>\n<td>0.3 \u03bcm \u6216 MPPS\uff08\u6700\u6613\u7a7f\u900f\u7c92\u5f84\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u63a5\u53d7\u6807\u51c6\uff08\u603b\u7a7f\u900f\u7387\uff09<\/td>\n<td>\u22640.005%\uff08H14\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u91c7\u6837\u6d41\u91cf<\/td>\n<td>28.3 L\/min\uff081 cfm\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u8986\u76d6\u7387<\/td>\n<td>\u2265100%\u6ee4\u9762<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u53c2\u8003\u6587\u732e\uff1aIEST-RP-CC034.3\u300aHEPA and ULPA Filter Leak Testing\u300b\u8be6\u7ec6\u89c4\u5b9a\u4e86\u8be5\u65b9\u6cd5\u7684\u64cd\u4f5c\u7ec6\u8282\u3002<\/p>\n<\/blockquote>\n<h3>3.3 \u4e24\u79cd\u65b9\u6cd5\u5bf9\u6bd4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u5149\u5ea6\u8ba1\u6cd5<\/th>\n<th>\u8ba1\u6570\u6cd5<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u7075\u654f\u5ea6<\/td>\n<td>\u4e2d\u7b49\uff080.01%\uff09<\/td>\n<td>\u9ad8\uff080.001%\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u6210\u672c<\/td>\n<td>\u8f83\u4f4e<\/td>\n<td>\u9ad8<\/td>\n<\/tr>\n<tr>\n<td>\u64cd\u4f5c\u96be\u5ea6<\/td>\n<td>\u7b80\u5355<\/td>\n<td>\u590d\u6742<\/td>\n<\/tr>\n<tr>\n<td>\u9002\u7528\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/td>\n<td>H13-H14<\/td>\n<td>H14-U15, ULPA<\/td>\n<\/tr>\n<tr>\n<td>\u662f\u5426\u9002\u5408A\u7ea7\u533a\u9a8c\u8bc1<\/td>\n<td>\u6709\u9650<\/td>\n<td>\u63a8\u8350<\/td>\n<\/tr>\n<tr>\n<td>\u6570\u636e\u8f93\u51fa\u5f62\u5f0f<\/td>\n<td>\u6a21\u62df\u4fe1\u53f7\/\u767e\u5206\u6bd4<\/td>\n<td>\u6570\u5b57\u5316\u7c92\u5b50\u6d53\u5ea6<\/td>\n<\/tr>\n<tr>\n<td>\u56fd\u9645\u8ba4\u53ef\u5ea6<\/td>\n<td>\u5e7f\u6cdb<\/td>\n<td>\u9ad8\u7aef\u5e94\u7528\u9996\u9009<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u56db\u3001\u6d4b\u8bd5\u5b9e\u65bd\u6d41\u7a0b\u4e0e\u6ce8\u610f\u4e8b\u9879<\/h2>\n<h3>4.1 \u6d4b\u8bd5\u524d\u51c6\u5907<\/h3>\n<ol>\n<li><strong>\u7cfb\u7edf\u505c\u673a\u4e0e\u9694\u79bb<\/strong>\uff1a\u5173\u95ed\u704c\u88c5\u7ebf\u8bbe\u5907\uff0c\u5207\u65ad\u98ce\u673a\u7535\u6e90\uff0c\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\u3002<\/li>\n<li><strong>\u4e0a\u6e38\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u5b89\u88c5<\/strong>\uff1a\u5c06PAO\u53d1\u751f\u5668\u63a5\u5165\u9001\u98ce\u7ba1\u9053\u4e0a\u6e38\uff0c\u786e\u4fdd\u6c14\u6eb6\u80f6\u5747\u5300\u5206\u5e03\u3002<\/li>\n<li><strong>\u4e0b\u6e38\u68c0\u6d4b\u4eea\u5668\u6821\u51c6<\/strong>\uff1a\u7c92\u5b50\u8ba1\u6570\u5668\u6216\u5149\u5ea6\u8ba1\u9700\u5728\u6709\u6548\u6821\u51c6\u671f\u5185\uff0c\u4f7f\u7528\u6807\u51c6\u7c92\u5b50\u6e90\u9a8c\u8bc1\u54cd\u5e94\u51c6\u786e\u6027\u3002<\/li>\n<li><strong>\u73af\u5883\u6761\u4ef6\u786e\u8ba4<\/strong>\uff1a\u6d01\u51c0\u5ba4\u6e29\u5ea6\uff0818\u201326\u2103\uff09\u3001\u6e7f\u5ea6\uff0845\u201365%RH\uff09\u3001\u538b\u5dee\u6b63\u5e38\uff0c\u907f\u514d\u5e72\u6270\u6d4b\u8bd5\u7ed3\u679c\u3002<\/li>\n<\/ol>\n<h3>4.2 \u6d4b\u8bd5\u8fc7\u7a0b\u63a7\u5236<\/h3>\n<ul>\n<li><strong>\u4e0a\u6e38\u6d53\u5ea6\u7a33\u5b9a\u6027\u76d1\u6d4b<\/strong>\uff1a\u8fde\u7eed\u76d1\u6d4b\u81f3\u5c115\u5206\u949f\uff0c\u6ce2\u52a8\u4e0d\u8d85\u8fc7\u00b115%\u3002<\/li>\n<li><strong>\u626b\u63cf\u8def\u5f84\u89c4\u5212<\/strong>\uff1a\u91c7\u7528\u201c\u4e4b\u201d\u5b57\u5f62\u6216\u7f51\u683c\u72b6\u8def\u5f84\uff0c\u8986\u76d6\u6574\u4e2a\u8fc7\u6ee4\u5668\u8868\u9762\u53ca\u8fb9\u6846\u3001\u63a5\u7f1d\u533a\u57df\u3002<\/li>\n<li><strong>\u9a7b\u7559\u65f6\u95f4<\/strong>\uff1a\u6bcf\u70b9\u505c\u7559\u65f6\u95f4\u4e0d\u5c11\u4e8e1\u79d2\uff0c\u786e\u4fdd\u6570\u636e\u4ee3\u8868\u6027\u3002<\/li>\n<li><strong>\u5f02\u5e38\u70b9\u590d\u6d4b<\/strong>\uff1a\u53d1\u73b0\u6cc4\u6f0f\u70b9\u540e\uff0c\u7f29\u5c0f\u63a2\u5934\u8ddd\u79bb\u81f31cm\uff0c\u786e\u8ba4\u662f\u5426\u4e3a\u771f\u5b9e\u6cc4\u6f0f\u3002<\/li>\n<\/ul>\n<h3>4.3 \u7ed3\u679c\u5224\u5b9a\u4e0e\u5904\u7406<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bd5\u7ed3\u679c<\/th>\n<th>\u5224\u5b9a<\/th>\n<th>\u5904\u7406\u63aa\u65bd<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u7a7f\u900f\u7387 &lt; \u63a5\u53d7\u6807\u51c6<\/td>\n<td>\u5408\u683c<\/td>\n<td>\u8bb0\u5f55\u5f52\u6863\uff0c\u7ee7\u7eed\u4f7f\u7528<\/td>\n<\/tr>\n<tr>\n<td>\u5c40\u90e8\u6cc4\u6f0f\u4f46\u603b\u9762\u79ef &lt; 0.005%<\/td>\n<td>\u53ef\u4fee\u590d<\/td>\n<td>\u4f7f\u7528\u7845\u80f6\u5bc6\u5c01\uff0c\u91cd\u65b0\u6d4b\u8bd5<\/td>\n<\/tr>\n<tr>\n<td>\u591a\u70b9\u6cc4\u6f0f\u6216\u603b\u7a7f\u900f\u8d85\u6807<\/td>\n<td>\u4e0d\u5408\u683c<\/td>\n<td>\u66f4\u6362\u8fc7\u6ee4\u5668\uff0c\u8c03\u67e5\u6839\u672c\u539f\u56e0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u5b9e\u8df5\u6848\u4f8b\uff1a\u67d0\u75ab\u82d7\u751f\u4ea7\u4f01\u4e1a\u5728\u5e74\u5ea6HEPA\u6d4b\u8bd5\u4e2d\u53d1\u73b0\u4e00\u5904\u8fb9\u6846\u5bc6\u5c01\u5f00\u88c2\uff0c\u7ecf\u7845\u80f6\u4fee\u8865\u540e\u590d\u6d4b\u5408\u683c\uff0c\u907f\u514d\u4e86\u6574\u7bb1\u66f4\u6362\u6210\u672c\u903e\u4e07\u5143\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e94\u3001\u6d4b\u8bd5\u9891\u7387\u4e0e\u5468\u671f\u7ba1\u7406<\/h2>\n<p>\u6839\u636eEU GMP Annex 1\u53caASME BPE\u6807\u51c6\uff0c\u5236\u836f\u4f01\u4e1a\u5e94\u5efa\u7acb\u57fa\u4e8e\u98ce\u9669\u7684\u6d4b\u8bd5\u5468\u671f\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u533a\u57df\u7b49\u7ea7<\/th>\n<th>\u6d4b\u8bd5\u9891\u7387<\/th>\n<th>\u7279\u6b8a\u60c5\u51b5<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7\uff08\u65e0\u83cc\u704c\u88c5\u533a\uff09<\/td>\n<td>\u6bcf6\u4e2a\u6708<\/td>\n<td>\u6bcf\u6b21\u91cd\u5927\u7ef4\u4fee\u540e<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7\uff08\u80cc\u666f\u533a\uff09<\/td>\n<td>\u6bcf\u5e74<\/td>\n<td>\u65b0\u5b89\u88c5\u6216\u66f4\u6362\u540e<\/td>\n<\/tr>\n<tr>\n<td>C\/D\u7ea7<\/td>\n<td>\u6bcf2\u5e74<\/td>\n<td>\u521d\u6b21\u5b89\u88c5\u65f6\u5fc5\u6d4b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u6b64\u5916\uff0c\u4ee5\u4e0b\u60c5\u5f62\u4e5f\u9700\u89e6\u53d1\u989d\u5916\u6d4b\u8bd5\uff1a<\/p>\n<ul>\n<li>\u8fc7\u6ee4\u5668\u66f4\u6362\u6216\u91cd\u65b0\u5b89\u88c5\uff1b<\/li>\n<li>\u6d01\u51c0\u5ba4\u7ed3\u6784\u6539\u9020\uff1b<\/li>\n<li>\u53d1\u751f\u538b\u5dee\u5f02\u5e38\u62a5\u8b66\uff1b<\/li>\n<li>\u65e0\u83cc\u5de5\u827a\u5931\u8d25\u4e14\u6000\u7591\u73af\u5883\u56e0\u7d20\u3002<\/li>\n<\/ul>\n<hr 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