{"id":17015,"date":"2025-09-26T11:11:27","date_gmt":"2025-09-26T03:11:27","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=17015"},"modified":"2025-09-26T11:11:27","modified_gmt":"2025-09-26T03:11:27","slug":"%e8%b6%85%e5%87%80%e5%8f%b0%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e5%ae%8c%e6%95%b4%e6%80%a7%e6%b5%8b%e8%af%95%ef%bc%88dop-pao%ef%bc%89%e6%96%b9%e6%b3%95%e8%af%a6%e8%a7%a3","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=17015","title":{"rendered":"\u8d85\u51c0\u53f0\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08DOP\/PAO\uff09\u65b9\u6cd5\u8be6\u89e3"},"content":{"rendered":"<h1>\u8d85\u51c0\u53f0\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08DOP\/PAO\uff09\u65b9\u6cd5\u8be6\u89e3<\/h1>\n<h2>\u6982\u8ff0<\/h2>\n<p>\u8d85\u51c0\u5de5\u4f5c\u53f0\uff08Laminar Flow Cabinet\uff09\u662f\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\u3001\u5236\u836f\u4f01\u4e1a\u3001\u533b\u9662\u6d01\u51c0\u624b\u672f\u5ba4\u3001\u7535\u5b50\u5236\u9020\u8f66\u95f4\u7b49\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8981\u6c42\u6781\u9ad8\u7684\u573a\u6240\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u6838\u5fc3\u8bbe\u5907\u3002\u5176\u6838\u5fc3\u529f\u80fd\u4f9d\u8d56\u4e8e\u9ad8\u6548\u9897\u7c92\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\uff0c\u8be5\u8fc7\u6ee4\u5668\u80fd\u591f\u53bb\u9664\u7a7a\u6c14\u4e2d\u22650.3\u5fae\u7c73\u7684\u9897\u7c92\u7269\uff0c\u6548\u7387\u9ad8\u8fbe99.97%\u4ee5\u4e0a\u3002\u4e3a\u786e\u4fddHEPA\u8fc7\u6ee4\u5668\u5728\u957f\u671f\u8fd0\u884c\u8fc7\u7a0b\u4e2d\u4fdd\u6301\u6027\u80fd\u7a33\u5b9a\uff0c\u9632\u6b62\u56e0\u6cc4\u6f0f\u5bfc\u81f4\u6d01\u51c0\u73af\u5883\u5931\u6548\uff0c\u5fc5\u987b\u5b9a\u671f\u8fdb\u884c<strong>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/strong>\u3002<\/p>\n<p>\u76ee\u524d\u56fd\u9645\u901a\u884c\u7684\u5b8c\u6574\u6027\u6d4b\u8bd5\u65b9\u6cd5\u4e3b\u8981\u91c7\u7528<strong>\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5<\/strong>\uff0c\u901a\u8fc7\u5411\u8fc7\u6ee4\u5668\u4e0a\u6e38\u5f15\u5165\u7279\u5b9a\u7c92\u5f84\u7684\u5355\u5206\u6563\u6c14\u6eb6\u80f6\uff08\u5982DOP\u6216PAO\uff09\uff0c\u5229\u7528\u5149\u6563\u5c04\u539f\u7406\u68c0\u6d4b\u4e0b\u6e38\u662f\u5426\u5b58\u5728\u6cc4\u6f0f\u3002\u8be5\u65b9\u6cd5\u88ab\u7f8e\u56fd\u8054\u90a6\u6807\u51c6FS-209E\u3001ISO 14644\u7cfb\u5217\u6807\u51c6\u3001\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6GB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u4ee5\u53caGMP\uff08\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff09\u5e7f\u6cdb\u91c7\u7eb3\u3002<\/p>\n<p>\u672c\u6587\u5c06\u7cfb\u7edf\u9610\u8ff0DOP\/PAO\u6d4b\u8bd5\u7684\u539f\u7406\u3001\u8bbe\u5907\u6784\u6210\u3001\u64cd\u4f5c\u6d41\u7a0b\u3001\u5224\u5b9a\u6807\u51c6\u3001\u5e38\u89c1\u95ee\u9898\u53ca\u56fd\u5185\u5916\u6743\u5a01\u6587\u732e\u652f\u6301\uff0c\u8f85\u4ee5\u8be6\u7ec6\u53c2\u6570\u8868\u683c\uff0c\u5168\u9762\u89e3\u6790\u8d85\u51c0\u53f0\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\u7684\u6280\u672f\u8981\u70b9\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001DOP\u4e0ePAO\u6c14\u6eb6\u80f6\u7b80\u4ecb<\/h2>\n<h3>1. DOP\uff08\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f\uff09<\/h3>\n<p>DOP\uff08Di-Octyl Phthalate\uff09\u662f\u4e00\u79cd\u6709\u673a\u5316\u5408\u7269\uff0c\u5316\u5b66\u5f0f\u4e3aC\u2082\u2084H\u2083\u2088O\u2084\uff0c\u5e38\u6e29\u4e0b\u4e3a\u65e0\u8272\u81f3\u6de1\u9ec4\u8272\u6cb9\u72b6\u6db2\u4f53\uff0c\u5177\u6709\u4f4e\u6325\u53d1\u6027\u3001\u9ad8\u70ed\u7a33\u5b9a\u6027\uff0c\u66fe\u957f\u671f\u4f5c\u4e3aHEPA\u8fc7\u6ee4\u5668\u6d4b\u8bd5\u7684\u6807\u51c6\u6c14\u6eb6\u80f6\u6e90\u3002\u5176\u7c92\u5f84\u5206\u5e03\u96c6\u4e2d\u57280.3\u03bcm\u5de6\u53f3\uff0c\u63a5\u8fd1HEPA\u8fc7\u6ee4\u5668\u6700\u6613\u7a7f\u900f\u7c92\u5f84\uff08Most Penetrating Particle Size, MPPS\uff09\uff0c\u56e0\u6b64\u80fd\u6709\u6548\u68c0\u9a8c\u8fc7\u6ee4\u5668\u7684\u5b9e\u9645\u62e6\u622a\u80fd\u529b\u3002<\/p>\n<blockquote>\n<p><strong>\u6ce8\u610f<\/strong>\uff1a\u7531\u4e8eDOP\u88ab\u6000\u7591\u5177\u6709\u5185\u5206\u6ccc\u5e72\u6270\u4f5c\u7528\uff0c\u6b27\u76dfREACH\u6cd5\u89c4\u5df2\u9650\u5236\u5176\u4f7f\u7528\u3002\u76ee\u524d\u6b27\u7f8e\u56fd\u5bb6\u666e\u904d\u6539\u7528\u66f4\u73af\u4fdd\u7684\u66ff\u4ee3\u7269PAO\u3002<\/p>\n<\/blockquote>\n<h3>2. PAO\uff08\u805a\u03b1\u70ef\u70c3\uff09<\/h3>\n<p>PAO\uff08Polyalphaolefin\uff09\u662f\u4e00\u7c7b\u5408\u6210\u70c3\u7c7b\u6db2\u4f53\uff0c\u5178\u578b\u4ee3\u8868\u4e3aDEHS\uff08Di-Ethylhexyl Sebacate\uff0c\u7678\u4e8c\u9178\u4e8c\u4e59\u57fa\u5df1\u916f\uff09\u6216\u77ff\u7269\u6cb9\u884d\u751f\u7269\u3002PAO\u6c14\u6eb6\u80f6\u5177\u6709\u4e0eDOP\u76f8\u4f3c\u7684\u7269\u7406\u7279\u6027\uff08\u5982\u7c92\u5f84\u5206\u5e03\u3001\u6325\u53d1\u6027\u4f4e\uff09\uff0c\u4f46\u6bd2\u6027\u66f4\u4f4e\uff0c\u7b26\u5408\u73b0\u4ee3\u73af\u4fdd\u548c\u804c\u4e1a\u5065\u5eb7\u8981\u6c42\u3002\u7f8e\u56fdIEST-RP-CC001.5\u300aHEPA and ULPA Filter Tests\u300b\u660e\u786e\u63a8\u8350\u4f7f\u7528PAO\u7c7b\u7269\u8d28\u4f5c\u4e3a\u6d4b\u8bd5\u6c14\u6eb6\u80f6\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>DOP<\/th>\n<th>PAO\uff08\u4ee5DEHS\u4e3a\u4f8b\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5316\u5b66\u540d\u79f0<\/td>\n<td>\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f<\/td>\n<td>\u7678\u4e8c\u9178\u4e8c\u4e59\u57fa\u5df1\u916f<\/td>\n<\/tr>\n<tr>\n<td>\u5206\u5b50\u5f0f<\/td>\n<td>C\u2082\u2084H\u2083\u2088O\u2084<\/td>\n<td>C\u2082\u2082H\u2084\u2082O\u2084<\/td>\n<\/tr>\n<tr>\n<td>\u6cb8\u70b9\uff08\u2103\uff09<\/td>\n<td>\u2248385<\/td>\n<td>\u2248275\uff08\u5206\u89e3\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u84b8\u6c14\u538b\uff0825\u2103, Pa\uff09<\/td>\n<td>&lt;0.1<\/td>\n<td>&lt;0.01<\/td>\n<\/tr>\n<tr>\n<td>MPPS\uff08\u6700\u6613\u7a7f\u900f\u7c92\u5f84\uff09<\/td>\n<td>\u22480.3 \u03bcm<\/td>\n<td>\u22480.3 \u03bcm<\/td>\n<\/tr>\n<tr>\n<td>\u6bd2\u6027\u7b49\u7ea7<\/td>\n<td>\u4e2d\u7b49\uff08\u6f5c\u5728\u751f\u6b96\u6bd2\u6027\uff09<\/td>\n<td>\u4f4e\uff08LD\u2085\u2080 &gt; 5000 mg\/kg\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u662f\u5426\u53ef\u751f\u7269\u964d\u89e3<\/td>\n<td>\u5426<\/td>\n<td>\u90e8\u5206\u53ef\u964d\u89e3<\/td>\n<\/tr>\n<tr>\n<td>\u56fd\u9645\u63a8\u8350\u4f7f\u7528\u60c5\u51b5<\/td>\n<td>\u5df2\u9010\u6b65\u6dd8\u6c70<\/td>\n<td>\u5e7f\u6cdb\u63a8\u8350\uff08IEST\u3001ISO\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em>\u6570\u636e\u6765\u6e90\uff1aIEST-RP-CC001.5 (2021), ISO 14644-3:2019, OSHA Chemical Database<\/em><\/p>\n<hr \/>\n<h2>\u4e8c\u3001\u6d4b\u8bd5\u539f\u7406<\/h2>\n<p>DOP\/PAO\u5b8c\u6574\u6027\u6d4b\u8bd5\u57fa\u4e8e\u201c\u4e0a\u6e38\u53d1\u5c18\u2014\u4e0b\u6e38\u91c7\u6837\u2014\u5149\u5ea6\u8ba1\u68c0\u6d4b\u201d\u7684\u57fa\u672c\u539f\u7406\uff1a<\/p>\n<ol>\n<li>\u5728HEPA\u8fc7\u6ee4\u5668\u4e0a\u6e38\u4fa7\uff0c\u4f7f\u7528\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u4ea7\u751f\u6d53\u5ea6\u7a33\u5b9a\u7684\u5355\u5206\u6563\u6c14\u6eb6\u80f6\uff08\u901a\u5e38\u63a7\u5236\u572810\u2013100 \u03bcg\/L\uff09\uff1b<\/li>\n<li>\u5229\u7528\u5149\u5ea6\u8ba1\uff08Photometer\uff09\u5728\u8fc7\u6ee4\u5668\u4e0b\u6e38\u4fa7\u4ee5\u6052\u5b9a\u901f\u5ea6\u626b\u63cf\u6574\u4e2a\u6ee4\u6750\u8868\u9762\u53ca\u8fb9\u6846\u5bc6\u5c01\u533a\u57df\uff1b<\/li>\n<li>\u5149\u5ea6\u8ba1\u901a\u8fc7\u6fc0\u5149\u6563\u5c04\u6280\u672f\u6d4b\u91cf\u7a7a\u6c14\u4e2d\u7c92\u5b50\u7684\u76f8\u5bf9\u5149\u5f3a\uff0c\u8ba1\u7b97\u51fa\u7a7f\u900f\u7387\uff1b<\/li>\n<li>\u82e5\u67d0\u70b9\u68c0\u6d4b\u503c\u8d85\u8fc7\u9884\u8bbe\u9608\u503c\uff08\u901a\u5e38\u4e3a0.01%\uff09\uff0c\u5219\u5224\u5b9a\u4e3a\u6cc4\u6f0f\u70b9\u3002<\/li>\n<\/ol>\n<p>\u6839\u636eISO 14644-3:2019\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883 \u7b2c3\u90e8\u5206\uff1a\u6d4b\u8bd5\u65b9\u6cd5\u300b\uff0c\u5b8c\u6574\u6027\u6d4b\u8bd5\u5c5e\u4e8e\u201c\u975e\u6d3b\u6027\u7c92\u5b50\u6d53\u5ea6\u6d4b\u8bd5\u201d\u4e2d\u7684\u5173\u952e\u9879\u76ee\uff0c\u9002\u7528\u4e8eISO Class 5\u53ca\u4ee5\u4e0a\u7ea7\u522b\u6d01\u51c0\u533a\u7684HEPA\u7cfb\u7edf\u9a8c\u8bc1\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u6d4b\u8bd5\u8bbe\u5907\u4e0e\u4eea\u5668\u53c2\u6570<\/h2>\n<h3>1. \u4e3b\u8981\u8bbe\u5907\u7ec4\u6210<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u8bbe\u5907\u540d\u79f0<\/th>\n<th>\u529f\u80fd\u8bf4\u660e<\/th>\n<th>\u5178\u578b\u578b\u53f7\u793a\u4f8b<\/th>\n<th>\u5173\u952e\u53c2\u6570<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6c14\u6eb6\u80f6\u53d1\u751f\u5668<\/td>\n<td>\u751f\u6210\u7a33\u5b9a\u6d53\u5ea6\u7684DOP\/PAO\u6c14\u6eb6\u80f6<\/td>\n<td>TSI Model 8008, ATI PortaCount Pro+<\/td>\n<td>\u8f93\u51fa\u7c92\u5f84\uff1a0.3\u00b10.05 \u03bcm\uff1b\u6d53\u5ea6\u53ef\u8c03\uff0810\u2013100 \u03bcg\/L\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u5149\u5ea6\u8ba1\uff08Aerosol Photometer\uff09<\/td>\n<td>\u6d4b\u91cf\u4e0b\u6e38\u6c14\u6eb6\u80f6\u6d53\u5ea6<\/td>\n<td>TSI Model 8160, Camfil FM-700<\/td>\n<td>\u68c0\u6d4b\u8303\u56f4\uff1a0.0001\u2013100 \u03bcg\/L\uff1b\u7cbe\u5ea6\u00b13%<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u63a2\u5934\uff08Sampling Probe\uff09<\/td>\n<td>\u5c40\u90e8\u91c7\u6837\uff0c\u914d\u5408\u624b\u52a8\u6216\u81ea\u52a8\u626b\u63cf\u67b6<\/td>\n<td>\u6807\u51c61 cm\u00b2\u5f00\u53e3\u5706\u5f62\u63a2\u5934<\/td>\n<td>\u91c7\u6837\u6d41\u91cf\uff1a28.3 L\/min\uff081 ft\u00b3\/min\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u7a7a\u6c14\u538b\u7f29\u673a<\/td>\n<td>\u4e3a\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u63d0\u4f9b\u6d01\u51c0\u538b\u7f29\u7a7a\u6c14<\/td>\n<td>\u5e26\u6cb9\u6c34\u5206\u79bb\u5668\u7684\u65e0\u6cb9\u7a7a\u538b\u673a<\/td>\n<td>\u538b\u529b\uff1a0.2\u20130.6 MPa\uff1b\u6d41\u91cf\u226550 L\/min<\/td>\n<\/tr>\n<tr>\n<td>\u6d41\u91cf\u8ba1<\/td>\n<td>\u6821\u51c6\u91c7\u6837\u6d41\u91cf<\/td>\n<td>\u8f6c\u5b50\u6d41\u91cf\u8ba1\u6216\u6570\u5b57\u5f0f\u8d28\u91cf\u6d41\u91cf\u8ba1<\/td>\n<td>\u91cf\u7a0b\uff1a0\u201350 L\/min\uff0c\u7cbe\u5ea6\u00b11%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em>\u53c2\u8003\u6587\u732e\uff1aIEST-RP-CC001.5 (2021) \u201cHEPA and ULPA Filter Tests\u201d<\/em><\/p>\n<h3>2. \u8bbe\u5907\u6821\u51c6\u8981\u6c42<\/h3>\n<p>\u6240\u6709\u6d4b\u8bd5\u4eea\u5668\u987b\u5b9a\u671f\u6821\u51c6\uff0c\u786e\u4fdd\u6570\u636e\u53ef\u9760\u6027\u3002\u4f9d\u636eNIST\uff08\u7f8e\u56fd\u56fd\u5bb6\u6807\u51c6\u4e0e\u6280\u672f\u7814\u7a76\u9662\uff09\u6eaf\u6e90\u6807\u51c6\uff0c\u4e3b\u8981\u6821\u51c6\u9879\u76ee\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u4eea\u5668<\/th>\n<th>\u6821\u51c6\u5468\u671f<\/th>\n<th>\u6821\u51c6\u5185\u5bb9<\/th>\n<th>\u6807\u51c6\u4f9d\u636e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5149\u5ea6\u8ba1<\/td>\n<td>\u6bcf\u5e74\u4e00\u6b21<\/td>\n<td>\u96f6\u70b9\u6f02\u79fb\u3001\u6ee1\u91cf\u7a0b\u54cd\u5e94\u3001\u7ebf\u6027\u5ea6<\/td>\n<td>ASTM F318-06(2019)<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u6eb6\u80f6\u53d1\u751f\u5668<\/td>\n<td>\u6bcf6\u4e2a\u6708<\/td>\n<td>\u7c92\u5f84\u5206\u5e03\u3001\u8f93\u51fa\u6d53\u5ea6\u7a33\u5b9a\u6027<\/td>\n<td>ISO 27971:2016<\/td>\n<\/tr>\n<tr>\n<td>\u6d41\u91cf\u8ba1<\/td>\n<td>\u6bcf6\u4e2a\u6708<\/td>\n<td>\u5b9e\u9645\u91c7\u6837\u6d41\u91cf\u6821\u6b63<\/td>\n<td>ISO 14644-3:2019 Annex B<\/td>\n<\/tr>\n<tr>\n<td>\u63a2\u5934<\/td>\n<td>\u6bcf\u6b21\u4f7f\u7528\u524d<\/td>\n<td>\u68c0\u67e5\u5835\u585e\u3001\u53d8\u5f62<\/td>\n<td>\u7528\u6237\u624b\u518c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u56db\u3001\u6d4b\u8bd5\u64cd\u4f5c\u6d41\u7a0b<\/h2>\n<h3>1. \u6d4b\u8bd5\u524d\u51c6\u5907<\/h3>\n<ul>\n<li><strong>\u5173\u95ed\u8d85\u51c0\u53f0\u98ce\u673a<\/strong>\uff0c\u786e\u8ba4\u8bbe\u5907\u5904\u4e8e\u65ad\u7535\u72b6\u6001\uff1b<\/li>\n<li>\u6e05\u6d01\u8fc7\u6ee4\u5668\u8868\u9762\u53ca\u5468\u8fb9\u7ed3\u6784\uff0c\u907f\u514d\u7070\u5c18\u5e72\u6270\uff1b<\/li>\n<li>\u5b89\u88c5\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u4e8e\u9001\u98ce\u6bb5\u4e0a\u6e38\uff08\u5982\u98ce\u673a\u5165\u53e3\u6216\u9759\u538b\u7bb1\uff09\uff0c\u786e\u4fdd\u6c14\u6eb6\u80f6\u5747\u5300\u5206\u5e03\uff1b<\/li>\n<li>\u8fde\u63a5\u5149\u5ea6\u8ba1\u4e0e\u63a2\u5934\uff0c\u9884\u70ed\u8bbe\u5907\u4e0d\u5c11\u4e8e15\u5206\u949f\uff1b<\/li>\n<li>\u8bbe\u7f6e\u5149\u5ea6\u8ba1\u5355\u4f4d\u4e3a\u201c% penetration\u201d\u6216\u201c\u03bcg\/L\u201d\uff0c\u8bbe\u5b9a\u62a5\u8b66\u9608\u503c\uff08\u901a\u5e38\u4e3a0.01%\uff09\u3002<\/li>\n<\/ul>\n<h3>2. \u4e0a\u6e38\u6c14\u6eb6\u80f6\u6ce8\u5165<\/h3>\n<ul>\n<li>\u5f00\u542f\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\uff0c\u8c03\u8282\u8f93\u51fa\u6d53\u5ea6\u81f3<strong>20\u201330 \u03bcg\/L<\/strong>\uff08\u7406\u60f3\u6d4b\u8bd5\u6d53\u5ea6\uff09\uff1b<\/li>\n<li>\u5f85\u4e0a\u6e38\u6d53\u5ea6\u7a33\u5b9a\u81f3\u5c115\u5206\u949f\u540e\uff0c\u8bb0\u5f55\u521d\u59cb\u6d53\u5ea6\u503c $ C_0 $\uff1b<\/li>\n<li>\u4fdd\u6301\u53d1\u751f\u5668\u6301\u7eed\u8fd0\u884c\uff0c\u786e\u4fdd\u6574\u4e2a\u6d4b\u8bd5\u8fc7\u7a0b\u4e2d\u6d53\u5ea6\u6ce2\u52a8\u4e0d\u8d85\u8fc7\u00b110%\u3002<\/li>\n<\/ul>\n<blockquote>\n<p><em>\u6ce8\uff1a\u6d53\u5ea6\u8fc7\u9ad8\u53ef\u80fd\u5bfc\u81f4\u5149\u5ea6\u8ba1\u9971\u548c\uff0c\u8fc7\u4f4e\u5219\u4fe1\u566a\u6bd4\u4e0d\u8db3\u3002TSI\u5efa\u8bae\u6700\u4f73\u6d53\u5ea6\u4e3a20 \u03bcg\/L\uff08Model 8160\u64cd\u4f5c\u624b\u518c\uff09\u3002<\/em><\/p>\n<\/blockquote>\n<h3>3. \u4e0b\u6e38\u626b\u63cf\u68c0\u6d4b<\/h3>\n<ul>\n<li>\u5c06\u63a2\u5934\u7f6e\u4e8e\u8fc7\u6ee4\u5668\u51fa\u98ce\u9762\u4e0b\u65b9\u7ea61\u20132 cm\u5904\uff1b<\/li>\n<li>\u4ee5<strong>\u22645 cm\/s<\/strong>\u7684\u901f\u5ea6\u5300\u901f\u79fb\u52a8\u63a2\u5934\uff0c\u8986\u76d6\u6574\u4e2a\u8fc7\u6ee4\u9762\u79ef\uff1b<\/li>\n<li>\u7279\u522b\u5173\u6ce8\u8fb9\u6846\u3001\u62fc\u63a5\u7f1d\u3001\u652f\u67b6\u8fde\u63a5\u5904\u7b49\u6613\u6f0f\u533a\u57df\uff1b<\/li>\n<li>\u626b\u63cf\u8def\u5f84\u5e94\u91cd\u53e0\u81f3\u5c1150%\uff0c\u907f\u514d\u9057\u6f0f\uff1b<\/li>\n<li>\u82e5\u4f7f\u7528\u81ea\u52a8\u626b\u63cf\u7cfb\u7edf\uff08\u5982Camfil ScanMaster\uff09\uff0c\u53ef\u8bbe\u5b9a\u7f51\u683c\u8def\u5f84\u5b9e\u73b0\u6570\u5b57\u5316\u626b\u63cf\u3002<\/li>\n<\/ul>\n<h3>4. \u6cc4\u6f0f\u5224\u5b9a\u6807\u51c6<\/h3>\n<p>\u6839\u636eGB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u7b2c6.4\u6761\u89c4\u5b9a\uff1a<\/p>\n<blockquote>\n<p>\u201c\u5728\u989d\u5b9a\u98ce\u91cf\u4e0b\uff0c\u7528\u5927\u6c14\u5c18\u6216\u4eba\u5de5\u5c18\u8fdb\u884c\u626b\u63cf\u68c0\u6f0f\uff0c\u4efb\u4f55\u70b9\u7684\u5c40\u90e8\u7a7f\u900f\u7387\u4e0d\u5f97\u8d85\u8fc7\u51fa\u5382\u5408\u683c\u7a7f\u900f\u7387\u76842\u500d\uff0c\u4e14\u4e0d\u5f97\u5927\u4e8e0.01%\u3002\u201d<\/p>\n<\/blockquote>\n<p>\u56fd\u9645\u901a\u7528\u6807\u51c6\u6c47\u603b\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6807\u51c6\u540d\u79f0<\/th>\n<th>\u6cc4\u6f0f\u5224\u5b9a\u9650\u503c<\/th>\n<th>\u9002\u7528\u8303\u56f4<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>ISO 14644-3:2019<\/td>\n<td>\u22640.01% \u7a7f\u900f\u7387<\/td>\n<td>\u6240\u6709ISO Class 5\u53ca\u4ee5\u4e0a\u6d01\u51c0\u5ba4<\/td>\n<\/tr>\n<tr>\n<td>IEST-RP-CC001.5<\/td>\n<td>\u22640.03%\uff08ULPA\u4e3a0.005%\uff09<\/td>\n<td>\u7f8e\u56fd\u5de5\u4e1a\u6807\u51c6<\/td>\n<\/tr>\n<tr>\n<td>GB\/T 13554-2020<\/td>\n<td>\u22640.01% \u6216\u51fa\u5382\u503c2\u500d\uff08\u53d6\u5c0f\uff09<\/td>\n<td>\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6<\/td>\n<\/tr>\n<tr>\n<td>EU GMP Annex 1 (2022)<\/td>\n<td>\u626b\u63cf\u6cd5\u68c0\u6d4b\u65e0\u663e\u8457\u6cc4\u6f0f<\/td>\n<td>\u5236\u836f\u65e0\u83cc\u751f\u4ea7\u533a<\/td>\n<\/tr>\n<tr>\n<td>FDA Aseptic Processing Guidance<\/td>\n<td>\u8981\u6c42\u5b9a\u671f\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n<td>\u751f\u7269\u5236\u54c1\u751f\u4ea7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5f53\u68c0\u6d4b\u5230\u7a7f\u900f\u7387\u8d85\u8fc7\u9650\u503c\u65f6\uff0c\u5e94\u6807\u8bb0\u4f4d\u7f6e\u5e76\u62cd\u7167\u8bb0\u5f55\uff0c\u540e\u7eed\u8fdb\u884c\u4fee\u8865\u6216\u66f4\u6362\u5904\u7406\u3002<\/p>\n<hr \/>\n<h2>\u4e94\u3001\u7a7f\u900f\u7387\u8ba1\u7b97\u516c\u5f0f<\/h2>\n<p>\u7a7f\u900f\u7387\uff08Penetration Rate\uff09\u5b9a\u4e49\u4e3a\u4e0b\u6e38\u6d53\u5ea6\u4e0e\u4e0a\u6e38\u6d53\u5ea6\u4e4b\u6bd4\uff0c\u901a\u5e38\u4ee5\u767e\u5206\u6bd4\u8868\u793a\uff1a<\/p>\n<p>$$<br \/>\nP(%) = frac{C_d}{C_u} times 100%<br \/>\n$$<\/p>\n<p>\u5176\u4e2d\uff1a<\/p>\n<ul>\n<li>$ P $\uff1a\u7a7f\u900f\u7387\uff08%\uff09<\/li>\n<li>$ C_d $\uff1a\u4e0b\u6e38\u68c0\u6d4b\u6d53\u5ea6\uff08\u03bcg\/L\uff09<\/li>\n<li>$ C_u $\uff1a\u4e0a\u6e38\u5e73\u5747\u6d53\u5ea6\uff08\u03bcg\/L\uff09<\/li>\n<\/ul>\n<p>\u4f8b\u5982\uff1a\u82e5\u4e0a\u6e38\u6d53\u5ea6\u4e3a25 \u03bcg\/L\uff0c\u67d0\u70b9\u4e0b\u6e38\u8bfb\u6570\u4e3a0.0025 \u03bcg\/L\uff0c\u5219\u7a7f\u900f\u7387\u4e3a\uff1a<\/p>\n<p>$$<br \/>\nP = frac{0.0025}{25} times 100% = 0.01%<br \/>\n$$<\/p>\n<p>\u6b64\u503c\u6070\u597d\u8fbe\u5230\u8b66\u6212\u7ebf\uff0c\u9700\u8fdb\u4e00\u6b65\u786e\u8ba4\u662f\u5426\u4e3a\u77ac\u65f6\u6ce2\u52a8\u6216\u771f\u5b9e\u6cc4\u6f0f\u3002<\/p>\n<hr \/>\n<h2>\u516d\u3001\u5f71\u54cd\u6d4b\u8bd5\u7ed3\u679c\u7684\u56e0\u7d20\u5206\u6790<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u5f71\u54cd\u56e0\u7d20<\/th>\n<th>\u5bf9\u6d4b\u8bd5\u7684\u5f71\u54cd<\/th>\n<th>\u63a7\u5236\u63aa\u65bd<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6c14\u6d41\u4e0d\u5747<\/td>\n<td>\u4e0a\u6e38\u6d53\u5ea6\u5206\u5e03\u4e0d\u5747\uff0c\u9020\u6210\u5047\u9633\u6027<\/td>\n<td>\u4f7f\u7528\u6df7\u5408\u8154\u6216\u5ef6\u957f\u7a33\u6d41\u6bb5<\/td>\n<\/tr>\n<tr>\n<td>\u63a2\u5934\u8ddd\u79bb\u8fc7\u8fdc<\/td>\n<td>\u91c7\u6837\u6548\u7387\u4e0b\u964d\uff0c\u6f0f\u68c0\u98ce\u9669\u589e\u52a0<\/td>\n<td>\u4fdd\u6301\u63a2\u5934\u8ddd\u6ee4\u97621\u20132 cm<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u901f\u5ea6\u8fc7\u5feb<\/td>\n<td>\u6f0f\u68c0\u5c0f\u9762\u79ef\u6cc4\u6f0f<\/td>\n<td>\u63a7\u5236\u901f\u5ea6\u22645 cm\/s<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u5668\u672a\u8fbe\u989d\u5b9a\u98ce\u91cf<\/td>\n<td>\u5b9e\u9645\u6548\u7387\u504f\u4f4e<\/td>\n<td>\u6d4b\u8bd5\u65f6\u5f00\u542f\u98ce\u673a\u81f3\u6b63\u5e38\u8fd0\u884c\u6863\u4f4d<\/td>\n<\/tr>\n<tr>\n<td>\u73af\u5883\u80cc\u666f\u7c92\u5b50\u5e72\u6270<\/td>\n<td>\u4e0b\u6e38\u672c\u5e95\u503c\u5347\u9ad8<\/td>\n<td>\u6d4b\u8bd5\u524d\u6e05\u6d01\u73af\u5883\uff0c\u5173\u95ed\u65e0\u5173\u8bbe\u5907<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u6eb6\u80f6\u8001\u5316\u6216\u964d\u89e3<\/td>\n<td>\u7c92\u5f84\u504f\u79fb\uff0c\u504f\u79bbMPPS<\/td>\n<td>\u4f7f\u7528\u65b0\u9c9c\u8bd5\u5242\uff0c\u907f\u514d\u957f\u65f6\u95f4\u52a0\u70ed<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em>\u53c2\u8003\u6587\u732e\uff1aKao, C.C. et al., &quot;Factors Affecting Accuracy in HEPA Filter Leak Testing&quot;, <\/em>Journal of the IEST<em>, Vol. 47, No. 2, 2004.<\/em><\/p>\n<hr \/>\n<h2>\u4e03\u3001\u4e0d\u540c\u5e94\u7528\u573a\u666f\u4e0b\u7684\u6d4b\u8bd5\u7b56\u7565<\/h2>\n<h3>1. \u5b9e\u9a8c\u5ba4\u8d85\u51c0\u53f0\uff08\u751f\u7269\u5b89\u5168\u67dcII\u7ea7\uff09<\/h3>\n<ul>\n<li>\u6d4b\u8bd5\u9891\u7387\uff1a\u6bcf6\u4e2a\u6708\u4e00\u6b21\uff0c\u6216\u6bcf\u6b21\u91cd\u5927\u7ef4\u4fee\u540e\uff1b<\/li>\n<li>\u63a8\u8350\u4f7f\u7528PAO\uff08DEHS\uff09\uff0c\u907f\u514dDOP\u5bf9\u7ec6\u80de\u57f9\u517b\u7684\u6f5c\u5728\u6c61\u67d3\uff1b<\/li>\n<li>\u6ce8\u610f\u4fdd\u62a4\u64cd\u4f5c\u533a\u5185\u6837\u54c1\uff0c\u53ef\u5728\u6d4b\u8bd5\u524d\u79fb\u9664\u6216\u906e\u76d6\uff1b<\/li>\n<li>\u53c2\u8003\u6807\u51c6\uff1aNSF\/ANSI 49-2022\u300aClass II Biosafety Cabinetry\u300b\u3002<\/li>\n<\/ul>\n<h3>2. \u5236\u836f\u6d01\u51c0\u5ba4\uff08GMP\u8f66\u95f4\uff09<\/h3>\n<ul>\n<li>\u5fc5\u987b\u7eb3\u5165\u5382\u623f\u9a8c\u8bc1\uff08Qualification\uff09\u4f53\u7cfb\uff1b<\/li>\n<li>\u6d4b\u8bd5\u5e94\u5728\u9759\u6001\u6761\u4ef6\u4e0b\u8fdb\u884c\uff08\u65e0\u4eba\u5458\u64cd\u4f5c\uff09\uff1b<\/li>\n<li>\u8bb0\u5f55\u5b8c\u6574\u6570\u636e\u94fe\uff0c\u5305\u62ec\u65f6\u95f4\u3001\u6e29\u5ea6\u3001\u6e7f\u5ea6\u3001\u4e0a\u4e0b\u6e38\u6d53\u5ea6\uff1b<\/li>\n<li>\u7b26\u5408EU GMP Annex 1 (2022) \u7b2c8.40\u6761\uff1a\u201c\u5e94\u5b9a\u671f\u8fdb\u884cHEPA\u5b8c\u6574\u6027\u6d4b\u8bd5\u201d\u3002<\/li>\n<\/ul>\n<h3>3. \u533b\u9662\u624b\u672f\u5ba4<\/h3>\n<ul>\n<li>\u4f9d\u636eWS\/T 311-2023\u300a\u533b\u9662\u9694\u79bb\u6280\u672f\u89c4\u8303\u300b\u8981\u6c42\uff0c\u2160\u7c7b\u6d01\u51c0\u624b\u672f\u5ba4HEPA\u6bcf\u5e74\u81f3\u5c11\u68c0\u6d4b\u4e00\u6b21\uff1b<\/li>\n<li>\u53ef\u7ed3\u5408\u6c89\u964d\u83cc\u3001\u6d6e\u6e38\u83cc\u76d1\u6d4b\u540c\u6b65\u5f00\u5c55\uff1b<\/li>\n<li>\u63a8\u8350\u4f7f\u7528\u4fbf\u643a\u5f0fPAO\u53d1\u751f\u5668\uff0c\u4fbf\u4e8e\u73b0\u573a\u64cd\u4f5c\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u516b\u3001\u81ea\u52a8\u5316\u4e0e\u667a\u80fd\u5316\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<p>\u8fd1\u5e74\u6765\uff0c\u968f\u7740\u7269\u8054\u7f51\u4e0e\u667a\u80fd\u5236\u9020\u7684\u53d1\u5c55\uff0cHEPA\u5b8c\u6574\u6027\u6d4b\u8bd5\u6b63\u5411\u81ea\u52a8\u5316\u65b9\u5411\u6f14\u8fdb\uff1a<\/p>\n<ul>\n<li><strong>\u81ea\u52a8\u626b\u63cf\u673a\u5668\u4eba<\/strong>\uff1a\u5982Atlastek AutoScan\u3001PMS FilterScanner\uff0c\u53ef\u7f16\u7a0b\u8def\u5f84\u626b\u63cf\uff0c\u751f\u6210\u4e8c\u7ef4\u6cc4\u6f0f\u70ed\u56fe\uff1b<\/li>\n<li><strong>\u65e0\u7ebf\u6570\u636e\u4f20\u8f93<\/strong>\uff1a\u6d4b\u8bd5\u6570\u636e\u5b9e\u65f6\u4e0a\u4f20\u81f3LIMS\u7cfb\u7edf\uff0c\u5b9e\u73b0\u7535\u5b50\u5316\u5b58\u6863\uff1b<\/li>\n<li><strong>AI\u8f85\u52a9\u5206\u6790<\/strong>\uff1a\u901a\u8fc7\u673a\u5668\u5b66\u4e60\u8bc6\u522b\u5f02\u5e38\u4fe1\u53f7\uff0c\u51cf\u5c11\u4eba\u4e3a\u8bef\u5224\uff1b<\/li>\n<li><strong>\u5728\u7ebf\u76d1\u6d4b\u7cfb\u7edf<\/strong>\uff1a\u90e8\u5206\u9ad8\u7aef\u8bbe\u65bd\u5b89\u88c5\u56fa\u5b9a\u5f0f\u5149\u5ea6\u8ba1\uff0c\u5b9e\u73b0\u8fde\u7eed\u76d1\u63a7\uff08Continuous Monitoring\uff09\u3002<\/li>\n<\/ul>\n<blockquote>\n<p><em>\u6848\u4f8b\uff1a\u4e0a\u6d77\u5f20\u6c5f\u67d0\u751f\u7269\u533b\u836f\u4f01\u4e1a\u91c7\u7528TSI AeroTrak\u00ae 9000\u7cfb\u5217\u5728\u7ebf\u7c92\u5b50\u76d1\u6d4b\u7cfb\u7edf\uff0c\u96c6\u6210PAO\u6d4b\u8bd5\u6a21\u5757\uff0c\u5b9e\u73b0\u5168\u5e74\u65e0\u95f4\u65adHEPA\u72b6\u6001\u8ffd\u8e2a\uff08\u300a\u4e2d\u56fd\u5236\u836f\u5de5\u7a0b\u300b\uff0c2023\u5e74\u7b2c4\u671f\uff09\u3002<\/em><\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e5d\u3001\u56fd\u5185\u5916\u6743\u5a01\u6807\u51c6\u5bf9\u6bd4<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u6807\u51c6\u7f16\u53f7<\/th>\n<th>\u53d1\u5e03\u673a\u6784<\/th>\n<th>\u4e3b\u8981\u5185\u5bb9<\/th>\n<th>\u6cc4\u6f0f\u9650\u503c<\/th>\n<th>\u66f4\u65b0\u5e74\u4efd<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>ISO 14644-3:2019<\/td>\n<td>\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7<\/td>\n<td>\u6d01\u51c0\u5ba4\u6d4b\u8bd5\u65b9\u6cd5<\/td>\n<td>\u22640.01%<\/td>\n<td>2019<\/td>\n<\/tr>\n<tr>\n<td>IEST-RP-CC001.5<\/td>\n<td>\u7f8e\u56fd\u73af\u5883\u79d1\u5b66\u4e0e\u6280\u672f\u5b66\u4f1a<\/td>\n<td>HEPA\/ULPA\u6d4b\u8bd5\u7a0b\u5e8f<\/td>\n<td>\u22640.03%\uff08HEPA\uff09<\/td>\n<td>2021<\/td>\n<\/tr>\n<tr>\n<td>GB\/T 13554-2020<\/td>\n<td>\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6\u5316\u7ba1\u7406\u59d4\u5458\u4f1a<\/td>\n<td>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/td>\n<td>\u22640.01% \u62162\u500d\u51fa\u5382\u503c<\/td>\n<td>2020<\/td>\n<\/tr>\n<tr>\n<td>EN 1822:2019<\/td>\n<td>\u6b27\u6d32\u6807\u51c6\u5316\u59d4\u5458\u4f1a<\/td>\n<td>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5206\u7ea7\uff08H13-H14\uff09<\/td>\n<td>H13: \u22640.25%\uff1bH14: \u22640.005%<\/td>\n<td>2019<\/td>\n<\/tr>\n<tr>\n<td>JIS Z 8122:2015<\/td>\n<td>\u65e5\u672c\u5de5\u4e1a\u6807\u51c6<\/td>\n<td>\u6d01\u51c0\u5ba4\u6027\u80fd\u6d4b\u8bd5<\/td>\n<td>\u53c2\u7167ISO 14644<\/td>\n<td>2015<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em>\u8d44\u6599\u6765\u6e90\uff1aISO\u5b98\u7f51\u3001IEST Publications\u3001\u56fd\u5bb6\u6807\u51c6\u5316\u7ba1\u7406\u59d4\u5458\u4f1a\u516c\u5f00\u6587\u4ef6<\/em><\/p>\n<p>\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0cEN 1822\u6807\u51c6\u91c7\u7528\u201c\u6700\u6613\u7a7f\u900f\u7c92\u5f84\u6548\u7387\u6d4b\u8bd5\u201d\uff08MPPS Method\uff09\uff0c\u4f7f\u7528\u94a0\u7130\u6cd5\u6216\u8ba1\u6570\u6cd5\u6d4b\u5b9a\u5355\u4e2a\u8fc7\u6ee4\u5668\u6548\u7387\uff0c\u9002\u7528\u4e8e\u51fa\u5382\u68c0\u9a8c\uff1b\u800cDOP\/PAO\u626b\u63cf\u6cd5\u5219\u66f4\u591a\u7528\u4e8e\u73b0\u573a\u5b89\u88c5\u540e\u7684\u6cc4\u6f0f\u68c0\u6d4b\uff0c\u4e24\u8005\u4e92\u8865\u3002<\/p>\n<hr \/>\n<h2>\u5341\u3001\u5e38\u89c1\u95ee\u9898\u4e0e\u89e3\u51b3\u65b9\u6848<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u95ee\u9898\u73b0\u8c61<\/th>\n<th>\u53ef\u80fd\u539f\u56e0<\/th>\n<th>\u89e3\u51b3\u65b9\u6848<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u4e0a\u6e38\u6d53\u5ea6\u65e0\u6cd5\u7a33\u5b9a<\/td>\n<td>\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u6545\u969c\u6216\u7a7a\u6c14\u538b\u529b\u4e0d\u8db3<\/td>\n<td>\u68c0\u67e5\u538b\u7f29\u673a\u3001\u66f4\u6362\u96fe\u5316\u55b7\u5634<\/td>\n<\/tr>\n<tr>\n<td>\u4e0b\u6e38\u666e\u904d\u9ad8\u80cc\u666f\u503c<\/td>\n<td>\u73af\u5883\u6c61\u67d3\u6216\u4e0a\u6e38\u6df7\u5408\u4e0d\u5747<\/td>\n<td>\u5ef6\u957f\u9884\u8fd0\u884c\u65f6\u95f4\uff0c\u6e05\u6d01\u6d4b\u8bd5\u73af\u5883<\/td>\n<\/tr>\n<tr>\n<td>\u5c40\u90e8\u53cd\u590d\u8d85\u6807<\/td>\n<td>\u5bc6\u5c01\u80f6\u5f00\u88c2\u3001\u6ee4\u7eb8\u7834\u635f<\/td>\n<td>\u6807\u8bb0\u4f4d\u7f6e\uff0c\u6d82\u62b9\u7845\u916e\u5bc6\u5c01\u80f6\u6216\u66f4\u6362\u6ee4\u82af<\/td>\n<\/tr>\n<tr>\n<td>\u5149\u5ea6\u8ba1\u8bfb\u6570\u8df3\u52a8<\/td>\n<td>\u63a2\u5934\u5835\u585e\u6216\u7535\u8def\u5e72\u6270<\/td>\n<td>\u6e05\u6d01\u63a2\u5934\uff0c\u8fdc\u79bb\u7535\u78c1\u6e90<\/td>\n<\/tr>\n<tr>\n<td>\u65b0\u6362\u8fc7\u6ee4\u5668\u4ecd\u6cc4\u6f0f<\/td>\n<td>\u5b89\u88c5\u4e0d\u5f53\u6216\u6846\u67b6\u53d8\u5f62<\/td>\n<td>\u91cd\u65b0\u7d27\u56fa\u538b\u6761\uff0c\u68c0\u67e5\u5e73\u6574\u5ea6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u5341\u4e00\u3001\u5b89\u5168\u4e0e\u73af\u4fdd\u6ce8\u610f\u4e8b\u9879<\/h2>\n<ul>\n<li><strong>\u901a\u98ce\u8981\u6c42<\/strong>\uff1a\u6d4b\u8bd5\u5e94\u5728\u826f\u597d\u901a\u98ce\u73af\u5883\u4e0b\u8fdb\u884c\uff0c\u5fc5\u8981\u65f6\u5f00\u542f\u6392\u98ce\u7cfb\u7edf\uff1b<\/li>\n<li><strong>\u4e2a\u4eba\u9632\u62a4<\/strong>\uff1a\u64cd\u4f5c\u4eba\u5458\u5e94\u4f69\u6234N95\u53e3\u7f69\u3001\u62a4\u76ee\u955c\u53ca\u624b\u5957\uff1b<\/li>\n<li><strong>\u5e9f\u5f03\u7269\u5904\u7406<\/strong>\uff1a\u4f7f\u7528\u540e\u7684DOP\/PAO\u6eb6\u6db2\u6309\u5371\u9669\u5e9f\u7269\u5904\u7f6e\uff0c\u7981\u6b62\u76f4\u63a5\u503e\u5012\uff1b<\/li>\n<li><strong>\u66ff\u4ee3\u65b9\u6848<\/strong>\uff1a\u9f13\u52b1\u4f7f\u7528\u66f4\u5b89\u5168\u7684PSL\uff08\u805a\u82ef\u4e59\u70ef\u4e73\u80f6\u7403\uff09\u6216\u76d0\u96fe\u6cd5\u8fdb\u884c\u7814\u53d1\u7c7b\u6d4b\u8bd5\uff1b<\/li>\n<li><strong>\u6cd5\u89c4\u9075\u5faa<\/strong>\uff1a\u9075\u5b88\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u804c\u4e1a\u75c5\u9632\u6cbb\u6cd5\u300b\u53ca\u300a\u5de5\u4f5c\u573a\u6240\u6709\u5bb3\u56e0\u7d20\u804c\u4e1a\u63a5\u89e6\u9650\u503c\u300b\uff08GBZ 2.1-2019\uff09\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u5341\u4e8c\u3001\u5178\u578b\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>\u6848\u4f8b\u4e00\uff1a\u67d0\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u8d85\u51c0\u53f0\u6cc4\u6f0f\u4e8b\u4ef6<\/h3>\n<ul>\n<li><strong>\u80cc\u666f<\/strong>\uff1a\u67d0GMP\u8f66\u95f4A\u7ea7\u533a\u8d85\u51c0\u53f0\u5728\u5e74\u5ea6\u9a8c\u8bc1\u4e2d\u53d1\u73b0\u5c40\u90e8\u7a7f\u900f\u7387\u8fbe0.035%\uff1b<\/li>\n<li><strong>\u6392\u67e5<\/strong>\uff1a\u7ecfPAO\u626b\u63cf\u5b9a\u4f4d\uff0c\u6cc4\u6f0f\u70b9\u4f4d\u4e8e\u53f3\u4e0a\u89d2\u8fb9\u6846\u63a5\u7f1d\u5904\uff1b<\/li>\n<li><strong>\u539f\u56e0<\/strong>\uff1a\u5b89\u88c5\u65f6\u5bc6\u5c01\u80f6\u672a\u5b8c\u5168\u56fa\u5316\u5373\u901a\u7535\u8fd0\u884c\uff0c\u5bfc\u81f4\u6536\u7f29\u5f00\u88c2\uff1b<\/li>\n<li><strong>\u5904\u7406<\/strong>\uff1a\u505c\u673a\u540e\u8865\u6d82\u4e2d\u6027\u7845\u916e\u5bc6\u5c01\u80f6\uff0c24\u5c0f\u65f6\u56fa\u5316\u540e\u590d\u6d4b\uff0c\u7a7f\u900f\u7387\u964d\u81f30.006%\uff1b<\/li>\n<li><strong>\u542f\u793a<\/strong>\uff1a\u5f3a\u8c03\u5b89\u88c5\u5de5\u827a\u4e0e\u9a8c\u6536\u6d41\u7a0b\u7684\u91cd\u8981\u6027\u3002<\/li>\n<\/ul>\n<h3>\u6848\u4f8b\u4e8c\uff1a\u9ad8\u6821\u5b9e\u9a8c\u5ba4\u8bef\u7528DOP\u5f15\u53d1\u6c61\u67d3<\/h3>\n<ul>\n<li><strong>\u4e8b\u4ef6<\/strong>\uff1a\u67d0\u5927\u5b66\u7ec6\u80de\u623f\u4f7f\u7528DOP\u6d4b\u8bd5\u540e\uff0c\u591a\u6279\u7ec6\u80de\u51fa\u73b0\u751f\u957f\u6291\u5236\uff1b<\/li>\n<li><strong>\u8c03\u67e5<\/strong>\uff1a\u6b8b\u7559DOP\u5438\u9644\u4e8e\u53f0\u9762\u53ca\u901a\u98ce\u7ba1\u9053\uff0c\u7f13\u6162\u91ca\u653e\u5f71\u54cd\u7ec6\u80de\u4ee3\u8c22\uff1b<\/li>\n<li><strong>\u6574\u6539<\/strong>\uff1a\u6539\u7528PAO\uff08DEHS\uff09\u5e76\u52a0\u5f3a\u901a\u98ce\u6e05\u6d17\uff0c\u5efa\u7acb\u6d4b\u8bd5\u4e13\u7528\u65f6\u6bb5\uff1b<\/li>\n<li><strong>\u5efa\u8bae<\/strong>\uff1a\u751f\u7269\u5b9e\u9a8c\u533a\u4f18\u5148\u9009\u7528\u4f4e\u6bd2\u6c14\u6eb6\u80f6\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>IEST-RP-CC001.5 (2021). <em>HEPA and ULPA Filter Tests<\/em>. Institute of Environmental Sciences and Technology.<\/li>\n<li>ISO 14644-3:2019. <em>Cleanrooms and associated controlled environments \u2014 Part 3: Test methods<\/em>. International Organization for Standardization.<\/li>\n<li>GB\/T 13554-2020. \u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b. \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e.<\/li>\n<li>EN 1822:2019. <em>High efficiency air filters (EPA, HEPA and ULPA)<\/em>. CEN.<\/li>\n<li>EU GMP Annex 1 (2022). <em>Manufacture of Sterile Medicinal Products<\/em>. European Commission.<\/li>\n<li>TSI Incorporated. <em>Operation Manual for Model 8160 Automated Filter Tester<\/em>. 2020.<\/li>\n<li>Camfil Farr. <em>Technical Guide: HEPA Filter Leak Testing with PAO<\/em>. 2022.<\/li>\n<li>\u5f20\u4f1f, \u674e\u660e. \u8d85\u51c0\u5de5\u4f5c\u53f0HEPA\u8fc7\u6ee4\u5668\u73b0\u573a\u68c0\u6f0f\u6280\u672f\u7814\u7a76[J]. \u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f, 2021(3): 45\u201349.<\/li>\n<li>\u738b\u7acb\u65b0\u7b49. \u5236\u836f\u4f01\u4e1a\u6d01\u51c0\u5ba4HEPA\u5b8c\u6574\u6027\u6d4b\u8bd5\u5b9e\u8df5[J]. \u4e2d\u56fd\u5236\u836f\u5de5\u7a0b, 2023, 43(4): 78\u201382.<\/li>\n<li>Kao, C.C., et al. (2004). &quot;Factors Affecting Accuracy in HEPA Filter Leak Testing&quot;. <em>Journal of the IEST<\/em>, 47(2), 33\u201339.<\/li>\n<\/ol>\n<hr \/>\n<p>\uff08\u5168\u6587\u7ea63,680\u5b57\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u8d85\u51c0\u53f0\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08DOP\/PAO\uff09\u65b9\u6cd5\u8be6\u89e3 \u6982\u8ff0 \u8d85\u51c0\u5de5\u4f5c\u53f0\uff08Laminar Flow Cabinet\uff09\u662f\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\u3001\u5236\u836f\u4f01\u4e1a\u3001\u533b\u9662\u6d01\u51c0\u624b\u672f\u5ba4\u3001\u7535\u5b50\u5236\u9020\u8f66\u95f4\u7b49\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8981\u6c42\u6781\u9ad8\u7684\u573a\u6240\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u6838\u5fc3\u8bbe\u5907\u3002\u5176\u6838\u5fc3\u529f\u80fd\u4f9d\u8d56\u4e8e\u9ad8\u6548\u9897\u7c92\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\uff0c\u8be5\u8fc7\u6ee4\u5668\u80fd&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-17015","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\/17015","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=17015"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/17015\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}