{"id":17066,"date":"2025-09-26T13:15:36","date_gmt":"2025-09-26T05:15:36","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=17066"},"modified":"2025-09-26T13:15:36","modified_gmt":"2025-09-26T05:15:36","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%89%e8%a3%85%e5%af%86%e5%b0%81%e6%80%a7%e6%a3%80%e6%b5%8b%e6%8a%80%e6%9c%af%e8%a7%84%e8%8c%83","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=17066","title":{"rendered":"\u8d85\u51c0\u53f0\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b89\u88c5\u5bc6\u5c01\u6027\u68c0\u6d4b\u6280\u672f\u89c4\u8303"},"content":{"rendered":"<h1>\u8d85\u51c0\u53f0\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b89\u88c5\u5bc6\u5c01\u6027\u68c0\u6d4b\u6280\u672f\u89c4\u8303<\/h1>\n<h2>1. \u5f15\u8a00<\/h2>\n<p>\u8d85\u51c0\u5de5\u4f5c\u53f0\uff08Laminar Flow Cabinet\uff09\u662f\u5b9e\u9a8c\u5ba4\u3001\u5236\u836f\u3001\u751f\u7269\u5b89\u5168\u3001\u7535\u5b50\u5236\u9020\u7b49\u9ad8\u6d01\u51c0\u5ea6\u73af\u5883\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u8bbe\u5907\uff0c\u5176\u6838\u5fc3\u529f\u80fd\u5728\u4e8e\u901a\u8fc7\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA, High-Efficiency Particulate Air Filter\uff09\u63d0\u4f9b\u5355\u5411\u3001\u65e0\u5c18\u3001\u65e0\u83cc\u7684\u6c14\u6d41\u73af\u5883\u3002\u4e3a\u786e\u4fdd\u6d01\u51c0\u533a\u8fbe\u5230\u89c4\u5b9a\u7684\u6d01\u51c0\u7b49\u7ea7\uff08\u5982ISO Class 5\u6216GMP A\u7ea7\uff09\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u5bc6\u5c01\u6027\u81f3\u5173\u91cd\u8981\u3002\u4e00\u65e6\u5b58\u5728\u6cc4\u6f0f\uff0c\u5c06\u5bfc\u81f4\u5916\u90e8\u6c61\u67d3\u7a7a\u6c14\u8fdb\u5165\u5de5\u4f5c\u533a\u57df\uff0c\u4e25\u91cd\u5f71\u54cd\u5b9e\u9a8c\u7ed3\u679c\u7684\u51c6\u786e\u6027\u6216\u4ea7\u54c1\u7684\u8d28\u91cf\u3002<\/p>\n<p>\u56e0\u6b64\uff0c\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5b89\u88c5\u540e\u7684\u5bc6\u5c01\u6027\u8fdb\u884c\u79d1\u5b66\u3001\u7cfb\u7edf\u7684\u68c0\u6d4b\uff0c\u5df2\u6210\u4e3a\u6d01\u51c0\u5ba4\u5de5\u7a0b\u9a8c\u6536\u548c\u65e5\u5e38\u7ef4\u62a4\u4e2d\u7684\u5173\u952e\u73af\u8282\u3002\u672c\u6587\u4f9d\u636e\u56fd\u5185\u5916\u76f8\u5173\u6807\u51c6\u4e0e\u6280\u672f\u6587\u732e\uff0c\u7cfb\u7edf\u9610\u8ff0\u8d85\u51c0\u53f0\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b89\u88c5\u5bc6\u5c01\u6027\u68c0\u6d4b\u7684\u6280\u672f\u89c4\u8303\uff0c\u6db5\u76d6\u68c0\u6d4b\u539f\u7406\u3001\u65b9\u6cd5\u3001\u4eea\u5668\u8bbe\u5907\u3001\u64cd\u4f5c\u6d41\u7a0b\u3001\u5224\u5b9a\u6807\u51c6\u53ca\u5e38\u89c1\u95ee\u9898\u5904\u7406\u7b49\u5185\u5bb9\uff0c\u5e76\u7ed3\u5408\u5b9e\u9645\u53c2\u6570\u8868\u683c\u4e0e\u6743\u5a01\u6587\u732e\u5f15\u7528\uff0c\u4e3a\u76f8\u5173\u4ece\u4e1a\u4eba\u5458\u63d0\u4f9b\u5168\u9762\u7684\u6280\u672f\u53c2\u8003\u3002<\/p>\n<hr \/>\n<h2>2. \u9ad8\u6548\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>2.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u662f\u4e00\u79cd\u80fd\u591f\u6355\u96c6\u7a7a\u6c14\u4e2d\u22650.3\u5fae\u7c73\u9897\u7c92\u7269\u6548\u7387\u4e0d\u4f4e\u4e8e99.97%\u7684\u8fc7\u6ee4\u88c5\u7f6e\u3002\u6839\u636e\u56fd\u9645\u6807\u51c6ISO 29463\u548c\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6GB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\uff0cHEPA\u8fc7\u6ee4\u5668\u6309\u6548\u7387\u7b49\u7ea7\u5206\u4e3a\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>\u5bf90.3\u03bcm\u7c92\u5b50\u7684\u6700\u4f4e\u6548\u7387<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H13<\/td>\n<td>GB\/T 13554-2020 \/ ISO 29463<\/td>\n<td>\u226599.95%<\/td>\n<\/tr>\n<tr>\n<td>H14<\/td>\n<td>GB\/T 13554-2020 \/ ISO 29463<\/td>\n<td>\u226599.995%<\/td>\n<\/tr>\n<tr>\n<td>U15<\/td>\n<td>ISO 29463<\/td>\n<td>\u226599.9995%<\/td>\n<\/tr>\n<tr>\n<td>U16<\/td>\n<td>ISO 29463<\/td>\n<td>\u226599.99995%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1aH\u7c7b\u9002\u7528\u4e8e\u4e00\u822c\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0cU\u7c7b\u4e3a\u8d85\u9ad8\u6548\uff08ULPA\uff09\u8fc7\u6ee4\u5668\uff0c\u5e38\u7528\u4e8e\u66f4\u9ad8\u8981\u6c42\u7684\u6d01\u51c0\u73af\u5883\u3002<\/p>\n<\/blockquote>\n<h3>2.2 \u4e3b\u8981\u6280\u672f\u53c2\u6570<\/h3>\n<p>\u4e0b\u8868\u5217\u51fa\u4e86\u5178\u578bHEPA\u8fc7\u6ee4\u5668\u7684\u4e3b\u8981\u6027\u80fd\u53c2\u6570\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u9879<\/th>\n<th>\u5178\u578b\u503c\/\u8303\u56f4<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fce\u98ce\u9762\u79ef<\/td>\n<td>484\u00d7484 mm \u81f3 610\u00d7610 mm<\/td>\n<td>\u5e38\u89c1\u6a21\u5757\u5c3a\u5bf8<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u963b\u529b<\/td>\n<td>\u2264200 Pa<\/td>\n<td>\u65b0\u88c5\u72b6\u6001\u4e0b\u538b\u964d<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf<\/td>\n<td>800\u20131200 m\u00b3\/h<\/td>\n<td>\u4f9d\u578b\u53f7\u800c\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387\uff080.3 \u03bcm\uff09<\/td>\n<td>\u226599.97%\uff08H13\u53ca\u4ee5\u4e0a\uff09<\/td>\n<td>DOP\u6216PAO\u6d4b\u8bd5\u6cd5\u6d4b\u5f97<\/td>\n<\/tr>\n<tr>\n<td>\u6846\u67b6\u6750\u8d28<\/td>\n<td>\u94dd\u5408\u91d1\u3001\u9540\u950c\u94a2\u677f\u3001\u4e0d\u9508\u94a2<\/td>\n<td>\u6297\u8150\u8680\u3001\u7ed3\u6784\u7a33\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u6750\u6599<\/td>\n<td>\u805a\u6c28\u916f\u53d1\u6ce1\u80f6\u3001\u7845\u80f6\u3001\u95ed\u5b54\u6d77\u7ef5<\/td>\n<td>\u786e\u4fdd\u5bc6\u5c01\u6027<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5bff\u547d<\/td>\n<td>3\u20135\u5e74\uff08\u89c6\u73af\u5883\u800c\u5b9a\uff09<\/td>\n<td>\u53ef\u901a\u8fc7\u538b\u5dee\u76d1\u63a7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6570\u636e\u6765\u6e90\uff1aGB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\uff1bASHRAE Standard 52.2-2017<\/p>\n<\/blockquote>\n<hr \/>\n<h2>3. \u5bc6\u5c01\u6027\u68c0\u6d4b\u7684\u91cd\u8981\u6027<\/h2>\n<p>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u8fd0\u8f93\u3001\u642c\u8fd0\u548c\u5b89\u88c5\u8fc7\u7a0b\u4e2d\uff0c\u53ef\u80fd\u56e0\u673a\u68b0\u5e94\u529b\u3001\u6846\u67b6\u53d8\u5f62\u6216\u5bc6\u5c01\u6750\u6599\u8001\u5316\u800c\u5bfc\u81f4\u5bc6\u5c01\u5931\u6548\u3002\u636e\u7f8e\u56fdASHRAE\uff08\u7f8e\u56fd\u91c7\u6696\u3001\u5236\u51b7\u4e0e\u7a7a\u8c03\u5de5\u7a0b\u5e08\u5b66\u4f1a\uff09\u7814\u7a76\u6307\u51fa\uff0c\u8d85\u8fc770%\u7684\u6d01\u51c0\u5ba4\u6c61\u67d3\u4e8b\u4ef6\u6e90\u4e8e\u8fc7\u6ee4\u5668\u5468\u8fb9\u7684\u6cc4\u6f0f\u800c\u975e\u8fc7\u6ee4\u4ecb\u8d28\u672c\u8eab\u7834\u635f\uff08ASHRAE Handbook\u2014HVAC Applications, 2020\uff09\u3002<\/p>\n<p>\u4e2d\u56fd\u300a\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303\u300b\uff08GB 50073-2013\uff09\u7b2c6.4.5\u6761\u660e\u786e\u89c4\u5b9a\uff1a\u201c\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b89\u88c5\u540e\u5e94\u8fdb\u884c\u68c0\u6f0f\uff0c\u786e\u8ba4\u65e0\u6cc4\u6f0f\u540e\u65b9\u53ef\u6295\u5165\u4f7f\u7528\u3002\u201d\u6b64\u5916\uff0c\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP 2010\u5e74\u4fee\u8ba2\u7248\uff09\u9644\u5f551\u4e2d\u4e5f\u5f3a\u8c03\uff1a\u201c\u5e94\u5b9a\u671f\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u3002\u201d<\/p>\n<p>\u5bc6\u5c01\u6027\u68c0\u6d4b\u7684\u76ee\u7684\u5728\u4e8e\uff1a<\/p>\n<ul>\n<li>\u9a8c\u8bc1\u8fc7\u6ee4\u5668\u4e0e\u7bb1\u4f53\u4e4b\u95f4\u7684\u5bc6\u5c01\u662f\u5426\u5b8c\u597d\uff1b<\/li>\n<li>\u53d1\u73b0\u5b89\u88c5\u8fc7\u7a0b\u4e2d\u7684\u7f1d\u9699\u3001\u7a7a\u6d1e\u6216\u5bc6\u5c01\u80f6\u5f00\u88c2\uff1b<\/li>\n<li>\u786e\u4fdd\u6c14\u6d41\u7ec4\u7ec7\u7b26\u5408\u5c42\u6d41\u8bbe\u8ba1\u8981\u6c42\uff1b<\/li>\n<li>\u6ee1\u8db3\u6cd5\u89c4\u5408\u89c4\u6027\u8981\u6c42\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>4. \u68c0\u6d4b\u539f\u7406\u4e0e\u65b9\u6cd5<\/h2>\n<h3>4.1 \u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5\uff08Aerosol Photometer Method\uff09<\/h3>\n<p>\u8be5\u65b9\u6cd5\u88ab\u5e7f\u6cdb\u5e94\u7528\u4e8e\u56fd\u5185\u5916\u6d01\u51c0\u5ba4\u68c0\u6d4b\u9886\u57df\uff0c\u5176\u539f\u7406\u662f\u5229\u7528\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u5728\u4e0a\u6e38\u91ca\u653e\u4e00\u5b9a\u6d53\u5ea6\u7684\u6d4b\u8bd5\u6c14\u6eb6\u80f6\uff08\u901a\u5e38\u4e3aDOP\u3001DEHS\u6216PAO\uff09\uff0c\u7136\u540e\u4f7f\u7528\u5149\u5ea6\u8ba1\u5728\u4e0b\u6e38\u626b\u63cf\u8fc7\u6ee4\u5668\u8868\u9762\u53ca\u8fb9\u6846\u533a\u57df\uff0c\u6d4b\u91cf\u7a7f\u900f\u7387\u3002<\/p>\n<h4>4.1.1 \u6d4b\u8bd5\u6c14\u6eb6\u80f6\u7c7b\u578b\u5bf9\u6bd4<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u6c14\u6eb6\u80f6\u7c7b\u578b<\/th>\n<th>\u5316\u5b66\u540d\u79f0<\/th>\n<th>\u7c92\u5f84\u5206\u5e03\uff08\u4e2d\u4f4d\u5f84\uff09<\/th>\n<th>\u5b89\u5168\u6027<\/th>\n<th>\u56fd\u5185\u5e94\u7528\u60c5\u51b5<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>PAO<\/td>\n<td>\u805a\u03b1\u70ef\u70c3\uff08Polyalphaolefin\uff09<\/td>\n<td>~0.3 \u03bcm<\/td>\n<td>\u4f4e\u6bd2\uff0c\u53ef\u63a5\u53d7<\/td>\n<td>\u5e7f\u6cdb\u4f7f\u7528<\/td>\n<\/tr>\n<tr>\n<td>DEHS<\/td>\n<td>\u5df1\u4e8c\u9178\u4e8c\u4e59\u57fa\u5df1\u916f<\/td>\n<td>~0.3 \u03bcm<\/td>\n<td>\u65e0\u6bd2\uff0c\u73af\u4fdd<\/td>\n<td>\u63a8\u8350\u66ff\u4ee3DOP<\/td>\n<\/tr>\n<tr>\n<td>DOP<\/td>\n<td>\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f<\/td>\n<td>~0.3 \u03bcm<\/td>\n<td>\u6f5c\u5728\u81f4\u764c\u6027<\/td>\n<td>\u9010\u6b65\u6dd8\u6c70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u53c2\u8003\u6587\u732e\uff1a\u5f20\u76ca\u662d\u7b49.\u300a\u6d01\u51c0\u5ba4\u9ad8\u6548\u8fc7\u6ee4\u5668\u68c0\u6f0f\u6280\u672f\u8fdb\u5c55\u300b[J]. \u6d01\u51c0\u4e0e\u5206\u79bb, 2021(3): 45-49.<\/p>\n<\/blockquote>\n<p>\u6839\u636eISO 14611-1:2014\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883\u2014\u2014\u8fc7\u6ee4\u5668\u68c0\u6f0f\u300b\u89c4\u5b9a\uff0c\u63a8\u8350\u4f7f\u7528\u975e\u81f4\u764c\u6027\u6c14\u6eb6\u80f6\u5982DEHS\u6216PAO\u3002<\/p>\n<h3>4.2 \u8ba1\u6570\u626b\u63cf\u6cd5\uff08Particle Counter Scan Method\uff09<\/h3>\n<p>\u91c7\u7528\u51b7\u53d1\u96fe\u65b9\u5f0f\u751f\u6210\u6c14\u6eb6\u80f6\uff0c\u914d\u5408\u591a\u901a\u9053\u7c92\u5b50\u8ba1\u6570\u5668\u8fdb\u884c\u626b\u63cf\u68c0\u6d4b\u3002\u6b64\u65b9\u6cd5\u7075\u654f\u5ea6\u66f4\u9ad8\uff0c\u9002\u7528\u4e8eU15\u53ca\u4ee5\u4e0a\u7b49\u7ea7\u7684\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u68c0\u6d4b\u3002<\/p>\n<p>\u4f18\u70b9\uff1a<\/p>\n<ul>\n<li>\u53ef\u68c0\u6d4b\u66f4\u5c0f\u7c92\u5f84\uff080.1 \u03bcm\uff09\uff1b<\/li>\n<li>\u6570\u636e\u6570\u5b57\u5316\uff0c\u4fbf\u4e8e\u8bb0\u5f55\u4e0e\u8ffd\u6eaf\uff1b<\/li>\n<li>\u7b26\u5408FDA\u5bf9\u65e0\u83cc\u5236\u836f\u7684\u8981\u6c42\u3002<\/li>\n<\/ul>\n<p>\u7f3a\u70b9\uff1a<\/p>\n<ul>\n<li>\u8bbe\u5907\u6210\u672c\u9ad8\uff1b<\/li>\n<li>\u5bf9\u73af\u5883\u6e29\u6e7f\u5ea6\u654f\u611f\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>5. \u68c0\u6d4b\u8bbe\u5907\u4e0e\u4eea\u5668<\/h2>\n<h3>5.1 \u4e3b\u8981\u68c0\u6d4b\u8bbe\u5907\u6e05\u5355<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u8bbe\u5907\u540d\u79f0<\/th>\n<th>\u529f\u80fd\u63cf\u8ff0<\/th>\n<th>\u63a8\u8350\u578b\u53f7\u793a\u4f8b<\/th>\n<th>\u6280\u672f\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6c14\u6eb6\u80f6\u53d1\u751f\u5668<\/td>\n<td>\u5728\u4e0a\u6e38\u4ea7\u751f\u7a33\u5b9a\u6d53\u5ea6\u7684\u6d4b\u8bd5\u6c14\u6eb6\u80f6<\/td>\n<td>TSI 8008, ATI PortaCount<\/td>\n<td>\u8f93\u51fa\u6d53\u5ea6\u53ef\u63a7\uff08\u226520 \u03bcg\/L\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u5149\u5ea6\u8ba1\uff08Photometer\uff09<\/td>\n<td>\u6d4b\u91cf\u4e0b\u6e38\u6c14\u6eb6\u80f6\u6d53\u5ea6\uff0c\u8ba1\u7b97\u7a7f\u900f\u7387<\/td>\n<td>TSI 8130, Camfil FMS100<\/td>\n<td>\u52a8\u6001\u8303\u56f40.0001\u2013100 mg\/m\u00b3<\/td>\n<\/tr>\n<tr>\n<td>\u7c92\u5b50\u8ba1\u6570\u5668<\/td>\n<td>\u626b\u63cf\u68c0\u6d4b\u5fae\u7c92\u6570\u91cf\uff0c\u7528\u4e8e\u9ad8\u7cbe\u5ea6\u68c0\u6f0f<\/td>\n<td>TSI 9020, Climet ICS-4<\/td>\n<td>\u901a\u9053\uff1a0.1, 0.3, 0.5 \u03bcm<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u63a2\u5934<\/td>\n<td>\u4e0e\u5149\u5ea6\u8ba1\u8fde\u63a5\uff0c\u7528\u4e8e\u9010\u70b9\u626b\u63cf<\/td>\n<td>\u6807\u51c6\u91c7\u6837\u5934\uff081 cm\u00b2\u5f00\u53e3\uff09<\/td>\n<td>\u626b\u63cf\u901f\u5ea6\u22645 cm\/s<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u901f\u4eea<\/td>\n<td>\u6d4b\u91cf\u9001\u98ce\u9762\u98ce\u901f\uff0c\u5224\u65ad\u6c14\u6d41\u5747\u5300\u6027<\/td>\n<td>Testo 405, KIMO VA200<\/td>\n<td>\u7cbe\u5ea6\u00b13%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6570\u636e\u6765\u6e90\uff1aTSI Incorporated Technical Notes; \u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u7814\u7a76\u603b\u9662\u300a\u6d01\u51c0\u5ba4\u68c0\u6d4b\u6280\u672f\u6307\u5357\u300b<\/p>\n<\/blockquote>\n<h3>5.2 \u6821\u51c6\u8981\u6c42<\/h3>\n<p>\u6240\u6709\u68c0\u6d4b\u4eea\u5668\u5fc5\u987b\u7ecf\u8fc7\u8ba1\u91cf\u90e8\u95e8\u6821\u51c6\uff0c\u5468\u671f\u4e0d\u8d85\u8fc712\u4e2a\u6708\u3002\u5149\u5ea6\u8ba1\u9700\u4f7f\u7528\u6807\u51c6\u6c14\u6eb6\u80f6\u8fdb\u884c\u96f6\u70b9\u548c\u6ee1\u91cf\u7a0b\u6821\u6b63\u3002<\/p>\n<hr \/>\n<h2>6. \u68c0\u6d4b\u6d41\u7a0b\u4e0e\u64cd\u4f5c\u89c4\u8303<\/h2>\n<h3>6.1 \u68c0\u6d4b\u524d\u51c6\u5907<\/h3>\n<ol>\n<li>\n<p><strong>\u73af\u5883\u6761\u4ef6\u63a7\u5236<\/strong>\uff1a<\/p>\n<ul>\n<li>\u6e29\u5ea6\uff1a18\u201326\u2103<\/li>\n<li>\u76f8\u5bf9\u6e7f\u5ea6\uff1a45\u201365%<\/li>\n<li>\u5ba4\u5185\u6d01\u51c0\u5ea6\u5e94\u4f18\u4e8eISO Class 8\uff0c\u907f\u514d\u80cc\u666f\u5e72\u6270<\/li>\n<\/ul>\n<\/li>\n<li>\n<p><strong>\u8bbe\u5907\u9884\u70ed<\/strong>\uff1a<\/p>\n<ul>\n<li>\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u9884\u70ed15\u5206\u949f\u4ee5\u4e0a<\/li>\n<li>\u5149\u5ea6\u8ba1\u5f00\u673a\u81ea\u68c0\u5e76\u6821\u51c6<\/li>\n<\/ul>\n<\/li>\n<li>\n<p><strong>\u4e0a\u6e38\u6d53\u5ea6\u5efa\u7acb<\/strong>\uff1a<\/p>\n<ul>\n<li>\u5c06\u6c14\u6eb6\u80f6\u6ce8\u5165\u9001\u98ce\u9759\u538b\u7bb1\u4e0a\u6e38<\/li>\n<li>\u4f7f\u7528\u5149\u5ea6\u8ba1\u6d4b\u91cf\u4e0a\u6e38\u6d53\u5ea6\uff0c\u7a33\u5b9a\u503c\u5e94\u572820\u2013100 \u03bcg\/L\u4e4b\u95f4<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<h3>6.2 \u626b\u63cf\u68c0\u6d4b\u6b65\u9aa4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6b65\u9aa4<\/th>\n<th>\u64cd\u4f5c\u5185\u5bb9<\/th>\n<th>\u6ce8\u610f\u4e8b\u9879<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>1<\/td>\n<td>\u8bbe\u7f6e\u626b\u63cf\u8def\u5f84\uff1a\u6cbf\u8fc7\u6ee4\u5668\u8868\u9762\u4ee5\u201cZ\u201d\u5b57\u5f62\u79fb\u52a8\u63a2\u5934<\/td>\n<td>\u8def\u5f84\u95f4\u8ddd\u22642 cm<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>\u63a7\u5236\u626b\u63cf\u901f\u5ea6\uff1a\u22645 cm\/s<\/td>\n<td>\u901f\u5ea6\u8fc7\u5feb\u5f71\u54cd\u68c0\u6d4b\u7cbe\u5ea6<\/td>\n<\/tr>\n<tr>\n<td>3<\/td>\n<td>\u63a2\u5934\u8ddd\u8fc7\u6ee4\u5668\u8868\u9762\u8ddd\u79bb\uff1a1\u20135 cm<\/td>\n<td>\u4e0d\u63a5\u89e6\u6ee4\u7eb8\u4ee5\u9632\u635f\u574f<\/td>\n<\/tr>\n<tr>\n<td>4<\/td>\n<td>\u91cd\u70b9\u68c0\u6d4b\u533a\u57df\uff1a\u8fb9\u6846\u3001\u62fc\u63a5\u7f1d\u3001\u56fa\u5b9a\u87ba\u9489\u5468\u56f4<\/td>\n<td>\u6cc4\u6f0f\u591a\u53d1\u533a<\/td>\n<\/tr>\n<tr>\n<td>5<\/td>\n<td>\u5b9e\u65f6\u8bb0\u5f55\u6570\u636e\uff1a\u5305\u62ec\u4f4d\u7f6e\u5750\u6807\u3001\u7a7f\u900f\u7387\u3001\u98ce\u901f<\/td>\n<td>\u5efa\u8bae\u4f7f\u7528\u81ea\u52a8\u8bb0\u5f55\u7cfb\u7edf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u53c2\u7167\u6807\u51c6\uff1aJGJ 71-90\u300a\u6d01\u51c0\u5ba4\u65bd\u5de5\u53ca\u9a8c\u6536\u89c4\u8303\u300b\u7b2c5.4\u8282<\/p>\n<\/blockquote>\n<h3>6.3 \u6cc4\u6f0f\u5224\u5b9a\u6807\u51c6<\/h3>\n<p>\u6839\u636eGB 50591-2010\u300a\u6d01\u51c0\u5ba4\u65bd\u5de5\u53ca\u9a8c\u6536\u89c4\u8303\u300b\u7b2c5.4.3\u6761\u89c4\u5b9a\uff1a<\/p>\n<ul>\n<li>\u5355\u70b9\u6700\u5927\u7a7f\u900f\u7387\u4e0d\u5f97\u8d85\u8fc7<strong>0.01%<\/strong>\uff08\u5373\u5149\u5ea6\u8ba1\u8bfb\u6570\u2264\u4e0a\u6e38\u6d53\u5ea6\u76840.01%\uff09<\/li>\n<li>\u82e5\u53d1\u73b0\u8d85\u6807\u70b9\uff0c\u5e94\u6807\u8bb0\u4f4d\u7f6e\u5e76\u91cd\u590d\u6d4b\u8bd5\u786e\u8ba4<\/li>\n<li>\u5bf9\u4e8e\u591a\u70b9\u8f7b\u5fae\u6cc4\u6f0f\uff08&lt;0.01%\uff09\uff0c\u5141\u8bb8\u5b58\u5728\uff0c\u4f46\u4e0d\u5f97\u96c6\u4e2d\u4e8e\u5c40\u90e8\u533a\u57df<\/li>\n<\/ul>\n<p>\u56fd\u9645\u6807\u51c6ISO 14611-1:2014\u4e2d\u89c4\u5b9a\uff0c\u5bf9\u4e8eH13\u53ca\u4ee5\u4e0a\u8fc7\u6ee4\u5668\uff0c\u5141\u8bb8\u6cc4\u6f0f\u9650\u503c\u4e3a<strong>0.03%<\/strong>\uff0c\u4f46\u5efa\u8bae\u91c7\u7528\u66f4\u4e25\u683c\u6807\u51c6\u3002<\/p>\n<hr \/>\n<h2>7. \u5e38\u89c1\u6cc4\u6f0f\u539f\u56e0\u4e0e\u5904\u7406\u63aa\u65bd<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u6cc4\u6f0f\u90e8\u4f4d<\/th>\n<th>\u53ef\u80fd\u539f\u56e0<\/th>\n<th>\u5904\u7406\u65b9\u6cd5<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fb9\u6846\u63a5\u53e3<\/td>\n<td>\u5bc6\u5c01\u80f6\u672a\u6253\u6ee1\u3001\u56fa\u5316\u4e0d\u5b8c\u5168<\/td>\n<td>\u8865\u5145\u65bd\u80f6\uff0c\u91cd\u65b0\u56fa\u5316\u540e\u590d\u6d4b<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u82af\u7834\u635f<\/td>\n<td>\u8fd0\u8f93\u649e\u51fb\u3001\u5b89\u88c5\u6324\u538b<\/td>\n<td>\u66f4\u6362\u6ee4\u82af\uff0c\u6574\u4f53\u9a8c\u6536<\/td>\n<\/tr>\n<tr>\n<td>\u6846\u67b6\u53d8\u5f62<\/td>\n<td>\u6750\u8d28\u5f3a\u5ea6\u4e0d\u8db3\u6216\u5b89\u88c5\u4e0d\u5f53<\/td>\n<td>\u8c03\u6574\u5b89\u88c5\u7ed3\u6784\uff0c\u52a0\u88c5\u652f\u6491<\/td>\n<\/tr>\n<tr>\n<td>\u56fa\u5b9a\u87ba\u6813\u677e\u52a8<\/td>\n<td>\u7d27\u56fa\u4e0d\u5230\u4f4d<\/td>\n<td>\u91cd\u65b0\u62e7\u7d27\u81f3\u89c4\u5b9a\u626d\u77e9<\/td>\n<\/tr>\n<tr>\n<td>\u9759\u538b\u7bb1\u88c2\u7f1d<\/td>\n<td>\u710a\u63a5\u7f3a\u9677\u6216\u8150\u8680<\/td>\n<td>\u8865\u710a\u6216\u66f4\u6362\u90e8\u4ef6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6848\u4f8b\u5206\u6790\uff1a\u67d0\u751f\u7269\u533b\u836f\u4f01\u4e1a\u8d85\u51c0\u53f0\u5728\u5e74\u5ea6\u9a8c\u8bc1\u4e2d\u53d1\u73b0\u8fb9\u6846\u6cc4\u6f0f\uff0c\u7ecf\u6392\u67e5\u4e3a\u805a\u6c28\u916f\u5bc6\u5c01\u80f6\u8001\u5316\u6536\u7f29\u6240\u81f4\uff0c\u66f4\u6362\u4e3a\u8010\u8001\u5316\u7684\u7845\u916e\u5bc6\u5c01\u80f6\u540e\u95ee\u9898\u89e3\u51b3\uff08\u5f15\u81ea\u300a\u4e2d\u56fd\u5236\u836f\u88c5\u5907\u300b2022\u5e74\u7b2c6\u671f\uff09\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>8. \u56fd\u5185\u5916\u6807\u51c6\u5bf9\u6bd4<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u6807\u51c6\u7f16\u53f7<\/th>\n<th>\u540d\u79f0<\/th>\n<th>\u5173\u952e\u8981\u6c42<\/th>\n<th>\u9002\u7528\u5730\u533a<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>GB 50591-2010<\/td>\n<td>\u300a\u6d01\u51c0\u5ba4\u65bd\u5de5\u53ca\u9a8c\u6536\u89c4\u8303\u300b<\/td>\n<td>\u7a7f\u900f\u7387\u22640.01%\uff0c\u626b\u63cf\u901f\u5ea6\u22645cm\/s<\/td>\n<td>\u4e2d\u56fd\u5927\u9646<\/td>\n<\/tr>\n<tr>\n<td>ISO 14611-1:2014<\/td>\n<td>Cleanrooms \u2014 Filter integrity testing<\/td>\n<td>\u5141\u8bb80.03%\u6cc4\u6f0f\uff0c\u63a8\u8350PAO\/DEHS<\/td>\n<td>\u56fd\u9645\u901a\u7528<\/td>\n<\/tr>\n<tr>\n<td>USP <\/td>\n<td>Good Microbiological Practices<\/td>\n<td>\u8981\u6c42\u5b9a\u671f\u68c0\u6f0f\uff0c\u7528\u4e8e\u65e0\u83cc\u5de5\u827a<\/td>\n<td>\u7f8e\u56fd\u836f\u5178<\/td>\n<\/tr>\n<tr>\n<td>GMP Annex 1 (2022)<\/td>\n<td>Manufacture of Sterile Medicinal Products<\/td>\n<td>\u5fc5\u987b\u8fdb\u884c\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n<td>\u6b27\u76df\u3001WHO<\/td>\n<\/tr>\n<tr>\n<td>JIS Z 8122:2004<\/td>\n<td>\u6d01\u51c0\u5ba4\u6027\u80fd\u6d4b\u8bd5\u65b9\u6cd5<\/td>\n<td>\u89c4\u5b9a\u4e86\u5149\u5ea6\u8ba1\u6cd5\u64cd\u4f5c\u7ec6\u8282<\/td>\n<td>\u65e5\u672c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u5c3d\u7ba1\u5404\u56fd\u6807\u51c6\u7565\u6709\u5dee\u5f02\uff0c\u4f46\u5747\u5f3a\u8c03\u201c\u5b89\u88c5\u540e\u9996\u6b21\u68c0\u6f0f\u201d\u548c\u201c\u5b9a\u671f\u518d\u9a8c\u8bc1\u201d\u7684\u5fc5\u8981\u6027\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>9. \u68c0\u6d4b\u62a5\u544a\u4e0e\u8bb0\u5f55\u7ba1\u7406<\/h2>\n<p>\u5b8c\u6574\u7684\u68c0\u6d4b\u62a5\u544a\u5e94\u5305\u542b\u4ee5\u4e0b\u5185\u5bb9\uff1a<\/p>\n<ul>\n<li>\u68c0\u6d4b\u65e5\u671f\u3001\u73af\u5883\u53c2\u6570\uff08\u6e29\u6e7f\u5ea6\u3001\u538b\u5dee\uff09<\/li>\n<li>\u8bbe\u5907\u4fe1\u606f\uff08\u578b\u53f7\u3001\u7f16\u53f7\u3001\u6821\u51c6\u6709\u6548\u671f\uff09<\/li>\n<li>\u4e0a\u6e38\u6c14\u6eb6\u80f6\u6d53\u5ea6\uff08\u5e73\u5747\u503c\uff09<\/li>\n<li>\u626b\u63cf\u8def\u5f84\u56fe\u793a\uff08\u53ef\u9644\u7167\u7247\u6216CAD\u56fe\uff09<\/li>\n<li>\u6cc4\u6f0f\u70b9\u4f4d\u7f6e\u3001\u5b9e\u6d4b\u7a7f\u900f\u7387<\/li>\n<li>\u7ed3\u8bba\u4e0e\u5efa\u8bae\uff08\u5408\u683c\/\u4e0d\u5408\u683c\uff0c\u662f\u5426\u9700\u6574\u6539\uff09<\/li>\n<li>\u68c0\u6d4b\u4eba\u5458\u7b7e\u540d\u4e0e\u5ba1\u6838\u610f\u89c1<\/li>\n<\/ul>\n<p>\u5efa\u8bae\u91c7\u7528\u7535\u5b50\u5316\u7ba1\u7406\u7cfb\u7edf\u5b58\u50a8\u5386\u53f2\u6570\u636e\uff0c\u4fbf\u4e8e\u8d8b\u52bf\u5206\u6790\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\u3002<\/p>\n<hr \/>\n<h2>10. \u7279\u6b8a\u5e94\u7528\u573a\u666f\u4e0b\u7684\u68c0\u6d4b\u8981\u6c42<\/h2>\n<h3>10.1 \u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\uff08BSL-3\/4\uff09<\/h3>\n<p>\u5728\u9ad8\u7b49\u7ea7\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\u4e2d\uff0c\u8d85\u51c0\u53f0\u5e38\u7528\u4e8e\u5904\u7406\u9ad8\u81f4\u75c5\u6027\u5fae\u751f\u7269\u3002\u6b64\u65f6\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5bc6\u5c01\u6027\u76f4\u63a5\u5173\u7cfb\u5230\u4eba\u5458\u5b89\u5168\u3002\u6839\u636e\u300a\u5b9e\u9a8c\u5ba4\u751f\u7269\u5b89\u5168\u901a\u7528\u8981\u6c42\u300b\uff08GB 19489-2008\uff09\uff0c\u5fc5\u987b\u91c7\u7528\u53cc\u5c42HEPA\u8fc7\u6ee4\u5668\uff0c\u5e76\u5bf9\u6392\u98ce\u7aef\u8fc7\u6ee4\u5668\u8fdb\u884c\u539f\u4f4d\u68c0\u6f0f\u3002<\/p>\n<h3>10.2 \u5236\u836f\u65e0\u83cc\u64cd\u4f5c\u533a<\/h3>\n<p>\u4f9d\u636eGMP\u9644\u5f551\u7b2c9.4\u6761\uff0c\u65e0\u83cc\u704c\u88c5\u533a\u7684\u8d85\u51c0\u53f0\u9700\u6bcf6\u4e2a\u6708\u8fdb\u884c\u4e00\u6b21\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u4e14\u5e94\u5728\u201c\u52a8\u6001\u201d\u548c\u201c\u9759\u6001\u201d\u4e24\u79cd\u5de5\u51b5\u4e0b\u5206\u522b\u8bc4\u4f30\u3002\u63a8\u8350\u4f7f\u7528\u81ea\u52a8\u5316\u626b\u63cf\u7cfb\u7edf\uff0c\u51cf\u5c11\u4eba\u4e3a\u8bef\u5dee\u3002<\/p>\n<h3>10.3 \u534a\u5bfc\u4f53\u6d01\u51c0\u8f66\u95f4<\/h3>\n<p>\u5728\u5fae\u7535\u5b50\u5236\u9020\u4e2d\uff0c\u5bf9\u4e9a\u5fae\u7c73\u7ea7\u9897\u7c92\u6781\u4e3a\u654f\u611f\u3002\u5e38\u91c7\u7528ULPA\u8fc7\u6ee4\u5668\uff08U15-U17\uff09\uff0c\u5e76\u7ed3\u5408\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u5668\u8fdb\u884c0.1 \u03bcm\u7ea7\u522b\u7684\u626b\u63cf\u68c0\u6d4b\uff0c\u786e\u4fdd\u5c40\u90e8\u6d01\u51c0\u5ea6\u8fbe\u5230ISO Class 3\u6c34\u5e73\u3002<\/p>\n<hr \/>\n<h2>11. \u81ea\u52a8\u5316\u68c0\u6d4b\u7cfb\u7edf\u7684\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<p>\u8fd1\u5e74\u6765\uff0c\u968f\u7740\u667a\u80fd\u5236\u9020\u548c\u6570\u5b57\u5316\u5de5\u5382\u7684\u63a8\u8fdb\uff0c\u5168\u81ea\u52a8\u8fc7\u6ee4\u5668\u68c0\u6f0f\u7cfb\u7edf\u9010\u6e10\u666e\u53ca\u3002\u6b64\u7c7b\u7cfb\u7edf\u96c6\u6210\u673a\u5668\u4eba\u81c2\u3001\u9ad8\u7cbe\u5ea6\u4f20\u611f\u5668\u4e0eAI\u7b97\u6cd5\uff0c\u53ef\u5b9e\u73b0\u65e0\u4eba\u503c\u5b88\u3001\u5168\u6d41\u7a0b\u81ea\u52a8\u5316\u68c0\u6d4b\u3002<\/p>\n<p>\u4f8b\u5982\uff0c\u5fb7\u56fdTest-Fuchs\u516c\u53f8\u5f00\u53d1\u7684AutoScan\u7cfb\u5217\u8bbe\u5907\uff0c\u53ef\u572815\u5206\u949f\u5185\u5b8c\u6210\u4e00\u53f0\u6807\u51c6\u8d85\u51c0\u53f0\u7684\u5168\u9762\u626b\u63cf\uff0c\u5e76\u751f\u6210\u4e09\u7ef4\u6cc4\u6f0f\u70ed\u529b\u56fe\u3002\u56fd\u5185\u5982\u82cf\u5dde\u5b89\u6cf0\u7a7a\u6c14\u6280\u672f\u6709\u9650\u516c\u53f8\u4e5f\u63a8\u51fa\u4e86\u56fd\u4ea7\u5316\u81ea\u52a8\u68c0\u6f0f\u5e73\u53f0\uff0c\u652f\u6301Modbus\u901a\u8baf\u534f\u8bae\uff0c\u4fbf\u4e8e\u63a5\u5165MES\u7cfb\u7edf\u3002<\/p>\n<p>\u4f18\u52bf\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u63d0\u9ad8\u68c0\u6d4b\u4e00\u81f4\u6027\uff1b<\/li>\n<li>\u51cf\u5c11\u4eba\u5de5\u5e72\u9884\u98ce\u9669\uff1b<\/li>\n<li>\u5b9e\u73b0\u5927\u6570\u636e\u5206\u6790\u4e0e\u9884\u6d4b\u6027\u7ef4\u62a4\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>12. \u7ef4\u62a4\u4e0e\u518d\u9a8c\u8bc1\u5468\u671f<\/h2>\n<p>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e76\u975e\u4e00\u52b3\u6c38\u9038\uff0c\u5176\u5bc6\u5c01\u6027\u80fd\u4f1a\u968f\u65f6\u95f4\u63a8\u79fb\u800c\u52a3\u5316\u3002\u5efa\u8bae\u6267\u884c\u5982\u4e0b\u7ef4\u62a4\u8ba1\u5212\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5e94\u7528\u573a\u666f<\/th>\n<th>\u9996\u6b21\u68c0\u6f0f<\/th>\n<th>\u518d\u9a8c\u8bc1\u5468\u671f<\/th>\n<th>\u7279\u6b8a\u60c5\u51b5<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u666e\u901a\u5b9e\u9a8c\u5ba4<\/td>\n<td>\u5b89\u88c5\u540e\u7acb\u5373\u8fdb\u884c<\/td>\n<td>\u6bcf\u5e74\u4e00\u6b21<\/td>\n<td>\u66f4\u6362\u6ee4\u82af\u540e\u91cd\u6d4b<\/td>\n<\/tr>\n<tr>\n<td>GMP\u5236\u836f<\/td>\n<td>\u5b89\u88c5+\u8c03\u8bd5\u9636\u6bb5<\/td>\n<td>\u6bcf6\u4e2a\u6708<\/td>\n<td>\u5de5\u827a\u53d8\u66f4\u3001\u505c\u4ea7\u91cd\u542f<\/td>\n<\/tr>\n<tr>\n<td>BSL-3\u5b9e\u9a8c\u5ba4<\/td>\n<td>\u5b89\u88c5+\u8d1f\u538b\u6d4b\u8bd5\u540e<\/td>\n<td>\u6bcf3\u4e2a\u6708<\/td>\n<td>\u53d1\u751f\u6cc4\u6f0f\u4e8b\u6545\u540e\u7acb\u5373\u590d\u6d4b<\/td>\n<\/tr>\n<tr>\n<td>\u534a\u5bfc\u4f53\u8f66\u95f4<\/td>\n<td>\u5b89\u88c5+\u6d01\u51c0\u5ea6\u8fbe\u6807\u540e<\/td>\n<td>\u6bcf\u5b63\u5ea6<\/td>\n<td>\u5927\u4fee\u6216\u88c5\u4fee\u540e<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u53c2\u8003\uff1a\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300a\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u73b0\u573a\u68c0\u67e5\u6307\u5357\u300b2021\u7248<\/p>\n<\/blockquote>\n<hr \/>\n<h2>13. \u57f9\u8bad\u4e0e\u4eba\u5458\u8d44\u8d28<\/h2>\n<p>\u68c0\u6d4b\u64cd\u4f5c\u4eba\u5458\u5e94\u5177\u5907\u4ee5\u4e0b\u80fd\u529b\uff1a<\/p>\n<ul>\n<li>\u719f\u6089\u6d01\u51c0\u5ba4\u539f\u7406\u4e0eHEPA\u8fc7\u6ee4\u673a\u5236\uff1b<\/li>\n<li>\u638c\u63e1\u6c14\u6eb6\u80f6\u53d1\u751f\u4e0e\u5149\u5ea6\u8ba1\u4f7f\u7528\u6280\u80fd\uff1b<\/li>\n<li>\u80fd\u6b63\u786e\u89e3\u8bfb\u6807\u51c6\u4e0e\u5224\u5b9a\u7ed3\u679c\uff1b<\/li>\n<li>\u5177\u5907\u57fa\u672c\u7684\u5b89\u5168\u9632\u62a4\u77e5\u8bc6\uff08\u5982\u4f69\u6234N95\u53e3\u7f69\u3001\u907f\u514d\u5438\u5165PAO\u96fe\u6ef4\uff09\u3002<\/li>\n<\/ul>\n<p>\u5efa\u8bae\u7531\u7b2c\u4e09\u65b9\u8ba4\u8bc1\u673a\u6784\uff08\u5982\u4e2d\u56fd\u5408\u683c\u8bc4\u5b9a\u56fd\u5bb6\u8ba4\u53ef\u59d4\u5458\u4f1aCNAS\u6388\u6743\u5b9e\u9a8c\u5ba4\uff09\u5f00\u5c55\u4e13\u4e1a\u57f9\u8bad\uff0c\u5e76\u9881\u53d1\u4e0a\u5c97\u8bc1\u4e66\u3002<\/p>\n<hr \/>\n<h2>14. \u5178\u578b\u95ee\u9898\u89e3\u7b54\uff08FAQ\uff09<\/h2>\n<p><strong>Q1\uff1a\u80fd\u5426\u7528\u70df\u96fe\u7b14\u4ee3\u66ff\u4e13\u4e1a\u8bbe\u5907\u8fdb\u884c\u68c0\u6f0f\uff1f<\/strong><br \/>\nA\uff1a\u4e0d\u53ef\u9760\u3002\u70df\u96fe\u7b14\u4ec5\u80fd\u5b9a\u6027\u89c2\u5bdf\u6c14\u6d41\u8d70\u5411\uff0c\u65e0\u6cd5\u5b9a\u91cf\u6d4b\u91cf\u6cc4\u6f0f\u7a0b\u5ea6\uff0c\u4e0d\u7b26\u5408\u6807\u51c6\u8981\u6c42\u3002<\/p>\n<p><strong>Q2\uff1a\u4e0a\u6e38\u6d53\u5ea6\u592a\u4f4e\u4f1a\u5f71\u54cd\u68c0\u6d4b\u7ed3\u679c\u5417\uff1f<\/strong><br \/>\nA\uff1a\u4f1a\u3002\u6d53\u5ea6\u8fc7\u4f4e\u4f1a\u5bfc\u81f4\u4fe1\u566a\u6bd4\u4e0b\u964d\uff0c\u6613\u9020\u6210\u8bef\u5224\u3002\u5e94\u786e\u4fdd\u4e0a\u6e38\u6d53\u5ea6\u7a33\u5b9a\u572820 \u03bcg\/L\u4ee5\u4e0a\u3002<\/p>\n<p><strong>Q3\uff1a\u68c0\u6d4b\u65f6\u662f\u5426\u9700\u8981\u5173\u95ed\u8d85\u51c0\u53f0\u7167\u660e\uff1f<\/strong><br \/>\nA\uff1a\u5efa\u8bae\u5173\u95ed\u6216\u906e\u853d\u5f3a\u5149\u6e90\uff0c\u907f\u514d\u5149\u7ebf\u5e72\u6270\u5149\u5ea6\u8ba1\u4f20\u611f\u5668\u3002<\/p>\n<p><strong>Q4\uff1a\u53d1\u73b0\u6cc4\u6f0f\u540e\u5982\u4f55\u4fee\u8865\uff1f<\/strong><br \/>\nA\uff1a\u5c0f\u8303\u56f4\u53ef\u8865\u6ce8\u5bc6\u5c01\u80f6\uff1b\u82e5\u6ee4\u6750\u635f\u4f24\u6216\u6846\u67b6\u53d8\u5f62\u4e25\u91cd\uff0c\u5e94\u6574\u4f53\u66f4\u6362\u3002<\/p>\n<hr \/>\n<h2>15. \u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>GB\/T 13554-2020. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668[S]. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2020.  <\/li>\n<li>GB 50073-2013. \u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303[S]. \u5317\u4eac: \u4e2d\u56fd\u8ba1\u5212\u51fa\u7248\u793e, 2013.  <\/li>\n<li>GB 50591-2010. \u6d01\u51c0\u5ba4\u65bd\u5de5\u53ca\u9a8c\u6536\u89c4\u8303[S]. \u5317\u4eac: \u4e2d\u56fd\u5efa\u7b51\u5de5\u4e1a\u51fa\u7248\u793e, 2010.  <\/li>\n<li>ISO 14611-1:2014. Cleanrooms and associated controlled environments \u2014 Filter integrity testing \u2014 Part 1: Measurement of airflow rate through filters by the aerosol photometry method[S]. Geneva: ISO, 2014.  <\/li>\n<li>ASHRAE Standard 52.2-2017. Method of Testing General Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size[S]. Atlanta: ASHRAE, 2017.  <\/li>\n<li>USP-NF . Good Microbiological Practices[J]. United States Pharmacopeia, 2023.  <\/li>\n<li>EU GMP Annex 1: Manufacture of Sterile Medicinal Products (2022 version)[S]. EMA, 2022.  <\/li>\n<li>\u5f20\u76ca\u662d, \u674e\u4f1f. \u6d01\u51c0\u5ba4\u9ad8\u6548\u8fc7\u6ee4\u5668\u68c0\u6f0f\u6280\u672f\u7814\u7a76\u8fdb\u5c55[J]. \u6d01\u51c0\u4e0e\u5206\u79bb, 2021, 21(3): 45-49.  <\/li>\n<li>\u738b\u5efa\u56fd. \u836f\u54c1\u751f\u4ea7\u6d01\u51c0\u533a\u73af\u5883\u63a7\u5236[M]. \u5317\u4eac: \u5316\u5b66\u5de5\u4e1a\u51fa\u7248\u793e, 2019.  <\/li>\n<li>TSI Incorporated. Aerosol Instrumentation Handbook[Z]. Shoreview, MN: TSI, 2020.<\/li>\n<\/ol>\n<hr \/>\n<h2>16. \u672f\u8bed\u89e3\u91ca\uff08\u9644\u5f55\uff09<\/h2>\n<ul>\n<li><strong>HEPA<\/strong>\uff1aHigh-Efficiency Particulate Air Filter\uff0c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668  <\/li>\n<li><strong>PAO<\/strong>\uff1aPolyalphaolefin\uff0c\u805a\u03b1\u70ef\u70c3\uff0c\u5e38\u7528\u6d4b\u8bd5\u6c14\u6eb6\u80f6  <\/li>\n<li><strong>\u5149\u5ea6\u8ba1<\/strong>\uff1aPhotometer\uff0c\u7528\u4e8e\u6d4b\u91cf\u6c14\u6eb6\u80f6\u5149\u6563\u5c04\u5f3a\u5ea6\u7684\u4eea\u5668  <\/li>\n<li><strong>\u7a7f\u900f\u7387<\/strong>\uff1aLeakage Rate\uff0c\u4e0b\u6e38\u6d53\u5ea6\u4e0e\u4e0a\u6e38\u6d53\u5ea6\u4e4b\u6bd4\uff0c\u8868\u793a\u6cc4\u6f0f\u7a0b\u5ea6  <\/li>\n<li><strong>\u5c42\u6d41<\/strong>\uff1aLaminar Flow\uff0c\u6c14\u6d41\u5448\u5e73\u884c\u76f4\u7ebf\u6d41\u52a8\uff0c\u901f\u5ea6\u5747\u5300  <\/li>\n<\/ul>\n<blockquote>\n<p>\u4fe1\u606f\u6574\u7406\u81ea\u767e\u5ea6\u767e\u79d1\u8bcd\u6761\u201c\u9ad8\u6548\u8fc7\u6ee4\u5668\u201d\u3001\u201c\u8d85\u51c0\u5de5\u4f5c\u53f0\u201d\u3001\u201c\u6d01\u51c0\u5ba4\u201d\u7b49\u76f8\u5173\u9875\u9762\uff08<a href=\"https:\/\/baike.baidu.com\">https:\/\/baike.baidu.com<\/a>\uff09<\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>\u8d85\u51c0\u53f0\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b89\u88c5\u5bc6\u5c01\u6027\u68c0\u6d4b\u6280\u672f\u89c4\u8303 1. \u5f15\u8a00 \u8d85\u51c0\u5de5\u4f5c\u53f0\uff08Laminar Flow Cabinet\uff09\u662f\u5b9e\u9a8c\u5ba4\u3001\u5236\u836f\u3001\u751f\u7269\u5b89\u5168\u3001\u7535\u5b50\u5236\u9020\u7b49\u9ad8\u6d01\u51c0\u5ea6\u73af\u5883\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u8bbe\u5907\uff0c\u5176\u6838\u5fc3\u529f\u80fd\u5728\u4e8e\u901a\u8fc7\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA, High-Efficiency Particulate Air Filter\uff09\u63d0\u4f9b\u5355\u5411\u3001\u65e0\u5c18\u3001\u65e0\u83cc\u7684\u6c14\u6d41\u73af\u5883\u3002\u4e3a\u786e\u4fdd\u6d01\u51c0\u533a\u8fbe\u5230\u89c4\u5b9a\u7684\u6d01\u51c0\u7b49\u7ea7\uff08&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-17066","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\/17066","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=17066"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/17066\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17066"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17066"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17066"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}