{"id":15248,"date":"2025-06-18T18:04:42","date_gmt":"2025-06-18T10:04:42","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15248"},"modified":"2025-06-18T18:04:42","modified_gmt":"2025-06-18T10:04:42","slug":"%e4%b8%8d%e9%94%88%e9%92%a2%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e5%88%b6%e8%8d%af%e8%a1%8c%e4%b8%9a%e4%b8%ad%e7%9a%84%e9%a2%97%e7%b2%92%e7%89%a9%e5%8e%bb%e9%99%a4%e6%95%88%e7%8e%87","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15248","title":{"rendered":"\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u9897\u7c92\u7269\u53bb\u9664\u6548\u7387\u5206\u6790"},"content":{"rendered":"<h1>\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u9897\u7c92\u7269\u53bb\u9664\u6548\u7387\u5206\u6790<\/h1>\n<h2>\u4e00\u3001\u5f15\u8a00\uff1a\u5236\u836f\u884c\u4e1a\u4e2d\u9897\u7c92\u7269\u63a7\u5236\u7684\u91cd\u8981\u6027<\/h2>\n<p>\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u751f\u4ea7\u8fc7\u7a0b\u5bf9\u73af\u5883\u6d01\u51c0\u5ea6\u7684\u8981\u6c42\u6781\u4e3a\u4e25\u683c\u3002\u7279\u522b\u662f\u5728\u65e0\u83cc\u5236\u5242\u548c\u9ad8\u7eaf\u5ea6\u836f\u7269\u7684\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u9897\u7c92\u7269\u7684\u6d53\u5ea6\u76f4\u63a5\u5f71\u54cd\u5230\u6700\u7ec8\u4ea7\u54c1\u7684\u8d28\u91cf\u4e0e\u5b89\u5168\u6027\u3002\u6839\u636e\u300a\u4e2d\u56fd\u836f\u5178\u300b\uff082020\u7248\uff09\u4ee5\u53ca\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u3001\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u7684\u76f8\u5173\u89c4\u8303\uff0c\u5236\u836f\u8f66\u95f4\u5fc5\u987b\u8fbe\u5230\u7279\u5b9a\u7684\u7a7a\u6c14\u6d01\u51c0\u7b49\u7ea7\uff08\u5982ISO 14644-1\u6807\u51c6\u4e0b\u7684Class 5\u81f3Class 8\uff09\uff0c\u4ee5\u786e\u4fdd\u4ea7\u54c1\u4e0d\u53d7\u6c61\u67d3\u3002<\/p>\n<p>\u5728\u6b64\u80cc\u666f\u4e0b\uff0c<strong>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/strong>\uff08High-Efficiency Particulate Air Filter, HEPA\uff09\u6210\u4e3a\u5236\u836f\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4e2d\u7684\u6838\u5fc3\u7ec4\u4ef6\u4e4b\u4e00\u3002\u800c\u8fd1\u5e74\u6765\uff0c\u968f\u7740\u6280\u672f\u8fdb\u6b65\u548c\u73af\u4fdd\u8981\u6c42\u7684\u63d0\u5347\uff0c<strong>\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668<\/strong>\u56e0\u5176\u4f18\u5f02\u7684\u8010\u8150\u8680\u6027\u3001\u957f\u5bff\u547d\u53ca\u53ef\u91cd\u590d\u4f7f\u7528\u7279\u6027\uff0c\u5728\u5236\u836f\u884c\u4e1a\u4e2d\u5f97\u5230\u4e86\u5e7f\u6cdb\u5e94\u7528\u3002<\/p>\n<p>\u672c\u6587\u5c06\u56f4\u7ed5\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u5e94\u7528\u5c55\u5f00\u5206\u6790\uff0c\u91cd\u70b9\u63a2\u8ba8\u5176\u5bf9\u9897\u7c92\u7269\u7684\u53bb\u9664\u6548\u7387\u3001\u6027\u80fd\u53c2\u6570\u3001\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\u53ca\u5176\u5bf9\u6bd4\u5206\u6790\uff0c\u5e76\u5f15\u7528\u56fd\u5185\u5916\u6743\u5a01\u6587\u732e\u8d44\u6599\uff0c\u529b\u6c42\u4e3a\u76f8\u5173\u9886\u57df\u63d0\u4f9b\u79d1\u5b66\u53c2\u8003\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u7ed3\u6784\u4e0e\u5de5\u4f5c\u539f\u7406<\/h2>\n<h3>2.1 \u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5b9a\u4e49<\/h3>\n<p>\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u91c7\u7528\u4e0d\u9508\u94a2\u6750\u6599\u4f5c\u4e3a\u6846\u67b6\u6216\u5916\u58f3\uff0c\u914d\u5408\u9ad8\u6548\u6ee4\u6750\uff08\u5982\u73bb\u7483\u7ea4\u7ef4\u3001\u805a\u4e19\u70ef\u7b49\uff09\u6784\u6210\u7684\u7a7a\u6c14\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u5177\u6709\u826f\u597d\u7684\u5316\u5b66\u7a33\u5b9a\u6027\u3001\u673a\u68b0\u5f3a\u5ea6\u548c\u70ed\u7a33\u5b9a\u6027\uff0c\u9002\u7528\u4e8e\u9ad8\u6e29\u3001\u9ad8\u6e7f\u3001\u8150\u8680\u6027\u5f3a\u7b49\u6076\u52a3\u5de5\u51b5\u73af\u5883\u3002<\/p>\n<h3>2.2 \u7ed3\u6784\u7ec4\u6210<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u90e8\u4ef6<\/th>\n<th>\u6750\u8d28<\/th>\n<th>\u529f\u80fd<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6846\u67b6<\/td>\n<td>SUS304\u6216SUS316\u4e0d\u9508\u94a2<\/td>\n<td>\u63d0\u4f9b\u7ed3\u6784\u652f\u6491\uff0c\u589e\u5f3a\u6297\u538b\u80fd\u529b<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u82af<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\/PTFE\/\u805a\u4e19\u70ef<\/td>\n<td>\u5b9e\u73b0\u9ad8\u6548\u8fc7\u6ee4\u529f\u80fd<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u6761<\/td>\n<td>\u7845\u6a61\u80f6\u6216EPDM<\/td>\n<td>\u4fdd\u8bc1\u5bc6\u5c01\u6027\u80fd\uff0c\u9632\u6b62\u6cc4\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>\u63a5\u53e3<\/td>\n<td>\u5361\u7b8d\u5f0f\u6216\u6cd5\u5170\u5f0f<\/td>\n<td>\u65b9\u4fbf\u5b89\u88c5\u4e0e\u62c6\u5378<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>2.3 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e3b\u8981\u901a\u8fc7\u4ee5\u4e0b\u51e0\u79cd\u673a\u5236\u5b9e\u73b0\u9897\u7c92\u7269\u7684\u6355\u96c6\uff1a<\/p>\n<ol>\n<li><strong>\u62e6\u622a\u4f5c\u7528<\/strong>\uff08Interception\uff09\uff1a\u5f53\u9897\u7c92\u7269\u63a5\u8fd1\u6ee4\u6750\u7ea4\u7ef4\u65f6\u88ab\u5438\u9644\u3002<\/li>\n<li><strong>\u60ef\u6027\u649e\u51fb<\/strong>\uff08Impaction\uff09\uff1a\u5927\u9897\u7c92\u56e0\u60ef\u6027\u504f\u79bb\u6c14\u6d41\u8def\u5f84\u800c\u649e\u51fb\u5230\u7ea4\u7ef4\u4e0a\u3002<\/li>\n<li><strong>\u6269\u6563\u4f5c\u7528<\/strong>\uff08Diffusion\uff09\uff1a\u5c0f\u9897\u7c92\u7531\u4e8e\u5e03\u6717\u8fd0\u52a8\u968f\u673a\u8fd0\u52a8\uff0c\u66f4\u5bb9\u6613\u88ab\u6355\u83b7\u3002<\/li>\n<li><strong>\u9759\u7535\u5438\u9644<\/strong>\uff08Electrostatic Attraction\uff09\uff1a\u90e8\u5206\u6ee4\u6750\u5e26\u6709\u9759\u7535\uff0c\u589e\u5f3a\u5438\u9644\u6548\u679c\u3002<\/li>\n<\/ol>\n<p>\u8fd9\u4e9b\u673a\u5236\u5171\u540c\u4f5c\u7528\uff0c\u4f7f\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u22650.3\u03bcm\u7684\u9897\u7c92\u7269\uff0c\u53bb\u9664\u6548\u7387\u53ef\u8fbe99.97%\u4ee5\u4e0a\uff08\u4f9d\u636eEN 1822\u6807\u51c6\uff09\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u5236\u836f\u884c\u4e1a\u5bf9\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u8981\u6c42<\/h2>\n<p>\u5236\u836f\u884c\u4e1a\u5bf9\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u7684\u6027\u80fd\u8981\u6c42\u6781\u9ad8\uff0c\u4e3b\u8981\u4f53\u73b0\u5728\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6027\u80fd\u6307\u6807<\/th>\n<th>\u8981\u6c42\u63cf\u8ff0<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u226599.97%\uff0c\u9488\u5bf90.3\u03bcm\u9897\u7c92<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u6d41\u963b\u529b<\/td>\n<td>\u2264250 Pa\uff08\u521d\u963b\u529b\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u88c5\u65b9\u5f0f<\/td>\n<td>\u6613\u4e8e\u66f4\u6362\u3001\u7ef4\u62a4<\/td>\n<\/tr>\n<tr>\n<td>\u5316\u5b66\u7a33\u5b9a\u6027<\/td>\n<td>\u80fd\u62b5\u6297\u5e38\u89c1\u6e05\u6d01\u5242\u3001\u6d88\u6bd2\u5242\uff08\u5982\u9152\u7cbe\u3001\u8fc7\u6c27\u5316\u6c22\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u8010\u6e29\u6027<\/td>\n<td>\u53ef\u9002\u5e94\u706d\u83cc\u6e29\u5ea6\uff08\u5982121\u2103\u84b8\u6c7d\u706d\u83cc\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u53ef\u91cd\u590d\u4f7f\u7528\u6027<\/td>\n<td>\u652f\u6301\u591a\u6b21\u6e05\u6d17\u6216\u5728\u7ebf\u706d\u83cc<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u6b64\u5916\uff0c\u8fd8\u9700\u6ee1\u8db3GMP\uff08Good Manufacturing Practice\uff09\u4e2d\u5173\u4e8e\u8bbe\u5907\u6750\u8d28\u3001\u7ed3\u6784\u8bbe\u8ba1\u3001\u9a8c\u8bc1\u8bb0\u5f55\u7b49\u65b9\u9762\u7684\u89c4\u5b9a\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1a\u7684\u5e94\u7528\u573a\u666f<\/h2>\n<h3>4.1 \u5e94\u7528\u4e8e\u6d01\u51c0\u5ba4\u901a\u98ce\u7cfb\u7edf<\/h3>\n<p>\u5236\u836f\u6d01\u51c0\u5ba4\u901a\u5e38\u91c7\u7528\u5c42\u6d41\u9001\u98ce\u7cfb\u7edf\uff08Laminar Flow System\uff09\uff0c\u5176\u4e2d\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u7ec8\u7aef\u8fc7\u6ee4\u5668\u5b89\u88c5\u5728\u9001\u98ce\u53e3\uff0c\u786e\u4fdd\u8fdb\u5165\u6d01\u51c0\u533a\u7684\u7a7a\u6c14\u8fbe\u5230\u89c4\u5b9a\u7684\u6d01\u51c0\u7b49\u7ea7\u3002<\/p>\n<h3>4.2 \u7528\u4e8e\u9694\u79bb\u5668\u4e0eRABS\u7cfb\u7edf<\/h3>\n<p>\u5728\u65e0\u83cc\u704c\u88c5\u533a\u57df\uff0c\u5e38\u4f7f\u7528<strong>\u9650\u5236\u8fdb\u5165\u5c4f\u969c\u7cfb\u7edf<\/strong>\uff08Restricted Access Barrier System, RABS\uff09\u6216<strong>\u9694\u79bb\u5668<\/strong>\uff08Isolator\uff09\uff0c\u5176\u4e2d\u5185\u7f6e\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u4ee5\u7ef4\u6301\u5185\u90e8\u5fae\u73af\u5883\u7684\u6d01\u51c0\u72b6\u6001\u3002<\/p>\n<h3>4.3 \u7528\u4e8e\u751f\u7269\u5b89\u5168\u67dc\u4e0e\u4f20\u9012\u7a97<\/h3>\n<p>\u5728\u5b9e\u9a8c\u5ba4\u6216\u751f\u4ea7\u8f66\u95f4\u5185\uff0c\u751f\u7269\u5b89\u5168\u67dc\uff08BSC\uff09\u548c\u7269\u6599\u4f20\u9012\u7a97\u4e5f\u5e7f\u6cdb\u91c7\u7528\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u8fdb\u884c\u6392\u98ce\u548c\u8fdb\u98ce\u8fc7\u6ee4\uff0c\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\u3002<\/p>\n<hr \/>\n<h2>\u4e94\u3001\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u9897\u7c92\u7269\u53bb\u9664\u6548\u7387\u5206\u6790<\/h2>\n<h3>5.1 \u6d4b\u8bd5\u65b9\u6cd5\u4e0e\u6807\u51c6<\/h3>\n<p>\u76ee\u524d\u56fd\u9645\u901a\u7528\u7684\u6d4b\u8bd5\u6807\u51c6\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>EN 1822<\/strong>\uff08\u6b27\u6d32\u6807\u51c6\uff09\uff1a\u89c4\u5b9a\u4e86HEPA\u548cULPA\u8fc7\u6ee4\u5668\u7684\u5206\u7ea7\u4e0e\u6d4b\u8bd5\u65b9\u6cd5\uff1b<\/li>\n<li><strong>IEST-RP-CC001<\/strong>\uff08\u7f8e\u56fd\u6807\u51c6\uff09\uff1a\u7528\u4e8e\u8bc4\u4f30HEPA\/ULPA\u8fc7\u6ee4\u5668\u6027\u80fd\uff1b<\/li>\n<li><strong>GB\/T 13554-2020<\/strong>\uff08\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6\uff09\uff1a\u6211\u56fd\u73b0\u884c\u7684\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6807\u51c6\u3002<\/li>\n<\/ul>\n<p>\u6d4b\u8bd5\u9879\u76ee\u4e3b\u8981\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u521d\u59cb\u6548\u7387\u6d4b\u8bd5<\/li>\n<li>\u538b\u5dee\u6d4b\u8bd5<\/li>\n<li>\u6cc4\u6f0f\u68c0\u6d4b\uff08\u5149\u5ea6\u8ba1\u6cd5\u6216\u7c92\u5b50\u8ba1\u6570\u6cd5\uff09<\/li>\n<li>\u5bff\u547d\u6d4b\u8bd5\uff08\u8010\u4e45\u6027\uff09<\/li>\n<\/ul>\n<h3>5.2 \u5b9e\u9a8c\u6570\u636e\u5206\u6790<\/h3>\n<p>\u67d0\u56fd\u5185\u5927\u578b\u5236\u836f\u4f01\u4e1a\u5bf9\u5176\u6d01\u51c0\u8f66\u95f4\u4f7f\u7528\u7684\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u8fdb\u884c\u4e86\u4e3a\u671f\u4e00\u5e74\u7684\u8ddf\u8e2a\u76d1\u6d4b\uff0c\u7ed3\u679c\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u521d\u503c<\/th>\n<th>\u4f7f\u75286\u4e2a\u6708\u540e<\/th>\n<th>\u4f7f\u752812\u4e2a\u6708\u540e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u59cb\u6548\u7387\uff08\u22650.3\u03bcm\uff09<\/td>\n<td>99.98%<\/td>\n<td>99.96%<\/td>\n<td>99.95%<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u538b\u5dee<\/td>\n<td>190 Pa<\/td>\n<td>210 Pa<\/td>\n<td>230 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u68c0\u6d4b\u6cc4\u6f0f\u70b9<\/td>\n<td>\u65e0<\/td>\n<td>\u65e0<\/td>\n<td>1\u5904\u8f7b\u5fae\u6cc4\u6f0f<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u7ed3\u679c\u663e\u793a\uff0c\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u957f\u671f\u8fd0\u884c\u4e2d\u4ecd\u4fdd\u6301\u8f83\u9ad8\u6548\u7387\uff0c\u4ec5\u51fa\u73b0\u8f7b\u5fae\u538b\u5dee\u4e0a\u5347\u548c\u5c40\u90e8\u6cc4\u6f0f\u73b0\u8c61\uff0c\u8868\u660e\u5176\u5177\u5907\u826f\u597d\u7684\u7a33\u5b9a\u6027\u548c\u53ef\u9760\u6027\u3002<\/p>\n<hr \/>\n<h2>\u516d\u3001\u4e0d\u540c\u54c1\u724c\u4e0e\u578b\u53f7\u7684\u6bd4\u8f83\u5206\u6790<\/h2>\n<p>\u4e3a\u4e86\u66f4\u5168\u9762\u5730\u8bc4\u4f30\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u5dee\u5f02\uff0c\u6211\u4eec\u9009\u53d6\u4e86\u56fd\u5185\u5916\u51e0\u4e2a\u4e3b\u6d41\u54c1\u724c\u7684\u4ee3\u8868\u6027\u4ea7\u54c1\u8fdb\u884c\u5bf9\u6bd4\u5206\u6790\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u54c1\u724c<\/th>\n<th>\u578b\u53f7<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387<\/th>\n<th>\u521d\u59cb\u538b\u5dee<\/th>\n<th>\u6750\u8d28<\/th>\n<th>\u8010\u6e29\u6027<\/th>\n<th>\u4ef7\u683c\u533a\u95f4\uff08\u5143\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Camfil\uff08\u745e\u5178\uff09<\/td>\n<td>Hi-Flo ES<\/td>\n<td>99.995%<\/td>\n<td>200 Pa<\/td>\n<td>SUS304<\/td>\n<td>121\u2103<\/td>\n<td>8000\u201312000<\/td>\n<\/tr>\n<tr>\n<td>Donaldson\uff08\u7f8e\u56fd\uff09<\/td>\n<td>Ultra-Web<\/td>\n<td>99.99%<\/td>\n<td>180 Pa<\/td>\n<td>SUS316<\/td>\n<td>130\u2103<\/td>\n<td>10000\u201315000<\/td>\n<\/tr>\n<tr>\n<td>\u82cf\u5dde\u5eb7\u6590\u5c14<\/td>\n<td>KF-H14<\/td>\n<td>99.97%<\/td>\n<td>220 Pa<\/td>\n<td>SUS304<\/td>\n<td>121\u2103<\/td>\n<td>5000\u20138000<\/td>\n<\/tr>\n<tr>\n<td>\u5e7f\u4e1c\u91d1\u5b87<\/td>\n<td>JY-HEPA<\/td>\n<td>99.95%<\/td>\n<td>230 Pa<\/td>\n<td>SUS304<\/td>\n<td>110\u2103<\/td>\n<td>4000\u20136000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u4ece\u8868\u4e2d\u53ef\u89c1\uff0c\u56fd\u5916\u54c1\u724c\u5728\u8fc7\u6ee4\u6548\u7387\u3001\u538b\u5dee\u63a7\u5236\u65b9\u9762\u7565\u4f18\u4e8e\u56fd\u5185\u54c1\u724c\uff0c\u4f46\u4ef7\u683c\u8f83\u9ad8\uff1b\u56fd\u5185\u54c1\u724c\u5219\u5728\u6027\u4ef7\u6bd4\u65b9\u9762\u5177\u6709\u4e00\u5b9a\u4f18\u52bf\uff0c\u9002\u5408\u4e2d\u5c0f\u578b\u5236\u836f\u4f01\u4e1a\u9009\u7528\u3002<\/p>\n<hr \/>\n<h2>\u4e03\u3001\u5f71\u54cd\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u6548\u7387\u7684\u56e0\u7d20\u5206\u6790<\/h2>\n<h3>7.1 \u6ee4\u6750\u7c7b\u578b\u4e0e\u7ed3\u6784\u8bbe\u8ba1<\/h3>\n<p>\u4e0d\u540c\u6ee4\u6750\u5bf9\u8fc7\u6ee4\u6548\u7387\u6709\u663e\u8457\u5f71\u54cd\u3002\u4f8b\u5982\uff1a<\/p>\n<ul>\n<li><strong>\u73bb\u7483\u7ea4\u7ef4\u6ee4\u7eb8<\/strong>\uff1a\u4f20\u7edf\u6750\u6599\uff0c\u8fc7\u6ee4\u6548\u7387\u9ad8\uff0c\u4f46\u6613\u788e\uff1b<\/li>\n<li><strong>\u805a\u56db\u6c1f\u4e59\u70ef\uff08PTFE\uff09\u819c<\/strong>\uff1a\u8010\u8150\u8680\u3001\u758f\u6c34\u6027\u5f3a\uff0c\u9002\u7528\u4e8e\u6f6e\u6e7f\u73af\u5883\uff1b<\/li>\n<li><strong>\u7eb3\u7c73\u7ea4\u7ef4\u590d\u5408\u6ee4\u6750<\/strong>\uff1a\u65b0\u578b\u6750\u6599\uff0c\u5177\u6709\u66f4\u9ad8\u7684\u6bd4\u8868\u9762\u79ef\u548c\u5438\u9644\u80fd\u529b\u3002<\/li>\n<\/ul>\n<h3>7.2 \u5b89\u88c5\u4e0e\u5bc6\u5c01\u6027<\/h3>\n<p>\u4e0d\u6070\u5f53\u7684\u5b89\u88c5\u6216\u5bc6\u5c01\u4e0d\u826f\u4f1a\u5bfc\u81f4\u65c1\u8def\u6cc4\u6f0f\uff0c\u4e25\u91cd\u5f71\u54cd\u6574\u4f53\u6548\u7387\u3002\u7814\u7a76\u8868\u660e\uff0c\u5373\u4f7f\u5b58\u57281%\u7684\u6cc4\u6f0f\uff0c\u4e5f\u4f1a\u5bfc\u81f4\u6d01\u51c0\u5ba4\u5185\u9897\u7c92\u7269\u6d53\u5ea6\u5347\u9ad8\u6570\u5341\u500d\u3002<\/p>\n<h3>7.3 \u64cd\u4f5c\u73af\u5883\u56e0\u7d20<\/h3>\n<ul>\n<li>\u6e29\u6e7f\u5ea6\u53d8\u5316\u53ef\u80fd\u5f71\u54cd\u6ee4\u6750\u7684\u7269\u7406\u6027\u80fd\uff1b<\/li>\n<li>\u9ad8\u9891\u6b21\u7684\u706d\u83cc\u64cd\u4f5c\u53ef\u80fd\u5bfc\u81f4\u6ee4\u6750\u8001\u5316\uff1b<\/li>\n<li>\u591a\u6b21\u6e05\u6d17\u53ef\u80fd\u9020\u6210\u6ee4\u6750\u7ed3\u6784\u635f\u4f24\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u516b\u3001\u56fd\u5185\u5916\u7814\u7a76\u8fdb\u5c55\u4e0e\u8d8b\u52bf<\/h2>\n<h3>8.1 \u56fd\u5916\u7814\u7a76\u52a8\u6001<\/h3>\n<p>\u6839\u636e<strong>WHO Technical Report Series No. 961<\/strong>\uff082011\u5e74\u4fee\u8ba2\u7248\uff09\uff0c\u63a8\u8350\u5728\u5173\u952e\u533a\u57df\u4f7f\u7528ULPA\u8fc7\u6ee4\u5668\uff08\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\uff09\uff0c\u6548\u7387\u53ef\u8fbe99.9995%\u4ee5\u4e0a\u3002\u540c\u65f6\uff0c\u56fd\u5916\u5b66\u8005\u4e5f\u5728\u63a2\u7d22\u667a\u80fd\u578b\u8fc7\u6ee4\u5668\uff0c\u5982\u5e26\u538b\u529b\u4f20\u611f\u5668\u3001\u81ea\u52a8\u62a5\u8b66\u529f\u80fd\u7684\u4ea7\u54c1\u3002<\/p>\n<p>\u7f8e\u56fdFDA\u5728\u5176\u53d1\u5e03\u7684\u300aGuidance for Industry: Sterile Drug Products Produced by Aseptic Processing\u300b\u4e2d\u5f3a\u8c03\uff0c\u5e94\u5b9a\u671f\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08Integrity Test\uff09\uff0c\u5e76\u5efa\u7acb\u5b8c\u6574\u7684\u9a8c\u8bc1\u6587\u6863\u4f53\u7cfb\u3002<\/p>\n<h3>8.2 \u56fd\u5185\u7814\u7a76\u73b0\u72b6<\/h3>\n<p>\u8fd1\u5e74\u6765\uff0c\u6211\u56fd\u5728\u9ad8\u6548\u8fc7\u6ee4\u5668\u56fd\u4ea7\u5316\u65b9\u9762\u53d6\u5f97\u4e86\u663e\u8457\u8fdb\u5c55\u3002\u6e05\u534e\u5927\u5b66\u73af\u5883\u5b66\u9662\u8054\u5408\u591a\u5bb6\u4f01\u4e1a\u5f00\u5c55\u201c\u9ad8\u6027\u80fd\u9ad8\u6548\u8fc7\u6ee4\u5668\u6750\u6599\u7814\u53d1\u201d\u9879\u76ee\uff0c\u6210\u529f\u5f00\u53d1\u51fa\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u7eb3\u7c73\u7ea4\u7ef4\u590d\u5408\u6ee4\u6750\uff0c\u5176\u8fc7\u6ee4\u6548\u7387\u8fbe\u523099.99%\u4ee5\u4e0a\uff0c\u4e14\u5177\u6709\u826f\u597d\u7684\u8010\u6e29\u6027\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u300a\u4e2d\u56fd\u836f\u5178\u300b2020\u7248\u65b0\u589e\u4e86\u5bf9\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u7684\u9a8c\u8bc1\u8981\u6c42\uff0c\u63a8\u52a8\u4e86\u5236\u836f\u4f01\u4e1a\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u9009\u578b\u4e0e\u7ba1\u7406\u7684\u89c4\u8303\u5316\u3002<\/p>\n<hr \/>\n<h2>\u4e5d\u3001\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>9.1 \u67d0\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1a\u6848\u4f8b<\/h3>\n<p>\u67d0\u5927\u578b\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1a\u5728\u6539\u9020\u5176A\u7ea7\u6d01\u51c0\u533a\u7a7a\u8c03\u7cfb\u7edf\u65f6\uff0c\u91c7\u7528\u4e86\u5fb7\u56fdCamfil\u516c\u53f8\u7684\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u3002\u6539\u9020\u540e\uff0c\u6d01\u51c0\u533a\u5185\u7684\u7c92\u5b50\u6d53\u5ea6\u7531\u539f\u6765\u7684\u22643500\u4e2a\/m\u00b3\uff08\u22650.5\u03bcm\uff09\u4e0b\u964d\u81f3\u22642000\u4e2a\/m\u00b3\uff0c\u5fae\u751f\u7269\u8d1f\u8377\u4e5f\u663e\u8457\u964d\u4f4e\uff0c\u8fbe\u5230\u4e86\u65b0\u7248GMP\u6807\u51c6\u3002<\/p>\n<h3>9.2 \u67d0\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u6848\u4f8b<\/h3>\n<p>\u5728\u67d0\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u4e2d\uff0c\u91c7\u7528\u5e7f\u4e1c\u91d1\u5b87\u516c\u53f8\u751f\u4ea7\u7684\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u914d\u5408VHP\uff08\u6c7d\u5316\u8fc7\u6c27\u5316\u6c22\uff09\u706d\u83cc\u7cfb\u7edf\u3002\u7ecf\u8fde\u7eed\u8fd0\u884c6\u4e2a\u6708\u540e\uff0c\u672a\u53d1\u73b0\u8fc7\u6ee4\u5668\u7834\u635f\u6216\u6cc4\u6f0f\u60c5\u51b5\uff0c\u4e14\u7ef4\u62a4\u6210\u672c\u8f83\u4f4e\uff0c\u4e3a\u4f01\u4e1a\u8282\u7701\u4e86\u5927\u91cf\u8fd0\u8425\u8d39\u7528\u3002<\/p>\n<hr \/>\n<h2>\u5341\u3001\u7ed3\u8bba\u4e0e\u5c55\u671b\uff08\u7565\uff09<\/h2>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a.\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff082020\u5e74\u7248\uff09[M]. \u5317\u4eac: \u5316\u5b66\u5de5\u4e1a\u51fa\u7248\u793e, 2020.  <\/li>\n<li>WHO. WHO Technical Report Series No. 961. Annex 8: Manufacture of sterile medicinal products [R]. Geneva: World Health Organization, 2011.  <\/li>\n<li>FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing [Z]. U.S. Department of Health and Human Services, 2004.  <\/li>\n<li>European Medicines Agency. EMA\/INS\/GMP\/485451\/2016 Rev.1 [R]. London: EMA, 2017.  <\/li>\n<li>ISO 14644-1:2015 Cleanrooms and associated controlled environments \u2014 Part 1: Classification and testing [S].  <\/li>\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>\u674e\u660e\u7b49. \u65b0\u578b\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u6750\u6599\u7684\u7814\u7a76\u8fdb\u5c55[J]. \u73af\u5883\u5de5\u7a0b\u5b66\u62a5, 2021, 15(6): 1821\u20131828.  <\/li>\n<li>\u5f20\u5f3a\u7b49. \u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u7814\u7a76[J]. \u5236\u836f\u88c5\u5907, 2020(12): 45\u201349.  <\/li>\n<li>Camfil. Hi-Flo ES Product Brochure [Z]. Sweden: Camfil Group, 2022.  <\/li>\n<li>Donaldson Company. Ultra-Web HEPA Filters Technical Data Sheet [Z]. 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