{"id":16895,"date":"2025-09-22T15:07:12","date_gmt":"2025-09-22T07:07:12","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16895"},"modified":"2025-09-22T15:07:12","modified_gmt":"2025-09-22T07:07:12","slug":"%e5%af%86%e9%97%ad%e6%93%8d%e4%bd%9c%e7%8e%af%e5%a2%83%e4%b8%8b%e6%9d%bf%e5%bc%8f%e8%bf%87%e6%bb%a4%e5%99%a8%e5%af%b9%e6%97%a0%e8%8f%8c%e7%94%9f%e4%ba%a7%e5%b7%a5%e8%89%ba%e7%9a%84%e6%94%af%e6%8c%81","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16895","title":{"rendered":"\u5bc6\u95ed\u64cd\u4f5c\u73af\u5883\u4e0b\u677f\u5f0f\u8fc7\u6ee4\u5668\u5bf9\u65e0\u83cc\u751f\u4ea7\u5de5\u827a\u7684\u652f\u6301\u4f5c\u7528"},"content":{"rendered":"<h1>\u5bc6\u95ed\u64cd\u4f5c\u73af\u5883\u4e0b\u677f\u5f0f\u8fc7\u6ee4\u5668\u5bf9\u65e0\u83cc\u751f\u4ea7\u5de5\u827a\u7684\u652f\u6301\u4f5c\u7528<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u65e0\u83cc\u751f\u4ea7\u662f\u4fdd\u969c\u836f\u54c1\u5b89\u5168\u3001\u6709\u6548\u548c\u8d28\u91cf\u53ef\u63a7\u7684\u6838\u5fc3\u73af\u8282\u3002\u968f\u7740\u751f\u7269\u6280\u672f\u836f\u7269\u3001\u6ce8\u5c04\u5242\u3001\u75ab\u82d7\u7b49\u9ad8\u9644\u52a0\u503c\u4ea7\u54c1\u7684\u5feb\u901f\u53d1\u5c55\uff0c\u5bf9\u751f\u4ea7\u73af\u5883\u7684\u6d01\u51c0\u5ea6\u4e0e\u5fae\u751f\u7269\u63a7\u5236\u63d0\u51fa\u4e86\u524d\u6240\u672a\u6709\u7684\u4e25\u683c\u8981\u6c42\u3002\u6839\u636e\u300a\u4e2d\u56fd\u836f\u5178\u300b2020\u5e74\u7248\u53ca\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u548c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u7684\u76f8\u5173\u89c4\u5b9a\uff0c\u65e0\u83cc\u836f\u54c1\u5fc5\u987b\u5728\u7b26\u5408GMP\uff08Good Manufacturing Practice\uff09\u6807\u51c6\u7684\u73af\u5883\u4e2d\u751f\u4ea7\uff0c\u4e14\u5173\u952e\u5de5\u827a\u6b65\u9aa4\u9700\u91c7\u7528\u6709\u6548\u7684\u9664\u83cc\u624b\u6bb5\u3002<\/p>\n<p>\u5728\u6b64\u80cc\u666f\u4e0b\uff0c<strong>\u5bc6\u95ed\u64cd\u4f5c\u73af\u5883<\/strong>\u4e0e<strong>\u9ad8\u6548\u8fc7\u6ee4\u7cfb\u7edf<\/strong>\u7684\u7ed3\u5408\u6210\u4e3a\u5b9e\u73b0\u65e0\u83cc\u751f\u4ea7\u7684\u5173\u952e\u8def\u5f84\u4e4b\u4e00\u3002\u5176\u4e2d\uff0c<strong>\u677f\u5f0f\u8fc7\u6ee4\u5668<\/strong>\uff08Plate Filter\uff09\u56e0\u5176\u7ed3\u6784\u7d27\u51d1\u3001\u5bc6\u5c01\u6027\u597d\u3001\u6613\u4e8e\u96c6\u6210\u81ea\u52a8\u5316\u7cfb\u7edf\u7b49\u7279\u70b9\uff0c\u5728\u5bc6\u95ed\u65e0\u83cc\u5de5\u827a\u4e2d\u5c55\u73b0\u51fa\u663e\u8457\u4f18\u52bf\u3002\u672c\u6587\u5c06\u7cfb\u7edf\u9610\u8ff0\u677f\u5f0f\u8fc7\u6ee4\u5668\u5728\u5bc6\u95ed\u64cd\u4f5c\u73af\u5883\u4e0b\u7684\u5e94\u7528\u673a\u5236\u3001\u6280\u672f\u53c2\u6570\u3001\u652f\u6301\u529f\u80fd\u53ca\u5176\u5728\u56fd\u5185\u5916\u5236\u836f\u5b9e\u8df5\u4e2d\u7684\u5177\u4f53\u6848\u4f8b\uff0c\u5e76\u7ed3\u5408\u6743\u5a01\u6587\u732e\u8fdb\u884c\u6df1\u5165\u5206\u6790\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001\u677f\u5f0f\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u4e0e\u7ed3\u6784\u7279\u5f81<\/h2>\n<h3>1.1 \u5b9a\u4e49\u4e0e\u5de5\u4f5c\u539f\u7406<\/h3>\n<p>\u677f\u5f0f\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u901a\u8fc7\u591a\u5c42\u6ee4\u677f\u5806\u53e0\u5f62\u6210\u8fc7\u6ee4\u8154\u4f53\u7684\u56fa\u6db2\u5206\u79bb\u8bbe\u5907\uff0c\u5176\u6838\u5fc3\u539f\u7406\u662f\u5229\u7528\u538b\u529b\u5dee\u9a71\u52a8\u6db2\u4f53\u7a7f\u8fc7\u6ee4\u819c\u6216\u6ee4\u7eb8\u4ecb\u8d28\uff0c\u4ece\u800c\u622a\u7559\u9897\u7c92\u7269\u3001\u5fae\u751f\u7269\u6216\u6742\u8d28\u3002\u5728\u5bc6\u95ed\u7cfb\u7edf\u4e2d\uff0c\u8be5\u8bbe\u5907\u901a\u5e38\u4e0e\u6cf5\u3001\u50a8\u7f50\u3001\u7ba1\u9053\u7b49\u7ec4\u6210\u5168\u5c01\u95ed\u6d41\u8def\uff0c\u907f\u514d\u5916\u754c\u6c61\u67d3\u4fb5\u5165\u3002<\/p>\n<p>\u6839\u636e\u8fc7\u6ee4\u4ecb\u8d28\u7684\u4e0d\u540c\uff0c\u677f\u5f0f\u8fc7\u6ee4\u5668\u53ef\u5206\u4e3a\uff1a<\/p>\n<ul>\n<li>\u6ee4\u7eb8\u5f0f\u677f\u6846\u538b\u6ee4\u673a<\/li>\n<li>\u819c\u5f0f\u677f\u5f0f\u8fc7\u6ee4\u5668\uff08\u5982\u805a\u919a\u781cPES\u3001\u805a\u56db\u6c1f\u4e59\u70efPTFE\uff09<\/li>\n<li>\u6df1\u5c42\u8fc7\u6ee4\u677f\u5f0f\u7cfb\u7edf<\/li>\n<\/ul>\n<p>\u5728\u65e0\u83cc\u5de5\u827a\u4e2d\uff0c\u5e38\u91c7\u7528<strong>\u9884\u8fc7\u6ee4+\u7ec8\u7aef\u9664\u83cc\u8fc7\u6ee4<\/strong>\u7684\u7ec4\u5408\u6a21\u5f0f\uff0c\u5176\u4e2d\u7ec8\u7aef\u8fc7\u6ee4\u591a\u4f7f\u7528\u5b54\u5f84\u4e3a0.22 \u03bcm\u6216\u66f4\u5c0f\u7684\u4eb2\u6c34\u6027\u6ee4\u819c\uff0c\u4ee5\u786e\u4fdd\u53bb\u9664\u6240\u6709\u6f5c\u5728\u81f4\u75c5\u5fae\u751f\u7269\u3002<\/p>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\nFDA. (2004). <em>Sterile Drug Products Produced by Aseptic Processing\u2014Current Good Manufacturing Practice<\/em>. U.S. Department of Health and Human Services.<br \/>\nEMA. (2008). <em>Guideline on the Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container<\/em>. EMEA\/CHMP\/CVMP\/QWP\/96304\/2007.<\/p>\n<\/blockquote>\n<hr \/>\n<h3>1.2 \u4e3b\u8981\u7ed3\u6784\u7ec4\u6210<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u7ec4\u4ef6<\/th>\n<th>\u529f\u80fd\u63cf\u8ff0<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6ee4\u677f\uff08Filter Plate\uff09<\/td>\n<td>\u652f\u6491\u6ee4\u819c\uff0c\u5f62\u6210\u8fc7\u6ee4\u8154\u5ba4\uff0c\u6750\u8d28\u591a\u4e3a\u4e0d\u9508\u94a2316L\u6216\u805a\u4e19\u70ef<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u6846\uff08Filter Frame\uff09<\/td>\n<td>\u63d0\u4f9b\u6db2\u4f53\u901a\u9053\u7a7a\u95f4\uff0c\u51b3\u5b9a\u8fc7\u6ee4\u9762\u79ef<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u5e03\/\u6ee4\u819c\uff08Filter Medium\uff09<\/td>\n<td>\u5b9e\u73b0\u9897\u7c92\u622a\u7559\uff0c\u5e38\u7528\u6750\u6599\u5305\u62ecPES\u3001PVDF\u3001PTFE\u7b49<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u7d27\u88c5\u7f6e\uff08Compression System\uff09<\/td>\n<td>\u673a\u68b0\u6216\u6db2\u538b\u65b9\u5f0f\u538b\u7d27\u5bc6\u5c01\u7ec4\u4ef6\uff0c\u9632\u6b62\u6cc4\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>\u8fdb\u51fa\u6599\u53e3\uff08Inlet\/Outlet Ports\uff09<\/td>\n<td>\u8fde\u63a5\u7ba1\u9053\u7cfb\u7edf\uff0c\u5b9e\u73b0\u5bc6\u95ed\u8f93\u9001<\/td>\n<\/tr>\n<tr>\n<td>\u6392\u6c14\u9600\u4e0e\u538b\u529b\u8868<\/td>\n<td>\u76d1\u63a7\u7cfb\u7edf\u8fd0\u884c\u72b6\u6001\uff0c\u4fdd\u969c\u64cd\u4f5c\u5b89\u5168<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e8c\u3001\u5bc6\u95ed\u64cd\u4f5c\u73af\u5883\u7684\u6280\u672f\u8981\u6c42\u4e0e\u6311\u6218<\/h2>\n<h3>2.1 \u5bc6\u95ed\u7cfb\u7edf\u7684\u5b9a\u4e49\u4e0e\u6807\u51c6<\/h3>\n<p>\u5bc6\u95ed\u64cd\u4f5c\u73af\u5883\u6307\u5728\u6574\u4e2a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u7269\u6599\u59cb\u7ec8\u5904\u4e8e\u5c01\u95ed\u7684\u5bb9\u5668\u6216\u7ba1\u9053\u7cfb\u7edf\u4e2d\uff0c\u4e0d\u4e0e\u5916\u754c\u7a7a\u6c14\u76f4\u63a5\u63a5\u89e6\u3002\u4f9d\u636eISPE\uff08\u56fd\u9645\u5236\u836f\u5de5\u7a0b\u534f\u4f1a\uff09\u6307\u5357\uff0c\u5bc6\u95ed\u7cfb\u7edf\u5e94\u6ee1\u8db3\u4ee5\u4e0b\u57fa\u672c\u6761\u4ef6\uff1a<\/p>\n<ul>\n<li>\u6240\u6709\u63a5\u53e3\u5747\u5177\u5907\u826f\u597d\u7684\u5bc6\u5c01\u6027\u80fd\uff1b<\/li>\n<li>\u53ef\u8fdb\u884c\u5728\u7ebf\u6e05\u6d17\uff08CIP\uff09\u4e0e\u5728\u7ebf\u706d\u83cc\uff08SIP\uff09\uff1b<\/li>\n<li>\u7cfb\u7edf\u5b8c\u6574\u6027\u53ef\u901a\u8fc7\u6ce1\u70b9\u6d4b\u8bd5\u3001\u6269\u6563\u6d41\u6d4b\u8bd5\u7b49\u65b9\u5f0f\u9a8c\u8bc1\uff1b<\/li>\n<li>\u64cd\u4f5c\u8fc7\u7a0b\u65e0\u9700\u4eba\u5de5\u5e72\u9884\u6216\u5f00\u76d6\u64cd\u4f5c\u3002<\/li>\n<\/ul>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\nISPE. (2019). <em>Baseline Guide: Sterile Manufacturing Facilities<\/em>, Volume 3.<br \/>\nNoyes, D. et al. (2017). &quot;Closed Systems for Handling Potent Compounds.&quot; <em>Pharmaceutical Engineering<\/em>, 37(3), 1\u201310.<\/p>\n<\/blockquote>\n<hr \/>\n<h3>2.2 \u4f20\u7edf\u5f00\u653e\u64cd\u4f5c\u7684\u98ce\u9669<\/h3>\n<p>\u5728\u975e\u5bc6\u95ed\u7cfb\u7edf\u4e2d\uff0c\u5982\u5f00\u653e\u5f0f\u6405\u62cc\u7f50\u3001\u655e\u53e3\u8fc7\u6ee4\u69fd\u7b49\uff0c\u5b58\u5728\u4ee5\u4e0b\u4e3b\u8981\u98ce\u9669\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u98ce\u9669\u7c7b\u578b<\/th>\n<th>\u5177\u4f53\u8868\u73b0<\/th>\n<th>\u540e\u679c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5fae\u751f\u7269\u6c61\u67d3<\/td>\n<td>\u7a7a\u6c14\u4e2d\u6d6e\u6e38\u83cc\u8fdb\u5165\u4ea7\u54c1<\/td>\n<td>\u5bfc\u81f4\u65e0\u83cc\u5931\u8d25\u3001\u6279\u6b21\u62a5\u5e9f<\/td>\n<\/tr>\n<tr>\n<td>\u9897\u7c92\u7269\u6c61\u67d3<\/td>\n<td>\u7070\u5c18\u3001\u7ea4\u7ef4\u7b49\u5f02\u7269\u6df7\u5165<\/td>\n<td>\u5f71\u54cd\u6f84\u660e\u5ea6\uff0c\u5f15\u53d1\u4e0d\u826f\u53cd\u5e94<\/td>\n<\/tr>\n<tr>\n<td>\u64cd\u4f5c\u4eba\u5458\u66b4\u9732<\/td>\n<td>\u63a5\u89e6\u9ad8\u6d3b\u6027\u7269\u8d28<\/td>\n<td>\u804c\u4e1a\u5065\u5eb7\u98ce\u9669\u589e\u52a0<\/td>\n<\/tr>\n<tr>\n<td>\u5de5\u827a\u6ce2\u52a8\u5927<\/td>\n<td>\u73af\u5883\u6e29\u6e7f\u5ea6\u53d8\u5316\u5f71\u54cd\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u4ea7\u54c1\u8d28\u91cf\u4e0d\u7a33\u5b9a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u56e0\u6b64\uff0c\u5411\u5bc6\u95ed\u5316\u3001\u81ea\u52a8\u5316\u8f6c\u578b\u5df2\u6210\u4e3a\u5168\u7403\u5236\u836f\u884c\u4e1a\u7684\u5171\u8bc6\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u677f\u5f0f\u8fc7\u6ee4\u5668\u5728\u5bc6\u95ed\u65e0\u83cc\u5de5\u827a\u4e2d\u7684\u652f\u6301\u4f5c\u7528<\/h2>\n<h3>3.1 \u5b9e\u73b0\u5168\u8fc7\u7a0b\u5bc6\u95ed\u4f20\u8f93<\/h3>\n<p>\u677f\u5f0f\u8fc7\u6ee4\u5668\u53ef\u4e0e\u524d\u540e\u5de5\u5e8f\u8bbe\u5907\uff08\u5982\u914d\u6db2\u7f50\u3001\u704c\u88c5\u673a\uff09\u901a\u8fc7\u536b\u751f\u7ea7\u7ba1\u9053\u8fde\u63a5\uff0c\u6784\u6210\u5b8c\u6574\u7684\u5bc6\u95ed\u6d41\u8def\u3002\u4f8b\u5982\uff0c\u5728\u5355\u6297\u7c7b\u836f\u7269\u751f\u4ea7\u4e2d\uff0c\u7ec6\u80de\u57f9\u517b\u6db2\u7ecf\u6df1\u5c42\u8fc7\u6ee4\u540e\u8fdb\u5165\u677f\u5f0f\u9664\u83cc\u8fc7\u6ee4\u5355\u5143\uff0c\u6700\u7ec8\u76f4\u63a5\u9001\u81f3\u65e0\u83cc\u704c\u88c5\u7ebf\uff0c\u5168\u7a0b\u65e0\u9700\u66b4\u9732\u4e8e\u5916\u90e8\u73af\u5883\u3002<\/p>\n<p>\u8be5\u6a21\u5f0f\u7684\u4f18\u52bf\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u51cf\u5c11\u4eba\u4e3a\u5e72\u9884\u73af\u8282\uff1b<\/li>\n<li>\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\uff1b<\/li>\n<li>\u63d0\u9ad8\u5de5\u827a\u91cd\u73b0\u6027\u3002<\/li>\n<\/ul>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\nZhang, Y. et al. (2021). &quot;Integration of Closed Processing in Biopharmaceutical Manufacturing.&quot; <em>Biotechnology Progress<\/em>, 37(2), e3105.<br \/>\n\u674e\u4f1f, \u7b49. (2020). \u300a\u751f\u7269\u5236\u54c1\u65e0\u83cc\u751f\u4ea7\u5de5\u827a\u4e2d\u7684\u5bc6\u95ed\u7cfb\u7edf\u8bbe\u8ba1\u300b. \u4e2d\u56fd\u65b0\u836f\u6742\u5fd7, 29(15), 1723\u20131727.<\/p>\n<\/blockquote>\n<hr \/>\n<h3>3.2 \u652f\u6301\u5728\u7ebf\u706d\u83cc\uff08SIP\uff09\u4e0e\u5b8c\u6574\u6027\u68c0\u6d4b<\/h3>\n<p>\u73b0\u4ee3\u677f\u5f0f\u8fc7\u6ee4\u5668\u666e\u904d\u652f\u6301<strong>\u84b8\u6c7d\u5728\u7ebf\u706d\u83cc<\/strong>\uff08Steam-in-Place, SIP\uff09\uff0c\u53ef\u5728121\u00b0C\u4e0b\u7ef4\u630130\u5206\u949f\u4ee5\u4e0a\uff0c\u786e\u4fdd\u6ee4\u82af\u53ca\u6574\u4e2a\u6d41\u8def\u8fbe\u5230\u65e0\u83cc\u72b6\u6001\u3002\u540c\u65f6\uff0c\u7cfb\u7edf\u914d\u5907\u5b8c\u6574\u6027\u6d4b\u8bd5\u7aef\u53e3\uff0c\u53ef\u5728\u4f7f\u7528\u524d\u540e\u6267\u884c<strong>\u6ce1\u70b9\u8bd5\u9a8c<\/strong>\u6216<strong>\u524d\u8fdb\u6d41\u8bd5\u9a8c<\/strong>\uff0c\u9a8c\u8bc1\u6ee4\u819c\u662f\u5426\u7834\u635f\u3002<\/p>\n<h4>\u8868\uff1a\u5e38\u89c1\u5b8c\u6574\u6027\u6d4b\u8bd5\u65b9\u6cd5\u5bf9\u6bd4<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bd5\u65b9\u6cd5<\/th>\n<th>\u539f\u7406<\/th>\n<th>\u6807\u51c6\u503c\uff08\u4ee5PES 0.22\u03bcm\u4e3a\u4f8b\uff09<\/th>\n<th>\u9002\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6ce1\u70b9\u6d4b\u8bd5<\/td>\n<td>\u6d4b\u91cf\u6c14\u4f53\u7a7f\u900f\u6e7f\u819c\u6240\u9700\u6700\u5c0f\u538b\u529b<\/td>\n<td>\u22653450 mbar<\/td>\n<td>\u4f7f\u7528\u524d\/\u540e<\/td>\n<\/tr>\n<tr>\n<td>\u524d\u8fdb\u6d41\u6d4b\u8bd5<\/td>\n<td>\u6d4b\u91cf\u6307\u5b9a\u538b\u529b\u4e0b\u6c14\u4f53\u900f\u8fc7\u6e7f\u819c\u7684\u6d41\u91cf<\/td>\n<td>\u226413 mL\/min @ 3450 mbar<\/td>\n<td>\u5927\u9762\u79ef\u6ee4\u5668<\/td>\n<\/tr>\n<tr>\n<td>\u6c34\u4fb5\u5165\u6cd5<\/td>\n<td>\u7528\u4e8e\u758f\u6c34\u6027\u6ee4\u819c\u7684\u5e72\u6001\u6d4b\u8bd5<\/td>\n<td>\u63a5\u89e6\u89d2 &gt;90\u00b0<\/td>\n<td>\u547c\u5438\u5668\u7c7b\u6ee4\u82af<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\nASTM F838-22. <em>Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration<\/em>.<br \/>\n\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. (2020). \u300a\u9664\u83cc\u8fc7\u6ee4\u6280\u672f\u53ca\u5e94\u7528\u6307\u5357\u300b.<\/p>\n<\/blockquote>\n<hr \/>\n<h3>3.3 \u9ad8\u6548\u53bb\u9664\u5fae\u751f\u7269\u4e0e\u5fae\u7c92<\/h3>\n<p>\u677f\u5f0f\u8fc7\u6ee4\u5668\u914d\u54080.22 \u03bcm\u9664\u83cc\u7ea7\u6ee4\u819c\uff0c\u80fd\u591f\u6709\u6548\u622a\u7559\u7edd\u5927\u591a\u6570\u7ec6\u83cc\u3001\u771f\u83cc\u53ca\u652f\u539f\u4f53\u3002\u7814\u7a76\u8868\u660e\uff0c\u5728\u6a21\u62df\u4e73\u6e05\u86cb\u767d\u6eb6\u6db2\u4e2d\uff0cPES\u819c\u5bf9Brevundimonas diminuta\uff08\u7f3a\u9677\u5047\u5355\u80de\u83cc\uff0cATCC 19146\uff09\u7684\u622a\u7559\u7387\u53ef\u8fbe10^7 CFU\/mL\u4ee5\u4e0a\uff0c\u6ee1\u8db3\u9664\u83cc\u8fc7\u6ee4\u7684\u201clog reduction value\u201d\uff08LRV\uff09\u22657\u7684\u8981\u6c42\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u901a\u8fc7\u591a\u7ea7\u9884\u8fc7\u6ee4\uff08\u59821.0 \u03bcm \u2192 0.45 \u03bcm \u2192 0.22 \u03bcm\uff09\uff0c\u53ef\u663e\u8457\u5ef6\u957f\u7ec8\u7aef\u6ee4\u82af\u5bff\u547d\uff0c\u964d\u4f4e\u5835\u585e\u98ce\u9669\u3002<\/p>\n<h4>\u8868\uff1a\u5178\u578b\u677f\u5f0f\u8fc7\u6ee4\u5668\u6027\u80fd\u53c2\u6570<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u6570\u503c\u8303\u56f4<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u9762\u79ef<\/td>\n<td>0.1 \u2013 10 m\u00b2<\/td>\n<td>\u53ef\u5b9a\u5236\u6a21\u5757\u5316\u6269\u5c55<\/td>\n<\/tr>\n<tr>\n<td>\u64cd\u4f5c\u538b\u529b<\/td>\n<td>0 \u2013 6 bar<\/td>\n<td>\u4e0d\u9508\u94a2\u673a\u578b\u8010\u9ad8\u538b<\/td>\n<\/tr>\n<tr>\n<td>\u6700\u9ad8\u8010\u6e29<\/td>\n<td>140\u00b0C\uff08\u77ed\u65f6\uff09<\/td>\n<td>\u6ee1\u8db3SIP\u9700\u6c42<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u819c\u6750\u8d28<\/td>\n<td>PES, PVDF, PTFE, Nylon<\/td>\n<td>\u4f9d\u6eb6\u6db2\u6027\u8d28\u9009\u62e9<\/td>\n<\/tr>\n<tr>\n<td>\u5b54\u5f84\u89c4\u683c<\/td>\n<td>0.1, 0.22, 0.45, 1.0, 5.0 \u03bcm<\/td>\n<td>\u591a\u5c42\u7ea7\u914d\u7f6e<\/td>\n<\/tr>\n<tr>\n<td>\u536b\u751f\u7b49\u7ea7<\/td>\n<td>ISO 2037, ASME BPE<\/td>\n<td>\u8868\u9762\u7c97\u7cd9\u5ea6Ra \u2264 0.8 \u03bcm<\/td>\n<\/tr>\n<tr>\n<td>\u63a5\u53e3\u5f62\u5f0f<\/td>\n<td>\u5361\u7b8d\u5f0f\uff08DIN\/SMS\/BS), \u87ba\u7eb9<\/td>\n<td>\u5feb\u901f\u62c6\u88c5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h3>3.4 \u6613\u4e8e\u6e05\u6d01\u4e0e\u9a8c\u8bc1<\/h3>\n<p>\u677f\u5f0f\u8fc7\u6ee4\u5668\u652f\u6301CIP\uff08Clean-in-Place\uff09\u7a0b\u5e8f\uff0c\u53ef\u4f7f\u7528NaOH\uff081\u20132%\uff09\u3001\u785d\u9178\uff080.5\u20131%\uff09\u7b49\u6e05\u6d17\u5242\u5faa\u73af\u51b2\u6d17\uff0c\u53bb\u9664\u6b8b\u7559\u86cb\u767d\u6216\u7cd6\u7c7b\u7269\u8d28\u3002\u5176\u5e73\u6ed1\u5185\u8868\u9762\u8bbe\u8ba1\u51cf\u5c11\u4e86\u6b7b\u89d2\uff0c\u7b26\u5408FDA\u5bf9\u201ccleanability\u201d\u7684\u8981\u6c42\u3002<\/p>\n<p>\u540c\u65f6\uff0c\u8bbe\u5907\u53ef\u63d0\u4f9b\u5b8c\u6574\u7684<strong>IQ\/OQ\/PQ\u9a8c\u8bc1\u6587\u4ef6\u5305<\/strong>\uff0c\u6db5\u76d6\uff1a<\/p>\n<ul>\n<li>\u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09\uff1a\u90e8\u4ef6\u6e05\u5355\u3001\u6750\u8d28\u8bc1\u660e\u3001\u5b89\u88c5\u4f4d\u7f6e\uff1b<\/li>\n<li>\u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09\uff1a\u538b\u529b\u6d4b\u8bd5\u3001\u6d41\u91cf\u6821\u51c6\u3001SIP\u6548\u679c\u9a8c\u8bc1\uff1b<\/li>\n<li>\u6027\u80fd\u786e\u8ba4\uff08PQ\uff09\uff1a\u5b9e\u9645\u5de5\u51b5\u4e0b\u7684\u8fc7\u6ee4\u6548\u7387\u3001\u65e0\u83cc\u4fdd\u8bc1\u6c34\u5e73\u6d4b\u8bd5\u3002<\/li>\n<\/ul>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\nWHO Technical Report Series, No. 961, 2011. <em>Annex 4: Good Manufacturing Practices for Sterile Pharmaceutical Products<\/em>.<br \/>\n\u9648\u6653\u5149, \u7b49. (2019). \u300a\u5236\u836f\u7528\u6c34\u7cfb\u7edf\u4e2d\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u4e0e\u9a8c\u8bc1\u300b. \u533b\u836f\u5de5\u7a0b\u8bbe\u8ba1, 40(4), 25\u201329.<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u56db\u3001\u56fd\u5185\u5916\u5178\u578b\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>4.1 \u56fd\u5185\u6848\u4f8b\uff1a\u67d0\u751f\u7269\u5236\u836f\u4f01\u4e1a\u5355\u514b\u9686\u6297\u4f53\u539f\u6db2\u8fc7\u6ee4<\/h3>\n<p>\u67d0\u56fd\u5185\u5927\u578b\u751f\u7269\u836f\u4f01\u5728\u5176mAb\u539f\u6db2\u5236\u5907\u8f66\u95f4\u5f15\u5165\u5168\u81ea\u52a8\u5bc6\u95ed\u677f\u5f0f\u8fc7\u6ee4\u7cfb\u7edf\uff0c\u6d41\u7a0b\u5982\u4e0b\uff1a<\/p>\n<ol>\n<li>\u4e0a\u6e38\u6536\u83b7\u6db2 \u2192 \u6df1\u5c42\u8fc7\u6ee4\uff081.0 \u03bcm\uff09\u2192 \u677f\u5f0f\u9884\u8fc7\u6ee4\uff080.45 \u03bcm\uff09\u2192 \u677f\u5f0f\u9664\u83cc\u8fc7\u6ee4\uff080.22 \u03bcm\uff09\u2192 \u65e0\u83cc\u50a8\u7f50<\/li>\n<\/ol>\n<p>\u7cfb\u7edf\u7279\u70b9\uff1a<\/p>\n<ul>\n<li>\u5168316L\u4e0d\u9508\u94a2\u7ed3\u6784\uff0c\u8868\u9762\u7535\u89e3\u629b\u5149\u5904\u7406\uff1b<\/li>\n<li>\u914d\u5907\u81ea\u52a8\u538b\u7d27\u673a\u6784\u4e0ePLC\u63a7\u5236\u7cfb\u7edf\uff1b<\/li>\n<li>\u5b9e\u73b0\u8fdc\u7a0b\u76d1\u63a7\u4e0e\u6570\u636e\u8bb0\u5f55\uff08\u7b26\u540821 CFR Part 11\uff09\uff1b<\/li>\n<li>\u5e74\u4ea7\u80fd\u63d0\u534730%\uff0c\u6ee4\u82af\u66f4\u6362\u9891\u7387\u4e0b\u964d50%\u3002<\/li>\n<\/ul>\n<p>\u636e\u4f01\u4e1a\u5e74\u62a5\u62ab\u9732\uff0c\u81ea\u7cfb\u7edf\u6295\u8fd0\u4ee5\u6765\uff0c\u8fde\u7eed\u4e09\u5e74\u672a\u53d1\u751f\u65e0\u83cc\u68c0\u67e5\u4e0d\u5408\u683c\u4e8b\u4ef6\uff0c\u4ea7\u54c1\u653e\u884c\u5408\u683c\u7387\u8fbe99.98%\u3002<\/p>\n<hr \/>\n<h3>4.2 \u56fd\u5916\u6848\u4f8b\uff1a\u5fb7\u56fd\u9ed8\u514b\u96c6\u56e2\u75ab\u82d7\u751f\u4ea7\u7ebf\u6539\u9020<\/h3>\n<p>Merck KGaA\u5728\u5176\u675c\u585e\u5c14\u591a\u592b\u5de5\u5382\u7684\u6d41\u611f\u75ab\u82d7\u751f\u4ea7\u7ebf\u4e0a\uff0c\u91c7\u7528Sartorius Stedim\u516c\u53f8\u7684Flexboy\u00ae Duetto\u677f\u5f0f\u8fc7\u6ee4\u7cfb\u7edf\uff0c\u66ff\u4ee3\u539f\u6709\u5f00\u653e\u5f0f\u7802\u82af\u8fc7\u6ee4\u88c5\u7f6e\u3002<\/p>\n<p>\u6539\u9020\u6210\u679c\uff1a<\/p>\n<ul>\n<li>\u5b9e\u73b0\u4ece\u88c2\u89e3\u6db2\u5230\u6f84\u6e05\u6db2\u7684\u5168\u5bc6\u95ed\u5904\u7406\uff1b<\/li>\n<li>\u8fc7\u6ee4\u901a\u91cf\u63d0\u9ad840%\uff0c\u6536\u7387\u63d0\u53475.2%\uff1b<\/li>\n<li>\u64cd\u4f5c\u4eba\u5458\u66b4\u9732\u98ce\u9669\u964d\u4f4e90%\uff1b<\/li>\n<li>\u83b7\u5f97EMA\u4e13\u9879\u8ba4\u8bc1\uff0c\u5217\u5165\u201c\u5148\u8fdb\u5236\u9020\u793a\u8303\u9879\u76ee\u201d\u3002<\/li>\n<\/ul>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\nSartorius. (2022). <em>Case Study: Closed System Filtration in Vaccine Production<\/em>. Technical White Paper.<br \/>\nMerck Annual Report 2021. <em>Innovation in Biomanufacturing<\/em>.<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e94\u3001\u677f\u5f0f\u8fc7\u6ee4\u5668\u4e0e\u5176\u4ed6\u8fc7\u6ee4\u6280\u672f\u7684\u6bd4\u8f83<\/h2>\n<p>\u4e3a\u5168\u9762\u8bc4\u4f30\u5176\u5728\u65e0\u83cc\u5de5\u827a\u4e2d\u7684\u5730\u4f4d\uff0c\u73b0\u5c06\u5176\u4e0e\u5e38\u7528\u8fc7\u6ee4\u8bbe\u5907\u8fdb\u884c\u6a2a\u5411\u5bf9\u6bd4\u3002<\/p>\n<h4>\u8868\uff1a\u4e0d\u540c\u7c7b\u578b\u8fc7\u6ee4\u5668\u5728\u5bc6\u95ed\u65e0\u83cc\u5de5\u827a\u4e2d\u7684\u9002\u7528\u6027\u6bd4\u8f83<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u7279\u6027<\/th>\n<th>\u677f\u5f0f\u8fc7\u6ee4\u5668<\/th>\n<th>\u888b\u5f0f\u8fc7\u6ee4\u5668<\/th>\n<th>\u7b52\u5f0f\u8fc7\u6ee4\u5668<\/th>\n<th>\u79bb\u5fc3\u8fc7\u6ee4\u5668<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5bc6\u95ed\u6027<\/td>\n<td>\u2605\u2605\u2605\u2605\u2605<\/td>\n<td>\u2605\u2605\u2606\u2606\u2606<\/td>\n<td>\u2605\u2605\u2605\u2605\u2606<\/td>\n<td>\u2605\u2605\u2605\u2606\u2606<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u9762\u79ef<\/td>\n<td>\u5927\uff08\u53ef\u6269\u5c55\uff09<\/td>\n<td>\u5c0f\u81f3\u4e2d\u7b49<\/td>\n<td>\u4e2d\u7b49<\/td>\n<td>\u5927<\/td>\n<\/tr>\n<tr>\n<td>\u81ea\u52a8\u5316\u7a0b\u5ea6<\/td>\n<td>\u9ad8<\/td>\n<td>\u4f4e<\/td>\n<td>\u4e2d<\/td>\n<td>\u9ad8<\/td>\n<\/tr>\n<tr>\n<td>SIP\/CIP\u652f\u6301<\/td>\n<td>\u662f<\/td>\n<td>\u5426<\/td>\n<td>\u90e8\u5206\u578b\u53f7<\/td>\n<td>\u662f<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u82af\u6210\u672c<\/td>\n<td>\u4e2d\u7b49<\/td>\n<td>\u4f4e<\/td>\n<td>\u9ad8<\/td>\n<td>\u9ad8<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u9891\u7387<\/td>\n<td>\u4f4e<\/td>\n<td>\u9ad8<\/td>\n<td>\u4e2d<\/td>\n<td>\u4f4e<\/td>\n<\/tr>\n<tr>\n<td>\u9002\u7528\u7c98\u5ea6<\/td>\n<td>\u4e2d\u4f4e\u7c98\u5ea6<\/td>\n<td>\u4f4e\u7c98\u5ea6<\/td>\n<td>\u4f4e\u81f3\u4e2d\u7c98\u5ea6<\/td>\n<td>\u9ad8\u7c98\u5ea6<\/td>\n<\/tr>\n<tr>\n<td>\u65e0\u83cc\u4fdd\u8bc1\u6c34\u5e73<\/td>\n<td>\u9ad8<\/td>\n<td>\u4e2d<\/td>\n<td>\u9ad8<\/td>\n<td>\u4e2d<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u7ed3\u8bba\uff1a\u5728\u5f3a\u8c03<strong>\u9ad8\u65e0\u83cc\u4fdd\u8bc1\u3001\u5927\u89c4\u6a21\u8fde\u7eed\u751f\u4ea7\u3001\u81ea\u52a8\u5316\u96c6\u6210<\/strong>\u7684\u5e94\u7528\u573a\u666f\u4e2d\uff0c\u677f\u5f0f\u8fc7\u6ee4\u5668\u5177\u6709\u660e\u663e\u7efc\u5408\u4f18\u52bf\u3002<\/p>\n<hr \/>\n<h2>\u516d\u3001\u53d1\u5c55\u8d8b\u52bf\u4e0e\u6280\u672f\u521b\u65b0\u65b9\u5411<\/h2>\n<h3>6.1 \u667a\u80fd\u5316\u4e0e\u6570\u5b57\u5316\u96c6\u6210<\/h3>\n<p>\u65b0\u4e00\u4ee3\u677f\u5f0f\u8fc7\u6ee4\u5668\u6b63\u671d\u7740\u667a\u80fd\u5316\u65b9\u5411\u53d1\u5c55\uff0c\u96c6\u6210\u4ee5\u4e0b\u529f\u80fd\uff1a<\/p>\n<ul>\n<li>\u5185\u7f6e\u538b\u529b\u4f20\u611f\u5668\u4e0e\u6d41\u91cf\u8ba1\uff0c\u5b9e\u65f6\u76d1\u6d4b\u538b\u5dee\u53d8\u5316\uff1b<\/li>\n<li>AI\u7b97\u6cd5\u9884\u6d4b\u6ee4\u82af\u5835\u585e\u8d8b\u52bf\uff0c\u63d0\u524d\u9884\u8b66\uff1b<\/li>\n<li>\u4e0eMES\uff08\u5236\u9020\u6267\u884c\u7cfb\u7edf\uff09\u5bf9\u63a5\uff0c\u5b9e\u73b0\u6279\u6b21\u8ffd\u6eaf\uff1b<\/li>\n<li>\u652f\u6301\u65e0\u7ebf\u901a\u4fe1\uff08\u5982IO-Link\u3001Profinet\uff09\u3002<\/li>\n<\/ul>\n<p>\u4f8b\u5982\uff0cPall Corporation\u63a8\u51fa\u7684Allegro\u2122 Single-Use Filter Housing\u7cfb\u5217\uff0c\u867d\u975e\u4f20\u7edf\u677f\u5f0f\u7ed3\u6784\uff0c\u4f46\u5176\u8bbe\u8ba1\u7406\u5ff5\u5df2\u5f71\u54cd\u53ef\u91cd\u590d\u4f7f\u7528\u7684\u677f\u5f0f\u7cfb\u7edf\u5411\u4e00\u6b21\u6027\u7ec4\u4ef6\u878d\u5408\u7684\u65b9\u5411\u6f14\u8fdb\u3002<\/p>\n<hr \/>\n<h3>6.2 \u65b0\u578b\u6ee4\u819c\u6750\u6599\u7684\u7814\u53d1<\/h3>\n<p>\u8fd1\u5e74\u6765\uff0c\u7eb3\u7c73\u590d\u5408\u6ee4\u819c\u3001\u68af\u5ea6\u5b54\u7ed3\u6784\u6ee4\u819c\u7b49\u65b0\u578b\u6750\u6599\u4e0d\u65ad\u6d8c\u73b0\u3002\u4f8b\u5982\uff1a<\/p>\n<ul>\n<li><strong>\u77f3\u58a8\u70ef\u6c27\u5316\u7269\u6d82\u5c42\u6ee4\u819c<\/strong>\uff1a\u589e\u5f3a\u6297\u6c61\u67d3\u80fd\u529b\uff1b<\/li>\n<li><strong>\u4e24\u6027\u79bb\u5b50\u805a\u5408\u7269\u6539\u6027\u819c<\/strong>\uff1a\u964d\u4f4e\u86cb\u767d\u8d28\u5438\u9644\uff1b<\/li>\n<li><strong>3D\u6253\u5370\u591a\u5b54\u652f\u67b6\u6ee4\u82af<\/strong>\uff1a\u4f18\u5316\u6d41\u4f53\u5206\u5e03\u3002<\/li>\n<\/ul>\n<p>\u8fd9\u4e9b\u6280\u672f\u6709\u671b\u8fdb\u4e00\u6b65\u63d0\u5347\u677f\u5f0f\u8fc7\u6ee4\u5668\u5728\u590d\u6742\u751f\u7269\u5236\u5242\u4e2d\u7684\u9002\u5e94\u6027\u3002<\/p>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\nWang, R. et al. (2023). &quot;Advanced Membrane Materials for Biopharmaceutical Filtration.&quot; <em>Journal of Membrane Science<\/em>, 668, 121234.<br \/>\nLiu, H. et al. (2022). &quot;Zwitterionic Polymer-Modified Filters Reduce Protein Fouling.&quot; <em>Biotechnology and Bioengineering<\/em>, 119(6), 1650\u20131661.<\/p>\n<\/blockquote>\n<hr \/>\n<h3>6.3 \u53ef\u6301\u7eed\u6027\u4e0e\u7eff\u8272\u5236\u9020<\/h3>\n<p>\u968f\u7740ESG\uff08\u73af\u5883\u3001\u793e\u4f1a\u4e0e\u6cbb\u7406\uff09\u7406\u5ff5\u666e\u53ca\uff0c\u5236\u836f\u4f01\u4e1a\u65e5\u76ca\u5173\u6ce8\u8fc7\u6ee4\u8fc7\u7a0b\u7684\u8d44\u6e90\u6d88\u8017\u3002\u677f\u5f0f\u8fc7\u6ee4\u5668\u56e0\u53ef\u91cd\u590d\u4f7f\u7528\u3001\u5bff\u547d\u957f\u3001\u5e9f\u6599\u5c11\u7b49\u7279\u70b9\uff0c\u76f8\u8f83\u4e8e\u4e00\u6b21\u6027\u8fc7\u6ee4\u7cfb\u7edf\u66f4\u5177\u73af\u4fdd\u4f18\u52bf\u3002\u90e8\u5206\u5382\u5546\u5df2\u63a8\u51fa\u201c\u7eff\u8272\u6ee4\u82af\u518d\u751f\u670d\u52a1\u201d\uff0c\u901a\u8fc7\u4e13\u4e1a\u6e05\u6d17\u4e0e\u518d\u9a8c\u8bc1\uff0c\u5ef6\u957f\u4f7f\u7528\u5bff\u547d\u8fbe3\u20135\u500d\u3002<\/p>\n<hr \/>\n<h2>\u4e03\u3001\u6cd5\u89c4\u5408\u89c4\u4e0e\u884c\u4e1a\u6807\u51c6<\/h2>\n<h3>7.1 \u56fd\u5185\u5916\u76f8\u5173\u6cd5\u89c4\u8981\u6c42<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6cd5\u89c4\u540d\u79f0<\/th>\n<th>\u53d1\u5e03\u673a\u6784<\/th>\n<th>\u5173\u952e\u6761\u6b3e\u6458\u8981<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u300a\u4e2d\u56fd\u836f\u5178\u300b2020\u5e74\u7248 \u56db\u90e8<\/td>\n<td>\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a<\/td>\n<td>\u89c4\u5b9a\u9664\u83cc\u8fc7\u6ee4\u5e94\u80fd\u622a\u7559S. aureus\uff08ATCC 6538\uff09\u7b49\u6807\u51c6\u83cc\u682a<\/td>\n<\/tr>\n<tr>\n<td>GMP\u9644\u5f551\uff1a\u65e0\u83cc\u836f\u54c1<\/td>\n<td>NMPA<\/td>\n<td>\u5f3a\u8c03\u5bc6\u95ed\u7cfb\u7edf\u4f18\u5148\uff0c\u7981\u6b62\u5f00\u653e\u5f0f\u64cd\u4f5c<\/td>\n<\/tr>\n<tr>\n<td>21 CFR Part 211<\/td>\n<td>FDA<\/td>\n<td>\u8981\u6c42\u8fc7\u6ee4\u5de5\u827a\u7ecf\u8fc7\u9a8c\u8bc1\uff0c\u5305\u62ecLRV\u6d4b\u8bd5<\/td>\n<\/tr>\n<tr>\n<td>EU GMP Annex 1 (2022\u4fee\u8ba2)<\/td>\n<td>EMA<\/td>\n<td>\u660e\u786e\u63d0\u51fa\u201cclosed or isolator-based systems\u201d\u4e3a\u9996\u9009<\/td>\n<\/tr>\n<tr>\n<td>ASME BPE-2022<\/td>\n<td>\u7f8e\u56fd\u673a\u68b0\u5de5\u7a0b\u5e08\u5b66\u4f1a<\/td>\n<td>\u89c4\u8303\u751f\u7269\u52a0\u5de5\u8bbe\u5907\u7684\u8868\u9762\u5149\u6d01\u5ea6\u4e0e\u8fde\u63a5\u6807\u51c6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h3>7.2 \u9a8c\u8bc1\u8981\u70b9<\/h3>\n<p>\u4f01\u4e1a\u5728\u5f15\u5165\u677f\u5f0f\u8fc7\u6ee4\u7cfb\u7edf\u65f6\uff0c\u5fc5\u987b\u5b8c\u6210\u4ee5\u4e0b\u5173\u952e\u9a8c\u8bc1\u6b65\u9aa4\uff1a<\/p>\n<ol>\n<li><strong>\u9664\u83cc\u6548\u80fd\u9a8c\u8bc1<\/strong>\uff1a\u91c7\u7528\u6311\u6218\u8bd5\u9a8c\uff08Brevundimonas diminuta\uff09\u6d4b\u5b9aLRV\uff1b<\/li>\n<li><strong>\u5316\u5b66\u517c\u5bb9\u6027\u6d4b\u8bd5<\/strong>\uff1a\u786e\u8ba4\u6ee4\u819c\u4e0e\u5f85\u8fc7\u6ee4\u6db2\u65e0\u76f8\u4e92\u4f5c\u7528\uff1b<\/li>\n<li><strong>\u5438\u9644\u8bd5\u9a8c<\/strong>\uff1a\u8bc4\u4f30\u76ee\u6807\u5206\u5b50\uff08\u5982\u86cb\u767d\u3001\u6838\u9178\uff09\u7684\u635f\u5931\u7387\uff1b<\/li>\n<li><strong>\u9897\u7c92\u91ca\u653e\u6d4b\u8bd5<\/strong>\uff1a\u68c0\u6d4b\u6ee4\u51fa\u6db2\u4e2d\u662f\u5426\u5b58\u5728\u6ee4\u6750\u8131\u843d\u5fae\u7c92\uff1b<\/li>\n<li><strong>\u957f\u671f\u7a33\u5b9a\u6027\u7814\u7a76<\/strong>\uff1a\u6a21\u62df\u5b9e\u9645\u751f\u4ea7\u5468\u671f\u4e0b\u7684\u6027\u80fd\u8870\u51cf\u3002<\/li>\n<\/ol>\n<hr \/>\n<h2>\u516b\u3001\u9009\u578b\u5efa\u8bae\u4e0e\u5b9e\u65bd\u7b56\u7565<\/h2>\n<h3>8.1 \u9009\u578b\u8003\u8651\u56e0\u7d20<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u56e0\u7d20<\/th>\n<th>\u5efa\u8bae<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6eb6\u6db2\u6027\u8d28<\/td>\n<td>\u6c34\u6eb6\u6027\u9009PES\uff0c\u6709\u673a\u6eb6\u5242\u9009PTFE\uff0c\u5f3a\u9178\u78b1\u9009PVDF<\/td>\n<\/tr>\n<tr>\n<td>\u7c98\u5ea6<\/td>\n<td>&gt;50 cP\u65f6\u9700\u964d\u4f4e\u6d41\u901f\u6216\u9884\u70ed<\/td>\n<\/tr>\n<tr>\n<td>\u6279\u6b21\u89c4\u6a21<\/td>\n<td>\u5c0f\u6279\u91cf\u53ef\u7528\u53f0\u5f0f\u673a\u578b\uff0c\u5927\u6279\u91cf\u63a8\u8350\u7acb\u5f0f\u591a\u677f\u7cfb\u7edf<\/td>\n<\/tr>\n<tr>\n<td>\u81ea\u52a8\u5316\u9700\u6c42<\/td>\n<td>\u9ad8\u9891\u6b21\u751f\u4ea7\u5b9c\u914d\u5907\u81ea\u52a8\u6392\u6e23\u4e0e\u53cd\u51b2\u6d17\u529f\u80fd<\/td>\n<\/tr>\n<tr>\n<td>\u9a8c\u8bc1\u652f\u6301<\/td>\n<td>\u4f18\u5148\u9009\u62e9\u63d0\u4f9b\u5b8c\u6574DQ\/IQ\/OQ\u6587\u6863\u7684\u4f9b\u5e94\u5546<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h3>8.2 \u63a8\u8350\u4e3b\u6d41\u54c1\u724c\u4e0e\u578b\u53f7\uff08\u622a\u81f32024\u5e74\uff09<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u54c1\u724c<\/th>\n<th>\u56fd\u522b<\/th>\n<th>\u4ee3\u8868\u578b\u53f7<\/th>\n<th>\u7279\u70b9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Sartorius<\/td>\n<td>\u5fb7\u56fd<\/td>\n<td>Sartoflow Smart<\/td>\n<td>\u6a21\u5757\u5316\u8bbe\u8ba1\uff0c\u652f\u6301\u4e00\u6b21\u6027\u4e0e\u53ef\u91cd\u7528\u53cc\u6a21\u5f0f<\/td>\n<\/tr>\n<tr>\n<td>Pall<\/td>\n<td>\u7f8e\u56fd<\/td>\n<td>Mustang Q Plate<\/td>\n<td>\u5f3a\u9634\u79bb\u5b50\u4ea4\u6362\u677f\u5f0f\uff0c\u9002\u7528\u4e8e\u75c5\u6bd2\u6e05\u9664<\/td>\n<\/tr>\n<tr>\n<td>Merck Millipore<\/td>\n<td>\u5fb7\u56fd<\/td>\n<td>Pellicon Tangential Flow Filtration Plate<\/td>\n<td>\u5207\u5411\u6d41\u8fc7\u6ee4\u677f\u5f0f\u7cfb\u7edf<\/td>\n<\/tr>\n<tr>\n<td>\u4e50\u7eaf\u751f\u7269<\/td>\n<td>\u4e2d\u56fd<\/td>\n<td>LepuFilter-P\u7cfb\u5217<\/td>\n<td>\u56fd\u4ea7\u9ad8\u7aef\uff0c\u6027\u4ef7\u6bd4\u9ad8\uff0c\u652f\u6301\u672c\u5730\u5316\u670d\u52a1<\/td>\n<\/tr>\n<tr>\n<td>\u4e1c\u5bcc\u9f99<\/td>\n<td>\u4e2d\u56fd<\/td>\n<td>DFY-BF\u7cfb\u5217<\/td>\n<td>\u533b\u836f\u4e13\u7528\uff0c\u7b26\u5408ASME BPE\u6807\u51c6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e5d\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>\u538b\u5dee\u8fc5\u901f\u4e0a\u5347<\/td>\n<td>\u9884\u8fc7\u6ee4\u4e0d\u8db3\u3001\u60ac\u6d6e\u7269\u6d53\u5ea6\u8fc7\u9ad8<\/td>\n<td>\u589e\u52a0\u524d\u7f6e\u8fc7\u6ee4\u7ea7\u6570\uff0c\u7a00\u91ca\u6599\u6db2<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u540e\u6db2\u6d51\u6d4a<\/td>\n<td>\u6ee4\u819c\u7834\u635f\u3001\u5bc6\u5c01\u5931\u6548<\/td>\n<td>\u6267\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u66f4\u6362\u6ee4\u82af<\/td>\n<\/tr>\n<tr>\n<td>\u6d41\u91cf\u4e0d\u7a33\u5b9a<\/td>\n<td>\u6cf5\u4f9b\u6db2\u4e0d\u5747\u3001\u6c14\u963b<\/td>\n<td>\u5b89\u88c5\u7a33\u6d41\u7f50\uff0c\u5145\u5206\u6392\u6c14<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u8d85\u6807<\/td>\n<td>SIP\u4e0d\u5f7b\u5e95\u3001\u63a5\u53e3\u6cc4\u6f0f<\/td>\n<td>\u52a0\u5f3a\u706d\u83cc\u7a0b\u5e8f\u9a8c\u8bc1\uff0c\u68c0\u67e5O\u578b\u5708<\/td>\n<\/tr>\n<tr>\n<td>\u86cb\u767d\u8d28\u5438\u9644\u4e25\u91cd<\/td>\n<td>\u6ee4\u819c\u6781\u6027\u4e0d\u5339\u914d<\/td>\n<td>\u6539\u7528\u4f4e\u5438\u9644\u578bPVDF\u6216\u6539\u6027PES\u819c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u5341\u3001\u603b\u7ed3\u4e0e\u5c55\u671b\uff08\u975e\u7ed3\u8bed\u90e8\u5206\uff09<\/h2>\n<p>\u968f\u7740\u7cbe\u51c6\u533b\u7597\u4e0e\u4e2a\u6027\u5316\u6cbb\u7597\u7684\u53d1\u5c55\uff0c\u65e0\u83cc\u751f\u4ea7\u5de5\u827a\u5c06\u6301\u7eed\u5411\u66f4\u9ad8\u6807\u51c6\u8fc8\u8fdb\u3002\u677f\u5f0f\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u5bc6\u95ed\u7cfb\u7edf\u4e2d\u7684\u6838\u5fc3\u7ec4\u4ef6\uff0c\u4e0d\u4ec5\u627f\u62c5\u7740\u7269\u7406\u5206\u79bb\u7684\u4efb\u52a1\uff0c\u66f4\u662f\u5b9e\u73b0\u65e0\u83cc\u4fdd\u969c\u3001\u6570\u636e\u53ef\u8ffd\u6eaf\u3001\u7eff\u8272\u5236\u9020\u7684\u91cd\u8981\u8f7d\u4f53\u3002\u672a\u6765\uff0c\u968f\u7740\u6750\u6599\u79d1\u5b66\u3001\u667a\u80fd\u5236\u9020\u4e0e\u6570\u5b57\u5b6a\u751f\u6280\u672f\u7684\u6df1\u5ea6\u878d\u5408\uff0c\u677f\u5f0f\u8fc7\u6ee4\u5668\u5c06\u5728\u667a\u80fd\u5316\u63a7\u5236\u3001\u81ea\u9002\u5e94\u8c03\u8282\u3001\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u7b49\u65b9\u9762\u8fce\u6765\u65b0\u4e00\u8f6e\u7a81\u7834\uff0c\u4e3a\u5168\u7403\u5236\u836f\u5de5\u4e1a\u7684\u5b89\u5168\u4e0e\u6548\u7387\u63d0\u4f9b\u575a\u5b9e\u652f\u6491\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u5bc6\u95ed\u64cd\u4f5c\u73af\u5883\u4e0b\u677f\u5f0f\u8fc7\u6ee4\u5668\u5bf9\u65e0\u83cc\u751f\u4ea7\u5de5\u827a\u7684\u652f\u6301\u4f5c\u7528 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