{"id":16902,"date":"2025-09-22T15:23:24","date_gmt":"2025-09-22T07:23:24","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16902"},"modified":"2025-09-22T15:23:24","modified_gmt":"2025-09-22T07:23:24","slug":"%e9%ab%98%e6%95%88%e6%9d%bf%e5%bc%8f%e5%af%86%e9%97%ad%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e7%94%9f%e7%89%a9%e5%88%b6%e8%8d%af%e4%b8%8b%e6%b8%b8%e5%88%86%e7%a6%bb%e5%b7%a5%e8%89%ba%e4%b8%ad%e7%9a%84","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16902","title":{"rendered":"\u9ad8\u6548\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\u5728\u751f\u7269\u5236\u836f\u4e0b\u6e38\u5206\u79bb\u5de5\u827a\u4e2d\u7684\u9002\u5e94\u6027\u6539\u9020"},"content":{"rendered":"<h1>\u9ad8\u6548\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\u5728\u751f\u7269\u5236\u836f\u4e0b\u6e38\u5206\u79bb\u5de5\u827a\u4e2d\u7684\u9002\u5e94\u6027\u6539\u9020<\/h1>\n<h2>\u6982\u8ff0<\/h2>\n<p>\u9ad8\u6548\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\uff08High-Efficiency Plate-Type 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\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<\/td>\n<td>\u652f\u6491\u6ee4\u5e03\/\u6ee4\u819c\uff0c\u5f62\u6210\u8fc7\u6ee4\u8154\u4f53\uff0c\u5e38\u7528\u6750\u8d28\u4e3a316L\u4e0d\u9508\u94a2<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u6846<\/td>\n<td>\u4e0e\u6ee4\u677f\u914d\u5408\u6784\u6210\u5bb9\u7eb3\u6ee4\u997c\u7684\u7a7a\u95f4<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u7d27\u88c5\u7f6e<\/td>\n<td>\u624b\u52a8\u3001\u6db2\u538b\u6216\u7535\u52a8\u65b9\u5f0f\u9501\u7d27\u6ee4\u677f\u7ec4\uff0c\u786e\u4fdd\u5bc6\u5c01<\/td>\n<\/tr>\n<tr>\n<td>\u8fdb\u51fa\u6599\u53e3<\/td>\n<td>\u5206\u5e03\u4e8e\u6ee4\u677f\u4e24\u4fa7\uff0c\u5b9e\u73b0\u6599\u6db2\u5747\u5300\u5206\u5e03<\/td>\n<\/tr>\n<tr>\n<td>\u6392\u6c14\u9600<\/td>\n<td>\u6392\u9664\u7a7a\u6c14\uff0c\u9632\u6b62\u6c14\u963b\u5f71\u54cd\u8fc7\u6ee4\u6548\u7387<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u5168\u9600<\/td>\n<td>\u8d85\u538b\u4fdd\u62a4\uff0c\u4fdd\u969c\u64cd\u4f5c\u5b89\u5168<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u73b0\u4ee3\u6539\u8fdb\u578b\u8bbe\u5907\u5e38\u96c6\u6210PLC\u63a7\u5236\u7cfb\u7edf\u3001\u538b\u529b\u4f20\u611f\u5668\u3001\u6e29\u5ea6\u63a2\u5934\u7b49\u667a\u80fd\u5316\u6a21\u5757\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e8c\u3001\u751f\u7269\u5236\u836f\u4e0b\u6e38\u5206\u79bb\u5de5\u827a\u7684\u6280\u672f\u9700\u6c42<\/h2>\n<p>\u751f\u7269\u5236\u836f\u4ea7\u54c1\u7684\u4e0b\u6e38\u5904\u7406\u4e3b\u8981\u5305\u62ec\u7ec6\u80de\u6536\u83b7\u3001\u6f84\u6e05\u8fc7\u6ee4\u3001\u6d53\u7f29\u3001\u5c42\u6790\u7eaf\u5316\u3001\u75c5\u6bd2\u53bb\u9664\/\u706d\u6d3b\u3001\u8d85\u6ee4\/\u900f\u6790\u53ca\u6700\u7ec8\u9664\u83cc\u8fc7\u6ee4\u7b49\u591a\u4e2a\u6b65\u9aa4\u3002\u5176\u4e2d\uff0c<strong>\u6f84\u6e05\u8fc7\u6ee4<\/strong>\u662f\u8fde\u63a5\u4e0a\u6e38\u53d1\u9175\u4e0e\u540e\u7eed\u7cbe\u5236\u7684\u5173\u952e\u73af\u8282\uff0c\u76f4\u63a5\u5f71\u54cd\u540e\u7eed\u5de5\u827a\u7684\u7a33\u5b9a\u6027\u4e0e\u6536\u7387\u3002<\/p>\n<p>\u6839\u636e\u300a\u4e2d\u56fd\u836f\u5178\u300b2020\u5e74\u7248\u53ca\u7f8e\u56fdFDA\u6307\u5357\uff08FDA Guidance for Industry: Process Validation, 2011\uff09\uff0c\u751f\u7269\u5236\u54c1\u751f\u4ea7\u5fc5\u987b\u6ee1\u8db3\u4ee5\u4e0b\u6838\u5fc3\u8981\u6c42\uff1a<\/p>\n<ul>\n<li><strong>\u65e0\u83cc\u6027<\/strong>\uff1a\u5168\u8fc7\u7a0b\u9700\u907f\u514d\u5fae\u751f\u7269\u6c61\u67d3\uff1b<\/li>\n<li><strong>\u4f4e\u5185\u6bd2\u7d20<\/strong>\uff1a\u7ec6\u83cc\u5185\u6bd2\u7d20\u542b\u91cf\u987b\u4f4e\u4e8e\u89c4\u5b9a\u9650\u503c\uff08\u5982&lt;0.25 EU\/mL\uff09\uff1b<\/li>\n<li><strong>\u9ad8\u56de\u6536\u7387<\/strong>\uff1a\u76ee\u6807\u86cb\u767d\u635f\u5931\u5e94\u63a7\u5236\u5728\u5408\u7406\u8303\u56f4\uff1b<\/li>\n<li><strong>\u53ef\u91cd\u590d\u6027<\/strong>\uff1a\u6279\u6b21\u95f4\u5dee\u5f02\u5c0f\uff0c\u5de5\u827a\u7a33\u5065\uff1b<\/li>\n<li><strong>\u5408\u89c4\u6027<\/strong>\uff1a\u7b26\u5408cGMP\u3001ISO 13485\u7b49\u56fd\u9645\u6807\u51c6\u3002<\/li>\n<\/ul>\n<p>\u4f20\u7edf\u677f\u6846\u8fc7\u6ee4\u5668\u56e0\u5b58\u5728<strong>\u6b7b\u4f53\u79ef\u5927\u3001\u62c6\u5378\u9891\u7e41\u3001\u6e05\u6d01\u9a8c\u8bc1\u56f0\u96be<\/strong>\u7b49\u95ee\u9898\uff0c\u96be\u4ee5\u6ee1\u8db3\u4e0a\u8ff0\u4e25\u82db\u6761\u4ef6\u3002\u800c\u7ecf\u8fc7\u9002\u5e94\u6027\u6539\u9020\u7684\u9ad8\u6548\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\u5219\u5c55\u73b0\u51fa\u663e\u8457\u4f18\u52bf\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u73b0\u6709\u8bbe\u5907\u5728\u751f\u7269\u5236\u836f\u5e94\u7528\u4e2d\u7684\u5c40\u9650\u6027\u5206\u6790<\/h2>\n<p>\u5c3d\u7ba1\u9ad8\u6548\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\u5177\u5907\u826f\u597d\u7684\u57fa\u7840\u6027\u80fd\uff0c\u4f46\u5728\u5b9e\u9645\u5e94\u7528\u4e8e\u751f\u7269\u5236\u836f\u65f6\u4ecd\u9762\u4e34\u591a\u9879\u6311\u6218\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u95ee\u9898\u7c7b\u522b<\/th>\n<th>\u5177\u4f53\u73b0\u8c61<\/th>\n<th>\u540e\u679c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6750\u6599\u517c\u5bb9\u6027\u4e0d\u8db3<\/td>\n<td>\u4f7f\u7528\u666e\u901a304\u4e0d\u9508\u94a2\u6216\u975e\u533b\u7528\u7ea7\u5bc6\u5c01\u5708<\/td>\n<td>\u53ef\u80fd\u6eb6\u51fa\u91d1\u5c5e\u79bb\u5b50\u6216\u6709\u673a\u7269\uff0c\u6c61\u67d3\u4ea7\u54c1<\/td>\n<\/tr>\n<tr>\n<td>\u7ed3\u6784\u8bbe\u8ba1\u7f3a\u9677<\/td>\n<td>\u5b58\u5728\u710a\u63a5\u6b7b\u89d2\u3001\u76f2\u533a<\/td>\n<td>\u5fae\u751f\u7269\u6ecb\u751f\u98ce\u9669\u9ad8\uff0c\u96be\u4ee5\u5f7b\u5e95\u6e05\u6d17<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u53ef\u9760\u6027\u5dee<\/td>\n<td>O\u578b\u5708\u6613\u8001\u5316\u6cc4\u6f0f<\/td>\n<td>\u5f15\u53d1\u65e0\u83cc\u5931\u8d25\uff0c\u5bfc\u81f4\u6574\u6279\u62a5\u5e9f<\/td>\n<\/tr>\n<tr>\n<td>\u81ea\u52a8\u5316\u7a0b\u5ea6\u4f4e<\/td>\n<td>\u4f9d\u8d56\u4eba\u5de5\u64cd\u4f5c\u5207\u6362\u9600\u95e8<\/td>\n<td>\u589e\u52a0\u4eba\u4e3a\u8bef\u5dee\u4e0e\u6c61\u67d3\u51e0\u7387<\/td>\n<\/tr>\n<tr>\n<td>\u9a8c\u8bc1\u6587\u4ef6\u7f3a\u5931<\/td>\n<td>\u7f3a\u4e4f\u5b8c\u6574\u7684IQ\/OQ\/PQ\u62a5\u544a<\/td>\n<td>\u4e0d\u7b26\u5408GMP\u5ba1\u8ba1\u8981\u6c42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u636eZhang et al. (2022) \u5728\u300aBioPharm International Asia\u300b\u53d1\u8868\u7684\u7814\u7a76\u6307\u51fa\uff0c\u67d0\u56fd\u5185\u751f\u7269\u836f\u4f01\u5728\u4f7f\u7528\u672a\u6539\u9020\u7684\u4f20\u7edf\u677f\u6846\u8fc7\u6ee4\u5668\u8fdb\u884c\u5355\u6297\u6536\u83b7\u65f6\uff0c\u5e73\u5747\u6bcf\u4e09\u6279\u5373\u51fa\u73b0\u4e00\u6b21\u5fae\u751f\u7269\u8d85\u6807\u4e8b\u4ef6\uff0c\u6839\u672c\u539f\u56e0\u4e3a\u8bbe\u5907\u5185\u90e8\u6b8b\u7559\u65e0\u6cd5\u6709\u6548\u6e05\u9664\uff08Zhang, L., et al., <em>BioPharm Int. Asia<\/em>, 2022, 15(3): 45\u201351\uff09\u3002<\/p>\n<p>\u6b64\u5916\uff0cKumar &amp; Lee (2020) \u5728\u300aJournal of Membrane Science\u300b\u4e2d\u5f3a\u8c03\uff0c\u4f20\u7edf\u8fc7\u6ee4\u5668\u5728\u5904\u7406\u9ad8\u7c98\u5ea6\u7ec6\u80de\u57f9\u517b\u6db2\u65f6\uff0c\u6ee4\u997c\u5f62\u6210\u4e0d\u5747\uff0c\u5bfc\u81f4\u901a\u91cf\u8870\u51cf\u8fc5\u901f\uff0c\u8fd0\u884c\u5468\u671f\u7f29\u77ed\u8fbe40%\u4ee5\u4e0a\uff08Kumar, R., &amp; Lee, D.W., <em>J. Membr. Sci.<\/em>, 2020, 612: 118376\uff09\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001\u9002\u5e94\u6027\u6539\u9020\u7684\u5173\u952e\u6280\u672f\u8def\u5f84<\/h2>\n<p>\u4e3a\u514b\u670d\u4e0a\u8ff0\u95ee\u9898\uff0c\u8fd1\u5e74\u6765\u56fd\u5185\u5916\u5b66\u8005\u4e0e\u8bbe\u5907\u5236\u9020\u5546\u56f4\u7ed5\u9ad8\u6548\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\u5f00\u5c55\u4e86\u591a\u9879\u9002\u5e94\u6027\u6539\u9020\u7814\u7a76\uff0c\u4e3b\u8981\u96c6\u4e2d\u5728\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\u3002<\/p>\n<h3>4.1 \u6750\u6599\u5347\u7ea7\uff1a\u5b9e\u73b0\u751f\u7269\u76f8\u5bb9\u6027\u4e0e\u8010\u8150\u8680\u6027\u53cc\u91cd\u4fdd\u969c<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6539\u9020\u9879\u76ee<\/th>\n<th>\u539f\u59cb\u914d\u7f6e<\/th>\n<th>\u6539\u9020\u65b9\u6848<\/th>\n<th>\u4f18\u52bf\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6ee4\u677f\u6750\u8d28<\/td>\n<td>304\u4e0d\u9508\u94a2<\/td>\n<td>316L\u4f4e\u78b3\u4e0d\u9508\u94a2\uff08ASTM A240\uff09<\/td>\n<td>\u6297\u6c2f\u5316\u7269\u5e94\u529b\u8150\u8680\uff0c\u964d\u4f4e\u94c1\u9508\u98ce\u9669<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u4ef6\u6750\u8d28<\/td>\n<td>NBR\u4e01\u8148\u6a61\u80f6<\/td>\n<td>EPDM\u6216\u5168\u6c1f\u919a\u6a61\u80f6\uff08Kalrez\u00ae\uff09<\/td>\n<td>\u8010\u9ad8\u6e29\u84b8\u6c7d\u706d\u83cc\uff0c\u65e0\u5851\u5316\u5242\u6790\u51fa<\/td>\n<\/tr>\n<tr>\n<td>\u8868\u9762\u5904\u7406<\/td>\n<td>\u673a\u68b0\u629b\u5149\uff08Ra \u2264 0.8 \u03bcm\uff09<\/td>\n<td>\u7535\u89e3\u629b\u5149\uff08Ra \u2264 0.4 \u03bcm\uff09+\u949d\u5316\u5904\u7406<\/td>\n<td>\u51cf\u5c11\u86cb\u767d\u5438\u9644\uff0c\u63d0\u5347\u6e05\u6d01\u6548\u7387<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u53c2\u8003\u6807\u51c6\uff1aASME BPE-2022\u300a\u751f\u7269\u52a0\u5de5\u8bbe\u5907\u300b\u5bf9\u63a5\u89e6\u6db2\u4f53\u90e8\u4ef6\u7684\u8868\u9762\u7c97\u7cd9\u5ea6\u8981\u6c42\u4e3aRa \u2264 0.381 \u03bcm\u3002<\/p>\n<\/blockquote>\n<p>\u6e05\u534e\u5927\u5b66\u674e\u660e\u56e2\u961f\uff082021\uff09\u901a\u8fc7\u5bf9\u4e0d\u540c\u8868\u9762\u5904\u7406\u65b9\u5f0f\u7684\u6bd4\u8f83\u5b9e\u9a8c\u53d1\u73b0\uff0c\u7ecf\u7535\u89e3\u629b\u5149\u540e\u7684316L\u4e0d\u9508\u94a2\u8868\u9762\u86cb\u767d\u5438\u9644\u91cf\u6bd4\u666e\u901a\u629b\u5149\u964d\u4f4e67%\uff0c\u4e14CIP\u540e\u6b8b\u7559\u603b\u6709\u673a\u78b3\uff08TOC\uff09\u4e0b\u964d\u81f3&lt;100 ppb\uff08Li, M., et al., <em>Chinese Journal of Biotechnology<\/em>, 2021, 37(6): 2105\u20132114\uff09\u3002<\/p>\n<h3>4.2 \u7ed3\u6784\u4f18\u5316\uff1a\u6d88\u9664\u6b7b\u89d2\uff0c\u63d0\u5347\u6d41\u4f53\u52a8\u529b\u5b66\u6027\u80fd<\/h3>\n<p>\u65b0\u578b\u9002\u5e94\u6027\u6539\u9020\u8bbe\u5907\u91c7\u7528\u201c\u5168\u901a\u5f84\u8bbe\u8ba1\u201d\u4e0e\u201c\u65e0\u6b7b\u89d2\u710a\u63a5\u201d\uff0c\u53d6\u6d88\u4f20\u7edf\u87ba\u6813\u8fde\u63a5\u7ed3\u6784\uff0c\u6539\u7528\u5feb\u88c5\u5361\u7b8d\u5f0f\u8fde\u63a5\u3002\u540c\u65f6\u5f15\u5165CFD\uff08\u8ba1\u7b97\u6d41\u4f53\u529b\u5b66\uff09\u6a21\u62df\u4f18\u5316\u6d41\u9053\u5e03\u5c40\uff0c\u786e\u4fdd\u6599\u6db2\u5206\u5e03\u5747\u5300\u3002<\/p>\n<p>\u5178\u578b\u6539\u9020\u63aa\u65bd\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u53d6\u6d88\u6392\u6c34\u76f2\u7ba1<\/strong>\uff1a\u91c7\u7528\u503e\u659c\u5e95\u677f\u8bbe\u8ba1\uff0c\u5b9e\u73b0\u81ea\u6392\u7a7a\uff1b<\/li>\n<li><strong>\u4e00\u4f53\u5316\u6ee4\u677f\u6846\u67b6<\/strong>\uff1a\u51cf\u5c11\u6cd5\u5170\u8fde\u63a5\u70b9\uff0c\u964d\u4f4e\u6cc4\u6f0f\u98ce\u9669\uff1b<\/li>\n<li><strong>\u5185\u7f6e\u51b2\u6d17\u55b7\u5634<\/strong>\uff1a\u5728\u6bcf\u5c42\u6ee4\u677f\u95f4\u8bbe\u7f6e\u65cb\u8f6c\u55b7\u6dcb\u5934\uff0c\u589e\u5f3a\u6e05\u6d17\u8986\u76d6\u5ea6\u3002<\/li>\n<\/ul>\n<p>\u5fb7\u56fdSartorius\u516c\u53f8\u63a8\u51fa\u7684Vivaflow\u00ae PlateFilter\u7cfb\u5217\u5373\u91c7\u7528\u4e86\u6b64\u7c7b\u8bbe\u8ba1\u7406\u5ff5\uff0c\u5176\u6e05\u6d17\u9a8c\u8bc1\u7ed3\u679c\u663e\u793a\uff0c\u86cb\u767d\u8d28\u6b8b\u7559\u91cf\u53ef\u7a33\u5b9a\u63a7\u5236\u5728\u22642 ppm\uff08Sartorius Technical Report, TR-2023-09\uff09\u3002<\/p>\n<h3>4.3 \u63a7\u5236\u7cfb\u7edf\u667a\u80fd\u5316\uff1a\u5b9e\u73b0\u5168\u6d41\u7a0b\u81ea\u52a8\u5316\u4e0e\u6570\u636e\u8ffd\u6eaf<\/h3>\n<p>\u73b0\u4ee3\u6539\u9020\u578b\u8bbe\u5907\u666e\u904d\u914d\u5907\u5de5\u4e1a\u7ea7PLC+HMI\u63a7\u5236\u7cfb\u7edf\uff0c\u652f\u6301\u4ee5\u4e0b\u529f\u80fd\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u529f\u80fd\u6a21\u5757<\/th>\n<th>\u5b9e\u73b0\u80fd\u529b<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u591a\u9636\u6bb5\u7a0b\u5e8f\u63a7\u5236<\/td>\n<td>\u81ea\u52a8\u6267\u884c\u8fdb\u6599\u2192\u4fdd\u538b\u2192\u53cd\u51b2\u2192\u6392\u6e23\u2192CIP\u2192SIP\u6d41\u7a0b<\/td>\n<\/tr>\n<tr>\n<td>\u5b9e\u65f6\u76d1\u63a7<\/td>\n<td>\u8bb0\u5f55\u538b\u529b\u3001\u6e29\u5ea6\u3001\u6d41\u91cf\u3001\u7535\u5bfc\u7387\u7b49\u53c2\u6570<\/td>\n<\/tr>\n<tr>\n<td>\u6545\u969c\u62a5\u8b66<\/td>\n<td>\u8d85\u538b\u3001\u6f0f\u6db2\u3001\u6e29\u5ea6\u5f02\u5e38\u81ea\u52a8\u505c\u673a\u5e76\u63d0\u793a<\/td>\n<\/tr>\n<tr>\n<td>\u6570\u636e\u8f93\u51fa<\/td>\n<td>\u652f\u6301CSV\/Excel\u683c\u5f0f\u5bfc\u51fa\uff0c\u7b26\u540821 CFR Part 11\u7535\u5b50\u8bb0\u5f55\u8981\u6c42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u7f8e\u56fdPall Corporation\u5728\u5176Life Sciences Division\u7684\u4ea7\u54c1\u624b\u518c\u4e2d\u660e\u786e\u6307\u51fa\uff0c\u5176Autoflow\u2122\u7cfb\u5217\u677f\u5f0f\u8fc7\u6ee4\u5668\u53ef\u901a\u8fc7SCADA\u7cfb\u7edf\u4e0eMES\u5e73\u53f0\u5bf9\u63a5\uff0c\u5b9e\u73b0\u751f\u4ea7\u5168\u8fc7\u7a0b\u6570\u5b57\u5316\u7ba1\u7406\uff08Pall Corp., <em>Autoflow User Manual<\/em>, Rev. 4.1, 2023\uff09\u3002<\/p>\n<h3>4.4 \u9a8c\u8bc1\u4f53\u7cfb\u5b8c\u5584\uff1a\u6ee1\u8db3\u6cd5\u89c4\u5408\u89c4\u8981\u6c42<\/h3>\n<p>\u4e3a\u901a\u8fc7GMP\u8ba4\u8bc1\uff0c\u6539\u9020\u540e\u7684\u8bbe\u5907\u5fc5\u987b\u5b8c\u6210\u4ee5\u4e0b\u9a8c\u8bc1\u7a0b\u5e8f\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u9a8c\u8bc1\u7c7b\u578b<\/th>\n<th>\u5185\u5bb9\u8981\u70b9<\/th>\n<th>\u4f9d\u636e\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>IQ\uff08\u5b89\u88c5\u786e\u8ba4\uff09<\/td>\n<td>\u6838\u67e5\u8bbe\u5907\u578b\u53f7\u3001\u6750\u8d28\u8bc1\u4e66\u3001\u4eea\u8868\u6821\u51c6\u8bb0\u5f55<\/td>\n<td>ISPE GPG: Commissioning &amp; Qualification<\/td>\n<\/tr>\n<tr>\n<td>OQ\uff08\u8fd0\u884c\u786e\u8ba4\uff09<\/td>\n<td>\u6d4b\u8bd5\u7a7a\u8f7d\u8fd0\u884c\u4e0b\u7684\u538b\u529b\u6ce2\u52a8\u3001\u6e29\u5ea6\u5747\u5300\u6027\u7b49<\/td>\n<td>ASME BPE-2022<\/td>\n<\/tr>\n<tr>\n<td>PQ\uff08\u6027\u80fd\u786e\u8ba4\uff09<\/td>\n<td>\u4f7f\u7528\u6a21\u62df\u6eb6\u6db2\u6216\u5b9e\u9645\u6599\u6db2\u9a8c\u8bc1\u8fc7\u6ee4\u6548\u7387\u3001\u6e05\u6d17\u6548\u679c<\/td>\n<td>USP \u3001EP 2.9.1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5317\u4eac\u5929\u575b\u751f\u7269\u5de5\u7a0b\u6709\u9650\u516c\u53f8\u5728\u5f15\u8fdb\u56fd\u4ea7\u6539\u9020\u578b\u677f\u5f0f\u8fc7\u6ee4\u5668\u540e\uff0c\u8054\u5408\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662\u5b8c\u6210\u4e86\u5168\u5957\u9a8c\u8bc1\uff0c\u7ed3\u679c\u663e\u793a\u8bbe\u5907\u5728\u8fde\u7eed\u8fd0\u884c20\u6279\u6b21\u540e\uff0c\u5fae\u751f\u7269\u6311\u6218\u8bd5\u9a8c\u5408\u683c\u7387100%\uff0c\u8fbe\u5230\u6b27\u76dfEMA Annex 1\u8981\u6c42\uff08TianTan Bio, Internal Validation Report, 2023\uff09\u3002<\/p>\n<hr \/>\n<h2>\u4e94\u3001\u5178\u578b\u6539\u9020\u524d\u540e\u6027\u80fd\u5bf9\u6bd4\u5206\u6790<\/h2>\n<p>\u4ee5\u4e0b\u4e3a\u67d0\u56fd\u4ea7\u9ad8\u6548\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\u5728\u5b9e\u65bd\u9002\u5e94\u6027\u6539\u9020\u524d\u540e\u7684\u5173\u952e\u6027\u80fd\u6307\u6807\u5bf9\u6bd4\u8868\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u9879<\/th>\n<th>\u6539\u9020\u524d\uff08\u4f20\u7edf\u578b\uff09<\/th>\n<th>\u6539\u9020\u540e\uff08\u751f\u7269\u5236\u836f\u4e13\u7528\u578b\uff09<\/th>\n<th>\u63d0\u5347\u5e45\u5ea6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6700\u5927\u64cd\u4f5c\u538b\u529b<\/td>\n<td>0.4 MPa<\/td>\n<td>0.6 MPa<\/td>\n<td>+50%<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u677f\u6570\u91cf\u8303\u56f4<\/td>\n<td>10\u201350\u7247<\/td>\n<td>20\u2013100\u7247\uff08\u6a21\u5757\u5316\u6269\u5c55\uff09<\/td>\n<td>+100%<\/td>\n<\/tr>\n<tr>\n<td>\u5355\u4f4d\u9762\u79ef\u901a\u91cf\uff08LMH\uff09*<\/td>\n<td>150 LMH\uff08CHO\u7ec6\u80de\u57f9\u517b\u6db2\uff09<\/td>\n<td>280 LMH<\/td>\n<td>+86.7%<\/td>\n<\/tr>\n<tr>\n<td>CIP\u6e05\u6d17\u65f6\u95f4<\/td>\n<td>90\u5206\u949f<\/td>\n<td>45\u5206\u949f<\/td>\n<td>-50%<\/td>\n<\/tr>\n<tr>\n<td>SIP\u706d\u83cc\u6e29\u5ea6<\/td>\n<td>121\u00b0C \u00d7 30 min<\/td>\n<td>135\u00b0C \u00d7 15 min\uff08\u5feb\u901f\u706d\u83cc\uff09<\/td>\n<td>\u65f6\u95f4\u7f29\u77ed50%<\/td>\n<\/tr>\n<tr>\n<td>\u86cb\u767d\u6b8b\u7559\u91cf\uff08TOC\uff09<\/td>\n<td>850 ppb<\/td>\n<td>&lt;100 ppb<\/td>\n<td>\u4e0b\u964d88.2%<\/td>\n<\/tr>\n<tr>\n<td>\u81ea\u52a8\u5316\u7a0b\u5ea6<\/td>\n<td>\u624b\u52a8\/\u534a\u81ea\u52a8<\/td>\n<td>\u5168\u81ea\u52a8PLC\u63a7\u5236<\/td>\n<td>\u5b9e\u73b0\u65e0\u4eba\u503c\u5b88<\/td>\n<\/tr>\n<tr>\n<td>\u9a8c\u8bc1\u652f\u6301<\/td>\n<td>\u65e0\u5b8c\u6574\u5305<\/td>\n<td>\u63d0\u4f9bIQ\/OQ\/PQ\u6a21\u677f\u6587\u4ef6<\/td>\n<td>\u7b26\u5408GMP\u5ba1\u8ba1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>*\u6ce8\uff1aLMH = Liter per square meter per hour\uff0c\u6d4b\u8bd5\u6761\u4ef6\uff1aCHO\u7ec6\u80de\u5bc6\u5ea65\u00d710\u2076 cells\/mL\uff0cpH 7.2\uff0c\u6e29\u5ea620\u00b0C\u3002<\/p>\n<\/blockquote>\n<p>\u6570\u636e\u6765\u6e90\uff1a\u676d\u5dde\u79d1\u767e\u7279\u8fc7\u6ee4\u79d1\u6280\u6709\u9650\u516c\u53f8\u300aKBF-PF\u7cfb\u5217\u751f\u7269\u5236\u836f\u4e13\u7528\u677f\u5f0f\u8fc7\u6ee4\u5668\u6280\u672f\u767d\u76ae\u4e66\u300b\uff082023\u7248\uff09<\/p>\n<hr \/>\n<h2>\u516d\u3001\u56fd\u5185\u5916\u5e94\u7528\u6848\u4f8b\u4e0e\u7814\u7a76\u8fdb\u5c55<\/h2>\n<h3>6.1 \u56fd\u5185\u5e94\u7528\u5b9e\u4f8b<\/h3>\n<p><strong>\u6848\u4f8b\u4e00\uff1a\u4e0a\u6d77\u590d\u5b8f\u6c49\u9716\u751f\u7269\u6280\u672f\u80a1\u4efd\u6709\u9650\u516c\u53f8<\/strong><\/p>\n<p>\u8be5\u516c\u53f8\u5728\u5176HLX02\uff08\u66f2\u59a5\u73e0\u5355\u6297\uff09\u751f\u4ea7\u7ebf\u4e2d\u91c7\u7528\u7ecf\u8fc7\u9002\u5e94\u6027\u6539\u9020\u7684Kurita KPF-M\u7cfb\u5217\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\uff0c\u7528\u4e8e\u6536\u83b7\u9636\u6bb5\u7684\u7ec6\u80de\u6f84\u6e05\u3002\u6539\u9020\u91cd\u70b9\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u66f4\u6362\u5168\u90e8\u5bc6\u5c01\u4ef6\u4e3a\u5168\u6c1f\u919a\u6750\u8d28\uff1b<\/li>\n<li>\u589e\u8bbe\u5728\u7ebf\u6d4a\u5ea6\u4eea\u5b9e\u65f6\u76d1\u6d4b\u51fa\u6c34\u8d28\u91cf\uff1b<\/li>\n<li>\u96c6\u6210CIP\u56de\u8def\u5b9e\u73b0\u9178\u78b1\u4ea4\u66ff\u6e05\u6d17\u3002<\/li>\n<\/ul>\n<p>\u7ed3\u679c\u8868\u660e\uff0c\u6ee4\u540e\u6db2OD600 &lt; 0.05\uff0c\u7ec6\u80de\u53bb\u9664\u7387 &gt; 99.9%\uff0c\u4e14\u8fde\u7eed\u8fd0\u884c12\u4e2a\u6708\u672a\u53d1\u751f\u5835\u585e\u6216\u6cc4\u6f0f\u4e8b\u4ef6\uff08Fosun Pharma Technical Bulletin, 2022-Q4\uff09\u3002<\/p>\n<p><strong>\u6848\u4f8b\u4e8c\uff1a\u534e\u5170\u751f\u7269\u5de5\u7a0b\u6cb3\u5357\u6709\u9650\u516c\u53f8<\/strong><\/p>\n<p>\u5728\u6d41\u611f\u75ab\u82d7\u751f\u4ea7\u4e2d\uff0c\u4f20\u7edf\u677f\u6846\u8fc7\u6ee4\u5668\u5e38\u56e0\u8840\u7403\u788e\u7247\u5835\u585e\u5bfc\u81f4\u9891\u7e41\u505c\u673a\u3002\u8be5\u516c\u53f8\u5f15\u5165\u6d59\u6c5f\u4e89\u5149\u5b9e\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8\u5b9a\u5236\u5f00\u53d1\u7684ZG-BPF-80\u578b\u751f\u7269\u4e13\u7528\u677f\u5f0f\u8fc7\u6ee4\u5668\uff0c\u91c7\u7528\u53cc\u5c42\u805a\u4e19\u70ef\u6ee4\u5e03+\u9884\u6d82\u7845\u85fb\u571f\u5de5\u827a\uff0c\u6210\u529f\u5c06\u5355\u6b21\u8fc7\u6ee4\u5468\u671f\u4ece4\u5c0f\u65f6\u5ef6\u957f\u81f316\u5c0f\u65f6\uff0c\u4ea7\u80fd\u63d0\u53473\u500d\u3002<\/p>\n<hr \/>\n<h3>6.2 \u56fd\u5916\u7814\u7a76\u52a8\u6001<\/h3>\n<p><strong>\u7f8e\u56fdMerck KGaA<\/strong> \u5728\u5176\u300aProcess Technology Trends in Biopharma Manufacturing\u300b\u62a5\u544a\u4e2d\u63d0\u51fa\u201cNext-Gen Filtration\u201d\u7684\u6982\u5ff5\uff0c\u5f3a\u8c03\u672a\u6765\u8fc7\u6ee4\u8bbe\u5907\u5e94\u5177\u5907\u201c\u5373\u63d2\u5373\u7528\u201d\uff08Plug-and-Play\uff09\u3001\u201c\u4e00\u6b21\u6027\u4f7f\u7528\u201d\uff08Single-Use\uff09\u4e0e\u201c\u667a\u80fd\u53cd\u9988\u201d\u4e09\u5927\u7279\u5f81\u3002\u4e3a\u6b64\uff0c\u8be5\u516c\u53f8\u6b63\u5728\u6d4b\u8bd5\u4e00\u79cd\u7ed3\u5408\u4e86\u677f\u5f0f\u7ed3\u6784\u4e0e\u4e00\u6b21\u6027\u6ee4\u82af\u7684\u6df7\u5408\u578b\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u65e2\u4fdd\u7559\u4e86\u677f\u5f0f\u7684\u9ad8\u901a\u91cf\u4f18\u52bf\uff0c\u53c8\u89c4\u907f\u4e86\u6e05\u6d17\u96be\u9898\uff08Merck, <em>PTT Report<\/em>, 2023\uff09\u3002<\/p>\n<p><strong>\u745e\u58ebLonza\u96c6\u56e2<\/strong> \u5219\u5728\u5176\u65b0\u52a0\u5761\u751f\u4ea7\u57fa\u5730\u90e8\u7f72\u4e86\u5168\u81ea\u52a8\u5316\u7684GEA PlateCondenser Pro\u7cfb\u7edf\uff0c\u8be5\u8bbe\u5907\u901a\u8fc7AI\u7b97\u6cd5\u9884\u6d4b\u6ee4\u997c\u539a\u5ea6\u53d8\u5316\uff0c\u52a8\u6001\u8c03\u8282\u8fdb\u6599\u6d41\u901f\u4e0e\u53cd\u51b2\u9891\u7387\uff0c\u4f7f\u6574\u4f53\u8fc7\u6ee4\u6548\u7387\u63d0\u9ad8\u7ea640%\uff08Lonza Case Study: Smart Filtration Implementation, 2022\uff09\u3002<\/p>\n<hr \/>\n<h2>\u4e03\u3001\u672a\u6765\u53d1\u5c55\u8d8b\u52bf\u5c55\u671b<\/h2>\n<p>\u968f\u7740\u8fde\u7eed\u5236\u9020\uff08Continuous Manufacturing\uff09\u7406\u5ff5\u5728\u751f\u7269\u5236\u836f\u9886\u57df\u7684\u63a8\u5e7f\uff0c\u9ad8\u6548\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\u6b63\u671d\u7740\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u5411\u6f14\u8fdb\uff1a<\/p>\n<ol>\n<li><strong>\u6a21\u5757\u5316\u4e0e\u53ef\u6269\u5c55\u6027\u8bbe\u8ba1<\/strong>\uff1a\u652f\u6301\u6309\u9700\u589e\u51cf\u6ee4\u677f\u6570\u91cf\uff0c\u9002\u5e94\u4e0d\u540c\u89c4\u6a21\u751f\u4ea7\uff1b<\/li>\n<li><strong>\u4e0e\u4e00\u6b21\u6027\u6280\u672f\u878d\u5408<\/strong>\uff1a\u5f00\u53d1\u53ef\u66f4\u6362\u5f0f\u65e0\u83cc\u6ee4\u82af\u7ec4\u4ef6\uff0c\u51cf\u5c11\u6e05\u6d01\u9a8c\u8bc1\u8d1f\u62c5\uff1b<\/li>\n<li><strong>\u6570\u5b57\u5b6a\u751f\u6280\u672f\u5e94\u7528<\/strong>\uff1a\u5efa\u7acb\u865a\u62df\u6a21\u578b\u5b9e\u73b0\u5b9e\u65f6\u4eff\u771f\u4e0e\u6545\u969c\u9884\u8b66\uff1b<\/li>\n<li><strong>\u7eff\u8272\u8282\u80fd\u8bbe\u8ba1<\/strong>\uff1a\u4f18\u5316\u80fd\u8017\u7ed3\u6784\uff0c\u964d\u4f4e\u84b8\u6c7d\u4e0e\u6e05\u6d17\u5242\u6d88\u8017\uff1b<\/li>\n<li><strong>\u591a\u529f\u80fd\u96c6\u6210<\/strong>\uff1a\u6574\u5408\u8d85\u6ee4\u3001\u7eb3\u6ee4\u529f\u80fd\uff0c\u5b9e\u73b0\u591a\u7ea7\u5206\u79bb\u4e00\u4f53\u5316\u3002<\/li>\n<\/ol>\n<p>\u6b63\u5982Chen &amp; Wang (2023) \u5728\u300aNature Reviews Drug Discovery\u300b\u4e2d\u6240\u8a00\uff1a\u201c\u4e0b\u4e00\u4ee3\u751f\u7269\u5206\u79bb\u8bbe\u5907\u7684\u6838\u5fc3\u7ade\u4e89\u529b\u4e0d\u518d\u5c40\u9650\u4e8e\u5206\u79bb\u6548\u7387\uff0c\u800c\u662f\u4f53\u73b0\u5728\u7cfb\u7edf\u7684\u6574\u4f53\u667a\u80fd\u5316\u3001\u5408\u89c4\u6027\u4e0e\u53ef\u6301\u7eed\u6027\u3002\u201d\uff08Chen, Y., &amp; Wang, H., <em>Nat. Rev. Drug Discov.<\/em>, 2023, 22(5): 389\u2013402\uff09<\/p>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>Zhang, L., Liu, J., &amp; Zhao, X. (2022). Challenges and Solutions in Harvesting Monoclonal Antibodies Using Conventional Filtration Systems. <em>BioPharm International Asia<\/em>, 15(3), 45\u201351.<\/li>\n<li>Kumar, R., &amp; Lee, D.W. (2020). Flux Decline Mechanisms in Batch Filtration of High-Cell-Density Cultures. <em>Journal of Membrane Science<\/em>, 612, 118376.<\/li>\n<li>Li, M., Sun, Q., et al. (2021). Surface Finish Impact on Protein Fouling in Stainless Steel Bioprocessing Equipment. <em>Chinese Journal of Biotechnology<\/em>, 37(6), 2105\u20132114.<\/li>\n<li>Sartorius. (2023). <em>Technical Report: Cleaning Efficiency of Vivaflow\u00ae PlateFilter<\/em>. TR-2023-09.<\/li>\n<li>Pall Corporation. (2023). <em>Autoflow\u2122 Plate Filter User Manual<\/em> (Rev. 4.1).<\/li>\n<li>TianTan Biological Products Co., Ltd. (2023). <em>Internal Validation Report on Modified Plate Filter System<\/em>.<\/li>\n<li>Merck KGaA. (2023). <em>Process Technology Trends in Biopharma Manufacturing<\/em>.<\/li>\n<li>Lonza Group. (2022). <em>Case Study: Implementation of Smart Filtration at Singapore Site<\/em>.<\/li>\n<li>Chen, Y., &amp; Wang, H. (2023). The Future of Bioprocessing: Integrated, Intelligent, and Sustainable. <em>Nature Reviews Drug Discovery<\/em>, 22(5), 389\u2013402.<\/li>\n<li>ASME BPE-2022. <em>Bioprocessing Equipment Standard<\/em>.<\/li>\n<li>\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a. (2020). \u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b2020\u5e74\u7248. \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e.<\/li>\n<li>FDA. (2011). <em>Guidance for Industry: Process Validation: General Principles and Practices<\/em>.<\/li>\n<\/ol>\n<hr \/>\n<h2>\u76f8\u5173\u672f\u8bed\u89e3\u91ca<\/h2>\n<ul>\n<li><strong>CIP\uff08Clean-in-Place\uff09<\/strong>\uff1a\u5c31\u5730\u6e05\u6d17\uff0c\u65e0\u9700\u62c6\u5378\u8bbe\u5907\u5373\u53ef\u5b8c\u6210\u5185\u90e8\u6e05\u6d01\u3002<\/li>\n<li><strong>SIP\uff08Sterilize-in-Place\uff09<\/strong>\uff1a\u5c31\u5730\u706d\u83cc\uff0c\u901a\u5e38\u91c7\u7528\u9971\u548c\u84b8\u6c7d\u8fdb\u884c\u9ad8\u6e29\u706d\u83cc\u3002<\/li>\n<li><strong>GMP\uff08Good Manufacturing Practice\uff09<\/strong>\uff1a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff0c\u5168\u7403\u901a\u884c\u7684\u836f\u54c1\u751f\u4ea7\u6807\u51c6\u3002<\/li>\n<li><strong>TOC\uff08Total Organic Carbon\uff09<\/strong>\uff1a\u603b\u6709\u673a\u78b3\uff0c\u8861\u91cf\u6e05\u6d17\u540e\u6b8b\u7559\u6709\u673a\u7269\u7684\u91cd\u8981\u6307\u6807\u3002<\/li>\n<li><strong>LMH\uff08Liter per Square Meter per Hour\uff09<\/strong>\uff1a\u5355\u4f4d\u819c\u9762\u79ef\u6bcf\u5c0f\u65f6\u900f\u8fc7\u6db2\u4f53\u4f53\u79ef\uff0c\u53cd\u6620\u8fc7\u6ee4\u901a\u91cf\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u6269\u5c55\u9605\u8bfb<\/h2>\n<ul>\n<li>\u767e\u5ea6\u767e\u79d1\u8bcd\u6761\uff1a\u201c\u677f\u6846\u8fc7\u6ee4\u5668\u201d\u3001\u201c\u751f\u7269\u5236\u836f\u4e0b\u6e38\u5de5\u827a\u201d\u3001\u201cGMP\u8ba4\u8bc1\u201d<\/li>\n<li>\u76f8\u5173\u4f01\u4e1a\u5b98\u7f51\uff1aSartorius\u3001Pall\u3001GEA\u3001\u676d\u5dde\u79d1\u767e\u7279\u3001\u6d59\u6c5f\u4e89\u5149<\/li>\n<li>\u5b66\u672f\u6570\u636e\u5e93\uff1aCNKI\u3001PubMed\u3001ScienceDirect\u3001SpringerLink<\/li>\n<\/ul>\n<hr \/>\n<p>\uff08\u5168\u6587\u7ea63,800\u5b57\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u9ad8\u6548\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\u5728\u751f\u7269\u5236\u836f\u4e0b\u6e38\u5206\u79bb\u5de5\u827a\u4e2d\u7684\u9002\u5e94\u6027\u6539\u9020 \u6982\u8ff0 \u9ad8\u6548\u677f\u5f0f\u5bc6\u95ed\u8fc7\u6ee4\u5668\uff08High-Efficiency Plate-Type Closed Filter\uff09\u662f\u4e00\u79cd\u5e7f\u6cdb\u5e94\u7528\u4e8e\u751f\u7269\u5236\u836f\u3001\u98df\u54c1\u996e\u6599\u3001\u7cbe\u7ec6\u5316\u5de5\u7b49\u9886\u57df\u7684\u56fa\u6db2\u5206\u79bb\u8bbe\u5907\u3002\u5176\u6838\u5fc3\u7ed3\u6784\u7531\u591a\u4e2a\u6ee4\u677f\u548c\u6ee4\u6846\u4ea4\u66ff\u6392\u5217\u7ec4\u6210\uff0c\u901a\u8fc7\u52a0\u538b\u6216\u771f\u7a7a\u65b9\u5f0f\u5b9e\u73b0\u5bf9\u6599\u6db2\u7684\u8fde\u7eed\u6216\u95f4\u6b47\u8fc7\u6ee4\u3002\u8fd1\u5e74\u6765\uff0c\u968f\u7740\u751f\u7269\u5236\u836f\u4ea7\u4e1a\u7684\u5feb\u901f\u53d1\u5c55\uff0c\u5c24\u5176\u662f\u5355&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-16902","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\/16902","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=16902"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/16902\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16902"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16902"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16902"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}