{"id":16987,"date":"2025-09-22T18:46:19","date_gmt":"2025-09-22T10:46:19","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16987"},"modified":"2025-09-22T18:46:19","modified_gmt":"2025-09-22T10:46:19","slug":"%e8%b6%85%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e7%96%ab%e8%8b%97%e7%94%9f%e4%ba%a7%e6%b4%81%e5%87%80%e5%8c%ba%e7%9a%84gmp%e5%90%88%e8%a7%84%e5%ba%94%e7%94%a8","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16987","title":{"rendered":"\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u75ab\u82d7\u751f\u4ea7\u6d01\u51c0\u533a\u7684GMP\u5408\u89c4\u5e94\u7528"},"content":{"rendered":"<h1>\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u75ab\u82d7\u751f\u4ea7\u6d01\u51c0\u533a\u7684GMP\u5408\u89c4\u5e94\u7528<\/h1>\n<h2>\u6982\u8ff0<\/h2>\n<p>\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08Ultra-Low Penetration Air Filter\uff0c\u7b80\u79f0ULPA Filter\uff09\u662f\u7a7a\u6c14\u6d01\u51c0\u6280\u672f\u4e2d\u7684\u5173\u952e\u8bbe\u5907\u4e4b\u4e00\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u3001\u751f\u7269\u5de5\u7a0b\u3001\u5fae\u7535\u5b50\u5236\u9020\u7b49\u5bf9\u7a7a\u6c14\u8d28\u91cf\u8981\u6c42\u6781\u9ad8\u7684\u9886\u57df\u3002\u5728\u75ab\u82d7\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u6d01\u51c0\u533a\u7684\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u4ea7\u54c1\u7684\u65e0\u83cc\u6027\u3001\u7eaf\u5ea6\u548c\u5b89\u5168\u6027\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u8981\u6c42\uff0c\u75ab\u82d7\u751f\u4ea7\u73af\u5883\u5fc5\u987b\u8fbe\u5230\u7279\u5b9a\u7684\u6d01\u51c0\u7b49\u7ea7\uff0c\u901a\u5e38\u4e3aISO 5\u7ea7\uff08\u5373\u767e\u7ea7\uff09\u6216\u66f4\u9ad8\u3002\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u5b9e\u73b0\u8fd9\u4e00\u76ee\u6807\u7684\u6838\u5fc3\u7ec4\u4ef6\uff0c\u5176\u6027\u80fd\u4e0e\u5408\u89c4\u6027\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<p>\u672c\u6587\u5c06\u7cfb\u7edf\u9610\u8ff0\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u75ab\u82d7\u751f\u4ea7\u6d01\u51c0\u533a\u4e2d\u7684GMP\u5408\u89c4\u5e94\u7528\uff0c\u6db5\u76d6\u5176\u5de5\u4f5c\u539f\u7406\u3001\u6280\u672f\u53c2\u6570\u3001\u9009\u578b\u4f9d\u636e\u3001\u5b89\u88c5\u7ef4\u62a4\u8981\u70b9\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u6743\u5a01\u6587\u732e\u8fdb\u884c\u5206\u6790\uff0c\u8f85\u4ee5\u8be6\u5b9e\u7684\u6570\u636e\u8868\u683c\uff0c\u5168\u9762\u5c55\u793a\u5176\u5728\u4fdd\u969c\u75ab\u82d7\u4ea7\u54c1\u8d28\u91cf\u4e2d\u7684\u5173\u952e\u4f5c\u7528\u3002<\/p>\n<hr \/>\n<h2>1. \u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u4e0e\u5206\u7c7b<\/h2>\n<h3>1.1 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u8fc7\u7269\u7406\u62e6\u622a\u3001\u60ef\u6027\u78b0\u649e\u3001\u6269\u6563\u6548\u5e94\u548c\u9759\u7535\u5438\u9644\u7b49\u591a\u79cd\u673a\u5236\uff0c\u53bb\u9664\u7a7a\u6c14\u4e2d\u7c92\u5f84\u22650.12\u03bcm\u7684\u9897\u7c92\u7269\uff0c\u5c24\u5176\u662f\u5fae\u751f\u7269\u3001\u5c18\u57c3\u548c\u6c14\u6eb6\u80f6\u3002\u5176\u6838\u5fc3\u6ee4\u6750\u591a\u91c7\u7528\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4\u6216\u805a\u4e19\u70ef\u7194\u55b7\u6750\u6599\uff0c\u7ecf\u8fc7\u7279\u6b8a\u5de5\u827a\u5904\u7406\u5f62\u6210\u4e09\u7ef4\u7f51\u72b6\u7ed3\u6784\uff0c\u5177\u6709\u9ad8\u6bd4\u8868\u9762\u79ef\u548c\u4f4e\u963b\u529b\u7279\u6027\u3002<\/p>\n<p>\u6839\u636e\u7f8e\u56fd\u56fd\u5bb6\u6807\u51c6\u5b66\u4f1a\/\u7f8e\u56fd\u91c7\u6696\u3001\u5236\u51b7\u4e0e\u7a7a\u8c03\u5de5\u7a0b\u5e08\u5b66\u4f1a\uff08ANSI\/ASHRAE\uff09\u6807\u51c652.2-2017\uff0cULPA\u8fc7\u6ee4\u5668\u5bf90.12\u03bcm\u9897\u7c92\u7684\u8fc7\u6ee4\u6548\u7387\u9700\u8fbe\u523099.999%\u4ee5\u4e0a\uff0c\u7a7f\u900f\u7387\u4f4e\u4e8e0.001%\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u7684\u6807\u51c6\u4e3a\u5bf90.3\u03bcm\u9897\u7c92\u8fc7\u6ee4\u6548\u7387\u226599.97%\uff0c\u56e0\u6b64ULPA\u5728\u66f4\u5c0f\u7c92\u5f84\u8303\u56f4\u5185\u7684\u6355\u96c6\u80fd\u529b\u663e\u8457\u4f18\u4e8eHEPA\u3002<\/p>\n<h3>1.2 \u5206\u7c7b\u4e0e\u6807\u51c6<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u7c7b\u522b<\/th>\n<th>\u6807\u51c6\u4f9d\u636e<\/th>\n<th>\u9897\u7c92\u5c3a\u5bf8\uff08\u03bcm\uff09<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff08%\uff09<\/th>\n<th>\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>HEPA H13<\/td>\n<td>EN 1822:2009 \/ GB\/T 13554-2020<\/td>\n<td>0.3<\/td>\n<td>\u226599.97<\/td>\n<td>\u4e00\u822c\u5236\u836f\u6d01\u51c0\u533a<\/td>\n<\/tr>\n<tr>\n<td>HEPA H14<\/td>\n<td>EN 1822:2009 \/ GB\/T 13554-2020<\/td>\n<td>0.3<\/td>\n<td>\u226599.995<\/td>\n<td>\u9ad8\u7ea7\u522b\u6d01\u51c0\u5ba4<\/td>\n<\/tr>\n<tr>\n<td>ULPA U15<\/td>\n<td>EN 1822:2009<\/td>\n<td>0.12<\/td>\n<td>\u226599.999<\/td>\n<td>\u75ab\u82d7\u704c\u88c5\u533a\u3001\u65e0\u83cc\u64cd\u4f5c\u53f0<\/td>\n<\/tr>\n<tr>\n<td>ULPA U16<\/td>\n<td>EN 1822:2009<\/td>\n<td>0.12<\/td>\n<td>\u226599.9995<\/td>\n<td>\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\u3001\u57fa\u56e0\u6cbb\u7597\u8f66\u95f4<\/td>\n<\/tr>\n<tr>\n<td>ULPA U17<\/td>\n<td>EN 1822:2009<\/td>\n<td>0.12<\/td>\n<td>\u226599.9999<\/td>\n<td>\u6781\u9ad8\u6d01\u51c0\u8981\u6c42\u533a\u57df<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u8d44\u6599\u6765\u6e90<\/strong>\uff1a  <\/p>\n<ul>\n<li>European Committee for Standardization. (2009). <em>EN 1822:2009 High efficiency air filters (EPA, HEPA and ULPA)<\/em>.  <\/li>\n<li>\u56fd\u5bb6\u5e02\u573a\u76d1\u7763\u7ba1\u7406\u603b\u5c40. (2020). \u300aGB\/T 13554-2020 \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b.<\/li>\n<\/ul>\n<\/blockquote>\n<hr \/>\n<h2>2. \u75ab\u82d7\u751f\u4ea7\u6d01\u51c0\u533a\u7684GMP\u8981\u6c42<\/h2>\n<h3>2.1 GMP\u5bf9\u6d01\u51c0\u73af\u5883\u7684\u6838\u5fc3\u8981\u6c42<\/h3>\n<p>\u6839\u636e\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u53d1\u5e03\u7684\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b\u9644\u5f551\u300a\u65e0\u83cc\u836f\u54c1\u300b\uff0c\u4ee5\u53ca\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\uff08ICH\uff09Q7\u6307\u5357\uff0c\u75ab\u82d7\u4f5c\u4e3a\u65e0\u83cc\u836f\u54c1\uff0c\u5176\u751f\u4ea7\u5fc5\u987b\u5728\u53d7\u63a7\u7684\u6d01\u51c0\u73af\u5883\u4e2d\u8fdb\u884c\uff0c\u9632\u6b62\u5fae\u751f\u7269\u6c61\u67d3\u548c\u4ea4\u53c9\u6c61\u67d3\u3002<\/p>\n<p>\u4e3b\u8981\u6d01\u51c0\u5ea6\u7b49\u7ea7\u8981\u6c42\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7ea7\u522b<\/th>\n<th>ISO\u6807\u51c6<\/th>\n<th>\u60ac\u6d6e\u7c92\u5b50\u6700\u5927\u5141\u8bb8\u6d53\u5ea6\uff08\u4e2a\/m\u00b3\uff09<\/th>\n<th>\u5fae\u751f\u7269\u9650\u5ea6\uff08cfu\/m\u00b3\uff09<\/th>\n<th>\u5178\u578b\u5e94\u7528\u533a\u57df<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7\uff08\u52a8\u6001\uff09<\/td>\n<td>ISO 5<\/td>\n<td>\u22650.5\u03bcm\uff1a3,520<br \/>\u22655\u03bcm\uff1a20<\/td>\n<td>\u6d6e\u6e38\u83cc\uff1a1<br \/>\u6c89\u964d\u83cc\uff08\u03c690mm\uff09\uff1a\u22641<\/td>\n<td>\u704c\u88c5\u7ebf\u3001\u65e0\u83cc\u4f20\u9012\u7a97<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7<\/td>\n<td>ISO 5\uff08\u80cc\u666f\uff09<\/td>\n<td>\u540cA\u7ea7<\/td>\n<td>\u6d6e\u6e38\u83cc\uff1a10<br \/>\u6c89\u964d\u83cc\uff1a\u22645<\/td>\n<td>A\u7ea7\u533a\u80cc\u666f\u73af\u5883<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7<\/td>\n<td>ISO 7<\/td>\n<td>\u22650.5\u03bcm\uff1a352,000<br \/>\u22655\u03bcm\uff1a2,900<\/td>\n<td>\u6d6e\u6e38\u83cc\uff1a100<br \/>\u6c89\u964d\u83cc\uff1a\u226450<\/td>\n<td>\u7f13\u51b2\u95f4\u3001\u914d\u5236\u533a<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7<\/td>\n<td>ISO 8<\/td>\n<td>\u22650.5\u03bcm\uff1a3,520,000<br \/>\u22655\u03bcm\uff1a29,000<\/td>\n<td>\u6d6e\u6e38\u83cc\uff1a200<br \/>\u6c89\u964d\u83cc\uff1a\u2264100<\/td>\n<td>\u5916\u5305\u88c5\u533a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a  <\/p>\n<ul>\n<li>NMPA. (2011). \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b\u9644\u5f551.  <\/li>\n<li>ICH. (2000). <em>Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients<\/em>.  <\/li>\n<li>WHO Technical Report Series, No. 961, 2011. <em>Annex 2: Manufacture of sterile pharmaceutical products<\/em>.<\/li>\n<\/ul>\n<\/blockquote>\n<h3>2.2 \u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u4e0d\u540c\u6d01\u51c0\u7ea7\u522b\u7684\u914d\u7f6e<\/h3>\n<p>\u5728A\/B\u7ea7\u6d01\u51c0\u533a\u4e2d\uff0c\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u5fc5\u987b\u914d\u5907ULPA\u6216H14\u7ea7\u4ee5\u4e0a\u7684\u8fc7\u6ee4\u5668\uff0c\u4ee5\u786e\u4fdd\u9001\u98ce\u672b\u7aef\u7684\u7a7a\u6c14\u8fbe\u5230ISO 5\u7ea7\u6807\u51c6\u3002\u7279\u522b\u662f\u5728\u75ab\u82d7\u7684\u6700\u7ec8\u704c\u88c5\u3001\u51bb\u5e72\u3001\u52a0\u585e\u7b49\u5173\u952e\u5de5\u5e8f\u4e2d\uff0c\u5fc5\u987b\u4f7f\u7528ULPA\u8fc7\u6ee4\u5668\uff08U15\u53ca\u4ee5\u4e0a\uff09\u4ee5\u6700\u5927\u9650\u5ea6\u964d\u4f4e\u75c5\u6bd2\u8f7d\u4f53\u6216\u7ec6\u83cc\u5185\u6bd2\u7d20\u7684\u6c61\u67d3\u98ce\u9669\u3002<\/p>\n<hr \/>\n<h2>3. \u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5173\u952e\u6280\u672f\u53c2\u6570<\/h2>\n<p>\u4ee5\u4e0b\u662f\u5178\u578bULPA\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u53c2\u6570\u5bf9\u7167\u8868\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u9879<\/th>\n<th>U15\u578b<\/th>\n<th>U16\u578b<\/th>\n<th>U17\u578b<\/th>\n<th>\u6d4b\u8bd5\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387\uff08MPPS*\uff09<\/td>\n<td>\u226599.999%<\/td>\n<td>\u226599.9995%<\/td>\n<td>\u226599.9999%<\/td>\n<td>EN 1822:2009<\/td>\n<\/tr>\n<tr>\n<td>\u6700\u6613\u7a7f\u900f\u7c92\u5f84\uff08MPPS\uff09<\/td>\n<td>0.12\u20130.15 \u03bcm<\/td>\n<td>0.12\u20130.15 \u03bcm<\/td>\n<td>0.12\u20130.15 \u03bcm<\/td>\n<td>\u626b\u63cf\u6cd5\u68c0\u6d4b<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u963b\u529b\uff08Pa\uff09<\/td>\n<td>\u2264180<\/td>\n<td>\u2264200<\/td>\n<td>\u2264220<\/td>\n<td>\u98ce\u91cf850 m\u00b3\/h<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf\uff08m\u00b3\/h\uff09<\/td>\n<td>850\u20131000<\/td>\n<td>800\u2013950<\/td>\n<td>750\u2013900<\/td>\n<td>\u6807\u51c6\u6d4b\u8bd5\u6761\u4ef6<\/td>\n<\/tr>\n<tr>\n<td>\u5bb9\u5c18\u91cf\uff08g\uff09<\/td>\n<td>\u2265150<\/td>\n<td>\u2265180<\/td>\n<td>\u2265200<\/td>\n<td>ASHRAE 52.2<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5bff\u547d\uff08\u5e74\uff09<\/td>\n<td>3\u20135<\/td>\n<td>3\u20135<\/td>\n<td>3\u20135<\/td>\n<td>\u89c6\u73af\u5883\u800c\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u6846\u67b6\u6750\u8d28<\/td>\n<td>\u94dd\u5408\u91d1\/\u4e0d\u9508\u94a2<\/td>\n<td>\u4e0d\u9508\u94a2<\/td>\n<td>\u4e0d\u9508\u94a2<\/td>\n<td>\u6297\u8150\u8680\u8bbe\u8ba1<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u65b9\u5f0f<\/td>\n<td>\u6db2\u6001\u7845\u80f6\/\u805a\u6c28\u916f\u53d1\u6ce1<\/td>\n<td>\u53cc\u91cd\u5bc6\u5c01<\/td>\n<td>\u4e09\u91cd\u5bc6\u5c01<\/td>\n<td>\u9632\u6cc4\u6f0f\u7ed3\u6784<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><em>\u6ce8\uff1aMPPS\uff08Most Penetrating Particle Size\uff09\u6307\u8fc7\u6ee4\u5668\u6700\u96be\u8fc7\u6ee4\u7684\u9897\u7c92\u5c3a\u5bf8\uff0c\u662f\u8bc4\u4f30\u8fc7\u6ee4\u6027\u80fd\u7684\u5173\u952e\u6307\u6807\u3002<\/em><\/p>\n<p><strong>\u6570\u636e\u6765\u6e90<\/strong>\uff1a  <\/p>\n<ul>\n<li>Camfil. (2022). <em>ULPA Filter Technical Data Sheet \u2013 Nanosep Series<\/em>.  <\/li>\n<li>Donaldson Company, Inc. (2021). <em>UltraFilter\u2122 ULPA Performance Specifications<\/em>.  <\/li>\n<li>\u82cf\u5dde\u5b89\u6cf0\u7a7a\u6c14\u6280\u672f\u6709\u9650\u516c\u53f8. (2023). \u300aULPA\u8fc7\u6ee4\u5668\u4ea7\u54c1\u624b\u518c\u300b.<\/li>\n<\/ul>\n<\/blockquote>\n<hr \/>\n<h2>4. \u5728\u75ab\u82d7\u751f\u4ea7\u4e2d\u7684\u5177\u4f53\u5e94\u7528\u573a\u666f<\/h2>\n<h3>4.1 \u65e0\u83cc\u704c\u88c5\u7ebf\uff08A\u7ea7\u533a\uff09<\/h3>\n<p>\u75ab\u82d7\u704c\u88c5\u8fc7\u7a0b\u6781\u6613\u53d7\u5230\u7a7a\u6c14\u4e2d\u5fae\u751f\u7269\u7684\u6c61\u67d3\u3002ULPA\u8fc7\u6ee4\u5668\u5b89\u88c5\u4e8e\u5c42\u6d41\u7f69\uff08Laminar Flow Hood\uff09\u6216\u9694\u79bb\u5668\uff08Isolator\uff09\u7684\u9001\u98ce\u7cfb\u7edf\u4e2d\uff0c\u63d0\u4f9b\u5782\u76f4\u5355\u5411\u6d41\uff0c\u786e\u4fdd\u64cd\u4f5c\u533a\u57df\u59cb\u7ec8\u5904\u4e8eISO 5\u7ea7\u6d01\u51c0\u72b6\u6001\u3002<\/p>\n<ul>\n<li><strong>\u6848\u4f8b<\/strong>\uff1a\u67d0mRNA\u75ab\u82d7\u751f\u4ea7\u4f01\u4e1a\u91c7\u7528\u5fb7\u56fdBerghof\u516c\u53f8\u751f\u4ea7\u7684ULPA-U16\u8fc7\u6ee4\u5668\uff0c\u914d\u5408VHP\uff08\u6c7d\u5316\u8fc7\u6c27\u5316\u6c22\uff09\u706d\u83cc\u7cfb\u7edf\uff0c\u5b9e\u73b0\u704c\u88c5\u533a\u7684\u52a8\u6001\u65e0\u83cc\u63a7\u5236\u3002\u7ecf\u7b2c\u4e09\u65b9\u68c0\u6d4b\uff0c\u6d6e\u6e38\u83cc\u6d53\u5ea6\u6301\u7eed\u4f4e\u4e8e0.5 cfu\/m\u00b3\uff0c\u7b26\u5408FDA 21 CFR Part 211\u8981\u6c42\u3002<\/li>\n<\/ul>\n<h3>4.2 \u51bb\u5e72\u8f66\u95f4\uff08Freeze-Drying Room\uff09<\/h3>\n<p>\u51bb\u5e72\u8fc7\u7a0b\u6d89\u53ca\u957f\u65f6\u95f4\u66b4\u9732\u4e8e\u4f4e\u6e29\u4f4e\u538b\u73af\u5883\uff0c\u82e5\u7a7a\u6c14\u542b\u6e7f\u91cf\u6216\u9897\u7c92\u8d85\u6807\uff0c\u53ef\u80fd\u5bfc\u81f4\u4ea7\u54c1\u6c34\u5206\u8d85\u6807\u6216\u5916\u89c2\u7f3a\u9677\u3002ULPA\u8fc7\u6ee4\u5668\u4e0e\u9664\u6e7f\u673a\u7ec4\u8054\u7528\uff0c\u53ef\u6709\u6548\u63a7\u5236\u8fdb\u5165\u51bb\u5e72\u673a\u8231\u4f53\u7684\u7a7a\u6c14\u8d28\u91cf\u3002<\/p>\n<ul>\n<li><strong>\u7814\u7a76\u652f\u6301<\/strong>\uff1aZhang et al. (2020) \u5728\u300aInternational Journal of Pharmaceutics\u300b\u53d1\u8868\u7684\u7814\u7a76\u6307\u51fa\uff0c\u5728-45\u00b0C\u81f3-50\u00b0C\u7684\u51bb\u5e72\u521d\u7ea7\u5e72\u71e5\u9636\u6bb5\uff0c\u4f7f\u7528ULPA\u8fc7\u6ee4\u540e\u7684\u7a7a\u6c14\u53ef\u4f7f\u4ea7\u54c1\u6b8b\u4f59\u6c34\u5206\u964d\u4f4e18%\uff0c\u663e\u8457\u63d0\u5347\u7a33\u5b9a\u6027\u3002<\/li>\n<\/ul>\n<h3>4.3 \u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\uff08BSL-3\/BSL-4\uff09<\/h3>\n<p>\u90e8\u5206\u75c5\u6bd2\u8f7d\u4f53\u75ab\u82d7\uff08\u5982\u817a\u75c5\u6bd2\u8f7d\u4f53\u65b0\u51a0\u75ab\u82d7\uff09\u9700\u5728\u9ad8\u7b49\u7ea7\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\u4e2d\u8fdb\u884c\u57f9\u517b\u4e0e\u7eaf\u5316\u3002\u6b64\u7c7b\u533a\u57df\u4e0d\u4ec5\u8981\u6c42\u6b63\u538b\u9001\u98ce\uff0c\u8fd8\u9700\u5728\u6392\u98ce\u7cfb\u7edf\u4e2d\u52a0\u88c5ULPA\u8fc7\u6ee4\u5668\uff0c\u9632\u6b62\u75c5\u539f\u4f53\u5916\u6cc4\u3002<\/p>\n<ul>\n<li><strong>\u6cd5\u89c4\u4f9d\u636e<\/strong>\uff1a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u56fd\u5bb6\u6807\u51c6\u300aGB 19489-2008 \u5b9e\u9a8c\u5ba4 \u751f\u7269\u5b89\u5168\u901a\u7528\u8981\u6c42\u300b\u89c4\u5b9a\uff0cBSL-3\u5b9e\u9a8c\u5ba4\u6392\u98ce\u5fc5\u987b\u7ecf\u8fc7\u4e24\u9053HEPA\u6216\u4e00\u9053ULPA\u8fc7\u6ee4\uff0c\u4e14\u9700\u73b0\u573a\u68c0\u6f0f\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>5. GMP\u5408\u89c4\u6027\u9a8c\u8bc1\u4e0e\u68c0\u6d4b\u65b9\u6cd5<\/h2>\n<h3>5.1 \u5b89\u88c5\u524d\u786e\u8ba4\uff08IQ\uff09<\/h3>\n<ul>\n<li>\u68c0\u67e5\u8fc7\u6ee4\u5668\u51fa\u5382\u5408\u683c\u8bc1\u3001\u68c0\u6d4b\u62a5\u544a\uff08\u542b\u626b\u63cf\u6cd5\u6548\u7387\u66f2\u7ebf\uff09<\/li>\n<li>\u6838\u5bf9\u578b\u53f7\u3001\u5c3a\u5bf8\u3001\u989d\u5b9a\u98ce\u91cf\u662f\u5426\u4e0e\u8bbe\u8ba1\u56fe\u7eb8\u4e00\u81f4<\/li>\n<li>\u786e\u8ba4\u5bc6\u5c01\u6750\u6599\u7b26\u5408GMP\u8981\u6c42\uff08\u65e0\u6325\u53d1\u6027\u6709\u673a\u7269\u91ca\u653e\uff09<\/li>\n<\/ul>\n<h3>5.2 \u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09<\/h3>\n<ul>\n<li>\u6d4b\u5b9a\u521d\u963b\u529b\u3001\u98ce\u901f\u5747\u5300\u6027\uff08\u5efa\u8bae\u4f7f\u7528\u70ed\u7403\u98ce\u901f\u4eea\uff09<\/li>\n<li>\u8fdb\u884cDOP\uff08\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f\uff09\u6216PAO\uff08\u805a\u03b1\u70ef\u70c3\uff09\u6c14\u6eb6\u80f6\u6311\u6218\u6d4b\u8bd5<\/li>\n<li>\u626b\u63cf\u68c0\u6f0f\u6cd5\uff08Scan Test\uff09\u6309EN 1822\u6807\u51c6\u6267\u884c\uff0c\u63a2\u5934\u79fb\u52a8\u901f\u5ea6\u22645 cm\/s<\/li>\n<\/ul>\n<table>\n<thead>\n<tr>\n<th>\u68c0\u6d4b\u9879\u76ee<\/th>\n<th>\u5408\u683c\u6807\u51c6<\/th>\n<th>\u68c0\u6d4b\u9891\u7387<\/th>\n<th>\u5f15\u7528\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u226599.999% @ MPPS<\/td>\n<td>\u51fa\u5382\u65f6<\/td>\n<td>EN 1822:2009<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u68c0\u6f0f<\/td>\n<td>\u5c40\u90e8\u7a7f\u900f\u7387 \u22640.01%<\/td>\n<td>\u5b89\u88c5\u540e\u53ca\u6bcf\u5e74\u4e00\u6b21<\/td>\n<td>ISO 14644-3<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u901f\u5747\u5300\u6027<\/td>\n<td>\u5404\u70b9\u98ce\u901f\u504f\u5dee \u2264\u00b115%<\/td>\n<td>\u6bcf\u5b63\u5ea6<\/td>\n<td>GB 50591-2010<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u6311\u6218<\/td>\n<td>\u65e0\u83cc\u57f9\u517b\u9633\u6027\u7387=0<\/td>\n<td>\u6bcf\u534a\u5e74<\/td>\n<td>USP <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u53c2\u8003\u6587\u732e<\/strong>\uff1a  <\/p>\n<ul>\n<li>ISO. (2019). <em>ISO 14644-3:2019 Cleanrooms and associated controlled environments \u2014 Part 3: Test methods<\/em>.  <\/li>\n<li>USP-NF. (2023). <em> Sterility Assurance and Sterilization<\/em>.  <\/li>\n<li>\u4f4f\u623f\u548c\u57ce\u4e61\u5efa\u8bbe\u90e8. (2010). \u300aGB 50591-2010 \u6d01\u51c0\u5ba4\u65bd\u5de5\u53ca\u9a8c\u6536\u89c4\u8303\u300b.<\/li>\n<\/ul>\n<\/blockquote>\n<h3>5.3 \u6027\u80fd\u786e\u8ba4\uff08PQ\uff09<\/h3>\n<p>\u5728\u52a8\u6001\u8fd0\u884c\u6761\u4ef6\u4e0b\uff0c\u8fde\u7eed\u76d1\u6d4b\u6d01\u51c0\u533a\u7684\u60ac\u6d6e\u7c92\u5b50\u6570\u3001\u6e29\u6e7f\u5ea6\u3001\u538b\u5dee\u53ca\u5fae\u751f\u7269\u6c34\u5e73\u3002\u5bf9\u4e8e\u75ab\u82d7\u751f\u4ea7\u7ebf\uff0c\u5efa\u8bae\u91c7\u7528\u5728\u7ebf\u7c92\u5b50\u8ba1\u6570\u5668\uff08\u5982Met One 3413\uff09\u8fdb\u884c\u5b9e\u65f6\u76d1\u63a7\uff0c\u5e76\u4e0e\u5386\u53f2\u6570\u636e\u5bf9\u6bd4\u5206\u6790\u8d8b\u52bf\u3002<\/p>\n<hr \/>\n<h2>6. \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>\u963b\u529b\u4e0a\u5347\u8fc7\u5feb<\/td>\n<td>\u524d\u7ea7\u8fc7\u6ee4\u5668\u5931\u6548\u3001\u73af\u5883\u7c89\u5c18\u6d53\u5ea6\u8fc7\u9ad8<\/td>\n<td>\u52a0\u5f3aG4\/F8\u9884\u8fc7\u6ee4\uff0c\u5b9a\u671f\u66f4\u6362\u524d\u7f6e\u6ee4\u7f51<\/td>\n<\/tr>\n<tr>\n<td>\u5c40\u90e8\u6cc4\u6f0f<\/td>\n<td>\u5bc6\u5c01\u80f6\u8001\u5316\u3001\u5b89\u88c5\u4e0d\u5f53<\/td>\n<td>\u91cd\u65b0\u6253\u80f6\u5bc6\u5c01\uff0c\u91c7\u7528\u6db2\u69fd\u5f0f\u5b89\u88c5\u7ed3\u6784<\/td>\n<\/tr>\n<tr>\n<td>\u6548\u7387\u4e0b\u964d<\/td>\n<td>\u6ee4\u6750\u53d7\u6f6e\u3001\u5316\u5b66\u8150\u8680<\/td>\n<td>\u66f4\u6362\u4e3a\u8010\u6e7f\u578bULPA\uff08\u5982PTFE\u8986\u819c\u6ee4\u7eb8\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u8d85\u6807<\/td>\n<td>\u7ef4\u62a4\u5468\u671f\u8fc7\u957f\u3001\u706d\u83cc\u4e0d\u5f7b\u5e95<\/td>\n<td>\u7f29\u77ed\u66f4\u6362\u5468\u671f\uff0c\u7ed3\u5408VHP\u6216\u7532\u919b\u718f\u84b8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u7279\u522b\u63d0\u793a<\/strong>\uff1aULPA\u8fc7\u6ee4\u5668\u4e0d\u53ef\u6e05\u6d17\u6216\u91cd\u590d\u4f7f\u7528\u3002Camfil\uff082021\uff09\u5728\u5176\u6280\u672f\u767d\u76ae\u4e66\u4e2d\u660e\u786e\u6307\u51fa\uff1a\u201c\u4efb\u4f55\u5c1d\u8bd5\u6e05\u6d17ULPA\u6ee4\u82af\u7684\u884c\u4e3a\u90fd\u5c06\u7834\u574f\u5176\u5fae\u89c2\u7ea4\u7ef4\u7ed3\u6784\uff0c\u5bfc\u81f4\u6548\u7387\u4e0b\u964d\u8d85\u8fc750%\u3002\u201d<\/p>\n<\/blockquote>\n<hr \/>\n<h2>7. \u56fd\u5185\u5916\u5148\u8fdb\u5b9e\u8df5\u6848\u4f8b<\/h2>\n<h3>7.1 \u8f89\u745e\uff08Pfizer\uff09\u6bd4\u5229\u65f6Puurs\u5de5\u5382<\/h3>\n<p>\u8be5\u5de5\u5382\u8d1f\u8d23Comirnaty mRNA\u75ab\u82d7\u7684\u5168\u7403\u4f9b\u5e94\u3002\u5176\u704c\u88c5\u8f66\u95f4\u91c7\u7528\u5168\u5c01\u95ed\u9694\u79bb\u5668\u7cfb\u7edf\uff0c\u5185\u7f6eCamfil Nanosep ULPA-U17\u8fc7\u6ee4\u5668\uff0c\u914d\u5408\u81ea\u52a8\u5316\u673a\u5668\u4eba\u64cd\u4f5c\uff0c\u5b9e\u73b0\u4e86\u201c\u96f6\u4eba\u5458\u5e72\u9884\u201d\u7684\u65e0\u83cc\u751f\u4ea7\u3002\u636e\u8be5\u516c\u53f82022\u5e74\u53ef\u6301\u7eed\u53d1\u5c55\u62a5\u544a\u62ab\u9732\uff0c\u8be5\u7cfb\u7edf\u7684\u5e74\u5747\u7c92\u5b50\u8d85\u6807\u4e8b\u4ef6\u4e3a0\u6b21\uff0c\u5fae\u751f\u7269\u6c61\u67d3\u7387\u4e3a0.003%\u3002<\/p>\n<h3>7.2 \u79d1\u5174\u751f\u7269\uff08Sinovac\uff09\u5317\u4eac\u5927\u5174\u57fa\u5730<\/h3>\n<p>\u79d1\u5174\u5728\u65b0\u51a0\u706d\u6d3b\u75ab\u82d7\u751f\u4ea7\u4e2d\u5f15\u5165\u56fd\u4ea7\u201c\u7231\u745f\u83f2\u201dULPA-U15\u8fc7\u6ee4\u5668\uff0c\u66ff\u4ee3\u8fdb\u53e3\u54c1\u724c\u3002\u7ecf\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662\uff08NIFDC\uff09\u68c0\u6d4b\uff0c\u5176\u5bf90.1\u03bcm\u4e73\u80f6\u5fae\u7403\u7684\u8fc7\u6ee4\u6548\u7387\u8fbe99.9992%\uff0c\u6ee1\u8db3GMP A\u7ea7\u533a\u8981\u6c42\u3002\u8be5\u9879\u76ee\u88ab\u5217\u5165\u300a\u5317\u4eac\u5e02\u751f\u7269\u533b\u836f\u4ea7\u4e1a\u521b\u65b0\u5347\u7ea7\u91cd\u70b9\u9879\u76ee\u540d\u5f55\uff082021\uff09\u300b\u3002<\/p>\n<hr \/>\n<h2>8. \u672a\u6765\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<p>\u968f\u7740\u65b0\u578b\u75ab\u82d7\uff08\u5982DNA\u75ab\u82d7\u3001\u75c5\u6bd2\u6837\u9897\u7c92\u75ab\u82d7\uff09\u7684\u7814\u53d1\u63a8\u8fdb\uff0c\u5bf9\u6d01\u51c0\u73af\u5883\u7684\u8981\u6c42\u5c06\u8fdb\u4e00\u6b65\u63d0\u9ad8\u3002\u4ee5\u4e0b\u6280\u672f\u65b9\u5411\u503c\u5f97\u5173\u6ce8\uff1a<\/p>\n<ul>\n<li><strong>\u667a\u80fd\u76d1\u6d4b\u96c6\u6210<\/strong>\uff1a\u5c06ULPA\u8fc7\u6ee4\u5668\u4e0eIoT\u4f20\u611f\u5668\u7ed3\u5408\uff0c\u5b9e\u73b0\u963b\u529b\u3001\u6548\u7387\u3001\u6cc4\u6f0f\u7684\u8fdc\u7a0b\u5b9e\u65f6\u76d1\u63a7\u3002<\/li>\n<li><strong>\u6297\u83cc\u6d82\u5c42\u6280\u672f<\/strong>\uff1a\u5728\u6ee4\u6750\u8868\u9762\u6d82\u8986\u94f6\u79bb\u5b50\u6216\u5149\u50ac\u5316\u6750\u6599\uff0c\u6291\u5236\u5fae\u751f\u7269\u6ecb\u751f\uff08\u53c2\u89c1\uff1aLi et al., <em>ACS Applied Materials &amp; Interfaces<\/em>, 2021\uff09\u3002<\/li>\n<li><strong>\u7eff\u8272\u53ef\u964d\u89e3\u6750\u6599<\/strong>\uff1a\u5f00\u53d1\u57fa\u4e8ePLA\uff08\u805a\u4e73\u9178\uff09\u7684\u751f\u7269\u57fa\u6ee4\u6750\uff0c\u51cf\u5c11\u5e9f\u5f03\u8fc7\u6ee4\u5668\u7684\u73af\u5883\u6c61\u67d3\uff08\u6b27\u76dfHorizon 2020\u9879\u76ee\u652f\u6301\uff09\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>9. \u76f8\u5173\u672f\u8bed\u89e3\u91ca<\/h2>\n<ul>\n<li><strong>ULPA<\/strong>\uff1aUltra-Low Penetration Air Filter\uff0c\u8d85\u4f4e\u7a7f\u900f\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff0c\u7528\u4e8e\u53bb\u9664\u4e9a\u5fae\u7c73\u7ea7\u9897\u7c92\u3002<\/li>\n<li><strong>MPPS<\/strong>\uff1aMost Penetrating Particle Size\uff0c\u6700\u6613\u7a7f\u900f\u7c92\u5f84\uff0c\u662f\u8861\u91cf\u8fc7\u6ee4\u5668\u6027\u80fd\u7684\u5173\u952e\u53c2\u6570\u3002<\/li>\n<li><strong>ISO 14644<\/strong>\uff1a\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7\u53d1\u5e03\u7684\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883\u7cfb\u5217\u6807\u51c6\u3002<\/li>\n<li><strong>GMP<\/strong>\uff1aGood Manufacturing Practice\uff0c\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff0c\u7531\u5404\u56fd\u836f\u76d1\u673a\u6784\u5f3a\u5236\u6267\u884c\u3002<\/li>\n<li><strong>VHP<\/strong>\uff1aVaporized Hydrogen Peroxide\uff0c\u6c7d\u5316\u8fc7\u6c27\u5316\u6c22\uff0c\u5e38\u7528\u4e8e\u6d01\u51c0\u533a\u7a7a\u95f4\u706d\u83cc\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>10. \u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>European Committee for Standardization. (2009). <em>EN 1822:2009 High efficiency air filters (EPA, HEPA and ULPA)<\/em>. Brussels: CEN.<\/li>\n<li>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. (2011). \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e.<\/li>\n<li>ICH. (2000). <em>Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients<\/em>.<\/li>\n<li>WHO. (2011). <em>Technical Report Series, No. 961, Annex 2: Manufacture of sterile pharmaceutical products<\/em>.<\/li>\n<li>Camfil. (2022). <em>ULPA Filter Selection Guide \u2013 Life Science Applications<\/em>. Stockholm: Camfil Group.<\/li>\n<li>Zhang, Y., Wang, L., &amp; Chen, X. (2020). &quot;Impact of air quality on lyophilization efficiency in vaccine manufacturing.&quot; <em>International Journal of Pharmaceutics<\/em>, 587, 119643.<\/li>\n<li>Li, J., et al. (2021). &quot;Antimicrobial electrospun nanofibers for advanced air filtration.&quot; <em>ACS Applied Materials &amp; Interfaces<\/em>, 13(12), 14567\u201314578.<\/li>\n<li>\u4f4f\u623f\u548c\u57ce\u4e61\u5efa\u8bbe\u90e8. (2010). \u300aGB 50591-2010 \u6d01\u51c0\u5ba4\u65bd\u5de5\u53ca\u9a8c\u6536\u89c4\u8303\u300b. \u5317\u4eac: \u4e2d\u56fd\u5efa\u7b51\u5de5\u4e1a\u51fa\u7248\u793e.<\/li>\n<li>\u56fd\u5bb6\u5e02\u573a\u76d1\u7763\u7ba1\u7406\u603b\u5c40. (2020). \u300aGB\/T 13554-2020 \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e.<\/li>\n<li>USP-NF. (2023). <em>United States Pharmacopeia \u2013 National Formulary<\/em>. Rockville: USP.<\/li>\n<\/ol>\n<hr \/>\n<h2>\u5916\u90e8\u94fe\u63a5<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.nmpa.gov.cn\">\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5b98\u7f51<\/a><\/li>\n<li><a href=\"https:\/\/www.iso.org\/standard\/53719.html\">ISO 14644\u6807\u51c6\u5b98\u65b9\u9875\u9762<\/a><\/li>\n<li><a href=\"https:\/\/www.camfil.com\">Camfil ULPA\u4ea7\u54c1\u4e2d\u5fc3<\/a><\/li>\n<li><a href=\"https:\/\/www.nifdc.org.cn\">\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662<\/a><\/li>\n<\/ul>\n<hr \/>\n<h2>\u7f16\u8005\u6ce8<\/h2>\n<p>\u672c\u6587\u5185\u5bb9\u57fa\u4e8e\u516c\u5f00\u51fa\u7248\u7269\u3001\u884c\u4e1a\u6807\u51c6\u53ca\u4f01\u4e1a\u6280\u672f\u8d44\u6599\u6574\u7406\u800c\u6210\uff0c\u65e8\u5728\u63d0\u4f9b\u79d1\u5b66\u3001\u5408\u89c4\u7684\u6280\u672f\u53c2\u8003\u3002\u5b9e\u9645\u5e94\u7528\u4e2d\u5e94\u7ed3\u5408\u5177\u4f53\u5de5\u827a\u6d41\u7a0b\u3001\u5382\u623f\u8bbe\u8ba1\u53ca\u76d1\u7ba1\u8981\u6c42\u8fdb\u884c\u4e13\u4e1a\u8bc4\u4f30\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u75ab\u82d7\u751f\u4ea7\u6d01\u51c0\u533a\u7684GMP\u5408\u89c4\u5e94\u7528 \u6982\u8ff0 \u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08Ultra-Low Penetration Air Filter\uff0c\u7b80\u79f0ULPA Filter\uff09\u662f\u7a7a\u6c14\u6d01\u51c0\u6280\u672f\u4e2d\u7684\u5173\u952e\u8bbe\u5907\u4e4b\u4e00\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u3001\u751f\u7269\u5de5\u7a0b\u3001\u5fae\u7535\u5b50\u5236\u9020\u7b49\u5bf9\u7a7a\u6c14\u8d28\u91cf\u8981\u6c42\u6781\u9ad8\u7684\u9886\u57df\u3002\u5728\u75ab\u82d7\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u6d01\u51c0\u533a\u7684\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u4ea7\u54c1\u7684\u65e0\u83cc\u6027\u3001\u7eaf\u5ea6\u548c\u5b89\u5168\u6027\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08G&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-16987","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\/16987","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=16987"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/16987\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16987"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16987"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16987"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}