{"id":16835,"date":"2025-09-11T13:27:25","date_gmt":"2025-09-11T05:27:25","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16835"},"modified":"2025-09-11T13:27:25","modified_gmt":"2025-09-11T05:27:25","slug":"%e5%88%b6%e8%8d%af%e8%a1%8c%e4%b8%9a%e6%97%a0%e8%8f%8c%e5%b7%a5%e8%89%ba%e4%b8%ad%e9%ab%98%e6%95%88%e5%a4%9a%e5%b1%82%e8%bf%87%e6%bb%a4%e5%99%a8%e7%9a%84%e5%ae%8c%e6%95%b4%e6%80%a7%e6%a3%80%e6%b5%8b","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16835","title":{"rendered":"\u5236\u836f\u884c\u4e1a\u65e0\u83cc\u5de5\u827a\u4e2d\u9ad8\u6548\u591a\u5c42\u8fc7\u6ee4\u5668\u7684\u5b8c\u6574\u6027\u68c0\u6d4b\u65b9\u6cd5"},"content":{"rendered":"<h1>\u9ad8\u6548\u591a\u5c42\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u68c0\u6d4b\u5728\u5236\u836f\u884c\u4e1a\u65e0\u83cc\u5de5\u827a\u4e2d\u7684\u5e94\u7528\u7814\u7a76<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u5c24\u5176\u662f\u65e0\u83cc\u836f\u54c1\u7684\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u786e\u4fdd\u4ea7\u54c1\u65e0\u83cc\u6027\u662f\u8d28\u91cf\u63a7\u5236\u7684\u6838\u5fc3\u8981\u6c42\u3002\u6839\u636e\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff082020\u5e74\u7248\uff09\u548c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u3001\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u7b49\u76d1\u7ba1\u673a\u6784\u7684\u89c4\u5b9a\uff0c\u65e0\u83cc\u751f\u4ea7\u5de5\u827a\u5fc5\u987b\u901a\u8fc7\u4e25\u683c\u7684\u9a8c\u8bc1\u4e0e\u76d1\u63a7\u624b\u6bb5\u6765\u9632\u6b62\u5fae\u751f\u7269\u6c61\u67d3\u3002\u5176\u4e2d\uff0c\u9ad8\u6548\u591a\u5c42\u8fc7\u6ee4\u5668\uff08High-Efficiency Multi-Layer Filter, HEMLF\uff09\u4f5c\u4e3a\u5173\u952e\u7684\u9664\u83cc\u7ea7\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u5728\u6db2\u4f53\u548c\u6c14\u4f53\u7684\u65e0\u83cc\u8fc7\u6ee4\u4e2d\u53d1\u6325\u7740\u4e0d\u53ef\u66ff\u4ee3\u7684\u4f5c\u7528\u3002<\/p>\n<p>\u7136\u800c\uff0c\u8fc7\u6ee4\u5668\u5728\u4f7f\u7528\u524d\u3001\u4f7f\u7528\u4e2d\u53ca\u4f7f\u7528\u540e\u662f\u5426\u4fdd\u6301\u7ed3\u6784\u5b8c\u6574\u6027\u548c\u8fc7\u6ee4\u6548\u80fd\uff0c\u76f4\u63a5\u5173\u7cfb\u5230\u6700\u7ec8\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u3002\u56e0\u6b64\uff0c<strong>\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u68c0\u6d4b<\/strong>\uff08Filter Integrity Testing, FIT\uff09\u6210\u4e3a\u65e0\u83cc\u5de5\u827a\u9a8c\u8bc1\u4e2d\u7684\u5f3a\u5236\u6027\u73af\u8282\u3002\u672c\u6587\u7cfb\u7edf\u9610\u8ff0\u9ad8\u6548\u591a\u5c42\u8fc7\u6ee4\u5668\u7684\u7ed3\u6784\u7279\u70b9\u3001\u5b8c\u6574\u6027\u68c0\u6d4b\u539f\u7406\u3001\u4e3b\u6d41\u68c0\u6d4b\u65b9\u6cd5\u3001\u76f8\u5173\u53c2\u6570\u6807\u51c6\u4ee5\u53ca\u56fd\u5185\u5916\u6743\u5a01\u673a\u6784\u7684\u6280\u672f\u89c4\u8303\uff0c\u5e76\u7ed3\u5408\u5b9e\u9645\u6848\u4f8b\u4e0e\u6570\u636e\u8868\u683c\u8fdb\u884c\u6df1\u5165\u5206\u6790\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001\u9ad8\u6548\u591a\u5c42\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>1.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p>\u9ad8\u6548\u591a\u5c42\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u7531\u591a\u5c42\u4e0d\u540c\u5b54\u5f84\u548c\u6750\u8d28\u6784\u6210\u7684\u590d\u5408\u578b\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u901a\u5e38\u7528\u4e8e\u53bb\u9664\u6eb6\u6db2\u6216\u6c14\u4f53\u4e2d\u7684\u5fae\u7c92\u3001\u7ec6\u83cc\u53ca\u5176\u4ed6\u6c61\u67d3\u7269\u3002\u5176\u6838\u5fc3\u8fc7\u6ee4\u5c42\u4e00\u822c\u4e3a\u805a\u919a\u781c\uff08PES\uff09\u3001\u805a\u504f\u6c1f\u4e59\u70ef\uff08PVDF\uff09\u6216\u5c3c\u9f99\u7b49\u6750\u6599\u5236\u6210\u7684\u5fae\u5b54\u819c\uff0c\u5b54\u5f84\u901a\u5e38\u4e3a0.22 \u03bcm\u62160.1 \u03bcm\uff0c\u7b26\u5408\u201c\u9664\u83cc\u7ea7\u201d\uff08Sterilizing Grade\uff09\u6807\u51c6\u3002<\/p>\n<p>\u6839\u636e\u7528\u9014\u53ef\u5206\u4e3a\uff1a<\/p>\n<ul>\n<li><strong>\u6db2\u4f53\u9664\u83cc\u8fc7\u6ee4\u5668<\/strong>\uff1a\u7528\u4e8e\u6ce8\u5c04\u5242\u3001\u773c\u7528\u5236\u5242\u3001\u7ec6\u80de\u57f9\u517b\u57fa\u7b49\u65e0\u83cc\u6db2\u4f53\u7684\u8fc7\u6ee4\u3002<\/li>\n<li><strong>\u6c14\u4f53\u9664\u83cc\u8fc7\u6ee4\u5668<\/strong>\uff1a\u7528\u4e8e\u6d01\u51c0\u5ba4\u7a7a\u6c14\u3001\u53d1\u9175\u7f50\u901a\u6c14\u3001\u538b\u7f29\u6c14\u4f53\u7b49\u7cfb\u7edf\u7684\u5fae\u751f\u7269\u963b\u9694\u3002<\/li>\n<\/ul>\n<h3>1.2 \u7ed3\u6784\u7ec4\u6210\u4e0e\u5de5\u4f5c\u539f\u7406<\/h3>\n<p>\u9ad8\u6548\u591a\u5c42\u8fc7\u6ee4\u5668\u901a\u5e38\u5305\u62ec\u4ee5\u4e0b\u51e0\u5c42\u7ed3\u6784\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5c42\u6b21<\/th>\n<th>\u6750\u6599<\/th>\n<th>\u529f\u80fd<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u9884\u8fc7\u6ee4\u5c42<\/td>\n<td>\u805a\u4e19\u70ef\uff08PP\uff09\u65e0\u7eba\u5e03<\/td>\n<td>\u62e6\u622a\u5927\u9897\u7c92\u6742\u8d28\uff0c\u5ef6\u957f\u4e3b\u819c\u5bff\u547d<\/td>\n<\/tr>\n<tr>\n<td>\u4e2d\u95f4\u652f\u6491\u5c42<\/td>\n<td>\u805a\u916f\u7f51\u6216\u591a\u5b54\u805a\u4e59\u70ef<\/td>\n<td>\u63d0\u4f9b\u673a\u68b0\u652f\u6491\uff0c\u9632\u6b62\u819c\u53d8\u5f62<\/td>\n<\/tr>\n<tr>\n<td>\u4e3b\u8fc7\u6ee4\u5c42<\/td>\n<td>PES\/PVDF\/\u5c3c\u9f99\u5fae\u5b54\u819c\uff080.22\u03bcm\uff09<\/td>\n<td>\u5b9e\u73b0\u7ec6\u83cc\u622a\u7559\uff08Bacteria Retention\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u540e\u7f6e\u4fdd\u62a4\u5c42<\/td>\n<td>\u591a\u5b54\u6750\u6599<\/td>\n<td>\u9632\u6b62\u4e0b\u6e38\u6c61\u67d3\uff0c\u7ef4\u6301\u6d41\u901f\u7a33\u5b9a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5176\u5de5\u4f5c\u539f\u7406\u57fa\u4e8e<strong>\u6df1\u5c42\u8fc7\u6ee4<\/strong>\u4e0e<strong>\u8868\u9762\u7b5b\u5206<\/strong>\u76f8\u7ed3\u5408\u673a\u5236\u3002\u5f53\u6d41\u4f53\u901a\u8fc7\u65f6\uff0c\u5927\u4e8e\u5b54\u5f84\u7684\u5fae\u751f\u7269\u88ab\u622a\u7559\u5728\u819c\u8868\u9762\uff0c\u800c\u5c0f\u5206\u5b50\u6eb6\u8d28\u5219\u987a\u5229\u901a\u8fc7\u3002<\/p>\n<h3>1.3 \u5173\u952e\u6027\u80fd\u53c2\u6570<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u6807\u51c6\u503c<\/th>\n<th>\u6d4b\u8bd5\u65b9\u6cd5<\/th>\n<th>\u53c2\u8003\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5b54\u5f84\u5927\u5c0f<\/td>\n<td>0.22 \u00b1 0.02 \u03bcm<\/td>\n<td>\u6ce1\u70b9\u6cd5\u3001\u8d77\u6ce1\u70b9\u6d4b\u8bd5<\/td>\n<td>ASTM F838-22<\/td>\n<\/tr>\n<tr>\n<td>\u6c34\u901a\u91cf\uff08\u7eaf\u6c34\uff0c25\u2103\uff09<\/td>\n<td>\u2265 20 L\/(m\u00b2\u00b7h\u00b7bar)<\/td>\n<td>\u6c34\u6e17\u900f\u6d4b\u8bd5<\/td>\n<td>ISO 15750<\/td>\n<\/tr>\n<tr>\n<td>\u7ec6\u83cc\u622a\u7559\u80fd\u529b<\/td>\n<td>\u2265 10\u2077 CFU\/cm\u00b2 of Brevundimonas diminuta<\/td>\n<td>\u7ec6\u83cc\u6311\u6218\u8bd5\u9a8c<\/td>\n<td>FDA Guidance for Industry (2016)<\/td>\n<\/tr>\n<tr>\n<td>\u8d77\u6ce1\u70b9\u538b\u529b\uff08\u6c34\u6da6\u6e7f\uff09<\/td>\n<td>\u2265 3450 mbar\uff08\u7ea63.4 bar\uff09<\/td>\n<td>\u6ce1\u70b9\u6d4b\u8bd5<\/td>\n<td>USP <\/td>\n<\/tr>\n<tr>\n<td>\u6269\u6563\u6d41\u9650\u503c\uff08N\u2082\u6c14\u6e90\uff0c25\u2103\uff09<\/td>\n<td>\u2264 0.3 mL\/min\u00b7cm\u00b2 @ 2.8 bar<\/td>\n<td>\u6269\u6563\u6d41\u6d4b\u8bd5<\/td>\n<td>EMA Guideline on Sterilising Filtration (2020)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1aBrevundimonas diminuta \u662f\u56fd\u9645\u516c\u8ba4\u7684\u6807\u51c6\u6311\u6218\u83cc\u682a\uff0c\u7528\u4e8e\u9a8c\u8bc1\u9664\u83cc\u7ea7\u8fc7\u6ee4\u5668\u7684\u6709\u6548\u6027\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e8c\u3001\u5b8c\u6574\u6027\u68c0\u6d4b\u7684\u5fc5\u8981\u6027\u4e0e\u6cd5\u89c4\u4f9d\u636e<\/h2>\n<h3>2.1 \u68c0\u6d4b\u76ee\u7684<\/h3>\n<p>\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u68c0\u6d4b\u65e8\u5728\u786e\u8ba4\u8fc7\u6ee4\u819c\u662f\u5426\u5b58\u5728\u88c2\u7f1d\u3001\u7a7f\u5b54\u3001\u5bc6\u5c01\u4e0d\u826f\u6216\u5176\u4ed6\u7ed3\u6784\u6027\u7f3a\u9677\uff0c\u4ece\u800c\u4fdd\u8bc1\u5176\u5177\u5907\u5e94\u6709\u7684\u5fae\u751f\u7269\u622a\u7559\u80fd\u529b\u3002\u5373\u4f7f\u5916\u89c2\u5b8c\u597d\uff0c\u5fae\u5c0f\u7684\u7834\u635f\u4e5f\u53ef\u80fd\u5bfc\u81f4\u6574\u6279\u4ea7\u54c1\u88ab\u6c61\u67d3\u3002<\/p>\n<h3>2.2 \u56fd\u5185\u5916\u6cd5\u89c4\u8981\u6c42<\/h3>\n<h4>\u4e2d\u56fd\u6cd5\u89c4<\/h4>\n<ul>\n<li>\u300a\u4e2d\u56fd\u836f\u5178\u300b2020\u5e74\u7248\u56db\u90e8\u901a\u5219 <strong> \u8fc7\u6ee4\u9664\u83cc\u6cd5<\/strong><br \/>\n<blockquote>\n<p>\u201c\u6bcf\u6b21\u4f7f\u7528\u524d\u540e\u5e94\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u6d4b\u8bd5\u7ed3\u679c\u5e94\u7b26\u5408\u89c4\u5b9a\u3002\u201d<\/p>\n<\/blockquote>\n<\/li>\n<li>GMP\uff082010\u5e74\u4fee\u8ba2\uff09\u9644\u5f551\u300a\u65e0\u83cc\u836f\u54c1\u300b\u7b2c46\u6761\uff1a<br \/>\n<blockquote>\n<p>\u201c\u9664\u83cc\u8fc7\u6ee4\u5668\u4f7f\u7528\u540e\u5fc5\u987b\u7acb\u5373\u8fdb\u884c\u5b8c\u6574\u6027\u68c0\u6d4b\u3002\u201d<\/p>\n<\/blockquote>\n<\/li>\n<\/ul>\n<h4>\u7f8e\u56fdFDA<\/h4>\n<ul>\n<li>FDA\u300aGuidance for Industry: Sterile Drug Products Produced by Aseptic Processing \u2014 Current Good Manufacturing Practice\u300b\uff082004, \u66f4\u65b02016\uff09<br \/>\n<blockquote>\n<p>\u660e\u786e\u6307\u51fa\uff1a\u201cIntegrity testing is required before and after filtration to ensure the filter has not been damaged.\u201d<\/p>\n<\/blockquote>\n<\/li>\n<\/ul>\n<h4>\u6b27\u76dfEMA<\/h4>\n<ul>\n<li>EMA\u300aGuideline on the sterilisation of the medicinal product, active substance, excipient and primary container\u300b\uff082020\u5e74\u53d1\u5e03\uff09<br \/>\n<blockquote>\n<p>\u201cIntegrity testing must be performed post-use unless validated otherwise.\u201d<\/p>\n<\/blockquote>\n<\/li>\n<\/ul>\n<p>\u6b64\u5916\uff0c\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7ISO 13408-5\u300aHealth care products \u2014 Processing of medical devices by filtration \u2014 Part 5: Determination of filter integrity\u300b\u4e5f\u63d0\u4f9b\u4e86\u901a\u7528\u6280\u672f\u6846\u67b6\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u5b8c\u6574\u6027\u68c0\u6d4b\u4e3b\u8981\u65b9\u6cd5<\/h2>\n<p>\u76ee\u524d\u5e7f\u6cdb\u5e94\u7528\u7684\u5b8c\u6574\u6027\u68c0\u6d4b\u65b9\u6cd5\u4e3b\u8981\u5305\u62ec\u4ee5\u4e0b\u4e09\u79cd\uff1a<strong>\u6ce1\u70b9\u6d4b\u8bd5\u6cd5<\/strong>\u3001<strong>\u6269\u6563\u6d41\u6d4b\u8bd5\u6cd5<\/strong> \u548c <strong>\u538b\u529b\u4fdd\u6301\u6d4b\u8bd5\u6cd5<\/strong>\u3002\u6bcf\u79cd\u65b9\u6cd5\u9002\u7528\u4e8e\u4e0d\u540c\u7684\u573a\u666f\u548c\u8bbe\u5907\u6761\u4ef6\u3002<\/p>\n<h3>3.1 \u6ce1\u70b9\u6d4b\u8bd5\u6cd5\uff08Bubble Point Test\uff09<\/h3>\n<h4>\u539f\u7406<\/h4>\n<p>\u4f9d\u636e\u6bdb\u7ec6\u7ba1\u73b0\u8c61\u7406\u8bba\uff0c\u5f53\u6c14\u4f53\u538b\u529b\u9010\u6e10\u5347\u9ad8\u81f3\u8db3\u4ee5\u514b\u670d\u6db2\u4f53\u5728\u819c\u5b54\u4e2d\u7684\u8868\u9762\u5f20\u529b\u65f6\uff0c\u6c14\u4f53\u5c06\u7a7f\u900f\u6e7f\u6da6\u819c\u5b54\u5e76\u5f62\u6210\u8fde\u7eed\u6c14\u6ce1\uff0c\u6b64\u65f6\u7684\u538b\u529b\u5373\u4e3a\u201c\u6ce1\u70b9\u201d\u3002\u8be5\u503c\u4e0e\u819c\u5b54\u5f84\u5448\u53cd\u6bd4\u5173\u7cfb\u3002<\/p>\n<p>\u516c\u5f0f\u5982\u4e0b\uff1a<br \/>\n[<br \/>\nP = frac{4gamma costheta}{d}<br \/>\n]<br \/>\n\u5176\u4e2d\uff1a<\/p>\n<ul>\n<li>( P )\uff1a\u6ce1\u70b9\u538b\u529b\uff08Pa\uff09<\/li>\n<li>( gamma )\uff1a\u6db2\u4f53\u8868\u9762\u5f20\u529b\uff08N\/m\uff09<\/li>\n<li>( theta )\uff1a\u63a5\u89e6\u89d2<\/li>\n<li>( d )\uff1a\u6700\u5927\u6709\u6548\u5b54\u5f84\uff08m\uff09<\/li>\n<\/ul>\n<h4>\u64cd\u4f5c\u6b65\u9aa4<\/h4>\n<ol>\n<li>\u5c06\u8fc7\u6ee4\u5668\u7528\u9002\u5f53\u6da6\u6e7f\u6db2\uff08\u5982\u6ce8\u5c04\u7528\u6c34\u6216\u5f02\u4e19\u9187\uff09\u5145\u5206\u6da6\u6e7f\uff1b<\/li>\n<li>\u4ece\u4e0a\u6e38\u4fa7\u7f13\u6162\u52a0\u538b\u60f0\u6027\u6c14\u4f53\uff08\u6c2e\u6c14\u6216\u538b\u7f29\u7a7a\u6c14\uff09\uff1b<\/li>\n<li>\u89c2\u5bdf\u4e0b\u6e38\u662f\u5426\u6709\u6301\u7eed\u6c14\u6ce1\u4ea7\u751f\uff1b<\/li>\n<li>\u8bb0\u5f55\u9996\u6b21\u51fa\u73b0\u7a33\u5b9a\u6c14\u6ce1\u65f6\u7684\u538b\u529b\u503c\uff1b<\/li>\n<li>\u5bf9\u7167\u5236\u9020\u5546\u63d0\u4f9b\u7684\u5408\u683c\u8303\u56f4\u5224\u65ad\u662f\u5426\u901a\u8fc7\u3002<\/li>\n<\/ol>\n<h4>\u9002\u7528\u8303\u56f4<\/h4>\n<ul>\n<li>\u65b0\u8fc7\u6ee4\u5668\u5b89\u88c5\u524d\u68c0\u6d4b<\/li>\n<li>\u975e\u5728\u7ebf\u5f0f\u5c0f\u578b\u8fc7\u6ee4\u5668<\/li>\n<li>\u9a8c\u8bc1\u9636\u6bb5\u7684\u57fa\u51c6\u6d4b\u8bd5<\/li>\n<\/ul>\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>\u6da6\u6e7f\u6db2\u79cd\u7c7b<\/td>\n<td>WFI\uff08\u6ce8\u5c04\u7528\u6c34\uff09\u621670% IPA<\/td>\n<td>\u4e0d\u540c\u6db2\u4f53\u5f71\u54cd\u6ce1\u70b9\u503c<\/td>\n<\/tr>\n<tr>\n<td>\u52a0\u538b\u901f\u7387<\/td>\n<td>\u2264 100 mbar\/min<\/td>\n<td>\u907f\u514d\u51b2\u51fb\u635f\u4f24<\/td>\n<\/tr>\n<tr>\n<td>\u5408\u683c\u6807\u51c6<\/td>\n<td>\u2265 \u5236\u9020\u5546\u6807\u79f0\u503c\u768490%<\/td>\n<td>\u5982\u6807\u79f0\u4e3a3450 mbar\uff0c\u5219\u5b9e\u6d4b\u22653105 mbar\u4e3a\u5408\u683c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6765\u6e90\uff1aASTM F838-22\u300aStandard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration\u300b<\/p>\n<\/blockquote>\n<hr \/>\n<h3>3.2 \u6269\u6563\u6d41\u6d4b\u8bd5\u6cd5\uff08Diffusion Flow Test\uff09<\/h3>\n<h4>\u539f\u7406<\/h4>\n<p>\u5f53\u65bd\u52a0\u7684\u538b\u529b\u4f4e\u4e8e\u6ce1\u70b9\u65f6\uff0c\u6eb6\u89e3\u4e8e\u6da6\u6e7f\u6db2\u4e2d\u7684\u6c14\u4f53\u5206\u5b50\u4f1a\u56e0\u6d53\u5ea6\u68af\u5ea6\u6cbf\u819c\u5b54\u5411\u4e0b\u6e38\u6269\u6563\uff0c\u5f62\u6210\u53ef\u6d4b\u91cf\u7684\u201c\u6269\u6563\u6d41\u201d\u3002\u8be5\u6d41\u91cf\u4e0e\u819c\u9762\u79ef\u3001\u538b\u529b\u3001\u6e29\u5ea6\u53ca\u6da6\u6e7f\u6db2\u6027\u8d28\u6709\u5173\u3002\u82e5\u5b58\u5728\u7f3a\u9677\uff0c\u6269\u6563\u6d41\u663e\u8457\u589e\u5927\u3002<\/p>\n<p>\u7406\u60f3\u72b6\u6001\u4e0b\uff0c\u6269\u6563\u6d41 ( Q_d ) \u53ef\u8868\u793a\u4e3a\uff1a<br \/>\n[<br \/>\nQ_d = k cdot A cdot P<br \/>\n]<br \/>\n\u5176\u4e2d\uff1a<\/p>\n<ul>\n<li>( k )\uff1a\u6269\u6563\u7cfb\u6570<\/li>\n<li>( A )\uff1a\u6709\u6548\u8fc7\u6ee4\u9762\u79ef\uff08cm\u00b2\uff09<\/li>\n<li>( P )\uff1a\u6d4b\u8bd5\u538b\u529b\uff08bar\uff09<\/li>\n<\/ul>\n<h4>\u64cd\u4f5c\u6d41\u7a0b<\/h4>\n<ol>\n<li>\u6ee4\u82af\u5b8c\u5168\u6da6\u6e7f\u540e\u5c01\u95ed\u4e0b\u6e38\uff1b<\/li>\n<li>\u4e0a\u6e38\u52a0\u538b\u81f3\u6307\u5b9a\u538b\u529b\uff08\u901a\u5e38\u4e3a\u6ce1\u70b9\u768480%\u5de6\u53f3\uff09\uff1b<\/li>\n<li>\u7a33\u5b9a\u4e00\u6bb5\u65f6\u95f4\uff08\u4e00\u822c5\u5206\u949f\uff09\uff0c\u8bb0\u5f55\u5355\u4f4d\u65f6\u95f4\u5185\u9038\u51fa\u7684\u6c14\u4f53\u4f53\u79ef\uff1b<\/li>\n<li>\u82e5\u6269\u6563\u6d41\u4f4e\u4e8e\u8bbe\u5b9a\u9608\u503c\uff0c\u5219\u5224\u5b9a\u5b8c\u6574\u3002<\/li>\n<\/ol>\n<h4>\u4f18\u52bf\u4e0e\u5c40\u9650<\/h4>\n<ul>\n<li><strong>\u4f18\u70b9<\/strong>\uff1a\u975e\u7834\u574f\u6027\u3001\u9002\u5408\u5728\u7ebf\u68c0\u6d4b\u3001\u81ea\u52a8\u5316\u7a0b\u5ea6\u9ad8<\/li>\n<li><strong>\u7f3a\u70b9<\/strong>\uff1a\u5bf9\u5c0f\u9762\u79ef\u6ee4\u5668\u7075\u654f\u5ea6\u8f83\u4f4e<\/li>\n<\/ul>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bd5\u6761\u4ef6<\/th>\n<th>\u53c2\u6570\u8bbe\u7f6e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6d4b\u8bd5\u538b\u529b<\/td>\n<td>2.8 bar\uff08\u5bf9\u5e940.22\u03bcm PES\u819c\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u5e73\u8861\u65f6\u95f4<\/td>\n<td>5 min<\/td>\n<\/tr>\n<tr>\n<td>\u6700\u5927\u5141\u8bb8\u6269\u6563\u6d41<\/td>\n<td>\u2264 0.3 mL\/min\u00b7cm\u00b2<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u6e90<\/td>\n<td>\u9ad8\u7eaf\u6c2e\u6c14\uff08\u226599.99%\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6570\u636e\u6765\u6e90\uff1aMilliporeSigma Technical Bulletin FTENG004<\/p>\n<\/blockquote>\n<hr \/>\n<h3>3.3 \u538b\u529b\u4fdd\u6301\u6d4b\u8bd5\u6cd5\uff08Pressure Hold Test\uff09<\/h3>\n<h4>\u539f\u7406<\/h4>\n<p>\u5728\u4e00\u5b9a\u538b\u529b\u4e0b\u4fdd\u6301\u7cfb\u7edf\u5bc6\u95ed\uff0c\u76d1\u6d4b\u538b\u529b\u968f\u65f6\u95f4\u7684\u53d8\u5316\u3002\u82e5\u538b\u529b\u4e0b\u964d\u8d85\u8fc7\u5141\u8bb8\u8303\u56f4\uff0c\u5219\u8868\u660e\u5b58\u5728\u6cc4\u6f0f\u6216\u7ed3\u6784\u6027\u7f3a\u9677\u3002<\/p>\n<p>\u0394P\u8ba1\u7b97\u516c\u5f0f\uff1a<br \/>\n[<br \/>\nDelta P = P_0 &#8211; P_t<br \/>\n]<br \/>\n\u5176\u4e2d ( P_0 ) \u4e3a\u521d\u59cb\u538b\u529b\uff0c( P_t ) \u4e3a\u4fdd\u6301t\u5206\u949f\u540e\u538b\u529b\u3002<\/p>\n<h4>\u5e94\u7528\u573a\u666f<\/h4>\n<ul>\n<li>\u5927\u578b\u56ca\u5f0f\u8fc7\u6ee4\u5668<\/li>\n<li>\u7ba1\u9053\u96c6\u6210\u7cfb\u7edf<\/li>\n<li>\u65e0\u6cd5\u8fdb\u884c\u6269\u6563\u6d41\u6d4b\u91cf\u7684\u60c5\u51b5<\/li>\n<\/ul>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u8bbe\u7f6e\u503c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6d4b\u8bd5\u538b\u529b<\/td>\n<td>\u63a5\u8fd1\u4f46\u4f4e\u4e8e\u6ce1\u70b9\uff08\u59823.0 bar\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u4fdd\u538b\u65f6\u95f4<\/td>\n<td>120\u79d2\u81f3600\u79d2\uff08\u4f9d\u7cfb\u7edf\u5bb9\u79ef\u8c03\u6574\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u5141\u8bb8\u538b\u964d<\/td>\n<td>\u2264 50 mbar\/10min<\/td>\n<\/tr>\n<tr>\n<td>\u6e29\u5ea6\u63a7\u5236<\/td>\n<td>\u6052\u6e29\u73af\u5883\uff08\u00b11\u2103\uff09\u4ee5\u51cf\u5c11\u70ed\u80c0\u51b7\u7f29\u5f71\u54cd<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u5f15\u7528\u6587\u732e\uff1aPDA Technical Report No. 26 (Revised 2008), <em>Sterilizing Filtration of Liquids<\/em><\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u56db\u3001\u68c0\u6d4b\u65b9\u6cd5\u9009\u62e9\u4e0e\u9a8c\u8bc1\u8981\u6c42<\/h2>\n<h3>4.1 \u65b9\u6cd5\u9009\u62e9\u4f9d\u636e<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u65b9\u6cd5<\/th>\n<th>\u7075\u654f\u5ea6<\/th>\n<th>\u81ea\u52a8\u5316<\/th>\n<th>\u6210\u672c<\/th>\n<th>\u63a8\u8350\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6ce1\u70b9\u6d4b\u8bd5<\/td>\n<td>\u9ad8<\/td>\n<td>\u4f4e<\/td>\n<td>\u4f4e<\/td>\n<td>\u5b9e\u9a8c\u5ba4\u9a8c\u8bc1\u3001\u5c0f\u6279\u91cf\u751f\u4ea7<\/td>\n<\/tr>\n<tr>\n<td>\u6269\u6563\u6d41\u6d4b\u8bd5<\/td>\n<td>\u4e2d\u9ad8<\/td>\n<td>\u9ad8<\/td>\n<td>\u4e2d<\/td>\n<td>\u5728\u7ebf\u8fde\u7eed\u751f\u4ea7\u3001\u81ea\u52a8\u704c\u88c5\u7ebf<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u529b\u4fdd\u6301\u6d4b\u8bd5<\/td>\n<td>\u4e2d<\/td>\n<td>\u4e2d<\/td>\n<td>\u4e2d<\/td>\n<td>\u590d\u6742\u7ba1\u8def\u7cfb\u7edf\u3001\u5927\u578b\u8bbe\u5907<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u5bf9\u4e8e\u9ad8\u98ce\u9669\u4ea7\u54c1\uff08\u5982\u5355\u514b\u9686\u6297\u4f53\u3001\u75ab\u82d7\uff09\uff0c\u63a8\u8350\u8054\u5408\u4f7f\u7528\u4e24\u79cd\u4ee5\u4e0a\u65b9\u6cd5\u3002<\/p>\n<\/blockquote>\n<h3>4.2 \u65b9\u6cd5\u5b66\u9a8c\u8bc1\u5185\u5bb9<\/h3>\n<p>\u6839\u636eICH Q2(R1)\u6307\u5bfc\u539f\u5219\uff0c\u5b8c\u6574\u6027\u68c0\u6d4b\u65b9\u6cd5\u9700\u8fdb\u884c\u4ee5\u4e0b\u9a8c\u8bc1\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u9a8c\u8bc1\u9879\u76ee<\/th>\n<th>\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u51c6\u786e\u6027<\/td>\n<td>\u4e0e\u5df2\u77e5\u6807\u51c6\u504f\u5dee\u22645%<\/td>\n<\/tr>\n<tr>\n<td>\u7cbe\u5bc6\u5ea6\uff08\u91cd\u590d\u6027\uff09<\/td>\n<td>RSD \u2264 3%\uff08n=6\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u4e13\u5c5e\u6027<\/td>\n<td>\u80fd\u533a\u5206\u5b8c\u6574\u4e0e\u4eba\u4e3a\u7834\u635f\u6ee4\u82af<\/td>\n<\/tr>\n<tr>\n<td>\u7ebf\u6027\u8303\u56f4<\/td>\n<td>\u6269\u6563\u6d41\u57280.1~1.0 mL\/min\u5185\u5448\u7ebf\u6027\u54cd\u5e94<\/td>\n<\/tr>\n<tr>\n<td>\u8010\u7528\u6027<\/td>\n<td>\u6e29\u5ea6\u6ce2\u52a8\u00b12\u2103\u4e0d\u5f71\u54cd\u7ed3\u679c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u6b64\u5916\uff0c\u8fd8\u9700\u5efa\u7acb<strong>\u9633\u6027\u5bf9\u7167<\/strong>\uff08\u4eba\u5de5\u6253\u5b54\u6ee4\u82af\uff09\u4e0e<strong>\u9634\u6027\u5bf9\u7167<\/strong>\uff08\u5168\u65b0\u5408\u683c\u6ee4\u82af\uff09\u4f5c\u4e3a\u53c2\u8003\u57fa\u51c6\u3002<\/p>\n<hr \/>\n<h2>\u4e94\u3001\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>\u6848\u4f8b\u4e00\uff1a\u67d0\u751f\u7269\u5236\u836f\u4f01\u4e1a\u5355\u6297\u5236\u5242\u751f\u4ea7\u7ebf<\/h3>\n<p><strong>\u80cc\u666f<\/strong>\uff1a\u4f01\u4e1a\u5728\u751f\u4ea7\u91cd\u7ec4\u4eba\u6e90\u5316\u5355\u514b\u9686\u6297\u4f53\u65f6\uff0c\u91c7\u75280.22 \u03bcm PVDF\u5e73\u677f\u8fc7\u6ee4\u5668\u5bf9\u7ec8\u4ea7\u54c1\u8fdb\u884c\u9664\u83cc\u8fc7\u6ee4\u3002<\/p>\n<p><strong>\u95ee\u9898<\/strong>\uff1a\u8fde\u7eed\u4e09\u6279\u4ea7\u54c1\u5728\u65e0\u83cc\u68c0\u67e5\u4e2d\u68c0\u51fa\u5047\u9633\u6027\u4fe1\u53f7\uff0c\u6000\u7591\u8fc7\u6ee4\u73af\u8282\u5f02\u5e38\u3002<\/p>\n<p><strong>\u8c03\u67e5\u8fc7\u7a0b<\/strong>\uff1a<\/p>\n<ol>\n<li>\u56de\u987e\u8bb0\u5f55\u53d1\u73b0\u7b2c\u4e09\u6279\u8fc7\u6ee4\u5668\u672a\u6267\u884c<strong>\u4f7f\u7528\u540e\u5b8c\u6574\u6027\u68c0\u6d4b<\/strong>\uff1b<\/li>\n<li>\u8865\u505a\u6ce1\u70b9\u6d4b\u8bd5\uff0c\u7ed3\u679c\u663e\u793a\u4ec5\u4e3a2800 mbar\uff08\u6807\u51c6\u22653450 mbar\uff09\uff1b<\/li>\n<li>\u89e3\u5256\u6ee4\u819c\u53d1\u73b0\u8fb9\u7f18\u5bc6\u5c01\u5904\u6709\u5fae\u88c2\u7eb9\uff1b<\/li>\n<li>\u6839\u672c\u539f\u56e0\u4e3a\u5b89\u88c5\u65f6\u626d\u77e9\u8fc7\u5927\u5bfc\u81f4O\u578b\u5708\u6324\u538b\u53d8\u5f62\u3002<\/li>\n<\/ol>\n<p><strong>\u6574\u6539\u63aa\u65bd<\/strong>\uff1a<\/p>\n<ul>\n<li>\u5f3a\u5236\u5b9e\u65bdSOP\uff1a\u6240\u6709\u8fc7\u6ee4\u5668\u5fc5\u987b\u5b8c\u6210<strong>\u524d\u540e\u4e24\u6b21\u5b8c\u6574\u6027\u6d4b\u8bd5<\/strong>\uff1b<\/li>\n<li>\u5f15\u5165\u81ea\u52a8\u68c0\u6d4b\u4eea\uff08\u5982Entegris AccuTite\u00ae\uff09\uff0c\u5b9e\u73b0\u6570\u636e\u7535\u5b50\u5316\u8bb0\u5f55\uff1b<\/li>\n<li>\u5f00\u5c55\u5458\u5de5\u57f9\u8bad\uff0c\u89c4\u8303\u5b89\u88c5\u64cd\u4f5c\u3002<\/li>\n<\/ul>\n<p><strong>\u6548\u679c<\/strong>\uff1a\u540e\u7eed20\u6279\u6b21\u5747\u901a\u8fc7\u65e0\u83cc\u68c0\u67e5\uff0cCAPA\u5173\u95ed\u3002<\/p>\n<hr \/>\n<h3>\u6848\u4f8b\u4e8c\uff1a\u8de8\u56fd\u836f\u4f01\u51bb\u5e72\u7c89\u9488\u5242\u9879\u76ee\u5ba1\u8ba1\u53d1\u73b0<\/h3>\n<p><strong>\u4e8b\u4ef6<\/strong>\uff1aFDA\u73b0\u573a\u5ba1\u8ba1\u4e2d\u6307\u51fa\u67d0\u5de5\u5382\u4f7f\u7528<strong>\u5f02\u4e19\u9187\u6da6\u6e7f\u7684\u6ce1\u70b9\u6d4b\u8bd5<\/strong>\u4f5c\u4e3a\u552f\u4e00\u68c0\u6d4b\u624b\u6bb5\uff0c\u4f46\u672a\u63d0\u4f9b\u6da6\u6e7f\u6db2\u517c\u5bb9\u6027\u7814\u7a76\u8d44\u6599\u3002<\/p>\n<p><strong>\u6cd5\u89c4\u5f15\u7528<\/strong>\uff1a<\/p>\n<blockquote>\n<p>FDA Form 483 Observation #3: \u201cThe firm failed to validate the use of 70% IPA as wetting agent for hydrophilic membrane filters.\u201d<\/p>\n<\/blockquote>\n<p><strong>\u6574\u6539\u65b9\u6848<\/strong>\uff1a<\/p>\n<ol>\n<li>\u8865\u5145\u5f00\u5c55\u6da6\u6e7f\u5b9e\u9a8c\uff1a\u6bd4\u8f83WFI\u4e0eIPA\u5bf9PES\u819c\u7684\u6da6\u6e7f\u6548\u679c\uff1b<\/li>\n<li>\u6d4b\u5b9a\u63a5\u89e6\u89d2\u4e0e\u8868\u9762\u5f20\u529b\uff0c\u786e\u8ba4IPA\u53ef\u80fd\u5bfc\u81f4\u6ce1\u70b9\u503c\u504f\u4f4e\uff1b<\/li>\n<li>\u6700\u7ec8\u6539\u4e3a\u7edf\u4e00\u4f7f\u7528WFI\u6da6\u6e7f\uff0c\u5e76\u91cd\u65b0\u6821\u51c6\u6240\u6709\u68c0\u6d4b\u53c2\u6570\u3002<\/li>\n<\/ol>\n<hr \/>\n<h2>\u516d\u3001\u5148\u8fdb\u68c0\u6d4b\u6280\u672f\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<p>\u968f\u7740\u667a\u80fd\u5236\u9020\u4e0e\u6570\u5b57\u5316\u5de5\u5382\u7684\u63a8\u8fdb\uff0c\u4f20\u7edf\u624b\u52a8\u68c0\u6d4b\u6b63\u9010\u6b65\u88ab\u667a\u80fd\u5316\u7cfb\u7edf\u53d6\u4ee3\u3002<\/p>\n<h3>6.1 \u5728\u7ebf\u5b9e\u65f6\u76d1\u6d4b\u7cfb\u7edf\uff08In-line Real-time Monitoring\uff09<\/h3>\n<p>\u5229\u7528\u4f20\u611f\u5668\u7f51\u7edc\u5b9e\u65f6\u91c7\u96c6\u538b\u529b\u3001\u6d41\u91cf\u3001\u6e29\u5ea6\u7b49\u53c2\u6570\uff0c\u7ed3\u5408AI\u7b97\u6cd5\u9884\u6d4b\u6ee4\u82af\u72b6\u6001\u3002\u4f8b\u5982GE Healthcare\u7684<strong>IntelliFlow\u2122\u7cfb\u7edf<\/strong>\u53ef\u5728\u8fc7\u6ee4\u8fc7\u7a0b\u4e2d\u52a8\u6001\u8bc4\u4f30\u5b8c\u6574\u6027\u8d8b\u52bf\u3002<\/p>\n<h3>6.2 \u65e0\u7ebf\u84dd\u7259\u5b8c\u6574\u6027\u6d4b\u8bd5\u4eea<\/h3>\n<p>\u5982Sartorius\u7684<strong>Minisette Connect<\/strong>\uff0c\u652f\u6301\u65e0\u7ebf\u4f20\u8f93\u6570\u636e\u81f3LIMS\u7cfb\u7edf\uff0c\u907f\u514d\u4eba\u4e3a\u5f55\u5165\u9519\u8bef\uff0c\u7b26\u540821 CFR Part 11\u7535\u5b50\u8bb0\u5f55\u8981\u6c42\u3002<\/p>\n<h3>6.3 \u591a\u53d8\u91cf\u878d\u5408\u8bca\u65ad\u6a21\u578b<\/h3>\n<p>\u7814\u7a76\u663e\u793a\uff0c\u7ed3\u5408<strong>\u58f0\u53d1\u5c04\u6280\u672f<\/strong>\uff08Acoustic Emission\uff09\u4e0e\u538b\u529b\u8870\u51cf\u66f2\u7ebf\u5206\u6790\uff0c\u53ef\u63d0\u524d\u8bc6\u522b\u6f5c\u5728\u7834\u635f\u98ce\u9669\uff08Zhang et al., 2021, <em>Journal of Pharmaceutical Sciences<\/em>\uff09\u3002<\/p>\n<hr \/>\n<h2>\u4e03\u3001\u5e38\u89c1\u95ee\u9898\u4e0e\u5bf9\u7b56<\/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\u63aa\u65bd<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6ce1\u70b9\u504f\u4f4e<\/td>\n<td>\u6da6\u6e7f\u4e0d\u5145\u5206\u3001\u819c\u5e72\u71e5\u3001\u4f4e\u6e29\u73af\u5883<\/td>\n<td>\u5ef6\u957f\u6da6\u6e7f\u65f6\u95f4\u3001\u9884\u70ed\u81f325\u2103<\/td>\n<\/tr>\n<tr>\n<td>\u6269\u6563\u6d41\u8d85\u6807<\/td>\n<td>O\u578b\u5708\u8001\u5316\u3001\u63a5\u5934\u677e\u52a8\u3001\u819c\u7834\u635f<\/td>\n<td>\u66f4\u6362\u5bc6\u5c01\u4ef6\u3001\u68c0\u67e5\u8fde\u63a5\u90e8\u4f4d<\/td>\n<\/tr>\n<tr>\n<td>\u65e0\u6cd5\u8fbe\u5230\u6d4b\u8bd5\u538b\u529b<\/td>\n<td>\u7cfb\u7edf\u6cc4\u6f0f\u3001\u9600\u95e8\u672a\u5173\u7d27<\/td>\n<td>\u5206\u6bb5\u6392\u67e5\u6c14\u5bc6\u6027<\/td>\n<\/tr>\n<tr>\n<td>\u6570\u636e\u6f02\u79fb<\/td>\n<td>\u4f20\u611f\u5668\u672a\u6821\u51c6\u3001\u6e29\u5ea6\u6ce2\u52a8\u5927<\/td>\n<td>\u5b9a\u671f\u8ba1\u91cf\u6821\u9a8c\u3001\u6052\u6e29\u64cd\u4f5c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\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\u56db\u90e8. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2020.  <\/li>\n<li>U.S. Food and Drug Administration. <em>Sterile Drug Products Produced by Aseptic Processing \u2014 CGMP<\/em>. Guidance for Industry, 2016.  <\/li>\n<li>European Medicines Agency. <em>Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container<\/em>, EMA\/CHMP\/CVMP\/SWP\/572132\/2019, 2020.  <\/li>\n<li>ASTM International. <em>ASTM F838-22: Standard Test Method for Determining Bacterial Retention of Membrane Filters Used for Liquid Filtration<\/em>. West Conshohocken, PA, 2022.  <\/li>\n<li>Parenteral Drug Association (PDA). <em>Technical Report No. 26: Sterilizing Filtration of Liquids<\/em> (Revised 2008).  <\/li>\n<li>MilliporeSigma. <em>Filter Integrity Testing: Principles and Practices<\/em>. Technical Bulletin FTENG004, 2021.  <\/li>\n<li>ISO. <em>ISO 13408-5:2018 \u2014 Health care products \u2014 Processing by filtration \u2014 Part 5: Determination of filter integrity<\/em>.  <\/li>\n<li>Zhang, L., Wang, Y., Chen, X. et al. &quot;Real-time integrity monitoring of sterilizing filters using acoustic emission and machine learning.&quot; <em>Journal of Pharmaceutical Sciences<\/em>, 110(4), 1567\u20131575, 2021. <a href=\"https:\/\/doi.org\/10.1016\/j.xphs.2020.12.015\">https:\/\/doi.org\/10.1016\/j.xphs.2020.12.015<\/a>  <\/li>\n<li>Hogg, A.H. &quot;Advances in filter integrity testing: From bubble point to digital connectivity.&quot; <em>Pharmaceutical Engineering<\/em>, 40(3), 1\u20138, 2020.  <\/li>\n<li>\u767e\u5ea6\u767e\u79d1. \u201c\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\u201d. <a href=\"https:\/\/baike.baidu.com\/item\/\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\">https:\/\/baike.baidu.com\/item\/\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5<\/a> \uff08\u8bbf\u95ee\u65e5\u671f\uff1a2024\u5e746\u6708\uff09<\/li>\n<\/ol>\n<hr \/>\n<p>\uff08\u5168\u6587\u7ea63,800\u5b57\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u9ad8\u6548\u591a\u5c42\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u68c0\u6d4b\u5728\u5236\u836f\u884c\u4e1a\u65e0\u83cc\u5de5\u827a\u4e2d\u7684\u5e94\u7528\u7814\u7a76 \u5f15\u8a00 \u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u5c24\u5176\u662f\u65e0\u83cc\u836f\u54c1\u7684\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u786e\u4fdd\u4ea7\u54c1\u65e0\u83cc\u6027\u662f\u8d28\u91cf\u63a7\u5236\u7684\u6838\u5fc3\u8981\u6c42\u3002\u6839\u636e\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff082020\u5e74\u7248\uff09\u548c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u3001\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u7b49\u76d1\u7ba1\u673a\u6784\u7684\u89c4\u5b9a\uff0c\u65e0\u83cc\u751f\u4ea7\u5de5\u827a\u5fc5\u987b\u901a\u8fc7\u4e25\u683c\u7684\u9a8c\u8bc1\u4e0e\u76d1\u63a7\u624b\u6bb5\u6765\u9632\u6b62\u5fae\u751f\u7269\u6c61\u67d3\u3002\u5176\u4e2d\uff0c\u9ad8\u6548\u591a\u5c42\u8fc7\u6ee4\u5668\uff08High-Eff&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-16835","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\/16835","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=16835"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/16835\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16835"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16835"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16835"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}