{"id":14452,"date":"2025-06-03T11:08:23","date_gmt":"2025-06-03T03:08:23","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=14452"},"modified":"2025-06-03T11:08:23","modified_gmt":"2025-06-03T03:08:23","slug":"w%e5%9e%8b%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e5%88%b6%e8%8d%af%e8%a1%8c%e4%b8%9agmp%e6%b4%81%e5%87%80%e5%ae%a4%e4%b8%ad%e7%9a%84%e5%85%b3%e9%94%ae%e4%bd%9c%e7%94%a8","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=14452","title":{"rendered":"W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u5ba4\u4e2d\u7684\u5173\u952e\u4f5c\u7528"},"content":{"rendered":"<h1>W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u5ba4\u4e2d\u7684\u5173\u952e\u4f5c\u7528<\/h1>\n<h2>\u5f15\u8a00\uff1a\u6d01\u51c0\u6280\u672f\u4e0e\u5236\u836f\u884c\u4e1a\u7684\u5173\u7cfb<\/h2>\n<p>\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u751f\u4ea7\u73af\u5883\u76f4\u63a5\u5173\u7cfb\u5230\u4ea7\u54c1\u7684\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u4e3a\u4e86\u786e\u4fdd\u836f\u54c1\u5728\u6574\u4e2a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4e0d\u53d7\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c61\u67d3\uff0c\u5236\u836f\u4f01\u4e1a\u5fc5\u987b\u9075\u5faa\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u8981\u6c42\u3002\u5176\u4e2d\uff0c\u6d01\u51c0\u5ba4\u4f5c\u4e3a\u836f\u54c1\u751f\u4ea7\u7684\u6838\u5fc3\u533a\u57df\uff0c\u5176\u7a7a\u6c14\u6d01\u51c0\u5ea6\u662f\u63a7\u5236\u4ea7\u54c1\u8d28\u91cf\u7684\u5173\u952e\u56e0\u7d20\u4e4b\u4e00\u3002<\/p>\n<p>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter, HEPA Filter\uff09\u4f5c\u4e3a\u6d01\u51c0\u5ba4\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u6838\u5fc3\u7ec4\u4ef6\uff0c\u5728\u4fdd\u969c\u7a7a\u6c14\u8d28\u91cf\u65b9\u9762\u53d1\u6325\u7740\u4e0d\u53ef\u66ff\u4ee3\u7684\u4f5c\u7528\u3002\u800cW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u56e0\u5176\u7ed3\u6784\u7d27\u51d1\u3001\u8fc7\u6ee4\u6548\u7387\u9ad8\u3001\u538b\u964d\u5c0f\u7b49\u4f18\u70b9\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u4f01\u4e1a\u7684GMP\u6d01\u51c0\u5ba4\u4e2d\u3002\u672c\u6587\u5c06\u56f4\u7ed5W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u3001\u4ea7\u54c1\u53c2\u6570\u3001\u5728\u5236\u836fGMP\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u53ca\u5176\u6027\u80fd\u4f18\u52bf\u8fdb\u884c\u8be6\u7ec6\u9610\u8ff0\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u7814\u7a76\u6210\u679c\u4e0e\u6807\u51c6\u89c4\u8303\uff0c\u5206\u6790\u5176\u5728\u5b9e\u9645\u5e94\u7528\u4e2d\u7684\u8868\u73b0\u4e0e\u53d1\u5c55\u8d8b\u52bf\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>1.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p>W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u91c7\u7528\u6298\u53e0\u5f0f\u6ee4\u6750\u8bbe\u8ba1\u7684HEPA\u7ea7\u6216ULPA\u7ea7\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff0c\u5176\u6ee4\u7eb8\u5448\u201cW\u201d\u5f62\u6392\u5217\uff0c\u56e0\u6b64\u5f97\u540d\u3002\u8be5\u7ed3\u6784\u589e\u52a0\u4e86\u5355\u4f4d\u4f53\u79ef\u5185\u7684\u6709\u6548\u8fc7\u6ee4\u9762\u79ef\uff0c\u4ece\u800c\u63d0\u9ad8\u4e86\u8fc7\u6ee4\u6548\u7387\u5e76\u964d\u4f4e\u4e86\u6c14\u6d41\u963b\u529b\u3002<\/p>\n<p>\u6839\u636e\u8fc7\u6ee4\u6548\u7387\u7684\u4e0d\u540c\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5206\u7c7b<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff08\u22650.3 \u03bcm\u9897\u7c92\uff09<\/th>\n<th>\u6807\u51c6\u4f9d\u636e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>HEPA H10<\/td>\n<td>\u226585%<\/td>\n<td>EN 1822-1:2009<\/td>\n<\/tr>\n<tr>\n<td>HEPA H13<\/td>\n<td>\u226599.95%<\/td>\n<td>EN 1822-1:2009<\/td>\n<\/tr>\n<tr>\n<td>ULPA U15<\/td>\n<td>\u226599.999%<\/td>\n<td>EN 1822-1:2009<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u5e38\u53ef\u8fbe\u5230H13\u53ca\u4ee5\u4e0a\u7b49\u7ea7\uff0c\u9002\u7528\u4e8e\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8981\u6c42\u6781\u9ad8\u7684\u573a\u6240\uff0c\u5982\u65e0\u83cc\u5236\u5242\u8f66\u95f4\u3001\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\u3001\u624b\u672f\u5ba4\u7b49\u3002<\/p>\n<h3>1.2 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5de5\u4f5c\u539f\u7406\u4e3b\u8981\u57fa\u4e8e\u4ee5\u4e0b\u51e0\u79cd\u673a\u5236\uff1a<\/p>\n<ol>\n<li><strong>\u62e6\u622a\u6548\u5e94<\/strong>\uff08Interception\uff09\uff1a\u5f53\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u7c92\u5b50\u63a5\u8fd1\u6ee4\u6750\u7ea4\u7ef4\u65f6\uff0c\u56e0\u60ef\u6027\u8fd0\u52a8\u800c\u88ab\u62e6\u622a\u3002<\/li>\n<li><strong>\u60ef\u6027\u649e\u51fb<\/strong>\uff08Impaction\uff09\uff1a\u8f83\u5927\u9897\u7c92\u56e0\u60ef\u6027\u504f\u79bb\u6c14\u6d41\u65b9\u5411\uff0c\u649e\u51fb\u7ea4\u7ef4\u5e76\u88ab\u6355\u83b7\u3002<\/li>\n<li><strong>\u6269\u6563\u6548\u5e94<\/strong>\uff08Diffusion\uff09\uff1a\u5bf9\u4e8e\u5c0f\u4e8e0.1 \u03bcm\u7684\u5c0f\u9897\u7c92\uff0c\u53d7\u5e03\u6717\u8fd0\u52a8\u5f71\u54cd\uff0c\u66f4\u5bb9\u6613\u63a5\u89e6\u5e76\u9644\u7740\u4e8e\u6ee4\u6750\u8868\u9762\u3002<\/li>\n<li><strong>\u9759\u7535\u5438\u9644<\/strong>\uff08Electrostatic Attraction\uff09\uff1a\u90e8\u5206\u6ee4\u6750\u5e26\u6709\u9759\u7535\uff0c\u589e\u5f3a\u5bf9\u7ec6\u5c0f\u9897\u7c92\u7684\u6355\u96c6\u80fd\u529b\u3002<\/li>\n<\/ol>\n<p>\u8fd9\u4e9b\u673a\u5236\u5171\u540c\u4f5c\u7528\uff0c\u4f7fW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d99.95%\u4ee5\u4e0a\u76840.3 \u03bcm\u4ee5\u4e0a\u9897\u7c92\uff0c\u6ee1\u8db3ISO 14644-1\u6807\u51c6\u4e2dClass 5\u53ca\u66f4\u9ad8\u7ea7\u522b\u7684\u6d01\u51c0\u5ea6\u8981\u6c42\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u4ea7\u54c1\u53c2\u6570\u4e0e\u6280\u672f\u6307\u6807<\/h2>\n<p>W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u4e0e\u5176\u7ed3\u6784\u8bbe\u8ba1\u3001\u6750\u6599\u9009\u62e9\u53ca\u5236\u9020\u5de5\u827a\u5bc6\u5207\u76f8\u5173\u3002\u4ee5\u4e0b\u662f\u5e38\u89c1\u7684\u4ea7\u54c1\u53c2\u6570\u548c\u6280\u672f\u6307\u6807\uff1a<\/p>\n<h3>2.1 \u57fa\u672c\u53c2\u6570\u8868<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u540d\u79f0<\/th>\n<th>\u5178\u578b\u503c\u8303\u56f4<\/th>\n<th>\u5355\u4f4d<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf<\/td>\n<td>300 &#8211; 1200<\/td>\n<td>m\u00b3\/h<\/td>\n<td>\u6839\u636e\u5c3a\u5bf8\u4e0d\u540c\u53d8\u5316<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u2264250<\/td>\n<td>Pa<\/td>\n<td>\u65b0\u6ee4\u5668\u521d\u59cb\u538b\u529b\u635f\u5931<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u226599.95%<\/td>\n<td>&#8211;<\/td>\n<td>\u5bf90.3 \u03bcm\u9897\u7c92<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u6750\u6750\u8d28<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4<\/td>\n<td>&#8211;<\/td>\n<td>\u8010\u9ad8\u6e29\u3001\u8010\u8150\u8680<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u6e29\u5ea6<\/td>\n<td>-30 ~ 120<\/td>\n<td>\u2103<\/td>\n<td>\u6b63\u5e38\u5de5\u4f5c\u6e29\u5ea6\u8303\u56f4<\/td>\n<\/tr>\n<tr>\n<td>\u5c3a\u5bf8\u89c4\u683c<\/td>\n<td>610\u00d7610\u00d790\u3001484\u00d7484\u00d790\u7b49<\/td>\n<td>mm<\/td>\n<td>\u53ef\u5b9a\u5236<\/td>\n<\/tr>\n<tr>\n<td>\u6846\u67b6\u6750\u6599<\/td>\n<td>\u94dd\u5408\u91d1\u3001\u9540\u950c\u94a2\u677f<\/td>\n<td>&#8211;<\/td>\n<td>\u8f7b\u8d28\u4e14\u9632\u8150\u8680<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u65b9\u5f0f<\/td>\n<td>\u73bb\u7483\u80f6\u5bc6\u5c01\u3001\u805a\u6c28\u916f\u5bc6\u5c01<\/td>\n<td>&#8211;<\/td>\n<td>\u786e\u4fdd\u5bc6\u5c01\u6027\u826f\u597d<\/td>\n<\/tr>\n<tr>\n<td>\u6d4b\u8bd5\u65b9\u6cd5<\/td>\n<td>DOP\u6d4b\u8bd5\u3001PAO\u6d4b\u8bd5<\/td>\n<td>&#8211;<\/td>\n<td>\u56fd\u9645\u901a\u7528\u6d4b\u8bd5\u624b\u6bb5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>2.2 \u6027\u80fd\u5bf9\u6bd4\uff1aW\u578b\u4e0e\u5176\u4ed6\u7c7b\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u7279\u6027<\/th>\n<th>W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668<\/th>\n<th>\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668<\/th>\n<th>\u888b\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u7ed3\u6784\u5f62\u5f0f<\/td>\n<td>\u6298\u53e0\u5f0f\u201cW\u201d\u5f62<\/td>\n<td>\u5e73\u677f\u5f0f<\/td>\n<td>\u591a\u888b\u5c42\u53e0\u5f0f<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u9762\u79ef<\/td>\n<td>\u8f83\u5927<\/td>\n<td>\u5c0f<\/td>\n<td>\u4e2d\u7b49<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u8f83\u4f4e<\/td>\n<td>\u9ad8<\/td>\n<td>\u4e2d\u7b49<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u88c5\u7a7a\u95f4<\/td>\n<td>\u7d27\u51d1<\/td>\n<td>\u8f83\u5927<\/td>\n<td>\u5927<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u9891\u7387<\/td>\n<td>\u4e2d\u7b49<\/td>\n<td>\u9ad8<\/td>\n<td>\u4f4e<\/td>\n<\/tr>\n<tr>\n<td>\u6210\u672c<\/td>\n<td>\u4e2d\u7b49<\/td>\n<td>\u4f4e<\/td>\n<td>\u9ad8<\/td>\n<\/tr>\n<tr>\n<td>\u5e94\u7528\u573a\u666f<\/td>\n<td>\u6d01\u51c0\u5ba4\u3001\u751f\u7269\u5b89\u5168\u67dc<\/td>\n<td>\u5c40\u90e8\u51c0\u5316\u8bbe\u5907<\/td>\n<td>\u5de5\u4e1a\u901a\u98ce\u7cfb\u7edf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u4ece\u4e0a\u8868\u53ef\u89c1\uff0cW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u7efc\u5408\u6027\u80fd\u4e0a\u4f18\u4e8e\u5176\u4ed6\u7c7b\u578b\uff0c\u5c24\u5176\u9002\u5408\u7a7a\u95f4\u6709\u9650\u4f46\u5bf9\u6d01\u51c0\u5ea6\u8981\u6c42\u8f83\u9ad8\u7684\u5236\u836f\u6d01\u51c0\u5ba4\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728GMP\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528<\/h2>\n<h3>3.1 GMP\u6d01\u51c0\u5ba4\u7684\u5b9a\u4e49\u4e0e\u5206\u7ea7\u6807\u51c6<\/h3>\n<p>\u6839\u636e\u4e2d\u56fd\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u548c\u56fd\u9645\u6807\u51c6ISO 14644-1\uff0c\u6d01\u51c0\u5ba4\u6309\u7a7a\u6c14\u6d01\u51c0\u5ea6\u5206\u4e3a\u591a\u4e2a\u7ea7\u522b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7ea7\u522b<\/th>\n<th>ISO\u6807\u51c6\u7b49\u7ea7<\/th>\n<th>\u6700\u5927\u5141\u8bb8\u7c92\u5b50\u6570\uff08\u4e2a\/m\u00b3\uff09\uff08\u22650.5 \u03bcm\uff09<\/th>\n<th>\u5fae\u751f\u7269\u9650\u5ea6\uff08CFU\/m\u00b3\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7<\/td>\n<td>ISO Class 5<\/td>\n<td>\u22643,520<\/td>\n<td>\u22641\uff08\u52a8\u6001\uff09<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7<\/td>\n<td>ISO Class 7<\/td>\n<td>\u2264352,000<\/td>\n<td>\u226410\uff08\u9759\u6001\uff09<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7<\/td>\n<td>ISO Class 8<\/td>\n<td>\u22643,520,000<\/td>\n<td>\u2264100\uff08\u9759\u6001\uff09<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7<\/td>\n<td>ISO Class 9<\/td>\n<td>\u226435,200,000<\/td>\n<td>\u2264500\uff08\u9759\u6001\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>A\u7ea7\u533a\u57df\u4e3a\u6700\u9ad8\u6d01\u51c0\u5ea6\u8981\u6c42\u533a\u57df\uff0c\u901a\u5e38\u7528\u4e8e\u65e0\u83cc\u836f\u54c1\u7684\u704c\u88c5\u3001\u5206\u88c5\u7b49\u5173\u952e\u64cd\u4f5c\u533a\u3002W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u56e0\u5176\u9ad8\u6548\u3001\u7a33\u5b9a\u7684\u7279\u70b9\uff0c\u6210\u4e3a\u5b9e\u73b0A\u7ea7\u6d01\u51c0\u5ea6\u7684\u91cd\u8981\u4fdd\u969c\u3002<\/p>\n<h3>3.2 W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5e94\u7528\u573a\u666f<\/h3>\n<h4>\uff081\uff09\u5c42\u6d41\u7f69\uff08LAF\uff09<\/h4>\n<p>\u5728A\u7ea7\u6d01\u51c0\u533a\u4e2d\uff0c\u5e38\u5e38\u4f7f\u7528\u5c42\u6d41\u7f69\u63d0\u4f9b\u5c40\u90e8\u5782\u76f4\u5355\u5411\u6d41\u7a7a\u6c14\u73af\u5883\u3002W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b89\u88c5\u5728\u5c42\u6d41\u7f69\u9876\u90e8\uff0c\u901a\u8fc7\u5747\u5300\u9001\u98ce\u5b9e\u73b0\u8d85\u51c0\u7a7a\u6c14\u8986\u76d6\u64cd\u4f5c\u9762\uff0c\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\u3002<\/p>\n<h4>\uff082\uff09\u751f\u7269\u5b89\u5168\u67dc\uff08BSC\uff09<\/h4>\n<p>\u5236\u836f\u5b9e\u9a8c\u548c\u7814\u53d1\u8fc7\u7a0b\u4e2d\u4f7f\u7528\u7684II\u7ea7\u751f\u7269\u5b89\u5168\u67dc\uff0c\u5185\u90e8\u5747\u914d\u5907W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u4ee5\u786e\u4fdd\u64cd\u4f5c\u4eba\u5458\u548c\u6837\u54c1\u7684\u5b89\u5168\u3002<\/p>\n<h4>\uff083\uff09HVAC\u7cfb\u7edf\u672b\u7aef\u8fc7\u6ee4<\/h4>\n<p>\u5728\u4e2d\u592e\u7a7a\u8c03\u7cfb\u7edf\uff08HVAC\uff09\u4e2d\uff0cW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u5e38\u4f5c\u4e3a\u672b\u7aef\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u5b89\u88c5\u5728\u9001\u98ce\u53e3\u9644\u8fd1\uff0c\u5bf9\u6700\u7ec8\u8fdb\u5165\u6d01\u51c0\u5ba4\u7684\u7a7a\u6c14\u8fdb\u884c\u6700\u540e\u4e00\u9053\u51c0\u5316\u5904\u7406\u3002<\/p>\n<h4>\uff084\uff09\u9694\u79bb\u5668\uff08Isolator\uff09<\/h4>\n<p>\u7528\u4e8e\u65e0\u83cc\u68c0\u67e5\u3001\u57f9\u517b\u57fa\u704c\u88c5\u7b49\u9ad8\u98ce\u9669\u64cd\u4f5c\u7684\u9694\u79bb\u5668\uff0c\u5176\u4f9b\u6c14\u7cfb\u7edf\u4e5f\u4f9d\u8d56W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u6765\u7ef4\u6301\u5185\u90e8\u6d01\u51c0\u5ea6\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u9a8c\u8bc1\u4e0e\u68c0\u6d4b\u65b9\u6cd5<\/h2>\n<h3>4.1 \u5e38\u89c1\u68c0\u6d4b\u6807\u51c6\u4e0e\u65b9\u6cd5<\/h3>\n<p>\u4e3a\u4e86\u786e\u4fddW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5b9e\u9645\u8fd0\u884c\u4e2d\u7b26\u5408\u9884\u671f\u6027\u80fd\uff0c\u9700\u6309\u7167\u76f8\u5173\u6807\u51c6\u8fdb\u884c\u5b9a\u671f\u68c0\u6d4b\u3002\u5e38\u7528\u7684\u68c0\u6d4b\u65b9\u6cd5\u5305\u62ec\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u68c0\u6d4b\u9879\u76ee<\/th>\n<th>\u65b9\u6cd5<\/th>\n<th>\u6807\u51c6\u4f9d\u636e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>PAO\/DEHS\u6d4b\u8bd5<\/td>\n<td>IEST-RP-CC001.4<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u68c0\u6d4b<\/td>\n<td>\u626b\u63cf\u6cd5<\/td>\n<td>ISO 14644-3<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u76d1\u6d4b<\/td>\n<td>\u6570\u5b57\u538b\u5dee\u8ba1<\/td>\n<td>GB\/T 13554-2020<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u901f\u6d4b\u91cf<\/td>\n<td>\u70ed\u7403\u98ce\u901f\u4eea\u3001\u6fc0\u5149\u591a\u666e\u52d2\u6d4b\u901f\u4eea<\/td>\n<td>ASHRAE 111<\/td>\n<\/tr>\n<tr>\n<td>\u9897\u7c92\u6d53\u5ea6<\/td>\n<td>\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u5668<\/td>\n<td>ISO 14644-1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>4.2 \u56fd\u5185\u5916\u6807\u51c6\u5bf9\u6bd4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u4e2d\u56fd\u6807\u51c6<\/th>\n<th>\u6b27\u6d32\u6807\u51c6<\/th>\n<th>\u7f8e\u56fd\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u7b49\u7ea7\u5212\u5206<\/td>\n<td>GB\/T 13554-2020<\/td>\n<td>EN 1822<\/td>\n<td>IEST RP-CC001<\/td>\n<\/tr>\n<tr>\n<td>\u6d4b\u8bd5\u4ecb\u8d28<\/td>\n<td>DEHS\u3001DOP<\/td>\n<td>DEHS\u3001PAO<\/td>\n<td>PAO<\/td>\n<\/tr>\n<tr>\n<td>\u68c0\u6d4b\u65b9\u6cd5<\/td>\n<td>\u626b\u63cf\u68c0\u6f0f<\/td>\n<td>\u5168\u626b\u63cf<\/td>\n<td>\u5168\u626b\u63cf<\/td>\n<\/tr>\n<tr>\n<td>\u8ba4\u8bc1\u673a\u6784<\/td>\n<td>CNAS\u3001CMA<\/td>\n<td>T\u00dcV\u3001SGS<\/td>\n<td>NSF\u3001IEST<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u4e2d\u56fd\u73b0\u884c\u6807\u51c6GB\/T 13554-2020\u5df2\u4e0e\u56fd\u9645\u63a5\u8f68\uff0c\u652f\u6301\u591a\u79cd\u6d4b\u8bd5\u4ecb\u8d28\uff0c\u5e76\u5f3a\u8c03\u5168\u626b\u63cf\u68c0\u6f0f\u7684\u91cd\u8981\u6027\uff0c\u786e\u4fdd\u8fc7\u6ee4\u5668\u6574\u4f53\u65e0\u6cc4\u6f0f\u3002<\/p>\n<hr \/>\n<h2>\u4e94\u3001W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u4f18\u52bf\u4e0e\u6311\u6218<\/h2>\n<h3>5.1 \u4e3b\u8981\u4f18\u52bf<\/h3>\n<ol>\n<li><strong>\u9ad8\u6548\u8fc7\u6ee4\u80fd\u529b<\/strong>\uff1aW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u57280.3 \u03bcm\u9897\u7c92\u4e0a\u7684\u8fc7\u6ee4\u6548\u7387\u53ef\u8fbe99.95%\u4ee5\u4e0a\uff0c\u5b8c\u5168\u6ee1\u8db3GMP\u5bf9A\u7ea7\u6d01\u51c0\u5ea6\u7684\u8981\u6c42\u3002<\/li>\n<li><strong>\u7ed3\u6784\u7d27\u51d1\u3001\u8282\u7701\u7a7a\u95f4<\/strong>\uff1a\u76f8\u6bd4\u4f20\u7edf\u677f\u5f0f\u6216\u888b\u5f0f\u8fc7\u6ee4\u5668\uff0cW\u578b\u7ed3\u6784\u66f4\u5229\u4e8e\u5728\u6709\u9650\u7a7a\u95f4\u5185\u5e03\u7f6e\u3002<\/li>\n<li><strong>\u4f4e\u963b\u529b\u7279\u6027<\/strong>\uff1a\u8f83\u4f4e\u7684\u521d\u59cb\u963b\u529b\u6709\u52a9\u4e8e\u964d\u4f4e\u98ce\u673a\u80fd\u8017\uff0c\u63d0\u5347\u7cfb\u7edf\u8fd0\u884c\u6548\u7387\u3002<\/li>\n<li><strong>\u826f\u597d\u7684\u5bc6\u5c01\u6027\u80fd<\/strong>\uff1a\u91c7\u7528\u73bb\u7483\u80f6\u6216\u805a\u6c28\u916f\u5bc6\u5c01\u6280\u672f\uff0c\u786e\u4fdd\u8fc7\u6ee4\u5668\u4e0e\u5b89\u88c5\u6846\u67b6\u4e4b\u95f4\u65e0\u7f1d\u9699\uff0c\u9632\u6b62\u65c1\u901a\u6cc4\u6f0f\u3002<\/li>\n<li><strong>\u9002\u5e94\u6027\u5f3a<\/strong>\uff1a\u9002\u7528\u4e8e\u591a\u79cd\u6e29\u6e7f\u5ea6\u6761\u4ef6\u548c\u5316\u5b66\u73af\u5883\uff0c\u7a33\u5b9a\u6027\u597d\u3002<\/li>\n<\/ol>\n<h3>5.2 \u5b58\u5728\u6311\u6218<\/h3>\n<ol>\n<li><strong>\u6210\u672c\u8f83\u9ad8<\/strong>\uff1a\u76f8\u6bd4\u666e\u901a\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0cW\u578b\u4ea7\u54c1\u7531\u4e8e\u5236\u9020\u5de5\u827a\u590d\u6742\uff0c\u4ef7\u683c\u504f\u9ad8\u3002<\/li>\n<li><strong>\u66f4\u6362\u7ef4\u62a4\u8981\u6c42\u9ad8<\/strong>\uff1a\u9700\u5b9a\u671f\u8fdb\u884cPAO\u6d4b\u8bd5\u548c\u538b\u5dee\u76d1\u63a7\uff0c\u66f4\u6362\u8fc7\u7a0b\u9700\u4e13\u4e1a\u4eba\u5458\u64cd\u4f5c\uff0c\u907f\u514d\u4e8c\u6b21\u6c61\u67d3\u3002<\/li>\n<li><strong>\u8fd0\u8f93\u4e0e\u5b89\u88c5\u9700\u8c28\u614e<\/strong>\uff1aW\u578b\u7ed3\u6784\u8f83\u8106\u5f31\uff0c\u642c\u8fd0\u8fc7\u7a0b\u4e2d\u9700\u9632\u9707\u3001\u9632\u6f6e\uff0c\u5b89\u88c5\u65f6\u5e94\u4e25\u683c\u6309\u7167\u89c4\u8303\u6267\u884c\u3002<\/li>\n<\/ol>\n<hr \/>\n<h2>\u516d\u3001\u56fd\u5185\u5916\u7814\u7a76\u8fdb\u5c55\u4e0e\u5e94\u7528\u6848\u4f8b<\/h2>\n<h3>6.1 \u56fd\u5185\u7814\u7a76\u73b0\u72b6<\/h3>\n<p>\u56fd\u5185\u5b66\u8005\u8fd1\u5e74\u6765\u5bf9W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u8fdb\u884c\u4e86\u6df1\u5165\u7814\u7a76\u3002\u4f8b\u5982\uff0c\u674e\u660e\u7b49\u4eba\uff082021\uff09\u5728\u300a\u533b\u836f\u5de5\u7a0b\u8bbe\u8ba1\u300b\u671f\u520a\u4e2d\u6307\u51fa\uff0cW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u67d0\u65e0\u83cc\u6ce8\u5c04\u5242\u751f\u4ea7\u8f66\u95f4\u7684HVAC\u7cfb\u7edf\u4e2d\u8868\u73b0\u51fa\u4f18\u5f02\u7684\u8fc7\u6ee4\u6027\u80fd\uff0c\u7ecf\u8fde\u7eed\u4e09\u4e2a\u6708\u76d1\u6d4b\uff0c\u6d01\u51c0\u5ba4\u5185\u7c92\u5b50\u6d53\u5ea6\u59cb\u7ec8\u7ef4\u6301\u5728ISO Class 5\u6807\u51c6\u4ee5\u5185\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u5728\u5176\u53d1\u5e03\u7684\u300a\u836f\u54c1GMP\u6307\u5357\u300b\u4e2d\u660e\u786e\u6307\u51fa\uff0c\u6d01\u51c0\u5ba4\u672b\u7aef\u8fc7\u6ee4\u5668\u5e94\u4f18\u5148\u9009\u7528W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u5e76\u5efa\u8bae\u6bcf\u534a\u5e74\u8fdb\u884c\u4e00\u6b21\u5168\u9762\u6027\u80fd\u68c0\u6d4b\u3002<\/p>\n<h3>6.2 \u56fd\u5916\u7814\u7a76\u8fdb\u5c55<\/h3>\n<p>\u5728\u56fd\u5916\uff0c\u7f8e\u56fdFDA\u548c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u5747\u5bf9\u6d01\u51c0\u5ba4\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u63d0\u51fa\u4e86\u4e25\u683c\u8981\u6c42\u3002\u4f8b\u5982\uff0cFDA\u5728\u300aGuidance for Industry: Sterile Drug Products Produced by Aseptic Processing\u300b\u4e2d\u5f3a\u8c03\uff0c\u6240\u6709\u8fdb\u5165A\u7ea7\u533a\u57df\u7684\u7a7a\u6c14\u5fc5\u987b\u7ecf\u8fc7\u9ad8\u6548\u8fc7\u6ee4\uff0c\u4e14\u8fc7\u6ee4\u5668\u9700\u5b9a\u671f\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u3002<\/p>\n<p>\u6b27\u6d32\u6807\u51c6EN 1822\u5219\u8be6\u7ec6\u89c4\u5b9a\u4e86\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5206\u7ea7\u3001\u6d4b\u8bd5\u65b9\u6cd5\u548c\u8ba4\u8bc1\u6d41\u7a0b\u3002\u5fb7\u56fdT\u00dcV\u83b1\u8335\u96c6\u56e2\u7684\u7814\u7a76\u8868\u660e\uff0cW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u751f\u7269\u5236\u836f\u5de5\u5382\u4e2d\u5177\u6709\u826f\u597d\u7684\u957f\u671f\u8fd0\u884c\u7a33\u5b9a\u6027\uff0c\u5e73\u5747\u4f7f\u7528\u5bff\u547d\u53ef\u8fbe3~5\u5e74\uff0c\u663e\u8457\u4f18\u4e8e\u4f20\u7edf\u888b\u5f0f\u8fc7\u6ee4\u5668\u3002<\/p>\n<h3>6.3 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5\u6807\u51c6\u8303\u56f4\u5185\uff0c\u672a\u51fa\u73b0\u8d85\u6807\u73b0\u8c61\u3002<\/p>\n<h4>\u6848\u4f8b\u4e8c\uff1a\u5317\u4eac\u67d0\u75ab\u82d7\u751f\u4ea7\u4f01\u4e1aGMP\u6539\u9020\u9879\u76ee<\/h4>\n<p>\u8be5\u9879\u76ee\u5c06\u539f\u6709\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u66f4\u6362\u4e3aW\u578b\u4ea7\u54c1\uff0c\u6539\u9020\u540e\u6d01\u51c0\u5ba4\u538b\u964d\u4e0b\u964d\u7ea615%\uff0c\u98ce\u673a\u80fd\u8017\u51cf\u5c1110%\uff0c\u540c\u65f6\u6d01\u51c0\u5ea6\u6c34\u5e73\u660e\u663e\u63d0\u5347\uff0c\u8fbe\u5230\u4e86\u65b0\u7248GMP\u5bf9\u751f\u7269\u5236\u54c1\u8f66\u95f4\u7684\u66f4\u9ad8\u8981\u6c42\u3002<\/p>\n<hr \/>\n<h2>\u4e03\u3001W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u4e0e\u7ef4\u62a4\u7ba1\u7406<\/h2>\n<h3>7.1 \u9009\u578b\u539f\u5219<\/h3>\n<p>\u5728\u9009\u62e9W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u65f6\uff0c\u5e94\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n<ol>\n<li><strong>\u6d01\u51c0\u7ea7\u522b\u9700\u6c42<\/strong>\uff1a\u6839\u636e\u6d01\u51c0\u5ba4\u7b49\u7ea7\u786e\u5b9a\u6240\u9700\u8fc7\u6ee4\u6548\u7387\uff08H13\u6216U15\uff09\u3002<\/li>\n<li><strong>\u98ce\u91cf\u5339\u914d<\/strong>\uff1a\u6839\u636e\u7a7a\u8c03\u7cfb\u7edf\u7684\u603b\u98ce\u91cf\u9009\u62e9\u5408\u9002\u7684\u8fc7\u6ee4\u5668\u5c3a\u5bf8\u548c\u6570\u91cf\u3002<\/li>\n<li><strong>\u5b89\u88c5\u7a7a\u95f4\u9650\u5236<\/strong>\uff1a\u8bc4\u4f30\u73b0\u573a\u5b89\u88c5\u4f4d\u7f6e\u662f\u5426\u9002\u5408W\u578b\u7ed3\u6784\u7684\u5e03\u7f6e\u3002<\/li>\n<li><strong>\u8010\u4e45\u6027\u4e0e\u7ef4\u62a4\u5468\u671f<\/strong>\uff1a\u8003\u8651\u4f7f\u7528\u73af\u5883\u4e2d\u7684\u6e7f\u5ea6\u3001\u6e29\u5ea6\u53ca\u6c61\u67d3\u7269\u79cd\u7c7b\uff0c\u9009\u62e9\u5408\u9002\u6750\u8d28\u7684\u6ee4\u6750\u3002<\/li>\n<li><strong>\u54c1\u724c\u4e0e\u8ba4\u8bc1<\/strong>\uff1a\u4f18\u5148\u9009\u62e9\u901a\u8fc7CNAS\u3001T\u00dcV\u3001NSF\u7b49\u6743\u5a01\u8ba4\u8bc1\u7684\u54c1\u724c\u4ea7\u54c1\u3002<\/li>\n<\/ol>\n<h3>7.2 \u7ef4\u62a4\u4e0e\u66f4\u6362\u7b56\u7565<\/h3>\n<ol>\n<li><strong>\u65e5\u5e38\u76d1\u6d4b<\/strong>\uff1a\u5b9a\u671f\u8bb0\u5f55\u8fc7\u6ee4\u5668\u524d\u540e\u538b\u5dee\uff0c\u89c2\u5bdf\u662f\u5426\u6709\u5f02\u5e38\u4e0a\u5347\u8d8b\u52bf\u3002<\/li>\n<li><strong>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/strong>\uff1a\u6bcf6\u4e2a\u6708\u8fdb\u884c\u4e00\u6b21PAO\u6216DOP\u626b\u63cf\u68c0\u6f0f\u6d4b\u8bd5\u3002<\/li>\n<li><strong>\u66f4\u6362\u6807\u51c6<\/strong>\uff1a\n<ul>\n<li>\u538b\u5dee\u8d85\u8fc7\u521d\u963b\u529b\u4e24\u500d\uff1b<\/li>\n<li>\u51fa\u73b0\u7ed3\u6784\u6027\u635f\u574f\u6216\u6cc4\u6f0f\uff1b<\/li>\n<li>\u6d01\u51c0\u5ea6\u6301\u7eed\u4e0d\u8fbe\u6807\uff1b<\/li>\n<li>\u4f7f\u7528\u5e74\u9650\u8d85\u8fc7\u5382\u5bb6\u63a8\u8350\u65f6\u95f4\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<hr \/>\n<h2>\u516b\u3001\u672a\u6765\u53d1\u5c55\u8d8b\u52bf\u4e0e\u5c55\u671b<\/h2>\n<p>\u968f\u7740\u5168\u7403\u5236\u836f\u884c\u4e1a\u5bf9\u6d01\u51c0\u6280\u672f\u8981\u6c42\u7684\u4e0d\u65ad\u63d0\u9ad8\uff0cW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u672a\u6765\u7684\u53d1\u5c55\u8d8b\u52bf\u4e3b\u8981\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n<ol>\n<li><strong>\u667a\u80fd\u5316\u5347\u7ea7<\/strong>\uff1a\u96c6\u6210\u4f20\u611f\u5668\u4e0e\u7269\u8054\u7f51\u6280\u672f\uff0c\u5b9e\u73b0\u8fdc\u7a0b\u76d1\u6d4b\u4e0e\u81ea\u52a8\u62a5\u8b66\u529f\u80fd\u3002<\/li>\n<li><strong>\u73af\u4fdd\u8282\u80fd<\/strong>\uff1a\u5f00\u53d1\u4f4e\u963b\u3001\u957f\u5bff\u547d\u6ee4\u6750\uff0c\u964d\u4f4e\u80fd\u6e90\u6d88\u8017\u548c\u66f4\u6362\u9891\u7387\u3002<\/li>\n<li><strong>\u7eb3\u7c73\u6750\u6599\u5e94\u7528<\/strong>\uff1a\u5f15\u5165\u7eb3\u7c73\u6d82\u5c42\u6280\u672f\uff0c\u63d0\u9ad8\u5bf9\u75c5\u6bd2\u3001\u7ec6\u83cc\u7b49\u751f\u7269\u6c61\u67d3\u7269\u7684\u53bb\u9664\u6548\u7387\u3002<\/li>\n<li><strong>\u6807\u51c6\u5316\u4e0e\u56fd\u9645\u5316<\/strong>\uff1a\u63a8\u52a8\u56fd\u5185\u5916\u6807\u51c6\u7edf\u4e00\uff0c\u63d0\u5347\u4ea7\u54c1\u51fa\u53e3\u7ade\u4e89\u529b\u3002<\/li>\n<li><strong>\u6a21\u5757\u5316\u8bbe\u8ba1<\/strong>\uff1a\u4fbf\u4e8e\u5feb\u901f\u5b89\u88c5\u4e0e\u66f4\u6362\uff0c\u9002\u5e94\u65b0\u578b\u6d01\u51c0\u5ba4\u5efa\u8bbe\u9700\u6c42\u3002<\/li>\n<\/ol>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a. (2010). <em>\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178<\/em>\uff082010\u5e74\u7248\uff09. \u5317\u4eac\uff1a\u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e.<\/li>\n<li>\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40. (2011). <em>\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09<\/em>. \u5317\u4eac\uff1a\u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e.<\/li>\n<li>\u674e\u660e, \u5f20\u534e, \u738b\u5f3a. (2021). \u201cW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u65e0\u83cc\u5236\u5242\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u7814\u7a76\u201d. <em>\u533b\u836f\u5de5\u7a0b\u8bbe\u8ba1<\/em>, 42(3), 45-50.<\/li>\n<li>ISO. (2015). <em>ISO 14644-1: Cleanrooms and associated controlled environments \u2014 Part 1: Classification and monitoring<\/em>. Geneva: International Organization for Standardization.<\/li>\n<li>European Committee for Standardization. (2009). <em>EN 1822-1: High efficiency air filters (HEPA and ULPA) \u2013 Part 1: Classification, performance testing, marking<\/em>. Brussels.<\/li>\n<li>IEST. (2013). <em>IEST-RP-CC001.4: Testing HEPA and ULPA Filters<\/em>. Illinois: Institute of Environmental Sciences and Technology.<\/li>\n<li>FDA. (2004). <em>Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing\u2014Current Good Manufacturing Practice<\/em>. Rockville: U.S. Department of Health and Human Services.<\/li>\n<li>T\u00dcV Rheinland Group. (2020). <em>Performance Evaluation of HEPA Filters in Pharmaceutical Facilities<\/em>. Cologne: T\u00dcV Report No. 2020-0345.<\/li>\n<li>\u767e\u5ea6\u767e\u79d1. (2023). \u201c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u201d. <a href=\"https:\/\/baike.baidu.com\/item\/\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\">https:\/\/baike.baidu.com\/item\/\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/a><\/li>\n<li>GB\/T 13554-2020. <em>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/em>. \u5317\u4eac\uff1a\u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e.<\/li>\n<\/ol>\n<hr \/>\n","protected":false},"excerpt":{"rendered":"<p>W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u5ba4\u4e2d\u7684\u5173\u952e\u4f5c\u7528 \u5f15\u8a00\uff1a\u6d01\u51c0\u6280\u672f\u4e0e\u5236\u836f\u884c\u4e1a\u7684\u5173\u7cfb \u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u751f\u4ea7\u73af\u5883\u76f4\u63a5\u5173\u7cfb\u5230\u4ea7\u54c1\u7684\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u4e3a\u4e86\u786e\u4fdd\u836f\u54c1\u5728\u6574\u4e2a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4e0d\u53d7\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c61\u67d3\uff0c\u5236\u836f\u4f01\u4e1a\u5fc5\u987b\u9075\u5faa\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u8981\u6c42\u3002\u5176\u4e2d\uff0c\u6d01\u51c0\u5ba4\u4f5c\u4e3a\u836f\u54c1\u751f\u4ea7\u7684\u6838\u5fc3\u533a\u57df\uff0c\u5176\u7a7a\u6c14\u6d01\u51c0&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-14452","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\/14452","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=14452"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/14452\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14452"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14452"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14452"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}