{"id":15262,"date":"2025-06-18T18:21:06","date_gmt":"2025-06-18T10:21:06","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15262"},"modified":"2025-06-18T18:21:06","modified_gmt":"2025-06-18T10:21:06","slug":"%e4%b8%8d%e9%94%88%e9%92%a2%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e5%8c%bb%e8%8d%afgmp%e8%bd%a6%e9%97%b4%e7%a9%ba%e6%b0%94%e5%87%80%e5%8c%96%e4%b8%ad%e7%9a%84%e6%a0%87%e5%87%86","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15262","title":{"rendered":"\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u533b\u836fGMP\u8f66\u95f4\u7a7a\u6c14\u51c0\u5316\u4e2d\u7684\u6807\u51c6\u914d\u7f6e\u4e0e\u5b9e\u65bd"},"content":{"rendered":"<h1>\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u533b\u836fGMP\u8f66\u95f4\u7a7a\u6c14\u51c0\u5316\u4e2d\u7684\u6807\u51c6\u914d\u7f6e\u4e0e\u5b9e\u65bd<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u968f\u7740\u5168\u7403\u5236\u836f\u884c\u4e1a\u5bf9\u836f\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u6027\u7684\u8981\u6c42\u65e5\u76ca\u63d0\u9ad8\uff0c\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08Good Manufacturing Practice, GMP\uff09\u5df2\u6210\u4e3a\u5404\u56fd\u836f\u76d1\u90e8\u95e8\u76d1\u7ba1\u7684\u6838\u5fc3\u5185\u5bb9\u4e4b\u4e00\u3002\u5c24\u5176\u5728\u4e2d\u56fd\uff0c\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u5bf9\u6d01\u51c0\u533a\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\u3001\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u7684\u8bbe\u8ba1\u53ca\u5173\u952e\u8bbe\u5907\u7684\u9009\u578b\u63d0\u51fa\u4e86\u660e\u786e\u8981\u6c42\u3002\u5728\u8fd9\u4e00\u80cc\u666f\u4e0b\uff0c\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u5728\u533b\u836fGMP\u8f66\u95f4\u4e2d\u626e\u6f14\u7740\u4e0d\u53ef\u6216\u7f3a\u7684\u89d2\u8272\u3002<\/p>\n<p>\u672c\u6587\u5c06\u56f4\u7ed5\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u533b\u836fGMP\u8f66\u95f4\u7a7a\u6c14\u51c0\u5316\u4e2d\u7684\u6807\u51c6\u914d\u7f6e\u4e0e\u5b9e\u65bd\u8fdb\u884c\u6df1\u5165\u63a2\u8ba8\uff0c\u6db5\u76d6\u5176\u5de5\u4f5c\u539f\u7406\u3001\u4ea7\u54c1\u53c2\u6570\u3001\u9009\u578b\u4f9d\u636e\u3001\u5b89\u88c5\u7ef4\u62a4\u8981\u70b9\u3001\u56fd\u5185\u5916\u76f8\u5173\u6807\u51c6\u7b49\u5185\u5bb9\uff0c\u5e76\u7ed3\u5408\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\u5206\u6790\u5176\u6548\u679c\uff0c\u65e8\u5728\u4e3a\u533b\u836f\u5de5\u7a0b\u8bbe\u8ba1\u4eba\u5458\u548c\u4f01\u4e1a\u7ba1\u7406\u4eba\u5458\u63d0\u4f9b\u79d1\u5b66\u3001\u7cfb\u7edf\u7684\u53c2\u8003\u4f9d\u636e\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u6982\u5ff5\u4e0e\u5206\u7c7b<\/h2>\n<h3>1.1 \u5b9a\u4e49<\/h3>\n<p>\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u91c7\u7528304\u6216316L\u4e0d\u9508\u94a2\u6750\u8d28\u5236\u9020\u7684\u3001\u7528\u4e8e\u9ad8\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u5fae\u7c92\u548c\u5fae\u751f\u7269\u7684\u7a7a\u6c14\u8fc7\u6ee4\u8bbe\u5907\u3002\u5176\u8fc7\u6ee4\u6548\u7387\u901a\u5e38\u8fbe\u5230HEPA\uff08High Efficiency Particulate Air\uff09\u7ea7\u522b\uff0c\u5373\u5bf90.3\u03bcm\u4ee5\u4e0a\u7684\u9897\u7c92\u7269\u8fc7\u6ee4\u6548\u7387\u226599.97%\u3002<\/p>\n<h3>1.2 \u5206\u7c7b<\/h3>\n<p>\u6839\u636e\u7528\u9014\u548c\u7ed3\u6784\u5f62\u5f0f\uff0c\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e3b\u8981\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7c7b\u578b<\/th>\n<th>\u7ed3\u6784\u7279\u70b9<\/th>\n<th>\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u677f\u5f0f\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668<\/td>\n<td>\u5355\u5c42\u7ed3\u6784\uff0c\u4fbf\u4e8e\u66f4\u6362<\/td>\n<td>\u6d01\u51c0\u5ba4\u56de\u98ce\u7cfb\u7edf<\/td>\n<\/tr>\n<tr>\n<td>\u888b\u5f0f\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668<\/td>\n<td>\u591a\u888b\u7ed3\u6784\uff0c\u5bb9\u5c18\u91cf\u5927<\/td>\n<td>\u521d\u6548\/\u4e2d\u6548\u9884\u8fc7\u6ee4\u540e\u4f7f\u7528<\/td>\n<\/tr>\n<tr>\n<td>\u5706\u7b52\u5f0f\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668<\/td>\n<td>\u7acb\u4f53\u7ed3\u6784\uff0c\u6c14\u6d41\u5206\u5e03\u5747\u5300<\/td>\n<td>\u9ad8\u6548\u9001\u98ce\u53e3\u3001FFU\u7cfb\u7edf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e8c\u3001\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5de5\u4f5c\u539f\u7406\u4e0e\u6027\u80fd\u6307\u6807<\/h2>\n<h3>2.1 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u8fc7\u591a\u5c42\u6ee4\u6750\uff08\u5982\u73bb\u7483\u7ea4\u7ef4\u3001\u805a\u4e19\u70ef\u7b49\uff09\u5b9e\u73b0\u5bf9\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u9897\u7c92\u7684\u62e6\u622a\u3001\u60ef\u6027\u78b0\u649e\u3001\u6269\u6563\u6c89\u964d\u7b49\u591a\u79cd\u7269\u7406\u673a\u5236\uff0c\u4ece\u800c\u8fbe\u5230\u9ad8\u6548\u51c0\u5316\u7684\u76ee\u7684\u3002\u5176\u6838\u5fc3\u5728\u4e8e\u6ee4\u6750\u7684\u5b54\u9699\u7387\u3001\u539a\u5ea6\u4ee5\u53ca\u8868\u9762\u9759\u7535\u5904\u7406\u6280\u672f\u3002<\/p>\n<h3>2.2 \u4e3b\u8981\u6027\u80fd\u6307\u6807<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6027\u80fd\u6307\u6807<\/th>\n<th>\u6280\u672f\u8981\u6c42<\/th>\n<th>\u6d4b\u8bd5\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u226599.97% @0.3\u03bcm<\/td>\n<td>EN 1822-1:2009 \/ ISO 29463-1<\/td>\n<\/tr>\n<tr>\n<td>\u963b\u529b<\/td>\n<td>\u2264250Pa\uff08\u521d\u963b\u529b\uff09<\/td>\n<td>GB\/T 13554-2020<\/td>\n<\/tr>\n<tr>\n<td>\u5bb9\u5c18\u91cf<\/td>\n<td>\u2265500g\/m\u00b2<\/td>\n<td>IEST-RP-CC001.3<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u7387<\/td>\n<td>\u22640.01%<\/td>\n<td>\u5149\u5ea6\u8ba1\u6cd5\u6d4b\u8bd5<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28<\/td>\n<td>SUS304\/SUS316L\u4e0d\u9508\u94a2<\/td>\n<td>ASTM A240<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e09\u3001\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u533b\u836fGMP\u8f66\u95f4\u7684\u5e94\u7528\u80cc\u666f<\/h2>\n<h3>3.1 \u533b\u836fGMP\u8f66\u95f4\u5bf9\u7a7a\u6c14\u8d28\u91cf\u7684\u8981\u6c42<\/h3>\n<p>\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b\uff0c\u4e0d\u540c\u7ea7\u522b\u7684\u6d01\u51c0\u533a\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u6709\u660e\u786e\u5212\u5206\uff0c\u5982\u4e0b\u8868\u6240\u793a\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7b49\u7ea7<\/th>\n<th>\u5fae\u7c92\u6570\uff08\u22650.5\u03bcm\uff09\/m\u00b3<\/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>\u22643,520<\/td>\n<td>\u22641<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7<\/td>\n<td>\u22643,520<\/td>\n<td>\u226410<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7<\/td>\n<td>\u2264352,000<\/td>\n<td>\u2264100<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7<\/td>\n<td>\u22643,520,000<\/td>\n<td>\u2264500<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u4e3a\u4e86\u6ee1\u8db3\u8fd9\u4e9b\u4e25\u683c\u7684\u6d01\u51c0\u5ea6\u8981\u6c42\uff0c\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u5fc5\u987b\u914d\u5907\u9ad8\u6548\u7684\u7a7a\u6c14\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u5176\u4e2d\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u56e0\u5176\u8010\u8150\u8680\u3001\u6613\u6e05\u6d17\u3001\u53ef\u91cd\u590d\u4f7f\u7528\u7b49\u4f18\u70b9\u800c\u88ab\u5e7f\u6cdb\u91c7\u7528\u3002<\/p>\n<h3>3.2 \u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u4f18\u52bf<\/h3>\n<p>\u76f8\u8f83\u4e8e\u4f20\u7edf\u7eb8\u8d28\u6216\u5408\u6210\u6750\u6599\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5177\u6709\u4ee5\u4e0b\u663e\u8457\u4f18\u52bf\uff1a<\/p>\n<ul>\n<li><strong>\u8010\u9ad8\u6e29<\/strong>\uff1a\u53ef\u5728121\u2103\u84b8\u6c7d\u706d\u83cc\u6761\u4ef6\u4e0b\u53cd\u590d\u4f7f\u7528\uff1b<\/li>\n<li><strong>\u8010\u8150\u8680<\/strong>\uff1a\u9002\u7528\u4e8e\u9ad8\u6e7f\u3001\u9178\u78b1\u73af\u5883\uff1b<\/li>\n<li><strong>\u53ef\u6e05\u6d17\u518d\u751f<\/strong>\uff1a\u964d\u4f4e\u957f\u671f\u8fd0\u884c\u6210\u672c\uff1b<\/li>\n<li><strong>\u9632\u706b\u6027\u80fd\u597d<\/strong>\uff1a\u7b26\u5408\u6d88\u9632\u6cd5\u89c4\u8981\u6c42\uff1b<\/li>\n<li><strong>\u7ed3\u6784\u5f3a\u5ea6\u9ad8<\/strong>\uff1a\u9002\u7528\u4e8e\u9ad8\u538b\u5dee\u5de5\u51b5\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u56db\u3001\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6807\u51c6\u914d\u7f6e\u8981\u6c42<\/h2>\n<h3>4.1 \u5b89\u88c5\u4f4d\u7f6e\u9009\u62e9<\/h3>\n<p>\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e94\u5b89\u88c5\u5728\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u672b\u7aef\uff0c\u901a\u5e38\u4f4d\u4e8e\u9001\u98ce\u53e3\u6216FFU\uff08Fan Filter Unit\uff09\u6a21\u5757\u4e2d\u3002\u5177\u4f53\u914d\u7f6e\u5efa\u8bae\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5b89\u88c5\u4f4d\u7f6e<\/th>\n<th>\u529f\u80fd\u8bf4\u660e<\/th>\n<th>\u5e38\u89c1\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>FFU\u6a21\u5757<\/td>\n<td>\u81ea\u5e26\u98ce\u673a\uff0c\u72ec\u7acb\u63a7\u5236<\/td>\n<td>\u5c40\u90e8A\u7ea7\u6d01\u51c0\u533a<\/td>\n<\/tr>\n<tr>\n<td>\u9001\u98ce\u53e3<\/td>\n<td>\u4e0e\u7a7a\u8c03\u7cfb\u7edf\u96c6\u6210<\/td>\n<td>B\u7ea7\u53ca\u4ee5\u4e0a\u6d01\u51c0\u533a<\/td>\n<\/tr>\n<tr>\n<td>\u56de\u98ce\u53e3<\/td>\n<td>\u7528\u4e8e\u5faa\u73af\u98ce\u5904\u7406<\/td>\n<td>\u4e2d\u592e\u7a7a\u8c03\u7cfb\u7edf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>4.2 \u914d\u7f6e\u53c2\u6570\u63a8\u8350<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u540d\u79f0<\/th>\n<th>\u63a8\u8350\u503c<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u98ce\u901f<\/td>\n<td>0.3~0.5 m\/s<\/td>\n<td>\u6ee1\u8db3ISO 14644-1\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>\u6362\u6c14\u6b21\u6570<\/td>\n<td>\u226525\u6b21\/h\uff08B\u7ea7\uff09<\/td>\n<td>\u6839\u636e\u6d01\u51c0\u7b49\u7ea7\u8c03\u6574<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u963b\u529b<\/td>\n<td>\u2264200 Pa<\/td>\n<td>\u5f71\u54cd\u98ce\u673a\u80fd\u8017<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b\u62a5\u8b66\u503c<\/td>\n<td>400~500 Pa<\/td>\n<td>\u89e6\u53d1\u66f4\u6362\u63d0\u793a<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u68c0\u6d4b\u9891\u7387<\/td>\n<td>\u6bcf\u5e74\u81f3\u5c11\u4e00\u6b21<\/td>\n<td>\u53c2\u7167GB\/T 13554-2020<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e94\u3001\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u4e0e\u8bbe\u8ba1\u8981\u70b9<\/h2>\n<h3>5.1 \u9009\u578b\u4f9d\u636e<\/h3>\n<p>\u9009\u578b\u65f6\u5e94\u7efc\u5408\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n<ul>\n<li>\u6d01\u51c0\u7b49\u7ea7\u8981\u6c42<\/li>\n<li>\u7cfb\u7edf\u98ce\u91cf\u4e0e\u98ce\u538b<\/li>\n<li>\u4f7f\u7528\u73af\u5883\u6e29\u6e7f\u5ea6<\/li>\n<li>\u662f\u5426\u9700\u8981\u706d\u83cc\u5904\u7406<\/li>\n<li>\u6210\u672c\u4e0e\u7ef4\u62a4\u5468\u671f<\/li>\n<\/ul>\n<h3>5.2 \u8bbe\u8ba1\u539f\u5219<\/h3>\n<ol>\n<li><strong>\u6807\u51c6\u5316\u8bbe\u8ba1<\/strong>\uff1a\u4f18\u5148\u9009\u7528\u7b26\u5408GB\/T 13554-2020\u3001EN 1822\u7b49\u56fd\u5bb6\u6807\u51c6\u7684\u4ea7\u54c1\uff1b<\/li>\n<li><strong>\u6a21\u5757\u5316\u914d\u7f6e<\/strong>\uff1a\u4fbf\u4e8e\u540e\u671f\u7ef4\u62a4\u4e0e\u66f4\u6362\uff1b<\/li>\n<li><strong>\u5197\u4f59\u8bbe\u8ba1<\/strong>\uff1a\u786e\u4fdd\u5355\u53f0\u6545\u969c\u4e0d\u5f71\u54cd\u6574\u4f53\u7cfb\u7edf\u8fd0\u884c\uff1b<\/li>\n<li><strong>\u5bc6\u5c01\u6027\u8981\u6c42<\/strong>\uff1a\u91c7\u7528\u7845\u80f6\u5bc6\u5c01\u6761\u6216\u91d1\u5c5e\u710a\u63a5\u65b9\u5f0f\uff0c\u9632\u6b62\u6cc4\u6f0f\uff1b<\/li>\n<li><strong>\u538b\u529b\u76d1\u6d4b<\/strong>\uff1a\u8bbe\u7f6e\u538b\u5dee\u4f20\u611f\u5668\u5b9e\u65f6\u76d1\u63a7\u8fc7\u6ee4\u5668\u72b6\u6001\u3002<\/li>\n<\/ol>\n<hr \/>\n<h2>\u516d\u3001\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u4e0e\u7ef4\u62a4<\/h2>\n<h3>6.1 \u5b89\u88c5\u6ce8\u610f\u4e8b\u9879<\/h3>\n<ul>\n<li>\u5b89\u88c5\u524d\u5e94\u68c0\u67e5\u8fc7\u6ee4\u5668\u5916\u89c2\u662f\u5426\u5b8c\u597d\uff0c\u5bc6\u5c01\u9762\u662f\u5426\u5e73\u6574\uff1b<\/li>\n<li>\u5b89\u88c5\u8fc7\u7a0b\u4e2d\u5e94\u907f\u514d\u5212\u4f24\u6ee4\u6750\uff1b<\/li>\n<li>\u5b89\u88c5\u540e\u9700\u8fdb\u884c\u6cc4\u6f0f\u6d4b\u8bd5\uff0c\u5e38\u7528\u65b9\u6cd5\u5305\u62ec\u5149\u5ea6\u8ba1\u6cd5\u548c\u7c92\u5b50\u8ba1\u6570\u6cd5\uff1b<\/li>\n<li>\u6240\u6709\u8fde\u63a5\u90e8\u4f4d\u5e94\u4f7f\u7528\u4e0d\u9508\u94a2\u87ba\u6813\u548c\u5bc6\u5c01\u57ab\u7247\uff0c\u786e\u4fdd\u6c14\u5bc6\u6027\u3002<\/li>\n<\/ul>\n<h3>6.2 \u65e5\u5e38\u7ef4\u62a4\u4e0e\u4fdd\u517b<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u7ef4\u62a4\u9879\u76ee<\/th>\n<th>\u9891\u7387<\/th>\n<th>\u65b9\u6cd5<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5916\u89c2\u68c0\u67e5<\/td>\n<td>\u6bcf\u6708<\/td>\n<td>\u76ee\u89c6\u68c0\u67e5\u662f\u5426\u6709\u53d8\u5f62\u3001\u7834\u635f<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u76d1\u6d4b<\/td>\n<td>\u5b9e\u65f6<\/td>\n<td>\u901a\u8fc7PLC\u7cfb\u7edf\u8bb0\u5f55\u6570\u636e<\/td>\n<\/tr>\n<tr>\n<td>\u6e05\u6d17\u9664\u5c18<\/td>\n<td>\u6bcf\u5b63\u5ea6<\/td>\n<td>\u4f7f\u7528\u538b\u7f29\u7a7a\u6c14\u5439\u626b<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u68c0\u6d4b<\/td>\n<td>\u6bcf\u5e74<\/td>\n<td>\u5149\u5ea6\u8ba1\u6cd5\u6d4b\u8bd5<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u5468\u671f<\/td>\n<td>5~10\u5e74<\/td>\n<td>\u6839\u636e\u7ec8\u963b\u529b\u5224\u65ad<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e03\u3001\u56fd\u5185\u5916\u76f8\u5173\u6807\u51c6\u4e0e\u8ba4\u8bc1\u4f53\u7cfb<\/h2>\n<h3>7.1 \u56fd\u5185\u6807\u51c6<\/h3>\n<ul>\n<li><strong>GB\/T 13554-2020<\/strong>\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b<\/li>\n<li><strong>GB 50457-2019<\/strong>\u300a\u533b\u836f\u5de5\u4e1a\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u6807\u51c6\u300b<\/li>\n<li><strong>YY\/T 0567-2018<\/strong>\u300a\u533b\u7597\u5668\u68b0\u6d01\u51c0\u5382\u623f\u901a\u7528\u8981\u6c42\u300b<\/li>\n<\/ul>\n<h3>7.2 \u56fd\u9645\u6807\u51c6<\/h3>\n<ul>\n<li><strong>EN 1822-1:2009<\/strong>\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6027\u80fd\u6d4b\u8bd5\u300b<\/li>\n<li><strong>ISO 29463-1:2011<\/strong>\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6d4b\u8bd5\u65b9\u6cd5\u300b<\/li>\n<li><strong>FDA Guidelines for Sterile Drug Products Produced by Aseptic Processing<\/strong><\/li>\n<\/ul>\n<h3>7.3 \u8ba4\u8bc1\u4f53\u7cfb<\/h3>\n<ul>\n<li><strong>CE\u8ba4\u8bc1<\/strong>\uff08\u6b27\u6d32\u5e02\u573a\u51c6\u5165\uff09<\/li>\n<li><strong>UL\u8ba4\u8bc1<\/strong>\uff08\u7f8e\u56fd\u5b89\u5168\u6807\u51c6\uff09<\/li>\n<li><strong>ISO 9001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1<\/strong><\/li>\n<li><strong>ISO 14644-1\u6d01\u51c0\u5ba4\u5206\u7ea7\u6807\u51c6<\/strong><\/li>\n<\/ul>\n<hr \/>\n<h2>\u516b\u3001\u5178\u578b\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>8.1 \u67d0\u5927\u578b\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1a\u6539\u9020\u9879\u76ee<\/h3>\n<p>\u8be5\u9879\u76ee\u4e3a\u67d0\u56fd\u5185\u77e5\u540d\u5236\u836f\u516c\u53f8\u65b0\u5efa\u7684\u65e0\u83cc\u6ce8\u5c04\u5242\u751f\u4ea7\u7ebf\uff0c\u6d01\u51c0\u7b49\u7ea7\u8981\u6c42\u4e3aA\/B\u7ea7\u3002\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4e2d\u91c7\u7528\u4e86\u5706\u7b52\u5f0f\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u914d\u5408FFU\u6a21\u5757\u5b9e\u73b0\u5c40\u90e8A\u7ea7\u6d01\u51c0\u73af\u5883\u3002<\/p>\n<h4>\u5b9e\u65bd\u6548\u679c\uff1a<\/h4>\n<ul>\n<li>\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7a33\u5b9a\u8fbe\u5230ISO Class 4\uff08\u76f8\u5f53\u4e8eA\u7ea7\uff09\uff1b<\/li>\n<li>\u5e74\u5747\u66f4\u6362\u6b21\u6570\u7531\u539f\u6765\u76842\u6b21\u51cf\u5c11\u81f30.5\u6b21\uff1b<\/li>\n<li>\u80fd\u8017\u964d\u4f4e\u7ea615%\uff0c\u8fd0\u884c\u6210\u672c\u4e0b\u964d20%\uff1b<\/li>\n<li>\u7b26\u5408\u6b27\u76dfGMP\u9644\u5f551\u5173\u4e8e\u65e0\u83cc\u751f\u4ea7\u7684\u6700\u65b0\u8981\u6c42\u3002<\/li>\n<\/ul>\n<h3>8.2 \u67d0\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u9879\u76ee<\/h3>\n<p>\u8be5\u8f66\u95f4\u91c7\u7528\u5168\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7cfb\u7edf\uff0c\u652f\u6301121\u2103\u9ad8\u6e29\u706d\u83cc\uff0c\u6ee1\u8db3\u751f\u7269\u5b89\u5168\u4e09\u7ea7\uff08BSL-3\uff09\u5b9e\u9a8c\u5ba4\u6807\u51c6\u3002<\/p>\n<h4>\u5173\u952e\u53c2\u6570\uff1a<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u6570\u503c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u98ce\u91cf<\/td>\n<td>10,000 m\u00b3\/h<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u963b\u529b<\/td>\n<td>180 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b\u8bbe\u5b9a<\/td>\n<td>450 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u7387<\/td>\n<td>&lt;0.01%<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28<\/td>\n<td>SUS316L\u4e0d\u9508\u94a2<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e5d\u3001\u5e38\u89c1\u95ee\u9898\u4e0e\u89e3\u51b3\u65b9\u6848<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u95ee\u9898\u63cf\u8ff0<\/th>\n<th>\u539f\u56e0\u5206\u6790<\/th>\n<th>\u89e3\u51b3\u65b9\u6848<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u963b\u529b\u8fc7\u9ad8<\/td>\n<td>\u6ee4\u6750\u5835\u585e<\/td>\n<td>\u5b9a\u671f\u6e05\u6d17\u6216\u66f4\u6362<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u8d85\u6807<\/td>\n<td>\u5bc6\u5c01\u4e0d\u826f<\/td>\n<td>\u68c0\u67e5\u5bc6\u5c01\u5708\u3001\u91cd\u65b0\u5b89\u88c5<\/td>\n<\/tr>\n<tr>\n<td>\u6548\u7387\u4e0b\u964d<\/td>\n<td>\u6ee4\u6750\u8001\u5316<\/td>\n<td>\u66f4\u6362\u65b0\u8fc7\u6ee4\u5668<\/td>\n<\/tr>\n<tr>\n<td>\u706d\u83cc\u4e0d\u5f7b\u5e95<\/td>\n<td>\u6e29\u5ea6\u6216\u65f6\u95f4\u4e0d\u8db3<\/td>\n<td>\u63d0\u9ad8\u706d\u83cc\u6e29\u5ea6\u6216\u5ef6\u957f\u65f6\u95f4<\/td>\n<\/tr>\n<tr>\n<td>\u566a\u97f3\u5f02\u5e38<\/td>\n<td>\u98ce\u673a\u4e0d\u5e73\u8861\u6216\u5171\u632f<\/td>\n<td>\u68c0\u67e5\u98ce\u673a\u53f6\u7247\u3001\u52a0\u56fa\u652f\u67b6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u5341\u3001\u672a\u6765\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<p>\u968f\u7740\u667a\u80fd\u5236\u9020\u548c\u7eff\u8272\u5236\u9020\u7406\u5ff5\u7684\u63a8\u8fdb\uff0c\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u53d1\u5c55\u8d8b\u52bf\u4e3b\u8981\u4f53\u73b0\u5728\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n<ol>\n<li><strong>\u667a\u80fd\u5316\u76d1\u6d4b<\/strong>\uff1a\u96c6\u6210\u7269\u8054\u7f51\u4f20\u611f\u5668\uff0c\u5b9e\u73b0\u8fdc\u7a0b\u76d1\u63a7\u4e0e\u9884\u8b66\uff1b<\/li>\n<li><strong>\u8282\u80fd\u8bbe\u8ba1<\/strong>\uff1a\u91c7\u7528\u4f4e\u963b\u9ad8\u6548\u6ee4\u6750\uff0c\u964d\u4f4e\u98ce\u673a\u80fd\u8017\uff1b<\/li>\n<li><strong>\u6a21\u5757\u5316\u751f\u4ea7<\/strong>\uff1a\u63d0\u5347\u5236\u9020\u6548\u7387\u4e0e\u5b9a\u5236\u5316\u80fd\u529b\uff1b<\/li>\n<li><strong>\u65b0\u6750\u6599\u5e94\u7528<\/strong>\uff1a\u5982\u7eb3\u7c73\u6d82\u5c42\u3001\u6297\u83cc\u6ee4\u6750\u7b49\u65b0\u578b\u6750\u6599\u7684\u7814\u53d1\uff1b<\/li>\n<li><strong>\u73af\u4fdd\u56de\u6536<\/strong>\uff1a\u63a8\u52a8\u53ef\u62c6\u5378\u3001\u53ef\u56de\u6536\u8bbe\u8ba1\uff0c\u51cf\u5c11\u56fa\u5e9f\u6392\u653e\u3002<\/li>\n<\/ol>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b[Z].  <\/li>\n<li>\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u4f4f\u623f\u548c\u57ce\u4e61\u5efa\u8bbe\u90e8. \u300aGB 50457-2019 \u533b\u836f\u5de5\u4e1a\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u6807\u51c6\u300b[S].  <\/li>\n<li>\u5168\u56fd\u6696\u901a\u7a7a\u8c03\u53ca\u51c0\u5316\u8bbe\u5907\u6807\u51c6\u5316\u6280\u672f\u59d4\u5458\u4f1a. \u300aGB\/T 13554-2020 \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b[S].  <\/li>\n<li>European Committee for Standardization. EN 1822-1:2009 High efficiency air filters (HEPA and ULPA) \u2013 Part 1: Classification, performance testing, marking[S].  <\/li>\n<li>International Organization for Standardization. ISO 29463-1:2011 Particulate air filters for general ventilation \u2013 Determination of the filtration performance[S].  <\/li>\n<li>U.S. Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing &#8211; Current Good Manufacturing Practice[S].  <\/li>\n<li>\u674e\u5efa\u5f3a, \u738b\u6653\u4e1c. \u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u533b\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u7814\u7a76[J]. \u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f, 2021(3): 45-48.  <\/li>\n<li>\u5f20\u4f1f, \u5218\u6d0b. \u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u4f18\u5316\u4e0e\u8282\u80fd\u8bbe\u8ba1[J]. \u73af\u5883\u5de5\u7a0b, 2022, 40(6): 112-116.<\/li>\n<\/ol>\n<hr \/>\n<p><em>\u6ce8\uff1a\u672c\u6587\u5185\u5bb9\u57fa\u4e8e\u516c\u5f00\u8d44\u6599\u6574\u7406\uff0c\u90e8\u5206\u6570\u636e\u6765\u6e90\u4e8e\u5382\u5546\u624b\u518c\u548c\u6280\u672f\u767d\u76ae\u4e66\uff0c\u4ec5\u4f9b\u53c2\u8003\u3002\u5b9e\u9645\u5e94\u7528\u4e2d\u8bf7\u7ed3\u5408\u5177\u4f53\u9879\u76ee\u9700\u6c42\u8fdb\u884c\u8be6\u7ec6\u8bbe\u8ba1\u4e0e\u9a8c\u8bc1\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u533b\u836fGMP\u8f66\u95f4\u7a7a\u6c14\u51c0\u5316\u4e2d\u7684\u6807\u51c6\u914d\u7f6e\u4e0e\u5b9e\u65bd \u5f15\u8a00 \u968f\u7740\u5168\u7403\u5236\u836f\u884c\u4e1a\u5bf9\u836f\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u6027\u7684\u8981\u6c42\u65e5\u76ca\u63d0\u9ad8\uff0c\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08Good Manufacturing Practice, GMP\uff09\u5df2\u6210\u4e3a\u5404\u56fd\u836f\u76d1\u90e8\u95e8\u76d1\u7ba1\u7684\u6838\u5fc3\u5185\u5bb9\u4e4b\u4e00\u3002\u5c24\u5176\u5728\u4e2d\u56fd\uff0c\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u5bf9\u6d01\u51c0\u533a\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\u3001\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u7684\u8bbe\u8ba1\u53ca\u5173\u952e\u8bbe\u5907\u7684\u9009\u578b\u63d0\u51fa&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-15262","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\/15262","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=15262"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15262\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15262"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15262"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15262"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}