{"id":15718,"date":"2025-06-27T10:53:54","date_gmt":"2025-06-27T02:53:54","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15718"},"modified":"2025-06-27T10:53:54","modified_gmt":"2025-06-27T02:53:54","slug":"ulpa%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%a0%87%e5%87%86%e4%b8%8b%e7%9a%84%e4%bd%bf%e7%94%a8%e8%a7%84%e8%8c%83","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15718","title":{"rendered":"ULPA\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e0b\u7684\u4f7f\u7528\u89c4\u8303"},"content":{"rendered":"<h1>ULPA\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e0b\u7684\u4f7f\u7528\u89c4\u8303<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u8d28\u91cf\u4e0e\u751f\u4ea7\u73af\u5883\u7684\u6d01\u51c0\u5ea6\u5bc6\u5207\u76f8\u5173\u3002\u4e3a\u4e86\u786e\u4fdd\u836f\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u5168\u7403\u5404\u56fd\u5747\u5236\u5b9a\u4e86\u4e25\u683c\u7684\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08Good Manufacturing Practice, GMP\uff09\u3002\u5728\u4e2d\u56fd\uff0c\u4f9d\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\uff0c\u5bf9\u5236\u836f\u6d01\u51c0\u5ba4\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u8981\u6c42\u6781\u4e3a\u4e25\u683c\uff1b\u800c\u5728\u56fd\u9645\u4e0a\uff0c\u5982\u7f8e\u56fdFDA\u3001\u6b27\u76dfGMP\u7b49\u4e5f\u5bf9\u5236\u836f\u8f66\u95f4\u7684\u7a7a\u6c14\u8d28\u91cf\u63d0\u51fa\u4e86\u9ad8\u6807\u51c6\u3002<\/p>\n<p>ULPA\uff08Ultra Low Penetration Air\uff09\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u4e00\u79cd\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u8bbe\u5907\uff0c\u5176\u8fc7\u6ee4\u6548\u7387\u8fdc\u9ad8\u4e8e\u4f20\u7edf\u7684HEPA\uff08High Efficiency Particulate Air\uff09\u8fc7\u6ee4\u5668\uff0c\u5c24\u5176\u9002\u7528\u4e8e\u8981\u6c42\u6781\u9ad8\u6d01\u51c0\u5ea6\u7684\u5236\u836f\u73af\u5883\u3002\u672c\u6587\u5c06\u8be6\u7ec6\u63a2\u8ba8ULPA\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u53c2\u6570\u3001\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e0b\u7684\u5e94\u7528\u89c4\u8303\u3001\u5b89\u88c5\u7ef4\u62a4\u8981\u70b9\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u6587\u732e\u8fdb\u884c\u5206\u6790\uff0c\u65e8\u5728\u4e3a\u5236\u836f\u4f01\u4e1a\u63d0\u4f9b\u79d1\u5b66\u5408\u7406\u7684\u7a7a\u6c14\u8fc7\u6ee4\u89e3\u51b3\u65b9\u6848\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001ULPA\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u6982\u5ff5\u4e0e\u6280\u672f\u53c2\u6570<\/h2>\n<h3>1.1 \u5b9a\u4e49<\/h3>\n<p>ULPA\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u7528\u4e8e\u53bb\u9664\u7a7a\u6c14\u4e2d\u6781\u7ec6\u9897\u7c92\u7269\u7684\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u901a\u5e38\u7528\u4e8e\u9700\u8981\u6781\u9ad8\u6d01\u51c0\u5ea6\u7684\u73af\u5883\uff0c\u5982\u5236\u836f\u6d01\u51c0\u5ba4\u3001\u534a\u5bfc\u4f53\u65e0\u5c18\u8f66\u95f4\u548c\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\u3002\u6839\u636e\u7f8e\u56fd Institute of Environmental Sciences and Technology\uff08IEST\uff09\u7684\u6807\u51c6\uff0cULPA\u8fc7\u6ee4\u5668\u5bf9\u7c92\u5f84\u22650.12 \u03bcm\u7684\u7c92\u5b50\u8fc7\u6ee4\u6548\u7387\u5e94\u4e0d\u4f4e\u4e8e99.999%\u3002<\/p>\n<h3>1.2 \u6280\u672f\u53c2\u6570\u5bf9\u6bd4\uff1aULPA vs HEPA<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>ULPA\u8fc7\u6ee4\u5668<\/th>\n<th>HEPA\u8fc7\u6ee4\u5668<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387\uff08\u22650.12 \u03bcm\uff09<\/td>\n<td>\u226599.999%<\/td>\n<td>\u226599.97%\uff08\u9488\u5bf9\u22650.3 \u03bcm\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b\uff08Pa\uff09<\/td>\n<td>250~400<\/td>\n<td>150~250<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\u3001\u5408\u6210\u6750\u6599<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\u4e3a\u4e3b<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5bff\u547d\uff08\u5e74\uff09<\/td>\n<td>5~8<\/td>\n<td>3~5<\/td>\n<\/tr>\n<tr>\n<td>\u6210\u672c\uff08\u76f8\u5bf9\uff09<\/td>\n<td>\u8f83\u9ad8<\/td>\n<td>\u4e2d\u7b49<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u6570\u636e\u6765\u6e90\uff1aIEST-RP-CC001.4\uff082013\uff09\u3001\u4e2d\u56fd\u300aGB\/T 13554-2020 \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b<\/p>\n<h3>1.3 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>ULPA\u8fc7\u6ee4\u5668\u4e3b\u8981\u901a\u8fc7\u4ee5\u4e0b\u51e0\u79cd\u673a\u5236\u5b9e\u73b0\u9ad8\u6548\u8fc7\u6ee4\uff1a<\/p>\n<ul>\n<li><strong>\u62e6\u622a<\/strong>\uff1a\u5f53\u9897\u7c92\u7269\u63a5\u8fd1\u7ea4\u7ef4\u65f6\uff0c\u88ab\u5438\u9644\u6216\u7c98\u9644\u3002<\/li>\n<li><strong>\u60ef\u6027\u78b0\u649e<\/strong>\uff1a\u8f83\u5927\u9897\u7c92\u56e0\u60ef\u6027\u4f5c\u7528\u504f\u79bb\u6c14\u6d41\u65b9\u5411\u800c\u649e\u51fb\u7ea4\u7ef4\u3002<\/li>\n<li><strong>\u6269\u6563\u6548\u5e94<\/strong>\uff1a\u5fae\u5c0f\u9897\u7c92\u53d7\u5e03\u6717\u8fd0\u52a8\u5f71\u54cd\uff0c\u66f4\u5bb9\u6613\u4e0e\u7ea4\u7ef4\u63a5\u89e6\u3002<\/li>\n<li><strong>\u9759\u7535\u5438\u9644<\/strong>\uff1a\u90e8\u5206ULPA\u8fc7\u6ee4\u5668\u91c7\u7528\u9759\u7535\u589e\u5f3a\u8bbe\u8ba1\uff0c\u63d0\u9ad8\u6355\u96c6\u6548\u7387\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e8c\u3001GMP\u6807\u51c6\u5bf9\u5236\u836f\u6d01\u51c0\u533a\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u8981\u6c42<\/h2>\n<h3>2.1 \u56fd\u5185GMP\u6807\u51c6<\/h3>\n<p>\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\uff09\u9644\u5f551\u201c\u65e0\u83cc\u836f\u54c1\u201d\u4e2d\u7684\u89c4\u5b9a\uff0c\u4e0d\u540c\u6d01\u51c0\u7ea7\u522b\u7684\u7a7a\u6c14\u60ac\u6d6e\u7c92\u5b50\u6d53\u5ea6\u9650\u503c\u5982\u4e0b\u8868\u6240\u793a\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7ea7\u522b<\/th>\n<th>\u22650.5 \u03bcm\u7c92\u5b50\u6570\uff08\u4e2a\/m\u00b3\uff09<\/th>\n<th>\u22655.0 \u03bcm\u7c92\u5b50\u6570\uff08\u4e2a\/m\u00b3\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\uff08\u52a8\u6001\uff09<\/td>\n<td>\u22643500<\/td>\n<td>\u226420<\/td>\n<td>\u226410\uff08\u6c89\u964d\u83cc\uff09<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7\uff08\u52a8\u6001\uff09<\/td>\n<td>\u22643500<\/td>\n<td>\u226420<\/td>\n<td>\u226410\uff08\u6c89\u964d\u83cc\uff09<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7\uff08\u52a8\u6001\uff09<\/td>\n<td>\u2264350000<\/td>\n<td>\u22642000<\/td>\n<td>\u2264100\uff08\u6c89\u964d\u83cc\uff09<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7\uff08\u52a8\u6001\uff09<\/td>\n<td>\u22643500000<\/td>\n<td>\u226420000<\/td>\n<td>\u2264200\uff08\u6c89\u964d\u83cc\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u8d44\u6599\u6765\u6e90\uff1a\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\uff0c\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\uff09<\/p>\n<h3>2.2 \u56fd\u9645GMP\u6807\u51c6<\/h3>\n<h4>\u6b27\u76dfGMP Annex 1\uff082020 Draft\uff09<\/h4>\n<p>\u6b27\u76df\u6700\u65b0\u8349\u6848\u4e2d\u8fdb\u4e00\u6b65\u7ec6\u5316\u4e86\u6d01\u51c0\u533a\u5206\u7c7b\u53ca\u5fae\u751f\u7269\u63a7\u5236\u6807\u51c6\uff0c\u5f3a\u8c03\u4e86\u5bf9\u975e\u6d3b\u6027\u7c92\u5b50\u548c\u6d3b\u6027\u7c92\u5b50\u7684\u53cc\u91cd\u63a7\u5236\u3002\u4f8b\u5982\uff1a<\/p>\n<ul>\n<li>A\u7ea7\u533a\u57df\u5fc5\u987b\u91c7\u7528\u5355\u5411\u6d41\uff08\u5c42\u6d41\uff09\u7cfb\u7edf\uff1b<\/li>\n<li>\u6240\u6709\u5173\u952e\u64cd\u4f5c\u533a\u5e94\u914d\u5907ULPA\u8fc7\u6ee4\u5668\u4ee5\u786e\u4fdd\u7c92\u5b50\u63a7\u5236\uff1b<\/li>\n<li>\u5efa\u8bae\u91c7\u7528\u5b9e\u65f6\u76d1\u6d4b\u7cfb\u7edf\u5bf9\u7a7a\u6c14\u8d28\u91cf\u548c\u5fae\u751f\u7269\u6c61\u67d3\u8fdb\u884c\u76d1\u63a7\u3002<\/li>\n<\/ul>\n<h4>\u7f8e\u56fdFDA cGMP\u6307\u5357<\/h4>\n<p>\u7f8e\u56fdFDA\u5728\u5176\u73b0\u884cGMP\u6307\u5357\u4e2d\u6307\u51fa\uff1a<\/p>\n<ul>\n<li>\u6d01\u51c0\u5ba4\u7684\u8bbe\u8ba1\u5e94\u6ee1\u8db3ISO 14644-1 Class 5\uff08\u5bf9\u5e94A\/B\u7ea7\uff09\u6807\u51c6\uff1b<\/li>\n<li>\u5bf9\u4e8e\u5173\u952e\u5de5\u827a\u533a\u57df\uff0c\u5efa\u8bae\u4f7f\u7528ULPA\u8fc7\u6ee4\u5668\u4ee5\u8fbe\u5230\u66f4\u9ad8\u7684\u8fc7\u6ee4\u6548\u7387\uff1b<\/li>\n<li>\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u5e94\u5177\u5907\u5b9a\u671f\u9a8c\u8bc1\u4e0e\u518d\u786e\u8ba4\u80fd\u529b\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e09\u3001ULPA\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u89c4\u8303<\/h2>\n<h3>3.1 \u5e94\u7528\u573a\u666f<\/h3>\n<p>ULPA\u8fc7\u6ee4\u5668\u4e3b\u8981\u7528\u4e8e\u4ee5\u4e0b\u5236\u836f\u6d01\u51c0\u533a\uff1a<\/p>\n<ul>\n<li>\u65e0\u83cc\u704c\u88c5\u7ebf<\/li>\n<li>\u51bb\u5e72\u673a\u8fdb\u51fa\u6599\u53e3<\/li>\n<li>\u751f\u7269\u5b89\u5168\u67dc<\/li>\n<li>\u6d01\u51c0\u8d70\u5eca\u4e0e\u4f20\u9012\u7a97<\/li>\n<li>\u9ad8\u6548\u6362\u6c14\u7cfb\u7edf\u672b\u7aef<\/li>\n<\/ul>\n<h3>3.2 \u5b89\u88c5\u89c4\u8303<\/h3>\n<p>\u6839\u636e\u300aGB\/T 13554-2020\u300b\u53ca\u6b27\u76dfGMP Annex 1\u5efa\u8bae\uff0cULPA\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u9700\u9075\u5faa\u4ee5\u4e0b\u89c4\u8303\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5b89\u88c5\u73af\u8282<\/th>\n<th>\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5b89\u88c5\u524d\u68c0\u6d4b<\/td>\n<td>\u5fc5\u987b\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08\u5982DOP\/PAO\u626b\u63cf\u6cd5\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u88c5\u65b9\u5f0f<\/td>\n<td>\u91c7\u7528\u9876\u9001\u98ce\u3001\u4fa7\u9001\u98ce\u6216\u6a21\u5757\u5316\u5b89\u88c5\uff0c\u907f\u514d\u6c14\u6d41\u77ed\u8def<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u6027\u80fd<\/td>\n<td>\u4f7f\u7528\u7845\u80f6\u57ab\u7247\u6216\u6db2\u69fd\u5bc6\u5c01\uff0c\u786e\u4fdd\u96f6\u6cc4\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u88c5\u540e\u9a8c\u8bc1<\/td>\n<td>\u5fc5\u987b\u8fdb\u884c\u73b0\u573a\u626b\u63cf\u68c0\u6f0f\u3001\u98ce\u901f\u6d4b\u5b9a\u3001\u538b\u5dee\u8c03\u8282<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>3.3 \u4f7f\u7528\u89c4\u8303<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u4f7f\u7528\u73af\u8282<\/th>\n<th>\u89c4\u8303\u5185\u5bb9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fd0\u884c\u98ce\u901f<\/td>\n<td>\u5355\u5411\u6d41\u7cfb\u7edf\u4e2d\u98ce\u901f\u5e94\u7ef4\u6301\u57280.36~0.54 m\/s<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u5468\u671f<\/td>\n<td>\u6839\u636e\u538b\u5dee\u53d8\u5316\u548c\u5236\u9020\u5546\u5efa\u8bae\uff0c\u4e00\u822c\u6bcf5~8\u5e74\u66f4\u6362\u4e00\u6b21<\/td>\n<\/tr>\n<tr>\n<td>\u6e05\u6d01\u7ef4\u62a4<\/td>\n<td>\u4e0d\u53ef\u6c34\u6d17\uff0c\u4ec5\u5141\u8bb8\u8868\u9762\u9664\u5c18<\/td>\n<\/tr>\n<tr>\n<td>\u76d1\u6d4b\u9891\u7387<\/td>\n<td>\u81f3\u5c11\u6bcf\u5e74\u8fdb\u884c\u4e00\u6b21\u5b8c\u6574\u6027\u6d4b\u8bd5\u4e0e\u6548\u7387\u9a8c\u8bc1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>3.4 \u63a7\u5236\u6307\u6807<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u63a7\u5236\u9879\u76ee<\/th>\n<th>\u6307\u6807\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u7c92\u5b50\u6d53\u5ea6<\/td>\n<td>\u7b26\u5408GMP\u5404\u6d01\u51c0\u7ea7\u522b\u6807\u51c6<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u6d53\u5ea6<\/td>\n<td>\u52a8\u6001\u6761\u4ef6\u4e0b\u226410 CFU\/m\u00b3\uff08A\/B\u7ea7\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u6362\u6c14\u6b21\u6570<\/td>\n<td>A\u7ea7\u533a\u57df\u226560\u6b21\/h\uff0cB\u7ea7\u226540\u6b21\/h<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u63a7\u5236<\/td>\n<td>\u76f8\u90bb\u6d01\u51c0\u533a\u4e4b\u95f4\u4fdd\u6301\u226510 Pa\u6b63\u538b\u68af\u5ea6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u56db\u3001ULPA\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u4e0e\u4f9b\u5e94\u5546\u7ba1\u7406<\/h2>\n<h3>4.1 \u9009\u578b\u539f\u5219<\/h3>\n<p>\u5728\u5236\u836f\u6d01\u51c0\u7cfb\u7edf\u4e2d\u9009\u62e9ULPA\u8fc7\u6ee4\u5668\u65f6\uff0c\u5e94\u7efc\u5408\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n<ul>\n<li><strong>\u8fc7\u6ee4\u6548\u7387\u7b49\u7ea7<\/strong>\uff1a\u4f18\u5148\u9009\u7528\u7b26\u5408EN 1822\u6807\u51c6H14\u7ea7\u4ee5\u4e0a\u7684ULPA\u6ee4\u6750\uff1b<\/li>\n<li><strong>\u7ed3\u6784\u5f62\u5f0f<\/strong>\uff1a\u5305\u62ec\u6709\u9694\u677f\u3001\u65e0\u9694\u677f\u3001\u6298\u53e0\u5f0f\u7b49\uff1b<\/li>\n<li><strong>\u8010\u6e7f\u8010\u6e29\u6027\u80fd<\/strong>\uff1a\u67d0\u4e9b\u706d\u83cc\u5de5\u827a\u4e2d\u53ef\u80fd\u6d89\u53ca\u9ad8\u6e29\u84b8\u6c7d\uff0c\u9700\u9009\u62e9\u8010\u9ad8\u6e29\u6750\u8d28\uff1b<\/li>\n<li><strong>\u914d\u5957\u98ce\u673a\u4e0e\u63a7\u5236\u7cfb\u7edf\u517c\u5bb9\u6027<\/strong>\uff1a\u786e\u4fdd\u4e0e\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u5339\u914d\u8fd0\u884c\u3002<\/li>\n<\/ul>\n<h3>4.2 \u56fd\u5185\u5916\u4e3b\u6d41\u54c1\u724c\u5bf9\u6bd4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u54c1\u724c<\/th>\n<th>\u56fd\u522b<\/th>\n<th>\u7279\u70b9<\/th>\n<th>\u5e94\u7528\u6848\u4f8b<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Camfil<\/td>\n<td>\u745e\u5178<\/td>\n<td>\u6a21\u5757\u5316\u8bbe\u8ba1\uff0c\u4f4e\u80fd\u8017<\/td>\n<td>\u4e0a\u6d77\u67d0\u5916\u8d44\u836f\u4f01<\/td>\n<\/tr>\n<tr>\n<td>Donaldson<\/td>\n<td>\u7f8e\u56fd<\/td>\n<td>\u9ad8\u6548\u4f4e\u963b\uff0c\u9002\u5408\u6d01\u51c0\u8d70\u5eca<\/td>\n<td>\u5317\u4eac\u67d0\u75ab\u82d7\u4f01\u4e1a<\/td>\n<\/tr>\n<tr>\n<td>KLC Filter<\/td>\n<td>\u4e2d\u56fd<\/td>\n<td>\u6027\u4ef7\u6bd4\u9ad8\uff0c\u672c\u5730\u670d\u52a1\u5b8c\u5584<\/td>\n<td>\u5e7f\u5dde\u767d\u4e91\u5c71\u5236\u836f<\/td>\n<\/tr>\n<tr>\n<td>Freudenberg<\/td>\n<td>\u5fb7\u56fd<\/td>\n<td>\u591a\u91cd\u8ba4\u8bc1\uff0c\u9002\u5408\u9ad8\u98ce\u9669\u533a\u57df<\/td>\n<td>\u82cf\u5dde\u4fe1\u8fbe\u751f\u7269<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u8d44\u6599\u6765\u6e90\uff1aCamfil\u5b98\u7f51\uff08<a href=\"https:\/\/www.camfil.com\uff09\u3001Donaldson\u516c\u53f8\u767d\u76ae\u4e66\uff082021\uff09\u3001KLC\">https:\/\/www.camfil.com\uff09\u3001Donaldson\u516c\u53f8\u767d\u76ae\u4e66\uff082021\uff09\u3001KLC<\/a> Filter\u4ea7\u54c1\u624b\u518c\uff082023\uff09<\/p>\n<h3>4.3 \u4f9b\u5e94\u5546\u8d44\u8d28\u5ba1\u6838\u8981\u70b9<\/h3>\n<p>\u5236\u836f\u4f01\u4e1a\u5728\u91c7\u8d2dULPA\u8fc7\u6ee4\u5668\u65f6\uff0c\u5e94\u5bf9\u4f9b\u5e94\u5546\u8fdb\u884c\u4e25\u683c\u8bc4\u4f30\uff0c\u91cd\u70b9\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u662f\u5426\u5177\u6709ISO 9001\u3001ISO 14644-1\u8ba4\u8bc1\uff1b<\/li>\n<li>\u662f\u5426\u63d0\u4f9b\u5b8c\u6574\u7684\u4ea7\u54c1\u68c0\u6d4b\u62a5\u544a\uff08\u5982MPPS\u6548\u7387\u6d4b\u8bd5\uff09\uff1b<\/li>\n<li>\u662f\u5426\u5177\u5907GMP\u76f8\u5173\u9879\u76ee\u7ecf\u9a8c\uff1b<\/li>\n<li>\u662f\u5426\u80fd\u63d0\u4f9b\u957f\u671f\u6280\u672f\u652f\u6301\u4e0e\u552e\u540e\u670d\u52a1\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e94\u3001ULPA\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u4e0e\u65e5\u5e38\u76d1\u6d4b<\/h2>\n<h3>5.1 \u9a8c\u8bc1\u6d41\u7a0b<\/h3>\n<p>ULPA\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u662fGMP\u5408\u89c4\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u901a\u5e38\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u6b65\u9aa4\uff1a<\/p>\n<ol>\n<li><strong>\u9884\u9a8c\u8bc1\u68c0\u67e5<\/strong>\uff1a\u68c0\u67e5\u5b89\u88c5\u662f\u5426\u7b26\u5408\u56fe\u7eb8\u4e0e\u89c4\u8303\uff1b<\/li>\n<li><strong>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/strong>\uff1a\u91c7\u7528PAO\/DOP\u626b\u63cf\u6cd5\u68c0\u6d4b\u662f\u5426\u5b58\u5728\u6cc4\u6f0f\uff1b<\/li>\n<li><strong>\u6548\u7387\u6d4b\u8bd5<\/strong>\uff1a\u6d4b\u91cf\u8fc7\u6ee4\u6548\u7387\u662f\u5426\u8fbe\u6807\uff1b<\/li>\n<li><strong>\u98ce\u901f\u4e0e\u538b\u5dee\u6d4b\u8bd5<\/strong>\uff1a\u786e\u4fdd\u6c14\u6d41\u5206\u5e03\u5408\u7406\uff1b<\/li>\n<li><strong>\u8bb0\u5f55\u5f52\u6863<\/strong>\uff1a\u5f62\u6210\u5b8c\u6574\u7684\u9a8c\u8bc1\u6587\u4ef6\u5e76\u5b58\u6863\u5907\u67e5\u3002<\/li>\n<\/ol>\n<h3>5.2 \u65e5\u5e38\u76d1\u6d4b\u5185\u5bb9<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u76d1\u6d4b\u9879\u76ee<\/th>\n<th>\u9891\u7387<\/th>\n<th>\u65b9\u6cd5<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u7c92\u5b50\u8ba1\u6570<\/td>\n<td>\u5b9e\u65f6\u5728\u7ebf\u76d1\u6d4b\u6216\u6bcf\u65e5\u624b\u52a8\u91c7\u6837<\/td>\n<td>\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u5668<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u91c7\u6837<\/td>\n<td>\u6bcf\u5468\u81f3\u5c11\u4e00\u6b21<\/td>\n<td>\u6c89\u964d\u83cc\u3001\u6d6e\u6e38\u83cc\u57f9\u517b<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u76d1\u6d4b<\/td>\n<td>\u6bcf\u65e5\u8bb0\u5f55<\/td>\n<td>\u6570\u5b57\u5f0f\u538b\u529b\u8ba1<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u901f\u68c0\u6d4b<\/td>\n<td>\u6bcf\u6708\u4e00\u6b21<\/td>\n<td>\u70ed\u7403\u98ce\u901f\u4eea<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u82af\u5b8c\u6574\u6027<\/td>\n<td>\u6bcf\u5e74\u4e00\u6b21<\/td>\n<td>PAO\u626b\u63cf\u6cd5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>5.3 \u6570\u636e\u8bb0\u5f55\u4e0e\u8ffd\u6eaf<\/h3>\n<p>\u6240\u6709\u76d1\u6d4b\u6570\u636e\u5e94\u5efa\u7acb\u7535\u5b50\u6863\u6848\uff0c\u5e76\u652f\u6301\u5ba1\u8ba1\u8ffd\u8e2a\u529f\u80fd\u3002\u5efa\u8bae\u4f7f\u7528LIMS\uff08\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406\u7cfb\u7edf\uff09\u6216MES\uff08\u5236\u9020\u6267\u884c\u7cfb\u7edf\uff09\u8fdb\u884c\u96c6\u4e2d\u7ba1\u7406\uff0c\u786e\u4fdd\u6570\u636e\u771f\u5b9e\u3001\u53ef\u8ffd\u6eaf\u3001\u4e0d\u53ef\u7be1\u6539\u3002<\/p>\n<hr \/>\n<h2>\u516d\u3001ULPA\u8fc7\u6ee4\u5668\u5e38\u89c1\u95ee\u9898\u4e0e\u5bf9\u7b56<\/h2>\n<h3>6.1 \u5e38\u89c1\u6545\u969c\u7c7b\u578b\u53ca\u5904\u7406\u65b9\u6cd5<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6545\u969c\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>\u98ce\u901f\u4e0b\u964d<\/td>\n<td>\u6ee4\u82af\u5835\u585e\u3001\u98ce\u673a\u8001\u5316<\/td>\n<td>\u66f4\u6362\u6ee4\u82af\u6216\u68c0\u4fee\u98ce\u673a<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u5f02\u5e38<\/td>\n<td>\u5b89\u88c5\u4e0d\u4e25\u5bc6\u3001\u5bc6\u5c01\u635f\u574f<\/td>\n<td>\u68c0\u67e5\u5bc6\u5c01\u6761\u5e76\u91cd\u65b0\u5b89\u88c5<\/td>\n<\/tr>\n<tr>\n<td>\u7c92\u5b50\u8d85\u6807<\/td>\n<td>\u6ee4\u82af\u7834\u635f\u3001\u6c14\u6d41\u7d0a\u4e71<\/td>\n<td>\u505c\u673a\u66f4\u6362\u6ee4\u82af\u5e76\u91cd\u65b0\u9a8c\u8bc1<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u8d85\u6807<\/td>\n<td>\u7cfb\u7edf\u6e05\u6d01\u4e0d\u5230\u4f4d\u3001\u56de\u98ce\u6c61\u67d3<\/td>\n<td>\u52a0\u5f3a\u6e05\u6d01\u6d88\u6bd2\uff0c\u8c03\u6574\u6c14\u6d41\u7ec4\u7ec7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>6.2 \u98ce\u9669\u63a7\u5236\u7b56\u7565<\/h3>\n<ul>\n<li><strong>\u9884\u9632\u6027\u7ef4\u62a4\u8ba1\u5212<\/strong>\uff1a\u5236\u5b9a\u5e74\u5ea6\u4fdd\u517b\u8ba1\u5212\uff0c\u5305\u62ec\u6ee4\u82af\u66f4\u6362\u3001\u7cfb\u7edf\u6e05\u6d17\u7b49\uff1b<\/li>\n<li><strong>\u5197\u4f59\u8bbe\u8ba1<\/strong>\uff1a\u5173\u952e\u533a\u57df\u8bbe\u7f6e\u5907\u7528\u8fc7\u6ee4\u5355\u5143\uff0c\u9632\u6b62\u7a81\u53d1\u5931\u6548\uff1b<\/li>\n<li><strong>\u4eba\u5458\u57f9\u8bad<\/strong>\uff1a\u5b9a\u671f\u5f00\u5c55GMP\u6cd5\u89c4\u4e0e\u64cd\u4f5c\u89c4\u7a0b\u57f9\u8bad\uff1b<\/li>\n<li><strong>\u5e94\u6025\u54cd\u5e94\u673a\u5236<\/strong>\uff1a\u5efa\u7acb\u6d01\u51c0\u533a\u5f02\u5e38\u60c5\u51b5\u7684\u5feb\u901f\u53cd\u5e94\u6d41\u7a0b\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e03\u3001\u56fd\u5185\u5916\u7814\u7a76\u4e0e\u5b9e\u8df5\u8fdb\u5c55<\/h2>\n<h3>7.1 \u56fd\u5185\u7814\u7a76\u73b0\u72b6<\/h3>\n<p>\u8fd1\u5e74\u6765\uff0c\u56fd\u5185\u5b66\u8005\u5bf9ULPA\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u9886\u57df\u7684\u5e94\u7528\u8fdb\u884c\u4e86\u5927\u91cf\u7814\u7a76\u3002\u4f8b\u5982\uff1a<\/p>\n<ul>\n<li><strong>\u674e\u6653\u5cf0\u7b49\uff082021\uff09<\/strong> \u5728\u300a\u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u6742\u5fd7\u300b\u53d1\u8868\u6587\u7ae0\u6307\u51fa\uff0cULPA\u8fc7\u6ee4\u5668\u5728\u51bb\u5e72\u8f66\u95f4\u7684\u5e94\u7528\u663e\u8457\u964d\u4f4e\u4e86\u7c92\u5b50\u4e0e\u5fae\u751f\u7269\u6c61\u67d3\u6c34\u5e73\uff1b<\/li>\n<li><strong>\u738b\u4f1f\uff082022\uff09<\/strong> \u5728\u300a\u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f\u300b\u4e2d\u63d0\u51fa\uff0cULPA+VHP\uff08\u8fc7\u6c27\u5316\u6c22\u706d\u83cc\uff09\u7ec4\u5408\u6a21\u5f0f\u53ef\u6709\u6548\u63d0\u5347\u706d\u83cc\u6548\u7387\u3002<\/li>\n<\/ul>\n<h3>7.2 \u56fd\u9645\u7814\u7a76\u8fdb\u5c55<\/h3>\n<ul>\n<li><strong>WHO Technical Report Series No. 961\uff082011\uff09<\/strong> \u63d0\u51fa\uff0cULPA\u8fc7\u6ee4\u5668\u5e94\u4f5c\u4e3a\u9ad8\u98ce\u9669\u533a\u57df\u7684\u6807\u51c6\u914d\u7f6e\uff1b<\/li>\n<li><strong>FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing\uff082023\uff09<\/strong> \u5f3a\u8c03ULPA\u8fc7\u6ee4\u5668\u5728\u65e0\u83cc\u5de5\u827a\u4e2d\u7684\u6838\u5fc3\u5730\u4f4d\uff1b<\/li>\n<li><strong>\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09<\/strong> \u5728\u5176\u6700\u65b0GMP\u9644\u5f55\u4e2d\u63a8\u8350\u91c7\u7528ULPA\u8fc7\u6ee4\u5668\u914d\u5408\u5b9e\u65f6\u76d1\u6d4b\u7cfb\u7edf\uff0c\u4ee5\u5b9e\u73b0\u8fc7\u7a0b\u63a7\u5236\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u516b\u3001\u7ed3\u8bba\uff08\u7565\uff09<\/h2>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>\n<p>\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40.\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\uff09[Z]. \u5317\u4eac\uff1a\u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e\uff0c2011.<\/p>\n<\/li>\n<li>\n<p>European Medicines Agency. Annex 1 to the EU GMP Guide \u2013 Manufacture of Sterile Medicinal Products (Draft 2020) [R]. EMA\/INS\/GMP\/153841\/2020.<\/p>\n<\/li>\n<li>\n<p>FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing &#8211; Current Good Manufacturing Practice [R]. U.S. Department of Health and Human Services, 2023.<\/p>\n<\/li>\n<li>\n<p>IEST. IEST-RP-CC001.4: Testing ULPA Filters [S]. Institute of Environmental Sciences and Technology, 2013.<\/p>\n<\/li>\n<li>\n<p>GB\/T 13554-2020 \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668[S]. \u4e2d\u56fd\u6807\u51c6\u5316\u59d4\u5458\u4f1a\uff0c2020.<\/p>\n<\/li>\n<li>\n<p>Camfil Official Website. ULPA Filter Product Catalogue [EB\/OL]. <a href=\"https:\/\/www.camfil.com\/\">https:\/\/www.camfil.com\/<\/a>, 2023.<\/p>\n<\/li>\n<li>\n<p>Donaldson Company. High-Efficiency Filtration Solutions for Cleanrooms [R]. 2021.<\/p>\n<\/li>\n<li>\n<p>\u674e\u6653\u5cf0, \u738b\u4e3d\u534e. ULPA\u8fc7\u6ee4\u5668\u5728\u51bb\u5e72\u8f66\u95f4\u4e2d\u7684\u5e94\u7528\u7814\u7a76[J]. \u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u6742\u5fd7, 2021, 52(6): 789\u2013792.<\/p>\n<\/li>\n<li>\n<p>\u738b\u4f1f. \u5236\u836f\u6d01\u51c0\u5ba4\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u7684\u4f18\u5316\u8bbe\u8ba1[J]. \u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f, 2022(4): 45\u201349.<\/p>\n<\/li>\n<li>\n<p>WHO. WHO Technical Report Series, No. 961, Annex 6: WHO good manufacturing practices for sterile pharmaceutical products [R]. Geneva: World Health Organization, 2011.<\/p>\n<\/li>\n<\/ol>\n<hr \/>\n<p><em>\u5168\u6587\u5171\u8ba1\u7ea63800\u5b57\uff0c\u6db5\u76d6ULPA\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u53c2\u6570\u3001GMP\u6807\u51c6\u8981\u6c42\u3001\u5e94\u7528\u89c4\u8303\u3001\u9009\u578b\u7ba1\u7406\u3001\u9a8c\u8bc1\u76d1\u6d4b\u53ca\u56fd\u5185\u5916\u7814\u7a76\u8fdb\u5c55\uff0c\u529b\u6c42\u4e3a\u5236\u836f\u4f01\u4e1a\u63d0\u4f9b\u5168\u9762\u7684\u53c2\u8003\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ULPA\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e0b\u7684\u4f7f\u7528\u89c4\u8303 \u5f15\u8a00 \u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u8d28\u91cf\u4e0e\u751f\u4ea7\u73af\u5883\u7684\u6d01\u51c0\u5ea6\u5bc6\u5207\u76f8\u5173\u3002\u4e3a\u4e86\u786e\u4fdd\u836f\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u5168\u7403\u5404\u56fd\u5747\u5236\u5b9a\u4e86\u4e25\u683c\u7684\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08Good Manufacturing Practice, GMP\uff09\u3002\u5728\u4e2d\u56fd\uff0c\u4f9d\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\uff0c\u5bf9\u5236\u836f\u6d01\u51c0\u5ba4\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u8981\u6c42\u6781\u4e3a\u4e25\u683c\uff1b\u800c\u5728\u56fd\u9645\u4e0a\uff0c\u5982\u7f8e&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-15718","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\/15718","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=15718"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15718\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15718"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15718"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15718"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}