\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u5408\u89c4\u6027\u63a2\u8ba8<\/h1>\n

\u5f15\u8a00<\/h2>\n

\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u8fc7\u6ee4\u6280\u672f\u662f\u786e\u4fdd\u836f\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u7684\u5173\u952e\u73af\u8282\u4e4b\u4e00\u3002\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u56e0\u5176\u9ad8\u6548\u3001\u8010\u7528\u548c\u6613\u4e8e\u64cd\u4f5c\u7684\u7279\u70b9\uff0c\u88ab\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u751f\u4ea7\u7684\u5404\u4e2a\u9636\u6bb5\u3002\u7136\u800c\uff0c\u968f\u7740\u5236\u836f\u884c\u4e1a\u5bf9\u4ea7\u54c1\u8d28\u91cf\u548c\u5408\u89c4\u6027\u8981\u6c42\u7684\u4e0d\u65ad\u63d0\u9ad8\uff0c\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7684\u5408\u89c4\u6027\u95ee\u9898\u4e5f\u65e5\u76ca\u53d7\u5230\u5173\u6ce8\u3002\u672c\u6587\u5c06\u6df1\u5165\u63a2\u8ba8\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u5408\u89c4\u6027\uff0c\u6db5\u76d6\u4ea7\u54c1\u53c2\u6570\u3001\u5e94\u7528\u573a\u666f\u3001\u5408\u89c4\u6027\u8981\u6c42\u4ee5\u53ca\u56fd\u5185\u5916\u76f8\u5173\u6587\u732e\u7684\u5f15\u7528\u3002<\/p>\n

\u4e00\u3001\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7684\u57fa\u672c\u6982\u5ff5\u4e0e\u4ea7\u54c1\u53c2\u6570<\/h2>\n

1.1 \u57fa\u672c\u6982\u5ff5<\/h3>\n

\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u662f\u4e00\u79cd\u9ad8\u6548\u8fc7\u6ee4\u8bbe\u5907\uff0c\u901a\u5e38\u7531\u805a\u4e19\u70ef\u3001\u805a\u919a\u781c\uff08PES\uff09\u3001\u805a\u504f\u6c1f\u4e59\u70ef\uff08PVDF\uff09\u7b49\u6750\u6599\u5236\u6210\u3002\u5176\u7ed3\u6784\u7279\u70b9\u662f\u901a\u8fc7\u6298\u53e0\u65b9\u5f0f\u589e\u52a0\u8fc7\u6ee4\u9762\u79ef\uff0c\u4ece\u800c\u63d0\u9ad8\u8fc7\u6ee4\u6548\u7387\u548c\u5904\u7406\u80fd\u529b\u3002\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u3001\u98df\u54c1\u3001\u5316\u5de5\u7b49\u884c\u4e1a\uff0c\u5c24\u5176\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u7528\u4e8e\u53bb\u9664\u6db2\u4f53\u4e2d\u7684\u5fae\u7c92\u3001\u7ec6\u83cc\u548c\u5176\u4ed6\u6c61\u67d3\u7269\u3002<\/p>\n

1.2 \u4ea7\u54c1\u53c2\u6570<\/h3>\n

\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7684\u4ea7\u54c1\u53c2\u6570\u4e3b\u8981\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n\n\n\n\n\n\n\n\n\n\n\n

\u53c2\u6570\u540d\u79f0<\/th>\n	\u53c2\u6570\u8303\u56f4<\/th>\n	\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n
\u8fc7\u6ee4\u7cbe\u5ea6<\/td>\n	0.1 \u00b5m – 10 \u00b5m<\/td>\n	\u6839\u636e\u5e94\u7528\u9700\u6c42\u9009\u62e9\u4e0d\u540c\u7684\u8fc7\u6ee4\u7cbe\u5ea6<\/td>\n<\/tr>\n
\u8fc7\u6ee4\u9762\u79ef<\/td>\n	0.5 m\u00b2 – 2.5 m\u00b2<\/td>\n	\u6298\u53e0\u7ed3\u6784\u8bbe\u8ba1\uff0c\u589e\u52a0\u8fc7\u6ee4\u9762\u79ef<\/td>\n<\/tr>\n
\u6d41\u91cf<\/td>\n	10 L\/min – 1000 L\/min<\/td>\n	\u5927\u6d41\u91cf\u8bbe\u8ba1\uff0c\u9002\u7528\u4e8e\u9ad8\u6d41\u91cf\u5e94\u7528<\/td>\n<\/tr>\n
\u6750\u8d28<\/td>\n	\u805a\u4e19\u70ef\u3001PES\u3001PVDF\u7b49<\/td>\n	\u4e0d\u540c\u6750\u8d28\u9002\u7528\u4e8e\u4e0d\u540c\u7684\u5316\u5b66\u73af\u5883<\/td>\n<\/tr>\n
\u8010\u538b\u80fd\u529b<\/td>\n	0.5 bar – 10 bar<\/td>\n	\u6839\u636e\u5e94\u7528\u573a\u666f\u9009\u62e9\u4e0d\u540c\u7684\u8010\u538b\u80fd\u529b<\/td>\n<\/tr>\n
\u8010\u6e29\u8303\u56f4<\/td>\n	-20\u00b0C – 120\u00b0C<\/td>\n	\u6839\u636e\u5e94\u7528\u73af\u5883\u9009\u62e9\u4e0d\u540c\u7684\u8010\u6e29\u8303\u56f4<\/td>\n<\/tr>\n
\u4f7f\u7528\u5bff\u547d<\/td>\n	3\u4e2a\u6708 – 12\u4e2a\u6708<\/td>\n	\u6839\u636e\u4f7f\u7528\u9891\u7387\u548c\u8fc7\u6ee4\u4ecb\u8d28\u51b3\u5b9a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n \u4e8c\u3001\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u5e94\u7528\u573a\u666f<\/h2>\n 2.1 \u539f\u6599\u836f\u751f\u4ea7<\/h3>\n \u5728\u539f\u6599\u836f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7528\u4e8e\u53bb\u9664\u539f\u6599\u6db2\u4e2d\u7684\u5fae\u7c92\u548c\u5fae\u751f\u7269\uff0c\u786e\u4fdd\u539f\u6599\u836f\u7684\u7eaf\u5ea6\u548c\u5b89\u5168\u6027\u3002\u4f8b\u5982\uff0c\u5728\u6297\u751f\u7d20\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u4f7f\u7528\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u53ef\u4ee5\u6709\u6548\u53bb\u9664\u53d1\u9175\u6db2\u4e2d\u7684\u83cc\u4f53\u548c\u6742\u8d28\uff0c\u63d0\u9ad8\u4ea7\u54c1\u7684\u7eaf\u5ea6\u548c\u6536\u7387\u3002<\/p>\n 2.2 \u6ce8\u5c04\u5242\u751f\u4ea7<\/h3>\n \u6ce8\u5c04\u5242\u5bf9\u65e0\u83cc\u8981\u6c42\u6781\u9ad8\uff0c\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u6ce8\u5c04\u5242\u751f\u4ea7\u4e2d\u4e3b\u8981\u7528\u4e8e\u53bb\u9664\u836f\u6db2\u4e2d\u7684\u5fae\u7c92\u548c\u7ec6\u83cc\u3002\u4f8b\u5982\uff0c\u5728\u6ce8\u5c04\u7528\u6c34\uff08WFI\uff09\u7684\u5236\u5907\u8fc7\u7a0b\u4e2d\uff0c\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7528\u4e8e\u53bb\u9664\u6c34\u4e2d\u7684\u5fae\u7c92\u548c\u7ec6\u83cc\uff0c\u786e\u4fdd\u6ce8\u5c04\u7528\u6c34\u7684\u65e0\u83cc\u6027\u3002<\/p>\n 2.3 \u751f\u7269\u5236\u836f<\/h3>\n \u5728\u751f\u7269\u5236\u836f\u9886\u57df\uff0c\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7528\u4e8e\u53bb\u9664\u7ec6\u80de\u57f9\u517b\u6db2\u4e2d\u7684\u7ec6\u80de\u788e\u7247\u3001\u86cb\u767d\u8d28\u805a\u96c6\u4f53\u7b49\u6742\u8d28\u3002\u4f8b\u5982\uff0c\u5728\u5355\u514b\u9686\u6297\u4f53\u751f\u4ea7\u4e2d\uff0c\u4f7f\u7528\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u53ef\u4ee5\u6709\u6548\u53bb\u9664\u7ec6\u80de\u57f9\u517b\u6db2\u4e2d\u7684\u7ec6\u80de\u788e\u7247\u548c\u86cb\u767d\u8d28\u805a\u96c6\u4f53\uff0c\u63d0\u9ad8\u4ea7\u54c1\u7684\u7eaf\u5ea6\u548c\u6536\u7387\u3002<\/p>\n 2.4 \u5236\u836f\u5e9f\u6c34\u5904\u7406<\/h3>\n \u5236\u836f\u5e9f\u6c34\u542b\u6709\u5927\u91cf\u7684\u6709\u673a\u7269\u548c\u5fae\u751f\u7269\uff0c\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7528\u4e8e\u53bb\u9664\u5e9f\u6c34\u4e2d\u7684\u60ac\u6d6e\u7269\u548c\u5fae\u751f\u7269\uff0c\u786e\u4fdd\u5e9f\u6c34\u6392\u653e\u7b26\u5408\u73af\u4fdd\u8981\u6c42\u3002\u4f8b\u5982\uff0c\u5728\u6297\u751f\u7d20\u5e9f\u6c34\u5904\u7406\u4e2d\uff0c\u4f7f\u7528\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u53ef\u4ee5\u6709\u6548\u53bb\u9664\u5e9f\u6c34\u4e2d\u7684\u6297\u751f\u7d20\u6b8b\u7559\u548c\u5fae\u751f\u7269\uff0c\u964d\u4f4e\u5e9f\u6c34\u5bf9\u73af\u5883\u7684\u6c61\u67d3\u3002<\/p>\n \u4e09\u3001\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7684\u5408\u89c4\u6027\u8981\u6c42<\/h2>\n 3.1 \u56fd\u9645\u6cd5\u89c4\u8981\u6c42<\/h3>\n 3.1.1 \u7f8e\u56fdFDA\u8981\u6c42<\/h4>\n \u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5bf9\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u8fc7\u6ee4\u8bbe\u5907\u6709\u4e25\u683c\u7684\u5408\u89c4\u6027\u8981\u6c42\u3002\u6839\u636eFDA\u7684\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08cGMP\uff09\uff0c\u8fc7\u6ee4\u8bbe\u5907\u5fc5\u987b\u7ecf\u8fc7\u9a8c\u8bc1\uff0c\u786e\u4fdd\u5176\u80fd\u591f\u6709\u6548\u53bb\u9664\u5fae\u7c92\u548c\u5fae\u751f\u7269\u3002\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u4f7f\u7528\u524d\u5fc5\u987b\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u8fc7\u6ee4\u6027\u80fd\u7b26\u5408\u8981\u6c42\u3002<\/p>\n 3.1.2 \u6b27\u76dfGMP\u8981\u6c42<\/h4>\n \u6b27\u76df\u7684\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u4e5f\u5bf9\u8fc7\u6ee4\u8bbe\u5907\u6709\u4e25\u683c\u7684\u5408\u89c4\u6027\u8981\u6c42\u3002\u6839\u636e\u6b27\u76dfGMP\uff0c\u8fc7\u6ee4\u8bbe\u5907\u5fc5\u987b\u7ecf\u8fc7\u9a8c\u8bc1\uff0c\u786e\u4fdd\u5176\u80fd\u591f\u6709\u6548\u53bb\u9664\u5fae\u7c92\u548c\u5fae\u751f\u7269\u3002\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u4f7f\u7528\u524d\u5fc5\u987b\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u8fc7\u6ee4\u6027\u80fd\u7b26\u5408\u8981\u6c42\u3002<\/p>\n 3.2 \u56fd\u5185\u6cd5\u89c4\u8981\u6c42<\/h3>\n 3.2.1 \u4e2d\u56fdGMP\u8981\u6c42<\/h4>\n \u4e2d\u56fd\u7684\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u5bf9\u8fc7\u6ee4\u8bbe\u5907\u6709\u4e25\u683c\u7684\u5408\u89c4\u6027\u8981\u6c42\u3002\u6839\u636e\u4e2d\u56fdGMP\uff0c\u8fc7\u6ee4\u8bbe\u5907\u5fc5\u987b\u7ecf\u8fc7\u9a8c\u8bc1\uff0c\u786e\u4fdd\u5176\u80fd\u591f\u6709\u6548\u53bb\u9664\u5fae\u7c92\u548c\u5fae\u751f\u7269\u3002\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u4f7f\u7528\u524d\u5fc5\u987b\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u8fc7\u6ee4\u6027\u80fd\u7b26\u5408\u8981\u6c42\u3002<\/p>\n 3.2.2 \u4e2d\u56fd\u836f\u5178\u8981\u6c42<\/h4>\n \u4e2d\u56fd\u836f\u5178\u5bf9\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u8fc7\u6ee4\u8bbe\u5907\u6709\u4e25\u683c\u7684\u5408\u89c4\u6027\u8981\u6c42\u3002\u6839\u636e\u4e2d\u56fd\u836f\u5178\uff0c\u8fc7\u6ee4\u8bbe\u5907\u5fc5\u987b\u7ecf\u8fc7\u9a8c\u8bc1\uff0c\u786e\u4fdd\u5176\u80fd\u591f\u6709\u6548\u53bb\u9664\u5fae\u7c92\u548c\u5fae\u751f\u7269\u3002\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u4f7f\u7528\u524d\u5fc5\u987b\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u8fc7\u6ee4\u6027\u80fd\u7b26\u5408\u8981\u6c42\u3002<\/p>\n 3.3 \u5408\u89c4\u6027\u9a8c\u8bc1<\/h3>\n 3.3.1 \u5b8c\u6574\u6027\u6d4b\u8bd5<\/h4>\n \u5b8c\u6574\u6027\u6d4b\u8bd5\u662f\u9a8c\u8bc1\u8fc7\u6ee4\u8bbe\u5907\u6027\u80fd\u7684\u91cd\u8981\u624b\u6bb5\u3002\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u4f7f\u7528\u524d\u5fc5\u987b\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u8fc7\u6ee4\u6027\u80fd\u7b26\u5408\u8981\u6c42\u3002\u5e38\u7528\u7684\u5b8c\u6574\u6027\u6d4b\u8bd5\u65b9\u6cd5\u5305\u62ec\u6c14\u6ce1\u70b9\u6d4b\u8bd5\u3001\u6269\u6563\u6d41\u6d4b\u8bd5\u548c\u538b\u529b\u4fdd\u6301\u6d4b\u8bd5\u3002<\/p>\n 3.3.2 \u5fae\u751f\u7269\u6311\u6218\u6d4b\u8bd5<\/h4>\n \u5fae\u751f\u7269\u6311\u6218\u6d4b\u8bd5\u662f\u9a8c\u8bc1\u8fc7\u6ee4\u8bbe\u5907\u53bb\u9664\u5fae\u751f\u7269\u80fd\u529b\u7684\u91cd\u8981\u624b\u6bb5\u3002\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u4f7f\u7528\u524d\u5fc5\u987b\u8fdb\u884c\u5fae\u751f\u7269\u6311\u6218\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u80fd\u591f\u6709\u6548\u53bb\u9664\u5fae\u751f\u7269\u3002\u5e38\u7528\u7684\u5fae\u751f\u7269\u6311\u6218\u6d4b\u8bd5\u65b9\u6cd5\u5305\u62ec\u7ec6\u83cc\u6311\u6218\u6d4b\u8bd5\u548c\u75c5\u6bd2\u6311\u6218\u6d4b\u8bd5\u3002<\/p>\n 3.3.3 \u5316\u5b66\u517c\u5bb9\u6027\u6d4b\u8bd5<\/h4>\n \u5316\u5b66\u517c\u5bb9\u6027\u6d4b\u8bd5\u662f\u9a8c\u8bc1\u8fc7\u6ee4\u8bbe\u5907\u6750\u6599\u4e0e\u8fc7\u6ee4\u4ecb\u8d28\u76f8\u5bb9\u6027\u7684\u91cd\u8981\u624b\u6bb5\u3002\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u4f7f\u7528\u524d\u5fc5\u987b\u8fdb\u884c\u5316\u5b66\u517c\u5bb9\u6027\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u6750\u6599\u4e0e\u8fc7\u6ee4\u4ecb\u8d28\u76f8\u5bb9\u3002\u5e38\u7528\u7684\u5316\u5b66\u517c\u5bb9\u6027\u6d4b\u8bd5\u65b9\u6cd5\u5305\u62ec\u6d78\u6ce1\u6d4b\u8bd5\u548c\u6d41\u52a8\u6d4b\u8bd5\u3002<\/p>\n \u56db\u3001\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7684\u5408\u89c4\u6027\u6848\u4f8b\u5206\u6790<\/h2>\n 4.1 \u6848\u4f8b\u4e00\uff1a\u67d0\u5236\u836f\u516c\u53f8\u539f\u6599\u836f\u751f\u4ea7\u4e2d\u7684\u5408\u89c4\u6027\u5e94\u7528<\/h3>\n \u67d0\u5236\u836f\u516c\u53f8\u5728\u539f\u6599\u836f\u751f\u4ea7\u4e2d\u4f7f\u7528\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u53bb\u9664\u539f\u6599\u6db2\u4e2d\u7684\u5fae\u7c92\u548c\u5fae\u751f\u7269\u3002\u5728\u4f7f\u7528\u524d\uff0c\u8be5\u516c\u53f8\u5bf9\u6ee4\u82af\u8fdb\u884c\u4e86\u5b8c\u6574\u6027\u6d4b\u8bd5\u3001\u5fae\u751f\u7269\u6311\u6218\u6d4b\u8bd5\u548c\u5316\u5b66\u517c\u5bb9\u6027\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u8fc7\u6ee4\u6027\u80fd\u7b26\u5408\u8981\u6c42\u3002\u901a\u8fc7\u4f7f\u7528\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\uff0c\u8be5\u516c\u53f8\u6210\u529f\u63d0\u9ad8\u4e86\u539f\u6599\u836f\u7684\u7eaf\u5ea6\u548c\u6536\u7387\uff0c\u786e\u4fdd\u4e86\u4ea7\u54c1\u7684\u8d28\u91cf\u548c\u5b89\u5168\u3002<\/p>\n 4.2 \u6848\u4f8b\u4e8c\uff1a\u67d0\u751f\u7269\u5236\u836f\u516c\u53f8\u5355\u514b\u9686\u6297\u4f53\u751f\u4ea7\u4e2d\u7684\u5408\u89c4\u6027\u5e94\u7528<\/h3>\n \u67d0\u751f\u7269\u5236\u836f\u516c\u53f8\u5728\u5355\u514b\u9686\u6297\u4f53\u751f\u4ea7\u4e2d\u4f7f\u7528\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u53bb\u9664\u7ec6\u80de\u57f9\u517b\u6db2\u4e2d\u7684\u7ec6\u80de\u788e\u7247\u548c\u86cb\u767d\u8d28\u805a\u96c6\u4f53\u3002\u5728\u4f7f\u7528\u524d\uff0c\u8be5\u516c\u53f8\u5bf9\u6ee4\u82af\u8fdb\u884c\u4e86\u5b8c\u6574\u6027\u6d4b\u8bd5\u3001\u5fae\u751f\u7269\u6311\u6218\u6d4b\u8bd5\u548c\u5316\u5b66\u517c\u5bb9\u6027\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u8fc7\u6ee4\u6027\u80fd\u7b26\u5408\u8981\u6c42\u3002\u901a\u8fc7\u4f7f\u7528\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\uff0c\u8be5\u516c\u53f8\u6210\u529f\u63d0\u9ad8\u4e86\u5355\u514b\u9686\u6297\u4f53\u7684\u7eaf\u5ea6\u548c\u6536\u7387\uff0c\u786e\u4fdd\u4e86\u4ea7\u54c1\u7684\u8d28\u91cf\u548c\u5b89\u5168\u3002<\/p>\n 4.3 \u6848\u4f8b\u4e09\uff1a\u67d0\u5236\u836f\u516c\u53f8\u6ce8\u5c04\u5242\u751f\u4ea7\u4e2d\u7684\u5408\u89c4\u6027\u5e94\u7528<\/h3>\n \u67d0\u5236\u836f\u516c\u53f8\u5728\u6ce8\u5c04\u5242\u751f\u4ea7\u4e2d\u4f7f\u7528\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u53bb\u9664\u836f\u6db2\u4e2d\u7684\u5fae\u7c92\u548c\u7ec6\u83cc\u3002\u5728\u4f7f\u7528\u524d\uff0c\u8be5\u516c\u53f8\u5bf9\u6ee4\u82af\u8fdb\u884c\u4e86\u5b8c\u6574\u6027\u6d4b\u8bd5\u3001\u5fae\u751f\u7269\u6311\u6218\u6d4b\u8bd5\u548c\u5316\u5b66\u517c\u5bb9\u6027\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u8fc7\u6ee4\u6027\u80fd\u7b26\u5408\u8981\u6c42\u3002\u901a\u8fc7\u4f7f\u7528\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\uff0c\u8be5\u516c\u53f8\u6210\u529f\u786e\u4fdd\u4e86\u6ce8\u5c04\u5242\u7684\u65e0\u83cc\u6027\uff0c\u786e\u4fdd\u4e86\u4ea7\u54c1\u7684\u8d28\u91cf\u548c\u5b89\u5168\u3002<\/p>\n \u4e94\u3001\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7684\u5408\u89c4\u6027\u6311\u6218\u4e0e\u89e3\u51b3\u65b9\u6848<\/h2>\n 5.1 \u6311\u6218\u4e00\uff1a\u8fc7\u6ee4\u7cbe\u5ea6\u4e0e\u6d41\u91cf\u7684\u5e73\u8861<\/h3>\n \u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u63d0\u9ad8\u6d41\u91cf\u7684\u540c\u65f6\uff0c\u53ef\u80fd\u4f1a\u5f71\u54cd\u8fc7\u6ee4\u7cbe\u5ea6\u3002\u4e3a\u89e3\u51b3\u8fd9\u4e00\u95ee\u9898\uff0c\u5236\u836f\u4f01\u4e1a\u53ef\u4ee5\u901a\u8fc7\u4f18\u5316\u6ee4\u82af\u7684\u6298\u53e0\u7ed3\u6784\u548c\u6750\u6599\u9009\u62e9\uff0c\u5b9e\u73b0\u8fc7\u6ee4\u7cbe\u5ea6\u4e0e\u6d41\u91cf\u7684\u5e73\u8861\u3002<\/p>\n 5.2 \u6311\u6218\u4e8c\uff1a\u5316\u5b66\u517c\u5bb9\u6027\u95ee\u9898<\/h3>\n \u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7684\u6750\u6599\u4e0e\u8fc7\u6ee4\u4ecb\u8d28\u7684\u5316\u5b66\u517c\u5bb9\u6027\u662f\u5f71\u54cd\u5176\u5408\u89c4\u6027\u7684\u91cd\u8981\u56e0\u7d20\u3002\u4e3a\u89e3\u51b3\u8fd9\u4e00\u95ee\u9898\uff0c\u5236\u836f\u4f01\u4e1a\u53ef\u4ee5\u901a\u8fc7\u5316\u5b66\u517c\u5bb9\u6027\u6d4b\u8bd5\uff0c\u9009\u62e9\u5408\u9002\u7684\u6ee4\u82af\u6750\u6599\uff0c\u786e\u4fdd\u5176\u4e0e\u8fc7\u6ee4\u4ecb\u8d28\u76f8\u5bb9\u3002<\/p>\n 5.3 \u6311\u6218\u4e09\uff1a\u5fae\u751f\u7269\u53bb\u9664\u6548\u679c<\/h3>\n \u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u7684\u5fae\u751f\u7269\u53bb\u9664\u6548\u679c\u662f\u5f71\u54cd\u5176\u5408\u89c4\u6027\u7684\u91cd\u8981\u56e0\u7d20\u3002\u4e3a\u89e3\u51b3\u8fd9\u4e00\u95ee\u9898\uff0c\u5236\u836f\u4f01\u4e1a\u53ef\u4ee5\u901a\u8fc7\u5fae\u751f\u7269\u6311\u6218\u6d4b\u8bd5\uff0c\u9a8c\u8bc1\u6ee4\u82af\u7684\u5fae\u751f\u7269\u53bb\u9664\u6548\u679c\uff0c\u786e\u4fdd\u5176\u7b26\u5408\u8981\u6c42\u3002<\/p>\n \u516d\u3001\u56fd\u5185\u5916\u76f8\u5173\u6587\u732e\u5f15\u7528<\/h2>\n 6.1 \u56fd\u5916\u6587\u732e<\/h3>\n \n \n PDA Technical Report No. 26<\/strong>: "Sterilizing Filtration of Liquids" – This report provides guidelines for the validation of sterilizing filtration processes, including integrity testing and microbial challenge testing.<\/p>\n<\/li>\n \n FDA Guidance for Industry<\/strong>: "Sterile Drug Products Produced by Aseptic Processing \u2014 Current Good Manufacturing Practice" – This guidance document outlines the regulatory requirements for sterile drug products, including the use of filtration devices.<\/p>\n<\/li>\n \n European Pharmacopoeia (Ph. Eur.)<\/strong>: "Sterilisation by Filtration" – This section of the European Pharmacopoeia provides standards and guidelines for the use of filtration in sterilization processes.<\/p>\n<\/li>\n<\/ol>\n 6.2 \u56fd\u5185\u6587\u732e<\/h3>\n \n \n \u4e2d\u56fd\u836f\u5178\uff082020\u5e74\u7248\uff09<\/strong>: "\u65e0\u83cc\u68c0\u67e5\u6cd5" – \u8be5\u90e8\u5206\u8be6\u7ec6\u89c4\u5b9a\u4e86\u65e0\u83cc\u68c0\u67e5\u7684\u65b9\u6cd5\u548c\u8981\u6c42\uff0c\u5305\u62ec\u8fc7\u6ee4\u8bbe\u5907\u7684\u4f7f\u7528\u548c\u9a8c\u8bc1\u3002<\/p>\n<\/li>\n \n \u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08GMP\uff09<\/strong>: "\u8fc7\u6ee4\u8bbe\u5907\u7684\u9a8c\u8bc1" – \u8be5\u90e8\u5206\u8be6\u7ec6\u89c4\u5b9a\u4e86\u8fc7\u6ee4\u8bbe\u5907\u7684\u9a8c\u8bc1\u8981\u6c42\uff0c\u5305\u62ec\u5b8c\u6574\u6027\u6d4b\u8bd5\u548c\u5fae\u751f\u7269\u6311\u6218\u6d4b\u8bd5\u3002<\/p>\n<\/li>\n \n \u5236\u836f\u5de5\u4e1a\u6c34\u5904\u7406\u6280\u672f<\/strong>: "\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u5236\u836f\u5e9f\u6c34\u5904\u7406\u4e2d\u7684\u5e94\u7528" – \u8be5\u6587\u732e\u8be6\u7ec6\u63a2\u8ba8\u4e86\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u5236\u836f\u5e9f\u6c34\u5904\u7406\u4e2d\u7684\u5e94\u7528\u548c\u5408\u89c4\u6027\u8981\u6c42\u3002<\/p>\n<\/li>\n<\/ol>\n \u53c2\u8003\u6587\u732e<\/h2>\n \n PDA Technical Report No. 26: Sterilizing Filtration of Liquids. Parenteral Drug Association, 2008.<\/li>\n FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing \u2014 Current Good Manufacturing Practice. U.S. Food and Drug Administration, 2004.<\/li>\n European Pharmacopoeia (Ph. Eur.): Sterilisation by Filtration. European Directorate for the Quality of Medicines & HealthCare, 2020.<\/li>\n \u4e2d\u56fd\u836f\u5178\uff082020\u5e74\u7248\uff09: \u65e0\u83cc\u68c0\u67e5\u6cd5. \u4e2d\u56fd\u836f\u5178\u59d4\u5458\u4f1a, 2020.<\/li>\n \u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08GMP\uff09: \u8fc7\u6ee4\u8bbe\u5907\u7684\u9a8c\u8bc1. \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40, 2010.<\/li>\n \u5236\u836f\u5de5\u4e1a\u6c34\u5904\u7406\u6280\u672f: \u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u5236\u836f\u5e9f\u6c34\u5904\u7406\u4e2d\u7684\u5e94\u7528. \u5316\u5b66\u5de5\u4e1a\u51fa\u7248\u793e, 2015.<\/li>\n<\/ol>\n \n \u901a\u8fc7\u4ee5\u4e0a\u63a2\u8ba8\uff0c\u6211\u4eec\u53ef\u4ee5\u770b\u5230\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u5408\u89c4\u6027\u662f\u4e00\u4e2a\u590d\u6742\u800c\u91cd\u8981\u7684\u8bfe\u9898\u3002\u53ea\u6709\u901a\u8fc7\u4e25\u683c\u7684\u9a8c\u8bc1\u548c\u6d4b\u8bd5\uff0c\u786e\u4fdd\u6ee4\u82af\u7684\u6027\u80fd\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\uff0c\u624d\u80fd\u6709\u6548\u4fdd\u969c\u836f\u54c1\u7684\u8d28\u91cf\u548c\u5b89\u5168\u3002\u5e0c\u671b\u672c\u6587\u7684\u63a2\u8ba8\u80fd\u591f\u4e3a\u5236\u836f\u4f01\u4e1a\u5728\u9009\u62e9\u548c\u4f7f\u7528\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u65f6\u63d0\u4f9b\u6709\u76ca\u7684\u53c2\u8003\u548c\u6307\u5bfc\u3002<\/p>\n \u6269\u5c55\u9605\u8bfb\uff1ahttps:\/\/www.china-fire-retardant.com\/post\/9373.html<\/a> \u6269\u5c55\u9605\u8bfb\uff1ahttps:\/\/www.alltextile.cn\/product\/product-13-157.html<\/a> \u6269\u5c55\u9605\u8bfb\uff1ahttps:\/\/www.alltextile.cn\/product\/product-48-945.html<\/a> \u6269\u5c55\u9605\u8bfb\uff1ahttps:\/\/www.alltextile.cn\/product\/product-46-543.html<\/a> \u6269\u5c55\u9605\u8bfb\uff1ahttps:\/\/www.alltextile.cn\/product\/product-54-687.html<\/a> \u6269\u5c55\u9605\u8bfb\uff1ahttps:\/\/www.alltextile.cn\/product\/product-35-757.html<\/a> \u6269\u5c55\u9605\u8bfb\uff1ahttps:\/\/www.brandfabric.net\/full-dull-dobby-2-5-layer-lamination-fabric\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" \u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u5728\u5236\u836f\u884c\u4e1a\u4e2d\u7684\u5408\u89c4\u6027\u63a2\u8ba8 \u5f15\u8a00 \u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u8fc7\u6ee4\u6280\u672f\u662f\u786e\u4fdd\u836f\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u7684\u5173\u952e\u73af\u8282\u4e4b\u4e00\u3002\u5927\u6d41\u91cf\u6298\u53e0\u6ee4\u82af\u56e0\u5176\u9ad8\u6548\u3001\u8010\u7528\u548c\u6613\u4e8e\u64cd… <\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[35],"_links":{"self":[{"href":"http:\/\/www.huaxingsi.com\/wp-json\/wp\/v2\/posts\/4460"}],"collection":[{"href":"http:\/\/www.huaxingsi.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.huaxingsi.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.huaxingsi.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.huaxingsi.com\/wp-json\/wp\/v2\/comments?post=4460"}],"version-history":[{"count":0,"href":"http:\/\/www.huaxingsi.com\/wp-json\/wp\/v2\/posts\/4460\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.huaxingsi.com\/wp-json\/wp\/v2\/media?parent=4460"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.huaxingsi.com\/wp-json\/wp\/v2\/categories?post=4460"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.huaxingsi.com\/wp-json\/wp\/v2\/tags?post=4460"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}