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\u8fd9\u4e9b\u5e94\u7528\u5b9e\u4f8b\u5145\u5206\u5c55\u793a\u4e86\u6291\u83cc\u8fc7\u6ee4\u5668\u5728\u73b0\u4ee3\u5de5\u4e1a\u751f\u4ea7\u4e2d\u7684\u4e0d\u53ef\u6216\u7f3a\u5730\u4f4d\uff0c\u4ee5\u53ca\u5176\u5bf9\u63d0\u9ad8\u4ea7\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u6027\u7684\u91cd\u8981\u8d21\u732e\u3002<\/p>\n
\u56fd\u5185\u5916\u7814\u7a76\u73b0\u72b6\u4e0e\u53d1\u5c55\u8d8b\u52bf<\/h3>\n
\u5728\u5168\u7403\u8303\u56f4\u5185\uff0c\u6291\u83cc\u8fc7\u6ee4\u5668\u7684\u7814\u7a76\u548c\u53d1\u5c55\u6b63\u7ecf\u5386\u5feb\u901f\u53d8\u9769\u3002\u56fd\u5916\u9886\u5148\u673a\u6784\u5982\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u548c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u5df2\u5236\u5b9a\u4e86\u4e25\u683c\u7684\u89c4\u8303\uff0c\u63a8\u52a8\u4e86\u6291\u83cc\u8fc7\u6ee4\u5668\u6280\u672f\u7684\u8fdb\u6b65\u3002\u4f8b\u5982\uff0c\u5fb7\u56fd\u5f17\u52b3\u6069\u970d\u592b\u7814\u7a76\u6240\u5f00\u53d1\u4e86\u4e00\u79cd\u65b0\u578b\u7eb3\u7c73\u7ea4\u7ef4\u8fc7\u6ee4\u6750\u6599\uff0c\u5176\u8fc7\u6ee4\u6548\u7387\u9ad8\u8fbe99.99%\uff0c\u5e76\u5177\u5907\u51fa\u8272\u7684\u6297\u83cc\u6027\u80fd\u3002\u6b64\u5916\uff0c\u65e5\u672c\u7684\u4e00\u4e9b\u516c\u53f8\u6b63\u5728\u63a2\u7d22\u5c06\u5149\u50ac\u5316\u6280\u672f\u5e94\u7528\u4e8e\u8fc7\u6ee4\u5668\u4e2d\uff0c\u5229\u7528\u7d2b\u5916\u7ebf\u6fc0\u6d3b\u4e8c\u6c27\u5316\u949b\u6d82\u5c42\u8fdb\u884c\u6301\u7eed\u6740\u83cc\u3002<\/p>\n
\u5728\u56fd\u5185\uff0c\u6e05\u534e\u5927\u5b66\u548c\u6d59\u6c5f\u5927\u5b66\u7b49\u9ad8\u6821\u5f00\u5c55\u4e86\u591a\u9879\u5173\u4e8e\u6291\u83cc\u8fc7\u6ee4\u5668\u7684\u57fa\u7840\u7814\u7a76\uff0c\u5176\u4e2d\u6e05\u534e\u5927\u5b66\u7814\u53d1\u7684\u590d\u5408\u578b\u8fc7\u6ee4\u819c\u5df2\u5728\u591a\u5bb6\u4f01\u4e1a\u4e2d\u5f97\u5230\u5e94\u7528\u3002\u636e\u300a\u4e2d\u56fd\u79d1\u5b66\u62a5\u300b\u62a5\u9053\uff0c\u8be5\u6280\u672f\u7ed3\u5408\u4e86\u9759\u7535\u5438\u9644\u548c\u5316\u5b66\u6740\u83cc\u53cc\u91cd\u673a\u5236\uff0c\u663e\u8457\u63d0\u5347\u4e86\u8fc7\u6ee4\u5668\u7684\u8010\u7528\u6027\u548c\u6297\u83cc\u6548\u679c\u3002\u540c\u65f6\uff0c\u4e2d\u79d1\u9662\u4e0a\u6d77\u7845\u9178\u76d0\u7814\u7a76\u6240\u4e5f\u5728\u79ef\u6781\u5f00\u53d1\u65b0\u578b\u9676\u74f7\u57fa\u8fc7\u6ee4\u6750\u6599\uff0c\u4ee5\u6ee1\u8db3\u9ad8\u6e29\u9ad8\u538b\u73af\u5883\u4e0b\u7684\u7279\u6b8a\u9700\u6c42\u3002<\/p>\n
\u4ece\u6280\u672f\u53d1\u5c55\u8d8b\u52bf\u6765\u770b\uff0c\u667a\u80fd\u5316\u548c\u591a\u529f\u80fd\u5316\u6210\u4e3a\u4e3b\u6d41\u65b9\u5411\u3002\u8d8a\u6765\u8d8a\u591a\u7684\u7814\u7a76\u96c6\u4e2d\u5728\u5982\u4f55\u901a\u8fc7\u7269\u8054\u7f51\u6280\u672f\u5b9e\u73b0\u8fc7\u6ee4\u5668\u7684\u5b9e\u65f6\u76d1\u63a7\u548c\u8fdc\u7a0b\u7ba1\u7406\uff0c\u8fd9\u4e0d\u4ec5\u63d0\u9ad8\u4e86\u8bbe\u5907\u8fd0\u884c\u7684\u900f\u660e\u5ea6\uff0c\u8fd8\u964d\u4f4e\u4e86\u7ef4\u62a4\u6210\u672c\u3002\u4f8b\u5982\uff0c\u7f8e\u56fd\u4e00\u5bb6\u521d\u521b\u516c\u53f8\u63a8\u51fa\u7684\u667a\u80fd\u8fc7\u6ee4\u5668\u914d\u5907\u4e86\u4f20\u611f\u5668\u9635\u5217\uff0c\u53ef\u4ee5\u81ea\u52a8\u68c0\u6d4b\u8fc7\u6ee4\u6548\u7387\u5e76\u9884\u8b66\u66f4\u6362\u65f6\u95f4\u70b9\u3002<\/p>\n
\u6b64\u5916\uff0c\u73af\u4fdd\u53ef\u6301\u7eed\u6027\u4e5f\u6210\u4e3a\u7814\u7a76\u70ed\u70b9\u3002\u56fd\u5916\u5b66\u8005\u63d0\u51fa\u4e86\u4f7f\u7528\u53ef\u964d\u89e3\u6750\u6599\u5236\u4f5c\u8fc7\u6ee4\u5668\u7684\u53ef\u80fd\u6027\uff0c\u4ee5\u51cf\u5c11\u5851\u6599\u5e9f\u5f03\u7269\u5bf9\u73af\u5883\u7684\u5f71\u54cd\u3002\u4e0e\u6b64\u540c\u65f6\uff0c\u56fd\u5185\u79d1\u7814\u56e2\u961f\u6b63\u5728\u63a2\u7d22\u5982\u4f55\u56de\u6536\u5e9f\u5f03\u8fc7\u6ee4\u5668\u4e2d\u7684\u8d35\u91d1\u5c5e\u6210\u5206\uff0c\u5982\u94f6\u79bb\u5b50\uff0c\u4ece\u800c\u5b9e\u73b0\u8d44\u6e90\u7684\u5faa\u73af\u5229\u7528\u3002<\/p>\n
\u4ee5\u4e0b\u8868\u683c\u6c47\u603b\u4e86\u56fd\u5185\u5916\u90e8\u5206\u4ee3\u8868\u6027\u7814\u7a76\u6210\u679c\u53ca\u5176\u4e3b\u8981\u7279\u70b9\uff1a<\/p>\n\n\n\n\n\n\n\n\n
\u7814\u7a76\u5355\u4f4d\/\u673a\u6784<\/th>\n \u6280\u672f\u4eae\u70b9<\/th>\n \u5e94\u7528\u9886\u57df<\/th>\n \u53d1\u8868\u5e74\u4efd<\/th>\n<\/tr>\n<\/thead>\n
\u5fb7\u56fd\u5f17\u52b3\u6069\u970d\u592b\u7814\u7a76\u6240<\/td>\n \u65b0\u578b\u7eb3\u7c73\u7ea4\u7ef4\u6750\u6599<\/td>\n \u533b\u836f\u3001\u98df\u54c1<\/td>\n 2021<\/td>\n<\/tr>\n
\u65e5\u672c\u4e1c\u4e3d\u516c\u53f8<\/td>\n \u5149\u50ac\u5316\u6740\u83cc\u6280\u672f<\/td>\n \u5de5\u4e1a\u51c0\u5316<\/td>\n 2020<\/td>\n<\/tr>\n
\u6e05\u534e\u5927\u5b66<\/td>\n \u590d\u5408\u578b\u9759\u7535\u5438\u9644\u819c<\/td>\n \u533b\u836f\u3001\u98df\u54c1<\/td>\n 2019<\/td>\n<\/tr>\n
\u4e2d\u79d1\u9662\u4e0a\u6d77\u7845\u9178\u76d0\u7814\u7a76\u6240<\/td>\n \u9ad8\u6e29\u9676\u74f7\u57fa\u8fc7\u6ee4\u5668<\/td>\n \u5316\u5de5\u3001\u80fd\u6e90<\/td>\n 2022<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\u8fd9\u4e9b\u7814\u7a76\u8fdb\u5c55\u8868\u660e\uff0c\u65e0\u8bba\u662f\u6280\u672f\u521b\u65b0\u8fd8\u662f\u5e94\u7528\u62d3\u5c55\uff0c\u6291\u83cc\u8fc7\u6ee4\u5668\u9886\u57df\u90fd\u5c55\u73b0\u51fa\u5de8\u5927\u7684\u53d1\u5c55\u6f5c\u529b\u548c\u5e7f\u9614\u7684\u5e94\u7528\u524d\u666f\u3002<\/p>\n
\u6291\u83cc\u8fc7\u6ee4\u5668\u7684\u9009\u62e9\u6807\u51c6\u53ca\u4f18\u5316\u5efa\u8bae<\/h3>\n
\u9009\u62e9\u5408\u9002\u7684\u6291\u83cc\u8fc7\u6ee4\u5668\u5bf9\u4e8e\u786e\u4fdd\u65e0\u83cc\u5305\u88c5\u5de5\u827a\u7684\u6210\u529f\u81f3\u5173\u91cd\u8981\u3002\u4ee5\u4e0b\u662f\u51e0\u4e2a\u5173\u952e\u7684\u9009\u62e9\u6807\u51c6\u53ca\u76f8\u5e94\u7684\u4f18\u5316\u5efa\u8bae\uff1a<\/p>\n
\n
\n
\u8fc7\u6ee4\u6548\u7387<\/strong>\uff1a\u8fd9\u662f\u8861\u91cf\u8fc7\u6ee4\u5668\u6027\u80fd\u7684\u9996\u8981\u6307\u6807\u3002\u6839\u636e\u5e94\u7528\u573a\u5408\u7684\u4e0d\u540c\uff0c\u6240\u9700\u8fc7\u6ee4\u6548\u7387\u4e5f\u4f1a\u6709\u6240\u53d8\u5316\u3002\u4f8b\u5982\uff0c\u5728\u533b\u836f\u5236\u9020\u4e2d\uff0c\u901a\u5e38\u9700\u8981\u8fbe\u523099.99%\u4ee5\u4e0a\u7684\u8fc7\u6ee4\u6548\u7387\u3002\u4e3a\u4e86\u4f18\u5316\u8fd9\u4e00\u6807\u51c6\uff0c\u5efa\u8bae\u5b9a\u671f\u6d4b\u8bd5\u8fc7\u6ee4\u5668\u7684\u5b9e\u9645\u6548\u7387\uff0c\u5e76\u4f9d\u636e\u6d4b\u8bd5\u7ed3\u679c\u8c03\u6574\u6216\u66f4\u6362\u8fc7\u6ee4\u5668\u3002<\/p>\n<\/li>\n
\n
\u538b\u529b\u635f\u5931<\/strong>\uff1a\u8fc7\u9ad8\u7684\u538b\u529b\u635f\u5931\u4f1a\u589e\u52a0\u80fd\u8017\uff0c\u5f71\u54cd\u7cfb\u7edf\u7684\u6574\u4f53\u6548\u7387\u3002\u9009\u62e9\u65f6\u5e94\u8003\u8651\u8fc7\u6ee4\u5668\u5728\u9884\u671f\u4f7f\u7528\u5bff\u547d\u5185\u7684\u5e73\u5747\u538b\u529b\u635f\u5931\u503c\u3002\u4f18\u5316\u7b56\u7565\u5305\u62ec\u9009\u7528\u4f4e\u963b\u529b\u6750\u6599\u548c\u6280\u672f\uff0c\u4ee5\u53ca\u5b9a\u671f\u6e05\u6d01\u8fc7\u6ee4\u5668\u4ee5\u4fdd\u6301\u5176\u4f73\u6027\u80fd\u3002<\/p>\n<\/li>\n
\n
\u4f7f\u7528\u5bff\u547d<\/strong>\uff1a\u8003\u8651\u5230\u66f4\u6362\u6210\u672c\u548c\u64cd\u4f5c\u4e2d\u65ad\uff0c\u9009\u62e9\u5177\u6709\u8f83\u957f\u4f7f\u7528\u5bff\u547d\u7684\u8fc7\u6ee4\u5668\u662f\u975e\u5e38\u7ecf\u6d4e\u7684\u3002\u53ef\u4ee5\u901a\u8fc7\u6539\u5584\u8fc7\u6ee4\u5668\u7684\u8bbe\u8ba1\u548c\u6750\u6599\u6765\u5ef6\u957f\u5176\u4f7f\u7528\u5bff\u547d\uff0c\u6bd4\u5982\u4f7f\u7528\u8010\u8150\u8680\u6216\u6297\u8001\u5316\u7684\u6750\u6599\u3002<\/p>\n<\/li>\n
\n
\u517c\u5bb9\u6027<\/strong>\uff1a\u786e\u4fdd\u6240\u9009\u8fc7\u6ee4\u5668\u4e0e\u5176\u4ed6\u7cfb\u7edf\u7ec4\u4ef6\u517c\u5bb9\u4e5f\u662f\u5173\u952e\u3002\u8fd9\u6d89\u53ca\u5230\u7269\u7406\u5c3a\u5bf8\u3001\u8fde\u63a5\u63a5\u53e3\u4ee5\u53ca\u7535\u6c14\u517c\u5bb9\u6027\u7b49\u65b9\u9762\u3002\u4f18\u5316\u65b9\u6cd5\u5305\u62ec\u8fdb\u884c\u8be6\u7ec6\u7684\u524d\u671f\u89c4\u5212\u548c\u6a21\u62df\u6d4b\u8bd5\uff0c\u786e\u4fdd\u6240\u6709\u7ec4\u4ef6\u534f\u540c\u5de5\u4f5c\u3002<\/p>\n<\/li>\n
\n
\u7ef4\u62a4\u4fbf\u6377\u6027<\/strong>\uff1a\u6613\u4e8e\u7ef4\u62a4\u7684\u8fc7\u6ee4\u5668\u53ef\u4ee5\u51cf\u5c11\u505c\u673a\u65f6\u95f4\u548c\u7ef4\u62a4\u6210\u672c\u3002\u4e3a\u6b64\uff0c\u5efa\u8bae\u9009\u62e9\u90a3\u4e9b\u8bbe\u8ba1\u4e0a\u4fbf\u4e8e\u62c6\u5378\u548c\u6e05\u6d17\u7684\u4ea7\u54c1\uff0c\u5e76\u4e14\u63d0\u4f9b\u8be6\u5c3d\u7684\u64cd\u4f5c\u6307\u5357\u548c\u57f9\u8bad\u3002<\/p>\n<\/li>\n<\/ol>\n
\u7efc\u4e0a\u6240\u8ff0\uff0c\u901a\u8fc7\u7efc\u5408\u8003\u8651\u4e0a\u8ff0\u56e0\u7d20\u5e76\u91c7\u53d6\u9002\u5f53\u7684\u4f18\u5316\u63aa\u65bd\uff0c\u53ef\u4ee5\u5927\u5927\u63d0\u9ad8\u6291\u83cc\u8fc7\u6ee4\u5668\u5728\u65e0\u83cc\u5305\u88c5\u5de5\u827a\u4e2d\u7684\u8868\u73b0\u548c\u6548\u7387\u3002\u4ee5\u4e0b\u8868\u683c\u603b\u7ed3\u4e86\u8fd9\u4e9b\u9009\u62e9\u6807\u51c6\u53ca\u5176\u5bf9\u5e94\u7684\u4f18\u5316\u5efa\u8bae\uff1a<\/p>\n\n\n\n\n\n\n\n\n\n
\u6807\u51c6<\/th>\n \u4f18\u5316\u5efa\u8bae<\/th>\n<\/tr>\n<\/thead>\n
\u8fc7\u6ee4\u6548\u7387<\/td>\n \u5b9a\u671f\u6d4b\u8bd5\u548c\u8c03\u6574<\/td>\n<\/tr>\n
\u538b\u529b\u635f\u5931<\/td>\n \u4f7f\u7528\u4f4e\u963b\u529b\u6280\u672f\u548c\u6750\u6599<\/td>\n<\/tr>\n
\u4f7f\u7528\u5bff\u547d<\/td>\n \u6539\u5584\u8bbe\u8ba1\u548c\u6750\u6599<\/td>\n<\/tr>\n
\u517c\u5bb9\u6027<\/td>\n \u8be6\u7ec6\u89c4\u5212\u548c\u6a21\u62df\u6d4b\u8bd5<\/td>\n<\/tr>\n
\u7ef4\u62a4\u4fbf\u6377\u6027<\/td>\n \u8bbe\u8ba1\u6613\u4e8e\u62c6\u5378\u548c\u6e05\u6d17\u7684\u4ea7\u54c1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\u901a\u8fc7\u8fd9\u6837\u7684\u6807\u51c6\u5316\u9009\u62e9\u548c\u4f18\u5316\u6d41\u7a0b\uff0c\u4f01\u4e1a\u53ef\u4ee5\u5728\u4fdd\u8bc1\u4ea7\u54c1\u8d28\u91cf\u7684\u540c\u65f6\uff0c\u5927\u5316\u6295\u8d44\u56de\u62a5\u3002<\/p>\n
\u6291\u83cc\u8fc7\u6ee4\u5668\u5bf9\u65e0\u83cc\u5305\u88c5\u5de5\u827a\u6548\u7387\u7684\u5f71\u54cd\u5206\u6790<\/h3>\n
\u6291\u83cc\u8fc7\u6ee4\u5668\u5728\u65e0\u83cc\u5305\u88c5\u5de5\u827a\u4e2d\u8d77\u5230\u81f3\u5173\u91cd\u8981\u7684\u4f5c\u7528\uff0c\u5176\u6027\u80fd\u76f4\u63a5\u5f71\u54cd\u6574\u4e2a\u5de5\u827a\u7684\u6548\u7387\u548c\u8d28\u91cf\u3002\u901a\u8fc7\u5f15\u5165\u5148\u8fdb\u7684\u6291\u83cc\u8fc7\u6ee4\u5668\u6280\u672f\uff0c\u4f01\u4e1a\u53ef\u4ee5\u663e\u8457\u63d0\u9ad8\u751f\u4ea7\u6548\u7387\uff0c\u964d\u4f4e\u6210\u672c\uff0c\u5e76\u589e\u5f3a\u4ea7\u54c1\u7684\u5e02\u573a\u7ade\u4e89\u529b\u3002\u4f8b\u5982\uff0c\u67d0\u56fd\u9645\u77e5\u540d\u98df\u54c1\u516c\u53f8\u5728\u5176\u751f\u4ea7\u7ebf\u4e2d\u5f15\u5165\u4e86\u65b0\u4e00\u4ee3\u7684\u9ad8\u6548\u6291\u83cc\u8fc7\u6ee4\u5668\u540e\uff0c\u53d1\u73b0\u5176\u751f\u4ea7\u7ebf\u7684\u505c\u673a\u65f6\u95f4\u51cf\u5c11\u4e8630%\uff0c\u4ea7\u54c1\u5408\u683c\u7387\u63d0\u5347\u4e8615%\u3002<\/p>\n
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\u6848\u4f8b<\/th>\n \u6548\u7387\u63d0\u5347<\/th>\n \u6210\u672c\u8282\u7ea6<\/th>\n \u5408\u89c4\u6027\u63d0\u5347<\/th>\n<\/tr>\n<\/thead>\n
\u98df\u54c1\u5382A<\/td>\n 20%<\/td>\n 15%<\/td>\n \u7b26\u5408FDA\u6807\u51c6<\/td>\n<\/tr>\n
\u5236\u836f\u5382B<\/td>\n 18%<\/td>\n 12%<\/td>\n \u8fbe\u5230GMP\u8981\u6c42<\/td>\n<\/tr>\n
\u5316\u5de5\u5382C<\/td>\n 25%<\/td>\n 20%<\/td>\n \u6ee1\u8db3ISO\u89c4\u8303<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
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\u53c2\u8003\u6587\u732e\u6765\u6e90<\/h3>\n
\n
\u5f17\u52b3\u6069\u970d\u592b\u7814\u7a76\u6240 (Fraunhofer Institute)\uff0c"Nanofiber Materials for Air Filtration," 2021.<\/li>\n
\u4e1c\u4e3d\u516c\u53f8 (Toray Industries)\uff0c"Photocatalytic Sterilization Technology in Industrial Purification Systems," 2020.<\/li>\n
\u6e05\u534e\u5927\u5b66\uff0c\u201c\u590d\u5408\u578b\u9759\u7535\u5438\u9644\u819c\u7684\u7814\u53d1\u4e0e\u5e94\u7528\u201d\uff0c\u300a\u4e2d\u56fd\u79d1\u5b66\u62a5\u300b\uff0c2019\u5e74\u3002<\/li>\n
\u4e2d\u79d1\u9662\u4e0a\u6d77\u7845\u9178\u76d0\u7814\u7a76\u6240\uff0c\u201c\u9ad8\u6e29\u9676\u74f7\u57fa\u8fc7\u6ee4\u5668\u7684\u7814\u7a76\u8fdb\u5c55\u201d\uff0c\u300a\u65b0\u6750\u6599\u6742\u5fd7\u300b\uff0c2022\u5e74\u3002<\/li>\n
\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA)\uff0c"Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing\u2014Current Good Manufacturing Practice," 2017.<\/li>\n
\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA)\uff0c"Annex 1: Manufacture of Sterile Medicinal Products," 2020.<\/li>\n
ISO\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7\uff0c"ISO 14644 Cleanrooms and associated controlled environments," 2015.<\/li>\n
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