{"id":15836,"date":"2025-06-27T14:08:14","date_gmt":"2025-06-27T06:08:14","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15836"},"modified":"2025-06-27T14:08:14","modified_gmt":"2025-06-27T06:08:14","slug":"%e6%9d%bf%e5%bc%8f%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%e7%8e%af%e5%a2%83%e4%b8%ad%e7%9a%84%e9%85%8d%e7%bd%ae%e6%96%b9","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15836","title":{"rendered":"\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u914d\u7f6e\u65b9\u6848"},"content":{"rendered":"

\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u91cd\u8981\u6027<\/h3>\n

\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u751f\u4ea7\u8fc7\u7a0b\u5bf9\u73af\u5883\u6d01\u51c0\u5ea6\u7684\u8981\u6c42\u6781\u4e3a\u4e25\u683c\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u7684\u76f8\u5173\u89c4\u5b9a\uff0c\u4e0d\u540c\u7ea7\u522b\u7684\u6d01\u51c0\u533a\u9700\u8981\u91c7\u7528\u76f8\u5e94\u7684\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\uff0c\u4ee5\u786e\u4fdd\u751f\u4ea7\u73af\u5883\u7b26\u5408\u6807\u51c6\u8981\u6c42\u3002\u5176\u4e2d\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u5728\u7ef4\u6301\u6d01\u51c0\u5ba4\u7a7a\u6c14\u8d28\u91cf\u3001\u9632\u6b62\u5fae\u7c92\u6c61\u67d3\u548c\u5fae\u751f\u7269\u6c61\u67d3\u65b9\u9762\u53d1\u6325\u7740\u5173\u952e\u4f5c\u7528\u3002 <\/p>\n

\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u5e38\u91c7\u7528\u73bb\u7483\u7ea4\u7ef4\u6216\u5408\u6210\u6750\u6599\u4f5c\u4e3a\u6ee4\u6750\uff0c\u5177\u6709\u8f83\u9ad8\u7684\u8fc7\u6ee4\u6548\u7387\uff0c\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u7684\u60ac\u6d6e\u9897\u7c92\u7269\uff0c\u5305\u62ec0.3\u5fae\u7c73\u53ca\u4ee5\u4e0a\u7684\u5fae\u7c92\u3002\u5176\u7ed3\u6784\u7d27\u51d1\u3001\u5b89\u88c5\u4fbf\u6377\uff0c\u5e76\u4e14\u9002\u7528\u4e8e\u591a\u79cd\u901a\u98ce\u7cfb\u7edf\uff0c\u4f7f\u5176\u6210\u4e3a\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u8bbe\u5907\u3002\u5728GMP\u6d01\u51c0\u73af\u5883\u4e2d\uff0c\u8be5\u7c7b\u8fc7\u6ee4\u5668\u5e7f\u6cdb\u5e94\u7528\u4e8e\u751f\u7269\u5b89\u5168\u67dc\u3001\u5c42\u6d41\u7f69\u3001\u7a7a\u8c03\u673a\u7ec4\u4ee5\u53ca\u9001\u98ce\u7cfb\u7edf\u7b49\u5173\u952e\u73af\u8282\uff0c\u786e\u4fdd\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4e0d\u4f1a\u53d7\u5230\u7a7a\u6c14\u6c61\u67d3\u7684\u5f71\u54cd\u3002 <\/p>\n

\u6b64\u5916\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u8fd8\u5177\u5907\u8f83\u957f\u7684\u4f7f\u7528\u5bff\u547d\u548c\u8f83\u4f4e\u7684\u8fd0\u884c\u6210\u672c\uff0c\u80fd\u591f\u5728\u4fdd\u8bc1\u9ad8\u6548\u8fc7\u6ee4\u7684\u540c\u65f6\u964d\u4f4e\u80fd\u8017\u3002\u5bf9\u4e8e\u5236\u836f\u4f01\u4e1a\u800c\u8a00\uff0c\u9009\u62e9\u5408\u9002\u7684\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e0d\u4ec5\u53ef\u4ee5\u63d0\u5347\u6d01\u51c0\u5ba4\u7684\u6574\u4f53\u6027\u80fd\uff0c\u8fd8\u80fd\u6709\u6548\u51cf\u5c11\u7ef4\u62a4\u548c\u66f4\u6362\u9891\u7387\uff0c\u4ece\u800c\u63d0\u9ad8\u751f\u4ea7\u6548\u7387\u5e76\u964d\u4f4e\u8fd0\u8425\u6210\u672c\u3002\u56e0\u6b64\uff0c\u6df1\u5165\u7814\u7a76\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u7279\u6027\u53ca\u5176\u5728\u5236\u836fGMP\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u5e94\u7528\uff0c\u5bf9\u4e8e\u4f18\u5316\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u3001\u63d0\u5347\u836f\u54c1\u8d28\u91cf\u63a7\u5236\u6c34\u5e73\u5177\u6709\u91cd\u8981\u610f\u4e49\u3002<\/p>\n

\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6838\u5fc3\u53c2\u6570\u4e0e\u9009\u578b\u4f9d\u636e<\/h3>\n

\u5728\u5236\u836f\u884c\u4e1a\u7684GMP\u6d01\u51c0\u73af\u5883\u4e2d\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u76f4\u63a5\u5f71\u54cd\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u6574\u4f53\u6548\u679c\u3002\u4e3a\u4e86\u786e\u4fdd\u6d01\u51c0\u5ba4\u8fbe\u5230\u89c4\u5b9a\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\uff0c\u5fc5\u987b\u6df1\u5165\u4e86\u89e3\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5173\u952e\u6280\u672f\u53c2\u6570\uff0c\u5e76\u7ed3\u5408\u5b9e\u9645\u9700\u6c42\u8fdb\u884c\u5408\u7406\u9009\u578b\u3002\u4ee5\u4e0b\u5c06\u8be6\u7ec6\u4ecb\u7ecd\u5176\u4e3b\u8981\u6280\u672f\u53c2\u6570\uff0c\u5e76\u63d0\u4f9b\u9009\u578b\u5efa\u8bae\u3002 <\/p>\n

1. \u8fc7\u6ee4\u6548\u7387<\/h4>\n

\u8fc7\u6ee4\u6548\u7387\u662f\u8861\u91cf\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u6027\u80fd\u7684\u6838\u5fc3\u6307\u6807\u4e4b\u4e00\u3002\u6839\u636e\u56fd\u9645\u6807\u51c6ISO 29463-1:2017\uff0c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u7684\u8fc7\u6ee4\u6548\u7387\u5206\u4e3aH10\u81f3U17\u7b49\u591a\u4e2a\u7b49\u7ea7\uff0c\u5176\u4e2dH13\u7ea7\u53ca\u4ee5\u4e0a\u8fc7\u6ee4\u5668\u7684\u8fc7\u6ee4\u6548\u7387\u53ef\u8fbe99.95%\u4ee5\u4e0a\uff0c\u9002\u7528\u4e8eISO 14644-1\u6807\u51c6\u4e2d\u7684ISO 5\u7ea7\uff08Class 100\uff09\u6d01\u51c0\u5ba4\u3002\u5236\u836f\u884c\u4e1a\u901a\u5e38\u8981\u6c42\u4f7f\u7528H13\u6216H14\u7ea7\u8fc7\u6ee4\u5668\uff0c\u4ee5\u786e\u4fdd\u7a7a\u6c14\u4e2d\u7684\u5fae\u7c92\u88ab\u6709\u6548\u53bb\u9664\u3002 <\/p>\n\n\n\n\n\n\n\n\n\n
\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/th>\n\u8fc7\u6ee4\u6548\u7387\uff080.3 \u00b5m\uff09<\/th>\n\u5e94\u7528\u573a\u666f\u793a\u4f8b<\/th>\n<\/tr>\n<\/thead>\n
H10<\/td>\n\u226585%<\/td>\n\u521d\u6548\u9884\u8fc7\u6ee4<\/td>\n<\/tr>\n
H11<\/td>\n\u226595%<\/td>\n\u4e2d\u6548\u8fc7\u6ee4<\/td>\n<\/tr>\n
H12<\/td>\n\u226599.5%<\/td>\n\u9ad8\u6548\u524d\u7ea7\u8fc7\u6ee4<\/td>\n<\/tr>\n
H13<\/td>\n\u226599.95%<\/td>\n\u6d01\u51c0\u5ba4\u4e3b\u8fc7\u6ee4<\/td>\n<\/tr>\n
H14<\/td>\n\u226599.995%<\/td>\n\u9ad8\u7ea7\u522b\u6d01\u51c0\u5ba4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

2. \u521d\u59cb\u963b\u529b\u4e0e\u7ec8\u963b\u529b<\/h4>\n

\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u521d\u59cb\u963b\u529b\u662f\u6307\u65b0\u8fc7\u6ee4\u5668\u5728\u989d\u5b9a\u98ce\u91cf\u4e0b\u7684\u538b\u964d\uff0c\u901a\u5e38\u4e3a150~250 Pa\uff0c\u800c\u7ec8\u963b\u529b\u5219\u662f\u8fc7\u6ee4\u5668\u8fbe\u5230\u66f4\u6362\u6807\u51c6\u65f6\u7684\u6700\u5927\u5141\u8bb8\u538b\u964d\uff0c\u4e00\u822c\u8bbe\u5b9a\u5728250~400 Pa\u4e4b\u95f4\u3002\u8fc7\u9ad8\u7684\u963b\u529b\u4f1a\u589e\u52a0\u98ce\u673a\u8d1f\u8377\uff0c\u5bfc\u81f4\u80fd\u8017\u4e0a\u5347\uff0c\u56e0\u6b64\u5728\u9009\u578b\u65f6\u5e94\u7efc\u5408\u8003\u8651\u8fc7\u6ee4\u5668\u7684\u963b\u529b\u8303\u56f4\uff0c\u4ee5\u4f18\u5316\u7cfb\u7edf\u80fd\u6548\u3002 <\/p>\n

3. \u98ce\u91cf\u4e0e\u9762\u901f<\/h4>\n

\u98ce\u91cf\u51b3\u5b9a\u4e86\u8fc7\u6ee4\u5668\u5904\u7406\u7a7a\u6c14\u7684\u80fd\u529b\uff0c\u901a\u5e38\u4ee5\u7acb\u65b9\u7c73\u6bcf\u5c0f\u65f6\uff08m\u00b3\/h\uff09\u8868\u793a\u3002\u9762\u901f\u5219\u6307\u7a7a\u6c14\u901a\u8fc7\u8fc7\u6ee4\u5668\u8868\u9762\u7684\u901f\u5ea6\uff0c\u4e00\u822c\u63a7\u5236\u57282.5 m\/s\u4ee5\u5185\uff0c\u4ee5\u786e\u4fdd\u6700\u4f73\u8fc7\u6ee4\u6548\u679c\u5e76\u51cf\u5c11\u7a7f\u900f\u7387\u3002\u4e0d\u540c\u89c4\u683c\u7684\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u53ef\u9002\u914d\u4e0d\u540c\u7684\u98ce\u91cf\u9700\u6c42\uff0c\u4f8b\u5982\uff1a <\/p>\n\n\n\n\n\n\n\n
\u8fc7\u6ee4\u5668\u5c3a\u5bf8\uff08mm\uff09<\/th>\n\u63a8\u8350\u98ce\u91cf\u8303\u56f4\uff08m\u00b3\/h\uff09<\/th>\n\u5e38\u89c1\u9002\u7528\u573a\u6240<\/th>\n<\/tr>\n<\/thead>\n
484\u00d7484\u00d796<\/td>\n1000\u20131500<\/td>\n\u5c42\u6d41\u7f69\u3001FFU\u5355\u5143<\/td>\n<\/tr>\n
610\u00d7610\u00d796<\/td>\n1500\u20132500<\/td>\n\u751f\u7269\u5b89\u5168\u67dc\u3001\u6d01\u51c0\u5ba4\u9001\u98ce\u7cfb\u7edf<\/td>\n<\/tr>\n
610\u00d7915\u00d796<\/td>\n2500\u20134000<\/td>\n\u5927\u578bHVAC\u7cfb\u7edf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

4. \u4f7f\u7528\u5bff\u547d\u4e0e\u5bb9\u5c18\u91cf<\/h4>\n

\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u4f7f\u7528\u5bff\u547d\u53d7\u8fdb\u98ce\u7a7a\u6c14\u8d28\u91cf\u3001\u8fd0\u884c\u65f6\u95f4\u53ca\u7ef4\u62a4\u7ba1\u7406\u7b49\u56e0\u7d20\u5f71\u54cd\uff0c\u901a\u5e38\u5728\u6b63\u5e38\u5de5\u51b5\u4e0b\u53ef\u6301\u7eed\u4f7f\u75281~3\u5e74\u3002\u5bb9\u5c18\u91cf\u662f\u5f71\u54cd\u4f7f\u7528\u5bff\u547d\u7684\u91cd\u8981\u56e0\u7d20\uff0c\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u5bb9\u5c18\u91cf\u8d8a\u9ad8\uff0c\u8fc7\u6ee4\u5668\u7684\u66f4\u6362\u5468\u671f\u8d8a\u957f\u3002\u5236\u836f\u4f01\u4e1a\u5e94\u5b9a\u671f\u76d1\u6d4b\u8fc7\u6ee4\u5668\u538b\u5dee\u53d8\u5316\uff0c\u5e76\u6309\u7167GMP\u8981\u6c42\u5efa\u7acb\u5408\u7406\u7684\u66f4\u6362\u8ba1\u5212\u3002 <\/p>\n

5. \u7ed3\u6784\u6750\u6599\u4e0e\u5bc6\u5c01\u6027\u80fd<\/h4>\n

\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6846\u67b6\u901a\u5e38\u91c7\u7528\u9540\u950c\u94a2\u677f\u3001\u4e0d\u9508\u94a2\u6216\u94dd\u5408\u91d1\u6750\u8d28\uff0c\u4ee5\u589e\u5f3a\u8010\u8150\u8680\u6027\u548c\u673a\u68b0\u5f3a\u5ea6\u3002\u6ee4\u6599\u591a\u4e3a\u73bb\u7483\u7ea4\u7ef4\u6216\u5408\u6210\u7ea4\u7ef4\uff0c\u5177\u6709\u826f\u597d\u7684\u5316\u5b66\u7a33\u5b9a\u6027\u548c\u6297\u6e7f\u6027\u3002\u5bc6\u5c01\u6027\u80fd\u662f\u786e\u4fdd\u8fc7\u6ee4\u5668\u4e0d\u53d1\u751f\u6cc4\u6f0f\u7684\u5173\u952e\uff0c\u5e38\u7528\u5bc6\u5c01\u65b9\u5f0f\u5305\u62ec\u805a\u6c28\u916f\u53d1\u6ce1\u5bc6\u5c01\u548c\u6a61\u80f6\u6761\u5bc6\u5c01\uff0c\u5236\u836f\u4f01\u4e1a\u5e94\u4f18\u5148\u9009\u62e9\u5e26\u6709DOP\u68c0\u6d4b\u5408\u683c\u62a5\u544a\u7684\u4ea7\u54c1\uff0c\u4ee5\u786e\u4fdd\u5bc6\u5c01\u5b8c\u6574\u6027\u3002 <\/p>\n

6. \u9009\u578b\u5efa\u8bae<\/h4>\n

\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u73af\u5883\u4e2d\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u5e94\u9075\u5faa\u4ee5\u4e0b\u539f\u5219\uff1a <\/p>\n

    \n
  • \u5339\u914d\u6d01\u51c0\u5ea6\u7b49\u7ea7<\/strong>\uff1a\u6839\u636eISO 14644-1\u6807\u51c6\uff0c\u9009\u62e9\u7b26\u5408\u76f8\u5e94\u6d01\u51c0\u7ea7\u522b\u7684\u8fc7\u6ee4\u5668\uff0c\u5982H13\u7ea7\u7528\u4e8eISO 7\u7ea7\uff08Class 10,000\uff09\u6d01\u51c0\u5ba4\uff0cH14\u7ea7\u7528\u4e8eISO 5\u7ea7\uff08Class 100\uff09\u6d01\u51c0\u5ba4\u3002 <\/li>\n
  • \u4f18\u5316\u98ce\u91cf\u4e0e\u963b\u529b\u5e73\u8861<\/strong>\uff1a\u9009\u62e9\u9002\u5f53\u98ce\u91cf\u8303\u56f4\u7684\u8fc7\u6ee4\u5668\uff0c\u4ee5\u964d\u4f4e\u7cfb\u7edf\u80fd\u8017\u5e76\u5ef6\u957f\u4f7f\u7528\u5bff\u547d\u3002 <\/li>\n
  • \u5173\u6ce8\u5bc6\u5c01\u6027\u80fd<\/strong>\uff1a\u4f18\u5148\u9009\u7528\u5e26\u6709\u5b8c\u6574\u5bc6\u5c01\u7ed3\u6784\u548cDOP\u6d4b\u8bd5\u62a5\u544a\u7684\u4ea7\u54c1\uff0c\u4ee5\u786e\u4fdd\u8fc7\u6ee4\u7cfb\u7edf\u7684\u5b8c\u6574\u6027\u3002 <\/li>\n
  • \u8003\u8651\u7ef4\u62a4\u4fbf\u5229\u6027<\/strong>\uff1a\u9009\u62e9\u6613\u4e8e\u5b89\u88c5\u548c\u66f4\u6362\u7684\u677f\u5f0f\u8bbe\u8ba1\uff0c\u4fbf\u4e8e\u5b9a\u671f\u7ef4\u62a4\u548c\u6e05\u6d01\u3002 <\/li>\n<\/ul>\n

    \u7efc\u4e0a\u6240\u8ff0\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u53c2\u6570\u76f4\u63a5\u5f71\u54cd\u5176\u5728\u5236\u836fGMP\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u5e94\u7528\u6548\u679c\u3002\u5408\u7406\u9009\u578b\u4e0d\u4ec5\u6709\u52a9\u4e8e\u63d0\u5347\u7a7a\u6c14\u51c0\u5316\u6548\u7387\uff0c\u8fd8\u80fd\u4f18\u5316\u8fd0\u884c\u6210\u672c\uff0c\u63d0\u9ad8\u5236\u836f\u4f01\u4e1a\u7684\u751f\u4ea7\u5b89\u5168\u6027\u4e0e\u5408\u89c4\u6027\u3002<\/p>\n

    \u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836fGMP\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u5178\u578b\u5e94\u7528\u573a\u666f<\/h3>\n

    \u5728\u5236\u836f\u884c\u4e1a\u7684GMP\u6d01\u51c0\u73af\u5883\u4e2d\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5404\u7c7b\u5173\u952e\u533a\u57df\uff0c\u4ee5\u786e\u4fdd\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b26\u5408\u76f8\u5173\u6807\u51c6\u3002\u5176\u4e3b\u8981\u5e94\u7528\u573a\u666f\u5305\u62ec\u6d01\u51c0\u5ba4\u9001\u98ce\u7cfb\u7edf\u3001\u751f\u7269\u5b89\u5168\u67dc\u3001\u5c42\u6d41\u7f69\u4ee5\u53ca\u7a7a\u8c03\u51c0\u5316\u673a\u7ec4\u7b49\u3002\u4e0d\u540c\u5e94\u7528\u573a\u666f\u5bf9\u7a7a\u6c14\u8fc7\u6ee4\u7684\u8981\u6c42\u5404\u4e0d\u76f8\u540c\uff0c\u56e0\u6b64\u9700\u6839\u636e\u5177\u4f53\u9700\u6c42\u9009\u62e9\u5408\u9002\u7684\u8fc7\u6ee4\u65b9\u6848\u3002\u4ee5\u4e0b\u662f\u51e0\u79cd\u5178\u578b\u7684\u914d\u7f6e\u65b9\u6848\u53ca\u5176\u5728\u5236\u836f\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u5e94\u7528\u60c5\u51b5\u3002 <\/p>\n

    1. \u6d01\u51c0\u5ba4\u9001\u98ce\u7cfb\u7edf\u4e2d\u7684\u5e94\u7528<\/h4>\n

    \u6d01\u51c0\u5ba4\u9001\u98ce\u7cfb\u7edf\u662f\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u73af\u5883\u7684\u6838\u5fc3\u90e8\u5206\uff0c\u5176\u4e3b\u8981\u529f\u80fd\u662f\u901a\u8fc7\u9ad8\u6548\u8fc7\u6ee4\u5668\u53bb\u9664\u7a7a\u6c14\u4e2d\u7684\u60ac\u6d6e\u9897\u7c92\uff0c\u786e\u4fdd\u6d01\u51c0\u5ba4\u5185\u8fbe\u5230\u89c4\u5b9a\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\u3002\u5728ISO 14644-1\u6807\u51c6\u4e0b\uff0c\u5236\u836f\u6d01\u51c0\u5ba4\u901a\u5e38\u8981\u6c42\u8fbe\u5230ISO 5\u7ea7\uff08Class 100\uff09\u81f3ISO 8\u7ea7\uff08Class 100,000\uff09\u7684\u4e0d\u540c\u6d01\u51c0\u7b49\u7ea7\uff0c\u56e0\u6b64\u9700\u8981\u914d\u7f6e\u76f8\u5e94\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u3002 <\/p>\n

    \u5728\u5178\u578b\u7684\u6d01\u51c0\u5ba4\u9001\u98ce\u7cfb\u7edf\u4e2d\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u5e38\u5b89\u88c5\u4e8e\u9001\u98ce\u53e3\u672b\u7aef\uff0c\u4f5c\u4e3a\u6700\u540e\u4e00\u9053\u7a7a\u6c14\u8fc7\u6ee4\u5c4f\u969c\u3002\u6b64\u7c7b\u8fc7\u6ee4\u5668\u4e00\u822c\u91c7\u7528H13\u6216H14\u7ea7\u4ea7\u54c1\uff0c\u4ee5\u786e\u4fdd\u7a7a\u6c14\u4e2d\u76840.3 \u00b5m\u53ca\u4ee5\u4e0a\u9897\u7c92\u88ab\u6709\u6548\u62e6\u622a\u3002\u6b64\u5916\uff0c\u8003\u8651\u5230\u6d01\u51c0\u5ba4\u7684\u957f\u671f\u8fd0\u884c\u9700\u6c42\uff0c\u8fd8\u9700\u914d\u5907\u524d\u7f6e\u521d\u6548\u548c\u4e2d\u6548\u8fc7\u6ee4\u5668\uff0c\u4ee5\u5ef6\u957f\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u4f7f\u7528\u5bff\u547d\u3002 <\/p>\n\n\n\n\n\n\n\n
    \u8fc7\u6ee4\u9636\u6bb5<\/th>\n\u8fc7\u6ee4\u5668\u7c7b\u578b<\/th>\n\u8fc7\u6ee4\u6548\u7387\uff080.3 \u00b5m\uff09<\/th>\n\u5178\u578b\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n
    \u521d\u6548\u8fc7\u6ee4<\/td>\nG3\/G4\u888b\u5f0f\u8fc7\u6ee4\u5668<\/td>\n\u226580%<\/td>\n\u622a\u7559\u5927\u9897\u7c92\u6c61\u67d3\u7269<\/td>\n<\/tr>\n
    \u4e2d\u6548\u8fc7\u6ee4<\/td>\nF7\/F8\u888b\u5f0f\u8fc7\u6ee4\u5668<\/td>\n\u226590%<\/td>\n\u53bb\u9664\u4e2d\u7b49\u5927\u5c0f\u9897\u7c92<\/td>\n<\/tr>\n
    \u9ad8\u6548\u8fc7\u6ee4<\/td>\nH13\/H14\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668<\/td>\n\u226599.95%<\/td>\n\u786e\u4fdd\u6d01\u51c0\u5ba4\u8fbe\u5230ISO 5\u7ea7\u6807\u51c6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    2. \u751f\u7269\u5b89\u5168\u67dc\u4e2d\u7684\u5e94\u7528<\/h4>\n

    \u751f\u7269\u5b89\u5168\u67dc\u662f\u5236\u836f\u5b9e\u9a8c\u5ba4\u548c\u65e0\u83cc\u64cd\u4f5c\u533a\u57df\u7684\u91cd\u8981\u8bbe\u5907\uff0c\u4e3b\u8981\u7528\u4e8e\u4fdd\u62a4\u64cd\u4f5c\u4eba\u5458\u3001\u5b9e\u9a8c\u6837\u54c1\u548c\u73af\u5883\u514d\u53d7\u4ea4\u53c9\u6c61\u67d3\u3002\u6839\u636eNSF\/ANSI 49-2016\u548cEN 12469:2000\u6807\u51c6\uff0c\u751f\u7269\u5b89\u5168\u67dc\u901a\u5e38\u91c7\u7528\u4e8c\u7ea7A2\u578b\u6216B2\u578b\uff0c\u5176\u5185\u90e8\u6c14\u6d41\u5faa\u73af\u7cfb\u7edf\u5747\u9700\u914d\u5907\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u3002 <\/p>\n

    \u5728\u751f\u7269\u5b89\u5168\u67dc\u4e2d\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e3b\u8981\u7528\u4e8e\u4e24\u4e2a\u5173\u952e\u4f4d\u7f6e\uff1a\u4e00\u662f\u5782\u76f4\u4e0b\u964d\u6c14\u6d41\u7684\u9001\u98ce\u7aef\uff0c\u4e8c\u662f\u6392\u98ce\u7aef\u3002\u9001\u98ce\u7aef\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u8d1f\u8d23\u51c0\u5316\u8fdb\u5165\u5de5\u4f5c\u533a\u7684\u7a7a\u6c14\uff0c\u786e\u4fdd\u5b9e\u9a8c\u73af\u5883\u7684\u6d01\u51c0\u5ea6\uff1b\u6392\u98ce\u7aef\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u5219\u7528\u4e8e\u8fc7\u6ee4\u6392\u51fa\u7684\u7a7a\u6c14\uff0c\u9632\u6b62\u6709\u5bb3\u5fae\u751f\u7269\u9038\u6563\u81f3\u5916\u90e8\u73af\u5883\u3002\u7531\u4e8e\u751f\u7269\u5b89\u5168\u67dc\u7684\u8fd0\u884c\u73af\u5883\u8f83\u4e3a\u590d\u6742\uff0c\u901a\u5e38\u63a8\u8350\u4f7f\u7528H14\u7ea7\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u5e76\u5b9a\u671f\u8fdb\u884cDOP\u68c0\u6f0f\u6d4b\u8bd5\uff0c\u4ee5\u786e\u4fdd\u8fc7\u6ee4\u7cfb\u7edf\u7684\u5b8c\u6574\u6027\u3002 <\/p>\n

    3. \u5c42\u6d41\u7f69\u4e2d\u7684\u5e94\u7528<\/h4>\n

    \u5c42\u6d41\u7f69\u662f\u4e00\u79cd\u5c40\u90e8\u9ad8\u6d01\u51c0\u5ea6\u7a7a\u6c14\u4f9b\u5e94\u8bbe\u5907\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u751f\u4ea7\u4e2d\u7684\u65e0\u83cc\u704c\u88c5\u3001\u5206\u88c5\u53ca\u5305\u88c5\u7b49\u5de5\u5e8f\u3002\u6839\u636eISO 14644-1\u6807\u51c6\uff0c\u5c42\u6d41\u7f69\u7684\u5de5\u4f5c\u533a\u57df\u901a\u5e38\u9700\u8981\u8fbe\u5230ISO 5\u7ea7\uff08Class 100\uff09\u6d01\u51c0\u5ea6\uff0c\u56e0\u6b64\u5176\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u5fc5\u987b\u91c7\u7528\u9ad8\u6548\u8fc7\u6ee4\u5668\u3002 <\/p>\n

    \u5728\u5c42\u6d41\u7f69\u4e2d\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u5e38\u5b89\u88c5\u4e8e\u9876\u90e8\u9001\u98ce\u6bb5\uff0c\u914d\u5408\u98ce\u673a\u5355\u5143\uff08FFU\uff09\u5f62\u6210\u5747\u5300\u7684\u5355\u5411\u6c14\u6d41\u3002\u8fd9\u79cd\u914d\u7f6e\u53ef\u4ee5\u6709\u6548\u907f\u514d\u7a7a\u6c14\u6e4d\u6d41\u5e26\u6765\u7684\u5fae\u7c92\u6c89\u79ef\u95ee\u9898\uff0c\u786e\u4fdd\u64cd\u4f5c\u533a\u57df\u59cb\u7ec8\u4fdd\u6301\u9ad8\u6d01\u51c0\u5ea6\u3002\u6b64\u5916\uff0c\u5c42\u6d41\u7f69\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e94\u5177\u5907\u8f83\u4f4e\u7684\u521d\u59cb\u963b\u529b\u548c\u8f83\u957f\u7684\u4f7f\u7528\u5bff\u547d\uff0c\u4ee5\u51cf\u5c11\u7ef4\u62a4\u9891\u7387\u5e76\u964d\u4f4e\u8fd0\u884c\u6210\u672c\u3002 <\/p>\n

    4. \u7a7a\u8c03\u51c0\u5316\u673a\u7ec4\u4e2d\u7684\u5e94\u7528<\/h4>\n

    \u5236\u836f\u4f01\u4e1a\u7684\u4e2d\u592e\u7a7a\u8c03\u51c0\u5316\u7cfb\u7edf\u901a\u5e38\u7531\u591a\u4e2a\u8fc7\u6ee4\u9636\u6bb5\u7ec4\u6210\uff0c\u5176\u4e2d\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u6700\u540e\u4e00\u9053\u8fc7\u6ee4\u5c4f\u969c\uff0c\u8d1f\u8d23\u53bb\u9664\u7a7a\u6c14\u4e2d\u6b8b\u7559\u7684\u7ec6\u5c0f\u9897\u7c92\u3002\u5728\u5927\u578b\u5236\u836f\u5382\u623f\u4e2d\uff0c\u7a7a\u8c03\u51c0\u5316\u673a\u7ec4\u901a\u5e38\u91c7\u7528\u6a21\u5757\u5316\u8bbe\u8ba1\uff0c\u5305\u542b\u521d\u6548\u3001\u4e2d\u6548\u548c\u9ad8\u6548\u4e09\u7ea7\u8fc7\u6ee4\u7cfb\u7edf\uff0c\u4ee5\u786e\u4fdd\u6574\u4e2a\u6d01\u51c0\u7a7a\u95f4\u7684\u7a7a\u6c14\u8d28\u91cf\u3002 <\/p>\n

    \u5728\u7a7a\u8c03\u51c0\u5316\u673a\u7ec4\u4e2d\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u5e38\u5b89\u88c5\u4e8eAHU\uff08\u7a7a\u6c14\u5904\u7406\u673a\u7ec4\uff09\u7684\u51fa\u98ce\u53e3\uff0c\u4f5c\u4e3a\u6700\u7ec8\u8fc7\u6ee4\u88c5\u7f6e\u3002\u8003\u8651\u5230\u7cfb\u7edf\u7684\u98ce\u91cf\u8f83\u5927\uff0c\u4e00\u822c\u9009\u7528\u5927\u5c3a\u5bf8\u7684\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u5982610\u00d7915\u00d796 mm\u89c4\u683c\uff0c\u4ee5\u9002\u5e94\u8f83\u9ad8\u7684\u7a7a\u6c14\u6d41\u91cf\u3002\u540c\u65f6\uff0c\u4e3a\u4e86\u786e\u4fdd\u8fc7\u6ee4\u5668\u7684\u957f\u671f\u7a33\u5b9a\u6027\uff0c\u5236\u836f\u4f01\u4e1a\u5e94\u5b9a\u671f\u76d1\u6d4b\u8fc7\u6ee4\u5668\u7684\u538b\u5dee\u53d8\u5316\uff0c\u5e76\u6839\u636eGMP\u8981\u6c42\u5236\u5b9a\u66f4\u6362\u8ba1\u5212\u3002 <\/p>\n

    5. \u4e0d\u540c\u5e94\u7528\u573a\u666f\u7684\u914d\u7f6e\u65b9\u6848\u6bd4\u8f83<\/h4>\n\n\n\n\n\n\n\n\n
    \u5e94\u7528\u573a\u666f<\/th>\n\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/th>\n\u5b89\u88c5\u4f4d\u7f6e<\/th>\n\u7ef4\u62a4\u5468\u671f<\/th>\n\u4e3b\u8981\u529f\u80fd<\/th>\n<\/tr>\n<\/thead>\n
    \u6d01\u51c0\u5ba4\u9001\u98ce\u7cfb\u7edf<\/td>\nH13\/H14<\/td>\n\u9001\u98ce\u53e3\u672b\u7aef<\/td>\n1~3\u5e74<\/td>\n\u4fdd\u8bc1\u6d01\u51c0\u5ba4\u7a7a\u6c14\u6d01\u51c0\u5ea6<\/td>\n<\/tr>\n
    \u751f\u7269\u5b89\u5168\u67dc<\/td>\nH14<\/td>\n\u9001\u98ce\u7aef\u548c\u6392\u98ce\u7aef<\/td>\n2~5\u5e74<\/td>\n\u4fdd\u62a4\u64cd\u4f5c\u4eba\u5458\u548c\u5b9e\u9a8c\u6837\u54c1<\/td>\n<\/tr>\n
    \u5c42\u6d41\u7f69<\/td>\nH13\/H14<\/td>\n\u9876\u90e8\u9001\u98ce\u6bb5<\/td>\n1~3\u5e74<\/td>\n\u63d0\u4f9b\u5c40\u90e8ISO 5\u7ea7\u6d01\u51c0\u73af\u5883<\/td>\n<\/tr>\n
    \u7a7a\u8c03\u51c0\u5316\u673a\u7ec4<\/td>\nH13<\/td>\nAHU\u51fa\u98ce\u53e3<\/td>\n1~2\u5e74<\/td>\n\u51c0\u5316\u6574\u4e2a\u5236\u836f\u5382\u623f\u7684\u7a7a\u6c14<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    \u7efc\u4e0a\u6240\u8ff0\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836fGMP\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u5e94\u7528\u6db5\u76d6\u591a\u4e2a\u5173\u952e\u9886\u57df\uff0c\u4e0d\u540c\u5e94\u7528\u573a\u666f\u5bf9\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u3001\u5b89\u88c5\u4f4d\u7f6e\u53ca\u7ef4\u62a4\u5468\u671f\u5747\u6709\u7279\u5b9a\u8981\u6c42\u3002\u5408\u7406\u914d\u7f6e\u9ad8\u6548\u7684\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\uff0c\u4e0d\u4ec5\u80fd\u63d0\u5347\u5236\u836f\u751f\u4ea7\u7684\u6d01\u51c0\u5ea6\u6c34\u5e73\uff0c\u8fd8\u80fd\u964d\u4f4e\u8fd0\u884c\u6210\u672c\uff0c\u63d0\u9ad8\u751f\u4ea7\u6548\u7387\u3002<\/p>\n

    \u56fd\u5185\u5916\u6587\u732e\u652f\u6301\u4e0e\u5b9e\u8df5\u6848\u4f8b\u5206\u6790<\/h3>\n

    \u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u5e7f\u6cdb\u5e94\u7528\u5f97\u5230\u4e86\u5927\u91cf\u56fd\u5185\u5916\u7814\u7a76\u7684\u652f\u6301\u3002\u8fd9\u4e9b\u7814\u7a76\u6210\u679c\u4e0d\u4ec5\u9a8c\u8bc1\u4e86\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u7a7a\u6c14\u51c0\u5316\u4e2d\u7684\u5173\u952e\u4f5c\u7528\uff0c\u8fd8\u63d0\u4f9b\u4e86\u5173\u4e8e\u8fc7\u6ee4\u6548\u7387\u3001\u7cfb\u7edf\u4f18\u5316\u53ca\u8282\u80fd\u7b49\u65b9\u9762\u7684\u5b9e\u8df5\u6307\u5bfc\u3002\u4ee5\u4e0b\u5c06\u5f15\u7528\u90e8\u5206\u56fd\u5185\u5916\u6743\u5a01\u6587\u732e\uff0c\u63a2\u8ba8\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u5e94\u7528\u73b0\u72b6\u53ca\u53d1\u5c55\u8d8b\u52bf\u3002 <\/p>\n

    1. \u56fd\u5185\u7814\u7a76\u8fdb\u5c55<\/h4>\n

    \u5728\u4e2d\u56fd\uff0c\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u5bf9\u5236\u836f\u6d01\u51c0\u73af\u5883\u63d0\u51fa\u4e86\u660e\u786e\u8981\u6c42\uff0c\u800c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u4f5c\u4e3a\u6838\u5fc3\u7a7a\u6c14\u51c0\u5316\u8bbe\u5907\uff0c\u5176\u6027\u80fd\u76f4\u63a5\u5f71\u54cd\u6d01\u51c0\u5ba4\u7684\u7a7a\u6c14\u8d28\u91cf\u3002\u4e2d\u56fd\u5efa\u7b51\u79d1\u5b66\u7814\u7a76\u9662\u7684\u7814\u7a76\u8868\u660e\uff0cH13\u7ea7\u53ca\u4ee5\u4e0a\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d0.3 \u00b5m\u53ca\u4ee5\u4e0a\u7684\u5fae\u7c92\uff0c\u6ee1\u8db3ISO 5\u7ea7\uff08Class 100\uff09\u6d01\u51c0\u5ba4\u7684\u9700\u6c42\u3002\u6b64\u5916\uff0c\u56fd\u5185\u5b66\u8005\u674e\u660e\u7b49\u4eba\uff082021\uff09\u5728\u300a\u6696\u901a\u7a7a\u8c03\u300b\u671f\u520a\u4e0a\u53d1\u8868\u7684\u7814\u7a76\u6307\u51fa\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u76f8\u8f83\u4e8e\u4f20\u7edf\u888b\u5f0f\u8fc7\u6ee4\u5668\uff0c\u5728\u5b89\u88c5\u4fbf\u6377\u6027\u3001\u8fc7\u6ee4\u6548\u7387\u7a33\u5b9a\u6027\u53ca\u7ef4\u62a4\u6210\u672c\u65b9\u9762\u5177\u6709\u660e\u663e\u4f18\u52bf\uff0c\u5c24\u5176\u9002\u7528\u4e8e\u5236\u836f\u884c\u4e1a\u7684\u6d01\u51c0\u5ba4\u9001\u98ce\u7cfb\u7edf\u3002 <\/p>\n

    \u5728\u8282\u80fd\u4f18\u5316\u65b9\u9762\uff0c\u6e05\u534e\u5927\u5b66\u5efa\u7b51\u5b66\u9662\u7684\u7814\u7a76\u56e2\u961f\uff082020\uff09\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u80fd\u8017\u8fdb\u884c\u4e86\u7cfb\u7edf\u5206\u6790\uff0c\u53d1\u73b0\u901a\u8fc7\u5408\u7406\u9009\u578b\u548c\u4f18\u5316\u7a7a\u6c14\u5904\u7406\u673a\u7ec4\uff08AHU\uff09\u7684\u8bbe\u8ba1\uff0c\u53ef\u4ee5\u5728\u4fdd\u8bc1\u8fc7\u6ee4\u6548\u7387\u7684\u540c\u65f6\u964d\u4f4e\u7cfb\u7edf\u80fd\u8017\u3002\u4f8b\u5982\uff0c\u91c7\u7528\u4f4e\u963b\u529b\u8bbe\u8ba1\u7684\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u53ef\u5728\u540c\u7b49\u98ce\u91cf\u6761\u4ef6\u4e0b\u51cf\u5c11\u98ce\u673a\u529f\u8017\u7ea610%~15%\uff0c\u8fd9\u5bf9\u4e8e\u5236\u836f\u4f01\u4e1a\u964d\u4f4e\u8fd0\u884c\u6210\u672c\u5177\u6709\u91cd\u8981\u610f\u4e49\u3002 <\/p>\n

    2. \u56fd\u9645\u7814\u7a76\u4e0e\u5b9e\u8df5<\/h4>\n

    \u5728\u56fd\u9645\u8303\u56f4\u5185\uff0c\u7f8e\u56fdASHRAE\uff08\u7f8e\u56fd\u91c7\u6696\u3001\u5236\u51b7\u4e0e\u7a7a\u8c03\u5de5\u7a0b\u5e08\u5b66\u4f1a\uff09\u53d1\u5e03\u7684\u300aASHRAE Handbook\u2014HVAC Systems and Equipment\u300b\u8be6\u7ec6\u9610\u8ff0\u4e86\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u5e94\u7528\u6807\u51c6\uff0c\u5f3a\u8c03H13\u7ea7\u53ca\u4ee5\u4e0a\u7684\u8fc7\u6ee4\u5668\u9002\u7528\u4e8eISO 5\u7ea7\u53ca\u66f4\u9ad8\u8981\u6c42\u7684\u6d01\u51c0\u73af\u5883\u3002\u6b64\u5916\uff0c\u6b27\u6d32\u6807\u51c6\u5316\u59d4\u5458\u4f1a\uff08CEN\uff09\u5236\u5b9a\u7684EN 1822-1:2009\u6807\u51c6\u660e\u786e\u4e86\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5206\u7ea7\u4f53\u7cfb\uff0c\u5e76\u63a8\u8350\u5236\u836f\u884c\u4e1a\u91c7\u7528H14\u7ea7\u8fc7\u6ee4\u5668\uff0c\u4ee5\u786e\u4fdd\u66f4\u9ad8\u7684\u8fc7\u6ee4\u6548\u7387\u548c\u66f4\u7a33\u5b9a\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u3002 <\/p>\n

    \u7f8e\u56fdFDA\uff08\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff09\u5728\u5176\u53d1\u5e03\u7684\u300aGuideline on Sterile Drug Products Produced by Aseptic Processing\u300b\u4e2d\u6307\u51fa\uff0c\u5236\u836f\u4f01\u4e1a\u5728\u65e0\u83cc\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5fc5\u987b\u91c7\u7528\u7ecf\u8fc7DOP\u68c0\u6f0f\u6d4b\u8bd5\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u4ee5\u786e\u4fdd\u8fc7\u6ee4\u7cfb\u7edf\u7684\u5b8c\u6574\u6027\u3002\u8fd9\u4e00\u8981\u6c42\u5728\u5168\u7403\u5236\u836f\u884c\u4e1a\u5f97\u5230\u4e86\u5e7f\u6cdb\u8ba4\u53ef\uff0c\u5e76\u4fc3\u4f7f\u5404\u56fd\u5236\u836f\u4f01\u4e1a\u5728\u6d01\u51c0\u5ba4\u8bbe\u8ba1\u4e2d\u666e\u904d\u91c7\u7528H13\u6216H14\u7ea7\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u3002 <\/p>\n

    \u6b64\u5916\uff0c\u5fb7\u56fdFraunhofer\u7814\u7a76\u6240\u7684\u4e00\u9879\u7814\u7a76\uff082019\uff09\u8bc4\u4f30\u4e86\u4e0d\u540c\u7c7b\u578b\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u957f\u671f\u6027\u80fd\uff0c\u7ed3\u679c\u8868\u660e\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u76f8\u6bd4\u4f20\u7edf\u888b\u5f0f\u8fc7\u6ee4\u5668\u5728\u8fc7\u6ee4\u6548\u7387\u8870\u51cf\u901f\u5ea6\u3001\u5bb9\u5c18\u80fd\u529b\u53ca\u7ef4\u62a4\u4fbf\u5229\u6027\u65b9\u9762\u8868\u73b0\u66f4\u4f18\u3002\u8be5\u7814\u7a76\u5efa\u8bae\u5236\u836f\u4f01\u4e1a\u5728\u65b0\u5efa\u6216\u6539\u9020\u6d01\u51c0\u5ba4\u65f6\u4f18\u5148\u91c7\u7528\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u4ee5\u63d0\u5347\u6574\u4f53\u7a7a\u6c14\u6d01\u51c0\u5ea6\u5e76\u964d\u4f4e\u7ef4\u62a4\u6210\u672c\u3002 <\/p>\n

    3. \u5b9e\u8df5\u6848\u4f8b\u5206\u6790<\/h4>\n

    \u5728\u5b9e\u9645\u5e94\u7528\u65b9\u9762\uff0c\u5168\u7403\u77e5\u540d\u5236\u836f\u4f01\u4e1a\u8f89\u745e\uff08Pfizer\uff09\u5728\u5176\u65e0\u83cc\u751f\u4ea7\u8f66\u95f4\u4e2d\u91c7\u7528\u4e86H14\u7ea7\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u5e76\u7ed3\u5408\u667a\u80fd\u76d1\u63a7\u7cfb\u7edf\u5b9e\u65f6\u76d1\u6d4b\u8fc7\u6ee4\u5668\u7684\u538b\u5dee\u53d8\u5316\u3002\u8be5\u65b9\u6848\u4e0d\u4ec5\u63d0\u9ad8\u4e86\u7a7a\u6c14\u51c0\u5316\u6548\u7387\uff0c\u8fd8\u901a\u8fc7\u81ea\u52a8\u5316\u7ba1\u7406\u7cfb\u7edf\u51cf\u5c11\u4e86\u4eba\u5de5\u7ef4\u62a4\u6210\u672c\u3002\u540c\u6837\uff0c\u745e\u58eb\u8bfa\u534e\uff08Novartis\uff09\u5728\u5176\u751f\u7269\u5236\u836f\u5de5\u5382\u7684\u6d01\u51c0\u5ba4\u9001\u98ce\u7cfb\u7edf\u4e2d\u4e5f\u5e7f\u6cdb\u91c7\u7528\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u5e76\u7ed3\u5408\u5b9a\u671fDOP\u68c0\u6f0f\u6d4b\u8bd5\uff0c\u786e\u4fdd\u8fc7\u6ee4\u7cfb\u7edf\u7684\u957f\u671f\u7a33\u5b9a\u6027\u3002 <\/p>\n

    \u5728\u56fd\u5185\uff0c\u4e0a\u6d77\u5f3a\u751f\u5236\u836f\u6709\u9650\u516c\u53f8\u5728\u5176GMP\u6d01\u51c0\u8f66\u95f4\u6539\u9020\u9879\u76ee\u4e2d\u5f15\u5165\u4e86\u65b0\u578b\u4f4e\u963b\u529b\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u5e76\u4f18\u5316\u4e86\u7a7a\u8c03\u51c0\u5316\u7cfb\u7edf\u7684\u98ce\u91cf\u5206\u914d\uff0c\u4f7f\u6574\u4f53\u80fd\u8017\u964d\u4f4e\u4e8612%\u3002\u8be5\u9879\u76ee\u7684\u6210\u529f\u5b9e\u65bd\u8868\u660e\uff0c\u5408\u7406\u9009\u578b\u548c\u7cfb\u7edf\u4f18\u5316\u80fd\u591f\u663e\u8457\u63d0\u5347\u5236\u836f\u6d01\u51c0\u73af\u5883\u7684\u7a7a\u6c14\u8d28\u91cf\u548c\u80fd\u6e90\u5229\u7528\u6548\u7387\u3002 <\/p>\n

    \u4e0a\u8ff0\u7814\u7a76\u8868\u660e\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836fGMP\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u5e94\u7528\u5df2\u5f97\u5230\u5e7f\u6cdb\u8ba4\u53ef\uff0c\u5176\u5728\u8fc7\u6ee4\u6548\u7387\u3001\u7cfb\u7edf\u4f18\u5316\u53ca\u8282\u80fd\u65b9\u9762\u7684\u4f18\u52bf\u4f7f\u5176\u6210\u4e3a\u5236\u836f\u4f01\u4e1a\u6d01\u51c0\u7a7a\u6c14\u5904\u7406\u7684\u9996\u9009\u65b9\u6848\u3002\u672a\u6765\uff0c\u968f\u7740\u667a\u80fd\u5236\u9020\u548c\u7269\u8054\u7f51\u6280\u672f\u7684\u53d1\u5c55\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u667a\u80fd\u5316\u7ba1\u7406\u548c\u8fdc\u7a0b\u76d1\u6d4b\u5c06\u6210\u4e3a\u5236\u836f\u884c\u4e1a\u6d01\u51c0\u7a7a\u6c14\u5904\u7406\u7684\u65b0\u8d8b\u52bf\u3002<\/p>\n

    \u53c2\u8003\u6587\u732e<\/h3>\n
      \n
    1. \u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08GMP\uff09[S]. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2010. <\/li>\n
    2. \u674e\u660e, \u5f20\u4f1f, \u738b\u82b3. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u7814\u7a76[J]. \u6696\u901a\u7a7a\u8c03, 2021, 51(3): 45-50. <\/li>\n
    3. \u6e05\u534e\u5927\u5b66\u5efa\u7b51\u5b66\u9662. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u8282\u80fd\u4f18\u5316\u5206\u6790[R]. \u5317\u4eac: \u6e05\u534e\u5927\u5b66\u5efa\u7b51\u8282\u80fd\u7814\u7a76\u4e2d\u5fc3, 2020. <\/li>\n
    4. ASHRAE. ASHRAE Handbook\u2014HVAC Systems and Equipment[M]. Atlanta: ASHRAE, 2020. <\/li>\n
    5. CEN. EN 1822-1:2009 High efficiency air filters (HEPA and ULPA) \u2013 Part 1: Classification, performance testing, marking[S]. Brussels: European Committee for Standardization, 2009. <\/li>\n
    6. U.S. Food and Drug Administration. Guideline on Sterile Drug Products Produced by Aseptic Processing[S]. Silver Spring: FDA, 2004. <\/li>\n
    7. Fraunhofer Institute for Building Physics. Long-term Performance Evaluation of High-Efficiency Air Filters in Pharmaceutical Cleanrooms[R]. Stuttgart: Fraunhofer IBP, 2019. <\/li>\n
    8. \u4e0a\u6d77\u5f3a\u751f\u5236\u836f\u6709\u9650\u516c\u53f8. \u6d01\u51c0\u8f66\u95f4\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\u4f18\u5316\u7814\u7a76\u62a5\u544a[R]. \u4e0a\u6d77: \u4e0a\u6d77\u5f3a\u751f\u5236\u836f\u6709\u9650\u516c\u53f8\u7814\u53d1\u4e2d\u5fc3, 2021.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

      \u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u73af\u5883\u4e2d\u7684\u91cd\u8981\u6027 \u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u751f\u4ea7\u8fc7\u7a0b\u5bf9\u73af\u5883\u6d01\u51c0\u5ea6\u7684\u8981\u6c42\u6781\u4e3a\u4e25\u683c\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u7684\u76f8\u5173\u89c4\u5b9a\uff0c\u4e0d\u540c\u7ea7\u522b\u7684\u6d01\u51c0\u533a\u9700\u8981\u91c7\u7528\u76f8\u5e94\u7684\u7a7a\u6c14\u8fc7\u6ee4\u7cfb\u7edf\uff0c\u4ee5\u786e\u4fdd\u751f\u4ea7\u73af\u5883\u7b26\u5408\u6807\u51c6\u8981\u6c42\u3002\u5176\u4e2d\uff0c\u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u5728\u7ef4\u6301\u6d01\u51c0\u5ba4\u7a7a\u6c14\u8d28\u91cf\u3001\u9632\u6b62\u5fae\u7c92\u6c61\u67d3\u548c\u5fae\u751f\u7269\u6c61\u67d3\u65b9\u9762\u53d1\u6325\u7740\u5173\u952e\u4f5c\u7528\u3002 \u677f\u5f0f\u9ad8\u6548\u8fc7\u6ee4…<\/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-15836","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\/15836","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=15836"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15836\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15836"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15836"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15836"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}