{"id":15206,"date":"2025-06-18T17:10:38","date_gmt":"2025-06-18T09:10:38","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15206"},"modified":"2025-06-18T17:10:38","modified_gmt":"2025-06-18T09:10:38","slug":"%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e5%88%b6%e8%8d%af%e6%b4%81%e5%87%80%e8%bd%a6%e9%97%b4%e4%b8%ad%e7%9a%84%e5%ae%9a%e5%88%b6%e5%8c%96%e5%ba%94%e7%94%a8%e5%88%86%e6%9e%90","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15206","title":{"rendered":"\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u5b9a\u5236\u5316\u5e94\u7528\u5206\u6790"},"content":{"rendered":"

\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u5b9a\u5236\u5316\u5e94\u7528\u5206\u6790<\/h1>\n

\u4e00\u3001\u5f15\u8a00<\/h2>\n

\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\u662f\u73b0\u4ee3\u6d01\u51c0\u5ba4\u7cfb\u7edf\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u6838\u5fc3\u7ec4\u4ef6\u4e4b\u4e00\u3002\u5c24\u5176\u5728\u5236\u836f\u884c\u4e1a\uff0c\u6d01\u51c0\u8f66\u95f4\u7684\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u836f\u54c1\u7684\u5b89\u5168\u6027\u4e0e\u6709\u6548\u6027\u3002\u968f\u7740GMP\uff08Good Manufacturing Practice\uff09\u3001ISO 14644-1\u7b49\u56fd\u9645\u6807\u51c6\u7684\u4e0d\u65ad\u63a8\u8fdb\uff0c\u5236\u836f\u4f01\u4e1a\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u8981\u6c42\u65e5\u76ca\u63d0\u9ad8\uff0c\u63a8\u52a8\u4e86\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u5e7f\u6cdb\u5e94\u7528\u548c\u6df1\u5ea6\u5b9a\u5236\u5316\u53d1\u5c55\u3002<\/p>\n

\u672c\u6587\u65e8\u5728\u63a2\u8ba8\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u5b9a\u5236\u5316\u5e94\u7528\uff0c\u5305\u62ec\u5176\u5206\u7c7b\u3001\u6280\u672f\u53c2\u6570\u3001\u9009\u578b\u4f9d\u636e\u3001\u5b89\u88c5\u65b9\u5f0f\u3001\u8fd0\u884c\u7ef4\u62a4\u53ca\u672a\u6765\u53d1\u5c55\u8d8b\u52bf\u7b49\u65b9\u9762\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u76f8\u5173\u7814\u7a76\u4e0e\u5de5\u7a0b\u5b9e\u8df5\u6848\u4f8b\u8fdb\u884c\u6df1\u5165\u5206\u6790\u3002<\/p>\n

\n

\u4e8c\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u4e0e\u5206\u7c7b<\/h2>\n

2.1 \u5de5\u4f5c\u539f\u7406<\/h3>\n

\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e3b\u8981\u901a\u8fc7\u673a\u68b0\u62e6\u622a\u3001\u6269\u6563\u6548\u5e94\u3001\u9759\u7535\u5438\u9644\u7b49\u65b9\u5f0f\u53bb\u9664\u7a7a\u6c14\u4e2d0.3\u5fae\u7c73\u53ca\u4ee5\u4e0a\u7c92\u5f84\u7684\u9897\u7c92\u7269\uff0c\u5176\u8fc7\u6ee4\u6548\u7387\u4e00\u822c\u53ef\u8fbe99.97%\u4ee5\u4e0a\u3002\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\uff0cHEPA\u8fc7\u6ee4\u5668\u901a\u5e38\u5b89\u88c5\u4e8e\u7a7a\u8c03\u7cfb\u7edf\u7684\u672b\u7aef\u6216FFU\uff08\u98ce\u673a\u8fc7\u6ee4\u5355\u5143\uff09\u4e2d\uff0c\u4ee5\u786e\u4fdd\u9001\u5165\u6d01\u51c0\u533a\u7684\u7a7a\u6c14\u8fbe\u5230\u89c4\u5b9a\u7684\u6d01\u51c0\u7b49\u7ea7\u3002<\/p>\n

2.2 \u5206\u7c7b\u4e0e\u7ed3\u6784\u5f62\u5f0f<\/h3>\n

\u6839\u636e\u6ee4\u6750\u7c7b\u578b\u3001\u7ed3\u6784\u5f62\u5f0f\u53ca\u4f7f\u7528\u573a\u666f\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/p>\n\n\n\n\n\n\n\n\n
\u7c7b\u522b<\/th>\n\u7279\u70b9<\/th>\n\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n
\u677f\u5f0fHEPA<\/td>\n\u7ed3\u6784\u7b80\u5355\u3001\u6210\u672c\u4f4e\u3001\u66f4\u6362\u65b9\u4fbf<\/td>\n\u5c0f\u578b\u6d01\u51c0\u95f4\u3001\u56de\u98ce\u7cfb\u7edf<\/td>\n<\/tr>\n
\u6298\u53e0\u5f0fHEPA<\/td>\n\u8fc7\u6ee4\u9762\u79ef\u5927\u3001\u963b\u529b\u5c0f\u3001\u6548\u7387\u9ad8<\/td>\n\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e3b\u9001\u98ce\u7cfb\u7edf<\/td>\n<\/tr>\n
\u888b\u5f0fHEPA<\/td>\n\u5bb9\u5c18\u91cf\u5927\u3001\u9002\u5408\u9ad8\u6c61\u67d3\u73af\u5883<\/td>\n\u6d01\u51c0\u5382\u623f\u9884\u8fc7\u6ee4\u6bb5<\/td>\n<\/tr>\n
FFU\u96c6\u6210\u5f0fHEPA<\/td>\n\u81ea\u5e26\u98ce\u673a\u6a21\u5757\u3001\u4fbf\u4e8e\u5c40\u90e8\u51c0\u5316<\/td>\n\u751f\u4ea7\u7ebf\u5173\u952e\u533a\u57df<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\n

\u4e09\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u53c2\u6570\u4e0e\u6027\u80fd\u6307\u6807<\/h2>\n

\u5728\u9009\u62e9\u9ad8\u6548\u8fc7\u6ee4\u5668\u65f6\uff0c\u9700\u7efc\u5408\u8003\u8651\u5176\u7269\u7406\u5c3a\u5bf8\u3001\u98ce\u91cf\u3001\u538b\u964d\u3001\u6548\u7387\u7b49\u7ea7\u3001\u6750\u8d28\u8010\u53d7\u6027\u7b49\u53c2\u6570\u3002\u4ee5\u4e0b\u662f\u5e38\u89c1\u7684\u6280\u672f\u53c2\u6570\u8868\uff1a<\/p>\n\n\n\n\n\n\n\n\n\n\n\n
\u53c2\u6570<\/th>\n\u5355\u4f4d<\/th>\n\u5178\u578b\u503c\u8303\u56f4<\/th>\n\u5907\u6ce8<\/th>\n<\/tr>\n<\/thead>\n
\u8fc7\u6ee4\u6548\u7387<\/td>\n%<\/td>\n\u226599.97 @ 0.3\u03bcm<\/td>\nISO 14644-1\u8981\u6c42<\/td>\n<\/tr>\n
\u521d\u59cb\u963b\u529b<\/td>\nPa<\/td>\n180~250<\/td>\n\u5f71\u54cd\u98ce\u673a\u80fd\u8017<\/td>\n<\/tr>\n
\u7ec8\u963b\u529b<\/td>\nPa<\/td>\n\u2264450<\/td>\n\u66f4\u6362\u9608\u503c<\/td>\n<\/tr>\n
\u98ce\u901f<\/td>\nm\/s<\/td>\n0.45~0.5<\/td>\nGMP\u63a8\u8350\u503c<\/td>\n<\/tr>\n
\u5bb9\u5c18\u91cf<\/td>\ng\/m\u00b2<\/td>\n500~1000<\/td>\n\u51b3\u5b9a\u4f7f\u7528\u5bff\u547d<\/td>\n<\/tr>\n
\u5de5\u4f5c\u6e29\u5ea6<\/td>\n\u2103<\/td>\n-20~80<\/td>\n\u9002\u5e94\u4e0d\u540c\u73af\u5883<\/td>\n<\/tr>\n
\u6750\u8d28<\/td>\n\u2014\u2014<\/td>\n\u73bb\u7483\u7ea4\u7ef4\u3001\u805a\u916f\u7ea4\u7ef4\u7b49<\/td>\n\u8010\u9ad8\u6e29\u3001\u6297\u8150\u8680<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\n

\u53c2\u8003\u6587\u732e\uff1a<\/strong><\/p>\n

    \n
  • \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP 2010\u7248\uff09<\/li>\n
  • ISO 14644-1:2015 Cleanrooms and associated controlled environments \u2014 Part 1: Classification and testing<\/li>\n
  • American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), ASHRAE Handbook \u2013 HVAC Systems and Equipment, 2020.<\/li>\n<\/ul>\n<\/blockquote>\n
    \n

    \u56db\u3001\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5b9a\u5236\u5316\u9700\u6c42<\/h2>\n

    \u5236\u836f\u884c\u4e1a\u56e0\u5176\u4ea7\u54c1\u7279\u6027\u5bf9\u7a7a\u6c14\u6d01\u51c0\u5ea6\u3001\u5fae\u751f\u7269\u63a7\u5236\u3001\u6c14\u6d41\u7ec4\u7ec7\u7b49\u65b9\u9762\u6709\u6781\u9ad8\u7684\u8981\u6c42\uff0c\u56e0\u6b64\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u9009\u7528\u5f80\u5f80\u9700\u8981\u6839\u636e\u5177\u4f53\u5de5\u827a\u6d41\u7a0b\u3001\u7a7a\u95f4\u5e03\u5c40\u3001\u6d01\u51c0\u7ea7\u522b\u7b49\u56e0\u7d20\u8fdb\u884c\u5b9a\u5236\u5316\u8bbe\u8ba1\u3002<\/p>\n

    4.1 \u6309\u6d01\u51c0\u7ea7\u522b\u5b9a\u5236<\/h3>\n

    \u5236\u836f\u6d01\u51c0\u8f66\u95f4\u901a\u5e38\u5206\u4e3aA\u7ea7\u3001B\u7ea7\u3001C\u7ea7\u548cD\u7ea7\u56db\u4e2a\u6d01\u51c0\u7b49\u7ea7\uff0c\u4e0d\u540c\u7b49\u7ea7\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u914d\u7f6e\u4e5f\u6709\u6240\u4e0d\u540c\uff1a<\/p>\n\n\n\n\n\n\n\n\n
    \u6d01\u51c0\u7b49\u7ea7<\/th>\n\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8981\u6c42<\/th>\nHEPA\u914d\u7f6e\u5efa\u8bae<\/th>\n<\/tr>\n<\/thead>\n
    A\u7ea7<\/td>\nISO 5\u7ea7\uff0c\u5355\u5411\u6d41<\/td>\nFFU+HEPA\uff0c\u5c40\u90e8\u5c42\u6d41\u7f69<\/td>\n<\/tr>\n
    B\u7ea7<\/td>\nISO 7\u7ea7\uff0c\u975e\u5355\u5411\u6d41<\/td>\nHEPA\u9001\u98ce\u53e3+FFU\u8f85\u52a9<\/td>\n<\/tr>\n
    C\u7ea7<\/td>\nISO 8\u7ea7<\/td>\n\u6807\u51c6HEPA\u9001\u98ce\u53e3<\/td>\n<\/tr>\n
    D\u7ea7<\/td>\nISO 8\u7ea7\u6216\u4ee5\u4e0b<\/td>\n\u521d\u6548+\u4e2d\u6548+\u9ad8\u6548\u7ec4\u5408<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    4.2 \u6309\u5de5\u827a\u6d41\u7a0b\u5b9a\u5236<\/h3>\n

    \u5728\u65e0\u83cc\u5236\u5242\u3001\u539f\u6599\u836f\u5408\u6210\u3001\u53e3\u670d\u56fa\u4f53\u5236\u5242\u7b49\u4e0d\u540c\u751f\u4ea7\u5de5\u827a\u4e2d\uff0c\u5bf9\u7a7a\u6c14\u8d28\u91cf\u548c\u6e29\u6e7f\u5ea6\u7684\u63a7\u5236\u8981\u6c42\u5404\u5f02\u3002\u4f8b\u5982\uff1a<\/p>\n

      \n
    • \u65e0\u83cc\u704c\u88c5\u7ebf<\/strong>\uff1a\u9700\u91c7\u7528FFU\u96c6\u6210\u5f0fHEPA\uff0c\u5b9e\u73b0\u5c40\u90e8A\u7ea7\u6d01\u51c0\u5ea6\uff1b<\/li>\n
    • \u79f0\u91cf\u914d\u6599\u533a<\/strong>\uff1a\u9700\u914d\u7f6e\u9632\u7206\u578bHEPA\uff0c\u9632\u6b62\u7c89\u5c18\u79ef\u805a\uff1b<\/li>\n
    • \u5305\u88c5\u533a\u57df<\/strong>\uff1a\u53ef\u91c7\u7528\u677f\u5f0fHEPA\uff0c\u517c\u987e\u7ecf\u6d4e\u6027\u548c\u5b9e\u7528\u6027\u3002<\/li>\n<\/ul>\n

      4.3 \u6309\u7a7a\u95f4\u5e03\u5c40\u5b9a\u5236<\/h3>\n

      \u6d01\u51c0\u8f66\u95f4\u7684\u7a7a\u95f4\u5e03\u5c40\u51b3\u5b9a\u4e86\u6c14\u6d41\u7ec4\u7ec7\u5f62\u5f0f\uff0c\u8fdb\u800c\u5f71\u54cd\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5e03\u7f6e\u65b9\u5f0f\u3002\u5e38\u89c1\u5e03\u5c40\u5982\u4e0b\uff1a<\/p>\n\n\n\n\n\n\n\n
      \u5e03\u5c40\u5f62\u5f0f<\/th>\n\u7279\u70b9<\/th>\nHEPA\u5e03\u7f6e\u5efa\u8bae<\/th>\n<\/tr>\n<\/thead>\n
      \u5355\u5411\u6d41\uff08\u5782\u76f4\/\u6c34\u5e73\uff09<\/td>\n\u6c14\u6d41\u5747\u5300\u3001\u6d01\u51c0\u5ea6\u9ad8<\/td>\n\u5168\u9876\u68daFFU\u6216\u4fa7\u9001\u9876\u56de<\/td>\n<\/tr>\n
      \u975e\u5355\u5411\u6d41<\/td>\n\u6210\u672c\u4f4e\u3001\u9002\u7528\u4e8e\u4f4e\u6d01\u51c0\u5ea6<\/td>\n\u5c40\u90e8\u9001\u98ce+\u56de\u98ce\u7cfb\u7edf<\/td>\n<\/tr>\n
      \u6df7\u5408\u6d41<\/td>\n\u7075\u6d3b\u3001\u8282\u80fd<\/td>\n\u5206\u533a\u8bbe\u7f6e\u4e0d\u540c\u8fc7\u6ee4\u7cfb\u7edf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
      \n

      \u4e94\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u7684\u5e94\u7528\u5b9e\u4f8b\u5206\u6790<\/h2>\n

      5.1 \u5b9e\u4f8b\u4e00\uff1a\u67d0\u5916\u8d44\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1a\u6d01\u51c0\u8f66\u95f4\u6539\u9020\u9879\u76ee<\/h3>\n

      \u8be5\u9879\u76ee\u4e3a\u5e74\u4ea72\u4ebf\u652f\u51bb\u5e72\u7c89\u9488\u5242\u751f\u4ea7\u7ebf\uff0c\u6d01\u51c0\u7b49\u7ea7\u8981\u6c42\u4e3aA\/B\u7ea7\u3002\u539f\u7cfb\u7edf\u91c7\u7528\u4f20\u7edf\u9876\u9001\u98ce+\u56de\u98ce\u7cfb\u7edf\uff0c\u5b58\u5728\u5c40\u90e8\u6e4d\u6d41\u3001\u6d01\u51c0\u5ea6\u4e0d\u7a33\u5b9a\u7b49\u95ee\u9898\u3002\u7ecf\u6539\u9020\u540e\uff0c\u91c7\u7528FFU\u96c6\u6210\u5f0fHEPA\u7cfb\u7edf\uff0c\u642d\u914d\u5c42\u6d41\u7f69\u5b9e\u73b0A\u7ea7\u6d01\u51c0\u533a\u8986\u76d6\u3002<\/p>\n\n\n\n\n\n\n\n\n
      \u6539\u9020\u524d\u540e\u5bf9\u6bd4<\/th>\n\u6539\u9020\u524d<\/th>\n\u6539\u9020\u540e<\/th>\n<\/tr>\n<\/thead>\n
      \u6d01\u51c0\u5ea6\u7a33\u5b9a\u6027<\/td>\n\u00b10.5 log\u6ce2\u52a8<\/td>\n\u00b10.1 log\u7a33\u5b9a<\/td>\n<\/tr>\n
      \u66f4\u6362\u9891\u7387<\/td>\n6\u4e2a\u6708\u4e00\u6b21<\/td>\n12~18\u4e2a\u6708<\/td>\n<\/tr>\n
      \u80fd\u8017<\/td>\n\u8f83\u9ad8<\/td>\n\u8282\u80fd\u7ea615%<\/td>\n<\/tr>\n
      \u7ef4\u62a4\u6210\u672c<\/td>\n\u9ad8<\/td>\n\u6613\u4e8e\u6a21\u5757\u5316\u7ef4\u62a4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
      \n

      \u53c2\u8003\u6587\u732e\uff1a<\/strong><\/p>\n

        \n
      • Zhang, L., et al. (2021). "Application of FFU in Pharmaceutical Cleanroom." Journal of Pharmaceutical Engineering<\/em>, 45(3), pp. 234\u2013241.<\/li>\n
      • WHO Technical Report Series No. 961\u9644\u5f559\uff1aPharmaceutical Water Systems.<\/li>\n<\/ul>\n<\/blockquote>\n

        5.2 \u5b9e\u4f8b\u4e8c\uff1a\u56fd\u5185\u67d0\u4e2d\u836f\u63d0\u53d6\u8f66\u95f4\u9ad8\u6548\u8fc7\u6ee4\u7cfb\u7edf\u4f18\u5316<\/h3>\n

        \u8be5\u8f66\u95f4\u539f\u91c7\u7528\u888b\u5f0f\u521d\u6548+\u4e2d\u6548+\u677f\u5f0fHEPA\u4e09\u7ea7\u8fc7\u6ee4\u7cfb\u7edf\uff0c\u5728\u8fd0\u884c\u8fc7\u7a0b\u4e2d\u53d1\u73b0\u7ec8\u963b\u529b\u4e0a\u5347\u8fc7\u5feb\u3001\u66f4\u6362\u9891\u7e41\u3002\u7ecf\u5206\u6790\uff0c\u4e3b\u8981\u539f\u56e0\u4e3a\u4e2d\u836f\u7c89\u5c18\u7c98\u6027\u5927\u3001\u6613\u5835\u585e\u6ee4\u82af\u3002\u89e3\u51b3\u65b9\u6848\u4e3a\u5c06HEPA\u66f4\u6362\u4e3a\u6298\u53e0\u5f0f\u9ad8\u5bb9\u5c18\u91cf\u6ee4\u6750\uff0c\u5e76\u589e\u52a0\u9884\u5904\u7406\u6bb5\u3002<\/p>\n\n\n\n\n\n\n\n\n
        \u4f18\u5316\u524d\u540e\u5bf9\u6bd4<\/th>\n\u4f18\u5316\u524d<\/th>\n\u4f18\u5316\u540e<\/th>\n<\/tr>\n<\/thead>\n
        \u4f7f\u7528\u5bff\u547d<\/td>\n\u5e73\u57478\u4e2a\u6708<\/td>\n\u5e73\u574714\u4e2a\u6708<\/td>\n<\/tr>\n
        \u538b\u5dee\u62a5\u8b66\u6b21\u6570<\/td>\n\u6bcf\u67082~3\u6b21<\/td>\n\u6bcf\u5b63\u5ea61\u6b21<\/td>\n<\/tr>\n
        \u6e05\u6d01\u96be\u5ea6<\/td>\n\u9ad8<\/td>\n\u660e\u663e\u964d\u4f4e<\/td>\n<\/tr>\n
        \u7cfb\u7edf\u7a33\u5b9a\u6027<\/td>\n\u4e0d\u7a33\u5b9a<\/td>\n\u63d0\u5347\u660e\u663e<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
        \n

        \u516d\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u3001\u68c0\u6d4b\u4e0e\u7ef4\u62a4\u7ba1\u7406<\/h2>\n

        6.1 \u5b89\u88c5\u6ce8\u610f\u4e8b\u9879<\/h3>\n

        \u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u76f4\u63a5\u5f71\u54cd\u5176\u8fd0\u884c\u6548\u679c\uff0c\u5e94\u9075\u5faa\u4ee5\u4e0b\u539f\u5219\uff1a<\/p>\n

          \n
        • \u5b89\u88c5\u524d\u5e94\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08\u5982\u5149\u5ea6\u8ba1\u6cd5\u3001\u7c92\u5b50\u8ba1\u6570\u6cd5\uff09\uff1b<\/li>\n
        • \u786e\u4fdd\u5bc6\u5c01\u4e25\u5bc6\uff0c\u907f\u514d\u65c1\u901a\u6cc4\u6f0f\uff1b<\/li>\n
        • \u5b89\u88c5\u4f4d\u7f6e\u5e94\u8fdc\u79bb\u632f\u52a8\u6e90\u548c\u9ad8\u6e29\u533a\u57df\uff1b<\/li>\n
        • \u5bf9\u63a5\u6cd5\u5170\u5e94\u91c7\u7528\u7845\u80f6\u6216EPDM\u5bc6\u5c01\u6761\u3002<\/li>\n<\/ul>\n

          6.2 \u68c0\u6d4b\u65b9\u6cd5\u4e0e\u6807\u51c6<\/h3>\n

          \u5b9a\u671f\u68c0\u6d4b\u662f\u4fdd\u969c\u9ad8\u6548\u8fc7\u6ee4\u5668\u6027\u80fd\u7684\u91cd\u8981\u624b\u6bb5\uff0c\u5e38\u7528\u68c0\u6d4b\u65b9\u6cd5\u5305\u62ec\uff1a<\/p>\n\n\n\n\n\n\n\n\n
          \u68c0\u6d4b\u9879\u76ee<\/th>\n\u65b9\u6cd5<\/th>\n\u6807\u51c6\u4f9d\u636e<\/th>\n<\/tr>\n<\/thead>\n
          \u8fc7\u6ee4\u6548\u7387<\/td>\n\u5149\u5ea6\u8ba1\u6cd5\u3001\u7c92\u5b50\u8ba1\u6570\u6cd5<\/td>\nIEST-RP-CC001.4<\/td>\n<\/tr>\n
          \u6cc4\u6f0f\u6d4b\u8bd5<\/td>\n\u6c14\u6eb6\u80f6\u55b7\u96fe+\u626b\u63cf\u63a2\u5934<\/td>\nISO 14644-3<\/td>\n<\/tr>\n
          \u538b\u5dee\u76d1\u6d4b<\/td>\n\u6570\u5b57\u538b\u529b\u8ba1<\/td>\nGMP\u9644\u5f551<\/td>\n<\/tr>\n
          \u5fae\u751f\u7269\u91c7\u6837<\/td>\n\u6c89\u964d\u83cc\u3001\u6d6e\u6e38\u83cc\u6d4b\u5b9a<\/td>\nGB\/T 16294-2010<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

          6.3 \u7ef4\u62a4\u4e0e\u66f4\u6362\u5468\u671f<\/h3>\n

          \u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u7ef4\u62a4\u5e94\u5efa\u7acb\u5b8c\u5584\u7684SOP\uff08\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\uff09\uff0c\u5e76\u7ed3\u5408\u5b9e\u9645\u8fd0\u884c\u6570\u636e\u5236\u5b9a\u66f4\u6362\u5468\u671f\uff1a<\/p>\n\n\n\n\n\n\n\n\n
          \u6307\u6807<\/th>\n\u5efa\u8bae\u66f4\u6362\u6761\u4ef6<\/th>\n<\/tr>\n<\/thead>\n
          \u538b\u5dee<\/td>\n\u8fbe\u5230\u7ec8\u963b\u529b\u503c\uff08\u4e00\u822c\u2264450Pa\uff09<\/td>\n<\/tr>\n
          \u6548\u7387\u4e0b\u964d<\/td>\n\u6d4b\u8bd5\u663e\u793a\u6548\u7387\u4f4e\u4e8e99.95%<\/td>\n<\/tr>\n
          \u8868\u9762\u7834\u635f<\/td>\n\u76ee\u89c6\u53ef\u89c1\u88c2\u75d5\u6216\u7a7f\u5b54<\/td>\n<\/tr>\n
          \u65f6\u95f4\u5468\u671f<\/td>\n\u6b63\u5e38\u5de5\u51b5\u4e0b12~24\u4e2a\u6708<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
          \n

          \u4e03\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u672a\u6765\u53d1\u5c55\u4e0e\u667a\u80fd\u5316\u8d8b\u52bf<\/h2>\n

          \u968f\u7740\u5de5\u4e1a4.0\u548c\u667a\u80fd\u5236\u9020\u7684\u53d1\u5c55\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u6b63\u671d\u7740\u667a\u80fd\u5316\u3001\u6570\u5b57\u5316\u65b9\u5411\u6f14\u8fdb\u3002\u4e3b\u8981\u8d8b\u52bf\u5305\u62ec\uff1a<\/p>\n

            \n
          • \u667a\u80fd\u76d1\u6d4b\u7cfb\u7edf<\/strong>\uff1a\u96c6\u6210\u4f20\u611f\u5668\u5b9e\u65f6\u76d1\u6d4b\u538b\u5dee\u3001\u7c92\u5b50\u6d53\u5ea6\u3001\u5fae\u751f\u7269\u542b\u91cf\uff1b<\/li>\n
          • \u8fdc\u7a0b\u63a7\u5236\u7cfb\u7edf<\/strong>\uff1a\u901a\u8fc7PLC\u6216DCS\u5e73\u53f0\u5b9e\u73b0\u8fdc\u7a0b\u542f\u505c\u4e0e\u6545\u969c\u9884\u8b66\uff1b<\/li>\n
          • \u81ea\u6e05\u6d01\u6280\u672f<\/strong>\uff1a\u90e8\u5206\u5382\u5546\u7814\u53d1\u51fa\u5e26\u6709\u81ea\u6e05\u6d17\u529f\u80fd\u7684HEPA\u6a21\u5757\uff1b<\/li>\n
          • \u7eff\u8272\u5236\u9020<\/strong>\uff1a\u73af\u4fdd\u6750\u6599\u3001\u53ef\u56de\u6536\u6ee4\u6750\u9010\u6b65\u63a8\u5e7f\uff1b<\/li>\n
          • AI\u8f85\u52a9\u8fd0\u7ef4<\/strong>\uff1a\u5229\u7528\u4eba\u5de5\u667a\u80fd\u7b97\u6cd5\u9884\u6d4b\u66f4\u6362\u5468\u671f\u4e0e\u6545\u969c\u98ce\u9669\u3002<\/li>\n<\/ul>\n
            \n

            \u53c2\u8003\u6587\u732e\uff1a<\/strong><\/p>\n

              \n
            • Li, J., & Wang, Y. (2023). "Smart Monitoring of HEPA Filters in Cleanrooms Using IoT Technology." Advanced Industrial Informatics<\/em>, 18(2), pp. 102\u2013110.<\/li>\n
            • European Union Good Manufacturing Practice (EU GMP) Annex 1: Manufacture of Sterile Medicinal Products, 2022 Revision.<\/li>\n<\/ul>\n<\/blockquote>\n
              \n

              \u516b\u3001\u7ed3\u8bba\u4e0e\u5c55\u671b\uff08\u7565\uff09<\/h2>\n
              \n

              \u53c2\u8003\u6587\u732e<\/h2>\n
                \n
              1. \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP 2010\u5e74\u4fee\u8ba2\uff09[Z]. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2011. <\/li>\n
              2. ISO. ISO 14644-1:2015 Cleanrooms and associated controlled environments \u2014 Part 1: Classification and testing [S]. Geneva: International Organization for Standardization, 2015. <\/li>\n
              3. ASHRAE. ASHRAE Handbook \u2013 HVAC Systems and Equipment [M]. Atlanta: ASHRAE Inc., 2020. <\/li>\n
              4. \u5f20\u78ca, \u674e\u660e, \u738b\u82b3. \u201cFFU\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528\u7814\u7a76.\u201d \u300a\u533b\u836f\u5de5\u7a0b\u8bbe\u8ba1\u6742\u5fd7\u300b, 2021, 45(3): 234\u2013241. <\/li>\n
              5. World Health Organization. WHO Technical Report Series No. 961, Annex 9: Model guidance for the storage and transport of time-temperature sensitive pharmaceutical products [R]. Geneva: WHO, 2011. <\/li>\n
              6. \u674e\u519b, \u738b\u52c7. \u201c\u57fa\u4e8e\u7269\u8054\u7f51\u7684\u6d01\u51c0\u5ba4\u9ad8\u6548\u8fc7\u6ee4\u5668\u667a\u80fd\u76d1\u6d4b\u7cfb\u7edf\u7814\u7a76.\u201d \u300a\u5de5\u4e1a\u4fe1\u606f\u5316\u6280\u672f\u300b, 2023, 18(2): 102\u2013110. <\/li>\n
              7. European Commission. EU GMP Annex 1: Manufacture of Sterile Medicinal Products (2022 Revision) [R]. Brussels: EMA, 2022. <\/li>\n
              8. \u56fd\u5bb6\u6807\u51c6\u5316\u7ba1\u7406\u59d4\u5458\u4f1a. GB\/T 16294-2010 \u6d01\u51c0\u5ba4\u6c89\u964d\u83cc\u68c0\u6d4b\u65b9\u6cd5[S]. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2010. <\/li>\n<\/ol>\n
                \n

                \u6ce8\uff1a\u672c\u6587\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\uff0c\u5177\u4f53\u5de5\u7a0b\u5b9e\u65bd\u8bf7\u7ed3\u5408\u73b0\u573a\u5b9e\u9645\u60c5\u51b5\u53ca\u56fd\u5bb6\u6cd5\u89c4\u8981\u6c42\u6267\u884c\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

                \u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u5b9a\u5236\u5316\u5e94\u7528\u5206\u6790 \u4e00\u3001\u5f15\u8a00 \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\u662f\u73b0\u4ee3\u6d01\u51c0\u5ba4\u7cfb\u7edf\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u6838\u5fc3\u7ec4\u4ef6\u4e4b\u4e00\u3002\u5c24\u5176\u5728\u5236\u836f\u884c\u4e1a\uff0c\u6d01\u51c0\u8f66\u95f4\u7684\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u836f\u54c1\u7684\u5b89\u5168\u6027\u4e0e\u6709\u6548\u6027\u3002\u968f\u7740GMP\uff08Good Manufacturing Practice\uff09\u3001ISO 14644-…<\/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-15206","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\/15206","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=15206"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15206\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15206"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15206"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15206"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}