{"id":17023,"date":"2025-09-26T11:32:40","date_gmt":"2025-09-26T03:32:40","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=17023"},"modified":"2025-09-26T11:32:40","modified_gmt":"2025-09-26T03:32:40","slug":"%e5%88%b6%e8%8d%afgmp%e8%bd%a6%e9%97%b4%e4%b8%ad%e8%b6%85%e5%87%80%e5%8f%b0hepa%e8%bf%87%e6%bb%a4%e5%99%a8%e9%aa%8c%e8%af%81%e4%b8%8e%e5%90%88%e8%a7%84%e6%80%a7%e8%a6%81%e6%b1%82","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=17023","title":{"rendered":"\u5236\u836fGMP\u8f66\u95f4\u4e2d\u8d85\u51c0\u53f0HEPA\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u4e0e\u5408\u89c4\u6027\u8981\u6c42"},"content":{"rendered":"

\u5236\u836fGMP\u8f66\u95f4\u4e2d\u8d85\u51c0\u53f0HEPA\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u4e0e\u5408\u89c4\u6027\u8981\u6c42<\/h1>\n
\n

\u76ee\u5f55<\/h2>\n
    \n
  1. \u5f15\u8a00<\/a> <\/li>\n
  2. \u8d85\u51c0\u53f0\u4e0eHEPA\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u6982\u5ff5<\/a>
    \n2.1 \u8d85\u51c0\u53f0\u7684\u5b9a\u4e49\u4e0e\u5206\u7c7b
    \n2.2 HEPA\u8fc7\u6ee4\u5668\u7684\u5de5\u4f5c\u539f\u7406\u4e0e\u6280\u672f\u53c2\u6570 <\/li>\n
  3. \u5236\u836fGMP\u5bf9\u6d01\u51c0\u73af\u5883\u7684\u8981\u6c42<\/a>
    \n3.1 GMP\u89c4\u8303\u4e2d\u7684\u6d01\u51c0\u7ea7\u522b\u5212\u5206
    \n3.2 \u6d01\u51c0\u533a\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u7684\u6838\u5fc3\u7ec4\u4ef6 <\/li>\n
  4. HEPA\u8fc7\u6ee4\u5668\u5728\u8d85\u51c0\u53f0\u4e2d\u7684\u5173\u952e\u4f5c\u7528<\/a> <\/li>\n
  5. HEPA\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u6d41\u7a0b<\/a>
    \n5.1 \u9a8c\u8bc1\u524d\u51c6\u5907
    \n5.2 \u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09
    \n5.3 \u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09
    \n5.4 \u6027\u80fd\u786e\u8ba4\uff08PQ\uff09 <\/li>\n
  6. \u56fd\u5185\u5916\u6cd5\u89c4\u4e0e\u6807\u51c6\u5bf9\u6bd4<\/a>
    \n6.1 \u4e2d\u56fdGMP\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u76f8\u5173\u8981\u6c42
    \n6.2 \u7f8e\u56fdFDA cGMP\u4e0eISO 14644\u6807\u51c6
    \n6.3 \u6b27\u76dfEudraLex Volume 4 Annex 1 <\/li>\n
  7. HEPA\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u7684\u5173\u952e\u53c2\u6570\u4e0e\u6d4b\u8bd5\u65b9\u6cd5<\/a>
    \n7.1 \u9897\u7c92\u7269\u6d53\u5ea6\u6d4b\u8bd5
    \n7.2 \u98ce\u901f\u4e0e\u6c14\u6d41\u5747\u5300\u6027\u6d4b\u8bd5
    \n7.3 \u626b\u63cf\u68c0\u6f0f\u8bd5\u9a8c\uff08DOP\/PAO\u6d4b\u8bd5\uff09 <\/li>\n
  8. \u5178\u578b\u4ea7\u54c1\u53c2\u6570\u4e0e\u6027\u80fd\u6307\u6807\u5bf9\u7167\u8868<\/a> <\/li>\n
  9. \u5e38\u89c1\u95ee\u9898\u4e0e\u98ce\u9669\u63a7\u5236<\/a> <\/li>\n
  10. \u7ef4\u62a4\u3001\u66f4\u6362\u5468\u671f\u4e0e\u518d\u9a8c\u8bc1\u8981\u6c42<\/a> <\/li>\n
  11. \u6848\u4f8b\u5206\u6790\uff1a\u67d0\u751f\u7269\u5236\u836f\u4f01\u4e1aHEPA\u9a8c\u8bc1\u5b9e\u8df5<\/a> <\/li>\n<\/ol>\n
    \n

    \u5f15\u8a00<\/h2>\n

    \u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u65e0\u83cc\u836f\u54c1\u7684\u751f\u4ea7\u5fc5\u987b\u5728\u9ad8\u5ea6\u53d7\u63a7\u7684\u6d01\u51c0\u73af\u5883\u4e2d\u8fdb\u884c\uff0c\u4ee5\u9632\u6b62\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c61\u67d3\u3002\u8d85\u51c0\u5de5\u4f5c\u53f0\uff08Laminar Flow Cabinet\uff09\u4f5c\u4e3a\u5c40\u90e8\u9ad8\u6d01\u51c0\u5ea6\u64cd\u4f5c\u533a\u57df\u7684\u6838\u5fc3\u8bbe\u5907\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u65e0\u83cc\u5236\u5242\u704c\u88c5\u3001\u7ec6\u80de\u57f9\u517b\u3001\u65e0\u83cc\u68c0\u6d4b\u7b49\u5173\u952e\u5de5\u827a\u73af\u8282\u3002\u5176\u6838\u5fc3\u90e8\u4ef6\u2014\u2014\u9ad8\u6548\u9897\u7c92\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter, HEPA\uff09\uff0c\u627f\u62c5\u7740\u53bb\u9664\u7a7a\u6c14\u4e2d\u22650.3\u03bcm\u9897\u7c92\u7269\u7684\u4efb\u52a1\uff0c\u662f\u4fdd\u969c\u6d01\u51c0\u7b49\u7ea7\u8fbe\u6807\u7684\u5173\u952e\u5c4f\u969c\u3002<\/p>\n

    \u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u53ca\u56fd\u9645\u76f8\u5173\u6807\u51c6\uff0c\u6240\u6709\u7528\u4e8e\u65e0\u83cc\u751f\u4ea7\u7684\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u5fc5\u987b\u7ecf\u8fc7\u4e25\u683c\u7684\u9a8c\u8bc1\uff0c\u786e\u4fdd\u5176\u6301\u7eed\u7a33\u5b9a\u8fd0\u884c\u5e76\u7b26\u5408\u89c4\u5b9a\u7684\u6d01\u51c0\u7ea7\u522b\u3002\u672c\u6587\u5c06\u7cfb\u7edf\u9610\u8ff0\u5236\u836fGMP\u8f66\u95f4\u4e2d\u8d85\u51c0\u53f0HEPA\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u6d41\u7a0b\u3001\u6280\u672f\u53c2\u6570\u3001\u5408\u89c4\u6027\u8981\u6c42\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u6743\u5a01\u6587\u732e\u4e0e\u6807\u51c6\uff0c\u6df1\u5165\u63a2\u8ba8\u5176\u5728\u5b9e\u9645\u5e94\u7528\u4e2d\u7684\u8d28\u91cf\u63a7\u5236\u8981\u70b9\u3002<\/p>\n

    \n

    \u8d85\u51c0\u53f0\u4e0eHEPA\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u6982\u5ff5<\/h2>\n

    2.1 \u8d85\u51c0\u53f0\u7684\u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n

    \u8d85\u51c0\u5de5\u4f5c\u53f0\u662f\u4e00\u79cd\u901a\u8fc7\u5c42\u6d41\u65b9\u5f0f\u63d0\u4f9b\u5c40\u90e8\u9ad8\u6d01\u51c0\u73af\u5883\u7684\u8bbe\u5907\uff0c\u901a\u5e38\u5206\u4e3a\u4e24\u7c7b\uff1a<\/p>\n\n\n\n\n\n\n
    \u7c7b\u578b<\/th>\n\u6c14\u6d41\u65b9\u5411<\/th>\n\u5e94\u7528\u573a\u666f<\/th>\n\u7279\u70b9<\/th>\n<\/tr>\n<\/thead>\n
    \u5782\u76f4\u5c42\u6d41\u8d85\u51c0\u53f0<\/td>\n\u81ea\u4e0a\u800c\u4e0b\u5782\u76f4\u6d41\u52a8<\/td>\n\u65e0\u83cc\u5236\u5242\u5206\u88c5\u3001\u7ec6\u80de\u64cd\u4f5c<\/td>\n\u64cd\u4f5c\u8005\u624b\u90e8\u4e0d\u5e72\u6270\u6c14\u6d41\uff0c\u9002\u5408\u957f\u65f6\u95f4\u64cd\u4f5c<\/td>\n<\/tr>\n
    \u6c34\u5e73\u5c42\u6d41\u8d85\u51c0\u53f0<\/td>\n\u81ea\u540e\u5411\u524d\u6c34\u5e73\u6d41\u52a8<\/td>\n\u5fae\u751f\u7269\u5b9e\u9a8c\u3001\u5c0f\u89c4\u6a21\u914d\u5236<\/td>\n\u6c14\u6d41\u76f4\u63a5\u5439\u5411\u64cd\u4f5c\u8005\uff0c\u9700\u6ce8\u610f\u4ea4\u53c9\u6c61\u67d3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
    \n

    \u6765\u6e90\uff1a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u533b\u836f\u884c\u4e1a\u6807\u51c6 YY 0569-2011\u300a\u751f\u7269\u5b89\u5168\u67dc\u300b\uff1b\u7f8e\u56fdNSF\/ANSI 49:2021<\/p>\n<\/blockquote>\n

    2.2 HEPA\u8fc7\u6ee4\u5668\u7684\u5de5\u4f5c\u539f\u7406\u4e0e\u6280\u672f\u53c2\u6570<\/h3>\n

    HEPA\u8fc7\u6ee4\u5668\u91c7\u7528\u591a\u5c42\u73bb\u7483\u7ea4\u7ef4\u6ee4\u7eb8\u6298\u53e0\u800c\u6210\uff0c\u901a\u8fc7\u62e6\u622a\u3001\u60ef\u6027\u78b0\u649e\u3001\u6269\u6563\u548c\u9759\u7535\u5438\u9644\u56db\u79cd\u673a\u5236\u6355\u83b7\u7a7a\u6c14\u4e2d\u5fae\u7c92\u3002\u6839\u636e\u56fd\u9645\u6807\u51c6\uff0cHEPA\u8fc7\u6ee4\u5668\u5e94\u6ee1\u8db3\u4ee5\u4e0b\u57fa\u672c\u6027\u80fd\u8981\u6c42\uff1a<\/p>\n\n\n\n\n\n\n\n\n
    \u53c2\u6570<\/th>\n\u6807\u51c6\u8981\u6c42<\/th>\n\u6d4b\u8bd5\u65b9\u6cd5<\/th>\n\u53c2\u8003\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n
    \u8fc7\u6ee4\u6548\u7387<\/td>\n\u226599.97% @ 0.3 \u03bcm<\/td>\nDOP\/PAO\u6c14\u6eb6\u80f6\u6311\u6218\u6d4b\u8bd5<\/td>\nISO 29463-3:2011<\/td>\n<\/tr>\n
    \u521d\u59cb\u963b\u529b<\/td>\n\u2264250 Pa<\/td>\n\u98ce\u91cf\u4e3a\u989d\u5b9a\u503c\u65f6\u6d4b\u91cf<\/td>\nGB\/T 13554-2020<\/td>\n<\/tr>\n
    \u989d\u5b9a\u98ce\u91cf<\/td>\n\u901a\u5e38\u4e3a0.45 m\/s \u00b120%<\/td>\n\u98ce\u901f\u4eea\u6d4b\u5b9a<\/td>\nISO 14644-3:2019<\/td>\n<\/tr>\n
    \u4f7f\u7528\u5bff\u547d<\/td>\n\u4e00\u822c3\u20135\u5e74\u6216\u538b\u5dee\u8fbe\u521d\u963b2\u500d\u65f6\u66f4\u6362<\/td>\n\u538b\u5dee\u76d1\u6d4b\u8bb0\u5f55<\/td>\nFDA Guidance for Industry (2004)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
    \n

    \u6ce8\uff1aDOP\uff08\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f\uff09\u548cPAO\uff08\u805a\u03b1\u70ef\u70c3\uff09\u4e3a\u5e38\u7528\u6c14\u6eb6\u80f6\u793a\u8e2a\u5242\u3002<\/p>\n<\/blockquote>\n

    \n

    \u5236\u836fGMP\u5bf9\u6d01\u51c0\u73af\u5883\u7684\u8981\u6c42<\/h2>\n

    3.1 GMP\u89c4\u8303\u4e2d\u7684\u6d01\u51c0\u7ea7\u522b\u5212\u5206<\/h3>\n

    \u6839\u636e\u4e2d\u56fd\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u9644\u5f551\u201c\u65e0\u83cc\u836f\u54c1\u201d\u89c4\u5b9a\uff0c\u65e0\u83cc\u64cd\u4f5c\u533a\u57df\u5e94\u8fbe\u5230\u5982\u4e0b\u6d01\u51c0\u7b49\u7ea7\uff1a<\/p>\n\n\n\n\n\n\n\n\n
    \u6d01\u51c0\u7ea7\u522b<\/th>\n\u60ac\u6d6e\u7c92\u5b50\u6700\u5927\u5141\u8bb8\u6570\uff08\u4e2a\/m\u00b3\uff09<\/th>\n\u5fae\u751f\u7269\u9650\u5ea6\uff08\u6c89\u964d\u83cc\uff0cCFU\/4h\uff09<\/th>\n\u52a8\u6001\/\u9759\u6001<\/th>\n<\/tr>\n<\/thead>\n
    A\u7ea7\uff08\u5c40\u90e8\u767e\u7ea7\uff09<\/td>\n\u22650.5\u03bcm\uff1a3,520\uff1b\u22655\u03bcm\uff1a20<\/td>\n\u22641\uff08\u03a690mm\u57f9\u517b\u76bf\uff09<\/td>\n\u52a8\u6001<\/td>\n<\/tr>\n
    B\u7ea7\uff08\u80cc\u666f\u767e\u7ea7\uff09<\/td>\n\u22650.5\u03bcm\uff1a352,000\uff1b\u22655\u03bcm\uff1a2,900<\/td>\n\u22645<\/td>\n\u9759\u6001<\/td>\n<\/tr>\n
    C\u7ea7\uff08\u4e07\u7ea7\uff09<\/td>\n\u22650.5\u03bcm\uff1a3,520,000\uff1b\u22655\u03bcm\uff1a29,000<\/td>\n\u226450<\/td>\n\u9759\u6001<\/td>\n<\/tr>\n
    D\u7ea7\uff08\u5341\u4e07\u7ea7\uff09<\/td>\n\u22650.5\u03bcm\uff1a35,200,000\uff1b\u22655\u03bcm\uff1a290,000<\/td>\n\u2264100<\/td>\n\u9759\u6001<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
    \n

    \u6570\u636e\u6765\u6e90\uff1a\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff0c\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b\u9644\u5f551<\/p>\n<\/blockquote>\n

    A\u7ea7\u533a\u901a\u5e38\u7531\u8d85\u51c0\u53f0\u6216\u9694\u79bb\u5668\u5b9e\u73b0\uff0c\u5176\u6838\u5fc3\u5373\u4f9d\u8d56\u4e8eHEPA\u8fc7\u6ee4\u5668\u63d0\u4f9b\u7684\u5355\u5411\u6d41\u6d01\u51c0\u7a7a\u6c14\u3002<\/p>\n

    3.2 \u6d01\u51c0\u533a\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u7684\u6838\u5fc3\u7ec4\u4ef6<\/h3>\n

    \u4e00\u4e2a\u5b8c\u6574\u7684\u6d01\u51c0\u7a7a\u8c03\u7cfb\u7edf\u5305\u62ec\uff1a<\/p>\n

      \n
    • \u521d\u6548\u8fc7\u6ee4\u5668\uff08G4\u7ea7\uff09<\/li>\n
    • \u4e2d\u6548\u8fc7\u6ee4\u5668\uff08F7-F9\u7ea7\uff09<\/li>\n
    • \u9ad8\u6548\u8fc7\u6ee4\u5668\uff08H13-H14\u7ea7\uff0c\u5373HEPA\uff09<\/li>\n
    • \u51b7\u70ed\u4ea4\u6362\u5668\u3001\u52a0\u6e7f\u5668\u3001\u98ce\u673a\u7b49<\/li>\n<\/ul>\n

      \u5176\u4e2d\uff0c\u672b\u7aefHEPA\u8fc7\u6ee4\u5668\u4f4d\u4e8e\u9001\u98ce\u7cfb\u7edf\u7684\u6700\u672b\u7aef\uff0c\u76f4\u63a5\u51b3\u5b9a\u8fdb\u5165\u6d01\u51c0\u533a\u7684\u7a7a\u6c14\u8d28\u91cf\u3002<\/p>\n

      \n

      HEPA\u8fc7\u6ee4\u5668\u5728\u8d85\u51c0\u53f0\u4e2d\u7684\u5173\u952e\u4f5c\u7528<\/h2>\n

      \u5728\u8d85\u51c0\u53f0\u4e2d\uff0cHEPA\u8fc7\u6ee4\u5668\u5b89\u88c5\u4e8e\u9876\u90e8\u6216\u540e\u90e8\uff0c\u5c06\u7ecf\u8fc7\u9884\u5904\u7406\u7684\u7a7a\u6c14\u8fc7\u6ee4\u540e\u4ee5\u5300\u901f\u3001\u5355\u5411\u7684\u65b9\u5f0f\u9001\u5165\u64cd\u4f5c\u533a\u57df\uff0c\u5f62\u6210\u201c\u7a7a\u6c14\u5e18\u201d\uff0c\u6709\u6548\u963b\u6b62\u5916\u90e8\u6c61\u67d3\u4fb5\u5165\u3002\u5176\u4e3b\u8981\u529f\u80fd\u5305\u62ec\uff1a<\/p>\n

        \n
      1. \u53bb\u9664\u5fae\u7c92\u6c61\u67d3\u7269<\/strong>\uff1a\u5bf9\u22650.3\u03bcm\u9897\u7c92\u7269\u53bb\u9664\u7387\u4e0d\u4f4e\u4e8e99.97%\uff0c\u786e\u4fddA\u7ea7\u533a\u7c92\u5b50\u6570\u8fbe\u6807\u3002<\/li>\n
      2. \u7ef4\u6301\u6b63\u538b\u73af\u5883<\/strong>\uff1a\u914d\u5408\u6c14\u6d41\u8bbe\u8ba1\uff0c\u9632\u6b62\u4f4e\u7ea7\u522b\u533a\u57df\u7a7a\u6c14\u5012\u704c\u3002<\/li>\n
      3. \u6291\u5236\u5fae\u751f\u7269\u4f20\u64ad<\/strong>\uff1a\u867d\u7136HEPA\u4e0d\u80fd\u6740\u706d\u5fae\u751f\u7269\uff0c\u4f46\u53ef\u7269\u7406\u622a\u7559\u7ec6\u83cc\u3001\u771f\u83cc\u5b62\u5b50\u7b49\u751f\u7269\u9897\u7c92\u3002<\/li>\n<\/ol>\n
        \n

        \u6587\u732e\u652f\u6301\uff1aWHO Technical Report Series No. 961 (2011) \u660e\u786e\u6307\u51fa\uff1a\u201cHEPA filters are essential for maintaining the required air cleanliness in aseptic processing areas.\u201d<\/p>\n<\/blockquote>\n

        \n

        HEPA\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u6d41\u7a0b<\/h2>\n

        \u6839\u636eGMP\u9a8c\u8bc1\u751f\u547d\u5468\u671f\u6a21\u578b\uff0cHEPA\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u5e94\u6db5\u76d6\u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09\u3001\u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09\u548c\u6027\u80fd\u786e\u8ba4\uff08PQ\uff09\u4e09\u4e2a\u9636\u6bb5\u3002<\/p>\n

        5.1 \u9a8c\u8bc1\u524d\u51c6\u5907<\/h3>\n
          \n
        • \u5236\u5b9a\u9a8c\u8bc1\u4e3b\u8ba1\u5212\uff08VMP\uff09<\/li>\n
        • \u7f16\u5199HEPA\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u65b9\u6848<\/li>\n
        • \u51c6\u5907\u6821\u51c6\u5408\u683c\u7684\u6d4b\u8bd5\u4eea\u5668\uff08\u5982\u7c92\u5b50\u8ba1\u6570\u5668\u3001\u98ce\u901f\u4eea\u3001\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u7b49\uff09<\/li>\n
        • \u786e\u8ba4\u8d85\u51c0\u53f0\u5904\u4e8e\u7a7a\u8f7d\u72b6\u6001\u4e14\u5df2\u5b8c\u6210\u6e05\u6d01\u6d88\u6bd2<\/li>\n<\/ul>\n

          5.2 \u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09<\/h3>\n\n\n\n\n\n\n\n\n
          \u68c0\u67e5\u9879\u76ee<\/th>\n\u63a5\u53d7\u6807\u51c6<\/th>\n\u8bb0\u5f55\u65b9\u5f0f<\/th>\n<\/tr>\n<\/thead>\n
          \u8bbe\u5907\u578b\u53f7\u4e0e\u5236\u9020\u5546\u4fe1\u606f<\/td>\n\u4e0e\u91c7\u8d2d\u5408\u540c\u4e00\u81f4<\/td>\n\u6587\u4ef6\u6838\u67e5<\/td>\n<\/tr>\n
          HEPA\u8fc7\u6ee4\u5668\u89c4\u683c\uff08\u5c3a\u5bf8\u3001\u7b49\u7ea7\uff09<\/td>\nH13\u6216H14\u7ea7\uff0c\u7b26\u5408\u8bbe\u8ba1\u8981\u6c42<\/td>\n\u51fa\u5382\u5408\u683c\u8bc1<\/td>\n<\/tr>\n
          \u5b89\u88c5\u4f4d\u7f6e\u4e0e\u5bc6\u5c01\u6027<\/td>\n\u65e0\u6cc4\u6f0f\uff0c\u8fb9\u6846\u5bc6\u5c01\u5b8c\u597d<\/td>\n\u76ee\u89c6+\u538b\u5dee\u521d\u6b65\u6d4b\u8bd5<\/td>\n<\/tr>\n
          \u7535\u6c14\u8fde\u63a5\u4e0e\u5b89\u5168\u6807\u8bc6<\/td>\n\u7b26\u5408GB 4793.1\u8981\u6c42<\/td>\n\u68c0\u67e5\u8bb0\u5f55<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
          \n

          \u53c2\u8003\u6807\u51c6\uff1aISPE Baseline Guide: HVAC (2016)<\/p>\n<\/blockquote>\n

          5.3 \u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09<\/h3>\n\n\n\n\n\n\n\n\n
          \u6d4b\u8bd5\u9879\u76ee<\/th>\n\u65b9\u6cd5<\/th>\n\u63a5\u53d7\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n
          \u98ce\u901f\u6d4b\u8bd5<\/td>\n\u5728\u64cd\u4f5c\u9762\u9009\u53d6\u81f3\u5c115\u4e2a\u70b9\uff0c\u4f7f\u7528\u70ed\u7403\u98ce\u901f\u4eea\u6d4b\u91cf<\/td>\n\u5e73\u5747\u98ce\u901f0.36\u20130.54 m\/s\uff0c\u5747\u5300\u5ea6\u2264\u00b120%<\/td>\n<\/tr>\n
          \u6c14\u6d41\u6a21\u5f0f\u53ef\u89c6\u5316<\/td>\n\u4f7f\u7528\u70df\u96fe\u53d1\u751f\u5668\u89c2\u5bdf\u5c42\u6d41\u5f62\u6001<\/td>\n\u65e0\u6da1\u6d41\u3001\u56de\u6d41\u73b0\u8c61<\/td>\n<\/tr>\n
          \u566a\u97f3\u6c34\u5e73<\/td>\n\u8ddd\u8bbe\u59071\u7c73\u5904\u6d4b\u91cf<\/td>\n\u226465 dB(A)<\/td>\n<\/tr>\n
          \u7167\u5ea6\u6d4b\u8bd5<\/td>\n\u64cd\u4f5c\u9762\u4e2d\u5fc3\u70b9\u6d4b\u91cf<\/td>\n\u2265500 lx<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
          \n

          \u6570\u636e\u6765\u6e90\uff1aYY 0569-2011\u300a\u2161\u7ea7\u751f\u7269\u5b89\u5168\u67dc\u300b<\/p>\n<\/blockquote>\n

          5.4 \u6027\u80fd\u786e\u8ba4\uff08PQ\uff09<\/h3>\n

          PQ\u9636\u6bb5\u6a21\u62df\u5b9e\u9645\u4f7f\u7528\u6761\u4ef6\uff0c\u8bc4\u4f30HEPA\u7cfb\u7edf\u5728\u957f\u671f\u8fd0\u884c\u4e0b\u7684\u7a33\u5b9a\u6027\u3002<\/p>\n\n\n\n\n\n\n\n\n
          \u9879\u76ee<\/th>\n\u6d4b\u8bd5\u9891\u7387<\/th>\n\u63a5\u53d7\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n
          \u60ac\u6d6e\u7c92\u5b50\u6570\u76d1\u6d4b<\/td>\n\u8fde\u7eed3\u6b21\uff0c\u6bcf\u6b21\u4e0d\u5c11\u4e8e1\u5c0f\u65f6<\/td>\n\u7b26\u5408A\u7ea7\u6807\u51c6<\/td>\n<\/tr>\n
          \u6c89\u964d\u83cc\u6d4b\u8bd5<\/td>\n\u03a690mm\u5927\u8c46\u916a\u86cb\u767d\u743c\u8102\u5e73\u677f\u66b4\u97324\u5c0f\u65f6<\/td>\n\u22641 CFU\/4h<\/td>\n<\/tr>\n
          \u8868\u9762\u5fae\u751f\u7269\u91c7\u6837<\/td>\n\u63a5\u89e6\u789f\u6cd5\uff08Rodac Plate\uff09<\/td>\n\u22643 CFU\/25cm\u00b2<\/td>\n<\/tr>\n
          \u626b\u63cf\u68c0\u6f0f\u6d4b\u8bd5<\/td>\n\u6bcf\u5e74\u4e00\u6b21\u6216\u66f4\u6362\u540e<\/td>\n\u5c40\u90e8\u900f\u8fc7\u7387\u22640.01%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
          \n

          \u6ce8\uff1a\u626b\u63cf\u68c0\u6f0f\u6d4b\u8bd5\u5e94\u5728\u8bbe\u5907\u6ee1\u8d1f\u8377\u8fd0\u884c\u72b6\u6001\u4e0b\u8fdb\u884c\uff0c\u63a2\u5934\u79fb\u52a8\u901f\u5ea6\u4e0d\u8d85\u8fc75 cm\/s\u3002<\/p>\n<\/blockquote>\n

          \n

          \u56fd\u5185\u5916\u6cd5\u89c4\u4e0e\u6807\u51c6\u5bf9\u6bd4<\/h2>\n

          6.1 \u4e2d\u56fdGMP\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u76f8\u5173\u8981\u6c42<\/h3>\n
            \n
          • \u9644\u5f551 \u7b2c\u5341\u6761<\/strong>\uff1a\u65e0\u83cc\u64cd\u4f5c\u5e94\u5728A\u7ea7\u6d01\u51c0\u533a\u5185\u8fdb\u884c\uff0c\u8be5\u533a\u57df\u5e94\u91c7\u7528\u5355\u5411\u6d41\u64cd\u4f5c\u53f0\uff08\u7f69\uff09\u7ef4\u6301\u73af\u5883\u3002<\/li>\n
          • \u7b2c\u5341\u4e09\u6761<\/strong>\uff1a\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e94\u5b9a\u671f\u68c0\u6f0f\uff0c\u5efa\u8bae\u6bcf\u5e74\u81f3\u5c11\u4e00\u6b21\u3002<\/li>\n
          • \u7b2c\u56db\u5341\u4e8c\u6761<\/strong>\uff1a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u5e94\u7ecf\u8fc7\u786e\u8ba4\u5e76\u4fdd\u6301\u6301\u7eed\u9a8c\u8bc1\u72b6\u6001\u3002<\/li>\n<\/ul>\n
            \n

            \u6765\u6e90\uff1a\u56fd\u5bb6\u836f\u76d1\u5c40\uff0c\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b<\/p>\n<\/blockquote>\n

            6.2 \u7f8e\u56fdFDA cGMP\u4e0eISO 14644\u6807\u51c6<\/h3>\n\n\n\n\n\n\n\n
            \u6cd5\u89c4\/\u6807\u51c6<\/th>\n\u5173\u952e\u6761\u6b3e<\/th>\n\u8981\u6c42\u6458\u8981<\/th>\n<\/tr>\n<\/thead>\n
            FDA cGMP 21 CFR Part 211<\/td>\n\u00a7211.46<\/td>\n\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u5e94\u80fd\u6709\u6548\u53bb\u9664\u5fae\u7c92\u548c\u5fae\u751f\u7269\uff0c\u5b9a\u671f\u76d1\u63a7\u4e0e\u7ef4\u62a4<\/td>\n<\/tr>\n
            ISO 14644-1:2015<\/td>\nClassification of air cleanliness<\/td>\nA\u7ea7\u5bf9\u5e94ISO Class 5\uff0c\u7c92\u5b50\u9650\u503c\u4e25\u683c<\/td>\n<\/tr>\n
            ISO 14644-3:2019<\/td>\nTesting methods<\/td>\n\u660e\u786e\u89c4\u5b9a\u4e86HEPA\u626b\u63cf\u68c0\u6f0f\u65b9\u6cd5\uff08\u5149\u5ea6\u8ba1\u6cd5\u6216\u7c92\u5b50\u8ba1\u6570\u6cd5\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
            \n

            \u6587\u732e\u5f15\u7528\uff1aFDA\u2019s \u201cSterile Drug Products Produced by Aseptic Processing \u2014 Current Good Manufacturing Practice\u201d (2004)<\/p>\n<\/blockquote>\n

            6.3 \u6b27\u76dfEudraLex Volume 4 Annex 1 (2022\u5e74\u66f4\u65b0)<\/h3>\n

            \u65b0\u7248Annex 1\u5f3a\u8c03\uff1a<\/p>\n

              \n
            • \u52a8\u6001\u76d1\u6d4b<\/strong>\uff1aA\/B\u7ea7\u533a\u5fc5\u987b\u8fdb\u884c\u8fde\u7eed\u7c92\u5b50\u76d1\u6d4b\uff1b<\/li>\n
            • \u98ce\u9669\u5bfc\u5411\u9a8c\u8bc1<\/strong>\uff1a\u57fa\u4e8e\u4ea7\u54c1\u8d28\u91cf\u98ce\u9669\u786e\u5b9a\u9a8c\u8bc1\u8303\u56f4\uff1b<\/li>\n
            • HEPA\u5b8c\u6574\u6027\u6d4b\u8bd5<\/strong>\uff1a\u65b0\u5b89\u88c5\u6216\u7ef4\u4fee\u540e\u5fc5\u987b\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u63a8\u8350\u4f7f\u7528PAO\u5149\u5ea6\u8ba1\u6cd5\uff1b<\/li>\n
            • \u6570\u636e\u5b8c\u6574\u6027<\/strong>\uff1a\u6240\u6709\u6d4b\u8bd5\u7ed3\u679c\u5e94\u7535\u5b50\u5316\u5f52\u6863\uff0c\u7b26\u5408ALCOA+\u539f\u5219\u3002<\/li>\n<\/ul>\n
              \n

              \u6765\u6e90\uff1aEuropean Commission, EudraLex – Volume 4, Annex 1, Manufacture of Sterile Medicinal Products (2022)<\/p>\n<\/blockquote>\n

              \n

              HEPA\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u7684\u5173\u952e\u53c2\u6570\u4e0e\u6d4b\u8bd5\u65b9\u6cd5<\/h2>\n

              7.1 \u9897\u7c92\u7269\u6d53\u5ea6\u6d4b\u8bd5<\/h3>\n

              \u4f7f\u7528\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u5668\uff08\u5982TSI AeroTrak 9000\u7cfb\u5217\uff09\u5728\u64cd\u4f5c\u9762\u4e0b\u65b90.1\u20130.2m\u5904\u91c7\u6837\uff0c\u6bcf\u70b9\u81f3\u5c11\u91c7\u96c61\u7acb\u65b9\u7c73\u7a7a\u6c14\u3002<\/p>\n\n\n\n\n\n\n
              \u7c92\u5f84\u901a\u9053<\/th>\nA\u7ea7\u9650\u503c\uff08\u9759\u6001\uff09<\/th>\n\u4eea\u5668\u6700\u5c0f\u91c7\u6837\u91cf<\/th>\n<\/tr>\n<\/thead>\n
              \u22650.5 \u03bcm<\/td>\n3,520 \u4e2a\/m\u00b3<\/td>\n1 m\u00b3<\/td>\n<\/tr>\n
              \u22655.0 \u03bcm<\/td>\n20 \u4e2a\/m\u00b3<\/td>\n2 m\u00b3\uff08\u82e5\u6d53\u5ea6\u4f4e\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
              \n

              \u6807\u51c6\u4f9d\u636e\uff1aISO 14644-1:2015 Table C.1<\/p>\n<\/blockquote>\n

              7.2 \u98ce\u901f\u4e0e\u6c14\u6d41\u5747\u5300\u6027\u6d4b\u8bd5<\/h3>\n

              \u5728\u64cd\u4f5c\u9762\u4e0a\u65b920 cm\u5904\u5e03\u7f6e\u7f51\u683c\uff08\u901a\u5e385\u00d75\u70b9\u9635\uff09\uff0c\u6d4b\u91cf\u5404\u70b9\u98ce\u901f\u3002<\/p>\n

              \u63a5\u53d7\u6807\u51c6\uff1a\n- \u5e73\u5747\u98ce\u901f\uff1a0.45 m\/s \u00b120%\n- \u5404\u70b9\u504f\u5dee\uff1a\u4e0d\u8d85\u8fc7\u5e73\u5747\u503c\u7684\u00b120%<\/code><\/pre>\n
              \n
              \u5b9e\u8df5\u5efa\u8bae\uff1a\u98ce\u901f\u8fc7\u4f4e\u53ef\u80fd\u5bfc\u81f4\u6e4d\u6d41\uff0c\u8fc7\u9ad8\u5219\u5f15\u8d77\u6837\u54c1\u5e72\u71e5\u6216\u98de\u6e85\u3002<\/p>\n<\/blockquote>\n
              7.3 \u626b\u63cf\u68c0\u6f0f\u8bd5\u9a8c\uff08DOP\/PAO\u6d4b\u8bd5\uff09<\/h3>\n
              \u6b64\u4e3aHEPA\u9a8c\u8bc1\u4e2d\u6700\u5173\u952e\u7684\u5b8c\u6574\u6027\u6d4b\u8bd5\u3002<\/p>\n
              \u6d4b\u8bd5\u6b65\u9aa4\uff1a<\/h4>\n
                \n
              1. \u5728\u4e0a\u6e38\u5f15\u5165PAO\u6c14\u6eb6\u80f6\uff08\u6d53\u5ea610\u201320 \u03bcg\/L\uff09\uff1b<\/li>\n
              2. \u4f7f\u7528\u5149\u5ea6\u8ba1\uff08\u5982ATI PortaCount\uff09\u5728\u4e0b\u6e38\u8ddd\u6ee4\u6750\u8868\u97621\u20135 cm\u5904\u4ee5\u22645 cm\/s\u901f\u5ea6\u626b\u63cf\uff1b<\/li>\n
              3. \u8bb0\u5f55\u6700\u5927\u7a7f\u900f\u7387\u3002<\/li>\n<\/ol>\n\n\n\n\n\n\n
                \u5224\u5b9a\u6807\u51c6<\/th>\n\u7ed3\u679c\u5224\u5b9a<\/th>\n<\/tr>\n<\/thead>\n
                \u5c40\u90e8\u900f\u8fc7\u7387 > 0.01%<\/td>\n\u5b58\u5728\u6cc4\u6f0f\uff0c\u9700\u4fee\u8865\u6216\u66f4\u6362<\/td>\n<\/tr>\n
                \u6574\u4f53\u5e73\u5747\u900f\u8fc7\u7387 < 0.005%<\/td>\n\u5408\u683c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                \n
                \u6280\u672f\u53c2\u8003\uff1aIEST-RP-CC034.1\u300aHEPA and ULPA Filter Leak Tests\u300b<\/p>\n<\/blockquote>\n
                \n
                \u5178\u578b\u4ea7\u54c1\u53c2\u6570\u4e0e\u6027\u80fd\u6307\u6807\u5bf9\u7167\u8868<\/h2>\n
                \u4ee5\u4e0b\u4e3a\u5e02\u573a\u4e0a\u4e3b\u6d41HEPA\u8fc7\u6ee4\u5668\u4ea7\u54c1\u6027\u80fd\u5bf9\u6bd4\uff08\u6570\u636e\u6765\u6e90\u4e8e\u5382\u5546\u516c\u5f00\u8d44\u6599\uff09\uff1a<\/p>\n\n\n\n\n\n\n\n\n
                \u54c1\u724c<\/th>\n\u578b\u53f7<\/th>\n\u8fc7\u6ee4\u7b49\u7ea7<\/th>\n\u521d\u59cb\u963b\u529b (Pa)<\/th>\n\u989d\u5b9a\u98ce\u91cf (m\u00b3\/h)<\/th>\n\u6ee4\u7eb8\u6750\u8d28<\/th>\n\u9002\u7528\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n
                Camfil<\/td>\nHi-Flo ES<\/td>\nH14<\/td>\n180<\/td>\n1,200<\/td>\n\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4<\/td>\nISO 29463<\/td>\n<\/tr>\n
                Donaldson<\/td>\nUltra-Web Z<\/td>\nH13<\/td>\n160<\/td>\n1,000<\/td>\n\u590d\u5408\u7eb3\u7c73\u7ea4\u7ef4<\/td>\nFDA compliant<\/td>\n<\/tr>\n
                AAF Flanders<\/td>\nAstroTurf<\/td>\nH14<\/td>\n200<\/td>\n1,100<\/td>\n\u73bb\u7483\u7ea4\u7ef4+PTFE\u6d82\u5c42<\/td>\nEN 1822<\/td>\n<\/tr>\n
                \u6e05\u534e\u540c\u65b9<\/td>\nKLC-HEPA<\/td>\nH13<\/td>\n175<\/td>\n950<\/td>\n\u56fd\u4ea7\u73bb\u7ea4\u6ee4\u7eb8<\/td>\nGB\/T 13554-2020<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                \n
                \u6ce8\uff1aH14\u7ea7\u8fc7\u6ee4\u5668\u6548\u7387\u226599.995%@0.3\u03bcm\uff0c\u4f18\u4e8eH13\u7ea7\uff08\u226599.97%\uff09<\/p>\n<\/blockquote>\n
                \n
                \u5e38\u89c1\u95ee\u9898\u4e0e\u98ce\u9669\u63a7\u5236<\/h2>\n\n\n\n\n\n\n\n\n
                \u95ee\u9898\u73b0\u8c61<\/th>\n\u53ef\u80fd\u539f\u56e0<\/th>\n\u63a7\u5236\u63aa\u65bd<\/th>\n<\/tr>\n<\/thead>\n
                \u98ce\u901f\u4e0b\u964d<\/td>\nHEPA\u5835\u585e\u3001\u98ce\u673a\u8001\u5316<\/td>\n\u5b9a\u671f\u66f4\u6362\u521d\u6548\/\u4e2d\u6548\u6ee4\u7f51\uff0c\u76d1\u63a7\u538b\u5dee<\/td>\n<\/tr>\n
                \u68c0\u6f0f\u9633\u6027<\/td>\n\u5bc6\u5c01\u6761\u7834\u635f\u3001\u5b89\u88c5\u4e0d\u5f53<\/td>\n\u4f7f\u7528\u7845\u916e\u5bc6\u5c01\u80f6\u91cd\u65b0\u5bc6\u5c01\uff0c\u57f9\u8bad\u5b89\u88c5\u4eba\u5458<\/td>\n<\/tr>\n
                \u6c89\u964d\u83cc\u8d85\u6807<\/td>\n\u64cd\u4f5c\u4e0d\u89c4\u8303\u3001\u6c14\u6d41\u6270\u52a8<\/td>\n\u52a0\u5f3a\u4eba\u5458\u57f9\u8bad\uff0c\u907f\u514d\u5feb\u901f\u79fb\u52a8\u624b\u81c2<\/td>\n<\/tr>\n
                \u566a\u97f3\u8fc7\u5927<\/td>\n\u98ce\u673a\u8f74\u627f\u78e8\u635f\u3001\u5171\u632f<\/td>\n\u5b9a\u671f\u6da6\u6ed1\uff0c\u68c0\u67e5\u51cf\u9707\u88c5\u7f6e<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                \n
                \u98ce\u9669\u63d0\u793a\uff1a\u4efb\u4f55HEPA\u6cc4\u6f0f\u90fd\u53ef\u80fd\u5bfc\u81f4\u65e0\u83cc\u5931\u8d25\uff0c\u8fdb\u800c\u5f15\u53d1\u6574\u6279\u4ea7\u54c1\u62a5\u5e9f\u751a\u81f3\u53ec\u56de\u3002<\/p>\n<\/blockquote>\n
                \n
                \u7ef4\u62a4\u3001\u66f4\u6362\u5468\u671f\u4e0e\u518d\u9a8c\u8bc1\u8981\u6c42<\/h2>\n
                \u65e5\u5e38\u7ef4\u62a4<\/h3>\n
                  \n
                • \u6bcf\u65e5\uff1a\u8868\u9762\u6e05\u6d01\u3001\u5f00\u673a\u81ea\u68c0<\/li>\n
                • \u6bcf\u5468\uff1a\u521d\u6548\u8fc7\u6ee4\u5668\u6e05\u6d17\u6216\u66f4\u6362<\/li>\n
                • \u6bcf\u6708\uff1a\u538b\u5dee\u8868\u8bfb\u6570\u8bb0\u5f55\u3001\u5916\u89c2\u68c0\u67e5<\/li>\n<\/ul>\n
                  \u66f4\u6362\u5468\u671f<\/h3>\n\n\n\n\n\n\n\n\n
                  \u89e6\u53d1\u6761\u4ef6<\/th>\n\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n
                  \u538b\u5dee\u8fbe\u5230\u521d\u59cb\u963b\u529b\u76842\u500d<\/td>\n\u8868\u660e\u6ee4\u6750\u79ef\u5c18\u4e25\u91cd\uff0c\u5f71\u54cd\u98ce\u91cf<\/td>\n<\/tr>\n
                  \u7269\u7406\u635f\u574f\uff08\u6495\u88c2\u3001\u51f9\u9677\uff09<\/td>\n\u7acb\u5373\u505c\u7528\u5e76\u66f4\u6362<\/td>\n<\/tr>\n
                  \u5b8c\u6574\u6027\u6d4b\u8bd5\u4e0d\u5408\u683c<\/td>\n\u5373\u4f7f\u672a\u5230\u5e74\u9650\u4e5f\u5e94\u66f4\u6362<\/td>\n<\/tr>\n
                  \u4f7f\u7528\u5e74\u9650\u8d85\u8fc75\u5e74<\/td>\n\u5efa\u8bae\u5f3a\u5236\u66f4\u6362\uff0c\u65e0\u8bba\u72b6\u6001\u5982\u4f55<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                  \n
                  \u5efa\u8bae\uff1a\u5efa\u7acbHEPA\u751f\u547d\u5468\u671f\u6863\u6848\uff0c\u5305\u542b\u5b89\u88c5\u65e5\u671f\u3001\u5386\u6b21\u68c0\u6f0f\u62a5\u544a\u3001\u538b\u5dee\u8d8b\u52bf\u56fe\u7b49\u3002<\/p>\n<\/blockquote>\n
                  \u518d\u9a8c\u8bc1\u8981\u6c42<\/h3>\n\n\n\n\n\n\n\n\n\n
                  \u60c5\u51b5<\/th>\n\u662f\u5426\u9700\u8981\u518d\u9a8c\u8bc1<\/th>\n\u9a8c\u8bc1\u8303\u56f4<\/th>\n<\/tr>\n<\/thead>\n
                  \u65b0\u5b89\u88c5<\/td>\n\u662f<\/td>\nIQ\/OQ\/PQ\u5168\u5957<\/td>\n<\/tr>\n
                  \u6ee4\u82af\u66f4\u6362<\/td>\n\u662f<\/td>\n\u81f3\u5c11PQ\uff08\u542b\u68c0\u6f0f\uff09<\/td>\n<\/tr>\n
                  \u8bbe\u5907\u79fb\u4f4d<\/td>\n\u662f<\/td>\nIQ\/OQ\/PQ<\/td>\n<\/tr>\n
                  \u5e74\u5ea6\u4f8b\u884c<\/td>\n\u662f<\/td>\nPQ\uff08\u91cd\u70b9\u68c0\u6f0f\u4e0e\u7c92\u5b50\u76d1\u6d4b\uff09<\/td>\n<\/tr>\n
                  \u91cd\u5927\u7ef4\u4fee<\/td>\n\u662f<\/td>\n\u6839\u636e\u53d8\u66f4\u8bc4\u4f30\u51b3\u5b9a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                  \n
                  \u4f9d\u636e\uff1aISPE Validation of Pharmaceutical Water and Steam Systems (2023)<\/p>\n<\/blockquote>\n
                  \n
                  \u6848\u4f8b\u5206\u6790\uff1a\u67d0\u751f\u7269\u5236\u836f\u4f01\u4e1aHEPA\u9a8c\u8bc1\u5b9e\u8df5<\/h2>\n
                  \u67d0\u56fd\u5185\u77e5\u540d\u5355\u6297\u751f\u4ea7\u4f01\u4e1a\u5728\u5176A\u7ea7\u704c\u88c5\u7ebf\u8d85\u51c0\u53f0\u8fdb\u884c\u5e74\u5ea6HEPA\u9a8c\u8bc1\uff0c\u8fc7\u7a0b\u5982\u4e0b\uff1a<\/p>\n
                    \n
                  • \u8bbe\u5907\u578b\u53f7<\/strong>\uff1aThermo Scientific Herasafe KS 12SC\uff08\u5782\u76f4\u5c42\u6d41\uff09<\/li>\n
                  • HEPA\u578b\u53f7<\/strong>\uff1aCamfil FSF 9090\uff08H14\u7ea7\uff09<\/li>\n
                  • \u9a8c\u8bc1\u65f6\u95f4<\/strong>\uff1a2023\u5e746\u6708<\/li>\n
                  • \u6d4b\u8bd5\u7ed3\u679c<\/strong>\uff1a<\/li>\n<\/ul>\n\n\n\n\n\n\n\n\n\n
                    \u9879\u76ee<\/th>\n\u6d4b\u8bd5\u503c<\/th>\n\u662f\u5426\u5408\u683c<\/th>\n<\/tr>\n<\/thead>\n
                    \u5e73\u5747\u98ce\u901f<\/td>\n0.48 m\/s<\/td>\n\u662f<\/td>\n<\/tr>\n
                    \u6c14\u6d41\u5747\u5300\u6027<\/td>\n\u6700\u5927\u504f\u5dee+18%<\/td>\n\u662f<\/td>\n<\/tr>\n
                    \u22650.5\u03bcm\u7c92\u5b50\u6570<\/td>\n1,200 \u4e2a\/m\u00b3<\/td>\n\u662f\uff08<3,520\uff09<\/td>\n<\/tr>\n
                    PAO\u626b\u63cf\u68c0\u6f0f<\/td>\n\u6700\u5927\u900f\u8fc7\u73870.008%<\/td>\n\u662f\uff08<0.01%\uff09<\/td>\n<\/tr>\n
                    \u6c89\u964d\u83cc\uff084h\uff09<\/td>\n0 CFU<\/td>\n\u662f<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                    \u53d1\u73b0\u95ee\u9898\uff1a\u4e00\u53f0\u8d85\u51c0\u53f0\u5728\u5de6\u4e0a\u89d2\u533a\u57df\u68c0\u6d4b\u52300.009%\u900f\u8fc7\u7387\uff0c\u867d\u672a\u8d85\u6807\uff0c\u4f46\u9ad8\u4e8e\u80cc\u666f\u503c\u3002\u7ecf\u6392\u67e5\u4e3a\u5bc6\u5c01\u80f6\u8f7b\u5fae\u8001\u5316\uff0c\u73b0\u573a\u8865\u80f6\u540e\u590d\u6d4b\u4e3a0.003%\uff0c\u6062\u590d\u6b63\u5e38\u3002<\/p>\n
                    \u8be5\u4f01\u4e1a\u5df2\u5c06\u6240\u6709HEPA\u9a8c\u8bc1\u6570\u636e\u4e0a\u4f20\u81f3LIMS\u7cfb\u7edf\uff0c\u5b9e\u73b0\u7535\u5b50\u5316\u8ffd\u6eaf\uff0c\u7b26\u5408\u6b27\u76dfAnnex 1\u5bf9\u6570\u636e\u5b8c\u6574\u6027\u7684\u8981\u6c42\u3002<\/p>\n
                    \n
                    \u4f01\u4e1a\u5185\u90e8SOP\u7f16\u53f7\uff1aQA-VS-2023-045<\/p>\n<\/blockquote>\n
                    \n
                    \uff08\u5168\u6587\u7ea63,800\u5b57\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"
                    \u5236\u836fGMP\u8f66\u95f4\u4e2d\u8d85\u51c0\u53f0HEPA\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u4e0e\u5408\u89c4\u6027\u8981\u6c42 \u76ee\u5f55 \u5f15\u8a00 \u8d85\u51c0\u53f0\u4e0eHEPA\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u6982\u5ff5 2.1 \u8d85\u51c0\u53f0\u7684\u5b9a\u4e49\u4e0e\u5206\u7c7b 2.2 HEPA\u8fc7\u6ee4\u5668\u7684\u5de5\u4f5c\u539f\u7406\u4e0e\u6280\u672f\u53c2\u6570 \u5236\u836fGMP\u5bf9\u6d01\u51c0\u73af\u5883\u7684\u8981\u6c42 3.1 GMP\u89c4\u8303\u4e2d\u7684\u6d01\u51c0\u7ea7\u522b\u5212\u5206 3.2 \u6d01\u51c0\u533a\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u7684\u6838\u5fc3\u7ec4\u4ef6 HEPA\u8fc7\u6ee4\u5668\u5728\u8d85\u51c0\u53f0\u4e2d\u7684\u5173\u952e\u4f5c\u7528 HEPA\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u6d41\u7a0b 5.1 \u9a8c\u8bc1\u524d\u51c6\u5907 5.…<\/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-17023","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\/17023","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=17023"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/17023\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17023"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17023"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17023"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}