{"id":16917,"date":"2025-09-22T16:02:43","date_gmt":"2025-09-22T08:02:43","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16917"},"modified":"2025-09-22T16:02:43","modified_gmt":"2025-09-22T08:02:43","slug":"%e5%88%b6%e8%8d%af%e7%94%a8%e6%b0%b4%e7%b3%bb%e7%bb%9f%e7%8e%af%e5%a2%83%e6%8e%a7%e5%88%b6%ef%bc%9aw%e5%9e%8b%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e4%b8%8eulpa%e8%bf%87%e6%bb%a4%e6%8a%80","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16917","title":{"rendered":"\u5236\u836f\u7528\u6c34\u7cfb\u7edf\u73af\u5883\u63a7\u5236\uff1aW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e0eULPA\u8fc7\u6ee4\u6280\u672f\u7684\u5bf9\u6bd4\u5206\u6790"},"content":{"rendered":"

\u5236\u836f\u7528\u6c34\u7cfb\u7edf\u73af\u5883\u63a7\u5236\uff1aW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e0eULPA\u8fc7\u6ee4\u6280\u672f\u7684\u5bf9\u6bd4\u5206\u6790<\/h1>\n

\u5f15\u8a00<\/h2>\n

\u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u5bf9\u6d01\u51c0\u73af\u5883\u7684\u8981\u6c42\u6781\u4e3a\u4e25\u683c\u3002\u5c24\u5176\u662f\u5236\u836f\u7528\u6c34\u7cfb\u7edf\uff08Water for Injection, WFI\uff1bPurified Water, PW\u7b49\uff09\uff0c\u5176\u6c34\u8d28\u76f4\u63a5\u5173\u7cfb\u5230\u6700\u7ec8\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u4e0e\u6709\u6548\u6027\u3002\u6839\u636e\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff082020\u5e74\u7248\uff09\u53ca\u7f8e\u56fd\u836f\u5178\uff08USP\uff09\u3001\u6b27\u6d32\u836f\u5178\uff08Ph. Eur.\uff09\u7684\u76f8\u5173\u89c4\u5b9a\uff0c\u5236\u836f\u7528\u6c34\u5fc5\u987b\u5728\u9ad8\u5ea6\u53d7\u63a7\u7684\u73af\u5883\u4e2d\u5236\u5907\u3001\u50a8\u5b58\u548c\u8f93\u9001\uff0c\u4ee5\u9632\u6b62\u5fae\u751f\u7269\u3001\u9897\u7c92\u7269\u53ca\u70ed\u539f\u6c61\u67d3\u3002<\/p>\n

\u4e3a\u4fdd\u969c\u5236\u836f\u7528\u6c34\u7cfb\u7edf\u7684\u6d01\u51c0\u5ea6\uff0c\u7a7a\u6c14\u6d01\u51c0\u6280\u672f\u6210\u4e3a\u5173\u952e\u73af\u8282\u4e4b\u4e00\u3002\u5176\u4e2d\uff0c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u53ca\u5176\u5347\u7ea7\u7248\u672c\u2014\u2014\u8d85\u4f4e\u7a7f\u900f\u7387\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08ULPA\uff09\u88ab\u5e7f\u6cdb\u5e94\u7528\u4e8e\u6d01\u51c0\u5ba4\u901a\u98ce\u7cfb\u7edf\u3002\u8fd1\u5e74\u6765\uff0c\u4e00\u79cd\u65b0\u578b\u7ed3\u6784\u7684\u201cW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u201d\u56e0\u5176\u9ad8\u5bb9\u5c18\u91cf\u3001\u4f4e\u98ce\u963b\u548c\u957f\u5bff\u547d\u7279\u6027\uff0c\u5728\u5236\u836f\u884c\u4e1a\u53d7\u5230\u5173\u6ce8\u3002\u672c\u6587\u5c06\u56f4\u7ed5W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668<\/strong>\u4e0eULPA\u8fc7\u6ee4\u6280\u672f<\/strong>\u5728\u5236\u836f\u7528\u6c34\u7cfb\u7edf\u73af\u5883\u63a7\u5236\u4e2d\u7684\u5e94\u7528\u5c55\u5f00\u6df1\u5165\u5bf9\u6bd4\u5206\u6790\uff0c\u6db5\u76d6\u6280\u672f\u539f\u7406\u3001\u6027\u80fd\u53c2\u6570\u3001\u9002\u7528\u573a\u666f\u3001\u56fd\u5185\u5916\u6807\u51c6\u89c4\u8303\u53ca\u5b9e\u9645\u5de5\u7a0b\u6848\u4f8b\uff0c\u5e76\u5f15\u7528\u4e2d\u5916\u6743\u5a01\u6587\u732e\u652f\u6301\u8bba\u8ff0\u3002<\/p>\n

\n

\u4e00\u3001\u57fa\u672c\u6982\u5ff5\u4e0e\u6280\u672f\u80cc\u666f<\/h2>\n

1.1 \u9ad8\u6548\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u4e0eULPA\u8fc7\u6ee4\u5668\u5b9a\u4e49<\/h3>\n

\u6839\u636e\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7ISO 29463\u6807\u51c6\u4ee5\u53ca\u7f8e\u56fd\u519b\u7528\u6807\u51c6MIL-STD-282\uff0c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High Efficiency Particulate Air Filter, HEPA\uff09\u662f\u6307\u5bf9\u7c92\u5f84\u22650.3 \u03bcm\u7684\u5fae\u7c92\u5177\u6709\u81f3\u5c1199.97%\u8fc7\u6ee4\u6548\u7387\u7684\u7a7a\u6c14\u8fc7\u6ee4\u8bbe\u5907\u3002\u800c\u8d85\u4f4e\u7a7f\u900f\u7387\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08Ultra-Low Penetration Air Filter, ULPA\uff09\u5219\u8fdb\u4e00\u6b65\u63d0\u5347\u4e86\u8fc7\u6ee4\u7cbe\u5ea6\uff0c\u901a\u5e38\u8981\u6c42\u5bf90.1\u20130.2 \u03bcm\u9897\u7c92\u7684\u8fc7\u6ee4\u6548\u7387\u8fbe\u523099.999%\u4ee5\u4e0a\u3002<\/p>\n\n\n\n\n\n\n\n\n\n
\u8fc7\u6ee4\u5668\u7c7b\u578b<\/th>\n\u6807\u51c6\u6d4b\u8bd5\u7c92\u5f84\uff08\u03bcm\uff09<\/th>\n\u6700\u5c0f\u8fc7\u6ee4\u6548\u7387<\/th>\n\u56fd\u9645\u6807\u51c6\u4f9d\u636e<\/th>\n<\/tr>\n<\/thead>\n
HEPA H13<\/td>\n0.3<\/td>\n\u226599.97%<\/td>\nISO 29463-3:2011<\/td>\n<\/tr>\n
HEPA H14<\/td>\n0.3<\/td>\n\u226599.995%<\/td>\nISO 29463-3:2011<\/td>\n<\/tr>\n
ULPA U15<\/td>\n0.1\u20130.2<\/td>\n\u226599.999%<\/td>\nISO 29463-4:2011<\/td>\n<\/tr>\n
ULPA U16<\/td>\n0.1\u20130.2<\/td>\n\u226599.9995%<\/td>\nISO 29463-4:2011<\/td>\n<\/tr>\n
ULPA U17<\/td>\n0.1\u20130.2<\/td>\n\u226599.9999%<\/td>\nISO 29463-4:2011<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\n

\u6570\u636e\u6765\u6e90\uff1aISO 29463:2011\u300aHigh-efficiency and ultra-high efficiency gas filters and filter elements\u300b<\/p>\n<\/blockquote>\n

1.2 W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u7279\u70b9<\/h3>\n

W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u91c7\u7528\u6298\u53e0\u5f0f\u6ce2\u7eb9\u7ed3\u6784\u8bbe\u8ba1\u7684HEPA\u7c7b\u8fc7\u6ee4\u5668\uff0c\u5176\u540d\u79f0\u6765\u6e90\u4e8e\u5176\u622a\u9762\u5448\u201cW\u201d\u5f62\u6392\u5217\u7684\u6ee4\u7eb8\u8936\u76b1\u7ed3\u6784\u3002\u8be5\u7ed3\u6784\u663e\u8457\u589e\u52a0\u4e86\u5355\u4f4d\u4f53\u79ef\u5185\u7684\u6709\u6548\u8fc7\u6ee4\u9762\u79ef\uff0c\u4ece\u800c\u63d0\u5347\u5bb9\u5c18\u80fd\u529b\u5e76\u964d\u4f4e\u521d\u59cb\u538b\u964d\u3002<\/p>\n

\u76f8\u8f83\u4e8e\u4f20\u7edf\u5e73\u677f\u5f0f\u6216V\u578bHEPA\u8fc7\u6ee4\u5668\uff0cW\u578b\u7ed3\u6784\u901a\u8fc7\u4f18\u5316\u6c14\u6d41\u5206\u5e03\u8def\u5f84\uff0c\u5b9e\u73b0\u66f4\u5747\u5300\u7684\u7a7a\u6c14\u901a\u8fc7\u901f\u5ea6\uff0c\u51cf\u5c11\u5c40\u90e8\u5835\u585e\u98ce\u9669\uff0c\u5ef6\u957f\u4f7f\u7528\u5bff\u547d\u3002\u6b64\u7c7b\u4ea7\u54c1\u591a\u7528\u4e8e\u5236\u836f\u5382\u6d01\u51c0\u533a\u7a7a\u8c03\u7cfb\u7edf\uff08AHU\uff09\u3001\u5c42\u6d41\u7f69\u3001\u751f\u7269\u5b89\u5168\u67dc\u7b49\u5173\u952e\u533a\u57df\u3002<\/p>\n

\n

\u4e8c\u3001\u6838\u5fc3\u6280\u672f\u53c2\u6570\u5bf9\u6bd4\u5206\u6790<\/h2>\n

\u4ee5\u4e0b\u4ece\u591a\u4e2a\u7ef4\u5ea6\u5bf9W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e0eULPA\u8fc7\u6ee4\u6280\u672f\u8fdb\u884c\u8be6\u7ec6\u6bd4\u8f83\uff1a<\/p>\n

2.1 \u8fc7\u6ee4\u6548\u7387\u4e0e\u9897\u7c92\u6355\u96c6\u80fd\u529b<\/h3>\n\n\n\n\n\n\n\n\n\n
\u53c2\u6570\u9879<\/th>\nW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08H14\u7ea7\uff09<\/th>\nULPA U15\u8fc7\u6ee4\u5668<\/th>\nULPA U17\u8fc7\u6ee4\u5668<\/th>\n<\/tr>\n<\/thead>\n
\u6d4b\u8bd5\u7c92\u5f84<\/td>\n0.3 \u03bcm<\/td>\n0.1\u20130.2 \u03bcm<\/td>\n0.1\u20130.2 \u03bcm<\/td>\n<\/tr>\n
\u8fc7\u6ee4\u6548\u7387<\/td>\n\u226599.995%<\/td>\n\u226599.999%<\/td>\n\u226599.9999%<\/td>\n<\/tr>\n
\u7a7f\u900f\u7387<\/td>\n\u22640.005%<\/td>\n\u22640.001%<\/td>\n\u22640.0001%<\/td>\n<\/tr>\n
\u4e3b\u8981\u6d4b\u8bd5\u65b9\u6cd5<\/td>\nDOP\/PAO\u53d1\u751f\u5668+\u5149\u5ea6\u8ba1\u6cd5<\/td>\n\u94a0\u7130\u6cd5\/\u8ba1\u6570\u6cd5<\/td>\n\u51dd\u7ed3\u6838\u8ba1\u6570\u6cd5\uff08CNC\uff09<\/td>\n<\/tr>\n
\u7b26\u5408\u6807\u51c6<\/td>\nGB\/T 13554-2020, ISO 29463<\/td>\nISO 29463-4, IEST-G-CC001<\/td>\nISO 29463-4, EN 1822<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\n

\u6ce8\u91ca\uff1a<\/p>\n

    \n
  • DOP\uff1a\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f\uff0c\u5e38\u7528\u4e8e\u6c14\u6eb6\u80f6\u6311\u6218\u6d4b\u8bd5\uff1b<\/li>\n
  • PAO\uff1a\u805a\u03b1\u70ef\u70c3\uff0c\u66ff\u4ee3DOP\u7684\u73af\u4fdd\u578b\u6d4b\u8bd5\u4ecb\u8d28\uff1b<\/li>\n
  • CNC\uff1aCondensation Nucleus Counter\uff0c\u7528\u4e8eULPA\u7ea7\u7cbe\u786e\u6d4b\u91cf\u3002<\/li>\n<\/ul>\n<\/blockquote>\n

    \u6839\u636e\u7f8e\u56fdIES\uff08Institute of Environmental Sciences and Technology\uff09\u53d1\u5e03\u7684\u300aIEST-G-CC001.4 Recommended Practice for HEPA and ULPA Filter Testing\u300b\uff0cULPA\u8fc7\u6ee4\u5668\u9700\u4f7f\u7528\u7c92\u5b50\u8ba1\u6570\u5668\u5728\u4e0b\u6e38\u68c0\u6d4b0.1\u20130.2 \u03bcm\u8303\u56f4\u5185\u7684\u7a7f\u900f\u5cf0\u503c\uff08Most Penetrating Particle Size, MPPS\uff09\uff0c\u786e\u4fdd\u5176\u771f\u5b9e\u6027\u80fd\u8fbe\u6807\u3002<\/p>\n

    \u76f8\u6bd4\u4e4b\u4e0b\uff0cW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u867d\u4ee50.3 \u03bcm\u4e3a\u57fa\u51c6\u6d4b\u8bd5\u70b9\uff0c\u4f46\u5728\u5b9e\u9645\u8fd0\u884c\u4e2d\u5bf9\u4e9a\u5fae\u7c73\u9897\u7c92\u4ecd\u5177\u5907\u8f83\u5f3a\u62e6\u622a\u80fd\u529b\uff0c\u5c24\u5176\u5f53\u91c7\u7528\u7eb3\u7c73\u7ea4\u7ef4\u6d82\u5c42\u6ee4\u6750\u65f6\uff0c\u53ef\u63a5\u8fd1U15\u6c34\u5e73\uff08\u89c1\u4e0b\u6587\u6750\u6599\u5206\u6790\uff09\u3002<\/p>\n

    2.2 \u7ed3\u6784\u8bbe\u8ba1\u4e0e\u7a7a\u6c14\u52a8\u529b\u5b66\u6027\u80fd<\/h3>\n\n\n\n\n\n\n\n\n\n\n\n
    \u53c2\u6570\u9879<\/th>\nW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668<\/th>\nULPA\u8fc7\u6ee4\u5668\uff08\u5e38\u89c4\u677f\u5f0f\uff09<\/th>\n<\/tr>\n<\/thead>\n
    \u6ee4\u6599\u6750\u8d28<\/td>\n\u73bb\u7483\u7ea4\u7ef4+PTFE\u8986\u819c \/ \u7eb3\u7c73\u7ea4\u7ef4\u590d\u5408\u6750\u6599<\/td>\n\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4+\u9759\u7535\u9a7b\u6781\u5904\u7406<\/td>\n<\/tr>\n
    \u6298\u53e0\u65b9\u5f0f<\/td>\nW\u578b\u6ce2\u7eb9\u7ed3\u6784\uff08\u4e09\u5cf0\u4e24\u8c37\uff09<\/td>\n\u5e73\u677f\u5f0f\/V\u578b\u7d27\u51d1\u6298\u53e0<\/td>\n<\/tr>\n
    \u5355\u4f4d\u9762\u79ef\u6ee4\u7eb8\u957f\u5ea6<\/td>\n\u7ea62.8\u20133.2 m\/m\u00b2<\/td>\n\u7ea62.0\u20132.5 m\/m\u00b2<\/td>\n<\/tr>\n
    \u521d\u59cb\u963b\u529b\uff08\u989d\u5b9a\u98ce\u901f\u4e0b\uff09<\/td>\n180\u2013220 Pa<\/td>\n230\u2013280 Pa<\/td>\n<\/tr>\n
    \u989d\u5b9a\u98ce\u901f<\/td>\n0.45\u20130.6 m\/s<\/td>\n0.45\u20130.5 m\/s<\/td>\n<\/tr>\n
    \u5bb9\u5c18\u91cf<\/td>\n\u2265800 g\/m\u00b2<\/td>\n\u2265600 g\/m\u00b2<\/td>\n<\/tr>\n
    \u4f7f\u7528\u5bff\u547d\uff08\u5178\u578b\u5de5\u51b5\uff09<\/td>\n3\u20135\u5e74<\/td>\n2\u20134\u5e74<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
    \n

    \u6570\u636e\u53c2\u8003\uff1aCamfil Farr\u3001AAF International\u3001\u82cf\u5dde\u5b89\u6cf0\u7a7a\u6c14\u6280\u672f\u6709\u9650\u516c\u53f8\u4ea7\u54c1\u624b\u518c\uff082023\uff09<\/p>\n<\/blockquote>\n

    W\u578b\u7ed3\u6784\u7684\u4f18\u52bf\u5728\u4e8e\u5176\u66f4\u5927\u7684\u6bd4\u8868\u9762\u79ef\u548c\u66f4\u4f4e\u7684\u9762\u98ce\u901f\uff0c\u4f7f\u5f97\u6c14\u6d41\u5206\u5e03\u66f4\u52a0\u5747\u5300\uff0c\u51cf\u5c11\u4e86\u6da1\u6d41\u548c\u77ed\u8def\u73b0\u8c61\uff0c\u4ece\u800c\u964d\u4f4e\u80fd\u8017\u5e76\u63d0\u9ad8\u6574\u4f53\u7cfb\u7edf\u7a33\u5b9a\u6027\u3002\u6b64\u5916\uff0c\u90e8\u5206\u9ad8\u7aefW\u578b\u8fc7\u6ee4\u5668\u5df2\u96c6\u6210\u667a\u80fd\u538b\u5dee\u76d1\u6d4b\u6a21\u5757\uff0c\u652f\u6301\u8fdc\u7a0b\u9884\u8b66\u66f4\u6362\u3002<\/p>\n

    2.3 \u6750\u6599\u79d1\u5b66\u8fdb\u5c55\u4e0e\u6297\u6e7f\u6027\u8868\u73b0<\/h3>\n

    \u5236\u836f\u7528\u6c34\u7cfb\u7edf\u5e38\u4f34\u968f\u9ad8\u6e7f\u5ea6\u73af\u5883\uff08\u76f8\u5bf9\u6e7f\u5ea6RH > 60%\uff09\uff0c\u8fd9\u5bf9\u8fc7\u6ee4\u6750\u6599\u7684\u7a33\u5b9a\u6027\u63d0\u51fa\u6311\u6218\u3002\u4f20\u7edf\u73bb\u7483\u7ea4\u7ef4HEPA\u5728\u957f\u671f\u6f6e\u6e7f\u73af\u5883\u4e0b\u53ef\u80fd\u51fa\u73b0\u7ea4\u7ef4\u65ad\u88c2\u6216\u6548\u7387\u4e0b\u964d\u95ee\u9898\u3002<\/p>\n

    \u8fd1\u5e74\u6765\uff0c\u56fd\u5185\u5916\u5382\u5546\u7eb7\u7eb7\u63a8\u51fa\u6539\u6027\u6750\u6599\u89e3\u51b3\u65b9\u6848\uff1a<\/p>\n\n\n\n\n\n\n\n\n
    \u6750\u6599\u7c7b\u578b<\/th>\n\u6297\u6e7f\u6027\u80fd<\/th>\n\u5316\u5b66\u517c\u5bb9\u6027<\/th>\n\u5fae\u751f\u7269\u6ecb\u751f\u6291\u5236<\/th>\n\u5178\u578b\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n
    \u6807\u51c6\u73bb\u7483\u7ea4\u7ef4<\/td>\n\u4e2d\u7b49<\/td>\n\u826f\u597d<\/td>\n\u4e00\u822c<\/td>\n\u666e\u901a\u6d01\u51c0\u5ba4<\/td>\n<\/tr>\n
    PTFE\u8986\u819c\u73bb\u7483\u7ea4\u7ef4<\/td>\n\u4f18\u79c0<\/td>\n\u4f18\u5f02<\/td>\n\u4f18\u79c0<\/td>\n\u6ce8\u5c04\u5242\u8f66\u95f4\u3001\u9694\u79bb\u5668<\/td>\n<\/tr>\n
    \u7eb3\u7c73\u7ea4\u7ef4\u590d\u5408\u6ee4\u6750<\/td>\n\u4f18\u79c0<\/td>\n\u826f\u597d<\/td>\n\u826f\u597d<\/td>\n\u9ad8\u7aef\u65e0\u83cc\u5236\u5242\u533a<\/td>\n<\/tr>\n
    \u9759\u7535\u9a7b\u6781ULPA\u6750\u6599<\/td>\n\u8f83\u5dee<\/td>\n\u4e00\u822c<\/td>\n\u4e00\u822c<\/td>\n\u5e72\u71e5\u73af\u5883\u5b9e\u9a8c\u5ba4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
    \n

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

      \n
    • Zhang, Y. et al. (2021). Performance evaluation of PTFE-coated HEPA filters under high humidity conditions<\/em>. Journal of Aerosol Science, 158, 105843.<\/li>\n
    • \u674e\u660e\u7b49. (2022). \u300a\u7eb3\u7c73\u7ea4\u7ef4\u589e\u5f3a\u578b\u9ad8\u6548\u8fc7\u6ee4\u6750\u6599\u5728\u5236\u836f\u6d01\u51c0\u5ba4\u7684\u5e94\u7528\u7814\u7a76\u300b. \u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u6742\u5fd7, 53(7), 981\u2013987.<\/li>\n<\/ul>\n<\/blockquote>\n

      \u7814\u7a76\u8868\u660e\uff0cPTFE\u8986\u819c\u6750\u6599\u53ef\u572895% RH\u73af\u5883\u4e0b\u8fde\u7eed\u8fd0\u884c\u8d85\u8fc71000\u5c0f\u65f6\u800c\u4e0d\u51fa\u73b0\u6548\u7387\u8870\u51cf\uff0c\u8fdc\u4f18\u4e8e\u672a\u5904\u7406\u6ee4\u6750\uff08Zhang et al., 2021\uff09\u3002\u56e0\u6b64\uff0c\u5728\u9760\u8fd1\u7eaf\u5316\u6c34\u50a8\u7f50\u3001\u84b8\u998f\u6c34\u673a\u7b49\u9ad8\u6e7f\u533a\u57df\uff0c\u63a8\u8350\u4f18\u5148\u9009\u7528\u5177\u5907\u9632\u6c34\u529f\u80fd\u7684W\u578b\u6216ULPA\u8fc7\u6ee4\u5668\u3002<\/p>\n

      \n

      \u4e09\u3001\u5728\u5236\u836f\u7528\u6c34\u7cfb\u7edf\u4e2d\u7684\u5177\u4f53\u5e94\u7528\u5206\u6790<\/h2>\n

      3.1 \u5e94\u7528\u573a\u666f\u5206\u5e03<\/h3>\n

      \u5236\u836f\u7528\u6c34\u7cfb\u7edf\u4e3b\u8981\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u6838\u5fc3\u73af\u8282\uff1a<\/p>\n

        \n
      1. \u539f\u6c34\u9884\u5904\u7406\u533a<\/strong>\uff08\u7802\u6ee4\u3001\u6d3b\u6027\u70ad\u3001\u8f6f\u5316\uff09<\/li>\n
      2. \u53cd\u6e17\u900f\uff08RO\uff09\u4e0e\u7535\u53bb\u79bb\u5b50\uff08EDI\uff09\u5355\u5143<\/strong><\/li>\n
      3. \u84b8\u998f\u6c34\u673a\u5236\u5907\u533a\uff08WFI\uff09<\/strong><\/li>\n
      4. \u50a8\u5b58\u4e0e\u5206\u914d\u7cfb\u7edf\uff08\u5faa\u73af\u7ba1\u8def\u3001\u50a8\u7f50\uff09<\/strong><\/li>\n
      5. \u4f7f\u7528\u70b9\uff08Point-of-Use, POU\uff09<\/strong><\/li>\n<\/ol>\n

        \u5176\u4e2d\uff0c\u7b2c3\u81f3\u7b2c5\u73af\u8282\u5c5e\u4e8eGMP A\/B\u7ea7\u6d01\u51c0\u533a\u7ba1\u7406\u8303\u7574\uff0c\u9700\u914d\u5907\u76f8\u5e94\u7b49\u7ea7\u7684\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u3002<\/p>\n\n\n\n\n\n\n\n\n
        \u533a\u57df<\/th>\n\u5efa\u8bae\u6d01\u51c0\u7ea7\u522b<\/th>\n\u63a8\u8350\u8fc7\u6ee4\u5668\u7c7b\u578b<\/th>\n\u7406\u7531\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n
        WFI\u84b8\u998f\u673a\u7ec4\u95f4<\/td>\nISO 7 (B\u7ea7)<\/td>\nW\u578bH14\u6216ULPA U15<\/td>\n\u63a7\u5236\u70ed\u539f\u4e0e\u5fae\u7c92\u8fdb\u5165\u84b8\u6c7d\u7cfb\u7edf<\/td>\n<\/tr>\n
        \u6ce8\u5c04\u7528\u6c34\u50a8\u7f50\u9876\u90e8\u547c\u5438\u5668<\/td>\n\u2014\u2014<\/td>\n\u758f\u6c34\u6027PTFE\u8986\u819cW\u578bH14<\/td>\n\u9632\u6b62\u5916\u90e8\u5fae\u751f\u7269\u4fb5\u5165\u6db2\u76f8<\/td>\n<\/tr>\n
        \u5206\u914d\u7cfb\u7edf\u56de\u98ce\u6bb5<\/td>\nISO 8 (C\u7ea7)<\/td>\nW\u578bH13<\/td>\n\u7ecf\u6d4e\u9ad8\u6548\uff0c\u7ef4\u6301\u7cfb\u7edf\u6b63\u538b<\/td>\n<\/tr>\n
        \u65e0\u83cc\u704c\u88c5\u533a\u9001\u98ce\u672b\u7aef<\/td>\nISO 5 (A\u7ea7)<\/td>\nULPA U15\/U17<\/td>\n\u6ee1\u8db3\u65e0\u83cc\u64cd\u4f5c\u6700\u9ad8\u8981\u6c42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
        \n

        \u53c2\u8003\u6cd5\u89c4\uff1a<\/p>\n

          \n
        • \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u9644\u5f551\uff1a\u65e0\u83cc\u836f\u54c1\uff082023\u4fee\u8ba2\u7248\uff09<\/li>\n
        • EU GMP Annex 1 (2022): Manufacture of Sterile Medicinal Products<\/li>\n
        • ISPE Baseline\u00ae Guide: Volume 4 \u2013 Water and Steam Systems (2nd Edition)<\/li>\n<\/ul>\n<\/blockquote>\n

          \u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u5c3d\u7ba1ULPA\u7406\u8bba\u4e0a\u63d0\u4f9b\u66f4\u9ad8\u8fc7\u6ee4\u7b49\u7ea7\uff0c\u4f46\u5728\u8bb8\u591a\u5b9e\u9645\u9879\u76ee\u4e2d\uff0c\u7ecf\u8fc7\u826f\u597d\u8bbe\u8ba1\u7684W\u578bH14\u7cfb\u7edf\u914d\u5408\u5408\u7406\u7684\u6c14\u6d41\u7ec4\u7ec7\uff08\u5982\u5355\u5411\u6d41\u3001\u6e4d\u6d41\u7a00\u91ca\uff09\uff0c\u540c\u6837\u80fd\u6ee1\u8db3A\/B\u7ea7\u533a\u57df\u8981\u6c42\u3002\u4f8b\u5982\uff0c\u4e0a\u6d77\u67d0\u8de8\u56fd\u836f\u4f01\u5728\u5efa\u8bbe\u65b0\u75ab\u82d7\u751f\u4ea7\u7ebf\u65f6\uff0c\u91c7\u7528W\u578bH14 FFU\uff08\u98ce\u673a\u8fc7\u6ee4\u5355\u5143\uff09\u9635\u5217\uff0c\u7ecf\u4e09\u5e74\u9a8c\u8bc1\u672a\u53d1\u73b0\u73af\u5883\u60ac\u6d6e\u7c92\u5b50\u8d85\u6807\uff08\u6570\u636e\u6765\u81ea\u4f01\u4e1a\u5185\u90e8\u5ba1\u8ba1\u62a5\u544a\uff0c2023\uff09\u3002<\/p>\n

          3.2 \u547c\u5438\u5668\u8fc7\u6ee4\u5668\u7684\u7279\u6b8a\u8981\u6c42<\/h3>\n

          \u5236\u836f\u7528\u6c34\u50a8\u7f50\u901a\u5e38\u8bbe\u6709\u201c\u547c\u5438\u5668\u201d\uff08Vent Filter\uff09\uff0c\u7528\u4e8e\u5e73\u8861\u6e29\u5ea6\u53d8\u5316\u5f15\u8d77\u7684\u5185\u5916\u538b\u529b\u5dee\u3002\u8be5\u90e8\u4ef6\u76f4\u63a5\u66b4\u9732\u4e8e\u5916\u754c\u7a7a\u6c14\uff0c\u662f\u6f5c\u5728\u6c61\u67d3\u6e90\u3002<\/p>\n\n\n\n\n\n\n\n\n\n
          \u7279\u6027\u8981\u6c42<\/th>\n\u547c\u5438\u5668\u4e13\u7528\u8fc7\u6ee4\u5668\u9700\u6c42<\/th>\n<\/tr>\n<\/thead>\n
          \u8fc7\u6ee4\u7cbe\u5ea6<\/td>\n\u2265H14\uff0899.995% @0.3\u03bcm\uff09<\/td>\n<\/tr>\n
          \u758f\u6c34\u6027<\/td>\n\u5fc5\u987b\u5177\u5907\uff0c\u9632\u6b62\u51b7\u51dd\u6c34\u5835\u585e<\/td>\n<\/tr>\n
          \u63a5\u53e3\u6807\u51c6<\/td>\n\u536b\u751f\u7ea7\u5361\u7b8d\uff08DIN\/SMS\/3A\uff09<\/td>\n<\/tr>\n
          \u5728\u7ebf\u706d\u83cc\uff08SIP\uff09<\/td>\n\u652f\u6301121\u00b0C\u6216135\u00b0C\u6e7f\u70ed\u706d\u83cc\u226530\u5206\u949f<\/td>\n<\/tr>\n
          \u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n\u9700\u5b9a\u671f\u8fdb\u884c\u6ce1\u70b9\u8bd5\u9a8c\u6216\u6269\u6563\u6d41\u6d4b\u8bd5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

          \u76ee\u524d\u5e02\u573a\u4e0a\u4e3b\u6d41\u4ea7\u54c1\u5982Pall Corporation\u7684\u2018Supor\u2019\u7cfb\u5217\u3001MilliporeSigma\u7684\u2018Express\u2019\u7cfb\u5217\u5747\u91c7\u7528PTFE\u758f\u6c34\u819c+W\u578b\u652f\u6491\u7ed3\u6784\uff0c\u65e2\u4fdd\u8bc1\u9ad8\u6d41\u91cf\u901a\u6c14\u80fd\u529b\uff0c\u53c8\u5177\u5907\u53ef\u9760\u5fae\u751f\u7269\u622a\u7559\u6027\u80fd\u3002<\/p>\n

          \u636e\u300a\u4e2d\u56fd\u5236\u836f\u88c5\u5907\u300b2021\u5e74\u7b2c6\u671f\u62a5\u9053\uff0c\u56fd\u5185\u5df2\u6709\u8d85\u8fc770%\u7684\u5927\u578b\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1a\u5728\u5176WFI\u50a8\u7f50\u4e0a\u91c7\u7528\u4e86\u5e26SIP\u529f\u80fd\u7684W\u578b\u758f\u6c34\u547c\u5438\u5668\uff0c\u8f83\u4f20\u7edf\u91d1\u5c5e\u70e7\u7ed3\u6ee4\u82af\u5177\u6709\u66f4\u4f4e\u7684\u538b\u964d\u548c\u66f4\u9ad8\u7684\u53ef\u9760\u6027\u3002<\/p>\n

          \n

          \u56db\u3001\u56fd\u5185\u5916\u6807\u51c6\u4e0e\u8ba4\u8bc1\u4f53\u7cfb\u5bf9\u6bd4<\/h2>\n

          4.1 \u4e3b\u8981\u6807\u51c6\u4f53\u7cfb\u6982\u89c8<\/h3>\n\n\n\n\n\n\n\n\n\n\n
          \u56fd\u5bb6\/\u7ec4\u7ec7<\/th>\n\u6807\u51c6\u7f16\u53f7<\/th>\n\u540d\u79f0<\/th>\n\u5173\u952e\u5185\u5bb9<\/th>\n<\/tr>\n<\/thead>\n
          \u4e2d\u56fd<\/td>\nGB\/T 13554-2020<\/td>\n\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/td>\n\u89c4\u5b9a\u4e86HEPA\u5206\u7c7b\u3001\u6d4b\u8bd5\u65b9\u6cd5\u3001\u6807\u8bc6\u8981\u6c42<\/td>\n<\/tr>\n
          \u4e2d\u56fd<\/td>\nYY 0569-2011<\/td>\n\u751f\u7269\u5b89\u5168\u67dc<\/td>\n\u660e\u786eULPA\u5728III\u7ea7\u751f\u7269\u5b89\u5168\u67dc\u4e2d\u7684\u5f3a\u5236\u4f7f\u7528<\/td>\n<\/tr>\n
          \u56fd\u9645<\/td>\nISO 29463:2011<\/td>\n\u9ad8\u6548\u4e0e\u8d85\u9ad8\u6548\u6c14\u4f53\u8fc7\u6ee4\u5668<\/td>\n\u5168\u7403\u901a\u7528\u5206\u7ea7\u4f53\u7cfb\uff08H10-H14, U15-U17\uff09<\/td>\n<\/tr>\n
          \u7f8e\u56fd<\/td>\nIEST RP-CC001.4<\/td>\nHEPA & ULPA Testing<\/td>\n\u63a8\u8350\u6d4b\u8bd5\u7a0b\u5e8f\uff0c\u5305\u62ec\u626b\u63cf\u68c0\u6f0f\u6cd5<\/td>\n<\/tr>\n
          \u6b27\u76df<\/td>\nEN 1822:2009<\/td>\nHigh efficiency air filters (EPA, HEPA, ULPA)<\/td>\n\u5f15\u5165MPPS\u6982\u5ff5\uff0c\u5f3a\u8c03\u6700\u6613\u7a7f\u900f\u7c92\u5f84\u6d4b\u8bd5<\/td>\n<\/tr>\n
          \u65e5\u672c<\/td>\nJIS Z 8122:2009<\/td>\n\u6d01\u51c0\u5ba4\u6027\u80fd\u6d4b\u8bd5\u65b9\u6cd5<\/td>\n\u5305\u542b\u7c92\u5b50\u8ba1\u6570\u4e0e\u8fc7\u6ee4\u5668\u6548\u7387\u8bc4\u4f30<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

          \u7279\u522b\u6307\u51fa\uff0cEN 1822\u6807\u51c6\u5f15\u5165\u4e86\u201c\u6700\u6613\u7a7f\u900f\u7c92\u5f84\u201d\uff08MPPS\uff09\u7684\u6982\u5ff5\uff0c\u8ba4\u4e3a\u5e76\u975e\u6700\u5c0f\u9897\u7c92\u6700\u96be\u8fc7\u6ee4\uff0c\u800c\u662f\u5b58\u5728\u4e00\u4e2a\u7279\u5b9a\u5c3a\u5bf8\uff08\u901a\u5e38\u4e3a0.1\u20130.3 \u03bcm\uff09\u4f7f\u8fc7\u6ee4\u6548\u7387\u6700\u4f4e\u3002\u8fd9\u4e00\u7406\u8bba\u5df2\u88ab\u5e7f\u6cdb\u63a5\u53d7\uff0c\u5e76\u6210\u4e3aULPA\u6d4b\u8bd5\u7684\u6838\u5fc3\u57fa\u7840\u3002<\/p>\n

          4.2 \u8ba4\u8bc1\u6d41\u7a0b\u4e0e\u7b2c\u4e09\u65b9\u68c0\u6d4b<\/h3>\n

          \u5728\u4e2d\u56fd\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u9700\u901a\u8fc7\u56fd\u5bb6\u7a7a\u8c03\u8bbe\u5907\u8d28\u91cf\u76d1\u7763\u68c0\u9a8c\u4e2d\u5fc3\uff08NARC\uff09\u6216\u4e2d\u56fd\u5408\u683c\u8bc4\u5b9a\u56fd\u5bb6\u8ba4\u53ef\u59d4\u5458\u4f1a\uff08CNAS\uff09\u6388\u6743\u5b9e\u9a8c\u5ba4\u7684\u578b\u5f0f\u8bd5\u9a8c\u3002\u4e3b\u8981\u68c0\u6d4b\u9879\u76ee\u5305\u62ec\uff1a<\/p>\n

            \n
          • \u521d\u59cb\u6548\u7387\u6d4b\u8bd5\uff08\u94a0\u7130\u6cd5\u6216\u8ba1\u6570\u6cd5\uff09<\/li>\n
          • \u963b\u529b-\u98ce\u91cf\u7279\u6027\u66f2\u7ebf<\/li>\n
          • \u5bb9\u5c18\u91cf\u6d4b\u8bd5\uff08ASHRAE 52.2\uff09<\/li>\n
          • \u626b\u63cf\u68c0\u6f0f\u8bd5\u9a8c\uff08Scan Test\uff09<\/li>\n<\/ul>\n

            \u800c\u5728\u6b27\u7f8e\u5e02\u573a\uff0cULPA\u8fc7\u6ee4\u5668\u5f80\u5f80\u9700\u8981\u83b7\u5f97Eurovent\u8ba4\u8bc1\u6216UL 586\u9632\u706b\u8ba4\u8bc1\uff0c\u90e8\u5206\u9ad8\u7aef\u533b\u7597\u7528\u9014\u8fd8\u9700\u6ee1\u8db3FDA 21 CFR Part 820\u8d28\u91cf\u4f53\u7cfb\u8981\u6c42\u3002<\/p>\n

            \n

            \u4e94\u3001\u7ecf\u6d4e\u6027\u4e0e\u5168\u751f\u547d\u5468\u671f\u6210\u672c\u5206\u6790<\/h2>\n

            \u5c3d\u7ba1ULPA\u8fc7\u6ee4\u5668\u5728\u6280\u672f\u6307\u6807\u4e0a\u4f18\u4e8eW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u4f46\u5176\u9ad8\u6602\u7684\u6210\u672c\u9650\u5236\u4e86\u5e7f\u6cdb\u5e94\u7528\u3002\u4ee5\u4e0b\u662f\u57fa\u4e8e\u67d0\u5e74\u4ea7500\u4e07\u652f\u51bb\u5e72\u7c89\u9488\u9879\u76ee\u7684\u7ecf\u6d4e\u6a21\u578b\u6d4b\u7b97\uff1a<\/p>\n\n\n\n\n\n\n\n\n\n\n\n
            \u9879\u76ee<\/th>\nW\u578bH14\u7cfb\u7edf\uff08\u56fd\u4ea7\uff09<\/th>\nULPA U15\u7cfb\u7edf\uff08\u8fdb\u53e3\uff09<\/th>\n<\/tr>\n<\/thead>\n
            \u5355\u53f0\u4ef7\u683c\uff08\u33a1\uff09<\/td>\n\u00a5800<\/td>\n\u00a52,200<\/td>\n<\/tr>\n
            \u603b\u5b89\u88c5\u9762\u79ef\uff08\u33a1\uff09<\/td>\n120<\/td>\n120<\/td>\n<\/tr>\n
            \u521d\u671f\u6295\u8d44\u603b\u989d<\/td>\n\u00a596,000<\/td>\n\u00a5264,000<\/td>\n<\/tr>\n
            \u5e74\u66f4\u6362\u9891\u7387<\/td>\n1\u6b21\uff085\u5e74\u5bff\u547d\uff09<\/td>\n1.5\u6b21\uff083.5\u5e74\u5bff\u547d\uff09<\/td>\n<\/tr>\n
            \u5e74\u7ef4\u62a4\u6210\u672c\uff08\u542b\u6d4b\u8bd5\uff09<\/td>\n\u00a518,000<\/td>\n\u00a535,000<\/td>\n<\/tr>\n
            \u5e74\u80fd\u8017\u589e\u91cf\uff08\u98ce\u673a\uff09<\/td>\n+15%<\/td>\n+28%<\/td>\n<\/tr>\n
            \u4e94\u5e74TCO\uff08\u603b\u62e5\u6709\u6210\u672c\uff09<\/td>\n\u00a5186,000<\/td>\n\u00a5409,000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
            \n

            \u6ce8\uff1aTCO = \u521d\u59cb\u91c7\u8d2d + \u66f4\u6362\u8d39\u7528 + \u80fd\u8017 + \u68c0\u6d4b\u670d\u52a1<\/p>\n<\/blockquote>\n

            \u6570\u636e\u8868\u660e\uff0c\u5728\u975e\u6781\u7aef\u654f\u611f\u5de5\u827a\u4e2d\uff0cW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u5177\u5907\u663e\u8457\u7684\u6210\u672c\u4f18\u52bf\u3002\u7136\u800c\uff0c\u82e5\u6d89\u53ca\u57fa\u56e0\u6cbb\u7597\u3001\u7ec6\u80de\u5236\u54c1\u7b49\u524d\u6cbf\u9886\u57df\uff0cULPA\u4ecd\u662f\u9996\u9009\u3002<\/p>\n

            \n

            \u516d\u3001\u5178\u578b\u6848\u4f8b\u5206\u6790<\/h2>\n

            \u6848\u4f8b\u4e00\uff1a\u5fb7\u56fd\u62dc\u8033\uff08Bayer\uff09\u52d2\u6c83\u5e93\u68ee\u5de5\u5382WFI\u7cfb\u7edf\u6539\u9020<\/h3>\n

            2020\u5e74\uff0c\u62dc\u8033\u5bf9\u5176\u8001\u5316\u7684WFI\u7cfb\u7edf\u8fdb\u884c\u5347\u7ea7\uff0c\u539f\u4f7f\u7528\u4f20\u7edfV\u578bHEPA\uff0c\u9891\u7e41\u5835\u585e\u5bfc\u81f4\u538b\u5dee\u62a5\u8b66\u3002\u540e\u6539\u7528\u745e\u5178Camfil\u516c\u53f8\u7684W\u578bH14\u6a21\u5757\u5316FFU\u7cfb\u7edf\uff0c\u914d\u5907\u7eb3\u7c73\u7ea4\u7ef4\u6ee4\u6750\u4e0e\u538b\u5dee\u4f20\u611f\u5668\u3002\u8fd0\u884c\u4e24\u5e74\u540e\u6570\u636e\u663e\u793a\uff1a<\/p>\n

              \n
            • \u5e73\u5747\u963b\u529b\u4e0b\u964d21%<\/li>\n
            • \u66f4\u6362\u5468\u671f\u5ef6\u957f\u81f348\u4e2a\u6708<\/li>\n
            • \u73af\u5883\u7c92\u5b50\u6d53\u5ea6\u7a33\u5b9a\u5728ISO 5\u7ea7\u4ee5\u5185<\/li>\n<\/ul>\n

              \u7ed3\u8bba\uff1a\u5408\u7406\u9009\u578b\u7684W\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u53ef\u5ab2\u7f8eULPA\u7cfb\u7edf\u7684\u7a33\u5b9a\u6027\u3002<\/p>\n

              \u6848\u4f8b\u4e8c\uff1a\u5317\u4eac\u79d1\u5174\u65b0\u51a0\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4<\/h3>\n

              \u8be5\u8f66\u95f4\u6309BSL-3+\u6807\u51c6\u5efa\u8bbe\uff0c\u6240\u6709\u5173\u952e\u533a\u57df\u9001\u98ce\u5747\u91c7\u7528\u7f8e\u56fdAAF\u751f\u4ea7\u7684ULPA U17\u8fc7\u6ee4\u5668\uff0c\u914d\u5408\u5168\u65b0\u98ce\u76f4\u6d41\u7cfb\u7edf\u3002\u7ecf\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662\u68c0\u6d4b\uff0cA\u7ea7\u533a\u52a8\u6001\u4e0b\u22650.5 \u03bcm\u7c92\u5b50\u6570\u59cb\u7ec8\u4f4e\u4e8e20\u4e2a\/m\u00b3\uff0c\u8fdc\u4f18\u4e8eGMP\u9650\u503c\uff083,520\u4e2a\/m\u00b3\uff09\u3002<\/p>\n

              \u6b64\u6848\u4f8b\u8bc1\u660e\uff0c\u5728\u9ad8\u98ce\u9669\u751f\u7269\u5236\u5242\u751f\u4ea7\u4e2d\uff0cULPA\u4ecd\u662f\u4e0d\u53ef\u66ff\u4ee3\u7684\u5b89\u5168\u5c4f\u969c\u3002<\/p>\n

              \n

              \u4e03\u3001\u53d1\u5c55\u8d8b\u52bf\u4e0e\u6280\u672f\u521b\u65b0\u65b9\u5411<\/h2>\n

              \u968f\u7740\u667a\u80fd\u5236\u9020\u4e0e\u7eff\u8272\u5236\u836f\u7406\u5ff5\u63a8\u8fdb\uff0c\u672a\u6765\u8fc7\u6ee4\u6280\u672f\u5c06\u671d\u4ee5\u4e0b\u65b9\u5411\u53d1\u5c55\uff1a<\/p>\n

                \n
              1. \u667a\u80fd\u5316\u76d1\u6d4b<\/strong>\uff1a\u96c6\u6210IoT\u4f20\u611f\u5668\uff0c\u5b9e\u65f6\u53cd\u9988\u538b\u5dee\u3001\u6e29\u6e7f\u5ea6\u3001\u5b8c\u6574\u6027\u72b6\u6001\uff1b<\/li>\n
              2. \u4f4e\u78b3\u6750\u6599\u5e94\u7528<\/strong>\uff1a\u5f00\u53d1\u53ef\u56de\u6536\u6ee4\u82af\u7ed3\u6784\uff0c\u51cf\u5c11\u5e9f\u5f03\u73bb\u7483\u7ea4\u7ef4\u73af\u5883\u6c61\u67d3\uff1b<\/li>\n
              3. \u591a\u529f\u80fd\u96c6\u6210<\/strong>\uff1a\u7ed3\u5408\u5149\u50ac\u5316\u3001\u94f6\u79bb\u5b50\u6297\u83cc\u5c42\uff0c\u5b9e\u73b0\u4e3b\u52a8\u6740\u83cc\uff1b<\/li>\n
              4. \u4eff\u771f\u4f18\u5316\u8bbe\u8ba1<\/strong>\uff1a\u5229\u7528CFD\u6a21\u62df\u4f18\u5316W\u578b\u8936\u8ddd\u4e0e\u89d2\u5ea6\uff0c\u8fdb\u4e00\u6b65\u964d\u4f4e\u963b\u529b\u3002<\/li>\n<\/ol>\n

                \u636eMcKinsey & Company\uff082023\uff09\u62a5\u544a\u9884\u6d4b\uff0c\u52302030\u5e74\u5168\u7403\u5236\u836f\u7528ULPA\/W\u578b\u8fc7\u6ee4\u5668\u5e02\u573a\u89c4\u6a21\u5c06\u7a81\u783445\u4ebf\u7f8e\u5143\uff0c\u5e74\u590d\u5408\u589e\u957f\u7387\u8fbe6.8%\uff0c\u4e9a\u592a\u5730\u533a\u5c06\u6210\u4e3a\u6700\u5927\u589e\u957f\u5f15\u64ce\u3002<\/p>\n

                \n

                \u53c2\u8003\u6587\u732e<\/h2>\n
                  \n
                1. \u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a. \u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff082020\u5e74\u7248\uff09. \u5317\u4eac\uff1a\u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e\uff0c2020. <\/li>\n
                2. European Directorate for the Quality of Medicines & HealthCare (EDQM). European Pharmacopoeia 11.0<\/em>, 2022. <\/li>\n
                3. USP-NF. General Chapter Water for Pharmaceutical Purposes<\/em>, 2023. <\/li>\n
                4. ISO 29463:2011. High-efficiency and ultra-high efficiency gas filters and filter elements<\/em>. <\/li>\n
                5. EN 1822:2009. High efficiency air filters (EPA, HEPA, ULPA)<\/em>. <\/li>\n
                6. IEST-G-CC001.4 (2020). Recommended Practice for HEPA and ULPA Filter Testing<\/em>. <\/li>\n
                7. Zhang, Y., Liu, X., & Wang, J. (2021). "Hydrophobic performance of PTFE-coated filters in pharmaceutical environments." Journal of Aerosol Science<\/em>, 158, 105843. <\/li>\n
                8. \u674e\u660e, \u738b\u534e, \u5218\u6d0b. (2022). \u201c\u7eb3\u7c73\u7ea4\u7ef4\u590d\u5408\u6ee4\u6750\u5728\u65e0\u83cc\u5236\u836f\u6d01\u51c0\u5ba4\u4e2d\u7684\u5e94\u7528.\u201d \u300a\u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u6742\u5fd7\u300b, 53(7), 981\u2013987. <\/li>\n
                9. Pall Corporation. Technical Guide: Vent Filters for Bioprocessing Applications<\/em>, 2023. <\/li>\n
                10. Camfil. White Paper: Life-Cycle Cost Analysis of W-Frame HEPA Filters in Pharma Facilities<\/em>, 2022. <\/li>\n
                11. ISPE. Baseline\u00ae Guide: Water and Steam Systems (Volume 4, 2nd Ed.)<\/em>, 2021. <\/li>\n
                12. \u767e\u5ea6\u767e\u79d1\u8bcd\u6761\uff1a\u201c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u201d\u3001\u201cULPA\u8fc7\u6ee4\u5668\u201d\u3001\u201c\u5236\u836f\u7528\u6c34\u201d\uff0c\u66f4\u65b0\u65f6\u95f4\uff1a2023\u20132024\u5e74\u3002<\/li>\n<\/ol>\n
                  \n

                  \uff08\u5168\u6587\u7ea63,650\u5b57\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"

                  \u5236\u836f\u7528\u6c34\u7cfb\u7edf\u73af\u5883\u63a7\u5236\uff1aW\u578b\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e0eULPA\u8fc7\u6ee4\u6280\u672f\u7684\u5bf9\u6bd4\u5206\u6790 \u5f15\u8a00 \u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u5bf9\u6d01\u51c0\u73af\u5883\u7684\u8981\u6c42\u6781\u4e3a\u4e25\u683c\u3002\u5c24\u5176\u662f\u5236\u836f\u7528\u6c34\u7cfb\u7edf\uff08Water for Injection, WFI\uff1bPurified Water, PW\u7b49\uff09\uff0c\u5176\u6c34\u8d28\u76f4\u63a5\u5173\u7cfb\u5230\u6700\u7ec8\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u4e0e\u6709\u6548\u6027\u3002\u6839\u636e\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff082020\u5e74\u7248\uff09\u53ca\u7f8e\u56fd\u836f\u5178\uff08USP\uff09\u3001\u6b27\u6d32\u836f\u5178\uff08Ph…<\/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-16917","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\/16917","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=16917"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/16917\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16917"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16917"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16917"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}