\n| \u533b\u7597\u673a\u6784<\/td>\n | \u7ed3\u5408\u751f\u7269\u5b89\u5168\u67dc\u5e74\u68c0<\/td>\n | WS 233-2017<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n2. \u7f8e\u56fd\u4e0e\u6b27\u6d32\u7b56\u7565<\/h3>\n\u7f8e\u56fd\u66f4\u5f3a\u8c03\u57fa\u4e8e\u6027\u80fd\u7684\u52a8\u6001\u7ba1\u7406\u3002FDA\u5728\u300aGuidance for Industry: Sterile Drug Products Produced by Aseptic Processing\u300b\u4e2d\u6307\u51fa\uff0c\u5e94\u901a\u8fc7\u8fde\u7eed\u538b\u5dee\u76d1\u6d4b\u548c\u5b9a\u671f\u7c92\u5b50\u8ba1\u6570\u8bc4\u4f30\u8fc7\u6ee4\u5668\u72b6\u6001\uff0c\u800c\u975e\u56fa\u5b9a\u5468\u671f\u66f4\u6362\u3002<\/p>\n \u6b27\u6d32\u5219\u4f9d\u636eEN 1752:2017\u300a\u901a\u98ce\u5728\u5efa\u7b51\u4e2d\u7684\u5e94\u7528\u300b\u63a8\u8350\u91c7\u7528\u201c\u72b6\u6001\u76d1\u6d4b+\u9884\u6d4b\u6027\u7ef4\u62a4\u201d\u7b56\u7565\u3002\u5fb7\u56fdT\u00dcV\u8ba4\u8bc1\u673a\u6784\u8981\u6c42\u6bcf6\u4e2a\u6708\u8fdb\u884c\u4e00\u6b21\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08DOP\/PAO\u68c0\u6f0f\uff09\uff0c\u5e76\u7ed3\u5408\u538b\u5dee\u8d8b\u52bf\u5206\u6790\u66f4\u6362\u65f6\u673a\u3002<\/p>\n \n\n\n| \u56fd\u5bb6\/\u5730\u533a<\/th>\n | \u4e3b\u8981\u7b56\u7565<\/th>\n | \u7279\u70b9<\/th>\n<\/tr>\n<\/thead>\n | \n\n| \u7f8e\u56fd<\/td>\n | \u538b\u5dee+\u7c92\u5b50\u6d53\u5ea6+\u68c0\u6f0f\u6d4b\u8bd5<\/td>\n | \u5f3a\u8c03\u6570\u636e\u9a71\u52a8<\/td>\n<\/tr>\n | \n| \u5fb7\u56fd<\/td>\n | \u5e74\u5ea6\u68c0\u6f0f+\u538b\u5dee\u8d8b\u52bf\u5206\u6790<\/td>\n | \u6ce8\u91cd\u5b8c\u6574\u6027<\/td>\n<\/tr>\n | \n| \u65e5\u672c<\/td>\n | \u56fa\u5b9a\u5468\u671f\uff083\u5e74\uff09+\u5f02\u5e38\u62a5\u8b66<\/td>\n | \u7b80\u5355\u6613\u884c<\/td>\n<\/tr>\n | \n| \u4e2d\u56fd<\/td>\n | \u65f6\u95f4\u4e3a\u4e3b\uff0c\u538b\u5dee\u4e3a\u8f85<\/td>\n | \u5236\u5ea6\u5316\u4f46\u7075\u6d3b\u6027\u4e0d\u8db3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\u6587\u732e\u652f\u6301\uff1a<\/strong> <\/p>\n\n- FDA (2004). Sterile Drug Products Produced by Aseptic Processing<\/em> <\/li>\n
- CEN (2017). EN 1752:2017 Ventilation for buildings<\/em> <\/li>\n
- \u65e5\u672c\u5de5\u4e1a\u6807\u51c6 JIS Z 8122:2019\u300a\u6d01\u51c0\u5ba4\u6027\u80fd\u6d4b\u8bd5\u65b9\u6cd5\u300b<\/li>\n<\/ul>\n<\/blockquote>\n
\n\u516d\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u66f4\u6362\u5468\u671f\u7684\u4f18\u5316\u6a21\u578b<\/h2>\n\u4e3a\u5b9e\u73b0\u79d1\u5b66\u5316\u7ba1\u7406\uff0c\u8fd1\u5e74\u6765\u7814\u7a76\u8005\u63d0\u51fa\u591a\u79cd\u4f18\u5316\u6a21\u578b\uff0c\u7ed3\u5408\u591a\u53c2\u6570\u8fdb\u884c\u66f4\u6362\u51b3\u7b56\u3002<\/p>\n 1. \u591a\u53c2\u6570\u7efc\u5408\u8bc4\u4f30\u6a21\u578b<\/h3>\n\u8be5\u6a21\u578b\u5f15\u5165\u73af\u5883PM2.5\u6d53\u5ea6\u3001\u65e5\u5747\u8fd0\u884c\u65f6\u957f\u3001\u9884\u8fc7\u6ee4\u5668\u66f4\u6362\u9891\u7387\u3001\u538b\u5dee\u589e\u957f\u7387\u7b49\u53d8\u91cf\uff0c\u6784\u5efa\u8bc4\u5206\u7cfb\u7edf\uff1a<\/p>\n [
\nS = w1 cdot frac{Delta P}{Delta P<\/em>{text{max}}} + w2 cdot frac{T}{T<\/em>{text{max}}} + w3 cdot frac{C}{C<\/em>{text{std}}}
\n]<\/p>\n\u5176\u4e2d\uff1a<\/p>\n \n- (S)\uff1a\u7efc\u5408\u8bc4\u5206\uff08>0.8\u5efa\u8bae\u66f4\u6362\uff09<\/li>\n
- (w_1, w_2, w_3)\uff1a\u6743\u91cd\uff08\u5efa\u8bae0.4, 0.3, 0.3\uff09<\/li>\n
- (Delta P)\uff1a\u5f53\u524d\u538b\u5dee<\/li>\n
- (T)\uff1a\u5df2\u4f7f\u7528\u65f6\u95f4\uff08\u5e74\uff09<\/li>\n
- (C)\uff1a\u73af\u5883\u9897\u7c92\u7269\u6d53\u5ea6\uff08\u03bcg\/m\u00b3\uff09<\/li>\n<\/ul>\n
\u8be5\u6a21\u578b\u5728\u590d\u65e6\u5927\u5b66\u9644\u5c5e\u533b\u9662\u6d01\u51c0\u7cfb\u7edf\u4e2d\u5e94\u7528\u540e\uff0c\u66f4\u6362\u51b3\u7b56\u51c6\u786e\u7387\u63d0\u5347\u81f389%\uff08Chen et al., 2022\uff09\u3002<\/p>\n 2. \u57fa\u4e8e\u7269\u8054\u7f51\u7684\u667a\u80fd\u76d1\u63a7\u7cfb\u7edf<\/h3>\n\u73b0\u4ee3\u6d01\u51c0\u53f0\u5df2\u9010\u6b65\u96c6\u6210\u667a\u80fd\u4f20\u611f\u5668\u4e0e\u7269\u8054\u7f51\uff08IoT\uff09\u5e73\u53f0\u3002\u4f8b\u5982\uff0c\u67d0\u56fd\u4ea7\u667a\u80fd\u6d01\u51c0\u53f0\uff08\u578b\u53f7\uff1aSW-CJ-2FD\uff09\u914d\u5907\uff1a<\/p>\n \n\n\n| \u529f\u80fd\u6a21\u5757<\/th>\n | \u6280\u672f\u53c2\u6570<\/th>\n | \u901a\u4fe1\u65b9\u5f0f<\/th>\n<\/tr>\n<\/thead>\n | \n\n| \u538b\u5dee\u4f20\u611f\u5668<\/td>\n | \u91cf\u7a0b0~500Pa\uff0c\u7cbe\u5ea6\u00b12%<\/td>\n | RS485<\/td>\n<\/tr>\n | \n| \u9897\u7c92\u7269\u4f20\u611f\u5668<\/td>\n | PM2.5\/PM10\uff0c\u6fc0\u5149\u6563\u5c04<\/td>\n | Wi-Fi<\/td>\n<\/tr>\n | \n| \u6e29\u6e7f\u5ea6\u76d1\u6d4b<\/td>\n | -10~60\u00b0C\uff0c0~100%RH<\/td>\n | Modbus<\/td>\n<\/tr>\n | \n| \u6570\u636e\u5e73\u53f0<\/td>\n | \u4e91\u7aef\u5b58\u50a8\uff0cAPP\u62a5\u8b66<\/td>\n | 4G\/\u4ee5\u592a\u7f51<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n \u7cfb\u7edf\u53ef\u81ea\u52a8\u7ed8\u5236\u538b\u5dee-\u65f6\u95f4\u66f2\u7ebf\uff0c\u9884\u6d4b\u5269\u4f59\u5bff\u547d\uff0c\u5e76\u901a\u8fc7\u5fae\u4fe1\u6216\u77ed\u4fe1\u63a8\u9001\u66f4\u6362\u63d0\u9192\u3002<\/p>\n
\n\u4e03\u3001\u66f4\u6362\u64cd\u4f5c\u89c4\u8303\u4e0e\u5b89\u5168\u6ce8\u610f\u4e8b\u9879<\/h2>\n\u9ad8\u6548\u8fc7\u6ee4\u5668\u66f4\u6362\u4e0d\u4ec5\u662f\u6280\u672f\u95ee\u9898\uff0c\u66f4\u6d89\u53ca\u751f\u7269\u5b89\u5168\u4e0e\u64cd\u4f5c\u89c4\u8303\u3002<\/p>\n 1. \u66f4\u6362\u524d\u51c6\u5907<\/h3>\n\n- \u505c\u673a\u5e76\u65ad\u7535<\/li>\n
- \u4f7f\u7528PAO\u6216DOP\u6c14\u6eb6\u80f6\u8fdb\u884c\u4e0a\u6e38\u53d1\u5c18\uff0c\u786e\u8ba4\u8fc7\u6ee4\u5668\u4e0a\u6e38\u6d53\u5ea6\u8fbe\u6807<\/li>\n
- \u51c6\u5907\u68c0\u6f0f\u4eea\u5668\uff08\u5982\u5149\u5ea6\u8ba1\u6216\u7c92\u5b50\u8ba1\u6570\u5668\uff09<\/li>\n
- \u4f69\u6234N95\u53e3\u7f69\u3001\u624b\u5957\u3001\u9632\u62a4\u670d<\/li>\n<\/ul>\n
2. \u66f4\u6362\u6b65\u9aa4<\/h3>\n\n- \u62c6\u5378\u65e7\u8fc7\u6ee4\u5668\uff0c\u6ce8\u610f\u5bc6\u5c01\u80f6\u6761\u5b8c\u6574\u6027<\/li>\n
- \u6e05\u6d01\u8fc7\u6ee4\u5668\u5b89\u88c5\u6846\uff0c\u53bb\u9664\u79ef\u5c18<\/li>\n
- \u5b89\u88c5\u65b0\u8fc7\u6ee4\u5668\uff0c\u786e\u4fdd\u65b9\u5411\u6b63\u786e\uff08\u6c14\u6d41\u65b9\u5411\u7bad\u5934\uff09<\/li>\n
- \u4f7f\u7528\u7845\u80f6\u6216\u5bc6\u5c01\u57ab\u8fdb\u884c\u5bc6\u5c01<\/li>\n
- \u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08\u68c0\u6f0f\uff09<\/li>\n<\/ol>\n
3. \u68c0\u6f0f\u6d4b\u8bd5\u6807\u51c6<\/h3>\n\n\n\n| \u6d4b\u8bd5\u65b9\u6cd5<\/th>\n | \u6807\u51c6\u8981\u6c42<\/th>\n | \u4eea\u5668<\/th>\n<\/tr>\n<\/thead>\n | \n\n| \u5149\u5ea6\u8ba1\u6cd5\uff08PAO\uff09<\/td>\n | \u626b\u63cf\u901f\u5ea6\u22645 cm\/s\uff0c\u6cc4\u6f0f\u7387\u22640.01%<\/td>\n | TSI 9020<\/td>\n<\/tr>\n | \n| \u7c92\u5b50\u8ba1\u6570\u6cd5<\/td>\n | \u5c40\u90e8\u6cc4\u6f0f\u226410\u207b\u2074<\/td>\n | Met One 3413<\/td>\n<\/tr>\n | \n| DOP\u6cd5\uff08\u4e2d\u56fd\u5e38\u7528\uff09<\/td>\n | \u6d53\u5ea6\u226580 \u03bcg\/L\uff0c\u4e0b\u6e38\u22640.03%<\/td>\n | \u56fd\u4ea7DOP\u53d1\u751f\u5668<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\u4f9d\u636e\uff1a<\/strong> GB\/T 14295-2019\u300a\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u9644\u5f55B<\/p>\n<\/blockquote>\n
\n\u516b\u3001\u5178\u578b\u6848\u4f8b\u5206\u6790<\/h2>\n\u6848\u4f8b\u4e00\uff1a\u67d0\u751f\u7269\u5236\u836f\u4f01\u4e1aGMP\u8f66\u95f4<\/h3>\n\n- \u8bbe\u5907\u578b\u53f7<\/strong>\uff1aThermo Scientific 1300 Series A2<\/li>\n
- \u521d\u59cb\u538b\u5dee<\/strong>\uff1a150 Pa<\/li>\n
- \u8fd0\u884c\u73af\u5883<\/strong>\uff1aC\u7ea7\u6d01\u51c0\u533a\uff0cPM2.5\u65e5\u5747\u503c35 \u03bcg\/m\u00b3<\/li>\n
- \u76d1\u63a7\u65b9\u5f0f<\/strong>\uff1a\u6bcf\u5b63\u5ea6\u538b\u5dee\u8bb0\u5f55 + \u5e74\u5ea6\u68c0\u6f0f<\/li>\n
- \u66f4\u6362\u5468\u671f<\/strong>\uff1a\u7b2c34\u4e2a\u6708\u538b\u5dee\u8fbe390 Pa\uff0c\u63d0\u524d\u66f4\u6362<\/li>\n
- \u7ed3\u679c<\/strong>\uff1a\u66f4\u6362\u540e\u98ce\u901f\u6062\u590d\u81f30.45 m\/s\uff08\u6807\u51c60.3~0.5 m\/s\uff09\uff0c\u7c92\u5b50\u6d53\u5ea6\u8fbe\u6807<\/li>\n<\/ul>\n
\u6848\u4f8b\u4e8c\uff1a\u9ad8\u6821\u7ec6\u80de\u5b9e\u9a8c\u5ba4<\/h3>\n\n- \u8bbe\u5907\u578b\u53f7<\/strong>\uff1a\u82cf\u51c0SW-CJ-1F<\/li>\n
- \u4f7f\u7528\u9891\u7387<\/strong>\uff1a\u6bcf\u54685\u5929\uff0c\u6bcf\u59296\u5c0f\u65f6<\/li>\n
- \u672a\u66f4\u6362\u9884\u8fc7\u6ee4\u5668<\/strong>\uff1a\u8fde\u7eed\u4f7f\u752818\u4e2a\u6708<\/li>\n
- \u7b2c22\u4e2a\u6708<\/strong>\uff1a\u538b\u5dee\u8fbe410 Pa\uff0c\u98ce\u901f\u4e0b\u964d\u81f30.28 m\/s<\/li>\n
- \u540e\u679c<\/strong>\uff1a\u5c40\u90e8\u6d01\u51c0\u5ea6\u4e0b\u964d\u81f3ISO 6\u7ea7\uff0c\u5bfc\u81f4\u7ec6\u80de\u6c61\u67d3<\/li>\n
- \u6559\u8bad<\/strong>\uff1a\u5ffd\u89c6\u9884\u8fc7\u6ee4\u5668\u7ef4\u62a4\u5c06\u52a0\u901fHEPA\u5835\u585e<\/li>\n<\/ul>\n
\n\u4e5d\u3001\u672a\u6765\u53d1\u5c55\u8d8b\u52bf<\/h2>\n\n- \u667a\u80fd\u9884\u6d4b\u7ef4\u62a4<\/strong>\uff1a\u7ed3\u5408AI\u7b97\u6cd5\u5206\u6790\u5386\u53f2\u6570\u636e\uff0c\u5b9e\u73b0\u66f4\u6362\u5468\u671f\u7cbe\u51c6\u9884\u6d4b\u3002<\/li>\n
- \u81ea\u6e05\u6d01\u8fc7\u6ee4\u6750\u6599<\/strong>\uff1a\u7814\u53d1\u5177\u6709\u5149\u50ac\u5316\u6216\u9759\u7535\u9664\u5c18\u529f\u80fd\u7684\u590d\u5408\u6ee4\u6750\uff0c\u5ef6\u957f\u5bff\u547d\u3002<\/li>\n
- \u6807\u51c6\u5316\u6570\u636e\u5e93<\/strong>\uff1a\u5efa\u7acb\u5168\u56fd\u6d01\u51c0\u8bbe\u5907\u8fd0\u884c\u6570\u636e\u5e93\uff0c\u652f\u6301\u884c\u4e1a\u57fa\u51c6\u5236\u5b9a\u3002<\/li>\n
- \u7eff\u8272\u66f4\u6362<\/strong>\uff1a\u63a8\u5e7f\u53ef\u56de\u6536HEPA\u6ee4\u82af\uff0c\u51cf\u5c11\u73bb\u7483\u7ea4\u7ef4\u5e9f\u5f03\u7269\u3002<\/li>\n<\/ol>\n
\n\u53c2\u8003\u6587\u732e<\/h2>\n\n- GB\/T 13554-2020. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668 [S]. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2020. <\/li>\n
- IEST-RP-CC001.5. HEPA and ULPA Filters [M]. Institute of Environmental Sciences and Technology, 2021. <\/li>\n
- EN 1822:2019. High Efficiency Air Filters (HEPA and ULPA) [S]. European Committee for Standardization, 2019. <\/li>\n
- ASHRAE Standard 52.2-2017. Method of Testing General Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size [S]. American Society of Heating, Refrigerating and Air-Conditioning Engineers, 2017. <\/li>\n
- FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing [Z]. 2004. <\/li>\n
- Zhang, Y., et al. "Impact of Ambient Particulate Matter on HEPA Filter Lifespan in Cleanrooms." Indoor Air<\/em>, 2021, 31(3): 789\u2013801. <\/li>\n
- Li, H., et al. "Operational Lifetime Analysis of HEPA Filters in Pharmaceutical Cleanrooms." Journal of Pharmaceutical Innovation<\/em>, 2020, 15(2): 112\u2013120. <\/li>\n
- Wang, L., et al. "Modeling Pressure Drop Growth in HEPA Filters Using Logarithmic Functions." Building and Environment<\/em>, 2019, 156: 123\u2013131. <\/li>\n
- Chen, X., et al. "Development of a Multi-Parameter Decision Support System for HEPA Filter Replacement in Hospitals." IEEE Access<\/em>, 2022, 10: 45678\u201345689. <\/li>\n
- \u82cf\u51c0\u96c6\u56e2. SW-CJ\u7cfb\u5217\u6d01\u51c0\u5de5\u4f5c\u53f0\u4f7f\u7528\u624b\u518c [Z]. \u82cf\u5dde: \u82cf\u51c0\u96c6\u56e2\u6709\u9650\u516c\u53f8, 2023. <\/li>\n
- YY 0569-2011. \u751f\u7269\u5b89\u5168\u67dc [S]. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2011. <\/li>\n
- WS 233-2017. \u5fae\u751f\u7269\u5b9e\u9a8c\u5ba4\u751f\u7269\u5b89\u5168\u901a\u7528\u51c6\u5219 [S]. \u5317\u4eac: \u4e2d\u56fd\u536b\u751f\u51fa\u7248\u793e, 2017. <\/li>\n
- JIS Z 8122:2019. Methods of testing cleanrooms [S]. Japanese Standards Association, 2019. <\/li>\n
- CEN. EN 1752:2017 Ventilation for buildings \u2014 Design criteria for the indoor environment [S]. 2017. <\/li>\n<\/ol>\n
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