{"id":16636,"date":"2025-08-22T17:09:51","date_gmt":"2025-08-22T09:09:51","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16636"},"modified":"2025-08-22T17:09:51","modified_gmt":"2025-08-22T09:09:51","slug":"%e5%8c%bb%e8%8d%afgmp%e7%8e%af%e5%a2%83%e4%b8%8b%e6%b4%81%e5%87%80%e5%b7%a5%e4%bd%9c%e5%8f%b0h14%e7%ba%a7%e8%bf%87%e6%bb%a4%e5%99%a8%e9%aa%8c%e8%af%81%e6%b5%81%e7%a8%8b%e8%af%a6%e8%a7%a3","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16636","title":{"rendered":"\u533b\u836fGMP\u73af\u5883\u4e0b\u6d01\u51c0\u5de5\u4f5c\u53f0H14\u7ea7\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u6d41\u7a0b\u8be6\u89e3"},"content":{"rendered":"<h1>\u533b\u836fGMP\u73af\u5883\u4e0b\u6d01\u51c0\u5de5\u4f5c\u53f0H14\u7ea7\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u6d41\u7a0b\u8be6\u89e3<\/h1>\n<p>\u5728\u533b\u836f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u6d01\u51c0\u73af\u5883\u662f\u786e\u4fdd\u836f\u54c1\u8d28\u91cf\u3001\u9632\u6b62\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c61\u67d3\u7684\u5173\u952e\u73af\u8282\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u8981\u6c42\uff0c\u65e0\u83cc\u836f\u54c1\u3001\u751f\u7269\u5236\u54c1\u7b49\u9ad8\u98ce\u9669\u4ea7\u54c1\u7684\u751f\u4ea7\u5fc5\u987b\u5728\u53d7\u63a7\u7684\u6d01\u51c0\u73af\u5883\u4e2d\u8fdb\u884c\u3002\u5176\u4e2d\uff0c\u6d01\u51c0\u5de5\u4f5c\u53f0\u4f5c\u4e3a\u5c40\u90e8\u6d01\u51c0\u533a\u57df\u7684\u6838\u5fc3\u8bbe\u5907\uff0c\u5176\u6027\u80fd\u76f4\u63a5\u5173\u7cfb\u5230\u4ea7\u54c1\u7684\u65e0\u83cc\u4fdd\u969c\u6c34\u5e73\u3002\u800c\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08High Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\u662f\u6d01\u51c0\u5de5\u4f5c\u53f0\u5b9e\u73b0\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7684\u5173\u952e\u90e8\u4ef6\uff0c\u5c24\u5176\u662fH14\u7ea7\u8fc7\u6ee4\u5668\uff0c\u56e0\u5176\u5bf90.3\u03bcm\u9897\u7c92\u7684\u8fc7\u6ee4\u6548\u7387\u4e0d\u4f4e\u4e8e99.995%\uff0c\u88ab\u5e7f\u6cdb\u5e94\u7528\u4e8eISO 5\u7ea7\uff08\u539f\u767e\u7ea7\uff09\u6d01\u51c0\u533a\u3002<\/p>\n<p>\u672c\u6587\u5c06\u7cfb\u7edf\u9610\u8ff0\u5728\u533b\u836fGMP\u73af\u5883\u4e0b\uff0c\u6d01\u51c0\u5de5\u4f5c\u53f0\u6240\u914d\u5907\u7684H14\u7ea7\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u6d41\u7a0b\uff0c\u6db5\u76d6\u8bbe\u8ba1\u786e\u8ba4\uff08DQ\uff09\u3001\u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09\u3001\u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09\u53ca\u6027\u80fd\u786e\u8ba4\uff08PQ\uff09\u56db\u4e2a\u9636\u6bb5\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u6743\u5a01\u6807\u51c6\u4e0e\u6587\u732e\uff0c\u63d0\u4f9b\u8be6\u7ec6\u7684\u6280\u672f\u53c2\u6570\u3001\u68c0\u6d4b\u65b9\u6cd5\u3001\u9a8c\u6536\u6807\u51c6\u53ca\u5b9e\u9645\u64cd\u4f5c\u5efa\u8bae\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001H14\u7ea7\u9ad8\u6548\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>1.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p>\u6839\u636e\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6\u300aGB\/T 13554-2020  \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u548c\u56fd\u9645\u6807\u51c6ISO 29463-2011\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u6309\u6548\u7387\u5206\u4e3aH10\uff5eH14\u4e94\u4e2a\u7b49\u7ea7\u3002\u5176\u4e2d\uff0cH14\u7ea7\u8fc7\u6ee4\u5668\u8981\u6c42\u5bf9\u7c92\u5f840.3\u03bcm\u7684\u9897\u7c92\u7269\u8fc7\u6ee4\u6548\u7387\u4e0d\u4f4e\u4e8e99.995%\uff08\u5373\u7a7f\u900f\u7387\u22640.005%\uff09\uff0c\u5c5e\u4e8e\u8d85\u9ad8\u6548\u8fc7\u6ee4\u5668\u8303\u7574\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/th>\n<th>\u6807\u51c6\u4f9d\u636e<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff080.3\u03bcm\uff09<\/th>\n<th>\u7a7f\u900f\u7387<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H13<\/td>\n<td>GB\/T 13554-2020 \/ ISO 29463<\/td>\n<td>\u226599.99%<\/td>\n<td>\u22640.01%<\/td>\n<\/tr>\n<tr>\n<td>H14<\/td>\n<td>GB\/T 13554-2020 \/ ISO 29463<\/td>\n<td>\u226599.995%<\/td>\n<td>\u22640.005%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u6d4b\u8bd5\u6c14\u6eb6\u80f6\u901a\u5e38\u4e3a\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916f\uff08DOP\uff09\u3001\u7678\u4e8c\u9178\u4e8c\u8f9b\u916f\uff08DEHS\uff09\u6216\u805a\u82ef\u4e59\u70ef\u4e73\u80f6\u7403\uff08PSL\uff09\u3002<\/p>\n<\/blockquote>\n<p>H14\u7ea7\u8fc7\u6ee4\u5668\u5e7f\u6cdb\u5e94\u7528\u4e8e\u65e0\u83cc\u5236\u5242\u704c\u88c5\u7ebf\u3001\u751f\u7269\u5b89\u5168\u67dc\u3001\u5c42\u6d41\u7f69\u53ca\u6d01\u51c0\u5de5\u4f5c\u53f0\u7b49\u5173\u952e\u533a\u57df\uff0c\u4ee5\u6ee1\u8db3GMP\u5bf9A\u7ea7\uff08\u52a8\u6001\uff09\u6216ISO 5\u7ea7\u6d01\u51c0\u73af\u5883\u7684\u8981\u6c42\u3002<\/p>\n<h3>1.2 \u4e3b\u8981\u6280\u672f\u53c2\u6570<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u9879<\/th>\n<th>\u5178\u578b\u503c\u6216\u8303\u56f4<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387\uff080.3\u03bcm\uff09<\/td>\n<td>\u226599.995%<\/td>\n<td>\u4f9d\u636eGB\/T 13554\u6216ISO 29463\u6d4b\u8bd5<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u2264220 Pa<\/td>\n<td>\u65b0\u8fc7\u6ee4\u5668\u5728\u989d\u5b9a\u98ce\u91cf\u4e0b\u7684\u538b\u964d<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf<\/td>\n<td>0.45 m\/s \u00b120%<\/td>\n<td>\u6d01\u51c0\u5de5\u4f5c\u53f0\u9762\u98ce\u901f\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u6599\u6750\u8d28<\/td>\n<td>\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4<\/td>\n<td>\u5177\u6709\u9ad8\u6355\u96c6\u6548\u7387\u548c\u4f4e\u963b\u529b\u7279\u6027<\/td>\n<\/tr>\n<tr>\n<td>\u6846\u67b6\u6750\u8d28<\/td>\n<td>\u94dd\u5408\u91d1\u6216\u55b7\u6d82\u94a2\u677f<\/td>\n<td>\u9632\u8150\u8680\u3001\u7ed3\u6784\u7a33\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5bff\u547d<\/td>\n<td>3\uff5e5\u5e74\uff08\u89c6\u73af\u5883\u800c\u5b9a\uff09<\/td>\n<td>\u53d7\u524d\u7ea7\u8fc7\u6ee4\u5668\u4fdd\u62a4\u7a0b\u5ea6\u5f71\u54cd<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e8c\u3001GMP\u5bf9\u6d01\u51c0\u5de5\u4f5c\u53f0\u53ca\u8fc7\u6ee4\u5668\u7684\u6cd5\u89c4\u8981\u6c42<\/h2>\n<h3>2.1 \u56fd\u5185\u6cd5\u89c4\u4f9d\u636e<\/h3>\n<p>\u6839\u636e\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u53d1\u5e03\u7684\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b\u9644\u5f551\u300a\u65e0\u83cc\u836f\u54c1\u300b\u7b2c32\u6761\u89c4\u5b9a\uff1a<\/p>\n<blockquote>\n<p>\u201c\u65e0\u83cc\u64cd\u4f5c\u7684\u6d01\u51c0\u533a\u57df\u5e94\u91c7\u7528\u5355\u5411\u6d41\uff08\u5c42\u6d41\uff09\u7cfb\u7edf\uff0c\u5176\u9001\u98ce\u5e94\u7ecf\u8fc7\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08H13\u7ea7\u4ee5\u4e0a\uff09\uff0c\u5e76\u5b9a\u671f\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u3002\u201d<\/p>\n<\/blockquote>\n<p>\u6b64\u5916\uff0c\u300a\u6d01\u51c0\u5ba4\u65bd\u5de5\u53ca\u9a8c\u6536\u89c4\u8303\u300b\uff08GB 50591-2010\uff09\u7b2c13.4.3\u6761\u660e\u786e\u6307\u51fa\uff1a<\/p>\n<blockquote>\n<p>\u201c\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b89\u88c5\u540e\u5e94\u8fdb\u884c\u6cc4\u6f0f\u6d4b\u8bd5\uff0c\u6d4b\u8bd5\u65b9\u6cd5\u53ef\u91c7\u7528\u626b\u63cf\u6cd5\u6216\u7c92\u5b50\u8ba1\u6570\u6cd5\uff0c\u91c7\u6837\u901f\u5ea6\u4e0d\u5c0f\u4e8e15 L\/min\uff0c\u626b\u63cf\u901f\u5ea6\u4e0d\u5927\u4e8e5 cm\/s\u3002\u201d<\/p>\n<\/blockquote>\n<h3>2.2 \u56fd\u9645\u6807\u51c6\u53c2\u8003<\/h3>\n<ul>\n<li><strong>\u7f8e\u56fdFDA<\/strong>\u300aGuide to Inspections of Aseptic Pharmaceutical Production\u300b\u5f3a\u8c03\uff1a\u6240\u6709\u8fdb\u5165\u65e0\u83cc\u64cd\u4f5c\u533a\u7684\u7a7a\u6c14\u5fc5\u987b\u901a\u8fc7\u7ecf\u9a8c\u8bc1\u7684HEPA\u8fc7\u6ee4\u5668\uff0c\u5e76\u5b9a\u671f\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u3002<\/li>\n<li><strong>\u6b27\u76dfGMP Annex 1 (2022)<\/strong> \u7b2c8.40\u6761\u6307\u51fa\uff1a\u201c\u5e94\u5b9a\u671f\u5bf9HEPA\u8fc7\u6ee4\u5668\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u63a8\u8350\u4f7f\u7528\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5\u6216\u7c92\u5b50\u8ba1\u6570\u6cd5\u3002\u201d<\/li>\n<li><strong>ISO 14644-3:2019<\/strong>\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883 \u7b2c3\u90e8\u5206\uff1a\u6d4b\u8bd5\u65b9\u6cd5\u300b\u4e2d\u8be6\u7ec6\u89c4\u5b9a\u4e86\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u626b\u63cf\u68c0\u6f0f\u7a0b\u5e8f\uff08Method B.7\uff09\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e09\u3001H14\u7ea7\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u6d41\u7a0b<\/h2>\n<p>\u9a8c\u8bc1\u5de5\u4f5c\u9075\u5faaGMP\u4e2d\u201c\u9a8c\u8bc1\u751f\u547d\u5468\u671f\u201d\u7406\u5ff5\uff0c\u5206\u4e3a\u56db\u4e2a\u9636\u6bb5\uff1a\u8bbe\u8ba1\u786e\u8ba4\uff08DQ\uff09\u3001\u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09\u3001\u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09\u548c\u6027\u80fd\u786e\u8ba4\uff08PQ\uff09\u3002\u6574\u4e2a\u8fc7\u7a0b\u9700\u5f62\u6210\u5b8c\u6574\u7684\u9a8c\u8bc1\u6587\u4ef6\uff0c\u5305\u62ec\u65b9\u6848\u3001\u8bb0\u5f55\u3001\u62a5\u544a\u53ca\u504f\u5dee\u5904\u7406\u3002<\/p>\n<h3>3.1 \u8bbe\u8ba1\u786e\u8ba4\uff08Design Qualification, DQ\uff09<\/h3>\n<p>DQ\u9636\u6bb5\u65e8\u5728\u786e\u8ba4\u8bbe\u5907\u8bbe\u8ba1\u7b26\u5408\u7528\u6237\u9700\u6c42\uff08URS\uff09\u548cGMP\u8981\u6c42\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u9a8c\u8bc1\u9879\u76ee<\/th>\n<th>\u9a8c\u8bc1\u5185\u5bb9<\/th>\n<th>\u63a5\u53d7\u6807\u51c6<\/th>\n<th>\u6587\u4ef6\u8bb0\u5f55<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/td>\n<td>\u662f\u5426\u4e3aH14\u7ea7<\/td>\n<td>\u7b26\u5408GB\/T 13554\u6216ISO 29463<\/td>\n<td>\u8fc7\u6ee4\u5668\u51fa\u5382\u68c0\u6d4b\u62a5\u544a<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u82af\u6750\u8d28<\/td>\n<td>\u662f\u5426\u4e3a\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4<\/td>\n<td>\u63d0\u4f9b\u6750\u8d28\u8bc1\u660e<\/td>\n<td>\u4f9b\u5e94\u5546COA<\/td>\n<\/tr>\n<tr>\n<td>\u6846\u67b6\u5bc6\u5c01\u6027<\/td>\n<td>\u662f\u5426\u91c7\u7528\u6db2\u69fd\u5bc6\u5c01\u6216\u673a\u68b0\u538b\u7d27<\/td>\n<td>\u65e0\u6cc4\u6f0f\u98ce\u9669<\/td>\n<td>\u8bbe\u8ba1\u56fe\u7eb8<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u901f\u5747\u5300\u6027\u8bbe\u8ba1<\/td>\n<td>\u662f\u5426\u6ee1\u8db30.36\uff5e0.54 m\/s<\/td>\n<td>\u7b26\u5408ISO 14644-4<\/td>\n<td>CFD\u6a21\u62df\u62a5\u544a\uff08\u53ef\u9009\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u53c2\u8003\u6587\u732e\u652f\u6301<\/strong>\uff1a  <\/p>\n<ul>\n<li>\u300a\u5236\u836f\u5de5\u7a0b\u539f\u7406\u4e0e\u5e94\u7528\u300b\uff08\u5510\u5fd7\u8363\u4e3b\u7f16\uff0c\u5316\u5b66\u5de5\u4e1a\u51fa\u7248\u793e\uff0c2018\uff09\u6307\u51fa\uff0cDQ\u662f\u9a8c\u8bc1\u7684\u8d77\u70b9\uff0c\u5fc5\u987b\u57fa\u4e8e\u79d1\u5b66\u98ce\u9669\u8bc4\u4f30\u8fdb\u884c\u3002<\/li>\n<li>ISPE\u300aBaseline Guide: HVAC\u300b\u5efa\u8bae\u5728DQ\u9636\u6bb5\u8bc4\u4f30\u8fc7\u6ee4\u5668\u66f4\u6362\u4fbf\u5229\u6027\u53ca\u7ef4\u62a4\u901a\u9053\u3002<\/li>\n<\/ul>\n<\/blockquote>\n<h3>3.2 \u5b89\u88c5\u786e\u8ba4\uff08Installation Qualification, IQ\uff09<\/h3>\n<p>IQ\u7528\u4e8e\u786e\u8ba4\u8bbe\u5907\u5df2\u6309\u8bbe\u8ba1\u8981\u6c42\u6b63\u786e\u5b89\u88c5\uff0c\u6240\u6709\u7ec4\u4ef6\u9f50\u5168\u4e14\u7b26\u5408\u89c4\u8303\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u68c0\u67e5\u9879\u76ee<\/th>\n<th>\u68c0\u67e5\u5185\u5bb9<\/th>\n<th>\u65b9\u6cd5<\/th>\n<th>\u63a5\u53d7\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u5668\u578b\u53f7<\/td>\n<td>\u6838\u5bf9\u94ed\u724c\u4fe1\u606f<\/td>\n<td>\u76ee\u89c6\u68c0\u67e5<\/td>\n<td>\u4e0e\u91c7\u8d2d\u6e05\u5355\u4e00\u81f4<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u88c5\u65b9\u5411<\/td>\n<td>\u6c14\u6d41\u65b9\u5411\u6807\u8bc6<\/td>\n<td>\u67e5\u9605\u8bf4\u660e\u4e66<\/td>\n<td>\u7bad\u5934\u6307\u5411\u51fa\u98ce\u4fa7<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u72b6\u51b5<\/td>\n<td>\u6846\u67b6\u4e0e\u7bb1\u4f53\u8fde\u63a5\u5904<\/td>\n<td>\u624b\u611f+\u76ee\u89c6<\/td>\n<td>\u65e0\u7f1d\u9699\u3001\u65e0\u53d8\u5f62<\/td>\n<\/tr>\n<tr>\n<td>\u524d\u540e\u538b\u5dee\u8868<\/td>\n<td>\u662f\u5426\u5b89\u88c5\u5e76\u6821\u51c6<\/td>\n<td>\u6838\u5bf9\u6821\u51c6\u8bc1\u4e66<\/td>\n<td>\u5728\u6709\u6548\u671f\u5185<\/td>\n<\/tr>\n<tr>\n<td>\u7535\u6c14\u8fde\u63a5<\/td>\n<td>\u98ce\u673a\u7535\u6e90\u63a5\u7ebf<\/td>\n<td>\u4e07\u7528\u8868\u68c0\u6d4b<\/td>\n<td>\u7535\u538b\u7a33\u5b9a\u3001\u65e0\u77ed\u8def<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>\u6ce8\u610f\u4e8b\u9879<\/strong>\uff1a<\/p>\n<ul>\n<li>\u5b89\u88c5\u8fc7\u7a0b\u4e2d\u5e94\u907f\u514d\u6ee4\u7eb8\u7834\u635f\uff0c\u7981\u6b62\u8e29\u8e0f\u6216\u6324\u538b\u8fc7\u6ee4\u5668\u8868\u9762\u3002<\/li>\n<li>\u82e5\u91c7\u7528\u6db2\u69fd\u5bc6\u5c01\uff0c\u5e94\u6ce8\u5165\u9002\u91cf\u5bc6\u5c01\u6cb9\uff08\u5982\u7845\u6cb9\uff09\uff0c\u786e\u4fdd\u201cO\u201d\u5f62\u73af\u5b8c\u6574\u3002<\/li>\n<\/ul>\n<blockquote>\n<p><strong>\u6587\u732e\u652f\u6301<\/strong>\uff1a  <\/p>\n<ul>\n<li>\u300a\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303\u300b\uff08GB 50073-2013\uff09\u7b2c9.4.2\u6761\u89c4\u5b9a\uff1a\u201c\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b89\u88c5\u65f6\u5e94\u91c7\u53d6\u4fdd\u62a4\u63aa\u65bd\uff0c\u9632\u6b62\u6c61\u67d3\u548c\u635f\u4f24\u3002\u201d<\/li>\n<li>\u7f8e\u56fdASHRAE Handbook\u2014HVAC Applications (2020) \u5f3a\u8c03\uff0c\u9519\u8bef\u5b89\u88c5\u662f\u5bfc\u81f4\u8fc7\u6ee4\u5668\u65e9\u671f\u5931\u6548\u7684\u4e3b\u8981\u539f\u56e0\u4e4b\u4e00\u3002<\/li>\n<\/ul>\n<\/blockquote>\n<h3>3.3 \u8fd0\u884c\u786e\u8ba4\uff08Operational Qualification, OQ\uff09<\/h3>\n<p>OQ\u9636\u6bb5\u6d4b\u8bd5\u8bbe\u5907\u5728\u7a7a\u8f7d\u72b6\u6001\u4e0b\u7684\u8fd0\u884c\u6027\u80fd\uff0c\u91cd\u70b9\u8bc4\u4f30\u98ce\u901f\u3001\u566a\u58f0\u3001\u632f\u52a8\u53ca\u63a7\u5236\u7cfb\u7edf\u529f\u80fd\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bd5\u9879\u76ee<\/th>\n<th>\u6d4b\u8bd5\u65b9\u6cd5<\/th>\n<th>\u4eea\u5668<\/th>\n<th>\u63a5\u53d7\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u9762\u98ce\u901f<\/td>\n<td>\u591a\u70b9\u6d4b\u91cf\uff085\u70b9\u6cd5\u62169\u70b9\u6cd5\uff09<\/td>\n<td>\u70ed\u7403\u98ce\u901f\u4eea\uff08\u7cbe\u5ea6\u00b13%\uff09<\/td>\n<td>0.36\uff5e0.54 m\/s\uff0c\u5747\u5300\u5ea6\u226580%<\/td>\n<\/tr>\n<tr>\n<td>\u566a\u58f0<\/td>\n<td>\u8ddd\u5de5\u4f5c\u53f0\u524d0.5m\u5904\u6d4b\u91cf<\/td>\n<td>\u58f0\u7ea7\u8ba1<\/td>\n<td>\u226465 dB(A)<\/td>\n<\/tr>\n<tr>\n<td>\u632f\u52a8<\/td>\n<td>\u8bbe\u5907\u8868\u9762\u6d4b\u91cf<\/td>\n<td>\u632f\u52a8\u4eea<\/td>\n<td>\u22642 mm\/s<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u6307\u793a<\/td>\n<td>\u6bd4\u5bf9\u538b\u5dee\u8868\u8bfb\u6570\u4e0e\u5b9e\u6d4b\u503c<\/td>\n<td>\u5fae\u538b\u8ba1<\/td>\n<td>\u8bef\u5dee\u226410%<\/td>\n<\/tr>\n<tr>\n<td>\u5f00\u5173\u673a\u529f\u80fd<\/td>\n<td>\u591a\u6b21\u542f\u505c\u6d4b\u8bd5<\/td>\n<td>\u2014\u2014<\/td>\n<td>\u6b63\u5e38\u54cd\u5e94\uff0c\u65e0\u5ef6\u8fdf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>\u98ce\u901f\u5747\u5300\u6027\u8ba1\u7b97\u516c\u5f0f<\/strong>\uff1a<\/p>\n<p>$$<br \/>\ntext{\u5747\u5300\u5ea6} = frac{text{\u6700\u5c0f\u98ce\u901f}}{text{\u5e73\u5747\u98ce\u901f}} times 100%<br \/>\n$$<\/p>\n<blockquote>\n<p>\u63a5\u53d7\u6807\u51c6\uff1a\u226580%<\/p>\n<p><strong>\u53c2\u8003\u6587\u732e<\/strong>\uff1a  <\/p>\n<ul>\n<li>ISO 14644-3:2019 Method B.6 \u89c4\u5b9a\uff0c\u5355\u5411\u6d41\u88c5\u7f6e\u7684\u98ce\u901f\u5747\u5300\u6027\u5e94\u901a\u8fc7\u7f51\u683c\u6cd5\u6d4b\u91cf\u3002<\/li>\n<li>\u300a\u533b\u836f\u5de5\u4e1a\u6d01\u51c0\u5ba4\uff08\u533a\uff09\u60ac\u6d6e\u7c92\u5b50\u7684\u6d4b\u8bd5\u65b9\u6cd5\u300b\uff08GB\/T 16292-2010\uff09\u63a8\u8350\u4f7f\u7528\u7b49\u52a8\u529b\u91c7\u6837\u63a2\u5934\u3002<\/li>\n<\/ul>\n<\/blockquote>\n<h3>3.4 \u6027\u80fd\u786e\u8ba4\uff08Performance Qualification, PQ\uff09<\/h3>\n<p>PQ\u662f\u9a8c\u8bc1\u7684\u6700\u7ec8\u9636\u6bb5\uff0c\u8bc4\u4f30\u6d01\u51c0\u5de5\u4f5c\u53f0\u5728\u6a21\u62df\u4f7f\u7528\u6761\u4ef6\u4e0b\u7684\u7efc\u5408\u6027\u80fd\uff0c\u6838\u5fc3\u4e3a<strong>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5<\/strong>\u548c<strong>\u6d01\u51c0\u5ea6\u7b49\u7ea7\u786e\u8ba4<\/strong>\u3002<\/p>\n<h4>3.4.1 \u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08Filter Integrity Test\uff09<\/h4>\n<p>\u5b8c\u6574\u6027\u6d4b\u8bd5\u662fPQ\u7684\u6838\u5fc3\u5185\u5bb9\uff0c\u76ee\u7684\u662f\u68c0\u6d4b\u8fc7\u6ee4\u5668\u662f\u5426\u5b58\u5728\u6cc4\u6f0f\u6216\u7834\u635f\u3002\u5e38\u7528\u65b9\u6cd5\u6709\u4e24\u79cd\uff1a<\/p>\n<ol>\n<li>\n<p><strong>\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5\uff08Photometer Method\uff09<\/strong><br \/>\n\u9002\u7528\u4e8e\u4e0a\u6e38\u6d53\u5ea6\u8f83\u9ad8\u7684\u6d4b\u8bd5\u573a\u666f\uff0c\u5e38\u7528\u4e8eH13\/H14\u7ea7\u8fc7\u6ee4\u5668\u3002<\/p>\n<\/li>\n<li>\n<p><strong>\u7c92\u5b50\u8ba1\u6570\u5668\u626b\u63cf\u6cd5\uff08Particle Counter Scan Method\uff09<\/strong><br \/>\n\u66f4\u7075\u654f\uff0c\u9002\u7528\u4e8e\u9ad8\u98ce\u9669\u533a\u57df\uff0c\u7b26\u5408FDA\u548cEU GMP\u63a8\u8350\u3002<\/p>\n<\/li>\n<\/ol>\n<table>\n<thead>\n<tr>\n<th>\u65b9\u6cd5<\/th>\n<th>\u539f\u7406<\/th>\n<th>\u4f18\u70b9<\/th>\n<th>\u7f3a\u70b9<\/th>\n<th>\u6807\u51c6\u4f9d\u636e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5149\u5ea6\u8ba1\u6cd5<\/td>\n<td>\u4e0a\u6e38\u53d1\u751fDOP\/DEHS\u6c14\u6eb6\u80f6\uff0c\u4e0b\u6e38\u7528\u5149\u5ea6\u8ba1\u68c0\u6d4b\u900f\u8fc7\u7684\u5149\u5f3a<\/td>\n<td>\u6210\u672c\u4f4e\u3001\u64cd\u4f5c\u5feb<\/td>\n<td>\u7075\u654f\u5ea6\u8f83\u4f4e\uff08\u68c0\u51fa\u9650\u7ea60.01%\uff09<\/td>\n<td>ISO 29463-4, GB\/T 13554<\/td>\n<\/tr>\n<tr>\n<td>\u7c92\u5b50\u8ba1\u6570\u6cd5<\/td>\n<td>\u4e0a\u6e38\u53d1\u751fPSL\u6216DEHS\uff0c\u4e0b\u6e38\u7528\u7c92\u5b50\u8ba1\u6570\u5668\u626b\u63cf<\/td>\n<td>\u7075\u654f\u5ea6\u9ad8\uff08\u53ef\u68c0\u51fa0.001%\u6cc4\u6f0f\uff09<\/td>\n<td>\u6210\u672c\u9ad8\u3001\u8017\u65f6\u957f<\/td>\n<td>ISO 14644-3, EU GMP Annex 1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>\u6d4b\u8bd5\u6b65\u9aa4\uff08\u4ee5\u7c92\u5b50\u8ba1\u6570\u6cd5\u4e3a\u4f8b\uff09<\/strong>\uff1a<\/p>\n<ol>\n<li>\u5c06\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u7f6e\u4e8e\u8fc7\u6ee4\u5668\u4e0a\u6e38\uff0c\u751f\u6210\u7a33\u5b9a\u6d53\u5ea6\u7684\u6311\u6218\u6c14\u6eb6\u80f6\uff08\u5982DEHS\uff0c\u6d53\u5ea6\u226520 \u03bcg\/L\uff09\uff1b<\/li>\n<li>\u4f7f\u7528\u7c92\u5b50\u8ba1\u6570\u5668\uff08\u5982TSI 9310\uff09\u5728\u4e0b\u6e38\u8ddd\u8fc7\u6ee4\u5668\u8868\u97622\uff5e4 cm\u5904\u4ee5\u22645 cm\/s\u901f\u5ea6\u626b\u63cf\uff1b<\/li>\n<li>\u91c7\u6837\u6d41\u91cf\u226528.3 L\/min\uff0c\u6bcf\u4e2a\u6d4b\u8bd5\u70b9\u505c\u7559\u65f6\u95f4\u226510\u79d2\uff1b<\/li>\n<li>\u8bb0\u5f55\u6700\u5927\u6cc4\u6f0f\u70b9\uff0c\u8ba1\u7b97\u5c40\u90e8\u7a7f\u900f\u7387\uff1a<\/li>\n<\/ol>\n<p>$$<br \/>\ntext{\u7a7f\u900f\u7387}(%) = frac{C<em>{text{downstream}}}{C<\/em>{text{upstream}}} times 100%<br \/>\n$$<\/p>\n<blockquote>\n<p>\u63a5\u53d7\u6807\u51c6\uff1a\u4efb\u610f\u70b9\u7a7f\u900f\u7387 \u2264 0.005%\uff08\u5373\u6548\u7387\u226599.995%\uff09<\/p>\n<\/blockquote>\n<p><strong>\u5178\u578b\u6d4b\u8bd5\u5e03\u5c40\u56fe\uff08\u793a\u610f\uff09<\/strong>\uff1a<\/p>\n<pre><code>+-----------------------------+\n|        \u8fc7\u6ee4\u5668\u8868\u9762           |\n|                             |\n|  \u25cf   \u25cf   \u25cf   \u25cf   \u25cf          | \u2190 \u626b\u63cf\u8def\u5f84\uff08\u7f51\u683c\u95f4\u8ddd\u22645cm\uff09\n|                             |\n|  \u25cf   \u25cf   \u25cf   \u25cf   \u25cf          |\n|                             |\n+-----------------------------+<\/code><\/pre>\n<blockquote>\n<p>\u6ce8\uff1a\u8fb9\u6846\u533a\u57df\u4e3a\u91cd\u70b9\u626b\u63cf\u533a\uff0c\u56e0\u5bc6\u5c01\u6613\u5931\u6548\u3002<\/p>\n<\/blockquote>\n<h4>3.4.2 \u6d01\u51c0\u5ea6\u6d4b\u8bd5\uff08Cleanroom Classification\uff09<\/h4>\n<p>\u4f9d\u636eGB\/T 16292-2010\u548cISO 14644-1:2015\uff0c\u5bf9\u6d01\u51c0\u5de5\u4f5c\u53f0\u64cd\u4f5c\u533a\u8fdb\u884c\u60ac\u6d6e\u7c92\u5b50\u76d1\u6d4b\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7c92\u5f84<\/th>\n<th>ISO 5\u7ea7\u9650\u503c\uff08\u22650.5\u03bcm\uff09<\/th>\n<th>\u91c7\u6837\u70b9\u6570<\/th>\n<th>\u91c7\u6837\u91cf<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u22650.5\u03bcm<\/td>\n<td>\u22643,520 particles\/m\u00b3<\/td>\n<td>\u22651\u70b9<\/td>\n<td>\u22652.83 L<\/td>\n<\/tr>\n<tr>\n<td>\u22655.0\u03bcm<\/td>\n<td>\u226429 particles\/m\u00b3<\/td>\n<td>\u53ef\u9009<\/td>\n<td>\u540c\u4e0a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>\u6d4b\u8bd5\u6761\u4ef6<\/strong>\uff1a<\/p>\n<ul>\n<li>\u7a7a\u6001\u6216\u9759\u6001\u6d4b\u8bd5\uff1b<\/li>\n<li>\u91c7\u6837\u70b9\u4f4d\u4e8e\u5de5\u4f5c\u53f0\u9762\u9ad8\u5ea6\uff08\u901a\u5e38\u8ddd\u53f0\u976230cm\uff09\uff1b<\/li>\n<li>\u6bcf\u70b9\u91c7\u6837\u65f6\u95f4\u4e0d\u5c11\u4e8e1\u5206\u949f\uff1b<\/li>\n<li>\u4f7f\u7528\u7ecf\u8fc7\u6821\u51c6\u7684\u7c92\u5b50\u8ba1\u6570\u5668\uff08\u5982Met One 3413\uff09\u3002<\/li>\n<\/ul>\n<h4>3.4.3 \u6c89\u964d\u83cc\u4e0e\u6d6e\u6e38\u83cc\u6d4b\u8bd5\uff08\u5fae\u751f\u7269\u9a8c\u8bc1\uff09<\/h4>\n<p>\u6839\u636eGMP\u9644\u5f551\u8981\u6c42\uff0c\u6d01\u51c0\u5de5\u4f5c\u53f0\u8fd8\u9700\u8fdb\u884c\u5fae\u751f\u7269\u9650\u5ea6\u6d4b\u8bd5\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u65b9\u6cd5<\/th>\n<th>\u57f9\u517b\u57fa<\/th>\n<th>\u57f9\u517b\u6761\u4ef6<\/th>\n<th>\u63a5\u53d7\u6807\u51c6\uff08A\u7ea7\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6c89\u964d\u83cc<\/td>\n<td>\u00d890mm\u57f9\u517b\u76bf\u66b4\u97324\u5c0f\u65f6<\/td>\n<td>TSA<\/td>\n<td>30\uff5e35\u2103, 48h<\/td>\n<td>\u22641 CFU\/4h<\/td>\n<\/tr>\n<tr>\n<td>\u6d6e\u6e38\u83cc<\/td>\n<td>\u7a7a\u6c14\u91c7\u6837\u5668\uff08\u5982Andersen\uff09<\/td>\n<td>SDA\u6216TSA<\/td>\n<td>\u540c\u4e0a<\/td>\n<td>\u22641 CFU\/m\u00b3<\/td>\n<\/tr>\n<tr>\n<td>\u8868\u9762\u5fae\u751f\u7269<\/td>\n<td>\u68c9\u7b7e\u64e6\u62ed\u6cd5<\/td>\n<td>TSA<\/td>\n<td>\u540c\u4e0a<\/td>\n<td>\u22645 CFU\/25cm\u00b2<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u6d4b\u8bd5\u5e94\u5728\u64cd\u4f5c\u6a21\u62df\u72b6\u6001\u4e0b\u8fdb\u884c\uff0c\u5982\u6a21\u62df\u704c\u88c5\u52a8\u4f5c\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u56db\u3001\u9a8c\u8bc1\u5468\u671f\u4e0e\u518d\u9a8c\u8bc1\u8981\u6c42<\/h2>\n<p>H14\u7ea7\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u5e76\u975e\u4e00\u6b21\u6027\u5de5\u4f5c\uff0c\u9700\u5efa\u7acb\u5b9a\u671f\u518d\u9a8c\u8bc1\u673a\u5236\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u9a8c\u8bc1\u7c7b\u578b<\/th>\n<th>\u9891\u6b21<\/th>\n<th>\u89e6\u53d1\u6761\u4ef6<\/th>\n<th>\u4f9d\u636e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n<td>\u6bcf6\u4e2a\u6708\u4e00\u6b21<\/td>\n<td>\u6b63\u5e38\u5468\u671f<\/td>\n<td>EU GMP Annex 1<\/td>\n<\/tr>\n<tr>\n<td>\u6d01\u51c0\u5ea6\u6d4b\u8bd5<\/td>\n<td>\u6bcf\u5e74\u4e00\u6b21<\/td>\n<td>\u6216\u53d8\u66f4\u540e<\/td>\n<td>ISO 14644-2<\/td>\n<\/tr>\n<tr>\n<td>\u518d\u9a8c\u8bc1<\/td>\n<td>\u6bcf2\uff5e3\u5e74<\/td>\n<td>\u8bbe\u5907\u5927\u4fee\u3001\u66f4\u6362\u8fc7\u6ee4\u5668<\/td>\n<td>GMP \u7b2c142\u6761<\/td>\n<\/tr>\n<tr>\n<td>\u7d27\u6025\u518d\u9a8c\u8bc1<\/td>\n<td>\u7acb\u5373\u6267\u884c<\/td>\n<td>\u8fc7\u6ee4\u5668\u7834\u635f\u3001\u4e25\u91cd\u6c61\u67d3\u4e8b\u4ef6<\/td>\n<td>\u4f01\u4e1aSOP<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u7279\u522b\u63d0\u793a<\/strong>\uff1a\u82e5\u5b8c\u6574\u6027\u6d4b\u8bd5\u53d1\u73b0\u6cc4\u6f0f\u70b9\uff0c\u5e94\u6807\u8bb0\u4f4d\u7f6e\u5e76\u8bc4\u4f30\u98ce\u9669\u3002\u5c0f\u8303\u56f4\u6cc4\u6f0f\u53ef\u5c1d\u8bd5\u5c40\u90e8\u5bc6\u5c01\u4fee\u590d\uff0c\u4f46\u5927\u9762\u79ef\u7834\u635f\u5fc5\u987b\u66f4\u6362\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e94\u3001\u5e38\u89c1\u95ee\u9898\u4e0e\u98ce\u9669\u63a7\u5236<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u95ee\u9898\u73b0\u8c61<\/th>\n<th>\u53ef\u80fd\u539f\u56e0<\/th>\n<th>\u89e3\u51b3\u63aa\u65bd<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u98ce\u901f\u504f\u4f4e<\/td>\n<td>\u8fc7\u6ee4\u5668\u5835\u585e\u3001\u98ce\u673a\u6545\u969c<\/td>\n<td>\u6e05\u6d17\u9884\u8fc7\u6ee4\u5668\uff0c\u68c0\u67e5\u7535\u673a<\/td>\n<\/tr>\n<tr>\n<td>\u4e0b\u6e38\u7c92\u5b50\u6570\u8d85\u6807<\/td>\n<td>\u8fc7\u6ee4\u5668\u6cc4\u6f0f\u3001\u5bc6\u5c01\u5931\u6548<\/td>\n<td>\u91cd\u65b0\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n<\/tr>\n<tr>\n<td>\u566a\u97f3\u5f02\u5e38<\/td>\n<td>\u98ce\u673a\u8f74\u627f\u78e8\u635f\u3001\u98ce\u9053\u5171\u632f<\/td>\n<td>\u6da6\u6ed1\u6216\u66f4\u6362\u98ce\u673a<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u8868\u8bfb\u6570\u5f02\u5e38<\/td>\n<td>\u4eea\u8868\u5931\u51c6\u3001\u53d6\u538b\u7ba1\u5835\u585e<\/td>\n<td>\u6821\u51c6\u6216\u5439\u626b\u7ba1\u8def<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>\u98ce\u9669\u63a7\u5236\u5efa\u8bae<\/strong>\uff1a<\/p>\n<ul>\n<li>\u5efa\u7acb\u8fc7\u6ee4\u5668\u751f\u547d\u5468\u671f\u6863\u6848\uff0c\u8bb0\u5f55\u6bcf\u6b21\u6d4b\u8bd5\u6570\u636e\uff1b<\/li>\n<li>\u4f7f\u7528\u7535\u5b50\u5316\u9a8c\u8bc1\u7ba1\u7406\u7cfb\u7edf\uff08\u5982TrackWise\uff09\u5b9e\u73b0\u6570\u636e\u8ffd\u6eaf\uff1b<\/li>\n<li>\u5bf9\u64cd\u4f5c\u4eba\u5458\u8fdb\u884c\u5b9a\u671f\u57f9\u8bad\uff0c\u907f\u514d\u4eba\u4e3a\u6c61\u67d3\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b\u9644\u5f551\uff1a\u65e0\u83cc\u836f\u54c1. 2011.  <\/li>\n<li>GB\/T 13554-2020. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668. \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e.  <\/li>\n<li>GB 50591-2010. \u6d01\u51c0\u5ba4\u65bd\u5de5\u53ca\u9a8c\u6536\u89c4\u8303. \u4e2d\u56fd\u8ba1\u5212\u51fa\u7248\u793e.  <\/li>\n<li>ISO 14644-3:2019. Cleanrooms and associated controlled environments \u2014 Part 3: Test methods.  <\/li>\n<li>ISO 29463-2011. High-efficiency filters and filter units for removing particles in air.  <\/li>\n<li>European Commission. EudraLex &#8211; Volume 4 &#8211; EU GMP Annex 1: Manufacture of Sterile Medicinal Products (2022).  <\/li>\n<li>FDA. Guide to Inspections of Aseptic Pharmaceutical Production. 2004.  <\/li>\n<li>ASHRAE. ASHRAE Handbook\u2014HVAC Applications. 2020.  <\/li>\n<li>\u5510\u5fd7\u8363. \u300a\u5236\u836f\u5de5\u7a0b\u539f\u7406\u4e0e\u5e94\u7528\u300b. \u5316\u5b66\u5de5\u4e1a\u51fa\u7248\u793e, 2018.  <\/li>\n<li>ISPE. Baseline Guide: HVAC (Volume 3). Second Edition, 2011.  <\/li>\n<li>\u767e\u5ea6\u767e\u79d1\uff1a\u9ad8\u6548\u8fc7\u6ee4\u5668. <a href=\"https:\/\/baike.baidu.com\/item\/\u9ad8\u6548\u8fc7\u6ee4\u5668\">https:\/\/baike.baidu.com\/item\/\u9ad8\u6548\u8fc7\u6ee4\u5668<\/a>  <\/li>\n<li>GB\/T 16292-2010. \u533b\u836f\u5de5\u4e1a\u6d01\u51c0\u5ba4\uff08\u533a\uff09\u60ac\u6d6e\u7c92\u5b50\u7684\u6d4b\u8bd5\u65b9\u6cd5.  <\/li>\n<\/ol>\n<p>\uff08\u5168\u6587\u7ea63,560\u5b57\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u533b\u836fGMP\u73af\u5883\u4e0b\u6d01\u51c0\u5de5\u4f5c\u53f0H14\u7ea7\u8fc7\u6ee4\u5668\u9a8c\u8bc1\u6d41\u7a0b\u8be6\u89e3 \u5728\u533b\u836f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u6d01\u51c0\u73af\u5883\u662f\u786e\u4fdd\u836f\u54c1\u8d28\u91cf\u3001\u9632\u6b62\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c61\u67d3\u7684\u5173\u952e\u73af\u8282\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u8981\u6c42\uff0c\u65e0\u83cc\u836f\u54c1\u3001\u751f\u7269\u5236\u54c1\u7b49\u9ad8\u98ce\u9669\u4ea7\u54c1\u7684\u751f\u4ea7\u5fc5\u987b\u5728\u53d7\u63a7\u7684\u6d01\u51c0\u73af\u5883\u4e2d\u8fdb\u884c\u3002\u5176\u4e2d\uff0c\u6d01\u51c0\u5de5\u4f5c\u53f0\u4f5c\u4e3a\u5c40\u90e8\u6d01\u51c0\u533a\u57df\u7684\u6838\u5fc3\u8bbe\u5907\uff0c\u5176\u6027\u80fd\u76f4\u63a5\u5173\u7cfb\u5230\u4ea7\u54c1\u7684\u65e0\u83cc\u4fdd\u969c\u6c34\u5e73\u3002\u800c\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08High Efficiency&hellip;<\/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-16636","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\/16636","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=16636"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/16636\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16636"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16636"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}