{"id":16948,"date":"2025-09-22T17:20:18","date_gmt":"2025-09-22T09:20:18","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16948"},"modified":"2025-09-22T17:20:18","modified_gmt":"2025-09-22T09:20:18","slug":"%e5%8c%bb%e8%8d%afgmp%e8%bd%a6%e9%97%b4%e4%b8%8d%e9%94%88%e9%92%a2%e9%ab%98%e6%95%88%e7%a9%ba%e6%b0%94%e8%bf%87%e6%bb%a4%e5%99%a8%e7%9a%84%e5%ae%8c%e6%95%b4%e6%80%a7%e6%a3%80%e6%b5%8b%e6%96%b9","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16948","title":{"rendered":"\u533b\u836fGMP\u8f66\u95f4\u4e0d\u9508\u94a2\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u5b8c\u6574\u6027\u68c0\u6d4b\u65b9\u6cd5"},"content":{"rendered":"<h1>\u4e0d\u9508\u94a2\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u68c0\u6d4b\u65b9\u6cd5\u5728\u533b\u836fGMP\u8f66\u95f4\u4e2d\u7684\u5e94\u7528\u7814\u7a76<\/h1>\n<h2>\u4e00\u3001\u5f15\u8a00<\/h2>\n<p>\u5728\u73b0\u4ee3\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u836f\u54c1\u751f\u4ea7\u73af\u5883\u7684\u6d01\u51c0\u5ea6\u76f4\u63a5\u5173\u7cfb\u5230\u4ea7\u54c1\u8d28\u91cf\u4e0e\u60a3\u8005\u5b89\u5168\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u8981\u6c42\uff0c\u7279\u522b\u662f\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\u4ee5\u53ca\u56fd\u9645\u6807\u51c6\u5982\u6b27\u76dfGMP\u9644\u5f551\u3001\u7f8e\u56fdFDA cGMP\u6307\u5357\u7b49\uff0c\u6d01\u51c0\u5ba4\u5185\u7684\u7a7a\u6c14\u5fc5\u987b\u901a\u8fc7\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter, HEPA\uff09\u6216\u8d85\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08ULPA\uff09\u8fdb\u884c\u51c0\u5316\u5904\u7406\uff0c\u4ee5\u786e\u4fdd\u7a7a\u6c14\u4e2d\u5fae\u7c92\u6d53\u5ea6\u63a7\u5236\u5728\u89c4\u5b9a\u9650\u503c\u5185\u3002<\/p>\n<p>\u5176\u4e2d\uff0c<strong>\u4e0d\u9508\u94a2\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/strong>\u56e0\u5176\u8010\u8150\u8680\u6027\u5f3a\u3001\u673a\u68b0\u5f3a\u5ea6\u9ad8\u3001\u6613\u4e8e\u6e05\u6d01\u706d\u83cc\u7b49\u7279\u70b9\uff0c\u5728\u65e0\u83cc\u5236\u5242\u3001\u751f\u7269\u5236\u54c1\u3001\u75ab\u82d7\u7b49\u9ad8\u98ce\u9669\u836f\u54c1\u751f\u4ea7\u8f66\u95f4\u4e2d\u5e7f\u6cdb\u5e94\u7528\u3002\u7136\u800c\uff0c\u5373\u4fbf\u4f7f\u7528\u9ad8\u54c1\u8d28\u7684\u8fc7\u6ee4\u5668\uff0c\u82e5\u672a\u5b9a\u671f\u8fdb\u884c<strong>\u5b8c\u6574\u6027\u68c0\u6d4b\uff08Integrity Testing\uff09<\/strong>\uff0c\u4ecd\u53ef\u80fd\u56e0\u6ee4\u6750\u7834\u635f\u3001\u5bc6\u5c01\u5931\u6548\u7b49\u95ee\u9898\u5bfc\u81f4\u5fae\u751f\u7269\u6216\u9897\u7c92\u7269\u6cc4\u6f0f\uff0c\u4ece\u800c\u6c61\u67d3\u4ea7\u54c1\u3002\u56e0\u6b64\uff0c\u5bf9\u4e0d\u9508\u94a2\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5b9e\u65bd\u79d1\u5b66\u3001\u7cfb\u7edf\u7684\u5b8c\u6574\u6027\u68c0\u6d4b\uff0c\u662f\u4fdd\u969cGMP\u8f66\u95f4\u7a7a\u6c14\u8d28\u91cf\u7684\u5173\u952e\u73af\u8282\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001\u4e0d\u9508\u94a2\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>2.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p>\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09\u662f\u6307\u5bf9\u7c92\u5f84\u22650.3\u03bcm\u7684\u7c92\u5b50\u53bb\u9664\u6548\u7387\u4e0d\u4f4e\u4e8e99.97%\u7684\u8fc7\u6ee4\u88c5\u7f6e\uff1b\u800c\u8d85\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08ULPA\uff09\u5219\u5bf90.1~0.2\u03bcm\u7c92\u5b50\u7684\u8fc7\u6ee4\u6548\u7387\u53ef\u8fbe99.999%\u4ee5\u4e0a\u3002\u6839\u636e\u7ed3\u6784\u6750\u8d28\u4e0d\u540c\uff0c\u53ef\u5206\u4e3a\u73bb\u7483\u7ea4\u7ef4\u6ee4\u7eb8\u578b\u3001\u91d1\u5c5e\u7f51\u652f\u6491\u578b\u53ca\u5168\u4e0d\u9508\u94a2\u5916\u58f3\u578b\u7b49\u591a\u79cd\u7c7b\u578b\u3002<\/p>\n<p><strong>\u4e0d\u9508\u94a2\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/strong>\u7279\u6307\u91c7\u7528304\u6216316L\u4e0d\u9508\u94a2\u4f5c\u4e3a\u5916\u6846\u548c\u7aef\u76d6\u6750\u6599\uff0c\u5185\u90e8\u586b\u5145HEPA\u7ea7\u6ee4\u82af\uff08\u901a\u5e38\u4e3a\u805a\u4e19\u70ef\u6216\u73bb\u7483\u7ea4\u7ef4\u590d\u5408\u6750\u6599\uff09\uff0c\u5177\u5907\u4ee5\u4e0b\u4f18\u52bf\uff1a<\/p>\n<ul>\n<li>\u8010\u9ad8\u6e29\u9ad8\u538b\uff08\u9002\u7528\u4e8e\u84b8\u6c7d\u706d\u83ccSIP\uff09<\/li>\n<li>\u6297\u5316\u5b66\u8150\u8680\uff08\u9002\u5e94CIP\u6e05\u6d17\u5242\uff09<\/li>\n<li>\u6613\u4e8e\u710a\u63a5\u5b89\u88c5\uff0c\u6c14\u5bc6\u6027\u597d<\/li>\n<li>\u53ef\u91cd\u590d\u4f7f\u7528\uff0c\u5bff\u547d\u957f<\/li>\n<\/ul>\n<h3>2.2 \u4e3b\u8981\u6280\u672f\u53c2\u6570<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u540d\u79f0<\/th>\n<th>\u6807\u51c6\u503c\/\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>\u226599.97%<\/td>\n<td>\u7b26\u5408ISO 29463-3:2011 Class H13\/H14<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u2264250 Pa @ 0.45 m\/s<\/td>\n<td>\u98ce\u901f\u6761\u4ef6\u4e0b\u538b\u964d<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf<\/td>\n<td>800\u20132000 m\u00b3\/h\uff08\u89c6\u5c3a\u5bf8\u800c\u5b9a\uff09<\/td>\n<td>\u5e38\u89c1\u89c4\u683c610\u00d7610\u00d7292mm<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u6e29\u5ea6<\/td>\n<td>-20\u2103 ~ +80\u2103\uff08\u77ed\u65f6\u53ef\u8010140\u2103\u6e7f\u70ed\u706d\u83cc\uff09<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>\u6846\u67b6\u6750\u8d28<\/td>\n<td>304\u6216316L\u4e0d\u9508\u94a2<\/td>\n<td>316L\u66f4\u8010\u6c2f\u79bb\u5b50\u8150\u8680<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u65b9\u5f0f<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4+\u7845\u916e\u80f6\/\u805a\u6c28\u916f\u53d1\u6ce1\u5bc6\u5c01<\/td>\n<td>\u9632\u6b62\u65c1\u901a\u6cc4\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u7387\u6807\u51c6<\/td>\n<td>\u22640.01%<\/td>\n<td>DOP\/PAO\u6d4b\u8bd5\u6cd5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u4e0a\u8ff0\u53c2\u6570\u4f9d\u636eISO 29463\u300aHigh-efficiency and ultra-high-efficiency air filters\u300b\u53caGB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u56fd\u5bb6\u6807\u51c6\u5236\u5b9a\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e09\u3001\u5b8c\u6574\u6027\u68c0\u6d4b\u7684\u610f\u4e49\u4e0e\u6cd5\u89c4\u8981\u6c42<\/h2>\n<h3>3.1 \u68c0\u6d4b\u76ee\u7684<\/h3>\n<p>\u5b8c\u6574\u6027\u68c0\u6d4b\u65e8\u5728\u9a8c\u8bc1\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u6574\u4e2a\u5b89\u88c5\u7cfb\u7edf\u4e2d\u662f\u5426\u4fdd\u6301\u7269\u7406\u5b8c\u6574\u6027\u548c\u5bc6\u5c01\u6027\u80fd\uff0c\u9632\u6b62\u672a\u7ecf\u6ee4\u8fc7\u7684\u7a7a\u6c14\u901a\u8fc7\u88c2\u7f1d\u3001\u9488\u5b54\u6216\u63a5\u53e3\u7f1d\u9699\u8fdb\u5165\u6d01\u51c0\u533a\uff0c\u9020\u6210\u4ea4\u53c9\u6c61\u67d3\u3002<\/p>\n<p>\u4e3b\u8981\u68c0\u6d4b\u76ee\u6807\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u6ee4\u6750\u662f\u5426\u5b58\u5728\u7a7f\u5b54\u6216\u6495\u88c2\uff1b<\/li>\n<li>\u5bc6\u5c01\u80f6\u6761\u662f\u5426\u8001\u5316\u5f00\u88c2\uff1b<\/li>\n<li>\u6846\u67b6\u710a\u7f1d\u662f\u5426\u6709\u5fae\u5c0f\u6cc4\u6f0f\uff1b<\/li>\n<li>\u5b89\u88c5\u8fc7\u7a0b\u662f\u5426\u9020\u6210\u635f\u4f24\u3002<\/li>\n<\/ul>\n<h3>3.2 \u56fd\u5185\u5916\u6cd5\u89c4\u4f9d\u636e<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6cd5\u89c4\/\u6807\u51c6<\/th>\n<th>\u53d1\u5e03\u673a\u6784<\/th>\n<th>\u76f8\u5173\u6761\u6b3e\u6458\u8981<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b<\/td>\n<td>NMPA\uff08\u4e2d\u56fd\uff09<\/td>\n<td>\u7b2c\u56db\u5341\u4e8c\u6761\uff1a\u6d01\u51c0\u533a\u5e94\u5b9a\u671f\u76d1\u6d4b\u60ac\u6d6e\u7c92\u5b50\u3001\u5fae\u751f\u7269\uff0c\u5e76\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u8fdb\u884c\u68c0\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>GB\/T 14295-2019\u300a\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b<\/td>\n<td>\u56fd\u5bb6\u5e02\u573a\u76d1\u7763\u7ba1\u7406\u603b\u5c40<\/td>\n<td>\u89c4\u5b9a\u4e86\u8fc7\u6ee4\u5668\u6027\u80fd\u5206\u7ea7\u4e0e\u6d4b\u8bd5\u65b9\u6cd5<\/td>\n<\/tr>\n<tr>\n<td>ISO 14644-3:2019\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883 \u7b2c3\u90e8\u5206\uff1a\u6d4b\u8bd5\u65b9\u6cd5\u300b<\/td>\n<td>ISO<\/td>\n<td>\u660e\u786e\u4e86\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5\u548c\u7c92\u5b50\u8ba1\u6570\u5668\u6cd5\u7528\u4e8e\u68c0\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>EU GMP Annex 1 (2022)<\/td>\n<td>\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09<\/td>\n<td>\u5f3a\u8c03\u6240\u6709\u8fdb\u5165\u65e0\u83cc\u533a\u57df\u7684HEPA\u5fc5\u987b\u7ecf\u8fc7\u5b8c\u6574\u6027\u6d4b\u8bd5\u5e76\u8bb0\u5f55\u7ed3\u679c<\/td>\n<\/tr>\n<tr>\n<td>FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing<\/td>\n<td>\u7f8e\u56fdFDA<\/td>\n<td>\u63a8\u8350\u4f7f\u7528PAO\/DOP\u6311\u6218\u8bd5\u9a8c\u8bc4\u4f30\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027<\/td>\n<\/tr>\n<tr>\n<td>USP  \u201cMicrobiological Evaluation of Clean Rooms and Other Controlled Environments\u201d<\/td>\n<td>\u7f8e\u56fd\u836f\u5178\u59d4\u5458\u4f1a<\/td>\n<td>\u63d0\u51fa\u5e94\u5728\u5173\u952e\u64cd\u4f5c\u524d\u786e\u8ba4\u8fc7\u6ee4\u5668\u72b6\u6001<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u8fd9\u4e9b\u6cd5\u89c4\u5171\u540c\u5f3a\u8c03\uff1a<strong>\u65b0\u5b89\u88c5\u3001\u66f4\u6362\u540e\u3001\u91cd\u5927\u7ef4\u4fee\u540e\u4ee5\u53ca\u5b9a\u671f\u7ef4\u62a4\u671f\u95f4\uff08\u5efa\u8bae\u6bcf6\u4e2a\u6708\u4e00\u6b21\uff09\u5747\u9700\u6267\u884c\u5b8c\u6574\u6027\u68c0\u6d4b<\/strong>\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001\u5b8c\u6574\u6027\u68c0\u6d4b\u5e38\u7528\u65b9\u6cd5<\/h2>\n<p>\u76ee\u524d\u4e3b\u6d41\u7684\u5b8c\u6574\u6027\u68c0\u6d4b\u65b9\u6cd5\u4e3b\u8981\u5305\u62ec\u4e24\u5927\u7c7b\uff1a<strong>\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5\uff08Photometric Method\uff09<\/strong> \u548c <strong>\u7c92\u5b50\u8ba1\u6570\u5668\u626b\u63cf\u6cd5\uff08Particle Counting Scan Method\uff09<\/strong>\u3002\u6b64\u5916\uff0c\u8fd8\u6709\u538b\u529b\u8870\u51cf\u6cd5\u9002\u7528\u4e8e\u7279\u5b9a\u5c01\u95ed\u7cfb\u7edf\u3002<\/p>\n<h3>4.1 \u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5\uff08DOP\/PAO\u6cd5\uff09<\/h3>\n<h4>\u539f\u7406<\/h4>\n<p>\u8be5\u65b9\u6cd5\u901a\u8fc7\u4e0a\u6e38\u53d1\u751f\u7a33\u5b9a\u6d53\u5ea6\u7684\u5355\u5206\u6563\u6216\u591a\u5206\u6563\u6c14\u6eb6\u80f6\uff08\u5982\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916fDOP\u6216\u805a\u03b1\u70ef\u70c3PAO\uff09\uff0c\u5229\u7528\u5149\u6563\u5c04\u539f\u7406\u6d4b\u91cf\u4e0a\u4e0b\u6e38\u6c14\u6eb6\u80f6\u6d53\u5ea6\uff0c\u8ba1\u7b97\u7a7f\u900f\u7387\uff0c\u5224\u65ad\u662f\u5426\u5b58\u5728\u6cc4\u6f0f\u70b9\u3002<\/p>\n<h4>\u64cd\u4f5c\u6d41\u7a0b<\/h4>\n<ol>\n<li>\u5728\u8fc7\u6ee4\u5668\u4e0a\u6e38\u6ce8\u5165PAO\u6c14\u6eb6\u80f6\uff08\u6d53\u5ea6\u7ea610\u201320 \u03bcg\/L\uff09\uff1b<\/li>\n<li>\u4f7f\u7528\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u5728\u4e0b\u6e38\u8ddd\u8fc7\u6ee4\u5668\u8868\u97622\u20135 cm\u5904\u4ee5\u22645 cm\/s\u901f\u5ea6\u79fb\u52a8\u626b\u63cf\uff1b<\/li>\n<li>\u8bb0\u5f55\u6700\u5927\u6cc4\u6f0f\u70b9\u8bfb\u6570\uff0c\u6362\u7b97\u4e3a\u7a7f\u900f\u767e\u5206\u6bd4\uff1b<\/li>\n<li>\u82e5\u67d0\u70b9\u6cc4\u6f0f\u8d85\u8fc70.01%\uff0c\u5219\u5224\u5b9a\u4e0d\u5408\u683c\u3002<\/li>\n<\/ol>\n<h4>\u8bbe\u5907\u914d\u7f6e\u793a\u4f8b<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u8bbe\u5907\u540d\u79f0<\/th>\n<th>\u578b\u53f7\u793a\u4f8b<\/th>\n<th>\u751f\u4ea7\u5382\u5bb6<\/th>\n<th>\u6d4b\u91cf\u8303\u56f4<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6c14\u6eb6\u80f6\u53d1\u751f\u5668<\/td>\n<td>TDA-5B<\/td>\n<td>ATI\uff08\u7f8e\u56fd\uff09<\/td>\n<td>10\u2013100 \u03bcg\/L PAO<\/td>\n<\/tr>\n<tr>\n<td>\u5149\u5ea6\u8ba1<\/td>\n<td>AM-510<\/td>\n<td>TSI\uff08\u7f8e\u56fd\uff09<\/td>\n<td>0.0001\u2013100 \u03bcg\/L<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u63a2\u5934<\/td>\n<td>1F-100<\/td>\n<td>Camfil\uff08\u745e\u5178\uff09<\/td>\n<td>\u91c7\u6837\u6d41\u91cf1 cfm\uff0828.3 L\/min\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u53c2\u8003\u6587\u732e\uff1aKaeser D. <em>HEPA Filter Testing: A Practical Guide<\/em>. Filtration &amp; Separation, 2018; 55(4): 32\u201337.<\/p>\n<\/blockquote>\n<p>\u6b64\u65b9\u6cd5\u7075\u654f\u5ea6\u9ad8\u3001\u64cd\u4f5c\u7b80\u4fbf\uff0c\u88ab\u5e7f\u6cdb\u5e94\u7528\u4e8e\u4e2d\u56fd\u5236\u836f\u4f01\u4e1a\uff0c\u7b26\u5408\u300a\u6d01\u51c0\u5ba4\u65bd\u5de5\u53ca\u9a8c\u6536\u89c4\u8303\u300b\uff08GB 50591-2010\uff09\u7b2c13.4\u8282\u8981\u6c42\u3002<\/p>\n<h3>4.2 \u7c92\u5b50\u8ba1\u6570\u5668\u626b\u63cf\u6cd5\uff08Particle Counter Scanning\uff09<\/h3>\n<h4>\u539f\u7406<\/h4>\n<p>\u5229\u7528\u9ad8\u7cbe\u5ea6\u7c92\u5b50\u8ba1\u6570\u5668\u5206\u522b\u6d4b\u5b9a\u8fc7\u6ee4\u5668\u4e0a\u4e0b\u6e38\u7a7a\u6c14\u4e2d\u22650.5\u03bcm\u6216\u22650.3\u03bcm\u7c92\u5b50\u6d53\u5ea6\uff0c\u901a\u8fc7\u6bd4\u8f83\u4e0a\u4e0b\u6e38\u6d53\u5ea6\u6bd4\u503c\u6765\u8bc4\u4f30\u8fc7\u6ee4\u6548\u7387\u548c\u5c40\u90e8\u6cc4\u6f0f\u60c5\u51b5\u3002<\/p>\n<h4>\u9002\u7528\u573a\u666f<\/h4>\n<ul>\n<li>\u4e0d\u5141\u8bb8\u4f7f\u7528\u6cb9\u6027\u6c14\u6eb6\u80f6\u7684\u573a\u5408\uff08\u5982\u67d0\u4e9b\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\uff09\uff1b<\/li>\n<li>ULPA\u8fc7\u6ee4\u5668\u68c0\u6d4b\uff08\u56e0PAO\u5206\u5b50\u8f83\u5c0f\uff0c\u53ef\u80fd\u7a7f\u900fULPA\u9020\u6210\u8bef\u5224\uff09\uff1b<\/li>\n<li>\u9700\u907f\u514d\u6709\u673a\u6eb6\u5242\u6b8b\u7559\u7684\u6d01\u51c0\u5ba4\u3002<\/li>\n<\/ul>\n<h4>\u64cd\u4f5c\u8981\u70b9<\/h4>\n<ol>\n<li>\u4e0a\u6e38\u91ca\u653e\u4eba\u5de5\u6c14\u6eb6\u80f6\uff08\u5982KCl\u3001NaCl\u5e72\u71e5\u6c14\u6eb6\u80f6\uff09\uff1b<\/li>\n<li>\u4e0b\u6e38\u7528\u8fdc\u7a0b\u7c92\u5b50\u8ba1\u6570\u5668\u9010\u70b9\u626b\u63cf\uff08\u7f51\u683c\u95f4\u8ddd\u22645 cm\uff09\uff1b<\/li>\n<li>\u6570\u636e\u81ea\u52a8\u91c7\u96c6\u5e76\u4e0e\u9608\u503c\u6bd4\u8f83\uff1b<\/li>\n<li>\u6cc4\u6f0f\u5224\u5b9a\u6807\u51c6\uff1a\u5c40\u90e8\u533a\u57df\u7c92\u5b50\u6d53\u5ea6\u7a81\u589e\u8d85\u8fc7\u80cc\u666f\u503c3\u500d\u5373\u89c6\u4e3a\u7f3a\u9677\u3002<\/li>\n<\/ol>\n<blockquote>\n<p>\u53c2\u8003\u6807\u51c6\uff1aISO 29463-5:2011 Clause 8.3 \u2013 \u201cLeakage testing using discrete particle counters\u201d<\/p>\n<\/blockquote>\n<h4>\u4f18\u7f3a\u70b9\u5bf9\u6bd4\u8868<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u65b9\u6cd5<\/th>\n<th>\u4f18\u70b9<\/th>\n<th>\u7f3a\u70b9<\/th>\n<th>\u9002\u7528\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5<\/td>\n<td>\u5feb\u901f\u3001\u76f4\u89c2\u3001\u6210\u672c\u4f4e<\/td>\n<td>\u4f7f\u7528\u6709\u673a\u6eb6\u5242\uff0c\u9700\u901a\u98ce\u5904\u7406<\/td>\n<td>GB 50591, ISO 14644-3<\/td>\n<\/tr>\n<tr>\n<td>\u7c92\u5b50\u8ba1\u6570\u5668\u6cd5<\/td>\n<td>\u65e0\u9700\u5316\u5b66\u54c1\uff0c\u73af\u4fdd<\/td>\n<td>\u6210\u672c\u9ad8\uff0c\u6613\u53d7\u80cc\u666f\u5e72\u6270<\/td>\n<td>ISO 29463, USP <\/td>\n<\/tr>\n<tr>\n<td>\u538b\u529b\u8870\u51cf\u6cd5<\/td>\n<td>\u9002\u7528\u4e8e\u5bc6\u95ed\u8231\u4f53<\/td>\n<td>\u4ec5\u80fd\u6574\u4f53\u5224\u65ad\uff0c\u65e0\u6cd5\u5b9a\u4f4d\u6cc4\u6f0f\u70b9<\/td>\n<td>ASME BPE-2022<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e94\u3001\u4e0d\u9508\u94a2\u8fc7\u6ee4\u5668\u7279\u6b8a\u68c0\u6d4b\u6ce8\u610f\u4e8b\u9879<\/h2>\n<p>\u7531\u4e8e\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e38\u7528\u4e8e\u9700\u706d\u83cc\u7684\u5de5\u827a\u73af\u5883\u4e2d\uff08\u5982\u51bb\u5e72\u673a\u8154\u4f53\u3001\u9694\u79bb\u5668\u3001RABS\u7cfb\u7edf\uff09\uff0c\u5176\u5b8c\u6574\u6027\u68c0\u6d4b\u8fd8\u9700\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n<h3>5.1 \u9ad8\u6e29\u706d\u83cc\u540e\u7684\u518d\u9a8c\u8bc1<\/h3>\n<p>\u7ecf121\u2103\u300130\u5206\u949f\u84b8\u6c7d\u706d\u83cc\uff08SIP\uff09\u540e\uff0c\u5bc6\u5c01\u6750\u6599\u53ef\u80fd\u53d1\u751f\u6536\u7f29\u6216\u53d8\u5f62\u3002\u5efa\u8bae\u5728\u706d\u83cc\u5faa\u73af\u7ed3\u675f\u540e\u51b7\u5374\u81f3\u5e38\u6e29\u518d\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u3002<\/p>\n<blockquote>\n<p>\u5b9e\u9a8c\u6570\u636e\u8868\u660e\uff1a\u67d0\u54c1\u724c316L\u4e0d\u9508\u94a2HEPA\u7ecf\u8fde\u7eed50\u6b21SIP\u5faa\u73af\u540e\uff0c\u521d\u59cb\u6cc4\u6f0f\u7387\u4ece0.005%\u4e0a\u5347\u81f30.009%\uff0c\u4f46\u4ecd\u7b26\u5408\u6807\u51c6\uff08Zhang et al., <em>Journal of Pharmaceutical Engineering<\/em>, 2021\uff09\u3002<\/p>\n<\/blockquote>\n<h3>5.2 \u710a\u63a5\u63a5\u53e3\u7684\u68c0\u6d4b\u91cd\u70b9<\/h3>\n<p>\u4e0d\u9508\u94a2\u8fc7\u6ee4\u5668\u591a\u91c7\u7528\u6c29\u5f27\u710a\u8fde\u63a5\u6cd5\u5170\u4e0e\u7bb1\u4f53\uff0c\u82e5\u710a\u63a5\u4e0d\u5747\u5300\u53ef\u80fd\u5bfc\u81f4\u5fae\u5b54\u6cc4\u6f0f\u3002\u5efa\u8bae\u7ed3\u5408<strong>\u6c26\u8d28\u8c31\u68c0\u6f0f\u6cd5<\/strong>\uff08He Leak Test\uff09\u8fdb\u884c\u51fa\u5382\u524d\u62bd\u68c0\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u68c0\u6d4b\u65b9\u6cd5<\/th>\n<th>\u7075\u654f\u5ea6<\/th>\n<th>\u5e94\u7528\u9636\u6bb5<\/th>\n<th>\u6210\u672c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6c26\u8d28\u8c31\u68c0\u6f0f<\/td>\n<td>1\u00d710\u207b\u2079 atm\u00b7cm\u00b3\/s<\/td>\n<td>\u51fa\u5382\u68c0\u9a8c<\/td>\n<td>\u9ad8<\/td>\n<\/tr>\n<tr>\n<td>PAO\u626b\u63cf\u6cd5<\/td>\n<td>~1\u00d710\u207b\u2076<\/td>\n<td>\u73b0\u573a\u5b89\u88c5\u540e<\/td>\n<td>\u4e2d\u7b49<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6765\u6e90\uff1aASHRAE Handbook\u2014HVAC Applications (2020), Chapter 48: &quot;Clean Spaces&quot;<\/p>\n<\/blockquote>\n<h3>5.3 \u81ea\u52a8\u5316\u5728\u7ebf\u76d1\u6d4b\u7cfb\u7edf\u7684\u53d1\u5c55\u8d8b\u52bf<\/h3>\n<p>\u8fd1\u5e74\u6765\uff0c\u90e8\u5206\u9ad8\u7aefGMP\u8f66\u95f4\u5df2\u5f15\u5165<strong>\u5728\u7ebf\u5b8c\u6574\u6027\u76d1\u6d4b\u7cfb\u7edf\uff08Online Integrity Monitoring System\uff09<\/strong>\uff0c\u901a\u8fc7\u9884\u57cb\u4e0a\u6e38\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u4e0e\u4e0b\u6e38\u4f20\u611f\u5668\uff0c\u5b9e\u73b0\u4e0d\u95f4\u65ad\u76d1\u63a7\u3002<\/p>\n<p>\u4f8b\u5982\uff0c\u5fb7\u56fdPall Corporation\u63a8\u51fa\u7684TruTest\u2122\u7cfb\u7edf\u53ef\u5728\u4e0d\u505c\u4ea7\u60c5\u51b5\u4e0b\u5b8c\u6210\u5e74\u5ea6\u68c0\u6f0f\u4efb\u52a1\uff0c\u6781\u5927\u63d0\u5347\u6548\u7387\u4e0e\u6570\u636e\u8ffd\u6eaf\u6027\u3002<\/p>\n<hr \/>\n<h2>\u516d\u3001\u68c0\u6d4b\u9891\u7387\u4e0e\u8bb0\u5f55\u7ba1\u7406<\/h2>\n<h3>6.1 \u63a8\u8350\u68c0\u6d4b\u5468\u671f<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u60c5\u51b5<\/th>\n<th>\u68c0\u6d4b\u9891\u7387<\/th>\n<th>\u4f9d\u636e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u65b0\u5b89\u88c5\u6216\u66f4\u6362\u540e<\/td>\n<td>\u9996\u6b21\u8fd0\u884c\u524d\u5fc5\u987b\u68c0\u6d4b<\/td>\n<td>GB 50591-2010<\/td>\n<\/tr>\n<tr>\n<td>\u6b63\u5e38\u8fd0\u884c\u671f\u95f4<\/td>\n<td>\u6bcf6\u4e2a\u6708\u4e00\u6b21<\/td>\n<td>EU GMP Annex 1<\/td>\n<\/tr>\n<tr>\n<td>\u7ecf\u5386\u6781\u7aef\u4e8b\u4ef6\u540e\uff08\u5982\u5730\u9707\u3001\u706b\u707e\uff09<\/td>\n<td>\u7acb\u5373\u590d\u6d4b<\/td>\n<td>ASHRAE Guideline 27-2018<\/td>\n<\/tr>\n<tr>\n<td>SIP\/CIP\u9891\u7e41\u4f7f\u7528\u7684\u7cfb\u7edf<\/td>\n<td>\u6bcf3\u4e2a\u6708\u4e00\u6b21<\/td>\n<td>\u4f01\u4e1aSOP\u5f3a\u5316\u7248<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>6.2 \u6570\u636e\u8bb0\u5f55\u8981\u6c42<\/h3>\n<p>\u5b8c\u6574\u6027\u68c0\u6d4b\u62a5\u544a\u5e94\u5305\u542b\u4f46\u4e0d\u9650\u4e8e\u4ee5\u4e0b\u4fe1\u606f\uff1a<\/p>\n<ul>\n<li>\u8fc7\u6ee4\u5668\u7f16\u53f7\u3001\u4f4d\u7f6e\u3001\u578b\u53f7\uff1b<\/li>\n<li>\u68c0\u6d4b\u65e5\u671f\u3001\u73af\u5883\u6e29\u6e7f\u5ea6\uff1b<\/li>\n<li>\u4f7f\u7528\u4eea\u5668\u578b\u53f7\u4e0e\u6821\u51c6\u8bc1\u4e66\u7f16\u53f7\uff1b<\/li>\n<li>\u4e0a\u6e38\u6c14\u6eb6\u80f6\u6d53\u5ea6\uff1b<\/li>\n<li>\u626b\u63cf\u8def\u5f84\u56fe\uff08\u63a8\u8350CAD\u5e73\u9762\u56fe\u6807\u6ce8\uff09\uff1b<\/li>\n<li>\u6700\u5927\u6cc4\u6f0f\u70b9\u5750\u6807\u53ca\u6570\u503c\uff1b<\/li>\n<li>\u68c0\u6d4b\u4eba\u5458\u7b7e\u540d\u4e0e\u5ba1\u6838\u610f\u89c1\u3002<\/li>\n<\/ul>\n<blockquote>\n<p>\u793a\u4f8b\u683c\u5f0f\u53c2\u89c1\u300a\u5236\u836f\u5de5\u7a0b\u9a8c\u8bc1\u6587\u4ef6\u7f16\u5199\u6307\u5357\u300b\uff08\u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e\uff0c2020\u5e74\u7248\uff09<\/p>\n<\/blockquote>\n<hr 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