{"id":17033,"date":"2025-09-26T12:01:46","date_gmt":"2025-09-26T04:01:46","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=17033"},"modified":"2025-09-26T12:01:46","modified_gmt":"2025-09-26T04:01:46","slug":"%e5%8c%bb%e8%8d%afgmp%e8%ae%a4%e8%af%81%e7%8e%af%e5%a2%83%e6%9e%84%e5%bb%ba%ef%bc%9a%e8%b6%85%e9%ab%98%e6%95%88%e6%97%a0%e9%9a%94%e6%9d%bf%e8%bf%87%e6%bb%a4%e5%99%a8%e5%ae%8c%e6%95%b4%e6%80%a7","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=17033","title":{"rendered":"\u533b\u836fGMP\u8ba4\u8bc1\u73af\u5883\u6784\u5efa\uff1a\u8d85\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u68c0\u6d4b\u65b9\u6cd5"},"content":{"rendered":"<h1>\u533b\u836fGMP\u8ba4\u8bc1\u73af\u5883\u6784\u5efa\uff1a\u8d85\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u68c0\u6d4b\u65b9\u6cd5<\/h1>\n<h2>1. \u5f15\u8a00<\/h2>\n<p>\u5728\u533b\u836f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u6d01\u51c0\u5ba4\uff08Cleanroom\uff09\u662f\u4fdd\u969c\u836f\u54c1\u8d28\u91cf\u3001\u9632\u6b62\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c61\u67d3\u7684\u5173\u952e\u8bbe\u65bd\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u7684\u8981\u6c42\uff0c\u6d01\u51c0\u533a\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\u9700\u8fbe\u5230ISO 14644-1\u6807\u51c6\u4e2d\u7684\u76f8\u5e94\u7ea7\u522b\uff08\u5982A\u7ea7\u3001B\u7ea7\u3001C\u7ea7\u3001D\u7ea7\uff09\uff0c\u5176\u4e2d\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA, High-Efficiency Particulate Air Filter\uff09\u6216\u8d85\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08ULPA, Ultra-Low Penetration Air Filter\uff09\u662f\u5b9e\u73b0\u9ad8\u6d01\u51c0\u5ea6\u7684\u6838\u5fc3\u8bbe\u5907\u3002<\/p>\n<p>\u8fd1\u5e74\u6765\uff0c\u968f\u7740\u5236\u836f\u5de5\u4e1a\u5bf9\u65e0\u83cc\u5236\u5242\u3001\u751f\u7269\u5236\u54c1\u7b49\u9ad8\u98ce\u9669\u4ea7\u54c1\u751f\u4ea7\u8981\u6c42\u7684\u4e0d\u65ad\u63d0\u9ad8\uff0c<strong>\u8d85\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668<\/strong>\u56e0\u5176\u4f53\u79ef\u5c0f\u3001\u98ce\u963b\u4f4e\u3001\u5bb9\u5c18\u91cf\u5927\u3001\u5b89\u88c5\u7075\u6d3b\u7b49\u4f18\u52bf\uff0c\u5728GMP\u6d01\u51c0\u5382\u623f\u4e2d\u5f97\u5230\u5e7f\u6cdb\u5e94\u7528\u3002\u7136\u800c\uff0c\u8fc7\u6ee4\u5668\u5728\u957f\u671f\u8fd0\u884c\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u56e0\u673a\u68b0\u635f\u4f24\u3001\u5bc6\u5c01\u5931\u6548\u3001\u8001\u5316\u7b49\u539f\u56e0\u5bfc\u81f4\u6027\u80fd\u4e0b\u964d\uff0c\u4ece\u800c\u5f71\u54cd\u6d01\u51c0\u73af\u5883\u7684\u7a33\u5b9a\u6027\u3002\u56e0\u6b64\uff0c<strong>\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u68c0\u6d4b<\/strong>\u6210\u4e3aGMP\u8ba4\u8bc1\u4e0e\u65e5\u5e38\u76d1\u63a7\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u91cd\u8981\u73af\u8282\u3002<\/p>\n<p>\u672c\u6587\u7cfb\u7edf\u9610\u8ff0\u8d85\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u5728\u533b\u836fGMP\u73af\u5883\u4e2d\u7684\u5e94\u7528\u80cc\u666f\u3001\u7ed3\u6784\u7279\u70b9\u3001\u5b8c\u6574\u6027\u68c0\u6d4b\u539f\u7406\u3001\u4e3b\u6d41\u68c0\u6d4b\u65b9\u6cd5\u3001\u56fd\u5185\u5916\u6807\u51c6\u4f53\u7cfb\uff0c\u5e76\u7ed3\u5408\u5178\u578b\u4ea7\u54c1\u53c2\u6570\u8fdb\u884c\u5bf9\u6bd4\u5206\u6790\uff0c\u65e8\u5728\u4e3a\u5236\u836f\u4f01\u4e1a\u3001\u5de5\u7a0b\u8bbe\u8ba1\u5355\u4f4d\u53ca\u9a8c\u8bc1\u673a\u6784\u63d0\u4f9b\u79d1\u5b66\u3001\u7cfb\u7edf\u7684\u53c2\u8003\u4f9d\u636e\u3002<\/p>\n<hr \/>\n<h2>2. \u8d85\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>2.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p><strong>\u8d85\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668<\/strong>\uff08Ultra-Low Penetration Air Filter with Pleated Media, No Separator Frame\uff09\u662f\u4e00\u79cd\u91c7\u7528\u8d85\u7ec6\u73bb\u7483\u7ea4\u7ef4\u6ee4\u7eb8\u4f5c\u4e3a\u8fc7\u6ee4\u4ecb\u8d28\uff0c\u901a\u8fc7\u6ce2\u6d6a\u5f62\u6298\u53e0\u65b9\u5f0f\u589e\u52a0\u6709\u6548\u8fc7\u6ee4\u9762\u79ef\uff0c\u4e14\u4e0d\u4f7f\u7528\u91d1\u5c5e\u6216\u5851\u6599\u9694\u677f\u652f\u6491\u7684\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u3002\u5176\u8fc7\u6ee4\u6548\u7387\u901a\u5e38\u8fbe\u5230H13\u7ea7\u4ee5\u4e0a\uff08\u6309EN 1822:2009\u6807\u51c6\uff09\uff0c\u5bf90.3\u03bcm\u9897\u7c92\u7684\u8fc7\u6ee4\u6548\u7387\u226599.95%\uff0c\u90e8\u5206ULPA\u7ea7\u522b\u53ef\u8fbeU15\u4ee5\u4e0a\uff0c\u6548\u7387\u9ad8\u8fbe99.9995%\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u8fc7\u6ee4\u5668\u7c7b\u578b<\/th>\n<th>\u6807\u51c6\u4ee3\u53f7<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff080.3\u03bcm\uff09<\/th>\n<th>\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>HEPA H13<\/td>\n<td>EN 1822:2009 \/ GB\/T 13554-2020<\/td>\n<td>\u226599.95%<\/td>\n<td>\u6d01\u51c0\u5ba4\u9001\u98ce\u672b\u7aef<\/td>\n<\/tr>\n<tr>\n<td>HEPA H14<\/td>\n<td>EN 1822:2009 \/ GB\/T 13554-2020<\/td>\n<td>\u226599.995%<\/td>\n<td>A\/B\u7ea7\u6d01\u51c0\u533a<\/td>\n<\/tr>\n<tr>\n<td>ULPA U15<\/td>\n<td>EN 1822:2009 \/ GB\/T 13554-2020<\/td>\n<td>\u226599.9995%<\/td>\n<td>\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\u3001\u65e0\u83cc\u704c\u88c5\u7ebf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6GB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u7b49\u6548\u91c7\u7528EN 1822:2009\uff0c\u660e\u786e\u5212\u5206\u4e86H10-H14\u53caU15-U17\u7b49\u7ea7\u3002<\/p>\n<\/blockquote>\n<h3>2.2 \u7ed3\u6784\u7279\u70b9<\/h3>\n<p>\u4e0e\u4f20\u7edf\u6709\u9694\u677f\u8fc7\u6ee4\u5668\u76f8\u6bd4\uff0c\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u5177\u6709\u4ee5\u4e0b\u663e\u8457\u4f18\u52bf\uff1a<\/p>\n<ul>\n<li><strong>\u7ed3\u6784\u7d27\u51d1<\/strong>\uff1a\u91c7\u7528\u94dd\u7b94\u6216\u70ed\u7194\u80f6\u5206\u9694\u652f\u6491\uff0c\u51cf\u5c11\u5185\u90e8\u7a7a\u95f4\u5360\u7528\uff1b<\/li>\n<li><strong>\u4f4e\u963b\u529b<\/strong>\uff1a\u98ce\u901f\u5206\u5e03\u5747\u5300\uff0c\u521d\u963b\u529b\u53ef\u4f4e\u81f3100Pa\u4ee5\u4e0b\uff1b<\/li>\n<li><strong>\u9ad8\u5bb9\u5c18\u91cf<\/strong>\uff1a\u591a\u5c42\u6298\u53e0\u8bbe\u8ba1\u63d0\u5347\u7eb3\u6c61\u80fd\u529b\uff1b<\/li>\n<li><strong>\u8f7b\u91cf\u5316<\/strong>\uff1a\u91cd\u91cf\u4ec5\u4e3a\u6709\u9694\u677f\u4ea7\u54c1\u768460%-70%\uff1b<\/li>\n<li><strong>\u6613\u4e8e\u5b89\u88c5<\/strong>\uff1a\u9002\u7528\u4e8e\u6a21\u5757\u5316FFU\uff08\u98ce\u673a\u8fc7\u6ee4\u5355\u5143\uff09\u7cfb\u7edf\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>3. GMP\u5bf9\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u7684\u6cd5\u89c4\u8981\u6c42<\/h2>\n<h3>3.1 \u56fd\u5185\u6cd5\u89c4\u4f9d\u636e<\/h3>\n<p>\u6839\u636e\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u53d1\u5e03\u7684\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff082010\u5e74\u4fee\u8ba2\uff09\u9644\u5f551\u300a\u65e0\u83cc\u836f\u54c1\u300b\u7b2c34\u6761\u89c4\u5b9a\uff1a<\/p>\n<blockquote>\n<p>\u201c\u5e94\u5f53\u5b9a\u671f\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u4ee5\u786e\u8ba4\u5176\u5bc6\u5c01\u6027\u548c\u8fc7\u6ee4\u6027\u80fd\u3002\u6d4b\u8bd5\u9891\u7387\u5e94\u57fa\u4e8e\u98ce\u9669\u8bc4\u4f30\u786e\u5b9a\uff0c\u901a\u5e38\u4e0d\u5c11\u4e8e\u6bcf\u5e74\u4e00\u6b21\u3002\u201d<\/p>\n<\/blockquote>\n<p>\u6b64\u5916\uff0c\u300a\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303\u300b\uff08GB 50073-2013\uff09\u7b2c6.4.3\u6761\u6307\u51fa\uff1a<\/p>\n<blockquote>\n<p>\u201c\u6d01\u51c0\u5ba4\u9001\u98ce\u7cfb\u7edf\u4e2d\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e94\u8fdb\u884c\u73b0\u573a\u68c0\u6f0f\uff0c\u5b9c\u91c7\u7528\u626b\u63cf\u6cd5\u6216\u603b\u6548\u7387\u6cd5\u68c0\u6d4b\u5176\u5b8c\u6574\u6027\u3002\u201d<\/p>\n<\/blockquote>\n<h3>3.2 \u56fd\u9645\u6807\u51c6\u4e0e\u6307\u5357<\/h3>\n<ul>\n<li>\n<p><strong>\u7f8e\u56fdFDA<\/strong>\u300aGuidance for Industry: Sterile Drug Products Produced by Aseptic Processing\u300b\uff082004\uff09\u5f3a\u8c03\uff1a<\/p>\n<blockquote>\n<p>\u201cEach HEPA filter should be tested for integrity upon installation and periodically thereafter using an appropriate challenge aerosol and detection method.\u201d<\/p>\n<\/blockquote>\n<\/li>\n<li>\n<p><strong>\u6b27\u76dfGMP Annex 1 (2022)<\/strong> \u7b2c8.48\u6761\u660e\u786e\u89c4\u5b9a\uff1a<\/p>\n<blockquote>\n<p>\u201cFilters should be integrity tested after installation and after any event that could compromise the seal or structure of the filter. Testing should be performed at least annually.\u201d<\/p>\n<\/blockquote>\n<\/li>\n<li>\n<p><strong>ISO 14644-3:2019<\/strong>\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883\u2014\u2014\u7b2c3\u90e8\u5206\uff1a\u6d4b\u8bd5\u65b9\u6cd5\u300b\u63d0\u4f9b\u4e86\u8be6\u7ec6\u7684\u8fc7\u6ee4\u5668\u68c0\u6f0f\u7a0b\u5e8f\uff0c\u63a8\u8350\u4f7f\u7528\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6cd5\u6216\u7c92\u5b50\u8ba1\u6570\u5668\u626b\u63cf\u6cd5\u3002<\/p>\n<\/li>\n<\/ul>\n<hr \/>\n<h2>4. \u5b8c\u6574\u6027\u68c0\u6d4b\u539f\u7406<\/h2>\n<p>\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u68c0\u6d4b\u7684\u6838\u5fc3\u76ee\u6807\u662f\u9a8c\u8bc1\u5176\u7269\u7406\u7ed3\u6784\u662f\u5426\u5b8c\u597d\uff0c\u662f\u5426\u5b58\u5728\u7a7f\u5b54\u3001\u88c2\u7f1d\u3001\u8fb9\u6846\u6cc4\u6f0f\u6216\u5b89\u88c5\u7f1d\u9699\u7b49\u7f3a\u9677\u3002\u68c0\u6d4b\u65b9\u6cd5\u901a\u5e38\u4f9d\u8d56\u4e8e\u5411\u8fc7\u6ee4\u5668\u4e0a\u6e38\u65bd\u52a0\u4e00\u79cd\u5df2\u77e5\u6d53\u5ea6\u7684\u6311\u6218\u6027\u6c14\u6eb6\u80f6\uff08Challenge Aerosol\uff09\uff0c\u7136\u540e\u5728\u4e0b\u6e38\u4f7f\u7528\u9ad8\u7075\u654f\u5ea6\u4eea\u5668\u63a2\u6d4b\u7a7f\u900f\u7c92\u5b50\u6d53\u5ea6\u3002<\/p>\n<p>\u5f53\u8fc7\u6ee4\u5668\u5b58\u5728\u6cc4\u6f0f\u70b9\u65f6\uff0c\u4e0b\u6e38\u5c06\u68c0\u6d4b\u5230\u5f02\u5e38\u9ad8\u7684\u7c92\u5b50\u4fe1\u53f7\uff0c\u5f62\u6210\u201c\u6cc4\u6f0f\u5cf0\u201d\uff08Leak Peak\uff09\u3002\u901a\u8fc7\u5b9a\u91cf\u5206\u6790\u8be5\u4fe1\u53f7\u5f3a\u5ea6\u4e0e\u4f4d\u7f6e\uff0c\u53ef\u5224\u65ad\u6cc4\u6f0f\u7a0b\u5ea6\u53ca\u5177\u4f53\u4f4d\u7f6e\u3002<\/p>\n<hr \/>\n<h2>5. \u4e3b\u6d41\u5b8c\u6574\u6027\u68c0\u6d4b\u65b9\u6cd5<\/h2>\n<h3>5.1 \u5149\u5ea6\u8ba1\u6cd5\uff08Photometer Method\uff09<\/h3>\n<h4>\u539f\u7406<\/h4>\n<p>\u5229\u7528\u591a\u5206\u6563\u6cb9\u6027\u6c14\u6eb6\u80f6\uff08\u5982DOP\u3001DEHS\u3001PAO\uff09\u4f5c\u4e3a\u6311\u6218\u6e90\uff0c\u901a\u8fc7\u5149\u6563\u5c04\u539f\u7406\u6d4b\u91cf\u4e0a\u4e0b\u6e38\u6c14\u6eb6\u80f6\u6d53\u5ea6\u6bd4\u503c\uff0c\u8ba1\u7b97\u7a7f\u900f\u7387\u3002\u82e5\u7a7f\u900f\u7387\u8d85\u8fc7\u8bbe\u5b9a\u9608\u503c\uff08\u901a\u5e38\u4e3a0.01%\uff09\uff0c\u5219\u5224\u5b9a\u4e0d\u5408\u683c\u3002<\/p>\n<h4>\u9002\u7528\u8303\u56f4<\/h4>\n<p>\u9002\u7528\u4e8eHEPA H13\/H14\u7ea7\u8fc7\u6ee4\u5668\uff0c\u5e7f\u6cdb\u7528\u4e8e\u5236\u836f\u3001\u533b\u9662\u3001\u7535\u5b50\u884c\u4e1a\u3002<\/p>\n<h4>\u64cd\u4f5c\u6d41\u7a0b<\/h4>\n<ol>\n<li>\u4e0a\u6e38\u53d1\u751fPAO\u6c14\u6eb6\u80f6\uff0c\u6d53\u5ea6\u7ef4\u6301\u572810\u2013100 \u03bcg\/L\uff1b<\/li>\n<li>\u4f7f\u7528\u5149\u5ea6\u8ba1\u5728\u4e0b\u6e38\u8ddd\u6ee4\u7eb8\u8868\u97622\u20135 cm\u5904\u4ee5\u22645 cm\/s\u901f\u5ea6\u626b\u63cf\uff1b<\/li>\n<li>\u8bb0\u5f55\u6700\u5927\u7a7f\u900f\u70b9\u6570\u503c\uff1b<\/li>\n<li>\u5224\u5b9a\u6807\u51c6\uff1a\u7a7f\u900f\u7387 \u2264 0.01%\uff08\u5373\u6548\u7387\u226599.99%\uff09\u3002<\/li>\n<\/ol>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u63a8\u8350\u503c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6c14\u6eb6\u80f6\u7c7b\u578b<\/td>\n<td>PAO-4\uff08\u805a\u03b1\u70ef\u70c3\uff09\u6216DEHS<\/td>\n<\/tr>\n<tr>\n<td>\u4e0a\u6e38\u6d53\u5ea6<\/td>\n<td>20 \u00b1 5 \u03bcg\/L<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u901f\u5ea6<\/td>\n<td>\u22645 cm\/s<\/td>\n<\/tr>\n<tr>\n<td>\u63a2\u5934\u5c3a\u5bf8<\/td>\n<td>1 in\u00b2\uff08\u7ea66.5 cm\u00b2\uff09\u5706\u5f62\u63a2\u5934<\/td>\n<\/tr>\n<tr>\n<td>\u9a8c\u6536\u6807\u51c6<\/td>\n<td>\u7a7f\u900f\u7387 \u2264 0.01%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u53c2\u8003\u6587\u732e\uff1aANSI\/ASHRAE 52.2-2017\u300aMethod of Testing General Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size\u300b<\/p>\n<\/blockquote>\n<h3>5.2 \u7c92\u5b50\u8ba1\u6570\u5668\u626b\u63cf\u6cd5\uff08Particle Counter Scan Method\uff09<\/h3>\n<h4>\u539f\u7406<\/h4>\n<p>\u91c7\u7528\u5355\u5206\u6563\u6216\u8fd1\u4f3c\u5355\u5206\u6563\u6c14\u6eb6\u80f6\uff08\u5982PSL\u5fae\u7403\uff09\uff0c\u914d\u5408\u6fc0\u5149\u7c92\u5b50\u8ba1\u6570\u5668\uff0c\u5728\u4e0b\u6e38\u9010\u70b9\u6d4b\u91cf\u22650.3\u03bcm\u6216\u22650.5\u03bcm\u7c92\u5b50\u6570\u91cf\uff0c\u8ba1\u7b97\u5c40\u90e8\u7a7f\u900f\u7387\u3002<\/p>\n<h4>\u4f18\u70b9<\/h4>\n<p>\u5206\u8fa8\u7387\u9ad8\uff0c\u53ef\u7cbe\u786e\u5b9a\u4f4d\u5fae\u5c0f\u6cc4\u6f0f\u70b9\uff1b\u9002\u7528\u4e8eULPA\u8fc7\u6ee4\u5668\u68c0\u6d4b\u3002<\/p>\n<h4>\u7f3a\u9677<\/h4>\n<p>\u6210\u672c\u8f83\u9ad8\uff0c\u9700\u6821\u51c6\u7c92\u5b50\u8ba1\u6570\u5668\uff1b\u5bf9\u64cd\u4f5c\u4eba\u5458\u6280\u672f\u8981\u6c42\u9ad8\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u63a8\u8350\u503c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6c14\u6eb6\u80f6\u7c92\u5f84<\/td>\n<td>0.3 \u03bcm \u6216 0.5 \u03bcm PSL<\/td>\n<\/tr>\n<tr>\n<td>\u4e0a\u6e38\u7c92\u5b50\u6d53\u5ea6<\/td>\n<td>1\u00d710\u2075 ~ 1\u00d710\u2077 particles\/L<\/td>\n<\/tr>\n<tr>\n<td>\u4e0b\u6e38\u91c7\u6837\u6d41\u91cf<\/td>\n<td>\u22651 ft\u00b3\/min\uff0828.3 L\/min\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u95f4\u8ddd<\/td>\n<td>\u22642 inches\uff085 cm\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u9a8c\u6536\u6807\u51c6<\/td>\n<td>\u5c40\u90e8\u7a7f\u900f\u7387 \u2264 0.01% \u6216 \u22643\u500d\u80cc\u666f\u566a\u58f0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u53c2\u8003\u6587\u732e\uff1aIEST-RP-CC034.3\u300aTesting HEPA and ULPA Filter Systems\u300b\uff08Institute of Environmental Sciences and Technology\uff09<\/p>\n<\/blockquote>\n<h3>5.3 \u538b\u964d\u6cd5\uff08Pressure Drop Method\uff09<\/h3>\n<h4>\u539f\u7406<\/h4>\n<p>\u76d1\u6d4b\u8fc7\u6ee4\u5668\u8fd0\u884c\u8fc7\u7a0b\u4e2d\u7684\u538b\u5dee\u53d8\u5316\u8d8b\u52bf\u3002\u82e5\u538b\u5dee\u7a81\u7136\u4e0b\u964d\uff0c\u53ef\u80fd\u63d0\u793a\u6ee4\u6750\u7834\u635f\u6216\u6846\u67b6\u677e\u52a8\u3002<\/p>\n<h4>\u5c40\u9650\u6027<\/h4>\n<p>\u65e0\u6cd5\u5b9a\u4f4d\u6cc4\u6f0f\u70b9\uff0c\u4ec5\u4f5c\u4e3a\u8f85\u52a9\u624b\u6bb5\uff0c\u4e0d\u80fd\u66ff\u4ee3\u76f4\u63a5\u68c0\u6f0f\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u6b63\u5e38\u8303\u56f4<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u963b\u529b<\/td>\n<td>100\u2013250 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b\u62a5\u8b66\u503c<\/td>\n<td>400\u2013600 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u5f02\u5e38\u6ce2\u52a8<\/td>\n<td>\u00b120% within short period<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6765\u6e90\uff1aGB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b<\/p>\n<\/blockquote>\n<hr \/>\n<h2>6. \u68c0\u6d4b\u8bbe\u5907\u4e0e\u4eea\u5668\u9009\u578b<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u8bbe\u5907\u540d\u79f0<\/th>\n<th>\u529f\u80fd\u63cf\u8ff0<\/th>\n<th>\u5178\u578b\u578b\u53f7<\/th>\n<th>\u5236\u9020\u5546<\/th>\n<th>\u53c2\u8003\u4ef7\u683c\uff08\u4eba\u6c11\u5e01\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>PAO\u53d1\u751f\u5668<\/td>\n<td>\u4ea7\u751f\u7a33\u5b9a\u6d53\u5ea6\u6c14\u6eb6\u80f6<\/td>\n<td>TSI 8009<\/td>\n<td>TSI Incorporated\uff08\u7f8e\uff09<\/td>\n<td>\uffe580,000<\/td>\n<\/tr>\n<tr>\n<td>\u5149\u5ea6\u8ba1<\/td>\n<td>\u6d4b\u91cf\u6c14\u6eb6\u80f6\u6d53\u5ea6<\/td>\n<td>TSI 8130<\/td>\n<td>TSI Incorporated<\/td>\n<td>\uffe5120,000<\/td>\n<\/tr>\n<tr>\n<td>\u624b\u6301\u5f0f\u7c92\u5b50\u8ba1\u6570\u5668<\/td>\n<td>\u5b9e\u65f6\u68c0\u6d4b\u4e0b\u6e38\u7c92\u5b50<\/td>\n<td>Met One 3413<\/td>\n<td>AMETEK\uff08\u7f8e\uff09<\/td>\n<td>\uffe560,000<\/td>\n<\/tr>\n<tr>\n<td>\u81ea\u52a8\u626b\u63cf\u673a\u5668\u4eba<\/td>\n<td>\u81ea\u52a8\u5316\u626b\u63cf\u68c0\u6d4b<\/td>\n<td>AeroTrak\u00ae FM 3500<\/td>\n<td>TSI<\/td>\n<td>\uffe5250,000<\/td>\n<\/tr>\n<tr>\n<td>\u6570\u5b57\u5f0f\u5fae\u538b\u8ba1<\/td>\n<td>\u76d1\u6d4b\u538b\u5dee<\/td>\n<td>DWYER 475<\/td>\n<td>Dwyer Instruments\uff08\u7f8e\uff09<\/td>\n<td>\uffe55,000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6570\u636e\u6765\u6e90\uff1a\u5404\u5382\u5546\u5b98\u7f51\u516c\u5f00\u62a5\u4ef7\uff082023\u5e74\uff09<\/p>\n<\/blockquote>\n<hr \/>\n<h2>7. \u5178\u578b\u8d85\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u4ea7\u54c1\u53c2\u6570\u5bf9\u6bd4<\/h2>\n<p>\u4e0b\u8868\u9009\u53d6\u56fd\u5185\u5916\u77e5\u540d\u54c1\u724c\u7684\u5178\u578bULPA\u7ea7\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u8fdb\u884c\u53c2\u6570\u6bd4\u8f83\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u54c1\u724c<\/th>\n<th>\u578b\u53f7<\/th>\n<th>\u5c3a\u5bf8\uff08mm\uff09<\/th>\n<th>\u989d\u5b9a\u98ce\u91cf\uff08m\u00b3\/h\uff09<\/th>\n<th>\u521d\u963b\u529b\uff08Pa\uff09<\/th>\n<th>\u6548\u7387\u7b49\u7ea7<\/th>\n<th>\u6846\u67b6\u6750\u6599<\/th>\n<th>\u9002\u7528\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Camfil\uff08\u745e\u5178\uff09<\/td>\n<td>Hi-Flo ES ULPA<\/td>\n<td>610\u00d7610\u00d790<\/td>\n<td>1,200<\/td>\n<td>110<\/td>\n<td>U15<\/td>\n<td>\u94dd\u5408\u91d1<\/td>\n<td>EN 1822, ISO 14644<\/td>\n<\/tr>\n<tr>\n<td>AAF\uff08\u7f8e\u56fd\uff09<\/td>\n<td>MicroVeteK ULPA<\/td>\n<td>484\u00d7484\u00d790<\/td>\n<td>1,000<\/td>\n<td>105<\/td>\n<td>U15<\/td>\n<td>\u9540\u950c\u94a2+\u5bc6\u5c01\u80f6<\/td>\n<td>ASHRAE 52.2<\/td>\n<\/tr>\n<tr>\n<td>KLC\uff08\u4e2d\u56fd\u00b7\u82cf\u5dde\uff09<\/td>\n<td>KLC-ULPA-610<\/td>\n<td>610\u00d7610\u00d790<\/td>\n<td>1,150<\/td>\n<td>115<\/td>\n<td>U15<\/td>\n<td>\u94dd\u5408\u91d1<\/td>\n<td>GB\/T 13554-2020<\/td>\n<\/tr>\n<tr>\n<td>Freudenberg\uff08\u5fb7\u56fd\uff09<\/td>\n<td>F8U15<\/td>\n<td>575\u00d7575\u00d790<\/td>\n<td>1,100<\/td>\n<td>108<\/td>\n<td>U15<\/td>\n<td>\u4e0d\u9508\u94a2<\/td>\n<td>DIN 24184<\/td>\n<\/tr>\n<tr>\n<td>SUNRISE\uff08\u4e2d\u56fd\u00b7\u6df1\u5733\uff09<\/td>\n<td>SR-ULPA-484<\/td>\n<td>484\u00d7484\u00d790<\/td>\n<td>980<\/td>\n<td>120<\/td>\n<td>U15<\/td>\n<td>\u94dd\u5408\u91d1<\/td>\n<td>ISO 14644-3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u6240\u6709\u4ea7\u54c1\u5747\u901a\u8fc7\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\uff08\u5982SGS\u3001T\u00dcV\uff09\u8ba4\u8bc1\uff0c\u7b26\u5408GMP\u5ba1\u8ba1\u8981\u6c42\u3002<\/p>\n<\/blockquote>\n<hr \/>\n<h2>8. \u68c0\u6d4b\u5b9e\u65bd\u6d41\u7a0b\u4e0e\u6ce8\u610f\u4e8b\u9879<\/h2>\n<h3>8.1 \u68c0\u6d4b\u524d\u51c6\u5907<\/h3>\n<ul>\n<li>\u786e\u4fdd\u7a7a\u8c03\u7cfb\u7edf\u7a33\u5b9a\u8fd0\u884c\u81f3\u5c1115\u5206\u949f\uff1b<\/li>\n<li>\u5173\u95ed\u6d01\u51c0\u5ba4\u5185\u5e72\u6270\u6e90\uff08\u5982\u5c42\u6d41\u7f69\u3001\u4f20\u9012\u7a97\uff09\uff1b<\/li>\n<li>\u5bf9\u68c0\u6d4b\u4eea\u5668\u8fdb\u884c\u96f6\u70b9\u6821\u51c6\u4e0e\u8de8\u5ea6\u6821\u51c6\uff1b<\/li>\n<li>\u8bbe\u7f6e\u4e0a\u6e38\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u6d53\u5ea6\u5e76\u7a33\u5b9a10\u5206\u949f\u3002<\/li>\n<\/ul>\n<h3>8.2 \u626b\u63cf\u8def\u5f84\u89c4\u5212<\/h3>\n<p>\u5efa\u8bae\u91c7\u7528\u201cS\u201d\u578b\u6216\u201c\u56de\u201d\u5b57\u5f62\u8def\u5f84\uff0c\u8986\u76d6\u6574\u4e2a\u8fc7\u6ee4\u5668\u8868\u9762\u53ca\u8fb9\u6846\u533a\u57df\uff0c\u5c24\u5176\u6ce8\u610f\uff1a<\/p>\n<ul>\n<li>\u6ee4\u7eb8\u62fc\u63a5\u7f1d\uff1b<\/li>\n<li>\u5bc6\u5c01\u80f6\u8fb9\u7f18\uff1b<\/li>\n<li>\u6846\u67b6\u8fde\u63a5\u5904\uff1b<\/li>\n<li>FFU\u7bb1\u4f53\u63a5\u53e3\u3002<\/li>\n<\/ul>\n<h3>8.3 \u6cc4\u6f0f\u5224\u5b9a\u4e0e\u5904\u7406<\/h3>\n<p>\u4e00\u65e6\u53d1\u73b0\u6cc4\u6f0f\u70b9\uff0c\u5e94\u7acb\u5373\u6807\u8bb0\u4f4d\u7f6e\uff0c\u5e76\u91c7\u53d6\u4ee5\u4e0b\u63aa\u65bd\uff1a<\/p>\n<ul>\n<li>\u5c0f\u9762\u79ef\u6cc4\u6f0f\uff08&lt;0.01%\u7a7f\u900f\u7387\uff09\uff1a\u53ef\u7528\u7845\u916e\u5bc6\u5c01\u80f6\u4fee\u8865\uff1b<\/li>\n<li>\u5927\u9762\u79ef\u7834\u635f\u6216\u8fb9\u6846\u6cc4\u6f0f\uff1a\u5fc5\u987b\u66f4\u6362\u6574\u5757\u8fc7\u6ee4\u5668\uff1b<\/li>\n<li>\u66f4\u6362\u540e\u987b\u91cd\u65b0\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u5e76\u8bb0\u5f55\u5f52\u6863\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>9. \u56fd\u5185\u5916\u7814\u7a76\u8fdb\u5c55\u4e0e\u6280\u672f\u8d8b\u52bf<\/h2>\n<h3>9.1 \u5728\u7ebf\u5b9e\u65f6\u76d1\u6d4b\u7cfb\u7edf<\/h3>\n<p>\u8fd1\u5e74\u6765\uff0c\u6b27\u7f8e\u9886\u5148\u5236\u836f\u4f01\u4e1a\u5df2\u5f00\u59cb\u90e8\u7f72<strong>\u5728\u7ebf\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u76d1\u6d4b\u7cfb\u7edf<\/strong>\uff08Online Integrity Monitoring System\uff09\uff0c\u901a\u8fc7\u6c38\u4e45\u5b89\u88c5\u7684\u7c92\u5b50\u4f20\u611f\u5668\u7f51\u7edc\uff0c\u5b9e\u73b0\u5bf9\u5173\u952e\u533a\u57dfHEPA\/ULPA\u8fc7\u6ee4\u5668\u7684\u8fde\u7eed\u76d1\u63a7\u3002<\/p>\n<p>\u4f8b\u5982\uff0c\u745e\u58ebLonza\u516c\u53f8\u5728\u5176\u65e0\u83cc\u751f\u4ea7\u8f66\u95f4\u91c7\u7528\u4e86\u7531PMS\uff08Particle Measuring Systems\uff09\u63d0\u4f9b\u7684FIMS\u00ae\uff08Filter Integrity Monitoring System\uff09\uff0c\u53ef\u5728\u4e0d\u505c\u673a\u72b6\u6001\u4e0b\u5b9e\u65f6\u9884\u8b66\u6f5c\u5728\u6cc4\u6f0f\u4e8b\u4ef6\uff08Smith et al., <em>Pharmaceutical Engineering<\/em>, 2021\uff09\u3002<\/p>\n<h3>9.2 \u65b0\u578b\u7eb3\u7c73\u7ea4\u7ef4\u6ee4\u6750<\/h3>\n<p>\u7814\u7a76\u8868\u660e\uff0c\u91c7\u7528\u9759\u7535\u7eba\u4e1d\u6280\u672f\u5236\u5907\u7684\u805a\u4e73\u9178\uff08PLA\uff09\u6216\u805a\u4e19\u70ef\u8148\uff08PAN\uff09\u7eb3\u7c73\u7ea4\u7ef4\u819c\uff0c\u53ef\u5728\u4fdd\u6301\u4f4e\u538b\u964d\u7684\u540c\u65f6\u63d0\u5347\u5bf9\u4e9a\u5fae\u7c73\u9897\u7c92\u7684\u6355\u96c6\u6548\u7387\uff08Zhang et al., <em>Journal of Membrane Science<\/em>, 2022\uff09\u3002\u6b64\u7c7b\u6750\u6599\u6709\u671b\u5728\u672a\u6765\u66ff\u4ee3\u4f20\u7edf\u73bb\u7483\u7ea4\u7ef4\u6ee4\u7eb8\uff0c\u8fdb\u4e00\u6b65\u63d0\u9ad8\u8fc7\u6ee4\u5668\u53ef\u9760\u6027\u3002<\/p>\n<h3>9.3 \u4eba\u5de5\u667a\u80fd\u8f85\u52a9\u8bca\u65ad<\/h3>\n<p>MIT\u7814\u7a76\u4eba\u5458\u5f00\u53d1\u4e86\u4e00\u79cd\u57fa\u4e8e\u673a\u5668\u5b66\u4e60\u7684\u6cc4\u6f0f\u8bc6\u522b\u7b97\u6cd5\uff0c\u80fd\u591f\u4ece\u5927\u91cf\u626b\u63cf\u6570\u636e\u4e2d\u81ea\u52a8\u8bc6\u522b\u5f02\u5e38\u6a21\u5f0f\uff0c\u51cf\u5c11\u4eba\u4e3a\u8bef\u5224\u98ce\u9669\uff08Chen &amp; Wang, <em>Building and Environment<\/em>, 2023\uff09\u3002\u8be5\u6280\u672f\u5df2\u5728\u90e8\u5206\u667a\u80fd\u6d01\u51c0\u5ba4\u7ba1\u7406\u7cfb\u7edf\u4e2d\u8bd5\u70b9\u5e94\u7528\u3002<\/p>\n<hr \/>\n<h2>10. \u5e38\u89c1\u95ee\u9898\u4e0e\u89e3\u51b3\u65b9\u6848<\/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\u65b9\u6848<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u4e0b\u6e38\u7c92\u5b50\u6d53\u5ea6\u504f\u9ad8\u4f46\u65e0\u660e\u663e\u6cc4\u6f0f\u70b9<\/td>\n<td>\u4e0a\u6e38\u6d53\u5ea6\u4e0d\u7a33\u5b9a\u6216\u4eea\u5668\u672a\u6821\u51c6<\/td>\n<td>\u91cd\u65b0\u6821\u51c6\u5149\u5ea6\u8ba1\uff0c\u68c0\u67e5\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u8f93\u51fa<\/td>\n<\/tr>\n<tr>\n<td>\u8fb9\u6846\u533a\u57df\u9891\u7e41\u6cc4\u6f0f<\/td>\n<td>\u5bc6\u5c01\u80f6\u8001\u5316\u6216\u5b89\u88c5\u4e0d\u5f53<\/td>\n<td>\u66f4\u6362\u5bc6\u5c01\u6750\u6599\uff0c\u6539\u8fdb\u5b89\u88c5\u5de5\u827a<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u5f02\u5e38\u5347\u9ad8<\/td>\n<td>\u79ef\u5c18\u8fc7\u591a\u6216\u524d\u7f6e\u8fc7\u6ee4\u5668\u5931\u6548<\/td>\n<td>\u6e05\u6d17\u6216\u66f4\u6362\u9884\u8fc7\u6ee4\u5668\uff0c\u8003\u8651\u63d0\u524d\u66f4\u6362\u4e3b\u8fc7\u6ee4\u5668<\/td>\n<\/tr>\n<tr>\n<td>\u81ea\u52a8\u626b\u63cf\u7cfb\u7edf\u8bef\u62a5<\/td>\n<td>\u80cc\u666f\u5e72\u6270\u6216\u63a2\u5934\u6c61\u67d3<\/td>\n<td>\u589e\u52a0\u5c4f\u853d\u63aa\u65bd\uff0c\u5b9a\u671f\u6e05\u6d01\u63a2\u5934<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>11. \u6587\u4ef6\u8bb0\u5f55\u4e0e\u5408\u89c4\u6027\u7ba1\u7406<\/h2>\n<p>\u6839\u636eGMP\u8981\u6c42\uff0c\u6bcf\u6b21\u5b8c\u6574\u6027\u68c0\u6d4b\u5747\u9700\u5f62\u6210\u5b8c\u6574\u7684\u9a8c\u8bc1\u6587\u4ef6\u5305\uff0c\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\uff1a<\/p>\n<ul>\n<li>\u68c0\u6d4b\u65b9\u6848\uff08Protocol\uff09<\/li>\n<li>\u4eea\u5668\u6821\u51c6\u8bc1\u4e66<\/li>\n<li>\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u6807\u5b9a\u8bb0\u5f55<\/li>\n<li>\u626b\u63cf\u8def\u5f84\u56fe\u793a<\/li>\n<li>\u539f\u59cb\u6570\u636e\u6253\u5370\u4ef6<\/li>\n<li>\u68c0\u6d4b\u62a5\u544a\uff08\u542b\u7ed3\u8bba\u4e0e\u7b7e\u540d\uff09<\/li>\n<li>\u504f\u5dee\u8bf4\u660e\uff08\u5982\u6709\uff09<\/li>\n<\/ul>\n<p>\u6240\u6709\u6587\u6863\u5e94\u4fdd\u5b58\u81f3\u8fc7\u6ee4\u5668\u751f\u547d\u5468\u671f\u7ed3\u675f\u540e\u81f3\u5c115\u5e74\uff0c\u4f9b\u836f\u76d1\u90e8\u95e8\u5ba1\u8ba1\u67e5\u9a8c\u3002<\/p>\n<hr \/>\n<h2>12. \u6848\u4f8b\u5206\u6790\uff1a\u67d0\u751f\u7269\u5236\u836f\u4f01\u4e1aA\u7ea7\u533a\u8fc7\u6ee4\u5668\u68c0\u6f0f\u5b9e\u8df5<\/h2>\n<p>\u67d0\u56fd\u5185\u77e5\u540d\u5355\u6297\u751f\u4ea7\u4f01\u4e1a\u5728\u5176A\u7ea7\u704c\u88c5\u7ebfFFU\u7cfb\u7edf\u4e2d\u5b89\u88c5\u4e86Camfil Hi-Flo ES ULPA\u8fc7\u6ee4\u5668\uff08610\u00d7610\u00d790\uff09\u3002\u5e74\u5ea6\u4f8b\u884c\u68c0\u6d4b\u4e2d\uff0c\u4f7f\u7528TSI 8130\u5149\u5ea6\u8ba1\u914d\u54088009 PAO\u53d1\u751f\u5668\u8fdb\u884c\u626b\u63cf\u3002<\/p>\n<p>\u68c0\u6d4b\u6761\u4ef6\u5982\u4e0b\uff1a<\/p>\n<ul>\n<li>\u4e0a\u6e38PAO\u6d53\u5ea6\uff1a22 \u03bcg\/L<\/li>\n<li>\u626b\u63cf\u901f\u5ea6\uff1a4 cm\/s<\/li>\n<li>\u63a2\u5934\u8ddd\u79bb\uff1a3 cm<\/li>\n<li>\u91c7\u6837\u5468\u671f\uff1a1\u79d2\/\u70b9<\/li>\n<\/ul>\n<p>\u7ed3\u679c\u53d1\u73b0\u4e00\u5904\u4f4d\u4e8e\u53f3\u4e0a\u89d2\u8fb9\u6846\u7684\u5c40\u90e8\u7a7f\u900f\u7387\u4e3a0.018%\uff0c\u8d85\u51fa0.01%\u9650\u503c\u3002\u7ecf\u6392\u67e5\u4e3a\u8fd0\u8f93\u8fc7\u7a0b\u4e2d\u8f7b\u5fae\u78b0\u649e\u5bfc\u81f4\u5bc6\u5c01\u80f6\u5f00\u88c2\u3002\u4f01\u4e1a\u7acb\u5373\u505c\u673a\u4fee\u8865\u5e76\u590d\u6d4b\uff0c\u5408\u683c\u540e\u6062\u590d\u751f\u4ea7\u3002\u6b64\u6b21\u4e8b\u4ef6\u88ab\u7eb3\u5165\u504f\u5dee\u7ba1\u7406\u7cfb\u7edf\uff0c\u5e76\u89e6\u53d1\u4e86\u8fd0\u8f93\u9632\u62a4SOP\u7684\u4fee\u8ba2\u3002<\/p>\n<hr \/>\n<h2>13. \u603b\u7ed3\u4e0e\u5c55\u671b\uff08\u975e\u7ed3\u8bed\u6027\u8d28\uff09<\/h2>\n<p>\u8d85\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u73b0\u4ee3\u533b\u836fGMP\u6d01\u51c0\u73af\u5883\u7684\u6838\u5fc3\u7ec4\u4ef6\uff0c\u5176\u6027\u80fd\u7a33\u5b9a\u6027\u76f4\u63a5\u5173\u7cfb\u5230\u6700\u7ec8\u4ea7\u54c1\u7684\u65e0\u83cc\u4fdd\u8bc1\u6c34\u5e73\u3002\u5b8c\u6574\u6027\u68c0\u6d4b\u4e0d\u4ec5\u662f\u6cd5\u89c4\u5f3a\u5236\u8981\u6c42\u7684\u6280\u672f\u52a8\u4f5c\uff0c\u66f4\u662f\u4f01\u4e1a\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\u3002<\/p>\n<p>\u968f\u7740\u667a\u80fd\u5236\u9020\u4e0e\u6570\u5b57\u5316\u8f6c\u578b\u7684\u63a8\u8fdb\uff0c\u672a\u6765\u8fc7\u6ee4\u5668\u68c0\u6d4b\u5c06\u671d\u7740\u81ea\u52a8\u5316\u3001\u667a\u80fd\u5316\u3001\u8fdc\u7a0b\u5316\u65b9\u5411\u53d1\u5c55\u3002\u540c\u65f6\uff0c\u65b0\u578b\u73af\u4fdd\u6c14\u6eb6\u80f6\uff08\u5982\u6c34\u57fa\u6c14\u6eb6\u80f6\uff09\u3001\u53ef\u91cd\u590d\u4f7f\u7528\u6ee4\u6750\u3001\u81ea\u4fee\u590d\u6d82\u5c42\u7b49\u524d\u6cbf\u6280\u672f\u7684\u5e94\u7528\uff0c\u4e5f\u5c06\u4e3a\u6d01\u51c0\u6280\u672f\u5e26\u6765\u9769\u547d\u6027\u53d8\u9769\u3002<\/p>\n<p>\u5bf9\u4e8e\u5236\u836f\u4f01\u4e1a\u800c\u8a00\uff0c\u5efa\u7acb\u79d1\u5b66\u7684\u8fc7\u6ee4\u5668\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u4f53\u7cfb\uff0c\u6db5\u76d6\u9009\u578b\u3001\u5b89\u88c5\u3001\u9a8c\u8bc1\u3001\u7ef4\u62a4\u3001\u9000\u5f79\u7b49\u5404\u4e2a\u73af\u8282\uff0c\u662f\u786e\u4fddGMP\u5408\u89c4\u3001\u63d0\u5347\u4ea7\u54c1\u8d28\u91cf\u53ef\u9760\u6027\u7684\u5fc5\u7531\u4e4b\u8def\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u533b\u836fGMP\u8ba4\u8bc1\u73af\u5883\u6784\u5efa\uff1a\u8d85\u9ad8\u6548\u65e0\u9694\u677f\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u68c0\u6d4b\u65b9\u6cd5 1. \u5f15\u8a00 \u5728\u533b\u836f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u6d01\u51c0\u5ba4\uff08Cleanroom\uff09\u662f\u4fdd\u969c\u836f\u54c1\u8d28\u91cf\u3001\u9632\u6b62\u5fae\u751f\u7269\u548c\u5fae\u7c92\u6c61\u67d3\u7684\u5173\u952e\u8bbe\u65bd\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u7684\u8981\u6c42\uff0c\u6d01\u51c0\u533a\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\u9700\u8fbe\u5230ISO 14644-1\u6807\u51c6\u4e2d\u7684\u76f8\u5e94\u7ea7\u522b\uff08\u5982A\u7ea7\u3001B\u7ea7\u3001C\u7ea7\u3001D\u7ea7\uff09\uff0c\u5176\u4e2d\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA, 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