{"id":16770,"date":"2025-09-11T11:25:54","date_gmt":"2025-09-11T03:25:54","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16770"},"modified":"2025-09-11T11:25:54","modified_gmt":"2025-09-11T03:25:54","slug":"%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e5%ae%8c%e6%95%b4%e6%80%a7%e6%b5%8b%e8%af%95%e6%96%b9%e6%b3%95%e5%8f%8a%e5%85%b6%e5%9c%a8gmp%e8%ae%a4%e8%af%81%e4%b8%ad%e7%9a%84%e5%ba%94%e7%94%a8","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16770","title":{"rendered":"\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\u65b9\u6cd5\u53ca\u5176\u5728GMP\u8ba4\u8bc1\u4e2d\u7684\u5e94\u7528"},"content":{"rendered":"<h1>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\u65b9\u6cd5\u53ca\u5176\u5728GMP\u8ba4\u8bc1\u4e2d\u7684\u5e94\u7528<\/h1>\n<h2>1. \u5f15\u8a00<\/h2>\n<p>\u9ad8\u6548\u8fc7\u6ee4\u5668\uff08High Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\u662f\u6d01\u51c0\u5ba4\u7cfb\u7edf\u4e2d\u6838\u5fc3\u7684\u7a7a\u6c14\u5904\u7406\u8bbe\u5907\u4e4b\u4e00\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u3001\u751f\u7269\u6280\u672f\u3001\u533b\u9662\u624b\u672f\u5ba4\u3001\u534a\u5bfc\u4f53\u5236\u9020\u7b49\u5bf9\u7a7a\u6c14\u8d28\u91cf\u8981\u6c42\u6781\u9ad8\u7684\u9886\u57df\u3002\u5176\u4e3b\u8981\u529f\u80fd\u662f\u53bb\u9664\u7a7a\u6c14\u4e2d\u76f4\u5f84\u22650.3\u5fae\u7c73\u7684\u9897\u7c92\u7269\uff0c\u8fc7\u6ee4\u6548\u7387\u901a\u5e38\u4e0d\u4f4e\u4e8e99.97%\u3002\u5728\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u7a7a\u6c14\u6d01\u51c0\u5ea6\u76f4\u63a5\u5173\u7cfb\u5230\u4ea7\u54c1\u7684\u65e0\u83cc\u6027\u548c\u8d28\u91cf\u7a33\u5b9a\u6027\uff0c\u56e0\u6b64\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u53ef\u9760\u6027\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<p>\u4e3a\u786e\u4fdd\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5b9e\u9645\u8fd0\u884c\u4e2d\u6301\u7eed\u6709\u6548\uff0c\u5fc5\u987b\u5b9a\u671f\u8fdb\u884c<strong>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/strong>\uff08Integrity Test\uff09\uff0c\u4ee5\u9a8c\u8bc1\u5176\u662f\u5426\u5b58\u5728\u6cc4\u6f0f\u6216\u7834\u635f\u3002\u8be5\u6d4b\u8bd5\u4e0d\u4ec5\u662f\u8bbe\u5907\u7ef4\u62a4\u7684\u91cd\u8981\u73af\u8282\uff0c\u66f4\u662f\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u8ba4\u8bc1\u4e2d\u7684\u5f3a\u5236\u6027\u8981\u6c42\u3002\u672c\u6587\u5c06\u7cfb\u7edf\u4ecb\u7ecd\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\u7684\u539f\u7406\u3001\u5e38\u7528\u65b9\u6cd5\u3001\u5173\u952e\u53c2\u6570\u3001\u56fd\u5185\u5916\u6807\u51c6\u53ca\u5728GMP\u8ba4\u8bc1\u4e2d\u7684\u5177\u4f53\u5e94\u7528\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u6743\u5a01\u6587\u732e\u548c\u884c\u4e1a\u5b9e\u8df5\u8fdb\u884c\u6df1\u5165\u5206\u6790\u3002<\/p>\n<hr \/>\n<h2>2. \u9ad8\u6548\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>2.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n<p>\u6839\u636e\u7f8e\u56fd\u56fd\u5bb6\u6807\u51c6\u5b66\u4f1a\/\u7f8e\u56fd\u91c7\u6696\u3001\u5236\u51b7\u4e0e\u7a7a\u8c03\u5de5\u7a0b\u5e08\u5b66\u4f1a\uff08ANSI\/ASHRAE\uff09\u6807\u51c652.2-2017\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u662f\u6307\u5bf9\u7c92\u5f840.3\u03bcm\u9897\u7c92\u7269\u7684\u8fc7\u6ee4\u6548\u7387\u8fbe\u523099.97%\u4ee5\u4e0a\u7684\u7a7a\u6c14\u8fc7\u6ee4\u5668\u3002\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7\uff08ISO\uff09\u5728ISO 16890:2016\u4e2d\u4e5f\u5bf9\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u5206\u7ea7\u8fdb\u884c\u4e86\u91cd\u65b0\u5b9a\u4e49\uff0c\u4f46HEPA\u4ecd\u6cbf\u7528\u4f20\u7edf\u5206\u7c7b\u4f53\u7cfb\u3002<\/p>\n<p>\u6309\u7167\u6b27\u6d32\u6807\u51c6EN 1822:2009\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u53ef\u5206\u4e3a\u4ee5\u4e0b\u7b49\u7ea7\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/th>\n<th>\u7c92\u5f84\uff08\u03bcm\uff09<\/th>\n<th>\u6700\u6613\u7a7f\u900f\u7c92\u5f84\u6548\u7387\uff08MPPS\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H10<\/td>\n<td>0.1\u20130.2<\/td>\n<td>\u226585%<\/td>\n<\/tr>\n<tr>\n<td>H11<\/td>\n<td>0.1\u20130.2<\/td>\n<td>\u226595%<\/td>\n<\/tr>\n<tr>\n<td>H12<\/td>\n<td>0.1\u20130.2<\/td>\n<td>\u226599.5%<\/td>\n<\/tr>\n<tr>\n<td>H13<\/td>\n<td>0.1\u20130.2<\/td>\n<td>\u226599.95%<\/td>\n<\/tr>\n<tr>\n<td>H14<\/td>\n<td>0.1\u20130.2<\/td>\n<td>\u226599.995%<\/td>\n<\/tr>\n<tr>\n<td>U15\u2013U17<\/td>\n<td><\/td>\n<td>\u8d85\u9ad8\u6548\uff08ULPA\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5176\u4e2d\uff0cH13\u53ca\u4ee5\u4e0a\u7b49\u7ea7\u5e38\u7528\u4e8eGMP A\/B\u7ea7\u6d01\u51c0\u533a\u3002<\/p>\n<h3>2.2 \u4e3b\u8981\u7ed3\u6784\u4e0e\u6750\u6599<\/h3>\n<p>\u9ad8\u6548\u8fc7\u6ee4\u5668\u901a\u5e38\u7531\u4ee5\u4e0b\u90e8\u5206\u6784\u6210\uff1a<\/p>\n<ul>\n<li><strong>\u6ee4\u6599<\/strong>\uff1a\u591a\u91c7\u7528\u73bb\u7483\u7ea4\u7ef4\u7eb8\uff0c\u5177\u6709\u9ad8\u6bd4\u8868\u9762\u79ef\u548c\u4f4e\u963b\u529b\u7279\u6027\uff1b<\/li>\n<li><strong>\u5206\u9694\u677f<\/strong>\uff1a\u94dd\u7b94\u6216\u7eb8\u5236\uff0c\u7528\u4e8e\u5f62\u6210\u6ce2\u7eb9\u72b6\u901a\u9053\uff0c\u589e\u52a0\u8fc7\u6ee4\u9762\u79ef\uff1b<\/li>\n<li><strong>\u5916\u6846<\/strong>\uff1a\u9540\u950c\u94a2\u677f\u3001\u94dd\u5408\u91d1\u6216\u4e0d\u9508\u94a2\uff0c\u4fdd\u8bc1\u7ed3\u6784\u5f3a\u5ea6\uff1b<\/li>\n<li><strong>\u5bc6\u5c01\u80f6<\/strong>\uff1a\u805a\u6c28\u916f\u6216\u7845\u916e\u80f6\uff0c\u9632\u6b62\u65c1\u8def\u6cc4\u6f0f\uff1b<\/li>\n<li><strong>\u9632\u62a4\u7f51<\/strong>\uff1a\u524d\u540e\u7f6e\u91d1\u5c5e\u7f51\uff0c\u9632\u6b62\u7269\u7406\u635f\u4f24\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>3. \u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\u539f\u7406<\/h2>\n<p>\u5b8c\u6574\u6027\u6d4b\u8bd5\u7684\u6838\u5fc3\u76ee\u6807\u662f\u68c0\u6d4b\u8fc7\u6ee4\u5668\u672c\u4f53\u3001\u8fb9\u6846\u5bc6\u5c01\u53ca\u5b89\u88c5\u63a5\u53e3\u662f\u5426\u5b58\u5728\u6cc4\u6f0f\u70b9\u3002\u6d4b\u8bd5\u57fa\u4e8e\u201c\u6311\u6218\u6c14\u6eb6\u80f6\u201d\u901a\u8fc7\u8fc7\u6ee4\u4ecb\u8d28\u540e\u4e0b\u6e38\u6d53\u5ea6\u7684\u53d8\u5316\u6765\u5224\u65ad\u5176\u5b8c\u6574\u6027\u3002<\/p>\n<p>\u6d4b\u8bd5\u7684\u57fa\u672c\u539f\u7406\u5982\u4e0b\uff1a<\/p>\n<ol>\n<li>\u5728\u4e0a\u6e38\u5f15\u5165\u5df2\u77e5\u6d53\u5ea6\u7684\u5355\u5206\u6563\u6216\u591a\u5206\u6563\u6c14\u6eb6\u80f6\u9897\u7c92\uff08\u5982DOP\u3001PAO\u3001PSL\u7b49\uff09\uff1b<\/li>\n<li>\u4f7f\u7528\u5149\u5ea6\u8ba1\u6216\u7c92\u5b50\u8ba1\u6570\u5668\u6d4b\u91cf\u4e0a\u6e38\u548c\u4e0b\u6e38\u7684\u9897\u7c92\u6d53\u5ea6\uff1b<\/li>\n<li>\u8ba1\u7b97\u7a7f\u900f\u7387\u6216\u6cc4\u6f0f\u7387\uff0c\u5224\u65ad\u662f\u5426\u8d85\u8fc7\u5141\u8bb8\u9608\u503c\u3002<\/li>\n<\/ol>\n<p>\u82e5\u4e0b\u6e38\u68c0\u6d4b\u5230\u663e\u8457\u9ad8\u4e8e\u80cc\u666f\u503c\u7684\u9897\u7c92\u6d53\u5ea6\uff0c\u5219\u8bf4\u660e\u5b58\u5728\u5c40\u90e8\u6cc4\u6f0f\uff0c\u9700\u5b9a\u4f4d\u5e76\u4fee\u590d\u3002<\/p>\n<hr \/>\n<h2>4. \u5e38\u89c1\u5b8c\u6574\u6027\u6d4b\u8bd5\u65b9\u6cd5<\/h2>\n<p>\u76ee\u524d\u56fd\u9645\u4e0a\u5e7f\u6cdb\u91c7\u7528\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\u65b9\u6cd5\u4e3b\u8981\u5305\u62ec<strong>\u5149\u5ea6\u8ba1\u6cd5<\/strong>\u548c<strong>\u7c92\u5b50\u8ba1\u6570\u5668\u6cd5<\/strong>\uff0c\u5206\u522b\u9002\u7528\u4e8e\u4e0d\u540c\u7b49\u7ea7\u7684\u8fc7\u6ee4\u5668\u548c\u5e94\u7528\u573a\u666f\u3002<\/p>\n<h3>4.1 \u5149\u5ea6\u8ba1\u6cd5\uff08Photometer Method\uff09<\/h3>\n<p>\u53c8\u79f0\u6c14\u6eb6\u80f6\u5149\u5ea6\u6cd5\uff0c\u9002\u7528\u4e8eH10-H13\u7ea7\u8fc7\u6ee4\u5668\uff0c\u5c24\u5176\u5e38\u89c1\u4e8e\u5236\u836f\u884c\u4e1a\u7684\u5e38\u89c4\u68c0\u6f0f\u3002<\/p>\n<h4>\u6d4b\u8bd5\u6d41\u7a0b\uff1a<\/h4>\n<ol>\n<li>\u4e0a\u6e38\u53d1\u751f\u6c14\u6eb6\u80f6\uff08\u5e38\u7528PAO\u2014\u805a\u03b1\u70ef\u70c3\uff09\uff1b<\/li>\n<li>\u4f7f\u7528\u5149\u5ea6\u8ba1\u6d4b\u91cf\u4e0a\u6e38\u6d53\u5ea6\uff08\u8bbe\u4e3a100%\u57fa\u51c6\uff09\uff1b<\/li>\n<li>\u4e0b\u6e38\u7528\u5149\u5ea6\u8ba1\u626b\u63cf\u6574\u4e2a\u8fc7\u6ee4\u5668\u8868\u9762\u53ca\u8fb9\u6846\uff1b<\/li>\n<li>\u6cc4\u6f0f\u7387\u8ba1\u7b97\u516c\u5f0f\uff1a<br \/>\n[<br \/>\ntext{\u6cc4\u6f0f\u7387} (%) = frac{C<em>{text{down}}}{C<\/em>{text{up}}} times 100%<br \/>\n]<br \/>\n\u5176\u4e2d ( C<em>{text{down}} ) \u4e3a\u4e0b\u6e38\u6d53\u5ea6\uff0c( C<\/em>{text{up}} ) \u4e3a\u4e0a\u6e38\u6d53\u5ea6\u3002<\/li>\n<\/ol>\n<h4>\u63a5\u53d7\u6807\u51c6\uff1a<\/h4>\n<ul>\n<li>\u5355\u70b9\u6700\u5927\u6cc4\u6f0f\u7387 \u2264 0.01%\uff08\u5373\u7a7f\u900f\u7387\u22640.01%\uff09<\/li>\n<li>\u5e73\u5747\u7a7f\u900f\u7387 \u2264 0.005%<\/li>\n<\/ul>\n<h4>\u4f18\u70b9\u4e0e\u5c40\u9650\uff1a<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u5185\u5bb9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u4f18\u70b9<\/td>\n<td>\u8bbe\u5907\u6210\u672c\u4f4e\u3001\u64cd\u4f5c\u7b80\u4fbf\u3001\u9002\u5408\u5927\u9762\u79ef\u626b\u63cf<\/td>\n<\/tr>\n<tr>\n<td>\u5c40\u9650<\/td>\n<td>\u5206\u8fa8\u7387\u8f83\u4f4e\uff0c\u96be\u4ee5\u68c0\u6d4b\u8d85\u7ec6\u9897\u7c92\u6cc4\u6f0f\uff1b\u4e0d\u9002\u7528\u4e8eULPA\u7ea7\u8fc7\u6ee4\u5668<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u53c2\u8003\u6807\u51c6<\/strong>\uff1a  <\/p>\n<ul>\n<li>ISO 14611-1:2010\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883\u2014\u9ad8\u6548\u548c\u8d85\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6027\u80fd\u6d4b\u8bd5\u300b  <\/li>\n<li>USP \u300a\u6d01\u51c0\u5ba4\u548c\u5176\u4ed6\u53d7\u63a7\u73af\u5883\u7684\u5fae\u751f\u7269\u63a7\u5236\u300b<\/li>\n<\/ul>\n<\/blockquote>\n<hr \/>\n<h3>4.2 \u7c92\u5b50\u8ba1\u6570\u5668\u6cd5\uff08Particle Counter Method\uff09<\/h3>\n<p>\u53c8\u79f0\u8ba1\u6570\u626b\u63cf\u6cd5\uff0c\u4e3b\u8981\u7528\u4e8eH14\u53ca\u4ee5\u4e0a\u7ea7\u522b\u6216ULPA\u8fc7\u6ee4\u5668\uff0c\u7cbe\u5ea6\u66f4\u9ad8\u3002<\/p>\n<h4>\u6d4b\u8bd5\u6d41\u7a0b\uff1a<\/h4>\n<ol>\n<li>\u4e0a\u6e38\u6ce8\u5165PSL\uff08\u805a\u82ef\u4e59\u70ef\u4e73\u80f6\uff09\u5fae\u7403\u6216DOP\u6c14\u6eb6\u80f6\uff1b<\/li>\n<li>\u4f7f\u7528\u51b7\u51dd\u7c92\u5b50\u8ba1\u6570\u5668\uff08CNC\uff09\u6216\u5149\u5b66\u7c92\u5b50\u8ba1\u6570\u5668\u6d4b\u91cf\u4e0a\u4e0b\u6e380.3\u03bcm\u4ee5\u4e0a\u9897\u7c92\u6570\u91cf\uff1b<\/li>\n<li>\u626b\u63cf\u901f\u5ea6\u63a7\u5236\u57285 cm\/s\u4ee5\u5185\uff0c\u63a2\u5934\u8ddd\u8fc7\u6ee4\u5668\u8868\u97621\u20135 cm\uff1b<\/li>\n<li>\u6cc4\u6f0f\u5224\u5b9a\u4f9d\u636eISO 14611-1\u89c4\u5b9a\u7684\u6700\u5927\u5141\u8bb8\u6cc4\u6f0f\u503c\u3002<\/li>\n<\/ol>\n<h4>\u63a5\u53d7\u6807\u51c6\uff08\u4f9d\u636eEN 1822:2009\uff09\uff1a<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/th>\n<th>MPPS\u6548\u7387<\/th>\n<th>\u5141\u8bb8\u6700\u5927\u5c40\u90e8\u7a7f\u900f\u7387<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H13<\/td>\n<td>99.95%<\/td>\n<td>0.25%<\/td>\n<\/tr>\n<tr>\n<td>H14<\/td>\n<td>99.995%<\/td>\n<td>0.025%<\/td>\n<\/tr>\n<tr>\n<td>U15<\/td>\n<td>99.9995%<\/td>\n<td>0.0025%<\/td>\n<\/tr>\n<tr>\n<td>U16<\/td>\n<td>99.99995%<\/td>\n<td>0.00025%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1aMPPS\uff08Most Penetrating Particle Size\uff09\u6307\u6700\u6613\u7a7f\u900f\u7c92\u5f84\uff0c\u901a\u5e38\u57280.1\u20130.3\u03bcm\u4e4b\u95f4\u3002<\/p>\n<\/blockquote>\n<h4>\u4f18\u70b9\u4e0e\u5c40\u9650\uff1a<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u5185\u5bb9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u4f18\u70b9<\/td>\n<td>\u9ad8\u7075\u654f\u5ea6\u3001\u53ef\u5b9a\u91cf\u5206\u6790\u3001\u9002\u7528\u4e8e\u9ad8\u6548\u7387\u8fc7\u6ee4\u5668<\/td>\n<\/tr>\n<tr>\n<td>\u5c40\u9650<\/td>\n<td>\u8bbe\u5907\u6602\u8d35\u3001\u9700\u6821\u51c6\u9891\u7e41\u3001\u64cd\u4f5c\u590d\u6742<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u53c2\u8003\u6807\u51c6<\/strong>\uff1a  <\/p>\n<ul>\n<li>EN 1822:2009\u300aHigh efficiency air filters (HEPA and ULPA)\u300b  <\/li>\n<li>IEST-G-CC001.3\u300aHEPA and ULPA Filter Leak Tests\u300b<\/li>\n<\/ul>\n<\/blockquote>\n<hr \/>\n<h3>4.3 \u5176\u4ed6\u8f85\u52a9\u68c0\u6d4b\u65b9\u6cd5<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u65b9\u6cd5<\/th>\n<th>\u539f\u7406<\/th>\n<th>\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u793a\u8e2a\u6c14\u4f53\u6cd5\uff08SF\u2086\uff09<\/td>\n<td>\u5229\u7528\u516d\u6c1f\u5316\u786b\u4f5c\u4e3a\u793a\u8e2a\u6c14\u4f53\uff0c\u8d28\u8c31\u4eea\u68c0\u6d4b<\/td>\n<td>\u5927\u578b\u901a\u98ce\u7cfb\u7edf\u3001\u96be\u4ee5\u63a5\u8fd1\u533a\u57df<\/td>\n<\/tr>\n<tr>\n<td>\u8367\u5149\u7d20\u94a0\u6cd5<\/td>\n<td>\u6c14\u6eb6\u80f6\u542b\u8367\u5149\u67d3\u6599\uff0c\u7d2b\u5916\u706f\u4e0b\u89c2\u5bdf\u6cc4\u6f0f\u70b9<\/td>\n<td>\u6559\u5b66\u6f14\u793a\u3001\u521d\u6b65\u7b5b\u67e5<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u964d\u76d1\u6d4b\u6cd5<\/td>\n<td>\u76d1\u6d4b\u8fc7\u6ee4\u5668\u524d\u540e\u538b\u5dee\u53d8\u5316\u8d8b\u52bf<\/td>\n<td>\u65e5\u5e38\u76d1\u63a7\uff0c\u975e\u66ff\u4ee3\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>5. \u6d4b\u8bd5\u8bbe\u5907\u4e0e\u5173\u952e\u53c2\u6570<\/h2>\n<h3>5.1 \u4e3b\u8981\u6d4b\u8bd5\u4eea\u5668\u53c2\u6570\u5bf9\u6bd4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u8bbe\u5907\u7c7b\u578b<\/th>\n<th>\u578b\u53f7\u793a\u4f8b<\/th>\n<th>\u68c0\u6d4b\u7c92\u5f84\u8303\u56f4<\/th>\n<th>\u6d53\u5ea6\u6d4b\u91cf\u8303\u56f4<\/th>\n<th>\u6570\u636e\u8f93\u51fa\u65b9\u5f0f<\/th>\n<th>\u6821\u51c6\u5468\u671f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5149\u5ea6\u8ba1<\/td>\n<td>TSI 3151<\/td>\n<td>0.1\u20135 \u03bcm<\/td>\n<td>0.0001\u2013100 \u03bcg\/L<\/td>\n<td>\u6a21\u62df\/\u6570\u5b57\u663e\u793a<\/td>\n<td>\u6bcf\u5e74\u4e00\u6b21<\/td>\n<\/tr>\n<tr>\n<td>\u51b7\u51dd\u7c92\u5b50\u8ba1\u6570\u5668<\/td>\n<td>TSI 3788<\/td>\n<td>0.007\u20133 \u03bcm<\/td>\n<td>0\u20131\u00d710\u2077 particles\/cm\u00b3<\/td>\n<td>USB\/RS232<\/td>\n<td>\u6bcf6\u4e2a\u6708<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u6eb6\u80f6\u53d1\u751f\u5668<\/td>\n<td>TSI 8120\uff08PAO\uff09<\/td>\n<td>0.3 \u03bcm\uff08MMD\uff09<\/td>\n<td>10\u2013100 \u03bcg\/L\u53ef\u8c03<\/td>\n<td>\u6052\u6d41\u8f93\u51fa<\/td>\n<td>\u6bcf\u5e74<\/td>\n<\/tr>\n<tr>\n<td>\u6c26\u8d28\u8c31\u68c0\u6f0f\u4eea<\/td>\n<td>INFICON ASM 340<\/td>\n<td>He\u5206\u5b50\u7ea7<\/td>\n<td>1\u00d710\u207b\u00b9\u00b2 mbar\u00b7L\/s<\/td>\n<td>\u5b9e\u65f6\u62a5\u8b66<\/td>\n<td>\u6bcf\u5b63\u5ea6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6765\u6e90\uff1aTSI Incorporated \u6280\u672f\u624b\u518c\uff082022\uff09<\/p>\n<\/blockquote>\n<h3>5.2 \u5173\u952e\u64cd\u4f5c\u53c2\u6570\u63a7\u5236<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u63a8\u8350\u503c<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u626b\u63cf\u901f\u5ea6<\/td>\n<td>\u22645 cm\/s<\/td>\n<td>\u9632\u6b62\u6f0f\u68c0<\/td>\n<\/tr>\n<tr>\n<td>\u63a2\u5934\u8ddd\u79bb<\/td>\n<td>1\u20135 cm<\/td>\n<td>\u907f\u514d\u6270\u52a8\u6c14\u6d41<\/td>\n<\/tr>\n<tr>\n<td>\u4e0a\u6e38\u6d53\u5ea6<\/td>\n<td>10\u201320 \u03bcg\/L\uff08PAO\uff09<\/td>\n<td>\u4fdd\u8bc1\u4fe1\u566a\u6bd4<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u6d41\u901f\u5ea6<\/td>\n<td>\u22650.3 m\/s<\/td>\n<td>\u786e\u4fdd\u5747\u5300\u5206\u5e03<\/td>\n<\/tr>\n<tr>\n<td>\u6e29\u6e7f\u5ea6<\/td>\n<td>20\u00b15\u00b0C, RH 30\u201370%<\/td>\n<td>\u51cf\u5c11\u5e72\u6270<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>6. \u56fd\u5185\u5916\u6cd5\u89c4\u4e0e\u6807\u51c6\u8981\u6c42<\/h2>\n<h3>6.1 \u4e2d\u56fdGMP\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u76f8\u5173\u89c4\u5b9a<\/h3>\n<p>\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\u7b2c44\u6761\u660e\u786e\u6307\u51fa\uff1a<\/p>\n<blockquote>\n<p>\u201c\u5e94\u5f53\u5b9a\u671f\u5bf9\u6d01\u51c0\u533a\u7684\u60ac\u6d6e\u7c92\u5b50\u548c\u5fae\u751f\u7269\u8fdb\u884c\u52a8\u6001\u76d1\u6d4b\uff0c\u5fc5\u8981\u65f6\u8fdb\u884c\u8868\u9762\u5fae\u751f\u7269\u76d1\u6d4b\u3002\u6d01\u51c0\u533a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u5e94\u7ecf\u8fc7\u786e\u8ba4\uff0c\u5e76\u5b9a\u671f\u8fdb\u884c\u518d\u786e\u8ba4\u3002\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e94\u5f53\u5b9a\u671f\u8fdb\u884c\u68c0\u6f0f\u8bd5\u9a8c\u3002\u201d<\/p>\n<\/blockquote>\n<p>\u6b64\u5916\uff0c\u300a\u533b\u836f\u5de5\u4e1a\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u6807\u51c6\u300b\uff08GB 50457-2019\uff09\u7b2c9.4.3\u6761\u89c4\u5b9a\uff1a<\/p>\n<blockquote>\n<p>\u201c\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5b89\u88c5\u540e\u5e94\u8fdb\u884c\u73b0\u573a\u68c0\u6f0f\uff0c\u68c0\u6f0f\u65b9\u6cd5\u53ef\u91c7\u7528\u626b\u63cf\u6cd5\uff0c\u68c0\u6f0f\u5408\u683c\u6807\u51c6\u5e94\u7b26\u5408\u73b0\u884c\u56fd\u5bb6\u6807\u51c6\u6216\u884c\u4e1a\u6807\u51c6\u7684\u8981\u6c42\u3002\u201d<\/p>\n<\/blockquote>\n<h3>6.2 \u7f8e\u56fdFDA\u4e0ecGMP\u8981\u6c42<\/h3>\n<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5728\u5176\u300aSterile Drug Products Produced by Aseptic Processing \u2014 Current Good Manufacturing Practice\u300b\u6307\u5357\u4e2d\u5f3a\u8c03\uff1a<\/p>\n<blockquote>\n<p>\u201cHEPA filters must be tested for integrity after installation and periodically thereafter (e.g., annually). The test should demonstrate that the filter meets its specified efficiency and is free of leaks.\u201d<\/p>\n<\/blockquote>\n<p>\u5373\uff1a\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u5b89\u88c5\u540e\u53ca\u5468\u671f\u6027\u4f7f\u7528\u4e2d\u5fc5\u987b\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff0c\u786e\u4fdd\u5176\u6548\u7387\u8fbe\u6807\u4e14\u65e0\u6cc4\u6f0f\u3002<\/p>\n<h3>6.3 \u6b27\u76dfGMP Annex 1\uff082022\u5e74\u66f4\u65b0\uff09<\/h3>\n<p>\u65b0\u7248\u6b27\u76dfGMP\u9644\u5f551\u300aManufacture of Sterile Medicinal Products\u300b\u7b2c8.10\u6761\u6307\u51fa\uff1a<\/p>\n<blockquote>\n<p>\u201cHEPA filters should be integrity tested at time of installation and thereafter at defined intervals. Testing frequency should be based on risk assessment but typically annually. Any replacement or maintenance work affecting the filter system should trigger re-testing.\u201d<\/p>\n<\/blockquote>\n<p>\u540c\u65f6\u89c4\u5b9aA\u7ea7\u533a\u4f7f\u7528\u7684\u8fc7\u6ee4\u5668\u5fc5\u987b\u6ee1\u8db3H14\u7ea7\u6216\u66f4\u9ad8\u6807\u51c6\uff0c\u5e76\u91c7\u7528\u7c92\u5b50\u8ba1\u6570\u6cd5\u8fdb\u884c\u9a8c\u8bc1\u3002<\/p>\n<hr \/>\n<h2>7. \u5b8c\u6574\u6027\u6d4b\u8bd5\u5728GMP\u8ba4\u8bc1\u4e2d\u7684\u5b9e\u9645\u5e94\u7528<\/h2>\n<h3>7.1 \u6d4b\u8bd5\u65f6\u673a\u4e0e\u9891\u7387<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9636\u6bb5<\/th>\n<th>\u6d4b\u8bd5\u8981\u6c42<\/th>\n<th>\u4f9d\u636e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u65b0\u5efa\/\u6539\u9020\u5b8c\u6210\u540e<\/td>\n<td>\u5b89\u88c5\u540e\u9996\u6b21\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n<td>GB 50457-2019<\/td>\n<\/tr>\n<tr>\n<td>\u6b63\u5e38\u8fd0\u884c\u671f\u95f4<\/td>\n<td>\u6bcf\u5e74\u81f3\u5c11\u4e00\u6b21<\/td>\n<td>ISPE Baseline Guide Vol.3<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u5668\u66f4\u6362\u540e<\/td>\n<td>\u5fc5\u987b\u91cd\u65b0\u6d4b\u8bd5<\/td>\n<td>EU GMP Annex 1<\/td>\n<\/tr>\n<tr>\n<td>\u53d1\u751f\u91cd\u5927\u7ef4\u4fee\u6216\u9707\u52a8\u540e<\/td>\n<td>\u89e6\u53d1\u5f0f\u518d\u6d4b\u8bd5<\/td>\n<td>FDA Guidance<\/td>\n<\/tr>\n<tr>\n<td>A\/B\u7ea7\u533a\u57df<\/td>\n<td>\u5efa\u8bae\u6bcf6\u4e2a\u6708\u4e00\u6b21<\/td>\n<td>\u4f01\u4e1aSOP\uff08\u57fa\u4e8e\u98ce\u9669\u8bc4\u4f30\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>7.2 \u5178\u578b\u5e94\u7528\u573a\u666f\u6848\u4f8b<\/h3>\n<h4>\u6848\u4f8b\u4e00\uff1a\u67d0\u751f\u7269\u5236\u836f\u4f01\u4e1aA\u7ea7\u5c42\u6d41\u7f69\u68c0\u6f0f<\/h4>\n<ul>\n<li><strong>\u8bbe\u5907<\/strong>\uff1aBSC II\u7ea7\u751f\u7269\u5b89\u5168\u67dc\uff08\u914d\u5907H14\u8fc7\u6ee4\u5668\uff09<\/li>\n<li><strong>\u65b9\u6cd5<\/strong>\uff1aPAO\u5149\u5ea6\u8ba1\u6cd5<\/li>\n<li><strong>\u7ed3\u679c<\/strong>\uff1a\u521d\u59cb\u6d4b\u8bd5\u53d1\u73b0\u8fb9\u6846\u4e00\u5904\u6cc4\u6f0f\u7387\u8fbe0.08%\uff0c\u7ecf\u91cd\u65b0\u7d27\u56fa\u5bc6\u5c01\u540e\u590d\u6d4b\u4e3a0.003%\uff0c\u7b26\u5408\u6807\u51c6\u3002<\/li>\n<li><strong>\u5f71\u54cd<\/strong>\uff1a\u907f\u514d\u6f5c\u5728\u6c61\u67d3\u98ce\u9669\uff0c\u4fdd\u969c\u7ec6\u80de\u57f9\u517b\u73af\u5883\u65e0\u83cc\u3002<\/li>\n<\/ul>\n<h4>\u6848\u4f8b\u4e8c\uff1a\u51bb\u5e72\u8f66\u95f4HVAC\u7cfb\u7edf\u5e74\u5ea6\u9a8c\u8bc1<\/h4>\n<ul>\n<li><strong>\u8303\u56f4<\/strong>\uff1a\u5168\u8f66\u95f428\u53f0\u9ad8\u6548\u9001\u98ce\u53e3<\/li>\n<li><strong>\u65b9\u6cd5<\/strong>\uff1a\u7c92\u5b50\u8ba1\u6570\u5668\u6cd5\uff08TSI 3788\uff09<\/li>\n<li><strong>\u6570\u636e\u8bb0\u5f55<\/strong>\uff1a\u6240\u6709\u70b9\u4f4d\u7a7f\u900f\u7387&lt;0.01%\uff0c\u5e73\u57470.004%<\/li>\n<li><strong>\u7ed3\u8bba<\/strong>\uff1a\u7cfb\u7edf\u5b8c\u6574\u6027\u826f\u597d\uff0c\u901a\u8fc7GMP\u5ba1\u8ba1\u3002<\/li>\n<\/ul>\n<hr \/>\n<h3>7.3 \u6570\u636e\u8bb0\u5f55\u4e0e\u6587\u4ef6\u7ba1\u7406\u8981\u6c42<\/h3>\n<p>GMP\u8981\u6c42\u6240\u6709\u6d4b\u8bd5\u6d3b\u52a8\u5fc5\u987b\u5f62\u6210\u5b8c\u6574\u7684\u4e66\u9762\u8bb0\u5f55\uff0c\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\uff1a<\/p>\n<ul>\n<li>\u6d4b\u8bd5\u65e5\u671f\u3001\u5730\u70b9\u3001\u4eba\u5458\uff1b<\/li>\n<li>\u4f7f\u7528\u4eea\u5668\u578b\u53f7\u53ca\u6821\u51c6\u72b6\u6001\uff1b<\/li>\n<li>\u6c14\u6eb6\u80f6\u7c7b\u578b\u4e0e\u6d53\u5ea6\uff1b<\/li>\n<li>\u626b\u63cf\u8def\u5f84\u56fe\uff08\u5efa\u8bae\u9644\u5e73\u9762\u56fe\u6807\u6ce8\uff09\uff1b<\/li>\n<li>\u5404\u6d4b\u70b9\u6570\u636e\u8868\u683c\uff1b<\/li>\n<li>\u5f02\u5e38\u5904\u7406\u63aa\u65bd\u4e0e\u590d\u6d4b\u7ed3\u679c\uff1b<\/li>\n<li>\u6700\u7ec8\u7ed3\u8bba\u4e0e\u7b7e\u5b57\u786e\u8ba4\u3002<\/li>\n<\/ul>\n<p>\u6b64\u7c7b\u6587\u4ef6\u9700\u4fdd\u5b58\u81f3\u8bbe\u5907\u9000\u5f79\u540e\u81f3\u5c115\u5e74\uff0c\u4f9b\u76d1\u7ba1\u673a\u6784\u5ba1\u67e5\u3002<\/p>\n<hr \/>\n<h2>8. \u5e38\u89c1\u95ee\u9898\u4e0e\u5bf9\u7b56<\/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\u6d53\u5ea6\u5f02\u5e38\u5347\u9ad8<\/td>\n<td>\u5bc6\u5c01\u80f6\u8001\u5316\u3001\u6846\u67b6\u53d8\u5f62<\/td>\n<td>\u66f4\u6362\u5bc6\u5c01\u6750\u6599\uff0c\u8c03\u6574\u5b89\u88c5\u7ed3\u6784<\/td>\n<\/tr>\n<tr>\n<td>\u4e0a\u6e38\u6d53\u5ea6\u4e0d\u7a33\u5b9a<\/td>\n<td>\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\u6545\u969c<\/td>\n<td>\u6e05\u6d01\u55b7\u5634\uff0c\u68c0\u67e5\u6cb9\u91cf\u4e0e\u538b\u7f29\u7a7a\u6c14\u538b\u529b<\/td>\n<\/tr>\n<tr>\n<td>\u626b\u63cf\u6570\u636e\u6ce2\u52a8\u5927<\/td>\n<td>\u63a2\u5934\u79fb\u52a8\u8fc7\u5feb\u6216\u8ddd\u79bb\u4e0d\u5f53<\/td>\n<td>\u89c4\u8303\u64cd\u4f5c\u6d41\u7a0b\uff0c\u52a0\u5f3a\u57f9\u8bad<\/td>\n<\/tr>\n<tr>\n<td>\u591a\u6b21\u590d\u6d4b\u4ecd\u4e0d\u5408\u683c<\/td>\n<td>\u6ee4\u7eb8\u7834\u635f\u6216\u8936\u76b1\u65ad\u88c2<\/td>\n<td>\u66f4\u6362\u8fc7\u6ee4\u5668\uff0c\u8ffd\u6eaf\u91c7\u8d2d\u8d28\u91cf<\/td>\n<\/tr>\n<tr>\n<td>\u73af\u5883\u80cc\u666f\u503c\u9ad8<\/td>\n<td>\u6d4b\u8bd5\u524d\u672a\u5145\u5206\u81ea\u51c0<\/td>\n<td>\u5ef6\u957f\u81ea\u51c0\u65f6\u95f4\u81f3\u226520\u5206\u949f<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>9. \u6280\u672f\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<p>\u968f\u7740\u667a\u80fd\u5236\u9020\u548c\u6570\u5b57\u5316\u8f6c\u578b\u63a8\u8fdb\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\u6b63\u671d\u7740\u81ea\u52a8\u5316\u3001\u667a\u80fd\u5316\u65b9\u5411\u53d1\u5c55\uff1a<\/p>\n<ol>\n<li><strong>\u81ea\u52a8\u626b\u63cf\u673a\u5668\u4eba<\/strong>\uff1a\u642d\u8f7d\u6fc0\u5149\u5bfc\u822a\u4e0e\u7c92\u5b50\u4f20\u611f\u5668\u7684\u673a\u5668\u4eba\u53ef\u5b9e\u73b0\u65e0\u4eba\u503c\u5b88\u5de1\u68c0\uff0c\u63d0\u9ad8\u6548\u7387\u4e0e\u4e00\u81f4\u6027\uff08\u5982Camfil SmartScan\u7cfb\u7edf\uff09\uff1b<\/li>\n<li><strong>\u8fdc\u7a0b\u76d1\u63a7\u5e73\u53f0<\/strong>\uff1a\u901a\u8fc7\u7269\u8054\u7f51\uff08IoT\uff09\u8fde\u63a5\u4f20\u611f\u5668\uff0c\u5b9e\u65f6\u4e0a\u4f20\u538b\u5dee\u3001\u6e29\u6e7f\u5ea6\u4e0e\u5386\u53f2\u6d4b\u8bd5\u6570\u636e\uff1b<\/li>\n<li><strong>AI\u6570\u636e\u5206\u6790<\/strong>\uff1a\u5229\u7528\u673a\u5668\u5b66\u4e60\u6a21\u578b\u9884\u6d4b\u8fc7\u6ee4\u5668\u5bff\u547d\u4e0e\u6cc4\u6f0f\u98ce\u9669\uff1b<\/li>\n<li><strong>\u7eff\u8272\u6c14\u6eb6\u80f6\u66ff\u4ee3<\/strong>\uff1a\u7814\u53d1\u4f4e\u6bd2\u3001\u53ef\u964d\u89e3\u7684\u66ff\u4ee3\u7269\uff08\u5982\u7518\u6cb9\u96fe\uff09\u4ee5\u51cf\u5c11PAO\u7684\u73af\u5883\u5f71\u54cd\u3002<\/li>\n<\/ol>\n<p>\u636eMcKinsey &amp; Company\uff082023\uff09\u62a5\u544a\u9884\u6d4b\uff0c\u52302027\u5e74\u5168\u7403\u7ea640%\u7684\u5236\u836f\u4f01\u4e1a\u5c06\u90e8\u7f72\u667a\u80fd\u6d01\u51c0\u5ba4\u76d1\u63a7\u7cfb\u7edf\uff0c\u5176\u4e2d\u5b8c\u6574\u6027\u6d4b\u8bd5\u81ea\u52a8\u5316\u8986\u76d6\u7387\u6709\u671b\u8fbe60%\u4ee5\u4e0a\u3002<\/p>\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\u300b\uff082010\u5e74\u4fee\u8ba2\uff09[Z]. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2011.  <\/li>\n<li>\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u4f4f\u623f\u548c\u57ce\u4e61\u5efa\u8bbe\u90e8. \u300a\u533b\u836f\u5de5\u4e1a\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u6807\u51c6\u300b\uff08GB 50457-2019\uff09[S]. \u5317\u4eac: \u4e2d\u56fd\u8ba1\u5212\u51fa\u7248\u793e, 2019.  <\/li>\n<li>European Commission. EudraLex &#8211; Volume 4: Good Manufacturing Practice (GMP) guidelines, Annex 1: Manufacture of Sterile Medicinal Products (2022 update) [EB\/OL]. <a href=\"https:\/\/ec.europa.eu\/health\/documents\/eudralex\/vol-4\">https:\/\/ec.europa.eu\/health\/documents\/eudralex\/vol-4<\/a>, 2022.  <\/li>\n<li>U.S. Food and Drug Administration. <em>Sterile Drug Products Produced by Aseptic Processing \u2014 cGMP Guidance<\/em> [R]. Rockville: FDA, 2004 (revised 2022).  <\/li>\n<li>International Organization for Standardization. <em>ISO 14611-1:2010 Cleanrooms and associated controlled environments \u2014 Test methods for evaluating performance of high-efficiency and ultra-low penetration air filters (EPA, HEPA and ULPA)<\/em> [S]. Geneva: ISO, 2010.  <\/li>\n<li>DIN CEN\/EN 1822:2009. <em>High efficiency air filters (HEPA and ULPA)<\/em> [S]. Berlin: Beuth Verlag, 2009.  <\/li>\n<li>Institute of Environmental Sciences and Technology (IEST). <em>IEST-G-CC001.3 Recommended Practice: HEPA and ULPA Filter Leak Tests<\/em> [R]. Mount Prospect: IEST, 2020.  <\/li>\n<li>TSI Incorporated. <em>Model 3151 Photometer Operating Manual<\/em> [Z]. Shoreview: TSI, 2022.  <\/li>\n<li>Camfil. <em>SmartScan Automated Filter Integrity Testing System<\/em> [EB\/OL]. <a href=\"https:\/\/www.camfil.com\">https:\/\/www.camfil.com<\/a>, 2023.  <\/li>\n<li>\u767e\u5ea6\u767e\u79d1. \u9ad8\u6548\u8fc7\u6ee4\u5668 [EB\/OL]. <a href=\"https:\/\/baike.baidu.com\/item\/\u9ad8\u6548\u8fc7\u6ee4\u5668\">https:\/\/baike.baidu.com\/item\/\u9ad8\u6548\u8fc7\u6ee4\u5668<\/a>, 2023\u5e7410\u6708\u66f4\u65b0.  <\/li>\n<li>\u90ed\u6653\u78ca, \u738b\u4f1f. \u6d01\u51c0\u5ba4\u9ad8\u6548\u8fc7\u6ee4\u5668\u68c0\u6f0f\u6280\u672f\u6bd4\u8f83\u7814\u7a76[J]. \u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f, 2020(3): 45-49.  <\/li>\n<li>McKinsey &amp; Company. <em>Digital Transformation in Pharma Manufacturing<\/em> [R]. New York: McKinsey, 2023.  <\/li>\n<\/ol>\n<hr \/>\n<p>\uff08\u5168\u6587\u7ea63,800\u5b57\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\u65b9\u6cd5\u53ca\u5176\u5728GMP\u8ba4\u8bc1\u4e2d\u7684\u5e94\u7528 1. \u5f15\u8a00 \u9ad8\u6548\u8fc7\u6ee4\u5668\uff08High Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\u662f\u6d01\u51c0\u5ba4\u7cfb\u7edf\u4e2d\u6838\u5fc3\u7684\u7a7a\u6c14\u5904\u7406\u8bbe\u5907\u4e4b\u4e00\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u3001\u751f\u7269\u6280\u672f\u3001\u533b\u9662\u624b\u672f\u5ba4\u3001\u534a\u5bfc\u4f53\u5236\u9020\u7b49\u5bf9\u7a7a\u6c14\u8d28\u91cf\u8981\u6c42\u6781\u9ad8\u7684\u9886\u57df\u3002\u5176\u4e3b\u8981\u529f\u80fd\u662f\u53bb\u9664\u7a7a\u6c14\u4e2d\u76f4\u5f84\u22650.3\u5fae\u7c73\u7684\u9897\u7c92\u7269\uff0c\u8fc7\u6ee4\u6548\u7387\u901a\u5e38\u4e0d\u4f4e\u4e8e99.97%\u3002&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-16770","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\/16770","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=16770"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/16770\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16770"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16770"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16770"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}