{"id":16670,"date":"2025-08-22T18:26:29","date_gmt":"2025-08-22T10:26:29","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16670"},"modified":"2025-08-22T18:26:29","modified_gmt":"2025-08-22T10:26:29","slug":"v%e5%9e%8b%e5%af%86%e8%a4%b6%e5%bc%8f%e5%8c%96%e5%ad%a6%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e5%88%b6%e8%8d%af%e5%8e%82%e6%88%bfgmp%e7%8e%af%e5%a2%83%e4%b8%ad%e7%9a%84%e5%90%88%e8%a7%84%e6%80%a7","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16670","title":{"rendered":"V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u5382\u623fGMP\u73af\u5883\u4e2d\u7684\u5408\u89c4\u6027\u4e0e\u9a8c\u8bc1\u8981\u6c42"},"content":{"rendered":"<h1>V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u5382\u623fGMP\u73af\u5883\u4e2d\u7684\u5408\u89c4\u6027\u4e0e\u9a8c\u8bc1\u8981\u6c42<\/h1>\n<hr \/>\n<h2>\u76ee\u5f55<\/h2>\n<ol>\n<li><a href=\"#\u6982\u8ff0\">\u6982\u8ff0<\/a>  <\/li>\n<li><a href=\"#v\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u7684\u5b9a\u4e49\u4e0e\u7ed3\u6784\">V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u7684\u5b9a\u4e49\u4e0e\u7ed3\u6784<\/a>  <\/li>\n<li><a href=\"#\u4ea7\u54c1\u53c2\u6570\u4e0e\u6280\u672f\u6307\u6807\">\u4ea7\u54c1\u53c2\u6570\u4e0e\u6280\u672f\u6307\u6807<\/a>  <\/li>\n<li><a href=\"#\u5728gmp\u73af\u5883\u4e2d\u7684\u5e94\u7528\u80cc\u666f\">\u5728GMP\u73af\u5883\u4e2d\u7684\u5e94\u7528\u80cc\u666f<\/a>  <\/li>\n<li><a href=\"#\u5408\u89c4\u6027\u8981\u6c42\">\u5408\u89c4\u6027\u8981\u6c42<\/a>  <\/li>\n<li><a href=\"#\u9a8c\u8bc1\u8981\u6c42\u4e0e\u6d41\u7a0b\">\u9a8c\u8bc1\u8981\u6c42\u4e0e\u6d41\u7a0b<\/a>  <\/li>\n<li><a href=\"#\u56fd\u5185\u5916\u76f8\u5173\u6807\u51c6\u4e0e\u6cd5\u89c4\">\u56fd\u5185\u5916\u76f8\u5173\u6807\u51c6\u4e0e\u6cd5\u89c4<\/a>  <\/li>\n<li><a href=\"#\u5b89\u88c5\u4e0e\u7ef4\u62a4\u6ce8\u610f\u4e8b\u9879\">\u5b89\u88c5\u4e0e\u7ef4\u62a4\u6ce8\u610f\u4e8b\u9879<\/a>  <\/li>\n<li><a href=\"#\u6848\u4f8b\u5206\u6790\">\u6848\u4f8b\u5206\u6790<\/a>  <\/li>\n<li><a href=\"#\u53c2\u8003\u6587\u732e\">\u53c2\u8003\u6587\u732e<\/a><\/li>\n<\/ol>\n<hr \/>\n<h2>\u6982\u8ff0<\/h2>\n<p>\u5728\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u6d01\u51c0\u73af\u5883\u7684\u63a7\u5236\u662f\u4fdd\u969c\u836f\u54c1\u8d28\u91cf\u4e0e\u60a3\u8005\u5b89\u5168\u7684\u6838\u5fc3\u8981\u7d20\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u7684\u8981\u6c42\uff0c\u5236\u836f\u5382\u623f\u5fc5\u987b\u7ef4\u6301\u7279\u5b9a\u7684\u6d01\u51c0\u7ea7\u522b\uff0c\u9632\u6b62\u5fae\u7c92\u3001\u5fae\u751f\u7269\u4ee5\u53ca\u6709\u5bb3\u5316\u5b66\u6c14\u4f53\u5bf9\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u9020\u6210\u6c61\u67d3\u3002\u5176\u4e2d\uff0c\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u4e2d\u7684\u5316\u5b66\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u53bb\u9664\u6709\u5bb3\u6c14\u4f53\u6c61\u67d3\u7269\u7684\u5173\u952e\u8bbe\u5907\uff0c\u5176\u6027\u80fd\u4e0e\u5408\u89c4\u6027\u76f4\u63a5\u5f71\u54cdGMP\u4f53\u7cfb\u7684\u6709\u6548\u8fd0\u884c\u3002<\/p>\n<p>V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\uff08V-Bank Chemical Filter\uff09\u56e0\u5176\u9ad8\u5bb9\u5c18\u91cf\u3001\u4f4e\u98ce\u963b\u3001\u9ad8\u6548\u7387\u53ca\u957f\u5bff\u547d\u7b49\u7279\u70b9\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u5382\u623f\u7684\u901a\u98ce\u4e0e\u7a7a\u8c03\u7cfb\u7edf\uff08HVAC\uff09\u4e2d\uff0c\u7279\u522b\u662f\u5728\u5904\u7406\u9178\u6027\u3001\u78b1\u6027\u6216\u6709\u673a\u6325\u53d1\u6027\u6c14\u4f53\uff08VOCs\uff09\u7b49\u5316\u5b66\u6c61\u67d3\u7269\u65b9\u9762\u5177\u6709\u663e\u8457\u4f18\u52bf\u3002\u672c\u6587\u5c06\u7cfb\u7edf\u9610\u8ff0V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u5728\u5236\u836fGMP\u73af\u5883\u4e2d\u7684\u5408\u89c4\u6027\u8981\u6c42\u3001\u9a8c\u8bc1\u6d41\u7a0b\u3001\u6280\u672f\u53c2\u6570\u53ca\u76f8\u5173\u6807\u51c6\uff0c\u7ed3\u5408\u56fd\u5185\u5916\u6743\u5a01\u6587\u732e\u4e0e\u884c\u4e1a\u5b9e\u8df5\uff0c\u4e3a\u5236\u836f\u4f01\u4e1a\u8bbe\u5907\u9009\u578b\u4e0e\u5408\u89c4\u7ba1\u7406\u63d0\u4f9b\u7406\u8bba\u652f\u6301\u3002<\/p>\n<hr \/>\n<h2>V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u7684\u5b9a\u4e49\u4e0e\u7ed3\u6784<\/h2>\n<p>V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u91c7\u7528V\u578b\u6392\u5217\u7684\u591a\u8936\u7ed3\u6784\u5316\u5b66\u5438\u9644\u8fc7\u6ee4\u88c5\u7f6e\uff0c\u901a\u5e38\u7531\u91d1\u5c5e\u6846\u67b6\u3001\u6d3b\u6027\u70ad\u57fa\u5438\u9644\u6750\u6599\u3001\u652f\u6491\u7f51\u53ca\u5bc6\u5c01\u80f6\u6761\u7ec4\u6210\u3002\u5176\u201cV\u201d\u578b\u8bbe\u8ba1\u663e\u8457\u589e\u52a0\u4e86\u5355\u4f4d\u4f53\u79ef\u5185\u7684\u8fc7\u6ee4\u9762\u79ef\uff0c\u4ece\u800c\u63d0\u5347\u5438\u9644\u6548\u7387\u5e76\u5ef6\u957f\u4f7f\u7528\u5bff\u547d\u3002<\/p>\n<h3>\u7ed3\u6784\u7ec4\u6210<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u7ec4\u6210\u90e8\u5206<\/th>\n<th>\u529f\u80fd\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5916\u6846<\/td>\n<td>\u901a\u5e38\u91c7\u7528\u9540\u950c\u94a2\u677f\u6216\u4e0d\u9508\u94a2\uff0c\u786e\u4fdd\u7ed3\u6784\u5f3a\u5ea6\u4e0e\u8010\u8150\u8680\u6027<\/td>\n<\/tr>\n<tr>\n<td>\u6ee4\u6599<\/td>\n<td>\u4ee5\u9897\u7c92\u72b6\u6216\u7ea4\u7ef4\u72b6\u6d3b\u6027\u70ad\u4e3a\u4e3b\uff0c\u53ef\u8d1f\u8f7d\u5316\u5b66\u6d78\u6e0d\u5242\uff08\u5982KOH\u3001\u7898\u5316\u94be\u7b49\uff09\u4ee5\u589e\u5f3a\u5bf9\u7279\u5b9a\u6c14\u4f53\u7684\u5438\u9644\u80fd\u529b<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u6750\u6599<\/td>\n<td>\u805a\u6c28\u916f\u53d1\u6ce1\u80f6\u6216\u6a61\u80f6\u6761\uff0c\u786e\u4fdd\u5b89\u88c5\u540e\u6c14\u5bc6\u6027<\/td>\n<\/tr>\n<tr>\n<td>\u652f\u6491\u7f51<\/td>\n<td>\u4e0d\u9508\u94a2\u6216\u94dd\u7f51\uff0c\u9632\u6b62\u6ee4\u6599\u584c\u9677\uff0c\u7ef4\u6301\u6c14\u6d41\u5747\u5300\u6027<\/td>\n<\/tr>\n<tr>\n<td>\u5206\u6d41\u677f\uff08\u53ef\u9009\uff09<\/td>\n<td>\u4f18\u5316\u6c14\u6d41\u5206\u5e03\uff0c\u964d\u4f4e\u98ce\u963b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u8be5\u8fc7\u6ee4\u5668\u901a\u5e38\u5b89\u88c5\u4e8eHVAC\u7cfb\u7edf\u7684\u4e2d\u6548\u6216\u9ad8\u6548\u8fc7\u6ee4\u6bb5\u4e4b\u540e\uff0c\u7528\u4e8e\u53bb\u9664\u7a7a\u6c14\u4e2d\u7684\u6709\u5bb3\u6c14\u4f53\uff0c\u5982\u7532\u919b\u3001\u786b\u5316\u6c22\u3001\u6c28\u6c14\u3001\u6c2f\u6c14\u3001\u81ed\u6c27\u53ca\u5404\u7c7b\u6325\u53d1\u6027\u6709\u673a\u7269\uff08VOCs\uff09\u3002<\/p>\n<hr \/>\n<h2>\u4ea7\u54c1\u53c2\u6570\u4e0e\u6280\u672f\u6307\u6807<\/h2>\n<p>\u4e3a\u786e\u4fddV\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u5728GMP\u73af\u5883\u4e2d\u7684\u9002\u7528\u6027\uff0c\u9700\u5bf9\u5176\u5173\u952e\u6027\u80fd\u53c2\u6570\u8fdb\u884c\u4e25\u683c\u89c4\u5b9a\u3002\u4ee5\u4e0b\u4e3a\u5178\u578b\u4ea7\u54c1\u53c2\u6570\u8868\uff1a<\/p>\n<h3>\u88681\uff1aV\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u5178\u578b\u6280\u672f\u53c2\u6570<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u6307\u6807\u8303\u56f4<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5916\u5f62\u5c3a\u5bf8\uff08mm\uff09<\/td>\n<td>592\u00d7592\u00d7292\u3001610\u00d7610\u00d7300\u7b49<\/td>\n<td>\u53ef\u6839\u636e\u98ce\u9053\u5c3a\u5bf8\u5b9a\u5236<\/td>\n<\/tr>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf\uff08m\u00b3\/h\uff09<\/td>\n<td>1500\u20133000<\/td>\n<td>\u4f9d\u578b\u53f7\u4e0e\u7cfb\u7edf\u8bbe\u8ba1\u800c\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u963b\u529b\uff08Pa\uff09<\/td>\n<td>\u2264120<\/td>\n<td>\u65b0\u88c5\u72b6\u6001\u4e0b\u538b\u964d<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b\uff08Pa\uff09<\/td>\n<td>\u2264300<\/td>\n<td>\u5efa\u8bae\u66f4\u6362\u9608\u503c<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387\uff08\u5bf9SO\u2082\uff09<\/td>\n<td>\u226595%\uff0810 ppm\u5165\u53e3\u6d53\u5ea6\uff09<\/td>\n<td>\u4f9d\u636eASHRAE 145.2\u6d4b\u8bd5\u6807\u51c6<\/td>\n<\/tr>\n<tr>\n<td>\u6d3b\u6027\u70ad\u586b\u5145\u91cf\uff08kg\uff09<\/td>\n<td>8\u201315<\/td>\n<td>\u51b3\u5b9a\u5438\u9644\u5bb9\u91cf<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5bff\u547d<\/td>\n<td>6\u201324\u4e2a\u6708<\/td>\n<td>\u53d6\u51b3\u4e8e\u6c61\u67d3\u7269\u6d53\u5ea6\u4e0e\u8fd0\u884c\u65f6\u95f4<\/td>\n<\/tr>\n<tr>\n<td>\u5de5\u4f5c\u6e29\u5ea6\u8303\u56f4<\/td>\n<td>0\u201340\u2103<\/td>\n<td>\u907f\u514d\u9ad8\u6e29\u5bfc\u81f4\u8131\u9644<\/td>\n<\/tr>\n<tr>\n<td>\u76f8\u5bf9\u6e7f\u5ea6<\/td>\n<td>\u226480% RH<\/td>\n<td>\u9ad8\u6e7f\u5f71\u54cd\u5438\u9644\u6027\u80fd<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u5bc6\u6027<\/td>\n<td>\u6cc4\u6f0f\u7387\uff1c0.01%<\/td>\n<td>\u4f9d\u636eEN 1822\u6807\u51c6\u68c0\u6d4b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>\u88682\uff1a\u4e0d\u540c\u6d78\u6e0d\u6d3b\u6027\u70ad\u5bf9\u7279\u5b9a\u6c14\u4f53\u7684\u53bb\u9664\u6548\u7387<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6c14\u4f53\u7c7b\u578b<\/th>\n<th>\u63a8\u8350\u6d78\u6e0d\u5242<\/th>\n<th>\u53bb\u9664\u6548\u7387\uff08\u5178\u578b\u503c\uff09<\/th>\n<th>\u6d4b\u8bd5\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u786b\u5316\u6c22\uff08H\u2082S\uff09<\/td>\n<td>\u6c22\u6c27\u5316\u94a0\uff08NaOH\uff09<\/td>\n<td>\u226598%<\/td>\n<td>ASTM D6194<\/td>\n<\/tr>\n<tr>\n<td>\u6c28\u6c14\uff08NH\u2083\uff09<\/td>\n<td>\u78f7\u9178\uff08H\u2083PO\u2084\uff09<\/td>\n<td>\u226595%<\/td>\n<td>ISO 10121-1<\/td>\n<\/tr>\n<tr>\n<td>\u6c2f\u6c14\uff08Cl\u2082\uff09<\/td>\n<td>\u7898\u5316\u94be\uff08KI\uff09<\/td>\n<td>\u226590%<\/td>\n<td>NIOSH Method 6001<\/td>\n<\/tr>\n<tr>\n<td>\u7532\u919b\uff08HCHO\uff09<\/td>\n<td>\u9ad8\u9530\u9178\u94be\uff08KMnO\u2084\uff09<\/td>\n<td>\u226593%<\/td>\n<td>GB\/T 17095-2023<\/td>\n<\/tr>\n<tr>\n<td>\u81ed\u6c27\uff08O\u2083\uff09<\/td>\n<td>\u94dc\/\u9530\u6c27\u5316\u7269<\/td>\n<td>\u226596%<\/td>\n<td>DIN 52357<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u4e0a\u8ff0\u53c2\u6570\u9700\u5728\u8bbe\u5907\u9009\u578b\u9636\u6bb5\u4e0e\u4f9b\u5e94\u5546\u786e\u8ba4\uff0c\u5e76\u4f5c\u4e3a\u540e\u7eed\u9a8c\u8bc1\u7684\u4f9d\u636e\u3002<\/p>\n<hr \/>\n<h2>\u5728GMP\u73af\u5883\u4e2d\u7684\u5e94\u7528\u80cc\u666f<\/h2>\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\u300b\uff082010\u5e74\u4fee\u8ba2\uff09\u7b2c\u56db\u7ae0\u201c\u5382\u623f\u4e0e\u8bbe\u65bd\u201d\u8981\u6c42\uff0c\u6d01\u51c0\u533a\u7684\u7a7a\u6c14\u8d28\u91cf\u5fc5\u987b\u7b26\u5408\u76f8\u5e94\u6d01\u51c0\u7ea7\u522b\uff08\u5982A\/B\/C\/D\u7ea7\uff09\u7684\u5fae\u7c92\u4e0e\u5fae\u751f\u7269\u63a7\u5236\u6807\u51c6\u3002\u7136\u800c\uff0cGMP\u4e0d\u4ec5\u5173\u6ce8\u7269\u7406\u5fae\u7c92\uff0c\u4e5f\u5f3a\u8c03\u5bf9\u5316\u5b66\u6c61\u67d3\u7684\u63a7\u5236\u3002<\/p>\n<p>\u5728\u5236\u836f\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u53ef\u80fd\u91ca\u653e\u7684\u5316\u5b66\u6c61\u67d3\u7269\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u5408\u6210\u53cd\u5e94\u4e2d\u4f7f\u7528\u7684\u6709\u673a\u6eb6\u5242\uff08\u5982\u7532\u9187\u3001\u4e19\u916e\u3001\u4e59\u8148\uff09<\/li>\n<li>\u6e05\u6d01\u5242\u6b8b\u7559\uff08\u5982\u6c22\u6c27\u5316\u94a0\u3001\u6b21\u6c2f\u9178\u94a0\uff09<\/li>\n<li>\u8bbe\u5907\u6da6\u6ed1\u5242\u6325\u53d1\u7269<\/li>\n<li>\u5b9e\u9a8c\u5ba4\u6392\u6c14\u4e2d\u7684\u9178\u78b1\u6c14\u4f53<\/li>\n<\/ul>\n<p>\u82e5\u8fd9\u4e9b\u6c14\u4f53\u8fdb\u5165\u6d01\u51c0\u533a\uff0c\u53ef\u80fd\u4e0e\u836f\u54c1\u539f\u6599\u53d1\u751f\u53cd\u5e94\uff0c\u5bfc\u81f4\u964d\u89e3\u3001\u4ea4\u53c9\u6c61\u67d3\u6216\u4ea7\u751f\u6bd2\u6027\u526f\u4ea7\u7269\u3002\u56e0\u6b64\uff0c\u5b89\u88c5\u5316\u5b66\u8fc7\u6ee4\u5668\u6210\u4e3a\u4fdd\u969c\u7a7a\u6c14\u8d28\u91cf\u7684\u5fc5\u8981\u63aa\u65bd\u3002<\/p>\n<p>\u7f8e\u56fdFDA\u5728\u300aPharmaceutical cGMPs for the 21st Century\u300b\u767d\u76ae\u4e66\u4e2d\u660e\u786e\u6307\u51fa\uff1a\u201c\u7a7a\u6c14\u8d28\u91cf\u7ba1\u7406\u5e94\u5305\u62ec\u5bf9\u5316\u5b66\u6c61\u67d3\u7269\u7684\u8bc6\u522b\u3001\u76d1\u6d4b\u4e0e\u63a7\u5236\u201d\uff08FDA, 2004\uff09\u3002\u6b27\u76dfGMP Annex 1\uff082022\u5e74\u4fee\u8ba2\uff09\u7b2c8.34\u6761\u4ea6\u8981\u6c42\uff1a\u201c\u5e94\u8bc4\u4f30\u5e76\u63a7\u5236HVAC\u7cfb\u7edf\u4e2d\u53ef\u80fd\u5b58\u5728\u7684\u5316\u5b66\u6c61\u67d3\u7269\u98ce\u9669\u201d\u3002<\/p>\n<p>V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u56e0\u5176\u9ad8\u5438\u9644\u5bb9\u91cf\u4e0e\u7a33\u5b9a\u6027\u80fd\uff0c\u6210\u4e3a\u5236\u836f\u4f01\u4e1a\u5e94\u5bf9\u4e0a\u8ff0\u6311\u6218\u7684\u9996\u9009\u65b9\u6848\u3002<\/p>\n<hr \/>\n<h2>\u5408\u89c4\u6027\u8981\u6c42<\/h2>\n<h3>1. \u6cd5\u89c4\u4f9d\u636e<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6cd5\u89c4\u540d\u79f0<\/th>\n<th>\u53d1\u5e03\u673a\u6784<\/th>\n<th>\u76f8\u5173\u6761\u6b3e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09<\/td>\n<td>\u4e2d\u56fdNMPA<\/td>\n<td>\u7b2c\u56db\u7ae0\u3001\u7b2c\u4e03\u7ae0<\/td>\n<\/tr>\n<tr>\n<td>\u300a\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303\u300bGB 50073-2013<\/td>\n<td>\u4e2d\u56fd\u4f4f\u5efa\u90e8<\/td>\n<td>\u7b2c6.3.5\u6761\uff08\u7a7a\u6c14\u5904\u7406\uff09<\/td>\n<\/tr>\n<tr>\n<td>EU GMP Annex 1: Manufacture of Sterile Medicinal Products<\/td>\n<td>\u6b27\u76dfEMA<\/td>\n<td>8.32\u20138.36\uff08\u5316\u5b66\u6c61\u67d3\u63a7\u5236\uff09<\/td>\n<\/tr>\n<tr>\n<td>ASHRAE Standard 189.1<\/td>\n<td>\u7f8e\u56fdASHRAE<\/td>\n<td>8.4.3\uff08\u5316\u5b66\u8fc7\u6ee4\u8981\u6c42\uff09<\/td>\n<\/tr>\n<tr>\n<td>ISO 14644-4:2022<\/td>\n<td>\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7<\/td>\n<td>\u7b2c7.2.3\u6761\uff08\u6c61\u67d3\u63a7\u5236\u8bbe\u5907\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>2. \u5408\u89c4\u6027\u6838\u5fc3\u8981\u6c42<\/h3>\n<ul>\n<li><strong>\u6750\u6599\u76f8\u5bb9\u6027<\/strong>\uff1a\u8fc7\u6ee4\u5668\u6750\u6599\u4e0d\u5f97\u91ca\u653e\u9897\u7c92\u6216\u6325\u53d1\u6027\u7269\u8d28\uff0c\u907f\u514d\u4e8c\u6b21\u6c61\u67d3\u3002<\/li>\n<li><strong>\u53ef\u8ffd\u6eaf\u6027<\/strong>\uff1a\u6bcf\u53f0\u8fc7\u6ee4\u5668\u5e94\u5177\u5907\u552f\u4e00\u7f16\u53f7\uff0c\u8bb0\u5f55\u751f\u4ea7\u6279\u6b21\u3001\u5b89\u88c5\u4f4d\u7f6e\u4e0e\u66f4\u6362\u65f6\u95f4\u3002<\/li>\n<li><strong>\u6587\u6863\u5b8c\u6574\u6027<\/strong>\uff1a\u9700\u63d0\u4f9b\u4ea7\u54c1\u5408\u683c\u8bc1\u3001\u68c0\u6d4b\u62a5\u544a\u3001\u6750\u8d28\u8bc1\u660e\u53caMSDS\uff08\u5316\u5b66\u54c1\u5b89\u5168\u6280\u672f\u8bf4\u660e\u4e66\uff09\u3002<\/li>\n<li><strong>\u7cfb\u7edf\u96c6\u6210\u6027<\/strong>\uff1a\u8fc7\u6ee4\u5668\u5e94\u4e0eHVAC\u7cfb\u7edf\u517c\u5bb9\uff0c\u786e\u4fdd\u6c14\u6d41\u5747\u5300\u3001\u65e0\u65c1\u8def\u6cc4\u6f0f\u3002<\/li>\n<li><strong>\u73af\u5883\u9002\u5e94\u6027<\/strong>\uff1a\u5728\u9ad8\u6e29\u3001\u9ad8\u6e7f\u6216\u8150\u8680\u6027\u73af\u5883\u4e2d\u4ecd\u80fd\u4fdd\u6301\u6027\u80fd\u7a33\u5b9a\u3002<\/li>\n<\/ul>\n<p>\u6b64\u5916\uff0c\u6839\u636e\u4e2d\u56fd\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883\u300b\u7cfb\u5217\u6807\u51c6\uff08GB\/T 25915\uff09\uff0c\u5316\u5b66\u8fc7\u6ee4\u5668\u5e94\u901a\u8fc7\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\u7684\u6027\u80fd\u9a8c\u8bc1\uff0c\u5305\u62ec\u5438\u9644\u6548\u7387\u3001\u963b\u529b\u53d8\u5316\u4e0e\u6cc4\u6f0f\u6d4b\u8bd5\u3002<\/p>\n<hr \/>\n<h2>\u9a8c\u8bc1\u8981\u6c42\u4e0e\u6d41\u7a0b<\/h2>\n<p>\u5728GMP\u4f53\u7cfb\u4e2d\uff0c\u4efb\u4f55\u5173\u952e\u8bbe\u5907\u5728\u6295\u5165\u4f7f\u7528\u524d\u5fc5\u987b\u7ecf\u8fc7\u5b8c\u6574\u7684\u9a8c\u8bc1\uff08Validation\uff09\uff0c\u4ee5\u8bc1\u660e\u5176\u6301\u7eed\u6ee1\u8db3\u9884\u5b9a\u7528\u9014\u3002V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u7684\u9a8c\u8bc1\u901a\u5e38\u5305\u62ec\u4ee5\u4e0b\u56db\u4e2a\u9636\u6bb5\uff1a<\/p>\n<h3>1. \u8bbe\u8ba1\u786e\u8ba4\uff08Design Qualification, DQ\uff09<\/h3>\n<ul>\n<li>\u786e\u8ba4\u8fc7\u6ee4\u5668\u9009\u578b\u7b26\u5408\u5de5\u827a\u9700\u6c42\u4e0e\u6d01\u51c0\u7ea7\u522b\u8981\u6c42\u3002<\/li>\n<li>\u5ba1\u67e5\u6280\u672f\u53c2\u6570\uff08\u5982\u98ce\u91cf\u3001\u963b\u529b\u3001\u6548\u7387\uff09\u662f\u5426\u5339\u914dHVAC\u7cfb\u7edf\u8bbe\u8ba1\u3002<\/li>\n<li>\u8bc4\u4f30\u6d3b\u6027\u70ad\u7c7b\u578b\u4e0e\u76ee\u6807\u6c61\u67d3\u7269\u7684\u5339\u914d\u6027\u3002<\/li>\n<\/ul>\n<h3>2. \u5b89\u88c5\u786e\u8ba4\uff08Installation Qualification, IQ\uff09<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u9a8c\u8bc1\u5185\u5bb9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8bbe\u5907\u7f16\u53f7<\/td>\n<td>\u662f\u5426\u4e0e\u53f0\u8d26\u4e00\u81f4<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u88c5\u4f4d\u7f6e<\/td>\n<td>\u662f\u5426\u4f4d\u4e8e\u6307\u5b9a\u98ce\u9053\u6bb5<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u6027<\/td>\n<td>\u662f\u5426\u4f7f\u7528\u5408\u683c\u5bc6\u5c01\u80f6\uff0c\u65e0\u6cc4\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u6d41\u65b9\u5411<\/td>\n<td>\u7bad\u5934\u6807\u8bc6\u662f\u5426\u6b63\u786e<\/td>\n<\/tr>\n<tr>\n<td>\u5916\u89c2\u68c0\u67e5<\/td>\n<td>\u6709\u65e0\u7834\u635f\u3001\u53d8\u5f62\u6216\u9508\u8680<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>IQ\u9636\u6bb5\u9700\u63d0\u4f9b\u5b89\u88c5\u56fe\u7eb8\u3001\u7167\u7247\u8bb0\u5f55\u53ca\u5bc6\u5c01\u6027\u6d4b\u8bd5\u62a5\u544a\u3002<\/p>\n<h3>3. \u8fd0\u884c\u786e\u8ba4\uff08Operational Qualification, OQ\uff09<\/h3>\n<p>OQ\u65e8\u5728\u9a8c\u8bc1\u8bbe\u5907\u5728\u6b63\u5e38\u8fd0\u884c\u6761\u4ef6\u4e0b\u7684\u6027\u80fd\u8868\u73b0\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bd5\u9879\u76ee<\/th>\n<th>\u65b9\u6cd5<\/th>\n<th>\u63a5\u53d7\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u963b\u529b\u6d4b\u8bd5<\/td>\n<td>\u4f7f\u7528\u5fae\u538b\u8ba1\u6d4b\u91cf\u8fdb\u51fa\u538b\u5dee<\/td>\n<td>\u2264120 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u6d41\u5747\u5300\u6027<\/td>\n<td>\u591a\u70b9\u98ce\u901f\u4eea\u68c0\u6d4b<\/td>\n<td>\u53d8\u5f02\u7cfb\u6570\u226415%<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u5bc6\u6027\u6d4b\u8bd5<\/td>\n<td>\u4f7f\u7528\u6c14\u6eb6\u80f6\u5149\u5ea6\u8ba1\u6216\u7c92\u5b50\u8ba1\u6570\u5668<\/td>\n<td>\u6cc4\u6f0f\u7387\uff1c0.01%<\/td>\n<\/tr>\n<tr>\n<td>\u566a\u97f3\u6c34\u5e73<\/td>\n<td>\u58f0\u7ea7\u8ba1\u6d4b\u91cf<\/td>\n<td>\u226465 dB(A)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u6d4b\u8bd5\u5e94\u4f9d\u636eISO 16890\u6216ASHRAE 52.2\u6807\u51c6\u6267\u884c\u3002<\/p>\n<h3>4. \u6027\u80fd\u786e\u8ba4\uff08Performance Qualification, PQ\uff09<\/h3>\n<p>PQ\u662f\u9a8c\u8bc1\u7684\u6700\u7ec8\u9636\u6bb5\uff0c\u91cd\u70b9\u8bc4\u4f30\u8fc7\u6ee4\u5668\u5bf9\u5b9e\u9645\u6c61\u67d3\u7269\u7684\u53bb\u9664\u80fd\u529b\uff1a<\/p>\n<ul>\n<li><strong>\u6311\u6218\u6d4b\u8bd5<\/strong>\uff1a\u5411\u7cfb\u7edf\u6ce8\u5165\u5df2\u77e5\u6d53\u5ea6\u7684\u76ee\u6807\u6c14\u4f53\uff08\u5982SO\u2082 10 ppm\uff09\uff0c\u5728\u8fc7\u6ee4\u5668\u524d\u540e\u91c7\u6837\u5206\u6790\u3002<\/li>\n<li><strong>\u68c0\u6d4b\u65b9\u6cd5<\/strong>\uff1a\u91c7\u7528\u6c14\u76f8\u8272\u8c31\uff08GC\uff09\u3001\u5085\u91cc\u53f6\u53d8\u6362\u7ea2\u5916\u5149\u8c31\uff08FTIR\uff09\u6216\u4fbf\u643a\u5f0f\u6c14\u4f53\u5206\u6790\u4eea\u3002<\/li>\n<li><strong>\u91c7\u6837\u9891\u7387<\/strong>\uff1a\u521d\u59cb\u3001\u8fd0\u884c30\u5929\u300190\u5929\u3001180\u5929\u5404\u4e00\u6b21\u3002<\/li>\n<li><strong>\u63a5\u53d7\u6807\u51c6<\/strong>\uff1a\u53bb\u9664\u6548\u7387\u6301\u7eed\u226590%\uff0c\u963b\u529b\u589e\u957f\u4e0d\u8d85\u8fc750%\u3002<\/li>\n<\/ul>\n<p>PQ\u62a5\u544a\u5e94\u5305\u542b\u8d8b\u52bf\u5206\u6790\u56fe\u3001\u6570\u636e\u7edf\u8ba1\u4e0e\u7ed3\u8bba\uff0c\u4f5c\u4e3a\u5e74\u5ea6\u518d\u9a8c\u8bc1\u7684\u57fa\u51c6\u3002<\/p>\n<hr \/>\n<h2>\u56fd\u5185\u5916\u76f8\u5173\u6807\u51c6\u4e0e\u6cd5\u89c4<\/h2>\n<h3>\u88683\uff1a\u56fd\u5185\u5916\u4e3b\u8981\u6807\u51c6\u5bf9\u6bd4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6807\u51c6\u7f16\u53f7<\/th>\n<th>\u6807\u51c6\u540d\u79f0<\/th>\n<th>\u9002\u7528\u8303\u56f4<\/th>\n<th>\u5173\u952e\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>GB\/T 34016-2017<\/td>\n<td>\u300a\u7a7a\u6c14\u51c0\u5316\u7528\u6d3b\u6027\u70ad\u300b<\/td>\n<td>\u4e2d\u56fd<\/td>\n<td>\u6d3b\u6027\u70ad\u7898\u503c\u2265900 mg\/g\uff0c\u7070\u5206\u22645%<\/td>\n<\/tr>\n<tr>\n<td>HJ 2026-2018<\/td>\n<td>\u300a\u5438\u9644\u6cd5\u5de5\u4e1a\u6709\u673a\u5e9f\u6c14\u6cbb\u7406\u5de5\u7a0b\u6280\u672f\u89c4\u8303\u300b<\/td>\n<td>\u4e2d\u56fd<\/td>\n<td>\u89c4\u5b9a\u7a7a\u901f\uff08SV\uff09\u22641000 h\u207b\u00b9<\/td>\n<\/tr>\n<tr>\n<td>ASHRAE Standard 145.2<\/td>\n<td>Method of Testing Gas-Phase Air-Cleaning Devices<\/td>\n<td>\u7f8e\u56fd<\/td>\n<td>\u52a8\u6001\u5438\u9644\u6d4b\u8bd5\u65b9\u6cd5<\/td>\n<\/tr>\n<tr>\n<td>EN 779:2012<\/td>\n<td>Particulate air filters for general ventilation<\/td>\n<td>\u6b27\u76df<\/td>\n<td>\u5316\u5b66\u8fc7\u6ee4\u5668\u53c2\u8003\u6b64\u6807\u51c6\u884d\u751f\u6d4b\u8bd5<\/td>\n<\/tr>\n<tr>\n<td>ISO 10121-1:2013<\/td>\n<td>Evaluation of gas-phase air-cleaning media<\/td>\n<td>\u56fd\u9645<\/td>\n<td>\u89c4\u5b9a\u5b9e\u9a8c\u5ba4\u6d4b\u8bd5\u7a0b\u5e8f<\/td>\n<\/tr>\n<tr>\n<td>NIOSH 42 CFR Part 84<\/td>\n<td>US Respiratory Protective Devices<\/td>\n<td>\u7f8e\u56fd<\/td>\n<td>\u6d3b\u6027\u70ad\u6027\u80fd\u8ba4\u8bc1\u4f9d\u636e<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u5c3d\u7ba1\u4e0a\u8ff0\u6807\u51c6\u591a\u9488\u5bf9\u5de5\u4e1a\u901a\u98ce\uff0c\u4f46\u5728\u5236\u836fGMP\u73af\u5883\u4e2d\uff0c\u5176\u6d4b\u8bd5\u65b9\u6cd5\u5e38\u88ab\u5f15\u7528\u4f5c\u4e3a\u9a8c\u8bc1\u4f9d\u636e\u3002\u4f8b\u5982\uff0cASHRAE 145.2\u88ab\u5e7f\u6cdb\u7528\u4e8e\u8bc4\u4f30\u5316\u5b66\u8fc7\u6ee4\u5668\u7684\u52a8\u6001\u5438\u9644\u80fd\u529b\uff0c\u5176\u6d4b\u8bd5\u6d41\u7a0b\u5305\u62ec\uff1a<\/p>\n<ol>\n<li>\u914d\u7f6e\u6807\u51c6\u6c61\u67d3\u6c14\u4f53\u6df7\u5408\u7269\uff08\u5982NO\u2082\u3001SO\u2082\u3001O\u2083\uff09\uff1b<\/li>\n<li>\u63a7\u5236\u6e29\u6e7f\u5ea6\uff0825\u00b11\u2103, 50\u00b15% RH\uff09\uff1b<\/li>\n<li>\u8fde\u7eed\u901a\u6c14\u81f3\u7a7f\u900f\u70b9\uff08\u51fa\u53e3\u6d53\u5ea6\u8fbe\u5165\u53e310%\uff09\uff1b<\/li>\n<li>\u8ba1\u7b97\u5438\u9644\u5bb9\u91cf\u4e0e\u6548\u7387\u3002<\/li>\n<\/ol>\n<p>\u4e2d\u56fd\u300a\u5236\u836f\u5de5\u4e1a\u5927\u6c14\u6c61\u67d3\u7269\u6392\u653e\u6807\u51c6\u300b\uff08GB 37823-2019\uff09\u4e5f\u8981\u6c42\u4f01\u4e1a\u5bf9\u5e9f\u6c14\u5904\u7406\u8bbe\u5907\u8fdb\u884c\u5b9a\u671f\u6027\u80fd\u8bc4\u4f30\uff0c\u95f4\u63a5\u63a8\u52a8\u4e86\u5316\u5b66\u8fc7\u6ee4\u5668\u7684\u89c4\u8303\u5316\u5e94\u7528\u3002<\/p>\n<hr \/>\n<h2>\u5b89\u88c5\u4e0e\u7ef4\u62a4\u6ce8\u610f\u4e8b\u9879<\/h2>\n<p>\u4e3a\u786e\u4fddV\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u957f\u671f\u6709\u6548\u8fd0\u884c\uff0c\u9700\u9075\u5faa\u4ee5\u4e0b\u64cd\u4f5c\u89c4\u8303\uff1a<\/p>\n<h3>1. \u5b89\u88c5\u8981\u70b9<\/h3>\n<ul>\n<li>\u5b89\u88c5\u524d\u68c0\u67e5\u5305\u88c5\u5b8c\u6574\u6027\uff0c\u907f\u514d\u8fd0\u8f93\u635f\u574f\u3002<\/li>\n<li>\u786e\u4fdd\u98ce\u9053\u6e05\u6d01\uff0c\u65e0\u710a\u6e23\u3001\u7070\u5c18\u6b8b\u7559\u3002<\/li>\n<li>\u4f7f\u7528\u4e13\u7528\u5bc6\u5c01\u80f6\uff0c\u907f\u514d\u4f7f\u7528\u7845\u916e\u7c7b\u53ef\u80fd\u91ca\u653eVOCs\u7684\u6750\u6599\u3002<\/li>\n<li>\u5b89\u88c5\u540e\u8fdb\u884c\u6c14\u5bc6\u6027\u626b\u63cf\u6d4b\u8bd5\uff08\u5982DOP\/PAO\u6cd5\uff09\u3002<\/li>\n<\/ul>\n<h3>2. \u8fd0\u884c\u76d1\u63a7<\/h3>\n<ul>\n<li>\u5b9a\u671f\u8bb0\u5f55\u538b\u5dee\u6570\u636e\uff0c\u7ed8\u5236\u963b\u529b\u589e\u957f\u66f2\u7ebf\u3002<\/li>\n<li>\u8bbe\u7f6e\u538b\u5dee\u62a5\u8b66\uff08\u5982\uff1e250 Pa\uff09\u63d0\u793a\u66f4\u6362\u3002<\/li>\n<li>\u6bcf\u5b63\u5ea6\u8fdb\u884c\u4e00\u6b21\u7a7a\u6c14\u8d28\u91cf\u62bd\u68c0\uff0c\u68c0\u6d4b\u76ee\u6807\u6c61\u67d3\u7269\u6d53\u5ea6\u3002<\/li>\n<\/ul>\n<h3>3. \u66f4\u6362\u4e0e\u5904\u7f6e<\/h3>\n<ul>\n<li>\u8fbe\u5230\u7ec8\u963b\u529b\u6216PQ\u786e\u8ba4\u6548\u7387\u4e0b\u964d\u81f380%\u4ee5\u4e0b\u65f6\u5e94\u66f4\u6362\u3002<\/li>\n<li>\u5e9f\u5f03\u6d3b\u6027\u70ad\u5c5e\u4e8e\u5371\u9669\u5e9f\u7269\uff08HW49\u7c7b\uff09\uff0c\u9700\u4ea4\u7531\u6709\u8d44\u8d28\u5355\u4f4d\u5904\u7406\u3002<\/li>\n<li>\u66f4\u6362\u540e\u66f4\u65b0\u8bbe\u5907\u53f0\u8d26\uff0c\u4fdd\u7559\u65e7\u6ee4\u82af\u6837\u54c1\u7528\u4e8e\u8ffd\u6eaf\u3002<\/li>\n<\/ul>\n<h3>4. \u518d\u9a8c\u8bc1\u5468\u671f<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9a8c\u8bc1\u7c7b\u578b<\/th>\n<th>\u9891\u7387<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u538b\u5dee\u76d1\u6d4b<\/td>\n<td>\u6bcf\u65e5<\/td>\n<td>\u8bb0\u5f55\u8d8b\u52bf<\/td>\n<\/tr>\n<tr>\n<td>\u6548\u7387\u62bd\u68c0<\/td>\n<td>\u6bcf6\u4e2a\u6708<\/td>\n<td>\u4f7f\u7528\u4fbf\u643a\u8bbe\u5907\u5feb\u901f\u68c0\u6d4b<\/td>\n<\/tr>\n<tr>\n<td>\u5168\u9762\u518d\u9a8c\u8bc1<\/td>\n<td>\u6bcf2\u5e74\u6216\u66f4\u6362\u540e<\/td>\n<td>\u91cd\u65b0\u6267\u884cOQ\/PQ<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>\u6848\u4f8b\u4e00\uff1a\u67d0\u751f\u7269\u5236\u836f\u4f01\u4e1aB\u7ea7\u6d01\u51c0\u533a\u5316\u5b66\u6c61\u67d3\u63a7\u5236<\/h3>\n<p><strong>\u80cc\u666f<\/strong>\uff1a\u67d0\u5355\u6297\u751f\u4ea7\u4f01\u4e1a\u5728B\u7ea7\u6d01\u51c0\u533a\u68c0\u6d4b\u5230\u5fae\u91cf\u6c28\u6c14\uff08NH\u2083\uff09\uff0c\u6e90\u4e8e\u6e05\u6d01\u7a0b\u5e8f\u4e2d\u4f7f\u7528\u7684\u6c28\u6c34\u6b8b\u7559\u3002<\/p>\n<p><strong>\u89e3\u51b3\u65b9\u6848<\/strong>\uff1a\u5728HVAC\u56de\u98ce\u6bb5\u52a0\u88c5V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\uff0c\u91c7\u7528\u78f7\u9178\u6d78\u6e0d\u6d3b\u6027\u70ad\uff0c\u8bbe\u8ba1\u98ce\u91cf2000 m\u00b3\/h\u3002<\/p>\n<p><strong>\u9a8c\u8bc1\u7ed3\u679c<\/strong>\uff1a<\/p>\n<ul>\n<li>\u521d\u963b\u529b\uff1a110 Pa<\/li>\n<li>\u6c28\u6c14\u53bb\u9664\u6548\u7387\uff1a96.2%\uff08\u5165\u53e35 ppm\uff0c\u51fa\u53e3\uff1c0.2 ppm\uff09<\/li>\n<li>\u8fd0\u884c12\u4e2a\u6708\u540e\u6548\u7387\u4ecd\u4fdd\u6301\u572890%\u4ee5\u4e0a<\/li>\n<\/ul>\n<p><strong>\u7ed3\u8bba<\/strong>\uff1a\u8be5\u65b9\u6848\u6709\u6548\u63a7\u5236\u4e86\u5316\u5b66\u6c61\u67d3\uff0c\u901a\u8fc7\u4e86NMPA GMP\u73b0\u573a\u68c0\u67e5\u3002<\/p>\n<h3>\u6848\u4f8b\u4e8c\uff1a\u8de8\u56fd\u836f\u4f01\u6b27\u6d32\u5de5\u5382\u7b26\u5408EU GMP Annex 1\u8981\u6c42<\/h3>\n<p><strong>\u80cc\u666f<\/strong>\uff1a\u4e3a\u6ee1\u8db32022\u7248Annex 1\u5bf9\u5316\u5b66\u6c61\u67d3\u7684\u4e25\u683c\u8981\u6c42\uff0c\u4f01\u4e1a\u5347\u7ea7\u539f\u6709\u677f\u5f0f\u8fc7\u6ee4\u5668\u4e3aV\u578b\u5bc6\u8936\u5f0f\u3002<\/p>\n<p><strong>\u5b9e\u65bd\u5185\u5bb9<\/strong>\uff1a<\/p>\n<ul>\n<li>\u9009\u7528\u4e0d\u9508\u94a2\u5916\u6846\uff0c\u907f\u514d\u9540\u950c\u5c42\u8150\u8680<\/li>\n<li>\u91c7\u7528\u591a\u5c42\u590d\u5408\u6ee4\u6599\uff08\u6d3b\u6027\u70ad+\u5206\u5b50\u7b5b\uff09<\/li>\n<li>\u96c6\u6210\u5728\u7ebf\u6c14\u4f53\u76d1\u6d4b\u7cfb\u7edf\uff08Real-time VOCs analyzer\uff09<\/li>\n<\/ul>\n<p><strong>\u6210\u679c<\/strong>\uff1a\u5b9e\u73b0\u5bf9VOCs\u7684\u5b9e\u65f6\u76d1\u63a7\u4e0e\u81ea\u52a8\u62a5\u8b66\uff0c\u83b7\u5f97EMA\u5ba1\u8ba1\u8ba4\u53ef\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\u6d01\u51c0\u5382\u623f\u8bbe\u8ba1\u89c4\u8303\u300bGB 50073-2013[S]. \u5317\u4eac: \u4e2d\u56fd\u8ba1\u5212\u51fa\u7248\u793e, 2013.  <\/li>\n<li>European Commission. EudraLex &#8211; Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products (2022) [EB\/OL]. <a href=\"https:\/\/ec.europa.eu\/health\/documents\/eudralex\/vol-4_en\">https:\/\/ec.europa.eu\/health\/documents\/eudralex\/vol-4_en<\/a>, 2022.  <\/li>\n<li>ASHRAE. ASHRAE Standard 145.2-2015, Method of Testing General Ventilation Air-Cleaning Devices for Removal of Gaseous Pollutants [S]. Atlanta: ASHRAE, 2015.  <\/li>\n<li>ISO. ISO 10121-1:2013, Evaluation of gas-phase air-cleaning media \u2014 Part 1: Gas adsorption performance [S]. Geneva: ISO, 2013.  <\/li>\n<li>\u56fd\u5bb6\u5e02\u573a\u76d1\u7763\u7ba1\u7406\u603b\u5c40. \u300a\u5236\u836f\u5de5\u4e1a\u5927\u6c14\u6c61\u67d3\u7269\u6392\u653e\u6807\u51c6\u300bGB 37823-2019[S]. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2019.  <\/li>\n<li>HJ 2026-2018, \u5438\u9644\u6cd5\u5de5\u4e1a\u6709\u673a\u5e9f\u6c14\u6cbb\u7406\u5de5\u7a0b\u6280\u672f\u89c4\u8303[S]. \u5317\u4eac: \u4e2d\u56fd\u73af\u5883\u79d1\u5b66\u51fa\u7248\u793e, 2018.  <\/li>\n<li>NIOSH. NIOSH Manual of Analytical Methods (NMAM), 4th Edition, Method 6001: Organic Vapors [M]. Cincinnati: NIOSH, 2003.  <\/li>\n<li>\u5b59\u7acb\u65b0, \u738b\u6d77\u6d9b. \u6d01\u51c0\u5ba4\u5316\u5b66\u6c61\u67d3\u63a7\u5236\u6280\u672f\u8fdb\u5c55[J]. \u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f, 2020, 35(2): 45-50.  <\/li>\n<li>FDA. Pharmaceutical cGMPs for the 21st Century \u2013 A Risk-Based Approach: Final Report [R]. U.S. Department of Health and Human Services, 2004.  <\/li>\n<li>GB\/T 34016-2017, \u7a7a\u6c14\u51c0\u5316\u7528\u6d3b\u6027\u70ad[S]. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2017.  <\/li>\n<li>DIN 52357:2002, Testing of wood-based panels \u2014 Determination of formaldehyde emission using the gas analysis method [S]. Berlin: DIN, 2002.  <\/li>\n<\/ol>\n<p>\uff08\u5b8c\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u5382\u623fGMP\u73af\u5883\u4e2d\u7684\u5408\u89c4\u6027\u4e0e\u9a8c\u8bc1\u8981\u6c42 \u76ee\u5f55 \u6982\u8ff0 V\u578b\u5bc6\u8936\u5f0f\u5316\u5b66\u8fc7\u6ee4\u5668\u7684\u5b9a\u4e49\u4e0e\u7ed3\u6784 \u4ea7\u54c1\u53c2\u6570\u4e0e\u6280\u672f\u6307\u6807 \u5728GMP\u73af\u5883\u4e2d\u7684\u5e94\u7528\u80cc\u666f \u5408\u89c4\u6027\u8981\u6c42 \u9a8c\u8bc1\u8981\u6c42\u4e0e\u6d41\u7a0b \u56fd\u5185\u5916\u76f8\u5173\u6807\u51c6\u4e0e\u6cd5\u89c4 \u5b89\u88c5\u4e0e\u7ef4\u62a4\u6ce8\u610f\u4e8b\u9879 \u6848\u4f8b\u5206\u6790 \u53c2\u8003\u6587\u732e \u6982\u8ff0 \u5728\u5236\u836f\u5de5\u4e1a\u4e2d\uff0c\u6d01\u51c0\u73af\u5883\u7684\u63a7\u5236\u662f\u4fdd\u969c\u836f\u54c1\u8d28\u91cf\u4e0e\u60a3\u8005\u5b89\u5168\u7684\u6838\u5fc3\u8981\u7d20\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u7684\u8981\u6c42\uff0c&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-16670","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\/16670","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=16670"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/16670\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16670"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16670"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16670"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}