{"id":16235,"date":"2025-07-21T12:01:14","date_gmt":"2025-07-21T04:01:14","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=16235"},"modified":"2025-07-21T12:01:14","modified_gmt":"2025-07-21T04:01:14","slug":"%e4%b8%ad%e6%95%88%e7%ae%b1%e5%bc%8f%e7%a9%ba%e6%b0%94%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e5%88%b6%e8%8d%af%e8%a1%8c%e4%b8%9agmp%e6%a0%87%e5%87%86%e4%b8%8b%e7%9a%84%e5%ba%94%e7%94%a8%e8%a7%84","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=16235","title":{"rendered":"\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e0b\u7684\u5e94\u7528\u89c4\u8303"},"content":{"rendered":"<h1>\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e0b\u7684\u5e94\u7528\u89c4\u8303<\/h1>\n<h2>\u4e00\u3001\u5f15\u8a00<\/h2>\n<p>\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5f71\u54cd\u836f\u54c1\u7684\u8d28\u91cf\u4e0e\u5b89\u5168\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice\uff0c\u7b80\u79f0GMP\uff09\u7684\u8981\u6c42\uff0c\u5236\u836f\u4f01\u4e1a\u5fc5\u987b\u5bf9\u751f\u4ea7\u73af\u5883\u4e2d\u7684\u7a7a\u6c14\u8fdb\u884c\u6709\u6548\u8fc7\u6ee4\u548c\u51c0\u5316\uff0c\u4ee5\u786e\u4fdd\u836f\u54c1\u4e0d\u53d7\u5fae\u751f\u7269\u3001\u9897\u7c92\u7269\u7b49\u6c61\u67d3\u7269\u7684\u6c61\u67d3\u3002\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4e2d\u7684\u5173\u952e\u8bbe\u5907\u4e4b\u4e00\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u8f66\u95f4\u7684\u6d01\u51c0\u7a7a\u8c03\u7cfb\u7edf\u4e2d\u3002\u672c\u6587\u5c06\u56f4\u7ed5\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728GMP\u6807\u51c6\u4e0b\u7684\u5e94\u7528\u89c4\u8303\u8fdb\u884c\u8be6\u7ec6\u9610\u8ff0\uff0c\u5305\u62ec\u5176\u6280\u672f\u53c2\u6570\u3001\u9009\u578b\u539f\u5219\u3001\u5b89\u88c5\u8981\u6c42\u3001\u7ef4\u62a4\u7ba1\u7406\u3001\u68c0\u6d4b\u6807\u51c6\u7b49\u65b9\u9762\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u76f8\u5173\u6587\u732e\u8d44\u6599\u8fdb\u884c\u5206\u6790\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001GMP\u6807\u51c6\u6982\u8ff0<\/h2>\n<h3>2.1 GMP\u7684\u5b9a\u4e49\u4e0e\u76ee\u6807<\/h3>\n<p>GMP\uff08Good Manufacturing Practice\uff09\u5373\u201c\u826f\u597d\u751f\u4ea7\u89c4\u8303\u201d\uff0c\u662f\u56fd\u9645\u4e0a\u901a\u7528\u7684\u836f\u54c1\u751f\u4ea7\u548c\u8d28\u91cf\u7ba1\u7406\u7684\u57fa\u672c\u51c6\u5219\u3002\u5176\u6838\u5fc3\u76ee\u6807\u662f\u786e\u4fdd\u836f\u54c1\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u59cb\u7ec8\u7b26\u5408\u9884\u5b9a\u7528\u9014\u548c\u6ce8\u518c\u8981\u6c42\uff0c\u9632\u6b62\u6c61\u67d3\u3001\u4ea4\u53c9\u6c61\u67d3\u3001\u6df7\u6dc6\u548c\u5dee\u9519\u7684\u53d1\u751f\u3002<\/p>\n<p>\u5728\u4e2d\u56fd\uff0cGMP\u7531\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u5236\u5b9a\u5e76\u5b9e\u65bd\uff0c\u73b0\u884c\u7248\u672c\u4e3a\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b\u3002\u8be5\u89c4\u8303\u5bf9\u836f\u54c1\u751f\u4ea7\u5382\u623f\u7684\u6d01\u51c0\u5ea6\u3001\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u3001\u4eba\u5458\u536b\u751f\u3001\u8bbe\u5907\u9a8c\u8bc1\u7b49\u65b9\u9762\u63d0\u51fa\u4e86\u660e\u786e\u8981\u6c42\u3002<\/p>\n<h3>2.2 GMP\u5bf9\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u8981\u6c42<\/h3>\n<p>\u6839\u636eGMP\u89c4\u8303\uff0c\u5236\u836f\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u7b26\u5408\u6d01\u51c0\u7b49\u7ea7\u8981\u6c42\u7684\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u3002\u4e0d\u540c\u6d01\u51c0\u7b49\u7ea7\u5bf9\u5e94\u4e0d\u540c\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8981\u6c42\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7b49\u7ea7<\/th>\n<th>\u7a7a\u6c14\u4e2d\u22650.5\u03bcm\u7c92\u5b50\u6570\uff08\u7c92\/m\u00b3\uff09<\/th>\n<th>\u22655\u03bcm\u7c92\u5b50\u6570\uff08\u7c92\/m\u00b3\uff09<\/th>\n<th>\u5fae\u751f\u7269\u9650\u5ea6\uff08CFU\/m\u00b3\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7\uff08\u5c40\u90e8\u767e\u7ea7\uff09<\/td>\n<td>\u22643520<\/td>\n<td>\u226420<\/td>\n<td>\u22641<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7\uff08\u52a8\u6001\u767e\u7ea7\uff09<\/td>\n<td>\u22643520<\/td>\n<td>\u226429<\/td>\n<td>\u226410<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7\uff08\u4e07\u7ea7\uff09<\/td>\n<td>\u2264352,000<\/td>\n<td>\u22642900<\/td>\n<td>\u2264100<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7\uff08\u5341\u4e07\u7ea7\uff09<\/td>\n<td>\u22643,520,000<\/td>\n<td>\u226429,000<\/td>\n<td>\u2264200<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5728\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4e2d\uff0c\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6309\u6548\u7387\u53ef\u5206\u4e3a\u521d\u6548\u3001\u4e2d\u6548\u3001\u9ad8\u6548\uff08HEPA\uff09\u4e09\u7c7b\u3002\u5176\u4e2d\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u627f\u62c5\u7740\u5bf9\u7a7a\u6c14\u4e2d\u4e2d\u7b49\u7c92\u5f84\u9897\u7c92\u7269\u7684\u8fc7\u6ee4\u4efb\u52a1\uff0c\u662f\u8fde\u63a5\u521d\u6548\u4e0e\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e4b\u95f4\u7684\u5173\u952e\u73af\u8282\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6982\u8ff0<\/h2>\n<h3>3.1 \u5b9a\u4e49\u4e0e\u7ed3\u6784<\/h3>\n<p>\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u7528\u4e8e\u4e2d\u592e\u7a7a\u8c03\u7cfb\u7edf\u6216\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4e2d\u7684\u8fc7\u6ee4\u8bbe\u5907\uff0c\u901a\u5e38\u91c7\u7528\u888b\u5f0f\u6216\u677f\u5f0f\u7ed3\u6784\uff0c\u5b89\u88c5\u4e8e\u7a7a\u8c03\u673a\u7ec4\u4e2d\uff0c\u7528\u4e8e\u53bb\u9664\u7a7a\u6c14\u4e2d\u7684\u4e2d\u7b49\u7c92\u5f84\u9897\u7c92\u7269\uff081~5\u03bcm\uff09\uff0c\u5982\u7070\u5c18\u3001\u82b1\u7c89\u3001\u7ec6\u83cc\u5b62\u5b50\u7b49\u3002<\/p>\n<p>\u5176\u4e3b\u8981\u7ed3\u6784\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u6ee4\u6750<\/strong>\uff1a\u901a\u5e38\u4e3a\u65e0\u7eba\u5e03\u3001\u73bb\u7483\u7ea4\u7ef4\u6216\u590d\u5408\u6750\u6599\uff1b<\/li>\n<li><strong>\u6846\u67b6<\/strong>\uff1a\u4e00\u822c\u4e3a\u9540\u950c\u94a2\u677f\u3001\u94dd\u5408\u91d1\u6216\u5851\u6599\uff1b<\/li>\n<li><strong>\u652f\u6491\u9aa8\u67b6<\/strong>\uff1a\u7528\u4e8e\u4fdd\u6301\u6ee4\u888b\u5c55\u5f00\uff0c\u63d0\u9ad8\u8fc7\u6ee4\u9762\u79ef\uff1b<\/li>\n<li><strong>\u5bc6\u5c01\u7ed3\u6784<\/strong>\uff1a\u4fdd\u8bc1\u8fc7\u6ee4\u5668\u4e0e\u5b89\u88c5\u6846\u67b6\u4e4b\u95f4\u7684\u5bc6\u5c01\u6027\u3002<\/li>\n<\/ul>\n<h3>3.2 \u8fc7\u6ee4\u6548\u7387\u7b49\u7ea7<\/h3>\n<p>\u6839\u636e\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6\u300aGB\/T 14295-2008 \u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u53ca\u6b27\u6d32\u6807\u51c6EN 779:2012\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u6548\u7387\u7b49\u7ea7\u5212\u5206\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6807\u51c6<\/th>\n<th>\u8fc7\u6ee4\u7b49\u7ea7<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff08\u9488\u5bf90.4\u03bcm\u9897\u7c92\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>GB\/T 14295<\/td>\n<td>F5<\/td>\n<td>40%~60%<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>F6<\/td>\n<td>60%~80%<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>F7<\/td>\n<td>80%~90%<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>F8<\/td>\n<td>90%~95%<\/td>\n<\/tr>\n<tr>\n<td>EN 779:2012<\/td>\n<td>M5<\/td>\n<td>&gt;40%<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>M6<\/td>\n<td>&gt;60%<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>M7<\/td>\n<td>&gt;80%<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>M8<\/td>\n<td>&gt;90%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u901a\u5e38\u9009\u7528F7\u6216M7\u7b49\u7ea7\u4ee5\u4e0a\u7684\u4e2d\u6548\u8fc7\u6ee4\u5668\uff0c\u4ee5\u786e\u4fdd\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u7684\u6574\u4f53\u6548\u7387\u3002<\/p>\n<hr \/>\n<h2>\u56db\u3001\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728GMP\u6807\u51c6\u4e0b\u7684\u5e94\u7528\u89c4\u8303<\/h2>\n<h3>4.1 \u6d01\u51c0\u8f66\u95f4\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u914d\u7f6e\u8981\u6c42<\/h3>\n<p>\u6839\u636eGMP\u89c4\u8303\uff0c\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u7684\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u5e94\u5305\u62ec\u521d\u6548\u3001\u4e2d\u6548\u3001\u9ad8\u6548\u4e09\u7ea7\u8fc7\u6ee4\u3002\u4e2d\u6548\u8fc7\u6ee4\u5668\u901a\u5e38\u4f4d\u4e8e\u7a7a\u8c03\u673a\u7ec4\u7684\u4e2d\u6bb5\uff0c\u8d77\u5230\u627f\u4e0a\u542f\u4e0b\u7684\u4f5c\u7528\u3002<\/p>\n<p>\u5178\u578b\u5236\u836f\u6d01\u51c0\u8f66\u95f4\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u6d41\u7a0b\u5982\u4e0b\uff1a<\/p>\n<pre><code>\u65b0\u98ce\u5165\u53e3 \u2192 \u521d\u6548\u8fc7\u6ee4\u5668 \u2192 \u9884\u52a0\u70ed\u6bb5 \u2192 \u52a0\u6e7f\u6bb5 \u2192 \u4e2d\u6548\u8fc7\u6ee4\u5668 \u2192 \u8868\u51b7\u6bb5 \u2192 \u98ce\u673a\u6bb5 \u2192 \u9ad8\u6548\u8fc7\u6ee4\u5668 \u2192 \u6d01\u51c0\u5ba4<\/code><\/pre>\n<h3>4.2 \u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u4e0d\u540c\u6d01\u51c0\u7b49\u7ea7\u4e2d\u7684\u914d\u7f6e\u5efa\u8bae<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7b49\u7ea7<\/th>\n<th>\u4e2d\u6548\u8fc7\u6ee4\u5668\u5efa\u8bae\u7b49\u7ea7<\/th>\n<th>\u662f\u5426\u9700\u914d\u5408\u9ad8\u6548\u8fc7\u6ee4\u5668\u4f7f\u7528<\/th>\n<th>\u5907\u6ce8<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7<\/td>\n<td>F7\u6216M7\u4ee5\u4e0a<\/td>\n<td>\u662f<\/td>\n<td>\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e3aHEPA\uff0cH13\u6216H14\u7ea7<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7<\/td>\n<td>F7<\/td>\n<td>\u662f<\/td>\n<td>\u5e38\u7528\u4e8e\u5c40\u90e8\u51c0\u5316\u533a\u57df<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7<\/td>\n<td>F6<\/td>\n<td>\u662f<\/td>\n<td>\u53ef\u9009\u7528F7\u63d0\u5347\u6548\u7387<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7<\/td>\n<td>F5<\/td>\n<td>\u5426<\/td>\n<td>\u53ef\u5355\u72ec\u4f7f\u7528\u4e2d\u6548\u8fc7\u6ee4\u5668<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>4.3 \u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u4f4d\u7f6e\u4e0e\u8981\u6c42<\/h3>\n<ul>\n<li><strong>\u5b89\u88c5\u4f4d\u7f6e<\/strong>\uff1a\u5e94\u5b89\u88c5\u5728\u7a7a\u8c03\u7cfb\u7edf\u7684\u4e2d\u6bb5\uff0c\u907f\u514d\u76f4\u63a5\u63a5\u89e6\u9ad8\u6e29\u9ad8\u6e7f\u7a7a\u6c14\uff0c\u9632\u6b62\u6ee4\u6750\u8001\u5316\uff1b<\/li>\n<li><strong>\u5b89\u88c5\u65b9\u5411<\/strong>\uff1a\u6ce8\u610f\u6c14\u6d41\u65b9\u5411\u6807\u8bc6\uff0c\u786e\u4fdd\u8fc7\u6ee4\u5668\u6b63\u786e\u5b89\u88c5\uff1b<\/li>\n<li><strong>\u5bc6\u5c01\u6027\u8981\u6c42<\/strong>\uff1a\u5fc5\u987b\u4f7f\u7528\u6a61\u80f6\u5bc6\u5c01\u6761\u6216\u5bc6\u5c01\u80f6\u6761\uff0c\u9632\u6b62\u65c1\u8def\u6cc4\u6f0f\uff1b<\/li>\n<li><strong>\u66f4\u6362\u5468\u671f<\/strong>\uff1a\u4e00\u822c\u5efa\u8bae\u6bcf6~12\u4e2a\u6708\u66f4\u6362\u4e00\u6b21\uff0c\u5177\u4f53\u89c6\u538b\u5dee\u62a5\u8b66\u5668\u63d0\u793a\u4e3a\u51c6\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e94\u3001\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u53c2\u6570\u4e0e\u9009\u578b\u6307\u5357<\/h2>\n<h3>5.1 \u4e3b\u8981\u6280\u672f\u53c2\u6570<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u540d\u79f0<\/th>\n<th>\u5355\u4f4d<\/th>\n<th>\u5178\u578b\u503c\u8303\u56f4<\/th>\n<th>\u5907\u6ce8<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>%<\/td>\n<td>80%~95%<\/td>\n<td>\u6839\u636eEN 779\u6216GB\/T 14295\u6807\u51c6<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>Pa<\/td>\n<td>50~150<\/td>\n<td>\u963b\u529b\u8d8a\u4f4e\u80fd\u8017\u8d8a\u5c0f<\/td>\n<\/tr>\n<tr>\n<td>\u6700\u7ec8\u963b\u529b\u8bbe\u5b9a\u503c<\/td>\n<td>Pa<\/td>\n<td>250~400<\/td>\n<td>\u8fbe\u5230\u8be5\u503c\u9700\u66f4\u6362<\/td>\n<\/tr>\n<tr>\n<td>\u5de5\u4f5c\u6e29\u5ea6\u8303\u56f4<\/td>\n<td>\u2103<\/td>\n<td>-10~80<\/td>\n<td>\u9002\u7528\u4e8e\u5927\u591a\u6570\u6d01\u51c0\u8f66\u95f4\u73af\u5883<\/td>\n<\/tr>\n<tr>\n<td>\u76f8\u5bf9\u6e7f\u5ea6\u8303\u56f4<\/td>\n<td>%RH<\/td>\n<td>20%~90%<\/td>\n<td>\u4e0d\u7ed3\u9732\u6761\u4ef6\u4e0b\u4f7f\u7528<\/td>\n<\/tr>\n<tr>\n<td>\u5c3a\u5bf8\u89c4\u683c<\/td>\n<td>mm<\/td>\n<td>\u6309\u5ba2\u6237\u9700\u6c42\u5b9a\u5236<\/td>\n<td>\u5e38\u89c1\u5c3a\u5bf8\uff1a592\u00d7592\u00d7460\u7b49<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28<\/td>\n<td>\u2014<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\u3001\u805a\u916f\u65e0\u7eba\u5e03<\/td>\n<td>\u5e38\u7528\u6750\u6599\u4e3a\u73bb\u7ea4\u590d\u5408\u6ee4\u6750<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>5.2 \u9009\u578b\u6307\u5357<\/h3>\n<p>\u5728\u9009\u62e9\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u65f6\uff0c\u5e94\u7efc\u5408\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n<ul>\n<li><strong>\u6d01\u51c0\u7b49\u7ea7\u8981\u6c42<\/strong>\uff1a\u4e0d\u540c\u6d01\u51c0\u7b49\u7ea7\u9700\u8981\u4e0d\u540c\u6548\u7387\u7b49\u7ea7\u7684\u8fc7\u6ee4\u5668\uff1b<\/li>\n<li><strong>\u98ce\u91cf\u4e0e\u98ce\u901f<\/strong>\uff1a\u6839\u636e\u7a7a\u8c03\u7cfb\u7edf\u98ce\u91cf\u9009\u62e9\u5408\u9002\u7684\u8fc7\u6ee4\u5668\u5c3a\u5bf8\uff1b<\/li>\n<li><strong>\u963b\u529b\u5339\u914d<\/strong>\uff1a\u786e\u4fdd\u8fc7\u6ee4\u5668\u963b\u529b\u4e0e\u98ce\u673a\u5339\u914d\uff0c\u907f\u514d\u80fd\u8017\u8fc7\u9ad8\uff1b<\/li>\n<li><strong>\u4f7f\u7528\u5bff\u547d\u4e0e\u7ef4\u62a4\u6210\u672c<\/strong>\uff1a\u9009\u62e9\u963b\u529b\u589e\u957f\u7f13\u6162\u3001\u66f4\u6362\u5468\u671f\u957f\u7684\u4ea7\u54c1\uff1b<\/li>\n<li><strong>\u6750\u6599\u5b89\u5168\u6027<\/strong>\uff1a\u4e0d\u5f97\u91ca\u653e\u6709\u5bb3\u7269\u8d28\uff0c\u5c24\u5176\u5728\u65e0\u83cc\u836f\u54c1\u751f\u4ea7\u4e2d\uff1b<\/li>\n<li><strong>\u8ba4\u8bc1\u6807\u51c6<\/strong>\uff1a\u4f18\u5148\u9009\u62e9\u901a\u8fc7ISO 9001\u3001EN 779\u3001GB\/T 14295\u7b49\u8ba4\u8bc1\u7684\u4ea7\u54c1\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u516d\u3001\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u68c0\u6d4b\u4e0e\u7ef4\u62a4<\/h2>\n<h3>6.1 \u68c0\u6d4b\u6807\u51c6\u4e0e\u65b9\u6cd5<\/h3>\n<p>\u6839\u636e\u300aGB\/T 14295-2008\u300b\u548c\u300aEN 779:2012\u300b\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u68c0\u6d4b\u9879\u76ee\u5305\u62ec\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u68c0\u6d4b\u9879\u76ee<\/th>\n<th>\u68c0\u6d4b\u65b9\u6cd5<\/th>\n<th>\u68c0\u6d4b\u9891\u7387<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u8ba1\u6570\u6cd5\u6216\u8d28\u91cf\u6cd5<\/td>\n<td>\u51fa\u5382\u524d\u5fc5\u68c0<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u5dee\u538b\u8ba1\u6d4b\u91cf<\/td>\n<td>\u51fa\u5382\u524d\u5fc5\u68c0<\/td>\n<\/tr>\n<tr>\n<td>\u8010\u706b\u6027\u80fd<\/td>\n<td>\u706b\u7130\u71c3\u70e7\u8bd5\u9a8c<\/td>\n<td>\u7279\u6b8a\u573a\u6240\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u68c0\u6d4b<\/td>\n<td>\u6c14\u6eb6\u80f6\u626b\u63cf\u6cd5<\/td>\n<td>\u5b89\u88c5\u540e\u9996\u6b21\u68c0\u6d4b<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u62a5\u8b66\u8bbe\u5b9a<\/td>\n<td>\u5b9e\u9645\u8fd0\u884c\u76d1\u6d4b<\/td>\n<td>\u65e5\u5e38\u8fd0\u884c\u4e2d\u76d1\u6d4b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>6.2 \u7ef4\u62a4\u4e0e\u66f4\u6362\u89c4\u8303<\/h3>\n<ul>\n<li><strong>\u538b\u5dee\u76d1\u6d4b<\/strong>\uff1a\u6bcf\u53f0\u4e2d\u6548\u8fc7\u6ee4\u5668\u5e94\u914d\u5907\u538b\u5dee\u8ba1\uff0c\u5f53\u538b\u5dee\u8fbe\u5230\u8bbe\u5b9a\u503c\uff08\u5982250Pa\uff09\u65f6\u5e94\u53ca\u65f6\u66f4\u6362\uff1b<\/li>\n<li><strong>\u5b9a\u671f\u5de1\u68c0<\/strong>\uff1a\u5efa\u8bae\u6bcf\u6708\u68c0\u67e5\u4e00\u6b21\u8fc7\u6ee4\u5668\u5bc6\u5c01\u6027\u3001\u538b\u5dee\u53d8\u5316\u53ca\u5916\u89c2\u5b8c\u6574\u6027\uff1b<\/li>\n<li><strong>\u66f4\u6362\u64cd\u4f5c<\/strong>\uff1a\u66f4\u6362\u65f6\u5e94\u4f69\u6234\u9632\u62a4\u88c5\u5907\uff0c\u907f\u514d\u4e8c\u6b21\u6c61\u67d3\uff0c\u65e7\u6ee4\u6750\u5e94\u6309\u533b\u7597\u5e9f\u7269\u5904\u7406\uff1b<\/li>\n<li><strong>\u8bb0\u5f55\u7ba1\u7406<\/strong>\uff1a\u5efa\u7acb\u8fc7\u6ee4\u5668\u66f4\u6362\u8bb0\u5f55\uff0c\u5305\u62ec\u66f4\u6362\u65f6\u95f4\u3001\u538b\u5dee\u6570\u636e\u3001\u64cd\u4f5c\u4eba\u5458\u7b49\u4fe1\u606f\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e03\u3001\u6848\u4f8b\u5206\u6790\u4e0e\u56fd\u5185\u5916\u7814\u7a76\u7efc\u8ff0<\/h2>\n<h3>7.1 \u56fd\u5185\u5e94\u7528\u6848\u4f8b<\/h3>\n<p>\u6839\u636e\u300a\u4e2d\u56fd\u5236\u836f\u88c5\u5907\u300b2021\u5e74\u7b2c5\u671f\u62a5\u9053\uff0c\u67d0\u5927\u578b\u5236\u836f\u4f01\u4e1a\u5728\u5efa\u8bbeC\u7ea7\u6d01\u51c0\u8f66\u95f4\u65f6\uff0c\u91c7\u7528F7\u7ea7\u4e2d\u6548\u7bb1\u5f0f\u8fc7\u6ee4\u5668\u914d\u5408HEPA\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u6210\u529f\u5c06\u7a7a\u6c14\u4e2d\u22650.5\u03bcm\u9897\u7c92\u6570\u63a7\u5236\u5728352,000\u7c92\/m\u00b3\u4ee5\u5185\uff0c\u8fbe\u5230GMP\u6807\u51c6\u8981\u6c42\u3002<\/p>\n<h3>7.2 \u56fd\u5916\u7814\u7a76\u8fdb\u5c55<\/h3>\n<p>\u6839\u636e\u7f8e\u56fdASHRAE\uff08\u7f8e\u56fd\u91c7\u6696\u3001\u5236\u51b7\u4e0e\u7a7a\u8c03\u5de5\u7a0b\u5e08\u534f\u4f1a\uff09\u53d1\u5e03\u7684\u300aASHRAE Handbook\u2014HVAC Systems and Equipment\u300b\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u6d01\u51c0\u7cfb\u7edf\u4e2d\u627f\u62c5\u7740\u5173\u952e\u7684\u4e2d\u95f4\u8fc7\u6ee4\u4f5c\u7528\uff0c\u63a8\u8350\u4f7f\u7528F7\/M7\u7b49\u7ea7\u4ee5\u4e0a\u7684\u8fc7\u6ee4\u5668\u4ee5\u63d0\u9ad8\u6574\u4f53\u7cfb\u7edf\u6548\u7387\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u6b27\u6d32\u5236\u836f\u5de5\u7a0b\u534f\u4f1a\uff08PDA\uff09\u5728\u5176\u300aTechnical Report No. 42\u300b\u4e2d\u6307\u51fa\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u5b9a\u671f\u66f4\u6362\u548c\u538b\u5dee\u76d1\u6d4b\u662f\u786e\u4fdd\u6d01\u51c0\u8f66\u95f4\u7a7a\u6c14\u8d28\u91cf\u7a33\u5b9a\u7684\u91cd\u8981\u624b\u6bb5\u3002<\/p>\n<hr \/>\n<h2>\u516b\u3001\u7ed3\u8bed\uff08\u7565\uff09<\/h2>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b[Z]. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2011.  <\/li>\n<li>\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u56fd\u5bb6\u6807\u51c6. GB\/T 14295-2008 \u7a7a\u6c14\u8fc7\u6ee4\u5668[S]. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2008.  <\/li>\n<li>European Committee for Standardization. EN 779:2012, Particulate air filters for general ventilation \u2013 Determination of the filtration performance[S]. Brussels, 2012.  <\/li>\n<li>ASHRAE. ASHRAE Handbook\u2014HVAC Systems and Equipment[M]. Atlanta: ASHRAE, 2020.  <\/li>\n<li>PDA. Technical Report No. 42: Heating, Ventilation, and Air-Conditioning (HVAC) Systems for Pharmaceutical Facilities[R]. Bethesda: PDA, 2017.  <\/li>\n<li>\u300a\u4e2d\u56fd\u5236\u836f\u88c5\u5907\u300b2021\u5e74\u7b2c5\u671f\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u5e94\u7528\u7814\u7a76[J].  <\/li>\n<li>\u767e\u5ea6\u767e\u79d1. \u7a7a\u6c14\u8fc7\u6ee4\u5668[EB\/OL]. <a href=\"https:\/\/baike.baidu.com\/item\/\u7a7a\u6c14\u8fc7\u6ee4\u5668\/5480189\">https:\/\/baike.baidu.com\/item\/\u7a7a\u6c14\u8fc7\u6ee4\u5668\/5480189<\/a>  <\/li>\n<li>\u767e\u5ea6\u767e\u79d1. GMP[EB\/OL]. <a href=\"https:\/\/baike.baidu.com\/item\/GMP\/1043354\">https:\/\/baike.baidu.com\/item\/GMP\/1043354<\/a>  <\/li>\n<\/ol>\n<p>\uff08\u5168\u6587\u7ea63800\u5b57\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6807\u51c6\u4e0b\u7684\u5e94\u7528\u89c4\u8303 \u4e00\u3001\u5f15\u8a00 \u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5f71\u54cd\u836f\u54c1\u7684\u8d28\u91cf\u4e0e\u5b89\u5168\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice\uff0c\u7b80\u79f0GMP\uff09\u7684\u8981\u6c42\uff0c\u5236\u836f\u4f01\u4e1a\u5fc5\u987b\u5bf9\u751f\u4ea7\u73af\u5883\u4e2d\u7684\u7a7a\u6c14\u8fdb\u884c\u6709\u6548\u8fc7\u6ee4\u548c\u51c0\u5316\uff0c\u4ee5\u786e\u4fdd\u836f\u54c1\u4e0d\u53d7\u5fae\u751f\u7269\u3001\u9897\u7c92\u7269\u7b49\u6c61\u67d3\u7269\u7684\u6c61\u67d3\u3002\u4e2d\u6548\u7bb1\u5f0f\u7a7a\u6c14\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4e2d\u7684\u5173\u952e\u8bbe\u5907\u4e4b\u4e00&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-16235","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\/16235","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=16235"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/16235\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=16235"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=16235"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=16235"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}