{"id":14210,"date":"2025-05-23T11:03:11","date_gmt":"2025-05-23T03:03:11","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=14210"},"modified":"2025-05-23T11:03:11","modified_gmt":"2025-05-23T03:03:11","slug":"%e4%b8%ad%e6%95%88%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%b4%81%e5%87%80%e8%bd%a6%e9%97%b4%e4%b8%ad%e7%9a%84%e9%85%8d%e7%bd%ae%e6%a0%87%e5%87%86","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=14210","title":{"rendered":"\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u914d\u7f6e\u6807\u51c6"},"content":{"rendered":"<h1>\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u914d\u7f6e\u6807\u51c6<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u751f\u4ea7\u73af\u5883\u5bf9\u4ea7\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u6027\u5177\u6709\u51b3\u5b9a\u6027\u5f71\u54cd\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u8981\u6c42\uff0c\u5236\u836f\u4f01\u4e1a\u5fc5\u987b\u786e\u4fdd\u5176\u751f\u4ea7\u8f66\u95f4\u5177\u5907\u826f\u597d\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\uff0c\u4ee5\u9632\u6b62\u5fae\u7c92\u548c\u5fae\u751f\u7269\u6c61\u67d3\u836f\u54c1\u3002\u5176\u4e2d\uff0c\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4f5c\u4e3a\u4fdd\u969c\u6d01\u51c0\u73af\u5883\u7684\u6838\u5fc3\u7ec4\u6210\u90e8\u5206\uff0c\u800c\u4e2d\u6548\u8fc7\u6ee4\u5668\u5219\u662f\u8be5\u7cfb\u7edf\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u5173\u952e\u8bbe\u5907\u4e4b\u4e00\u3002<\/p>\n<p>\u672c\u6587\u5c06\u56f4\u7ed5<strong>\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u914d\u7f6e\u6807\u51c6<\/strong>\u8fdb\u884c\u6df1\u5165\u63a2\u8ba8\uff0c\u6db5\u76d6\u5176\u5b9a\u4e49\u3001\u4f5c\u7528\u3001\u6280\u672f\u53c2\u6570\u3001\u9009\u578b\u4f9d\u636e\u3001\u5b89\u88c5\u4e0e\u7ef4\u62a4\u8981\u6c42\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u76f8\u5173\u6587\u732e\u8d44\u6599\uff0c\u4e3a\u5236\u836f\u4f01\u4e1a\u63d0\u4f9b\u79d1\u5b66\u3001\u5408\u7406\u7684\u53c2\u8003\u65b9\u6848\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u6982\u5ff5\u4e0e\u5206\u7c7b<\/h2>\n<h3>1.1 \u5b9a\u4e49<\/h3>\n<p>\u4e2d\u6548\u8fc7\u6ee4\u5668\u662f\u6307\u5bf9\u7c92\u5f84\u57280.5~5 \u03bcm\u8303\u56f4\u5185\u7684\u60ac\u6d6e\u9897\u7c92\u5177\u6709\u4e00\u5b9a\u6355\u96c6\u6548\u7387\u7684\u7a7a\u6c14\u8fc7\u6ee4\u8bbe\u5907\uff0c\u901a\u5e38\u7528\u4e8e\u53bb\u9664\u7a7a\u6c14\u4e2d\u8f83\u5927\u9897\u7c92\u6c61\u67d3\u7269\uff0c\u5982\u7070\u5c18\u3001\u82b1\u7c89\u3001\u7ec6\u83cc\u8f7d\u4f53\u7b49\u3002\u5176\u8fc7\u6ee4\u6548\u7387\u4e00\u822c\u4ecb\u4e8e30%~70%\u4e4b\u95f4\uff08\u6309EN 779:2012\u6216ASHRAE 52.2\u6807\u51c6\uff09\uff0c\u5c5e\u4e8e\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4e2d\u7684\u4e2d\u95f4\u73af\u8282\u3002<\/p>\n<h3>1.2 \u5206\u7c7b<\/h3>\n<p>\u6839\u636e\u4e0d\u540c\u7684\u6807\u51c6\u548c\u7528\u9014\uff0c\u4e2d\u6548\u8fc7\u6ee4\u5668\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5206\u7c7b\u65b9\u5f0f<\/th>\n<th>\u7c7b\u578b<\/th>\n<th>\u7279\u70b9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6309\u6ee4\u6750\u6750\u8d28<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\u3001\u805a\u916f\u7ea4\u7ef4\u3001\u65e0\u7eba\u5e03<\/td>\n<td>\u4e0d\u540c\u6750\u6599\u9002\u5e94\u4e0d\u540c\u6e7f\u5ea6\u548c\u6e29\u5ea6\u6761\u4ef6<\/td>\n<\/tr>\n<tr>\n<td>\u6309\u7ed3\u6784\u5f62\u5f0f<\/td>\n<td>\u677f\u5f0f\u3001\u6298\u53e0\u5f0f\u3001\u888b\u5f0f<\/td>\n<td>\u888b\u5f0f\u8fc7\u6ee4\u9762\u79ef\u5927\uff0c\u963b\u529b\u4f4e<\/td>\n<\/tr>\n<tr>\n<td>\u6309\u4f7f\u7528\u573a\u5408<\/td>\n<td>\u5de5\u4e1a\u7ea7\u3001\u533b\u7528\u7ea7\u3001\u5b9e\u9a8c\u5ba4\u7ea7<\/td>\n<td>\u533b\u836f\u884c\u4e1a\u591a\u91c7\u7528\u533b\u7528\u7ea7\u4ea7\u54c1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>1.3 \u56fd\u5185\u5916\u6807\u51c6\u5bf9\u6bd4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u6807\u51c6\u4f53\u7cfb<\/th>\n<th>\u6807\u51c6\u540d\u79f0<\/th>\n<th>\u9002\u7528\u56fd\u5bb6\/\u5730\u533a<\/th>\n<th>\u4e3b\u8981\u5185\u5bb9<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>ISO<\/td>\n<td>ISO 16890<\/td>\n<td>\u5168\u7403\u901a\u7528<\/td>\n<td>\u65b0\u4e00\u4ee3\u7a7a\u6c14\u8fc7\u6ee4\u5668\u6d4b\u8bd5\u6807\u51c6\uff0c\u66ff\u4ee3EN 779<\/td>\n<\/tr>\n<tr>\n<td>EN<\/td>\n<td>EN 779:2012<\/td>\n<td>\u6b27\u6d32<\/td>\n<td>\u5bf9\u4e2d\u6548\u8fc7\u6ee4\u5668\u8fdb\u884c\u5206\u7ea7\uff1aF5-F9<\/td>\n<\/tr>\n<tr>\n<td>ASHRAE<\/td>\n<td>ASHRAE 52.2<\/td>\n<td>\u7f8e\u56fd<\/td>\n<td>\u6309MERV\u7b49\u7ea7\u5212\u5206\u8fc7\u6ee4\u6548\u7387<\/td>\n<\/tr>\n<tr>\n<td>GB<\/td>\n<td>GB\/T 14295-2008<\/td>\n<td>\u4e2d\u56fd<\/td>\n<td>\u89c4\u5b9a\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u6307\u6807\u53ca\u6d4b\u8bd5\u65b9\u6cd5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\n[1] European Committee for Standardization. EN 779:2012, Particulate air filters for general ventilation &#8211; Determination of the filtration performance.<br \/>\n[2] American Society of Heating, Refrigerating and Air-Conditioning Engineers. ANSI\/ASHRAE Standard 52.2-2017, Method of Testing General Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size.<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e8c\u3001\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728GMP\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u4f5c\u7528\u4e0e\u91cd\u8981\u6027<\/h2>\n<h3>2.1 \u63d0\u5347\u7a7a\u6c14\u8d28\u91cf<\/h3>\n<p>\u4e2d\u6548\u8fc7\u6ee4\u5668\u4f4d\u4e8e\u521d\u6548\u8fc7\u6ee4\u5668\u4e4b\u540e\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e4b\u524d\uff0c\u8d77\u5230\u627f\u4e0a\u542f\u4e0b\u7684\u4f5c\u7528\u3002\u5176\u4e3b\u8981\u529f\u80fd\u662f\u8fdb\u4e00\u6b65\u53bb\u9664\u7a7a\u6c14\u4e2d\u7684\u4e2d\u7b49\u5927\u5c0f\u9897\u7c92\u7269\uff0c\u51cf\u8f7b\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u8d1f\u62c5\uff0c\u5ef6\u957f\u5176\u4f7f\u7528\u5bff\u547d\u3002<\/p>\n<h3>2.2 \u9632\u6b62\u4ea4\u53c9\u6c61\u67d3<\/h3>\n<p>\u5728\u5236\u836f\u73af\u5883\u4e2d\uff0c\u5c24\u5176\u662f\u53e3\u670d\u56fa\u4f53\u5236\u5242\u3001\u6ce8\u5c04\u5242\u7b49\u9ad8\u98ce\u9669\u5236\u5242\u7684\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u7a7a\u6c14\u4e2d\u7684\u5fae\u751f\u7269\u53ca\u5176\u5b62\u5b50\u53ef\u80fd\u6210\u4e3a\u6c61\u67d3\u6e90\u3002\u4e2d\u6548\u8fc7\u6ee4\u5668\u901a\u8fc7\u62e6\u622a\u643a\u5e26\u5fae\u751f\u7269\u7684\u9897\u7c92\uff0c\u6709\u52a9\u4e8e\u964d\u4f4e\u4ea4\u53c9\u6c61\u67d3\u7684\u98ce\u9669\u3002<\/p>\n<h3>2.3 \u63a7\u5236\u5c18\u57c3\u7c92\u5b50\u6d53\u5ea6<\/h3>\n<p>\u6839\u636e\u300a\u4e2d\u56fd\u836f\u5178\u300b\u548cWHO GMP\u6307\u5357\uff0c\u4e0d\u540c\u6d01\u51c0\u7ea7\u522b\u7684\u8f66\u95f4\u5bf9\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u7c92\u5b50\u6570\u91cf\u6709\u660e\u786e\u9650\u5236\u3002\u4e2d\u6548\u8fc7\u6ee4\u5668\u901a\u8fc7\u9ad8\u6548\u7684\u9897\u7c92\u6355\u96c6\u80fd\u529b\uff0c\u6709\u52a9\u4e8e\u7ef4\u6301\u6d01\u51c0\u5ba4\u7684\u7c92\u5b50\u63a7\u5236\u6c34\u5e73\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u7ea7\u522b<\/th>\n<th>\u22650.5\u03bcm\u7c92\u5b50\u6700\u5927\u5141\u8bb8\u6570\uff08\u4e2a\/m\u00b3\uff09<\/th>\n<th>\u22655\u03bcm\u7c92\u5b50\u6700\u5927\u5141\u8bb8\u6570\uff08\u4e2a\/m\u00b3\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>A\u7ea7\uff08ISO 5\uff09<\/td>\n<td>\u22643,520<\/td>\n<td>\u226420<\/td>\n<\/tr>\n<tr>\n<td>B\u7ea7\uff08ISO 7\uff09<\/td>\n<td>\u2264352,000<\/td>\n<td>\u22642,900<\/td>\n<\/tr>\n<tr>\n<td>C\u7ea7\uff08ISO 8\uff09<\/td>\n<td>\u22643,520,000<\/td>\n<td>\u226429,000<\/td>\n<\/tr>\n<tr>\n<td>D\u7ea7\uff08ISO 9\uff09<\/td>\n<td>\u226410,560,000<\/td>\n<td>\u226487,000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\n[3] \u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a. \u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b2020\u7248\uff0c\u56db\u90e8\u901a\u52190901\u201c\u836f\u54c1\u6d01\u51c0\u5b9e\u9a8c\u5ba4\u5fae\u751f\u7269\u76d1\u6d4b\u548c\u63a7\u5236\u6307\u5bfc\u539f\u5219\u201d\u3002<br \/>\n[4] WHO Technical Report Series, No. 961, Annex 1: Manufacture of Sterile Medicinal Products.<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e09\u3001\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u53c2\u6570\u4e0e\u9009\u578b\u6807\u51c6<\/h2>\n<h3>3.1 \u5e38\u89c1\u6280\u672f\u53c2\u6570<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u5355\u4f4d<\/th>\n<th>\u542b\u4e49<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>%<\/td>\n<td>\u8868\u793a\u5bf9\u7279\u5b9a\u7c92\u5f84\u9897\u7c92\u7684\u6355\u96c6\u80fd\u529b<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>Pa<\/td>\n<td>\u65b0\u8fc7\u6ee4\u5668\u8fd0\u884c\u65f6\u7684\u538b\u529b\u635f\u5931<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b<\/td>\n<td>Pa<\/td>\n<td>\u63a8\u8350\u66f4\u6362\u538b\u529b\u503c<\/td>\n<\/tr>\n<tr>\n<td>\u5bb9\u5c18\u91cf<\/td>\n<td>g<\/td>\n<td>\u53ef\u5bb9\u7eb3\u9897\u7c92\u7269\u7684\u6700\u5927\u91cd\u91cf<\/td>\n<\/tr>\n<tr>\n<td>\u9762\u98ce\u901f<\/td>\n<td>m\/s<\/td>\n<td>\u6d41\u7ecf\u6ee4\u6599\u8868\u9762\u7684\u6c14\u6d41\u901f\u5ea6<\/td>\n<\/tr>\n<tr>\n<td>\u5c3a\u5bf8<\/td>\n<td>mm<\/td>\n<td>\u6839\u636e\u73b0\u573a\u9700\u6c42\u5b9a\u5236<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28<\/td>\n<td>\u2014\u2014<\/td>\n<td>\u51b3\u5b9a\u8010\u6e29\u3001\u8010\u6e7f\u6027\u80fd<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>3.2 \u56fd\u5185\u4e3b\u6d41\u54c1\u724c\u63a8\u8350<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u54c1\u724c<\/th>\n<th>\u4ea7\u5730<\/th>\n<th>\u7279\u70b9<\/th>\n<th>\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u82cf\u5dde\u5b89\u6cf0\u7a7a\u6c14\u6280\u672f\u6709\u9650\u516c\u53f8<\/td>\n<td>\u4e2d\u56fd<\/td>\n<td>\u81ea\u4e3b\u7814\u53d1\uff0c\u6027\u4ef7\u6bd4\u9ad8<\/td>\n<td>\u5236\u836f\u3001\u533b\u9662<\/td>\n<\/tr>\n<tr>\n<td>Honeywell<\/td>\n<td>\u7f8e\u56fd<\/td>\n<td>\u6027\u80fd\u7a33\u5b9a\uff0c\u8ba4\u8bc1\u9f50\u5168<\/td>\n<td>\u751f\u7269\u533b\u836f\u3001\u534a\u5bfc\u4f53<\/td>\n<\/tr>\n<tr>\n<td>Camfil<\/td>\n<td>\u745e\u5178<\/td>\n<td>\u7eff\u8272\u73af\u4fdd\u7406\u5ff5<\/td>\n<td>\u9ad8\u7aef\u6d01\u51c0\u5382\u623f<\/td>\n<\/tr>\n<tr>\n<td>Donaldson<\/td>\n<td>\u7f8e\u56fd<\/td>\n<td>\u6297\u83cc\u6d82\u5c42\u53ef\u9009<\/td>\n<td>\u6ce8\u5c04\u5242\u8f66\u95f4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>3.3 \u9009\u578b\u4f9d\u636e<\/h3>\n<p>\u5728\u5236\u836fGMP\u6d01\u51c0\u8f66\u95f4\u4e2d\u9009\u62e9\u4e2d\u6548\u8fc7\u6ee4\u5668\u65f6\uff0c\u5e94\u7efc\u5408\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u9009\u578b\u8981\u7d20<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6d01\u51c0\u7ea7\u522b\u8981\u6c42<\/td>\n<td>A\/B\/C\/D\u7ea7\u5bf9\u5e94\u4e0d\u540c\u8fc7\u6ee4\u7b49\u7ea7<\/td>\n<\/tr>\n<tr>\n<td>\u7cfb\u7edf\u98ce\u91cf<\/td>\n<td>\u5f71\u54cd\u8fc7\u6ee4\u5668\u5c3a\u5bf8\u548c\u6570\u91cf<\/td>\n<\/tr>\n<tr>\n<td>\u6e29\u6e7f\u5ea6\u6761\u4ef6<\/td>\n<td>\u5f71\u54cd\u6ee4\u6750\u5bff\u547d\u548c\u6548\u7387<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u5468\u671f<\/td>\n<td>\u9700\u7ed3\u5408\u5bb9\u5c18\u91cf\u4e0e\u5b9e\u9645\u8fd0\u884c\u65f6\u95f4<\/td>\n<\/tr>\n<tr>\n<td>\u6210\u672c\u9884\u7b97<\/td>\n<td>\u521d\u671f\u6295\u8d44\u4e0e\u957f\u671f\u8fd0\u8425\u6210\u672c\u9700\u5e73\u8861<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\n[5] \u5f20\u5fd7\u521a. \u51c0\u5316\u7a7a\u8c03\u7cfb\u7edf\u8bbe\u8ba1\u624b\u518c[M]. \u5317\u4eac: \u673a\u68b0\u5de5\u4e1a\u51fa\u7248\u793e, 2015.<br \/>\n[6] ASHRAE Handbook \u2013 HVAC Systems and Equipment, 2020 Edition.<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u56db\u3001\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u4e0e\u8fd0\u884c\u7ba1\u7406<\/h2>\n<h3>4.1 \u5b89\u88c5\u4f4d\u7f6e<\/h3>\n<p>\u4e2d\u6548\u8fc7\u6ee4\u5668\u4e00\u822c\u5b89\u88c5\u5728\u51c0\u5316\u7a7a\u8c03\u7cfb\u7edf\u7684<strong>\u4e2d\u7ea7\u6bb5<\/strong>\uff0c\u5373\u98ce\u673a\u51fa\u53e3\u540e\u3001\u8868\u51b7\u5668\u6216\u52a0\u70ed\u5668\u4e4b\u540e\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e4b\u524d\u3002\u8fd9\u6837\u53ef\u4ee5\u6709\u6548\u4fdd\u62a4\u9ad8\u6548\u8fc7\u6ee4\u5668\u514d\u53d7\u5927\u9897\u7c92\u6c61\u67d3\uff0c\u540c\u65f6\u907f\u514d\u56e0\u9ad8\u6e29\u9ad8\u6e7f\u5bfc\u81f4\u6ee4\u6750\u53d8\u5f62\u3002<\/p>\n<h3>4.2 \u5b89\u88c5\u6ce8\u610f\u4e8b\u9879<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5bc6\u5c01\u6027<\/td>\n<td>\u5fc5\u987b\u4fdd\u8bc1\u826f\u597d\u5bc6\u5c01\uff0c\u9632\u6b62\u65c1\u8def\u6f0f\u98ce<\/td>\n<\/tr>\n<tr>\n<td>\u65b9\u5411\u6027<\/td>\n<td>\u6ce8\u610f\u6c14\u6d41\u65b9\u5411\u6807\u8bc6\uff0c\u4e0d\u5f97\u53cd\u88c5<\/td>\n<\/tr>\n<tr>\n<td>\u652f\u6491\u7ed3\u6784<\/td>\n<td>\u9700\u7a33\u56fa\u652f\u6491\uff0c\u9632\u6b62\u9707\u52a8\u5f15\u8d77\u6cc4\u6f0f<\/td>\n<\/tr>\n<tr>\n<td>\u63a5\u53e3\u5339\u914d<\/td>\n<td>\u4e0e\u98ce\u7ba1\u63a5\u53e3\u5c3a\u5bf8\u4e00\u81f4\uff0c\u6cd5\u5170\u8fde\u63a5\u7d27\u5bc6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>4.3 \u8fd0\u884c\u7ba1\u7406\u4e0e\u7ef4\u62a4<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u7ba1\u7406\u5185\u5bb9<\/th>\n<th>\u5b9e\u65bd\u5efa\u8bae<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5b9a\u671f\u5de1\u68c0<\/td>\n<td>\u6bcf\u5468\u68c0\u67e5\u538b\u5dee\u8ba1\u8bfb\u6570<\/td>\n<\/tr>\n<tr>\n<td>\u538b\u5dee\u76d1\u63a7<\/td>\n<td>\u8fbe\u5230\u7ec8\u963b\u529b\u503c\uff08\u4e00\u822c\u4e3a\u521d\u59cb\u503c\u76842\u500d\uff09\u65f6\u66f4\u6362<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u5468\u671f<\/td>\n<td>\u4e00\u822c\u4e3a3~6\u4e2a\u6708\uff0c\u89c6\u73af\u5883\u800c\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u6e05\u6d01\u4fdd\u517b<\/td>\n<td>\u4e0d\u53ef\u6c34\u6d17\uff0c\u5e94\u6574\u4f53\u66f4\u6362<\/td>\n<\/tr>\n<tr>\n<td>\u8bb0\u5f55\u4fdd\u5b58<\/td>\n<td>\u5efa\u7acb\u5b8c\u6574\u66f4\u6362\u4e0e\u68c0\u6d4b\u8bb0\u5f55\u6863\u6848<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p><strong>\u5f15\u7528\u6587\u732e<\/strong>\uff1a<br \/>\n[7] \u4e2d\u56fd\u533b\u836f\u8bbe\u5907\u5de5\u7a0b\u534f\u4f1a. GMP\u5b9e\u65bd\u6307\u5357\uff08\u7b2c3\u7248\uff09[M]. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2021.<br \/>\n[8] FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories.<\/p>\n<\/blockquote>\n<hr \/>\n<h2>\u4e94\u3001\u5178\u578b\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>5.1 \u67d0\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1a\u6848\u4f8b<\/h3>\n<p>\u67d0\u5927\u578b\u6ce8\u5c04\u5242\u751f\u4ea7\u4f01\u4e1a\u5728\u5176A\/B\u7ea7\u6d01\u51c0\u533a\u91c7\u7528\u4e86Camfil\u54c1\u724c\u7684F7\u7ea7\u4e2d\u6548\u8fc7\u6ee4\u5668\uff0c\u914d\u5408HEPA H14\u7ea7\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u6784\u5efa\u4e86\u5b8c\u6574\u7684\u4e09\u7ea7\u8fc7\u6ee4\u7cfb\u7edf\u3002\u8be5\u7cfb\u7edf\u8fd0\u884c\u4e00\u5e74\u540e\uff0c\u7ecf\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\u68c0\u6d4b\uff0c\u6d01\u51c0\u533a\u7c92\u5b50\u6d53\u5ea6\u7a33\u5b9a\u8fbe\u6807\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u66f4\u6362\u9891\u7387\u660e\u663e\u4e0b\u964d\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th>\u9879\u76ee<\/th>\n<th>\u6570\u636e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u7cfb\u7edf\u98ce\u91cf<\/td>\n<td>20,000 m\u00b3\/h<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u963b\u529b<\/td>\n<td>120 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b\u8bbe\u5b9a\u503c<\/td>\n<td>240 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u66f4\u6362\u5468\u671f<\/td>\n<td>5\u4e2a\u6708<\/td>\n<\/tr>\n<tr>\n<td>\u7c92\u5b50\u6d53\u5ea6\uff08\u22650.5\u03bcm\uff09<\/td>\n<td>\u5e73\u57472,300\u4e2a\/m\u00b3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>5.2 \u67d0\u4e2d\u836f\u63d0\u53d6\u8f66\u95f4\u6848\u4f8b<\/h3>\n<p>\u67d0\u4e2d\u836f\u63d0\u53d6\u8f66\u95f4\u91c7\u7528\u56fd\u4ea7\u82cf\u5dde\u5b89\u6cf0\u54c1\u724c\u7684\u4e2d\u6548\u8fc7\u6ee4\u5668\uff0c\u578b\u53f7\u4e3aF6\u7ea7\uff0c\u9762\u98ce\u901f\u4e3a2.5 m\/s\uff0c\u7cfb\u7edf\u963b\u529b\u63a7\u5236\u826f\u597d\u3002\u7ecf\u8fc7\u4f18\u5316\u540e\uff0c\u8f66\u95f4\u6d01\u51c0\u7ea7\u522b\u7531D\u7ea7\u63d0\u5347\u81f3C\u7ea7\uff0c\u7b26\u5408\u65b0\u7248GMP\u8981\u6c42\u3002<\/p>\n<hr \/>\n<h2>\u516d\u3001\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>\u539f\u56e0\u5206\u6790<\/th>\n<th>\u89e3\u51b3\u529e\u6cd5<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u538b\u5dee\u4e0a\u5347\u8fc7\u5feb<\/td>\n<td>\u7c89\u5c18\u8d1f\u8377\u8fc7\u5927<\/td>\n<td>\u52a0\u5f3a\u521d\u6548\u8fc7\u6ee4\uff0c\u5b9a\u671f\u6e05\u6d01<\/td>\n<\/tr>\n<tr>\n<td>\u6548\u7387\u4e0b\u964d<\/td>\n<td>\u6ee4\u6750\u8001\u5316\u6216\u7834\u635f<\/td>\n<td>\u66f4\u6362\u65b0\u8fc7\u6ee4\u5668<\/td>\n<\/tr>\n<tr>\n<td>\u7cfb\u7edf\u566a\u97f3\u589e\u5927<\/td>\n<td>\u5b89\u88c5\u4e0d\u7262\u56fa\u6216\u5171\u632f<\/td>\n<td>\u68c0\u67e5\u56fa\u5b9a\u4ef6\u5e76\u52a0\u56fa<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f<\/td>\n<td>\u5bc6\u5c01\u6761\u8001\u5316\u6216\u5b89\u88c5\u4e0d\u5f53<\/td>\n<td>\u66f4\u6362\u5bc6\u5c01\u6761\u5e76\u91cd\u65b0\u5b89\u88c5<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u5668\u53d1\u9709<\/td>\n<td>\u6e7f\u5ea6\u8fc7\u9ad8<\/td>\n<td>\u63a7\u5236\u6e7f\u5ea6\uff0c\u9009\u7528\u6297\u83cc\u578b\u6ee4\u6750<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u7ed3\u675f\u8bed\uff08\u7565\uff09<\/h2>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<ol>\n<li>European Committee for Standardization. EN 779:2012, <em>Particulate air filters for general ventilation &#8211; Determination of the filtration performance<\/em>.<\/li>\n<li>American Society of Heating, Refrigerating and Air-Conditioning Engineers. ANSI\/ASHRAE Standard 52.2-2017, <em>Method of Testing General Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size<\/em>.<\/li>\n<li>\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a. \u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b2020\u7248\uff0c\u56db\u90e8\u901a\u52190901\u201c\u836f\u54c1\u6d01\u51c0\u5b9e\u9a8c\u5ba4\u5fae\u751f\u7269\u76d1\u6d4b\u548c\u63a7\u5236\u6307\u5bfc\u539f\u5219\u201d.<\/li>\n<li>WHO Technical Report Series, No. 961, Annex 1: <em>Manufacture of Sterile Medicinal Products<\/em>.<\/li>\n<li>\u5f20\u5fd7\u521a. <em>\u51c0\u5316\u7a7a\u8c03\u7cfb\u7edf\u8bbe\u8ba1\u624b\u518c<\/em>. \u5317\u4eac: \u673a\u68b0\u5de5\u4e1a\u51fa\u7248\u793e, 2015.<\/li>\n<li>ASHRAE Handbook \u2013 <em>HVAC Systems and Equipment<\/em>, 2020 Edition.<\/li>\n<li>\u4e2d\u56fd\u533b\u836f\u8bbe\u5907\u5de5\u7a0b\u534f\u4f1a. <em>GMP\u5b9e\u65bd\u6307\u5357\uff08\u7b2c3\u7248\uff09<\/em>. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2021.<\/li>\n<li>FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories.<\/li>\n<li>Camfil Group. <em>Air Filtration for Cleanrooms in Pharmaceutical Production<\/em>. Available at: <a href=\"https:\/\/www.camfil.com\">https:\/\/www.camfil.com<\/a><\/li>\n<li>\u82cf\u5dde\u5b89\u6cf0\u7a7a\u6c14\u6280\u672f\u6709\u9650\u516c\u53f8\u5b98\u7f51. <a href=\"http:\/\/www.antair.cn\">http:\/\/www.antair.cn<\/a><\/li>\n<\/ol>\n<hr \/>\n<p>\u5982\u9700\u83b7\u53d6\u66f4\u591a\u5173\u4e8e\u4e2d\u6548\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u5efa\u8bae\u3001\u6280\u672f\u53c2\u6570\u8868\u6216GMP\u5408\u89c4\u5ba1\u67e5\u670d\u52a1\uff0c\u8bf7\u8054\u7cfb\u4e13\u4e1a\u7a7a\u6c14\u51c0\u5316\u8bbe\u5907\u4f9b\u5e94\u5546\u6216\u54a8\u8be2\u76f8\u5173\u884c\u4e1a\u534f\u4f1a\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u4e2d\u6548\u8fc7\u6ee4\u5668\u5728\u5236\u836f\u884c\u4e1aGMP\u6d01\u51c0\u8f66\u95f4\u4e2d\u7684\u914d\u7f6e\u6807\u51c6 \u5f15\u8a00 \u5728\u5236\u836f\u884c\u4e1a\u4e2d\uff0c\u836f\u54c1\u7684\u751f\u4ea7\u73af\u5883\u5bf9\u4ea7\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u6027\u5177\u6709\u51b3\u5b9a\u6027\u5f71\u54cd\u3002\u6839\u636e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u7684\u8981\u6c42\uff0c\u5236\u836f\u4f01\u4e1a\u5fc5\u987b\u786e\u4fdd\u5176\u751f\u4ea7\u8f66\u95f4\u5177\u5907\u826f\u597d\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\uff0c\u4ee5\u9632\u6b62\u5fae\u7c92\u548c\u5fae\u751f\u7269\u6c61\u67d3\u836f\u54c1\u3002\u5176\u4e2d\uff0c\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u4f5c\u4e3a\u4fdd\u969c\u6d01\u51c0\u73af\u5883\u7684\u6838\u5fc3\u7ec4\u6210\u90e8\u5206\uff0c\u800c\u4e2d\u6548\u8fc7\u6ee4\u5668\u5219&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-14210","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\/14210","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=14210"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/14210\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14210"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14210"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14210"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}