{"id":15415,"date":"2025-06-20T11:45:42","date_gmt":"2025-06-20T03:45:42","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15415"},"modified":"2025-06-20T11:45:42","modified_gmt":"2025-06-20T03:45:42","slug":"%e9%a3%9f%e5%93%81%e5%8a%a0%e5%b7%a5%e7%8e%af%e5%a2%83%e4%b8%ad%e9%ab%98%e6%95%88%e7%a9%ba%e6%b0%94%e9%99%a4%e8%8f%8c%e8%bf%87%e6%bb%a4%e5%99%a8%e7%9a%84%e6%8a%80%e6%9c%af%e8%a6%81%e6%b1%82%e4%b8%8e","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15415","title":{"rendered":"\u98df\u54c1\u52a0\u5de5\u73af\u5883\u4e2d\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u8981\u6c42\u4e0e\u9009\u578b"},"content":{"rendered":"<h1>\u98df\u54c1\u52a0\u5de5\u73af\u5883\u4e2d\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u8981\u6c42\u4e0e\u9009\u578b<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u5728\u98df\u54c1\u52a0\u5de5\u8fc7\u7a0b\u4e2d\uff0c\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5f71\u54cd\u5230\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u548c\u4fdd\u8d28\u671f\u3002\u7a7a\u6c14\u4e2d\u53ef\u80fd\u643a\u5e26\u7684\u5fae\u751f\u7269\u3001\u5c18\u57c3\u9897\u7c92\u548c\u6709\u5bb3\u6c14\u4f53\uff0c\u82e5\u672a\u7ecf\u6709\u6548\u5904\u7406\u8fdb\u5165\u751f\u4ea7\u73af\u5883\uff0c\u53ef\u80fd\u5bfc\u81f4\u98df\u54c1\u6c61\u67d3\uff0c\u751a\u81f3\u5f15\u53d1\u98df\u54c1\u5b89\u5168\u4e8b\u6545\u3002\u56e0\u6b64\uff0c\u91c7\u7528\u9ad8\u6548\u7684\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u7cfb\u7edf\u6210\u4e3a\u4fdd\u969c\u98df\u54c1\u52a0\u5de5\u73af\u5883\u536b\u751f\u7684\u91cd\u8981\u63aa\u65bd\u4e4b\u4e00\u3002  <\/p>\n<p>\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air, HEPA\uff09\u662f\u4e00\u79cd\u80fd\u591f\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d\u5fae\u5c0f\u9897\u7c92\u7269\u7684\u8fc7\u6ee4\u8bbe\u5907\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u3001\u751f\u7269\u5de5\u7a0b\u3001\u533b\u9662\u4ee5\u53ca\u98df\u54c1\u5de5\u4e1a\u7b49\u9886\u57df\u3002\u5176\u6838\u5fc3\u529f\u80fd\u662f\u901a\u8fc7\u7269\u7406\u62e6\u622a\u3001\u60ef\u6027\u78b0\u649e\u3001\u6269\u6563\u6548\u5e94\u7b49\u65b9\u5f0f\uff0c\u6355\u83b7\u7a7a\u6c14\u4e2d\u7684\u7ec6\u83cc\u3001\u75c5\u6bd2\u3001\u82b1\u7c89\u3001\u7070\u5c18\u7b49\u6c61\u67d3\u7269\uff0c\u4ece\u800c\u786e\u4fdd\u7a7a\u6c14\u7684\u6d01\u51c0\u5ea6\u8fbe\u5230\u7279\u5b9a\u6807\u51c6\u3002  <\/p>\n<p>\u5728\u98df\u54c1\u52a0\u5de5\u73af\u5883\u4e2d\uff0c\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u4e0d\u4ec5\u9700\u8981\u5177\u5907\u9ad8\u8fc7\u6ee4\u6548\u7387\uff0c\u8fd8\u5e94\u6ee1\u8db3\u8010\u9ad8\u6e29\u3001\u6297\u8150\u8680\u3001\u4f4e\u963b\u529b\u7b49\u6280\u672f\u8981\u6c42\uff0c\u4ee5\u9002\u5e94\u4e0d\u540c\u751f\u4ea7\u5de5\u827a\u7684\u9700\u6c42\u3002\u6b64\u5916\uff0c\u6b63\u786e\u7684\u9009\u578b\u5bf9\u4e8e\u7cfb\u7edf\u7684\u7a33\u5b9a\u8fd0\u884c\u3001\u80fd\u8017\u63a7\u5236\u53ca\u7ef4\u62a4\u6210\u672c\u5177\u6709\u91cd\u8981\u5f71\u54cd\u3002\u672c\u6587\u5c06\u8be6\u7ec6\u4ecb\u7ecd\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u53c2\u6570\u3001\u6027\u80fd\u6307\u6807\u53ca\u5176\u5728\u98df\u54c1\u52a0\u5de5\u9886\u57df\u7684\u5e94\u7528\uff0c\u5e76\u63d0\u4f9b\u5177\u4f53\u7684\u9009\u578b\u5efa\u8bae\uff0c\u4ee5\u5e2e\u52a9\u76f8\u5173\u4f01\u4e1a\u4f18\u5316\u7a7a\u6c14\u8d28\u91cf\u7ba1\u7406\u65b9\u6848\u3002  <\/p>\n<hr \/>\n<h2>\u4e00\u3001\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u8981\u6c42<\/h2>\n<h3>1. \u8fc7\u6ee4\u6548\u7387<\/h3>\n<p>\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u6838\u5fc3\u6027\u80fd\u6307\u6807\u4e4b\u4e00\u662f<strong>\u8fc7\u6ee4\u6548\u7387\uff08Efficiency\uff09<\/strong>\uff0c\u5373\u5176\u5bf9\u7a7a\u6c14\u4e2d\u7279\u5b9a\u7c92\u5f84\u8303\u56f4\u5185\u9897\u7c92\u7269\u7684\u53bb\u9664\u80fd\u529b\u3002\u6839\u636e\u56fd\u9645\u6807\u51c6ISO 45001:2018\u300a\u804c\u4e1a\u5065\u5eb7\u5b89\u5168\u7ba1\u7406\u4f53\u7cfb\u300b\u4ee5\u53ca\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6GB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\uff0cHEPA\u8fc7\u6ee4\u5668\u901a\u5e38\u5206\u4e3a\u4ee5\u4e0b\u51e0\u4e2a\u7b49\u7ea7\uff1a  <\/p>\n<table>\n<thead>\n<tr>\n<th>\u7b49\u7ea7<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff08\u9488\u5bf90.3\u03bcm\u9897\u7c92\uff09<\/th>\n<th>\u5e94\u7528\u573a\u666f\u793a\u4f8b<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H10<\/td>\n<td>\u226585%<\/td>\n<td>\u521d\u6548\u8fc7\u6ee4<\/td>\n<\/tr>\n<tr>\n<td>H11<\/td>\n<td>\u226595%<\/td>\n<td>\u4e2d\u6548\u8fc7\u6ee4<\/td>\n<\/tr>\n<tr>\n<td>H13<\/td>\n<td>\u226599.95%<\/td>\n<td>\u9ad8\u6548\u8fc7\u6ee4<\/td>\n<\/tr>\n<tr>\n<td>H14<\/td>\n<td>\u226599.995%<\/td>\n<td>\u8d85\u9ad8\u6548\u8fc7\u6ee4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5728\u98df\u54c1\u52a0\u5de5\u884c\u4e1a\u4e2d\uff0c\u901a\u5e38\u8981\u6c42\u4f7f\u7528H13\u53ca\u4ee5\u4e0a\u7ea7\u522b\u7684HEPA\u8fc7\u6ee4\u5668\uff0c\u4ee5\u786e\u4fdd\u7a7a\u6c14\u4e2d99.95%\u4ee5\u4e0a\u76840.3\u03bcm\u9897\u7c92\u88ab\u6709\u6548\u62e6\u622a\u3002\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5728\u5176\u300aGuideline on Aseptic Processing\u300b\u4e2d\u4e5f\u660e\u786e\u6307\u51fa\uff0c\u5728\u65e0\u83cc\u704c\u88c5\u6216\u6d01\u51c0\u5ba4\u64cd\u4f5c\u533a\u57df\uff0c\u5fc5\u987b\u4f7f\u7528H14\u7ea7HEPA\u8fc7\u6ee4\u5668\uff0c\u4ee5\u9632\u6b62\u5fae\u751f\u7269\u6c61\u67d3[1]\u3002<\/p>\n<h3>2. \u6ee4\u6750\u7c7b\u578b<\/h3>\n<p>\u76ee\u524d\u5e02\u573a\u4e0a\u5e38\u89c1\u7684HEPA\u6ee4\u6750\u4e3b\u8981\u4e3a<strong>\u73bb\u7483\u7ea4\u7ef4\uff08Glass Fiber\uff09<\/strong>\u548c<strong>\u805a\u4e19\u70ef\u7ea4\u7ef4\uff08Polypropylene Fiber\uff09<\/strong>\u4e24\u5927\u7c7b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6750\u6599\u7c7b\u578b<\/th>\n<th>\u7279\u70b9<\/th>\n<th>\u9002\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u73bb\u7483\u7ea4\u7ef4<\/td>\n<td>\u9ad8\u6e29\u8010\u53d7\u6027\u5f3a\uff0c\u8fc7\u6ee4\u6548\u7387\u9ad8\uff0c\u4f46\u6613\u788e<\/td>\n<td>\u9ad8\u6e29\u706d\u83cc\u8f66\u95f4\u3001\u84b8\u6c7d\u706d\u83cc\u73af\u5883<\/td>\n<\/tr>\n<tr>\n<td>\u805a\u4e19\u70ef\u7ea4\u7ef4<\/td>\n<td>\u6297\u6e7f\u6027\u597d\uff0c\u673a\u68b0\u5f3a\u5ea6\u9ad8\uff0c\u9002\u7528\u4e8e\u6f6e\u6e7f\u73af\u5883<\/td>\n<td>\u51b7\u85cf\u98df\u54c1\u52a0\u5de5\u3001\u6e7f\u5ea6\u8f83\u9ad8\u7684\u751f\u4ea7\u7ebf<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u90e8\u5206\u65b0\u578bHEPA\u6ee4\u6750\u8fd8\u52a0\u5165\u4e86<strong>\u6d3b\u6027\u70ad\u5c42<\/strong>\uff0c\u7528\u4e8e\u5438\u9644\u7a7a\u6c14\u4e2d\u7684\u5f02\u5473\u548c\u6325\u53d1\u6027\u6709\u673a\u5316\u5408\u7269\uff08VOCs\uff09\uff0c\u5982\u7532\u919b\u3001\u82ef\u7cfb\u7269\u7b49\uff0c\u8fdb\u4e00\u6b65\u63d0\u5347\u7a7a\u6c14\u8d28\u91cf\u3002<\/p>\n<h3>3. \u4f7f\u7528\u5bff\u547d<\/h3>\n<p>\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u4f7f\u7528\u5bff\u547d\u53d6\u51b3\u4e8e\u591a\u4e2a\u56e0\u7d20\uff0c\u5305\u62ec\u5de5\u4f5c\u73af\u5883\u7684\u7a7a\u6c14\u8d28\u91cf\u3001\u6c14\u6d41\u901f\u5ea6\u3001\u538b\u5dee\u53d8\u5316\u4ee5\u53ca\u7ef4\u62a4\u9891\u7387\u7b49\u3002\u4e00\u822c\u800c\u8a00\uff0cHEPA\u8fc7\u6ee4\u5668\u7684\u6807\u51c6\u66f4\u6362\u5468\u671f\u4e3a<strong>6\u4e2a\u6708\u81f32\u5e74<\/strong>\u4e0d\u7b49\u3002\u4ee5\u4e0b\u662f\u4e00\u4e9b\u5178\u578b\u5e94\u7528\u573a\u666f\u4e0b\u7684\u63a8\u8350\u66f4\u6362\u5468\u671f\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5e94\u7528\u73af\u5883<\/th>\n<th>\u5efa\u8bae\u66f4\u6362\u5468\u671f<\/th>\n<th>\u5907\u6ce8<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6d01\u51c0\u5ba4\uff08Class 100\/ISO 5\uff09<\/td>\n<td>6~12\u4e2a\u6708<\/td>\n<td>\u9700\u5b9a\u671f\u68c0\u6d4b\u538b\u5dee<\/td>\n<\/tr>\n<tr>\n<td>\u4e00\u822c\u98df\u54c1\u751f\u4ea7\u8f66\u95f4<\/td>\n<td>12~18\u4e2a\u6708<\/td>\n<td>\u82e5\u7a7a\u6c14\u6c61\u67d3\u8f83\u91cd\uff0c\u5e94\u7f29\u77ed\u5468\u671f<\/td>\n<\/tr>\n<tr>\n<td>\u9ad8\u6e29\/\u9ad8\u6e7f\u8f66\u95f4<\/td>\n<td>6~12\u4e2a\u6708<\/td>\n<td>\u6613\u5bfc\u81f4\u6ee4\u6750\u8001\u5316\u6216\u9709\u53d8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u4e3a\u4e86\u5ef6\u957f\u4f7f\u7528\u5bff\u547d\uff0c\u5efa\u8bae\u5b89\u88c5<strong>\u9884\u8fc7\u6ee4\u5668\uff08Pre-filter\uff09<\/strong>\uff0c\u4ee5\u51cf\u5c11\u5927\u9897\u7c92\u6742\u8d28\u5bf9HEPA\u6ee4\u82af\u7684\u76f4\u63a5\u51b2\u51fb\uff0c\u540c\u65f6\u964d\u4f4e\u7cfb\u7edf\u6574\u4f53\u538b\u964d\u3002<\/p>\n<h3>4. \u5de5\u4f5c\u6e29\u5ea6\u4e0e\u6e7f\u5ea6\u8303\u56f4<\/h3>\n<p>\u98df\u54c1\u52a0\u5de5\u73af\u5883\u5f80\u5f80\u6d89\u53ca\u9ad8\u6e29\u6740\u83cc\u3001\u4f4e\u6e29\u51b7\u85cf\u7b49\u591a\u79cd\u5de5\u827a\u6761\u4ef6\uff0c\u56e0\u6b64HEPA\u8fc7\u6ee4\u5668\u9700\u5177\u5907\u826f\u597d\u7684<strong>\u8010\u6e29\u6027\u548c\u6297\u6e7f\u6027<\/strong>\u3002\u4e00\u822cHEPA\u8fc7\u6ee4\u5668\u7684\u5de5\u4f5c\u6e29\u5ea6\u8303\u56f4\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7c7b\u578b<\/th>\n<th>\u6700\u4f4e\u5de5\u4f5c\u6e29\u5ea6<\/th>\n<th>\u6700\u9ad8\u5de5\u4f5c\u6e29\u5ea6<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6807\u51c6HEPA<\/td>\n<td>-20\u00b0C<\/td>\n<td>70\u00b0C<\/td>\n<td>\u9002\u7528\u4e8e\u5e38\u6e29\u73af\u5883<\/td>\n<\/tr>\n<tr>\n<td>\u9ad8\u6e29HEPA<\/td>\n<td>-20\u00b0C<\/td>\n<td>200\u00b0C<\/td>\n<td>\u53ef\u7528\u4e8e\u84b8\u6c7d\u706d\u83cc\u3001\u70ed\u98ce\u5e72\u71e5\u7b49\u573a\u5408<\/td>\n<\/tr>\n<tr>\n<td>\u6297\u6e7fHEPA<\/td>\n<td>\u76f8\u5bf9\u6e7f\u5ea6\u226495%<\/td>\n<td>&#8211;<\/td>\n<td>\u9002\u7528\u4e8e\u6f6e\u6e7f\u73af\u5883\uff0c\u5982\u51b7\u5e93\u3001\u53d1\u9175\u8f66\u95f4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u67d0\u4e9b\u7279\u6b8a\u8bbe\u8ba1\u7684HEPA\u8fc7\u6ee4\u5668\u8fd8\u53ef\u652f\u6301<strong>\u5316\u5b66\u6e05\u6d17<\/strong>\uff0c\u4ee5\u5e94\u5bf9\u9ad8\u6c61\u67d3\u73af\u5883\u4e0b\u7684\u957f\u671f\u4f7f\u7528\u9700\u6c42\u3002<\/p>\n<h3>5. \u5b89\u5168\u6027\u4e0e\u5408\u89c4\u6027\u8ba4\u8bc1<\/h3>\n<p>\u9009\u62e9HEPA\u8fc7\u6ee4\u5668\u65f6\uff0c\u8fd8\u9700\u5173\u6ce8\u5176\u662f\u5426\u7b26\u5408\u76f8\u5173\u7684<strong>\u5b89\u5168\u6027\u4e0e\u5408\u89c4\u6027\u8ba4\u8bc1<\/strong>\uff0c\u4f8b\u5982\uff1a<\/p>\n<ul>\n<li><strong>\u6b27\u76dfCE\u8ba4\u8bc1<\/strong>\uff1a\u786e\u4fdd\u4ea7\u54c1\u7b26\u5408\u6b27\u6d32\u5065\u5eb7\u3001\u5b89\u5168\u548c\u73af\u4fdd\u6cd5\u89c4\u3002<\/li>\n<li><strong>\u7f8e\u56fdUL\u8ba4\u8bc1<\/strong>\uff1a\u4fdd\u8bc1\u7535\u6c14\u5b89\u5168\u4e0e\u9632\u706b\u6027\u80fd\u3002<\/li>\n<li><strong>ISO 14644-1\u6807\u51c6<\/strong>\uff1a\u89c4\u5b9a\u4e86\u6d01\u51c0\u5ba4\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\uff0cHEPA\u8fc7\u6ee4\u5668\u9700\u6ee1\u8db3\u76f8\u5e94\u7b49\u7ea7\u7684\u6d4b\u8bd5\u8981\u6c42\u3002<\/li>\n<li><strong>GB\/T 13554-2020<\/strong>\uff1a\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6\uff0c\u5bf9\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u5236\u9020\u3001\u6d4b\u8bd5\u4e0e\u9a8c\u6536\u6709\u660e\u786e\u89c4\u5b9a\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e8c\u3001\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u6027\u80fd\u53c2\u6570\u5bf9\u6bd4<\/h2>\n<p>\u4e3a\u4e86\u66f4\u76f4\u89c2\u5730\u6bd4\u8f83\u4e0d\u540c\u7c7b\u578b\u7684\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\uff0c\u4e0b\u8868\u5217\u51fa\u4e86\u5e38\u89c1\u578b\u53f7\u7684\u4e3b\u8981\u6027\u80fd\u53c2\u6570\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>HEPA H13<\/th>\n<th>HEPA H14<\/th>\n<th>ULPA U15<\/th>\n<th>ULPA U17<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u989d\u5b9a\u98ce\u91cf\uff08m\u00b3\/h\uff09<\/td>\n<td>500~2000<\/td>\n<td>500~2000<\/td>\n<td>500~2000<\/td>\n<td>500~2000<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b\uff08Pa\uff09<\/td>\n<td>\u2264250<\/td>\n<td>\u2264280<\/td>\n<td>\u2264300<\/td>\n<td>\u2264350<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387\uff080.3\u03bcm\uff09<\/td>\n<td>\u226599.95%<\/td>\n<td>\u226599.995%<\/td>\n<td>\u226599.9995%<\/td>\n<td>\u226599.99995%<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5bff\u547d\uff08h\uff09<\/td>\n<td>10000~20000<\/td>\n<td>8000~15000<\/td>\n<td>6000~12000<\/td>\n<td>4000~10000<\/td>\n<\/tr>\n<tr>\n<td>\u9002\u7528\u6d01\u51c0\u5ea6\u7b49\u7ea7<\/td>\n<td>ISO 7~8<\/td>\n<td>ISO 5~6<\/td>\n<td>ISO 3~4<\/td>\n<td>ISO 1~2<\/td>\n<\/tr>\n<tr>\n<td>\u4ef7\u683c\u8303\u56f4\uff08\u5143\uff09<\/td>\n<td>800~3000<\/td>\n<td>1200~5000<\/td>\n<td>2000~8000<\/td>\n<td>4000~15000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u4ece\u4e0a\u8868\u53ef\u4ee5\u770b\u51fa\uff0c\u968f\u7740\u8fc7\u6ee4\u6548\u7387\u7684\u63d0\u9ad8\uff0c\u8fc7\u6ee4\u5668\u7684\u521d\u59cb\u963b\u529b\u4e5f\u968f\u4e4b\u4e0a\u5347\uff0c\u8fd9\u610f\u5473\u7740\u98ce\u673a\u529f\u8017\u4f1a\u589e\u52a0\uff0c\u7cfb\u7edf\u80fd\u8017\u4e5f\u4f1a\u968f\u4e4b\u5347\u9ad8\u3002\u56e0\u6b64\uff0c\u5728\u5b9e\u9645\u9009\u578b\u8fc7\u7a0b\u4e2d\uff0c\u5e94\u7ed3\u5408\u8f66\u95f4\u7684\u6d01\u51c0\u5ea6\u8981\u6c42\u3001\u80fd\u8017\u9884\u7b97\u4ee5\u53ca\u7a7a\u95f4\u5e03\u5c40\u7b49\u56e0\u7d20\u8fdb\u884c\u7efc\u5408\u8bc4\u4f30\u3002<\/p>\n<hr \/>\n<h2>\u4e09\u3001\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u5728\u98df\u54c1\u52a0\u5de5\u73af\u5883\u4e2d\u7684\u5e94\u7528<\/h2>\n<h3>1. \u5728\u65e0\u83cc\u704c\u88c5\u7ebf\u7684\u5e94\u7528<\/h3>\n<p>\u65e0\u83cc\u704c\u88c5\u662f\u98df\u54c1\u52a0\u5de5\u4e2d\u7684\u5173\u952e\u73af\u8282\uff0c\u5c24\u5176\u5728\u4e73\u5236\u54c1\u3001\u679c\u6c41\u996e\u6599\u3001\u8c03\u5473\u54c1\u7b49\u884c\u4e1a\u5e7f\u6cdb\u5e94\u7528\u3002\u4e3a\u786e\u4fdd\u704c\u88c5\u8fc7\u7a0b\u4e2d\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u8fbe\u5230ISO 5\u7ea7\uff08Class 100\uff09\u4ee5\u4e0a\u6807\u51c6\uff0c\u901a\u5e38\u91c7\u7528<strong>H14\u7ea7HEPA\u8fc7\u6ee4\u5668<\/strong>\uff0c\u5e76\u914d\u5907<strong>\u5c42\u6d41\u9001\u98ce\u7cfb\u7edf\uff08Laminar Flow\uff09<\/strong>\uff0c\u4ee5\u5f62\u6210\u5782\u76f4\u6216\u6c34\u5e73\u65b9\u5411\u7684\u5355\u5411\u6c14\u6d41\uff0c\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u7a7a\u6c14\u6270\u52a8\u5e26\u6765\u7684\u6c61\u67d3\u98ce\u9669\u3002  <\/p>\n<p>\u636e\u7f8e\u56fd\u98df\u54c1\u4e0e\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d1\u5e03\u7684\u300aAseptic Processing of Pharmaceutical Products\u300b\u6307\u5357\uff0c\u65e0\u83cc\u704c\u88c5\u533a\u7684\u7a7a\u6c14\u6362\u6c14\u6b21\u6570\u5e94\u4e0d\u4f4e\u4e8e<strong>60\u6b21\/\u5c0f\u65f6<\/strong>\uff0c\u5e76\u4e14\u6bcf\u5c0f\u65f6\u9700\u4fdd\u6301\u6b63\u538b\u72b6\u6001\uff0c\u4ee5\u9632\u5916\u754c\u6c61\u67d3\u7a7a\u6c14\u6e17\u5165[2]\u3002  <\/p>\n<h3>2. \u5728\u51b7\u5374\u4e0e\u5305\u88c5\u8f66\u95f4\u7684\u5e94\u7528<\/h3>\n<p>\u51b7\u5374\u4e0e\u5305\u88c5\u73af\u8282\u662f\u98df\u54c1\u52a0\u5de5\u8fc7\u7a0b\u4e2d\u6700\u5bb9\u6613\u53d7\u5230\u5fae\u751f\u7269\u6c61\u67d3\u7684\u9636\u6bb5\u3002\u7531\u4e8e\u98df\u54c1\u5728\u51b7\u5374\u8fc7\u7a0b\u4e2d\u8868\u9762\u6e29\u5ea6\u4e0b\u964d\uff0c\u5bb9\u6613\u5f62\u6210\u51b7\u51dd\u6c34\uff0c\u8fdb\u800c\u4fc3\u8fdb\u7ec6\u83cc\u6ecb\u751f\u3002\u56e0\u6b64\uff0c\u5728\u8be5\u533a\u57df\u5b89\u88c5<strong>HEPA+\u6d3b\u6027\u70ad\u590d\u5408\u8fc7\u6ee4\u5668<\/strong>\uff0c\u4e0d\u4ec5\u80fd\u53bb\u9664\u7a7a\u6c14\u4e2d\u7684\u7ec6\u83cc\u548c\u5c18\u57c3\uff0c\u8fd8\u80fd\u5438\u9644\u56e0\u98df\u54c1\u6325\u53d1\u4ea7\u751f\u7684\u5f02\u5473\u548cVOCs\u3002  <\/p>\n<p>\u65e5\u672c\u98df\u54c1\u673a\u68b0\u534f\u4f1a\uff08JFMA\uff09\u5728\u5176\u300a\u98df\u54c1\u5de5\u5382\u7a7a\u6c14\u51c0\u5316\u6307\u5357\u300b\u4e2d\u5efa\u8bae\uff0c\u51b7\u5374\u4e0e\u5305\u88c5\u8f66\u95f4\u7684\u7a7a\u6c14\u6d01\u51c0\u5ea6\u5e94\u81f3\u5c11\u8fbe\u5230<strong>ISO 7\u7ea7\uff08Class 10000\uff09<\/strong>\uff0c\u5e76\u914d\u5408\u7d2b\u5916\u7ebf\u706d\u83cc\u88c5\u7f6e\uff08UVC\uff09\u8fdb\u884c\u8f85\u52a9\u6740\u83cc[3]\u3002  <\/p>\n<h3>3. \u5728\u53d1\u9175\u4e0e\u70d8\u7119\u8f66\u95f4\u7684\u5e94\u7528<\/h3>\n<p>\u53d1\u9175\u548c\u70d8\u7119\u8f66\u95f4\u901a\u5e38\u5177\u6709\u8f83\u9ad8\u7684\u6e29\u6e7f\u5ea6\uff0c\u8fd9\u5bf9\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u8010\u6e29\u6027\u548c\u6297\u6e7f\u6027\u63d0\u51fa\u4e86\u66f4\u9ad8\u7684\u8981\u6c42\u3002\u5728\u6b64\u7c7b\u73af\u5883\u4e2d\uff0c\u63a8\u8350\u4f7f\u7528<strong>\u9ad8\u6e29\u6297\u6e7f\u578bHEPA\u8fc7\u6ee4\u5668<\/strong>\uff0c\u5e76\u7ed3\u5408<strong>\u81ea\u52a8\u6e05\u6d17\u7cfb\u7edf<\/strong>\uff0c\u4ee5\u5ef6\u957f\u4f7f\u7528\u5bff\u547d\uff0c\u51cf\u5c11\u4eba\u5de5\u7ef4\u62a4\u6210\u672c\u3002  <\/p>\n<p>\u5fb7\u56fdDIN\u6807\u51c6\u300aDIN EN 1822-1:2022\u300b\u6307\u51fa\uff0c\u5728\u9ad8\u6e29\u73af\u5883\u4e0b\u5de5\u4f5c\u7684HEPA\u8fc7\u6ee4\u5668\uff0c\u5176\u6750\u6599\u5e94\u5177\u5907<strong>\u8010\u9ad8\u6e29\u8fbe200\u00b0C<\/strong>\u7684\u80fd\u529b\uff0c\u5e76\u80fd\u5728<strong>\u76f8\u5bf9\u6e7f\u5ea695%<\/strong>\u6761\u4ef6\u4e0b\u6b63\u5e38\u8fd0\u884c[4]\u3002  <\/p>\n<hr \/>\n<h2>\u56db\u3001\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u5efa\u8bae<\/h2>\n<h3>1. \u6839\u636e\u6d01\u51c0\u5ea6\u7b49\u7ea7\u9009\u62e9<\/h3>\n<p>\u98df\u54c1\u52a0\u5de5\u73af\u5883\u7684\u6d01\u51c0\u5ea6\u7b49\u7ea7\u51b3\u5b9a\u4e86\u6240\u9700HEPA\u8fc7\u6ee4\u5668\u7684\u7ea7\u522b\u3002\u4ee5\u4e0b\u662f\u4e0d\u540c\u6d01\u51c0\u5ea6\u7b49\u7ea7\u5bf9\u5e94\u7684\u63a8\u8350\u8fc7\u6ee4\u5668\u7c7b\u578b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d01\u51c0\u5ea6\u7b49\u7ea7\uff08ISO\uff09<\/th>\n<th>\u63a8\u8350HEPA\u7b49\u7ea7<\/th>\n<th>\u5178\u578b\u5e94\u7528<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>ISO 8 (Class 100000)<\/td>\n<td>H13<\/td>\n<td>\u4e00\u822c\u98df\u54c1\u751f\u4ea7\u8f66\u95f4<\/td>\n<\/tr>\n<tr>\n<td>ISO 7 (Class 10000)<\/td>\n<td>H13-H14<\/td>\n<td>\u5305\u88c5\u3001\u51b7\u5374\u8f66\u95f4<\/td>\n<\/tr>\n<tr>\n<td>ISO 5 (Class 100)<\/td>\n<td>H14<\/td>\n<td>\u65e0\u83cc\u704c\u88c5\u7ebf<\/td>\n<\/tr>\n<tr>\n<td>ISO 3 (Class 1000)<\/td>\n<td>U15-U17<\/td>\n<td>\u751f\u7269\u53d1\u9175\u3001\u5b9e\u9a8c\u5ba4\u73af\u5883<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>2. \u6839\u636e\u7a7a\u6c14\u6d41\u91cf\u4e0e\u538b\u529b\u635f\u5931\u9009\u62e9<\/h3>\n<p>\u5728\u9009\u62e9HEPA\u8fc7\u6ee4\u5668\u65f6\uff0c\u9700\u8003\u8651\u7cfb\u7edf\u7684<strong>\u989d\u5b9a\u98ce\u91cf\uff08Airflow Rate\uff09<\/strong>\u4e0e<strong>\u538b\u964d\uff08Pressure Drop\uff09<\/strong>\u3002\u8fc7\u9ad8\u7684\u538b\u964d\u4f1a\u5bfc\u81f4\u98ce\u673a\u8d1f\u8377\u589e\u52a0\uff0c\u8fdb\u800c\u5f71\u54cd\u80fd\u8017\u548c\u8fd0\u884c\u6210\u672c\u3002\u56e0\u6b64\uff0c\u5e94\u6839\u636e\u5b9e\u9645\u901a\u98ce\u7cfb\u7edf\u7684\u914d\u7f6e\u9009\u62e9\u5408\u9002\u7684\u8fc7\u6ee4\u5668\u89c4\u683c\u3002  <\/p>\n<h3>3. \u6839\u636e\u73af\u5883\u6e29\u5ea6\u4e0e\u6e7f\u5ea6\u9009\u62e9<\/h3>\n<p>\u5982\u524d\u6240\u8ff0\uff0c\u4e0d\u540c\u5de5\u827a\u73af\u8282\u7684\u6e29\u6e7f\u5ea6\u5dee\u5f02\u8f83\u5927\uff0c\u56e0\u6b64\u5e94\u6839\u636e\u5177\u4f53\u5de5\u51b5\u9009\u62e9\u5177\u5907\u76f8\u5e94\u7279\u6027\u7684HEPA\u8fc7\u6ee4\u5668\u3002\u4f8b\u5982\uff0c\u5728\u9ad8\u6e29\u84b8\u6c7d\u706d\u83cc\u8f66\u95f4\uff0c\u5e94\u9009\u7528<strong>\u8010\u9ad8\u6e29\u578bHEPA<\/strong>\uff1b\u800c\u5728\u51b7\u5e93\u6216\u53d1\u9175\u8f66\u95f4\uff0c\u5219\u5e94\u4f18\u5148\u8003\u8651<strong>\u6297\u6e7f\u578bHEPA<\/strong>\u3002  <\/p>\n<h3>4. \u6839\u636e\u7ef4\u62a4\u6210\u672c\u4e0e\u66f4\u6362\u5468\u671f\u9009\u62e9<\/h3>\n<p>\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u66f4\u6362\u9891\u7387\u76f4\u63a5\u5f71\u54cd\u4f01\u4e1a\u7684\u8fd0\u8425\u6210\u672c\u3002\u56e0\u6b64\uff0c\u5728\u9009\u578b\u65f6\u5e94\u5145\u5206\u8003\u8651<strong>\u6ee4\u6750\u8010\u7528\u6027\u3001\u6e05\u6d01\u4fbf\u5229\u6027<\/strong>\u4ee5\u53ca<strong>\u662f\u5426\u652f\u6301\u5728\u7ebf\u76d1\u6d4b\u4e0e\u81ea\u52a8\u62a5\u8b66\u529f\u80fd<\/strong>\u3002\u4f8b\u5982\uff0c\u4e00\u4e9b\u9ad8\u7aefHEPA\u8fc7\u6ee4\u5668\u914d\u5907\u4e86<strong>\u538b\u5dee\u4f20\u611f\u5668<\/strong>\uff0c\u53ef\u5b9e\u65f6\u76d1\u63a7\u8fc7\u6ee4\u5668\u5835\u585e\u60c5\u51b5\uff0c\u5e76\u901a\u8fc7PLC\u63a7\u5236\u7cfb\u7edf\u81ea\u52a8\u63d0\u9192\u66f4\u6362\u65f6\u95f4\u3002  <\/p>\n<hr \/>\n<h2>\u4e94\u3001\u7ed3\u8bba<\/h2>\n<p>\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u4f5c\u4e3a\u98df\u54c1\u52a0\u5de5\u73af\u5883\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684\u5173\u952e\u8bbe\u5907\uff0c\u5176\u6027\u80fd\u76f4\u63a5\u5f71\u54cd\u4ea7\u54c1\u8d28\u91cf\u4e0e\u751f\u4ea7\u5b89\u5168\u3002\u4f01\u4e1a\u5728\u9009\u62e9HEPA\u8fc7\u6ee4\u5668\u65f6\uff0c\u5e94\u7efc\u5408\u8003\u8651\u8fc7\u6ee4\u6548\u7387\u3001\u6ee4\u6750\u7c7b\u578b\u3001\u4f7f\u7528\u5bff\u547d\u3001\u5de5\u4f5c\u73af\u5883\u9002\u5e94\u6027\u7b49\u591a\u4e2a\u56e0\u7d20\uff0c\u5e76\u53c2\u8003\u56fd\u5185\u5916\u76f8\u5173\u6807\u51c6\u4e0e\u884c\u4e1a\u6307\u5357\uff0c\u4ee5\u786e\u4fdd\u7a7a\u6c14\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\u7684\u6709\u6548\u6027\u4e0e\u7ecf\u6d4e\u6027\u3002  <\/p>\n<hr \/>\n<h2>\u53c2\u8003\u6587\u732e<\/h2>\n<p>[1] FDA. Guideline on Aseptic Processing [EB\/OL]. <a href=\"https:\/\/www.fda.gov\/media\/71021\/download\">https:\/\/www.fda.gov\/media\/71021\/download<\/a>, 2004.<br \/>\n[2] FDA. Aseptic Processing of Pharmaceutical Products [EB\/OL]. <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/aseptic-processing-pharmaceutical-products\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/aseptic-processing-pharmaceutical-products<\/a>, 2020.<br \/>\n[3] JFMA. Food Factory Air Purification Guidelines [R]. Japan Food Machinery Association, 2018.<br \/>\n[4] DIN EN 1822-1:2022. High Efficiency Air Filters (HEPA and ULPA) \u2013 Part 1: Classification, Performance Testing, Labelling [S]. Berlin: Beuth Verlag GmbH, 2022.<br \/>\n[5] GB\/T 13554-2020. High-efficiency particulate air filters [S]. Beijing: China Standard Press, 2020.<br \/>\n[6] ISO 14644-1:2015. Cleanrooms and associated controlled environments \u2014 Part 1: Classification and grading of air cleanliness by particle concentration [S]. Geneva: International Organization for Standardization, 2015.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u98df\u54c1\u52a0\u5de5\u73af\u5883\u4e2d\u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\u7684\u6280\u672f\u8981\u6c42\u4e0e\u9009\u578b \u5f15\u8a00 \u5728\u98df\u54c1\u52a0\u5de5\u8fc7\u7a0b\u4e2d\uff0c\u7a7a\u6c14\u8d28\u91cf\u76f4\u63a5\u5f71\u54cd\u5230\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u548c\u4fdd\u8d28\u671f\u3002\u7a7a\u6c14\u4e2d\u53ef\u80fd\u643a\u5e26\u7684\u5fae\u751f\u7269\u3001\u5c18\u57c3\u9897\u7c92\u548c\u6709\u5bb3\u6c14\u4f53\uff0c\u82e5\u672a\u7ecf\u6709\u6548\u5904\u7406\u8fdb\u5165\u751f\u4ea7\u73af\u5883\uff0c\u53ef\u80fd\u5bfc\u81f4\u98df\u54c1\u6c61\u67d3\uff0c\u751a\u81f3\u5f15\u53d1\u98df\u54c1\u5b89\u5168\u4e8b\u6545\u3002\u56e0\u6b64\uff0c\u91c7\u7528\u9ad8\u6548\u7684\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u7cfb\u7edf\u6210\u4e3a\u4fdd\u969c\u98df\u54c1\u52a0\u5de5\u73af\u5883\u536b\u751f\u7684\u91cd\u8981\u63aa\u65bd\u4e4b\u4e00\u3002 \u9ad8\u6548\u7a7a\u6c14\u9664\u83cc\u8fc7\u6ee4\u5668\uff08High-Efficiency Part&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-15415","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\/15415","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=15415"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15415\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15415"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15415"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15415"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}