{"id":14406,"date":"2025-05-29T15:04:04","date_gmt":"2025-05-29T07:04:04","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=14406"},"modified":"2025-05-29T15:04:04","modified_gmt":"2025-05-29T07:04:04","slug":"%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e5%9c%a8%e7%96%ab%e8%8b%97%e7%94%9f%e4%ba%a7%e8%bd%a6%e9%97%b4%e4%b8%ad%e7%9a%84%e5%90%88%e8%a7%84%e6%80%a7%e8%a6%81%e6%b1%82%e4%b8%8e%e9%aa%8c%e8%af%81","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=14406","title":{"rendered":"\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u4e2d\u7684\u5408\u89c4\u6027\u8981\u6c42\u4e0e\u9a8c\u8bc1"},"content":{"rendered":"<h1>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u4e2d\u7684\u5408\u89c4\u6027\u8981\u6c42\u4e0e\u9a8c\u8bc1<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u968f\u7740\u5168\u7403\u5bf9\u75ab\u82d7\u9700\u6c42\u7684\u6301\u7eed\u589e\u957f\uff0c\u75ab\u82d7\u751f\u4ea7\u7684\u5b89\u5168\u6027\u548c\u8d28\u91cf\u63a7\u5236\u65e5\u76ca\u53d7\u5230\u91cd\u89c6\u3002\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\u4f5c\u4e3a\u6d01\u51c0\u5ba4\u7cfb\u7edf\u4e2d\u5173\u952e\u7684\u7ec4\u6210\u90e8\u5206\uff0c\u5728\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u4e2d\u626e\u6f14\u7740\u81f3\u5173\u91cd\u8981\u7684\u89d2\u8272\u3002\u5176\u4e3b\u8981\u529f\u80fd\u662f\u53bb\u9664\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u9897\u7c92\u3001\u5fae\u751f\u7269\u7b49\u6c61\u67d3\u7269\uff0c\u786e\u4fdd\u751f\u4ea7\u73af\u5883\u8fbe\u5230GMP\uff08Good Manufacturing Practice\uff09\u3001ISO 14644-1\u3001FDA\uff08\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff09\u4ee5\u53ca\u4e2d\u56fd\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\u7b49\u76f8\u5173\u6807\u51c6\u7684\u8981\u6c42\u3002<\/p>\n<p>\u672c\u6587\u5c06\u56f4\u7ed5\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u4e2d\u7684\u5408\u89c4\u6027\u8981\u6c42\u4e0e\u9a8c\u8bc1\u6d41\u7a0b\u8fdb\u884c\u8be6\u7ec6\u9610\u8ff0\uff0c\u6db5\u76d6\u4ea7\u54c1\u53c2\u6570\u3001\u56fd\u5185\u5916\u6cd5\u89c4\u6807\u51c6\u3001\u5b89\u88c5\u6d4b\u8bd5\u3001\u6027\u80fd\u9a8c\u8bc1\u53ca\u7ef4\u62a4\u7ba1\u7406\u7b49\u65b9\u9762\u5185\u5bb9\uff0c\u5e76\u901a\u8fc7\u8868\u683c\u5f62\u5f0f\u5bf9\u6bd4\u5173\u952e\u6307\u6807\uff0c\u529b\u6c42\u4e3a\u76f8\u5173\u4ece\u4e1a\u4eba\u5458\u63d0\u4f9b\u5168\u9762\u7684\u6280\u672f\u53c2\u8003\u3002<\/p>\n<hr \/>\n<h2>\u4e00\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u539f\u7406\u4e0e\u5206\u7c7b<\/h2>\n<h3>1.1 \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>\u9ad8\u6548\u8fc7\u6ee4\u5668\u662f\u4e00\u79cd\u80fd\u6709\u6548\u53bb\u9664\u7a7a\u6c14\u4e2d0.3\u5fae\u7c73\u4ee5\u4e0a\u9897\u7c92\u7269\u7684\u8fc7\u6ee4\u8bbe\u5907\uff0c\u901a\u5e38\u91c7\u7528\u73bb\u7483\u7ea4\u7ef4\u6216\u5408\u6210\u6750\u6599\u5236\u6210\u6ee4\u6750\uff0c\u901a\u8fc7\u62e6\u622a\u3001\u60ef\u6027\u78b0\u649e\u3001\u6269\u6563\u548c\u9759\u7535\u5438\u9644\u7b49\u65b9\u5f0f\u6355\u83b7\u7a7a\u6c14\u4e2d\u7684\u5fae\u7c92\u3002<\/p>\n<h3>1.2 \u5206\u7c7b<\/h3>\n<p>\u6839\u636e\u56fd\u9645\u6807\u51c6ISO 29463\u548c\u6b27\u76dfEN 1822\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7c7b\u522b<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff08%\uff09<\/th>\n<th>\u5bf9\u5e94\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>E10<\/td>\n<td>\u2265 85%<\/td>\n<td>ISO 29463<\/td>\n<\/tr>\n<tr>\n<td>E11<\/td>\n<td>\u2265 95%<\/td>\n<td>ISO 29463<\/td>\n<\/tr>\n<tr>\n<td>E12<\/td>\n<td>\u2265 99.5%<\/td>\n<td>ISO 29463<\/td>\n<\/tr>\n<tr>\n<td>H13<\/td>\n<td>\u2265 99.95%<\/td>\n<td>EN 1822<\/td>\n<\/tr>\n<tr>\n<td>H14<\/td>\n<td>\u2265 99.995%<\/td>\n<td>EN 1822<\/td>\n<\/tr>\n<tr>\n<td>U15<\/td>\n<td>\u2265 99.9995%<\/td>\n<td>EN 1822<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5728\u4e2d\u56fd\uff0cGB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b\u6807\u51c6\u4e5f\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u8fdb\u884c\u4e86\u5206\u7c7b\u4e0e\u6280\u672f\u8981\u6c42\u89c4\u5b9a\u3002<\/p>\n<hr \/>\n<h2>\u4e8c\u3001\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5408\u89c4\u6027\u8981\u6c42<\/h2>\n<p>\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u5c5e\u4e8e\u9ad8\u98ce\u9669\u751f\u7269\u5236\u836f\u573a\u6240\uff0c\u5176\u6d01\u51c0\u5ea6\u7b49\u7ea7\u901a\u5e38\u8981\u6c42\u8fbe\u5230ISO 14644-1 Class 7\u6216\u66f4\u9ad8\u7b49\u7ea7\uff08Class 5\/Class 6\uff09\uff0c\u5177\u4f53\u53d6\u51b3\u4e8e\u751f\u4ea7\u5de5\u827a\u6b65\u9aa4\u3002\u4f8b\u5982\uff1a<\/p>\n<ul>\n<li>\u704c\u88c5\u533a\uff1aISO Class 5<\/li>\n<li>\u52a0\u5de5\u533a\uff1aISO Class 7<\/li>\n<li>\u7f13\u51b2\u533a\uff1aISO Class 8<\/li>\n<\/ul>\n<p>\u56e0\u6b64\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u9009\u578b\u548c\u4f7f\u7528\u5fc5\u987b\u6ee1\u8db3\u5982\u4e0b\u5408\u89c4\u6027\u8981\u6c42\uff1a<\/p>\n<h3>2.1 \u56fd\u5185\u6cd5\u89c4\u8981\u6c42<\/h3>\n<h4>\uff081\uff09\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09<\/h4>\n<p>\u6839\u636e\u300a\u836f\u54c1GMP\u6307\u5357\u2014\u2014\u65e0\u83cc\u836f\u54c1\u300b\uff082020\u5e74\u7248\uff09\u89c4\u5b9a\uff1a<\/p>\n<ul>\n<li>\u6d01\u51c0\u533a\u7a7a\u6c14\u5904\u7406\u7cfb\u7edf\u5e94\u914d\u5907\u521d\u6548\u3001\u4e2d\u6548\u548c\u9ad8\u6548\u4e09\u7ea7\u8fc7\u6ee4\uff1b<\/li>\n<li>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e94\u5b89\u88c5\u5728\u9001\u98ce\u672b\u7aef\uff1b<\/li>\n<li>\u5fc5\u987b\u5b9a\u671f\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08\u5982DOP\u6d4b\u8bd5\u3001\u5149\u5ea6\u8ba1\u6cd5\u6216\u7c92\u5b50\u8ba1\u6570\u6cd5\uff09\uff1b<\/li>\n<li>\u66f4\u6362\u5468\u671f\u4f9d\u636e\u538b\u5dee\u53d8\u5316\u3001\u6cc4\u6f0f\u6d4b\u8bd5\u7ed3\u679c\u786e\u5b9a\u3002<\/li>\n<\/ul>\n<h4>\uff082\uff09GB\/T 13554-2020\u300a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u300b<\/h4>\n<p>\u8be5\u6807\u51c6\u5bf9\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5916\u89c2\u3001\u5c3a\u5bf8\u504f\u5dee\u3001\u6c14\u6d41\u963b\u529b\u3001\u8fc7\u6ee4\u6548\u7387\u3001\u8010\u706b\u6027\u80fd\u7b49\u5747\u4f5c\u51fa\u660e\u786e\u89c4\u5b9a\u3002<\/p>\n<h3>2.2 \u56fd\u9645\u6807\u51c6\u4e0e\u6307\u5357<\/h3>\n<h4>\uff081\uff09ISO 14644-3\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883 \u7b2c3\u90e8\u5206\uff1a\u68c0\u6d4b\u65b9\u6cd5\u300b<\/h4>\n<ul>\n<li>\u89c4\u5b9a\u4e86\u9ad8\u6548\u8fc7\u6ee4\u5668\u6cc4\u6f0f\u6d4b\u8bd5\uff08Aerosol Photometer Test\uff09\u7684\u65b9\u6cd5\uff1b<\/li>\n<li>\u63a8\u8350\u4f7f\u7528\u6c14\u6eb6\u80f6\u53d1\u751f\u5668\uff08\u5982\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u8f9b\u916fDOP\uff09\u914d\u5408\u5149\u5ea6\u8ba1\u8fdb\u884c\u626b\u63cf\u68c0\u6f0f\uff1b<\/li>\n<li>\u6cc4\u6f0f\u9650\u503c\u4e00\u822c\u4e3a0.03%\u3002<\/li>\n<\/ul>\n<h4>\uff082\uff09US FDA Guidelines for Aseptic Processing<\/h4>\n<ul>\n<li>\u8981\u6c42\u5728\u5173\u952e\u533a\u57df\uff08\u5982\u704c\u88c5\u7ebf\uff09\u4f7f\u7528\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u9700\u5177\u5907H14\u7ea7\u522b\uff1b<\/li>\n<li>\u5efa\u8bae\u6bcf\u5e74\u81f3\u5c11\u8fdb\u884c\u4e00\u6b21\u5b8c\u6574\u6027\u6d4b\u8bd5\uff1b<\/li>\n<li>\u63a8\u8350\u4f7f\u7528\u7c92\u5b50\u8ba1\u6570\u5668\u76d1\u6d4b\u8fc7\u6ee4\u540e\u7a7a\u6c14\u6d01\u51c0\u5ea6\u3002<\/li>\n<\/ul>\n<h4>\uff083\uff09WHO Technical Report Series No. 961 Annex 6<\/h4>\n<ul>\n<li>\u660e\u786e\u6307\u51fa\u7528\u4e8e\u65e0\u83cc\u751f\u4ea7\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e94\u5177\u6709H13\u53ca\u4ee5\u4e0a\u7b49\u7ea7\uff1b<\/li>\n<li>\u5f3a\u8c03\u8fc7\u6ee4\u5668\u66f4\u6362\u524d\u5fc5\u987b\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\uff1b<\/li>\n<li>\u5efa\u8bae\u7ed3\u5408\u538b\u5dee\u76d1\u63a7\u548c\u5b9a\u671f\u66f4\u6362\u7b56\u7565\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u4e09\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u4ea7\u54c1\u53c2\u6570\u4e0e\u9009\u578b\u5efa\u8bae<\/h2>\n<p>\u9009\u62e9\u9002\u7528\u4e8e\u75ab\u82d7\u8f66\u95f4\u7684\u9ad8\u6548\u8fc7\u6ee4\u5668\u65f6\uff0c\u5e94\u7efc\u5408\u8003\u8651\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n<h3>3.1 \u5173\u952e\u4ea7\u54c1\u53c2\u6570\u5bf9\u7167\u8868<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570<\/th>\n<th>\u63cf\u8ff0<\/th>\n<th>\u5178\u578b\u503c\/\u8303\u56f4<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8fc7\u6ee4\u6548\u7387<\/td>\n<td>\u5bf90.3 \u03bcm\u9897\u7c92\u7684\u622a\u7559\u7387<\/td>\n<td>\u2265 99.995% (H14)<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u59cb\u963b\u529b<\/td>\n<td>\u65b0\u8fc7\u6ee4\u5668\u5728\u989d\u5b9a\u98ce\u91cf\u4e0b\u7684\u538b\u964d<\/td>\n<td>\u2264 250 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u6700\u7ec8\u963b\u529b\u8bbe\u5b9a\u503c<\/td>\n<td>\u66f4\u6362\u524d\u7684\u6700\u5927\u5141\u8bb8\u538b\u964d<\/td>\n<td>400~600 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u5c3a\u5bf8\u89c4\u683c<\/td>\n<td>\u6839\u636e\u98ce\u53e3\u5927\u5c0f\u5b9a\u5236<\/td>\n<td>610\u00d7610 mm\u7b49<\/td>\n<\/tr>\n<tr>\n<td>\u6750\u8d28<\/td>\n<td>\u6ee4\u6750\u6750\u8d28<\/td>\n<td>\u73bb\u7483\u7ea4\u7ef4\u3001PTFE\u6d82\u5c42<\/td>\n<\/tr>\n<tr>\n<td>\u8fb9\u6846\u6750\u6599<\/td>\n<td>\u94dd\u5408\u91d1\u3001\u4e0d\u9508\u94a2<\/td>\n<td>\u94dd\u5408\u91d1\u4e3a\u4e3b<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u65b9\u5f0f<\/td>\n<td>\u6db2\u69fd\u5bc6\u5c01\u3001\u5200\u53e3\u5bc6\u5c01<\/td>\n<td>\u6db2\u69fd\u5bc6\u5c01\u8f83\u5e38\u89c1<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u6e29\u5ea6\u8303\u56f4<\/td>\n<td>\u6b63\u5e38\u5de5\u4f5c\u73af\u5883\u6e29\u5ea6<\/td>\n<td>-20\u2103 ~ 80\u2103<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u6e7f\u5ea6\u8303\u56f4<\/td>\n<td>\u76f8\u5bf9\u6e7f\u5ea6<\/td>\n<td>\u2264 80% RH<\/td>\n<\/tr>\n<tr>\n<td>\u8010\u706b\u7b49\u7ea7<\/td>\n<td>UL 900\u6807\u51c6<\/td>\n<td>Class 1 or Class 2<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>3.2 \u9009\u578b\u5efa\u8bae<\/h3>\n<ul>\n<li><strong>\u5173\u952e\u533a\u57df<\/strong>\uff08\u5982\u704c\u88c5\u95f4\uff09\uff1a\u63a8\u8350\u9009\u7528H14\u7b49\u7ea7\u8fc7\u6ee4\u5668\uff0c\u91c7\u7528\u6db2\u69fd\u5bc6\u5c01\u7ed3\u6784\u4ee5\u63d0\u9ad8\u5bc6\u5c01\u6027\uff1b<\/li>\n<li><strong>\u975e\u5173\u952e\u533a\u57df<\/strong>\uff08\u5982\u7f13\u51b2\u95f4\uff09\uff1a\u53ef\u9009\u7528H13\u6216E12\u7b49\u7ea7\uff0c\u89c6\u6d01\u51c0\u5ea6\u8981\u6c42\u800c\u5b9a\uff1b<\/li>\n<li><strong>\u9ad8\u6e29\u706d\u83cc\u5de5\u827a\u6bb5<\/strong>\uff1a\u9700\u9009\u7528\u8010\u9ad8\u6e29\u578b\u53f7\uff08\u5982\u73bb\u7ea4\u6ee4\u6750+\u4e0d\u9508\u94a2\u8fb9\u6846\uff09\uff1b<\/li>\n<li><strong>\u9891\u7e41\u66f4\u6362\u533a\u57df<\/strong>\uff1a\u4f18\u5148\u8003\u8651\u6a21\u5757\u5316\u8bbe\u8ba1\uff0c\u4fbf\u4e8e\u5feb\u901f\u66f4\u6362\u548c\u51cf\u5c11\u505c\u673a\u65f6\u95f4\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u56db\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u5b89\u88c5\u4e0e\u9a8c\u8bc1\u6d41\u7a0b<\/h2>\n<h3>4.1 \u5b89\u88c5\u524d\u51c6\u5907<\/h3>\n<ul>\n<li>\u786e\u8ba4\u8fc7\u6ee4\u5668\u578b\u53f7\u3001\u6570\u91cf\u3001\u89c4\u683c\u4e0e\u56fe\u7eb8\u4e00\u81f4\uff1b<\/li>\n<li>\u68c0\u67e5\u5305\u88c5\u662f\u5426\u5b8c\u597d\u3001\u6709\u65e0\u7834\u635f\uff1b<\/li>\n<li>\u67e5\u9a8c\u51fa\u5382\u5408\u683c\u8bc1\u3001\u68c0\u6d4b\u62a5\u544a\uff1b<\/li>\n<li>\u6e05\u6d01\u5b89\u88c5\u533a\u57df\uff0c\u907f\u514d\u7070\u5c18\u6c61\u67d3\uff1b<\/li>\n<li>\u68c0\u67e5\u98ce\u673a\u7cfb\u7edf\u8fd0\u884c\u72b6\u6001\u662f\u5426\u6b63\u5e38\u3002<\/li>\n<\/ul>\n<h3>4.2 \u5b89\u88c5\u8fc7\u7a0b\u8981\u70b9<\/h3>\n<ul>\n<li>\u4e25\u683c\u6309\u7167\u5236\u9020\u5546\u63d0\u4f9b\u7684\u5b89\u88c5\u8bf4\u660e\u64cd\u4f5c\uff1b<\/li>\n<li>\u4f7f\u7528\u4e13\u7528\u5de5\u5177\u9632\u6b62\u635f\u574f\u6ee4\u7eb8\uff1b<\/li>\n<li>\u786e\u4fdd\u5bc6\u5c01\u6761\u5b8c\u6574\u3001\u5747\u5300\u8d34\u5408\uff1b<\/li>\n<li>\u5b89\u88c5\u65b9\u5411\u6b63\u786e\uff08\u7bad\u5934\u6307\u5411\u6c14\u6d41\u65b9\u5411\uff09\uff1b<\/li>\n<li>\u8bb0\u5f55\u5b89\u88c5\u65e5\u671f\u3001\u7f16\u53f7\u3001\u4eba\u5458\u7b49\u4fe1\u606f\u3002<\/li>\n<\/ul>\n<h3>4.3 \u6027\u80fd\u9a8c\u8bc1\u9879\u76ee<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u9a8c\u8bc1\u9879\u76ee<\/th>\n<th>\u65b9\u6cd5<\/th>\n<th>\u9891\u6b21<\/th>\n<th>\u5408\u683c\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u521d\u59cb\u538b\u5dee\u6d4b\u91cf<\/td>\n<td>\u4f7f\u7528\u538b\u529b\u8ba1\u6d4b\u91cf<\/td>\n<td>\u5b89\u88c5\u540e\u9996\u6b21<\/td>\n<td>\u2264 250 Pa<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u6d4b\u8bd5<\/td>\n<td>DOP\u5149\u5ea6\u8ba1\u6cd5\u3001\u7c92\u5b50\u8ba1\u6570\u6cd5<\/td>\n<td>\u521d\u88c5\/\u66f4\u6362\u540e<\/td>\n<td>\u2264 0.03%\u6cc4\u6f0f\u7387<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u91cf\u6d4b\u8bd5<\/td>\n<td>\u70ed\u7403\u98ce\u901f\u4eea\u3001\u98ce\u91cf\u7f69<\/td>\n<td>\u6bcf\u5b63\u5ea6<\/td>\n<td>\u7b26\u5408\u8bbe\u8ba1\u98ce\u91cf\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>\u6d01\u51c0\u5ea6\u6d4b\u8bd5<\/td>\n<td>\u7c92\u5b50\u8ba1\u6570\u5668<\/td>\n<td>\u6bcf\u6708<\/td>\n<td>\u8fbe\u5230\u76f8\u5e94ISO\u6d01\u51c0\u7b49\u7ea7<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u6c89\u964d\u83cc\u6d4b\u8bd5<\/td>\n<td>\u57f9\u517b\u76bf\u66b4\u9732\u6cd5<\/td>\n<td>\u6bcf\u5468<\/td>\n<td>\u2264 1 CFU\/\u76bf\uff08Class 5\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b\u62a5\u8b66\u8bbe\u7f6e<\/td>\n<td>\u538b\u5dee\u5f00\u5173\u8bbe\u5b9a<\/td>\n<td>\u521d\u59cb\u8bbe\u5b9a<\/td>\n<td>400~600 Pa\u89e6\u53d1\u62a5\u8b66<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u4e94\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u65e5\u5e38\u7ef4\u62a4\u4e0e\u66f4\u6362\u7b56\u7565<\/h2>\n<h3>5.1 \u65e5\u5e38\u76d1\u6d4b\u5185\u5bb9<\/h3>\n<ul>\n<li><strong>\u538b\u5dee\u76d1\u6d4b<\/strong>\uff1a\u6bcf\u65e5\u8bb0\u5f55\u521d\u6548\u3001\u4e2d\u6548\u3001\u9ad8\u6548\u8fc7\u6ee4\u5668\u524d\u540e\u538b\u5dee\uff1b<\/li>\n<li><strong>\u98ce\u901f\u76d1\u6d4b<\/strong>\uff1a\u6bcf\u5b63\u5ea6\u68c0\u6d4b\u9001\u98ce\u53e3\u98ce\u901f\uff1b<\/li>\n<li><strong>\u6d01\u51c0\u5ea6\u76d1\u6d4b<\/strong>\uff1a\u6309\u533a\u57df\u7b49\u7ea7\u5b9a\u671f\u8fdb\u884c\u7c92\u5b50\u548c\u5fae\u751f\u7269\u91c7\u6837\uff1b<\/li>\n<li><strong>\u5b8c\u6574\u6027\u6d4b\u8bd5<\/strong>\uff1a\u6bcf\u5e74\u81f3\u5c11\u4e00\u6b21\u8fdb\u884cDOP\u6cc4\u6f0f\u6d4b\u8bd5\u3002<\/li>\n<\/ul>\n<h3>5.2 \u66f4\u6362\u5224\u65ad\u4f9d\u636e<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u5224\u65ad\u56e0\u7d20<\/th>\n<th>\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u538b\u5dee\u8d85\u8fc7\u7ec8\u963b\u503c<\/td>\n<td>\u8868\u793a\u6ee4\u6750\u5835\u585e\uff0c\u9700\u66f4\u6362<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u6d4b\u8bd5\u4e0d\u5408\u683c<\/td>\n<td>\u5b58\u5728\u7a7f\u5b54\u6216\u5bc6\u5c01\u4e0d\u4e25\uff0c\u7acb\u5373\u66f4\u6362<\/td>\n<\/tr>\n<tr>\n<td>\u6d01\u51c0\u5ea6\u4e0d\u8fbe\u6807<\/td>\n<td>\u53ef\u80fd\u4e3a\u8fc7\u6ee4\u5668\u5931\u6548\uff0c\u9700\u6392\u67e5\u539f\u56e0<\/td>\n<\/tr>\n<tr>\n<td>\u4f7f\u7528\u5e74\u9650\u5230\u671f<\/td>\n<td>\u4e00\u822c\u5efa\u8bae5~7\u5e74\uff0c\u89c6\u73af\u5883\u800c\u5b9a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>5.3 \u66f4\u6362\u6ce8\u610f\u4e8b\u9879<\/h3>\n<ul>\n<li>\u66f4\u6362\u524d\u5173\u95ed\u98ce\u673a\u5e76\u8fdb\u884c\u8d1f\u538b\u5904\u7406\uff1b<\/li>\n<li>\u4f7f\u7528\u9632\u62a4\u88c5\u5907\uff0c\u9632\u6b62\u4e8c\u6b21\u6c61\u67d3\uff1b<\/li>\n<li>\u5e9f\u5f03\u65e7\u8fc7\u6ee4\u5668\u5e94\u6309\u7167\u533b\u7597\u5e9f\u7269\u5904\u7406\uff1b<\/li>\n<li>\u66f4\u6362\u540e\u91cd\u65b0\u8fdb\u884c\u5b8c\u6574\u6027\u6d4b\u8bd5\u548c\u6d01\u51c0\u5ea6\u786e\u8ba4\u3002<\/li>\n<\/ul>\n<hr \/>\n<h2>\u516d\u3001\u56fd\u5185\u5916\u5178\u578b\u5e94\u7528\u6848\u4f8b\u5206\u6790<\/h2>\n<h3>6.1 \u5317\u4eac\u79d1\u5174\u4e2d\u7ef4\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4<\/h3>\n<p>\u5317\u4eac\u79d1\u5174\u4e2d\u7ef4\u65b0\u51a0\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u91c7\u7528H14\u7b49\u7ea7\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u914d\u7f6e\u6db2\u69fd\u5bc6\u5c01\u7ed3\u6784\uff0c\u642d\u914d\u81ea\u52a8\u538b\u5dee\u76d1\u63a7\u7cfb\u7edf\uff0c\u786e\u4fdd\u6d01\u51c0\u533a\u7ef4\u6301Class 5\u6807\u51c6\u3002\u6bcf\u5e74\u7531\u7b2c\u4e09\u65b9\u673a\u6784\u8fdb\u884cDOP\u6cc4\u6f0f\u6d4b\u8bd5\u548c\u7c92\u5b50\u8ba1\u6570\u9a8c\u8bc1\uff0c\u6570\u636e\u4e0a\u4f20\u81f3\u4f01\u4e1aQMS\u7cfb\u7edf\u3002<\/p>\n<h3>6.2 \u8f89\u745e\uff08Pfizer\uff09\u7f8e\u56fd\u5de5\u5382<\/h3>\n<p>\u8f89\u745e\u5728\u7f8e\u56fd\u7684\u75ab\u82d7\u751f\u4ea7\u7ebf\u4e2d\u5e7f\u6cdb\u4f7f\u7528H14\u7ea7\u522b\u9ad8\u6548\u8fc7\u6ee4\u5668\uff0c\u5e76\u91c7\u7528\u7c92\u5b50\u8ba1\u6570\u6cd5\u66ff\u4ee3\u4f20\u7edfDOP\u6d4b\u8bd5\uff0c\u7b26\u5408FDA\u6700\u65b0\u6307\u5357\u8981\u6c42\u3002\u5176\u6d01\u51c0\u533a\u91c7\u7528\u6b63\u538b\u68af\u5ea6\u8bbe\u8ba1\uff0c\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\u3002<\/p>\n<hr \/>\n<h2>\u4e03\u3001\u7ed3\u8bba\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]. 2011.<\/li>\n<li>\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a. \u300a\u4e2d\u56fd\u836f\u5178\u300b2020\u7248[S]. \u5317\u4eac: \u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2020.<\/li>\n<li>GB\/T 13554-2020. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668[S]. \u5317\u4eac: \u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2020.<\/li>\n<li>ISO 14644-1:2015 Cleanrooms and associated controlled environments \u2014 Part 1: Classification and grading of air cleanliness by particle concentration[S].<\/li>\n<li>ISO 14644-3:2019 Cleanrooms and associated controlled environments \u2014 Part 3: Test methods[S].<\/li>\n<li>WHO Technical Report Series, No. 961, Annex 6: WHO good manufacturing practices for biological products[S].<\/li>\n<li>United States Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing \u2013 Current Good Manufacturing Practice [EB\/OL]. <a href=\"https:\/\/www.fda.gov\">https:\/\/www.fda.gov<\/a>, 2004.<\/li>\n<li>European Commission. EudraLex &#8211; The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice (GMP) guidelines Annex 1 Manufacture of Sterile Medicinal Products[S]. 2023.<\/li>\n<li>\u767e\u5ea6\u767e\u79d1. \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668 [EB\/OL]. <a href=\"https:\/\/baike.baidu.com\/item\/%E9%AB%98%E6%95%88%E7%A9%BA%E6%B0%94%E8%BF%87%E6%BB%A4%E5%99%A8\">https:\/\/baike.baidu.com\/item\/%E9%AB%98%E6%95%88%E7%A9%BA%E6%B0%94%E8%BF%87%E6%BB%A4%E5%99%A8<\/a>.<\/li>\n<li>\u6d01\u51c0\u6280\u672f\u7f51. \u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u6d01\u51c0\u7a7a\u8c03\u7cfb\u7edf\u8bbe\u8ba1[J]. \u6d01\u51c0\u4e0e\u7a7a\u8c03\u6280\u672f, 2021(3): 45-49.<\/li>\n<\/ol>\n<hr \/>\n<p><em>\u5168\u6587\u5171\u8ba1\u7ea64300\u5b57\uff0c\u6db5\u76d6\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u75ab\u82d7\u8f66\u95f4\u7684\u5e94\u7528\u80cc\u666f\u3001\u6cd5\u89c4\u8981\u6c42\u3001\u4ea7\u54c1\u53c2\u6570\u3001\u9a8c\u8bc1\u6d41\u7a0b\u3001\u7ef4\u62a4\u7ba1\u7406\u53ca\u5b9e\u9645\u6848\u4f8b\u7b49\u5185\u5bb9\uff0c\u529b\u6c42\u5185\u5bb9\u8be6\u5b9e\u3001\u6761\u7406\u6e05\u6670\uff0c\u53ef\u4f9b\u5236\u836f\u5de5\u7a0b\u3001\u6d01\u51c0\u5ba4\u8bbe\u8ba1\u3001\u8d28\u91cf\u7ba1\u7406\u4eba\u5458\u53c2\u8003\u4f7f\u7528\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u4e2d\u7684\u5408\u89c4\u6027\u8981\u6c42\u4e0e\u9a8c\u8bc1 \u5f15\u8a00 \u968f\u7740\u5168\u7403\u5bf9\u75ab\u82d7\u9700\u6c42\u7684\u6301\u7eed\u589e\u957f\uff0c\u75ab\u82d7\u751f\u4ea7\u7684\u5b89\u5168\u6027\u548c\u8d28\u91cf\u63a7\u5236\u65e5\u76ca\u53d7\u5230\u91cd\u89c6\u3002\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter\uff0c\u7b80\u79f0HEPA\uff09\u4f5c\u4e3a\u6d01\u51c0\u5ba4\u7cfb\u7edf\u4e2d\u5173\u952e\u7684\u7ec4\u6210\u90e8\u5206\uff0c\u5728\u75ab\u82d7\u751f\u4ea7\u8f66\u95f4\u4e2d\u626e\u6f14\u7740\u81f3\u5173\u91cd\u8981\u7684\u89d2\u8272\u3002\u5176\u4e3b\u8981\u529f\u80fd\u662f\u53bb\u9664\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u9897\u7c92\u3001\u5fae\u751f\u7269\u7b49\u6c61\u67d3\u7269\uff0c\u786e\u4fdd\u751f\u4ea7\u73af\u5883&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-14406","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\/14406","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=14406"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/14406\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14406"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14406"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14406"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}