{"id":216,"date":"2021-05-20T23:46:11","date_gmt":"2021-05-20T15:46:11","guid":{"rendered":"http:\/\/203.67.9.89\/?page_id=216"},"modified":"2021-05-20T23:46:11","modified_gmt":"2021-05-20T15:46:11","slug":"envirment","status":"publish","type":"page","link":"https:\/\/www.softbiohealth.com\/index.php\/envirment\/","title":{"rendered":"\u74b0\u5883\u4fdd\u8b77"},"content":{"rendered":"<link href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/css\/bootstrap.css\" rel=\"stylesheet\">\n \t \t \t \t \t<link href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/css\/style.css\" rel=\"stylesheet\">\n \t \t \t \t \t<link href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/css\/responsive-style.css\" rel=\"stylesheet\">\n \t \t \t \t \t<link href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/css\/theme-color-5.css\" rel=\"stylesheet\" id=\"changeColorScheme\">\n \t \t \t \t \t<link href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/css\/custom.css\" rel=\"stylesheet\">\n<div class=\"wrapper\">\n<div class=\"ssl-certificate-single pd-20-0-50\">\n            <!--\n\n\n<div class=\"container\"> --><\/p>\n<div class=\"section--title text-center\">\n<h2 class=\"h2\">Protak<\/h2>\n<\/div>\n<div class=\"page--content clearfix\">\n<h3 class=\"font_blue\">60\u79d2\u9a57\u8b49  EI \u9175\u7d20\u751f\u7269\u6307\u793a\u5668<\/h3>\n<p><span class=\"font_blue\">\u300a\u6578\u4f4d\u5316\u751f\u7269\u6307\u793a\u5668\u300b<\/span>\u6578\u4f4d\u5316\u7684 EI (Enzyme Indicator) \u9175\u7d20\u751f\u7269\u9a57\u8b49\u6280\u8853\u70ba vH2O2, VHP, HVP, iHP \u9019\u4e9b\u9ad8\u7d1a\u6ec5\u83cc\u8a2d\u5099\u958b\u555f\u4e86\u5373\u6642\u78ba\u6548\u9a57\u7684\u65b0\u91cc\u7a0b\u3002<\/p>\n<p>\u9019\u4e9b\u9ad8\u7d1a\u6ec5\u83cc\u8a2d\u5099\u900f\u904e\u81ea\u5bb6\u6ec5\u83cc\u5291\u8207\u8d77\u9727\u88dd\u7f6e,\u90fd\u5f37\u8abf\u5b83\u5011\u53ef\u4ee5\u5728\u76f8\u5c0d\u7a7a\u9593,\u6642\u9593\u8207\u6eab\u5ea6\u4e0b\u9054\u5230\u6700\u9ad8\u7b49\u7d1a( 6 Log \u621699.99 %\u6216\u66f4\u9ad8\u7b49\u7d1a) \u7684\u6ec5\u83cc\u6548\u679c\u3002Protak Scientific \u7684EI\u9175\u7d20\u9a57\u8b49\u7522\u54c1\u8207\u6280\u8853\uff0c\u8b93\u6ec5\u83cc\u662f\u5426\u9054\u6a19\uff0c\u53ef\u4ee5\u572860\u79d2\u5f8c\u5448\u73fe\u5728\u7b26\u5408 FDA \u8981\u6c42\u7684\u6578\u4f4d\u5316\u5831\u544a\u4e0a\u3002<\/p>\n<p><span class=\"font_blue\">\u300a\u50b3\u7d71 BI\u751f\u7269\u6307\u793a\u5668\u7684\u7121\u5f62\u6210\u672c\u300b<\/span>\u6578\u5341\u5e74\u4f86\uff0c\u4e0d\u8ad6\u662f\u8a2d\u5099\u696d\u8005\u6216\u662f\u5c08\u696d\u7528\u6236\u90fd\u63a1\u7528\u751f\u7269\u6307\u793a\u8a08(\u7c21\u7a31 BI, Biological Indicator) \u7684\u6aa2\u6e2c\u6280\u8853\u4f86\u9a57\u8b49\u81ea\u5bb6\u8a2d\u5099\u7684\u6ec5\u83cc\u6548\u679c\u4ee5\u53ca\u63a7\u7ba1\u7522\u54c1\u7684\u751f\u7522\u904e\u7a0b\uff0c\u74b0\u5883\u54c1\u8cea\u3002\u901a\u5e38\u5f9e\u653e\u7f6e\u6e2c\u8a66\u689d(BI Strip)\uff0c\u6216\u653e\u5165\u57f9\u990a\u76bf\u5b75\u5316(incubator) \u5230\u53d6\u5f97\u4e00\u500b\u4ee5\u984f\u8272\u3001\u4ee5\u985e\u6bd4\u5f0f\u7684\u8272\u584a\u6216\u8272\u6fa4\uff0c\u4f86\u78ba\u8a8d\u6aa2\u6e2c\u7d50\u679c(Reader)\uff0c\u9084\u662f\u9700\u8981\u591a\u65e5\uff0c\u751a\u81f3\u591a\u9054\u4e03\u5929\u4e0d\u7b49\u7684\u9031\u671f\u3002<\/p>\n<p><span class=\"font_blue\">\u300aEI\u9175\u7d20\u751f\u7269\u6307\u793a\u5668\u88ab10\u5927\u63a1\u7528\u300b<\/span>\u5b83\u7684\u7d44\u6210\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>tAK Catalyst ( Enzyme Strip\u9175\u7d20\u6307\u793a\u689d)<\/li>\n<li>Bioluminescent Assay (\u751f\u7269\u767c\u5149\u542b\u91cf\u6e2c\u5b9a\u5291 )<\/li>\n<li>Luminometer PR2A ( \u5149\u5ea6\u5224\u8b80\u6a5f)<\/li>\n<li>Athena software (\u7522\u51fa\u7b26\u5408FDA 21 CFR Part 11\u6e96\u5247\u7684\u6578\u4f4d\u91cf\u5316\u5831\u544a)<\/li>\n<\/ul>\n<p>\u4ee5\u4e0a\u56db\u500b\u90e8\u5206\uff0c\u524d\u5169\u8005\u50c5\u9700\u5728\u4e00\u822c\u51b7\u85cf\u74b0\u5883\u4fdd\u5b58\u3002\u4e8b\u5148\u5c07Enzyme strip \u8a66\u689d, \u7f6e\u653e\u5728\u6240\u6b32\u53d7\u6e2c\u7684\u4efb\u4f55\u4f4d\u7f6e\uff0c\u7b49\u5230\u6ec5\u83cc\u7d50\u675f\u5f8c\uff0c\u5c07\u4e00\u7d44\u6216\u591a\u7d44\u8a66\u689d\u7f6e\u5165\u5df2\u8abf\u6821\u5f85\u547d\u597d\u7684\u5149\u5ea6\u8b80\u5beb\u6a5f\uff0c\u300a60\u79d2\u300b\u4e4b\u5f8c\u60a8\u7684\u96fb\u8166\u5c31\u6703\u4f9d\u5149\u5ea6\u81ea\u52d5\u7522\u51fa\u4e00\u500b\u83cc\u9ad4\u6b98\u7559\u6578\u503c\u3002<\/p>\n<p><span class=\"font_blue\">\u300a\u53ef\u4fe1\u8cf4\u7684\u570b\u5bb6\u7d1a\u6280\u8853\u300b<\/span>\u6b77\u7d9315\u5e74\u7814\u767c\u8207\u8a66\u7528\uff0c Protak Scientific \u516c\u53f8\u662f\u5728\u82f1\u570bPublic Health England (PHE) \u652f\u6301\u7814\u7a76tAK\u6280\u8853\u4e26\u5f97\u5230\u5546\u696d\u5316\u652f\u6301\u6240\u6210\u7acb\u3002PHE\u662fUK Department of Health\u8f44\u4e0b\u7684\u4e00\u500b\u4ee3\u7406\u57f7\u884c\u6a5f\u69cb\uff0c\u6574\u5408\u5168\u570b70\u591a\u500b\u7d44\u7e54\uff0c\u63a8\u52d5\u5404\u7a2e\u5065\u5eb7\u3001\u798f\u7949\u76f8\u95dc\u7684\u4f5c\u696d\uff0c\u8a0a\u606f\u8207\u65b0\u578b\u767c\u5c55\u3002<\/p>\n<h3 class=\"font_blue\">\u7522\u54c1\u7279\u8272<\/h3>\n<ul>\n<li><span class=\"font_blue\">\u5feb\u901f\uff1a<\/span>\u81ea\u7f6e\u5165\u8a66\u689d\u5230\u7522\u51fa\u5831\u544a\u50c5\u970060\u79d2\uff0c\u4e0d\u9700\u8981\u5b75\u5316\u5668(Incubator)\uff0c\u4e0d\u5360\u7a7a\u9593\u3001\u4e0d\u9700\u6392\u5e8f\u653e\u7f6e\u3001\u4e0d\u9700\u7b49\u5f85\u6bcf\u500b\u5468\u671f\u7684\u7d50\u679c\u3002<\/li>\n<li><span class=\"font_blue\">\u771f\u5be6\u6578\u5b57\uff1a<\/span>\u900f\u904e\u5149\u5ea6\u8a08\u53d6\u5f97\u53ef\u91cf\u5316\u7684\u6578\u503c ; \u53ef\u4ee5\u548cBI\u751f\u7269\u6307\u5f0f\u5291\u7684\u7d50\u679c\u505a\u76f8\u95dc\u6027\u6bd4\u5c0d\u3002<\/li>\n<li><span class=\"font_blue\">\u54c1\u8cea\uff1a<\/span>\u7ba1\u7406\u55ae\u4f4d\u53ef\u8a2d\u8a08\u9023\u7e8c\u5f0f\uff0c\u5728\u524d\u5f8c\u88fd\u7a0b\u5c55\u958b\u65b0\u7684\u5168\u7a0b\u9632\u8b77\u6e2c\u8a66\u8207\u9a57\u8b49\u3002<\/li>\n<li><span class=\"font_blue\">\u6578\u4f4d\u5316\u4f5c\u696d\uff1a<\/span>\u4e0d\u9700\u8981\u4eba\u624b\u505a\u7d00\u9304\u3001\u7121\u9808\u6587\u5b57\u63cf\u8ff0\uff0c\u5927\u5e45\u6d3b\u5316\u9ad8\u7d1a\u4eba\u529b\u4f7f\u7528\u6210\u672c\u3002<\/li>\n<\/ul>\n<div><img decoding=\"async\" src=\"http:\/\/180.176.211.8\/wp-content\/uploads\/prd_img\/ps01.jpg\"><\/div>\n<h3 class=\"font_blue\">\u7522\u54c1\u5404\u90e8\u4ef6\u7c21\u4ecb<\/h3>\n<ul>\n<li><span class=\"font_blue\">\u6307\u793a\u689d\u4f7f\u7528\u7684\u9175\u7d20\u539f\u9ad4\uff1a<\/span>\u6307\u793a\u689d\u4f7f\u7528\u7684\u9175\u7d20\u539f\u9ad4\u662f\u5f9e\u55dc\u71b1\u7d30\u83cc\uff08Sulpholobus acidocaldarius\uff09\u5206\u96e2\u51fa\u71b1\u7a69\u5b9a\u7684\u817a\u82f7\u9178\u6fc0\u9176(tAK)\uff0c\u53ef\u7528\u767c\u5149\u6cd5\u6e2c\u91cf\u5176\u5b58\u5728\u548c\u6d3b\u6027\u3002tAK\u5177\u53ef\u9810\u6e2c\u7684\u6ec5\u6d3b\u66f2\u7dda\uff0c\u53ef\u5728\u8f03\u5bec\u7684\u52d5\u614b\u7bc4\u570d\u5167\u9032\u884c\u6e2c\u91cf\uff0c\u9019\u4e9b\u7279\u6027\u4f7ftAK\u6210\u70ba\u76e3\u6e2c\u6ec5\u83cc\uff0c\u53bb\u6c61\u904e\u7a0b\u4e2d\u66ff\u4ee3\u6a19\u8a18\u7684\u7406\u60f3\u9078\u64c7\u3002<\/li>\n<li><span class=\"font_blue\">tAK test Strip\u9175\u7d20\u751f\u7269\u6307\u793a\u689d\uff1a<\/span>\u900f\u904e\u7cbe\u7d30\u3001\u7121\u5bb3\u7121\u6bd2\u7684\u88fd\u7a0b\uff0c\u5c07\u5fae\u514b(pico gram)\u5291\u91cf\u7684tAK\u7f6e\u5165\u8f09\u9ad4\uff0c\u5167\u6bd2\u7d20(Endotoxins)\u4e5f\u88ab\u9810\u5148\u6e05\u9664\u3002\u91cf\u7522\u51b7\u85cf\u597d\u7684EI strip \u5728\u62c6\u5c01\u5f8c\u53ef\u4ee5\u5f88\u65b9\u4fbf\u7684\u5f48\u5165\u7121\u83cc\u8b80\u53d6\u7ba1\u3002<\/li>\n<li><span class=\"font_blue\">\u87a2\u5149-\u767c\u5149\u542b\u91cf\u6e2c\u5b9a\u5291\uff1a<\/span>\u5149\u5ea6\u8b80\u53d6\u6a5f\u9700\u4e8b\u5148\u6e05\u6d17\u6e2c\u5b9a\uff0c\u7136\u5f8c\u5728\u652f\u67b6\u4e0a\u9023\u63a5\u597d\u6e2c\u5b9a\u5291\u8207\u9001\u6db2\u7ba1\u3002\u56fa\u5b9a\u7684\u904b\u4f5c\u904e\u7a0b\u6703\u91cf\u6e2c\u4f7f\u7528\u904e\u7684EI\u6e2c\u8a66\u689d\u4e0a\u9084\u5016\u5b58\u7684tAK\u8207\u87a2\u5149\u7d20\u9176\u50ac\u5316\u5f8c\u7684\u767c\u5149\u6578\u503c\u3002<\/li>\n<li><span class=\"font_blue\">PR2A Reader\u5149\u5ea6\u5224\u8b80\u6a5f\uff1a<\/span>\u9019\u662f\u88fd\u85e5\u7522\u696d\u6700\u65b0\u8a8d\u8b49\u7684\u5149\u5ea6\u8b80\u53d6\u88dd\u7f6e\uff0c\u5b83\u53ef\u4ee5\u9023\u7e8c\u5f0f\u3001\u5168\u81ea\u52d5\u7684\u91cf\u6e2c\uff0c\u8b80\u53d6\u8a66\u7ba1\u7576\u4e2d\u7684RLU\u767c\u5149\u53cd\u61c9\u6578\u64da\u3002<\/li>\n<li><span class=\"font_blue\">Athena \u5831\u8868\u8edf\u6a5f\uff1a<\/span>\u900f\u904e\u4e00\u500b\u52a0\u5bc6\u4fdd\u8b77\u7684 USB key \u9470\u5319\uff0c\u53ef\u4ee5\u81ea\u52d5\u8b80\u53d6\u548c\u5149\u5ea6\u6a5f\u76f8\u9023\u96fb\u8166\u7684\u6578\u64da\uff0c\u4f7f\u7528\u8005\u53ea\u9700\u9ede\u9078\u64cd\u4f5c\u9375\u5132\u5b58\u6216\u5217\u5370\u5831\u8868\uff0c\u800c\u7121\u6cd5\u7570\u52d5\u5167\u5b58\u6578\u64da\u3002<\/li>\n<\/ul>\n<div><img decoding=\"async\" src=\"http:\/\/180.176.211.8\/wp-content\/uploads\/prd_img\/ps02.jpg\"><\/div>\n<h3 class=\"font_blue\">\u5e02\u5834\u61c9\u7528<\/h3>\n<p><span class=\"font_blue\">\u300a\u9069\u7528\u7684\u6ec5\u83cc\u8a2d\u5099\u300b<\/span>\u9069\u5408\u4ee5\u904e\u6c27\u5316\u6c2b\u3001\u4e59\u70ef\u6c27\u5316\u7269\u70ba\u6ec5\u83cc\u5291\u7684\u9ad8\u7d1a\u5674\u9727\u6ec5\u83cc\u8a2d\u5099\u5728\u5404\u5834\u6240\u4f7f\u7528\u5f8c\u7684\u6548\u679c\u9a57\u8b49\u3002<\/p>\n<p><span class=\"font_blue\">\u300a\u9069\u5408\u7684\u6ec5\u83cc\u5834\u5408\u300b<\/span>\u9069\u5408 P3\u3001P4\u3001\u751f\u6280\u3001\u91ab\u7642\u7167\u8b77\u6a5f\u69cb\u3001\u85e5\u5ee0\u3001\u5be6\u9a57\u5ba4\u3001\u52d5\u7269\u990a\u6b96\u3001\u4ee5\u53ca\u5176\u4ed6\u96fb\u5b50\u3001\u5316\u5b78\u9808\u6ec5\u83cc\u8655\u7406\u88fd\u7a0b\u7684\u7522\u696d\uff0c\u5176\u4ed6\u7121\u83cc\u4f5c\u696d\u8981\u6c42\u74b0\u5883\uff0c\u5728\u6ec5\u83cc\u4f5c\u696d\u5f8c\u7684\u5373\u6642\u9a57\u8b49\u3002<\/p>\n<\/div>\n<p><!--<\/div>\n\n\n--><\/p>\n<\/div>\n<div id=\"features\" class=\"pd-20-0-50 bg--color-lightgray\">\n<div class=\"section--title text-center\">\n<h2 class=\"h2\">\u7522\u54c1\u898f\u683c\u578b\u9304<\/h2>\n<\/div>\n<div class=\"row AdjustRow\">\n<div class=\"feature--item col-md-6 col-xs-12\">\n                        <i class=\"fa fm fa-download\"><\/i><\/p>\n<div class=\"h4\">2021-01-Protak Scientific &#8211; Enzyme Indicators 20210118v3<\/div>\n<p><a href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/download\/ps_prd\/2021-01-Protak Scientific - Enzyme Indicators 20210118v3.pdf\" download=\"\" class=\"btn btn-default\">\u8cc7\u6599\u4e0b\u8f09<\/a><\/p>\n<\/div>\n<div class=\"feature--item col-md-6 col-xs-12\">\n                        <i class=\"fa fm fa-download\"><\/i><\/p>\n<h3 class=\"h4\">Brochure-Protak Enzyme Indicator (ENG)<\/h3>\n<p><a href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/download\/ps_prd\/Brochure-Protak Enzyme Indicator (ENG).pdf\" download=\"\" class=\"btn btn-default\">\u8cc7\u6599\u4e0b\u8f09<\/a><\/p>\n<\/div>\n<div class=\"feature--item col-md-6 col-xs-12\">\n                        <i class=\"fa fm fa-download\"><\/i><\/p>\n<h3 class=\"h4\">Brochure-Protak Scientific-(\u4e2d\u6587)60\u79d2\u9175\u7d20\u9a57\u83cc\u6aa2\u6e2c<\/h3>\n<p><a href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/download\/ps_prd\/Brochure-Protak Scientific-(\u4e2d\u6587)60\u79d2\u9175\u7d20\u9a57\u83cc\u6aa2\u6e2c.pdf\" download=\"\" class=\"btn btn-default\">\u8cc7\u6599\u4e0b\u8f09<\/a><\/p>\n<\/div>\n<div class=\"feature--item col-md-6 col-xs-12\">\n                        <i class=\"fa fm fa-download\"><\/i><\/p>\n<h3 class=\"h4\">Brochure-Protak Scientific-(\u4e2d\u6587\u53cd\u9762)60\u79d2\u9175\u7d20\u9a57\u83cc\u6aa2\u6e2c\u8a2d\u5099<\/h3>\n<p><a href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/download\/ps_prd\/Brochure-Protak Scientific-(\u4e2d\u6587\u53cd\u9762)60\u79d2\u9175\u7d20\u9a57\u83cc\u6aa2\u6e2c\u8a2d\u5099.jpg\" download=\"\" class=\"btn btn-default\">\u8cc7\u6599\u4e0b\u8f09<\/a><\/p>\n<\/div>\n<div class=\"feature--item col-md-6 col-xs-12\">\n                        <i class=\"fa fm fa-download\"><\/i><\/p>\n<h3 class=\"h4\">Brochure-Protak Scientific-(\u4e2d\u6587\u6b63\u9762)60\u79d2\u9175\u7d20\u9a57\u83cc\u6aa2\u6e2c\u8a2d\u5099<\/h3>\n<p><a href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/download\/ps_prd\/Brochure-Protak Scientific-(\u4e2d\u6587\u6b63\u9762)60\u79d2\u9175\u7d20\u9a57\u83cc\u6aa2\u6e2c\u8a2d\u5099.png\" download=\"\" class=\"btn btn-default\">\u8cc7\u6599\u4e0b\u8f09<\/a><\/p>\n<\/div>\n<div class=\"feature--item col-md-6 col-xs-12\">\n                        <i class=\"fa fm fa-download\"><\/i><\/p>\n<h3 class=\"h4\">FRM091_A &#8211; PR2A and Athena 21 CFR Part 11 Statement &#8211; ISSUED<\/h3>\n<p><a href=\"http:\/\/180.176.211.8\/wp-content\/uploads\/download\/ps_prd\/FRM091_A - PR2A and Athena 21 CFR Part 11 Statement - ISSUED.pdf\" download=\"\" class=\"btn btn-default\">\u8cc7\u6599\u4e0b\u8f09<\/a><\/p>\n<\/div>\n<div class=\"feature--item col-md-6 col-xs-12\">\n                        <i class=\"fa fm 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