{"id":178,"date":"2019-12-30T11:43:07","date_gmt":"2019-12-30T03:43:07","guid":{"rendered":"https:\/\/www.bihec.com\/misco\/?p=178"},"modified":"2019-12-30T11:43:07","modified_gmt":"2019-12-30T03:43:07","slug":"misco-vip2%e5%9c%a8%e7%ba%bf%e6%8a%98%e5%85%89%e4%bb%aa%e5%9c%a8%e5%88%b6%e8%8d%af%e5%b7%a5%e8%89%ba%e4%b8%ad%e5%be%97%e5%ba%94%e7%94%a8","status":"publish","type":"post","link":"https:\/\/www.bihec.com\/misco\/misco-vip2%e5%9c%a8%e7%ba%bf%e6%8a%98%e5%85%89%e4%bb%aa%e5%9c%a8%e5%88%b6%e8%8d%af%e5%b7%a5%e8%89%ba%e4%b8%ad%e5%be%97%e5%ba%94%e7%94%a8\/","title":{"rendered":"MISCO VIP2\u5728\u7ebf\u6298\u5149\u4eea\u5728\u5236\u836f\u5de5\u827a\u4e2d\u5f97\u5e94\u7528"},"content":{"rendered":"
<\/p>\n
\u6d3b\u6027\u836f\u7528\u6210\u5206(API\u2019S),\u539f\u6599\u836f<\/p>\n
\u5178\u578b\u7ec8\u7aef \u4ea7\u54c1<\/p>\n
\u6d3b\u6027\u836f\u7528\u6210\u5206\uff0c\u8f85\u6599\uff0c\u4e2d\u95f4\u4f53\u548c\u533b\u836f\u539f\u6599\u836f<\/p>\n
\u7b80\u4ecb <\/p>\n \u5178\u578b\u5e94\u7528<\/p>\n \uf0b7 \u5236\u836f\u5316\u5b66\u54c1 \uf0b7 \u539f\u6599\u836f \uf0b7 \u5408\u6210\u6fc0\u7d20 \uf0b7 \u5916\u79d1\u7f1d\u5408\u53ca\u4eba\u4f53\u7ec4\u7ec7\u80f6\u7c98\u7269 FDA \u6cd5\u89c4\u53ca\u9a8c\u8bc1 \u5de5\u827a\u8bbe\u8ba1\u662f\u5c06\u4ea7\u54c1\u6784\u60f3\u548c\u8981\u6c42\u8f6c\u5316\u4e3a\u5236\u9020\u7684\u4fe1\u606f\u8f6c\u6362\u8fc7\u7a0b\u3002\u4ea7\u54c1\u5236\u9020\u8fc7\u7a0b\u4e2d\u5e94\u4f7f\u7528\u79d1\u5b66\u7684\u548c\u57fa\u4e8e\u98ce\u9669\u7684\u8bbe\u8ba1\u7b56\u7565\u6765\u7ba1\u7406\u671f\u95f4\u4ea7\u751f\u7684\u53d8\u5316\u3002\u4e3a\u4e86\u5b9e\u73b0\u8fd9\u4e00\u76ee\u6807\uff0c\u5de5\u827a\u8bbe\u8ba1\u65f6\u8003\u8651\u8fc7\u7a0b\u5206\u6790\u6280\u672f MISCO \u5728\u7ebf\u6298\u5149\u4eea\u662f\u4e00\u79cd\u7406\u60f3\u7684\u8fc7\u7a0b\u6d4b\u91cf\u5de5\u5177\u3002\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u53ef\u4ee5\u5728\u4ea7\u54c1\u7814\u53d1\u3001\u8bd5\u9a8c\u53ca\u6b63\u5f0f\u751f\u4ea7\u6574\u4e2a\u9636\u6bb5\u4f7f\u7528\u5b83\u6765\u68c0\u6d4b\u6837\u54c1\u7684\u6298\u5c04\u7387\u53ca\u6d53\u5ea6\u5c5e\u6027\u53d8\u5316\uff0c\u8b6c\u5982\u63d0\u53d6\u3001\u6d53\u7f29\u3001\u8c03\u914d\u3001\u5206\u79bb\u3001\u53d1\u9175\u3001\u5408\u6210\u7b49\u8fc7\u7a0b\u3002\u6574\u4e2a\u4ea7\u54c1\u751f\u547d\u5468\u671f\u4e0d\u540c\u9636\u6bb5\u5747\u4f7f\u7528\u76f8\u540c\u7684\u5206\u6790\u5de5\u5177\uff0c\u53ef\u4ee5\u907f\u514d\u56e0\u4e0d\u540c\u6d4b\u91cf\u539f\u7406\u548c\u624b\u6bb5\u5e26\u6765\u7684\u7ed3\u679c\u504f\u5dee\u548c\u6ce2\u52a8\uff0c\u6709\u5229\u4e8e\u4fdd\u8bc1\u6d4b\u8bd5\u6570\u636e\u7684\u4e00\u81f4\u6027\uff0c\u7f29\u77ed\u5f00\u53d1\u65f6\u95f4\u548c\u63d0\u9ad8\u4ea7\u54c1\u7684\u8d28\u91cf\u3002 \u4eea\u8868\u7279\u70b9<\/p>\n MISCO\u5728\u7ebf\u6298\u5149\u4eea\u6ee1\u8db3FDA \u6240\u9700\u8981\u7684\u8bf8\u591a\u5176\u5b83\u6280\u672f\u8981\u6c42\uff0c\u5305\u62ec\uff1a<\/p>\n – \u5de5\u827a\u6750\u8d28\uff1a\u4e0d\u9508\u94a2 AISI316L\u3001PTFE Teflon\u3001\u84dd\u5b9d\u77f3\u6216\u5c16\u6676\u77f3\u3001EPDM\u3001Viton\u3002 MISCO\u5728\u7ebf\u6298\u5149\u4eea\u62e5\u6709FDA \u8981\u6c42\u4ee5\u5916\u7684\u5f88\u591a\u7a81\u51fa\u7279\u70b9\u548c\u6027\u80fd\uff0c\u8b6c\u5982\u6d4b\u91cf\u7ed3\u679c\u4e0d\u53d7\u6c14\u6ce1\u3001\u9897\u7c92\u7269\u3001\u989c\u8272\u3001\u632f\u52a8\u7b49\u5f71\u54cd\uff0c\u7ec8\u8eab\u65e0\u4fe1\u53f7\u6f02\u79fb\u3001\u667a\u80fd\u5149\u5b66\u56fe\u50cf\u8bca\u65ad\u7b49\uff0c\u6055\u5728\u6b64\u65e0\u6cd5\u8be6\u8ff0\u3002<\/p>\n \u4eea\u8868\u9009\u578b<\/p>\n
\n\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u5236\u5b9a\u7684\u6807\u51c6\u89c4\u8303\u662f\u836f\u54c1\u5f00\u53d1\u548c\u751f\u4ea7\u5e94\u9075\u4ece\u7684\u57fa\u672c\u51c6\u5219\uff0c\u6b64\u5916\uff0c\u8fd8\u5fc5\u987b\u7b26\u5408\u826f\u597d\u751f\u4ea7\u89c4\u8303\uff08GMPs\uff09\uff0c\u4ee5\u53ca\u4e00\u5957\u4e0d\u53ef\u8fdd\u80cc\u7684\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\uff0c\u5236\u9020\u7684\u6bcf\u4e00\u73af\u8282\u90fd\u9700\u8981\u5168\u9762\u5b8c\u6574\u5730\u8bb0\u5f55\u5728\u6848\u3002
\nMISCO\u5728\u7ebf\u6298\u5149\u4eea<\/a>\u80fd\u5168\u9762\u6ee1\u8db3\u8fd9\u4e9b\u8981\u6c42\uff0c\u662f\u7406\u60f3\u7684\u5728\u7ebf\u5b9e\u65f6\u76d1\u6d4b\u4eea\u5668\u3002\u5b83\u80fd\u51c6\u786e\u800c\u7a33\u5b9a\u5730\u6d4b\u91cf\u8fc7\u7a0b\u6eb6\u6db2\u6298\u5c04\u7387 nD \u53ca\u6d53\u5ea6\u53d8\u5316\uff0c\u4e3a\u5de5\u827a\u4f18\u5316\u63a7\u5236\u3001\u63d0\u9ad8\u751f\u4ea7\u6548\u7387\u63d0\u4f9b\u5b9e\u65f6\u4fe1\u606f\u3002<\/p>\n
\n\uf0b7 \u963f\u53f8\u5339\u6797\uff0c\u8461\u8404\u7cd6\u9178\u9499\uff0c\u7518\u6cb9\u78f7\u9178\u916f\uff0c\u6c34\u5408\u6c2f\u919b\uff0c\u6297\u4e1d\u866b\u836f\uff0c\u6297\u7ec4\u7ec7\u80fa\u836f\uff0c\u9547\u9759\u5242\uff0c\u7cd6\u7cbe\uff0c\u6d77\u7fa4\u751f\uff0c\u6297\u7cd6\u5c3f\u75c5\u836f\u7b49\u3002<\/p>\n
\n\u6d3b\u6027\u7269\uff0c\u8d4b\u5f62\u5242\uff0c\u4e2d\u95f4\u4f53\uff0c\u539f\u6599\uff0c \u7cbe\u7ec6\u5316\u5b66\u836f\u54c1\uff0c\u53ca\u6563\u88c5\u5316\u5b66\u836f\u54c1\u3002
\n\uf0b7 \u6297\u751f\u7d20
\n\u9752\u9709\u7d20\uff0c\u94fe\u9709\u7d20\uff0c\u56db\u73af\u7d20\uff0c\u6c2f\u9709\u7d20\uff0c\u4ee5\u53ca\u6297\u771f\u83cc\u836f\u7269\u3002
\n\uf0b7 \u8840\u5236\u54c1
\n\u8840\u6db2\uff0c\u8840\u6d46\uff0c\u8840\u6e05\uff0c\u6ce8\u5c04\u6db2\uff0c\u751f\u7406\u76d0\u6c34\u548c\u8461\u8404\u7cd6\u3002
\n\uf0b7 \u86cb\u767d\u8d28
\n\uf0b7 \u86cb\u767d\u8d28\u53ca\u86cb\u767d\u8d28\u7f13\u51b2\u6db2\u3002
\n\uf0b7 \u5408\u6210\u836f\u7269
\n\u78fa\u80fa\u836f\uff0c\u6297\u7ed3\u6838\u836f\uff0c\u6297\u9ebb\u98ce\u836f\uff0c\u6b62\u75db\u836f\uff0c\u9ebb\u9189\u836f\uff0c\u6297\u759f\u836f\u3002
\n\uf0b7 \u7ef4\u751f\u7d20
\n\u6297\u574f\u8840\u9178\uff0c\u963f\u62c9\u4f2f\u7cd6\u9178\u9499\uff0c\u7ef4\u751f\u7d20B\uff0c\u7ef4\u751f\u7d20C\uff0c\u6cdb\u9178\u94a0\u7b49\u3002<\/p>\n
\n\uf0b7 \u7cd6\u6d46\u7c7b\u836f\u54c1
\n\uf0b7 \u6d53\u7f29\u7684\u8517\u7cd6\u6c34\u6eb6\u6db2
\n\uf0b7 \u690d\u7269\u836f
\n\u594e\u5b81\uff0c\u58eb\u7684\u5b81\u548c\u9a6c\u94b1\u5b50\u78b1\uff0c\u5410\u6839\u78b1\uff0c\u6bdb\u5730\u9ec4\u7cd6\u82f7\uff0c\u8349\u672c\u63d0\u53d6\u7269\u7b49\u3002
\n\uf0b7 \u75ab\u82d7\u4ee5\u53ca\u514d\u75ab\u8840\u6e05<\/p>\n
\n\uf0b7 \u9178\uff0c\u57fa\u6599\u53ca\u6eb6\u5242<\/p>\n
\nFDA \u6cd5\u89c4\u8981\u6c42\u4e00\u5207\u90fd\u8981\u8fdb\u884c\u5f7b\u5e95\u6d4b\u8bd5\uff0c\u4ee5\u786e\u4fdd\u6240\u751f\u4ea7\u51fa\u6765\u7684\u836f\u54c1\u7b26\u5408\u6807\u51c6\u3002\u8fd9\u5c31\u662f\u6240\u8c13\u7684\u9a8c\u8bc1\u3002\u9a8c\u8bc1\u7684\u7b80\u8981\u5b9a\u4e49\u662f\uff1a\u201c\u8bc1\u660e\u6307\u5b9a\u7684\u6027\u80fd\u201d\u3002\u8fc7\u7a0b\u4eea\u5668\u9a8c\u8bc1\u7684\u4e00\u4e2a\u91cd\u8981\u5185\u5bb9\u5c31\u662f\u786e\u5b9a\u548c\u8bc1\u660e\u5176\u7b26\u5408\u7528\u6237\u6307\u5b9a\u7684\u529f\u80fd\u548c\u9002\u7528\u6027\u3002
\n\u56e0\u6b64\uff0c\u9700\u8981\u5728\u5b9e\u9a8c\u5ba4\u548c\u8bd5\u9a8c\u88c5\u7f6e\u5bf9\u4efb\u4f55\u65b0\u7684\u4eea\u5668
\n\u8fdb\u884c\u4e0a\u5f7b\u5e95\u6d4b\u8bd5\u3002 MISCO\u5728\u7ebf\u6298\u5149\u4eea<\/a>\u652f\u6301\u8fd9\u6837\u7684\u6d4b\u8bd5\u3002\u5168\u9762\u6d4b\u8bd5\u5408\u683c\u53ca\u5468\u8be6\u7684\u6587\u4ef6\u8bb0\u5f55
\n\u540e\uff0cMISCO\u88ab\u6295\u653e\u5728\u5168\u89c4\u6a21\u6b63\u5f0f\u751f\u4ea7\u7ebf\u4e0a\u3002
\n\u5236\u836f\u5de5\u827a\u8bbe\u8ba1\u53caPAT \u5e94\u7528<\/p>\n
\n\uff08PAT\uff09\u548c\u5de5\u5177\u662f\u6709\u5fc5\u8981\u7684\uff0c\u56e0\u4e3a PAT \u6709\u52a9\u4e8e\u5728\u6574\u4e2a\u4ea7\u54c1\u751f\u547d\u5468\u671f\u4e2d\u5efa\u7acb\u3001\u4fdd\u6301\u548c\u6269\u5927\u5bf9\u5de5\u827a\u8fc7\u7a0b\u7684\u8ba4\u8bc6\u3002\u4ea7\u54c1\u751f\u547d\u5468\u671f\u5305\u62ec\u751f\u4ea7\u548c\u7814\u53d1\u3002\u5de5\u827a\u7406\u89e3\u662f\u4ea7\u54c1\u5236\u9020\uff08\u5de5\u827a\u9009\u62e9\u3001\u65b9\u6cd5\u3001\u5b9e\u65bd\u548c\u5b9e\u8df5\uff09\u3001\u8fc7\u7a0b\u63a7\u5236\uff08\u57fa\u4e8e\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u5b9e\u65f6\u63a7\u5236\uff09\u3001\u6709\u6548\u98ce\u9669\u7f13\u89e3\u548c\u4ea7\u54c1\u53d1\u5e03\u7684\u57fa\u7840\u3002<\/p>\n
\nFDA 21 CFR Part 11 \u53ca\u4ee5\u592a\u7f51\u6570\u636e\u91c7\u96c6
\n\u8054\u90a6\u6cd5\u89c4\u7b2c21 \u7ae0\u7b2c11 \u6761\uff08FDA 21 CFR Part 11\uff09\u5bf9\u7535\u5b50\u8bb0\u5f55\u548c\u7535\u5b50\u7b7e\u540d\u505a\u4e86\u7eb2\u8981\u6027\u89c4\u5b9a\uff0cPart 11\u786e\u5b9a\u7535\u5b50\u8bb0\u5f55\u548c\u7b7e\u540d\u4e0e\u7eb8\u8d28\u8bb0\u5f55\u4e00\u6837\uff0c\u662f\u503c\u5f97\u4fe1\u8d56\u7684\uff0c\u8981\u6c42\u836f\u7269\u5236\u9020\u5546\u3001\u533b\u7597\u8bbe\u5907\u5236\u9020\u5546\uff0c\u751f\u7269\u6280\u672f\u516c\u53f8\u3001\u751f\u7269\u5236\u54c1\u516c\u53f8\u548c\u5176\u5b83\u53d7FDA \u76d1\u7ba1\u884c\u4e1a\u5bf9\u7535\u5b50\u7b7e\u540d\u548c\u8bb0\u5f55\u5b9e\u65bd\u63a7\u5236\uff0c\u5305\u62ec\u7cfb\u7edf\u9a8c\u8bc1\uff0c\u5ba1\u8ba1\uff0c\u5ba1\u8ba1\u8ddf\u8e2a\uff0c\u7535\u5b50\u7b7e\u540d\uff0c\u6d89\u53ca\u7535\u5b50\u6570\u636e\u5904\u7406\u7684\u8f6f\u4ef6\u548c\u7cfb\u7edf\u6587\u4ef6\u8bb0\u5f55\u7b49\u3002
\nMISCO\u5728\u7ebf\u6298\u5149\u4eea\u4ece\u6280\u672f\u4e0a\u80fd\u5f88\u597d\u652f\u6301 21 CFR Part 11 \u8fd9\u4e9b\u89c4\u5b9a\u3002
\n\u9664\u4e86\u6807\u51c6\u7684 4-20mA \u7ed3\u679c\u8f93\u51fa\uff0cMISCO \u5728\u7ebf\u6298\u5149\u4eea\u8fd8\u8bbe\u6709\u4ee5\u592a\u7f51\u901a\u8baf\u63a5\u53e3\uff0c\u652f\u6301 FDA 21 CFR Part 11 \u7535\u5b50\u6570\u636e\u8bb0\u5f55\uff0c\u663e\u793a\u53d8\u9001\u5668\u901a\u8fc7 UDP\/IP \u4e0e\u4efb\u4f55\u7c7b\u578b\u7684\u8ba1\u7b97\u673a\u901a\u8baf\uff0c\u6d4b\u91cf\u7ed3\u679c\u53ca\u4eea\u8868\u72b6\u6001\u7b49\u6240\u6709\u5b9e\u65f6\u4fe1\u606f\u88ab\u4f20\u8f93\u81f3 PC \u8fdb\u884c\u50a8\u5b58\u3001\u5206\u6790\u4ee5\u53ca\u751f\u6210\u6d4b\u91cf\u62a5\u544a\uff0c\u6574\u4e2a\u8fc7\u7a0b\u4e0d\u4f1a\u5f15\u5165\u4eba\u4e3a\u64cd\u4f5c\u5e26\u6765\u7684\u5931\u8bef\u3002
\nMISCO\u514d\u8d39\u63d0\u4f9b\u6570\u636e\u4e0b\u8f7d\u8f6f\u4ef6\u5305\uff0c\u652f\u6301\u7528\u6237\u81ea\u6709\u7684\u901a\u8baf\u7a0b\u5e8f\u3002\u5bf9\u6298\u5149\u4eea\u53ca\u751f\u6210\u6570\u636e\u8bbf\u95ee\u5b9e\u884c\u5bc6\u7801\u4fdd\u62a4\uff0c\u914d\u5408\u7528\u6237\u7684\u5185\u90e8\u7ba1\u7406\u63a7\u5236\uff0c\u4ee5\u786e\u4fdd\u7b26\u540821 CFR Part 11 \u89c4\u8303\u3002<\/p>\n
\n– \u5236\u836f\u578b\u8ff7\u4f60\u6d41\u901a\u6c60PMFC\uff0c\u6ee1\u8db3\u8bd5\u9a8c\u9636\u6bb5\u6781\u5c0f\u6d41\u91cf\u6837\u54c1\u6d4b\u91cf\u3002
\n– \u7535\u5b50\u7ea7\u629b\u5149(Ra 0.4\u03bcm)
\n– \u5236\u9020\u8fc7\u7a0b\u4e2d\u4e0d\u4f7f\u7528\u5230\u52a8\u7269\u6e90\u6027\u4ecb\u8d28
\n– \u4e30\u5bcc\u7684\u4f20\u611f\u5668\u53ca\u6d41\u901a\u6c60\u5f62\u6001\uff0c\u6ee1\u8db3\u5c0f\u8bd5\u3001\u4e2d\u8bd5\u53ca\u6b63\u5f0f\u751f\u4ea7\u4e0d\u540c\u9636\u6bb5\u4e0d\u540c\u573a\u5408\u9700\u8981\u3002
\n– \u652f\u6301\u7528\u6237\u73b0\u573a\u8fdb\u884c\u53ef\u8ffd\u6eaf\u7684\u56fd\u9645\u6807\u51c6\u4e0b\u9a8c\u8bc1\uff0c\u5e76\u81ea\u52a8\u751f\u6210\u9a8c\u8bc1\u62a5\u544a\u3002<\/p>\n