{"id":25661,"date":"2024-09-12T15:21:17","date_gmt":"2024-09-12T07:21:17","guid":{"rendered":"https:\/\/shchimay.com\/?p=25661"},"modified":"2024-09-13T21:09:45","modified_gmt":"2024-09-13T13:09:45","slug":"21-cfr-ph-meter","status":"publish","type":"post","link":"https:\/\/shchimay.com\/zh\/21-cfr-ph-meter\/","title":{"rendered":"21 CFR PH \u8ba1"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_50 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/shchimay.com\/zh\/21-cfr-ph-meter\/#%E5%9C%A8%E8%8D%AF%E5%93%81%E5%88%B6%E9%80%A0%E4%B8%AD%E4%BD%BF%E7%94%A8%E7%AC%A6%E5%90%88_21_CFR_%E6%A0%87%E5%87%86%E7%9A%84_pH_%E8%AE%A1%E7%9A%84%E5%A5%BD%E5%A4%84\" title=\"\u5728\u836f\u54c1\u5236\u9020\u4e2d\u4f7f\u7528\u7b26\u5408 21 CFR \u6807\u51c6\u7684 pH \u8ba1\u7684\u597d\u5904\">\u5728\u836f\u54c1\u5236\u9020\u4e2d\u4f7f\u7528\u7b26\u5408 21 CFR \u6807\u51c6\u7684 pH \u8ba1\u7684\u597d\u5904<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/shchimay.com\/zh\/21-cfr-ph-meter\/#%E5%9C%A8%E9%A3%9F%E5%93%81%E5%92%8C%E9%A5%AE%E6%96%99%E8%A1%8C%E4%B8%9A%E4%BD%BF%E7%94%A8_pH_%E8%AE%A1%E6%97%B6%E5%A6%82%E4%BD%95%E7%A1%AE%E4%BF%9D%E7%AC%A6%E5%90%88_21_CFR_%E6%B3%95%E8%A7%84\" title=\"\u5728\u98df\u54c1\u548c\u996e\u6599\u884c\u4e1a\u4f7f\u7528 pH \u8ba1\u65f6\u5982\u4f55\u786e\u4fdd\u7b26\u5408 21 CFR \u6cd5\u89c4\">\u5728\u98df\u54c1\u548c\u996e\u6599\u884c\u4e1a\u4f7f\u7528 pH \u8ba1\u65f6\u5982\u4f55\u786e\u4fdd\u7b26\u5408 21 CFR \u6cd5\u89c4<\/a><\/li><\/ul><\/nav><\/div>\n<h1 id=\"benefits-of-using-21-cfr-compliant-ph-meters-in-pharmaceutical-manufacturing-wpaicgheading\"><span class=\"ez-toc-section\" id=\"%E5%9C%A8%E8%8D%AF%E5%93%81%E5%88%B6%E9%80%A0%E4%B8%AD%E4%BD%BF%E7%94%A8%E7%AC%A6%E5%90%88_21_CFR_%E6%A0%87%E5%87%86%E7%9A%84_pH_%E8%AE%A1%E7%9A%84%E5%A5%BD%E5%A4%84\"><\/span>\u5728\u836f\u54c1\u5236\u9020\u4e2d\u4f7f\u7528\u7b26\u5408 21 CFR \u6807\u51c6\u7684 pH \u8ba1\u7684\u597d\u5904<span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p>\n\u5728\u5236\u836f\u884c\u4e1a\uff0c\u786e\u4fdd pH \u6d4b\u91cf\u7684\u51c6\u786e\u6027\u548c\u53ef\u9760\u6027\u5bf9\u4e8e\u7ef4\u6301\u4ea7\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u81f3\u5173\u91cd\u8981\u3002 pH \u8ba1\u662f\u7528\u4e8e\u6d4b\u91cf\u6eb6\u6db2\u9178\u5ea6\u6216\u78b1\u5ea6\u7684\u91cd\u8981\u5de5\u5177\uff0c\u8fd9\u5bf9\u836f\u54c1\u7684\u6709\u6548\u6027\u548c\u7a33\u5b9a\u6027\u4ea7\u751f\u91cd\u5927\u5f71\u54cd\u3002\u4e3a\u4e86\u6ee1\u8db3\u76d1\u7ba1\u8981\u6c42\u5e76\u786e\u4fdd\u6570\u636e\u5b8c\u6574\u6027\uff0c\u8bb8\u591a\u5236\u836f\u516c\u53f8\u6b63\u5728\u8f6c\u5411\u7b26\u5408 21 CFR \u6807\u51c6\u7684 pH \u8ba1\u3002<\/p>\n<figure class=\"wp-block-table\">\n<table>\n<tbody>\n<tr>\n<td colspan=\"3\">FL-9900\u9ad8\u7cbe\u5ea6\u578b\u8f6c\u8f6e\u6d41\u91cf\u63a7\u5236\u5668<\/td>\n<\/tr>\n<tr>\n<td rowspan=\"4\">\u6d4b\u91cf\u8303\u56f4<\/td>\n<td>\u9891\u7387<\/td>\n<td>0\\\uff5e2K Hz<\/td>\n<\/tr>\n<tr>\n<td>\u6d41\u901f<\/td>\n<td>0.5\\\uff5e5\u7c73\/\u79d2<\/td>\n<\/tr>\n<tr>\n<td>\u77ac\u65f6\u6d41\u91cf<\/td>\n<td>0\\\uff5e2000\u7c73\\\u00b3\/h<\/td>\n<\/tr>\n<tr>\n<td>\u7d2f\u8ba1\u6d41\u91cf<\/td>\n<td>0\\\uff5e9999 9999.999 m\\\u00b3<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u9002\u7528\u7ba1\u5f84\u8303\u56f4<\/td>\n<td>DN15\\\uff5eDN100;DN125\\\uff5eDN300<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u5206\u8fa8\u7387<\/td>\n<td>0.01\u7c73\\\u00b3\/h<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u5237\u65b0\u7387<\/td>\n<td>1\u79d2<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u7cbe\u5ea6\u7b49\u7ea7<\/td>\n<td>2.0\u7ea7<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u91cd\u590d\u6027<\/td>\n<td>\\\u00b10.5% <\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" rowspan=\"2\">\u4f20\u611f\u5668\u8f93\u5165<\/td>\n<td>\u534a\u5f84\uff1a0\\\uff5e2K Hz<\/td>\n<\/tr>\n<tr>\n<td>\u4f9b\u7535\u7535\u538b\uff1aDC 24V\uff08\u4eea\u5668\u5185\u90e8\u4f9b\u7535\uff09<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u7535\u5b50\u5355\u5143\u81ea\u52a8\u6e29\u5ea6\u8865\u507f\u8bef\u5dee<\/td>\n<td>+0.5% FS\uff1b<\/td>\n<\/tr>\n<tr>\n<td rowspan=\"3\">4-20mA<\/td>\n<td>\u6280\u672f\u7279\u70b9<\/td>\n<td>\u4eea\u8868\/\u53d8\u9001\u5668\u53cc\u6a21\u5f0f\uff08\u5149\u7535\u9694\u79bb\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u56de\u8def\u7535\u963b<\/td>\n<td>500Q(\u6700\u5927)\\\uff0cDC24V;<\/td>\n<\/tr>\n<tr>\n<td>\u4f20\u8f93\u7cbe\u5ea6<\/td>\n<td>\\\u00b10.01mA<\/td>\n<\/tr>\n<tr>\n<td rowspan=\"3\">\u63a7\u5236\u7aef\u53e3<\/td>\n<td>\u63a5\u89e6\u65b9\u5f0f<\/td>\n<td>\u65e0\u6e90\u7ee7\u7535\u5668\u63a7\u5236\u8f93\u51fa<\/td>\n<\/tr>\n<tr>\n<td>\u8d1f\u8f7d\u80fd\u529b<\/td>\n<td>\u8d1f\u8f7d\u7535\u6d415A\uff08\u6700\u5927\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u529f\u80fd\u9009\u62e9<\/td>\n<td>\u77ac\u65f6\u6d41\u91cf\u4e0a\u9650\/\u4e0b\u9650\u62a5\u8b66<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u4e3b\u7535\u6e90<\/td>\n<td>\u5de5\u4f5c\u7535\u538b\uff1aDC24V 4V \u529f\u8017\uff1a<; 3.OW<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u7535\u7f06\u957f\u5ea6<\/td>\n<td>\u5de5\u5382\u914d\u7f6e\uff1a5m\uff0c\u53ef\u7ea6\u5b9a\uff1a\uff081~500\uff09m<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u73af\u5883\u8981\u6c42<\/td>\n<td>\u6e29\u5ea6\uff1a0~50\u2103\uff1b\u76f8\u5bf9\u6e7f\u5ea6\uff1a\\\u226485% RH<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u5b58\u50a8\u73af\u5883<\/td>\n<td>\u6e29\u5ea6\uff1a(-20\u2103~60\u2103)\\\u2103;\u6e7f\u5ea6\uff1a85%RH<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u5916\u5f62\u5c3a\u5bf8<\/td>\n<td>96\\\u00d796\\\u00d772mm\\\uff08\u9ad8\u5ea6\\\u00d7\u5bbd\u5ea6\\\u00d7\u6df1\u5ea6\\\uff09<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u5f00\u53e3\u5c3a\u5bf8<\/td>\n<td>92\\\u00d792mm<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u5b89\u88c5\u65b9\u5f0f<\/td>\n<td>\u76d8\u88c5\u3001\u5feb\u901f\u56fa\u5b9a<\/td>\n<\/tr>\n<tr>\n<td rowspan=\"8\">\u4f20\u611f\u5668<\/td>\n<td>\u672c\u4f53\u6750\u8d28<\/td>\n<td>\u672c\u4f53\uff1a\u5de5\u7a0b\u5851\u6599PP\uff1b\u8f74\u627f\uff1aZr02\u9ad8\u6e29\u6c27\u5316\u9506<\/td>\n<\/tr>\n<tr>\n<td>\u6d41\u91cf\u8303\u56f4<\/td>\n<td>0.5\\\uff5e5\u7c73\/\u79d2<\/td>\n<\/tr>\n<tr>\n<td>\u8010\u538b<\/td>\n<td>\\\u22640.6MPa<\/td>\n<\/tr>\n<tr>\n<td>\u7535\u6e90\u7535\u538b<\/td>\n<td>lDC 24V<\/td>\n<\/tr>\n<tr>\n<td>\u8f93\u51fa\u8109\u51b2\u5e45\u5ea6\n<\/td>\n<td>Vp\\\u22658V<\/td>\n<\/tr>\n<tr>\n<td>\u666e\u901a\u7ba1\u5f84<\/td>\n<td>DN15\\\uff5eDN100;DN125\\\uff5eDN600<\/td>\n<\/tr>\n<tr>\n<td>\u4e2d\u7b49\u7279\u5f81<\/td>\n<td>\u5355\u76f8\u4ecb\u8d28\\\uff080~60\\\u2103\\\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u88c5\u65b9\u5f0f<\/td>\n<td>\u76f4\u63a5\u63d2\u5165\u884c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n<p>\n21 CFR Part 11 \u662f\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u5236\u5b9a\u7684\u4e00\u9879\u6cd5\u89c4\uff0c\u89c4\u5b9a\u4e86\u5236\u836f\u884c\u4e1a\u7535\u5b50\u8bb0\u5f55\u548c\u7b7e\u540d\u7684\u6307\u5357\u3002\u9075\u5b88 21 CFR \u7b2c 11 \u90e8\u5206\u5bf9\u4e8e\u5236\u836f\u516c\u53f8\u786e\u4fdd\u7535\u5b50\u8bb0\u5f55\uff08\u5305\u62ec pH \u6d4b\u91cf\uff09\u7684\u5b8c\u6574\u6027\u3001\u771f\u5b9e\u6027\u548c\u4fdd\u5bc6\u6027\u81f3\u5173\u91cd\u8981\u3002\u901a\u8fc7\u4f7f\u7528\u7b26\u5408 21 CFR \u6807\u51c6\u7684 pH \u8ba1\uff0c\u836f\u54c1\u5236\u9020\u5546\u53ef\u4ee5\u8bc1\u660e\u4ed6\u4eec\u5bf9\u8d28\u91cf\u548c\u6cd5\u89c4\u9075\u4ece\u6027\u7684\u627f\u8bfa\u3002<\/p>\n<p>\u5728\u836f\u54c1\u751f\u4ea7\u4e2d\u4f7f\u7528\u7b26\u5408 21 CFR \u6807\u51c6\u7684 pH \u8ba1\u7684\u4e3b\u8981\u597d\u5904\u4e4b\u4e00\u662f\u4fdd\u8bc1\u6570\u636e\u5b8c\u6574\u6027\u3002\u8fd9\u4e9b pH \u8ba1\u65e8\u5728\u6ee1\u8db3 21 CFR \u7b2c 11 \u90e8\u5206\u4e2d\u6982\u8ff0\u7684\u4e25\u683c\u8981\u6c42\uff0c\u5305\u62ec\u7535\u5b50\u8bb0\u5f55\u4fdd\u5b58\u3001\u6570\u636e\u5b89\u5168\u548c\u5ba1\u8ba1\u8ddf\u8e2a\u3002\u901a\u8fc7\u4f7f\u7528\u7b26\u5408 21 CFR \u7684 pH \u8ba1\uff0c\u5236\u836f\u516c\u53f8\u53ef\u4ee5\u786e\u4fdd pH \u6d4b\u91cf\u51c6\u786e\u3001\u53ef\u9760\u4e14\u53ef\u8ffd\u6eaf\uff0c\u8fd9\u5bf9\u4e8e\u7ef4\u62a4\u4ea7\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<p>\u4f7f\u7528\u7b26\u5408 21 CFR \u7684 pH \u8ba1\u7684\u53e6\u4e00\u4e2a\u597d\u5904\u662f\u80fd\u591f\u7b80\u5316\u9a8c\u8bc1\u8fc7\u7a0b\u3002\u9a8c\u8bc1\u662f\u836f\u54c1\u751f\u4ea7\u4e2d\u7684\u5173\u952e\u6b65\u9aa4\uff0c\u4ee5\u786e\u4fdd\u8bbe\u5907\u3001\u5de5\u827a\u548c\u7cfb\u7edf\u6ee1\u8db3\u6cd5\u89c4\u8981\u6c42\u5e76\u4ea7\u751f\u4e00\u81f4\u4e14\u53ef\u9760\u7684\u7ed3\u679c\u3002\u901a\u8fc7\u4f7f\u7528\u7b26\u5408 21 CFR \u7684 pH \u8ba1\uff0c\u5236\u836f\u516c\u53f8\u53ef\u4ee5\u5229\u7528\u7b26\u5408 21 CFR \u7b2c 11 \u90e8\u5206\u8981\u6c42\u7684\u9884\u914d\u7f6e\u9a8c\u8bc1\u534f\u8bae\u548c\u6587\u6863\u6765\u7b80\u5316\u9a8c\u8bc1\u8fc7\u7a0b\u3002<\/p>\n<p>\u9664\u4e86\u786e\u4fdd\u6570\u636e\u5b8c\u6574\u6027\u548c\u7b80\u5316\u9a8c\u8bc1\u4e4b\u5916\uff0c\u8fd8\u53ef\u4ee5\u5229\u7528\u7b26\u5408 21 CFR \u7684 pH \u503c\u4eea\u8868\u63d0\u4f9b\u5148\u8fdb\u7684\u7279\u6027\u548c\u529f\u80fd\uff0c\u53ef\u4ee5\u63d0\u9ad8\u836f\u54c1\u5236\u9020\u7684\u6548\u7387\u548c\u751f\u4ea7\u7387\u3002\u8fd9\u4e9b pH \u8ba1\u914d\u5907\u7528\u6237\u53cb\u597d\u7684\u754c\u9762\u3001\u76f4\u89c2\u7684\u8f6f\u4ef6\u548c\u81ea\u52a8\u6570\u636e\u8bb0\u5f55\u529f\u80fd\uff0c\u4f7f\u64cd\u4f5c\u5458\u80fd\u591f\u66f4\u8f7b\u677e\u5730\u51c6\u786e\u3001\u9ad8\u6548\u5730\u6267\u884c pH \u6d4b\u91cf\u3002\u901a\u8fc7\u4f7f\u7528\u7b26\u5408 21 CFR \u6807\u51c6\u7684 pH 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