{"id":13161,"date":"2020-02-15T17:15:07","date_gmt":"2020-02-15T09:15:07","guid":{"rendered":"https:\/\/blog.kohan.com.tw\/?p=13161"},"modified":"2021-05-14T12:00:33","modified_gmt":"2021-05-14T04:00:33","slug":"%e8%97%a5%e7%89%a9%e6%ba%b6%e9%9b%a2%e8%a9%a6%e9%a9%97%e7%9a%84%e6%88%90%e5%8a%9f%e8%a6%81%e7%b4%a0%ef%bc%8d%e6%ba%b6%e9%9b%a2%e8%a8%ad%e5%82%99%e7%9a%84%e7%89%a9%e6%80%a7%e6%a0%a1%e9%a9%97%e8%88%87","status":"publish","type":"post","link":"https:\/\/blog.kohan.com.tw\/%e8%97%a5%e7%89%a9%e6%aa%a2%e9%a9%97%e5%8f%8a%e8%a3%bd%e8%97%a5%e7%9b%b8%e9%97%9c\/%e8%97%a5%e7%89%a9%e6%ba%b6%e9%9b%a2%e8%a9%a6%e9%a9%97%e7%9a%84%e6%88%90%e5%8a%9f%e8%a6%81%e7%b4%a0%ef%bc%8d%e6%ba%b6%e9%9b%a2%e8%a8%ad%e5%82%99%e7%9a%84%e7%89%a9%e6%80%a7%e6%a0%a1%e9%a9%97%e8%88%87\/","title":{"rendered":"\u85e5\u7269\u6eb6\u96e2\u8a66\u9a57\u7684\u6210\u529f\u8981\u7d20 \u2014 \u6eb6\u96e2\u8a2d\u5099\u7684\u7269\u6027\u6821\u9a57\u8207\u6027\u80fd\u9a57\u8b49"},"content":{"rendered":"

\u5728\u4e0a\u4e00\u7bc7\u6211\u5011\u5df2\u4ecb\u7d39\u9032\u884c\u85e5\u7269\u6eb6\u96e2\u8a66\u9a57\u61c9\u8a72\u6ce8\u610f\u7684\u4e8b\u9805<\/span><\/span><\/a>\uff0c\u4ecb\u7d39\u4e86\u85e5\u7269\u6eb6\u96e2\u8a66\u9a57\u7684\u57fa\u672c\u914d\u7f6e\u3001\u6ce8\u610f\u4e8b\u9805\u8207\u64cd\u4f5c\u6eb6\u96e2\u8a66\u9a57\u6a5f<\/span><\/a><\/span>\u7684\u6280\u8853\u3002\u5728\u6eb6\u96e2\u8a66\u9a57\u524d\u8a72\u9032\u884c\u7684\u5100\u5668\u6aa2\u67e5\uff0c\u53c8\u53ef\u5206\u70ba\u57fa\u672c\u6aa2\u67e5\u8207\u8a73\u7d30\u6aa2\u67e5\u6821\u6b63\uff0c\u8a73\u7d30\u7684\u6aa2\u67e5\u6821\u6b63\u7a31\u4e4b\u70ba\u7269\u6027\u6821\u9a57\uff08Maintenance Qualification\uff0cMQ\uff09\uff1b\u9032\u884cMQ\u4e4b\u5f8c\uff0c\u4f9d\u7167\u6240\u9075\u5faa\u898f\u7bc4\uff08USP\u6216ASTM\uff09\u7684\u4e0d\u540c\uff0c\u4f86\u6c7a\u5b9a\u9032\u884c\u6027\u80fd\u78ba\u8a8d\u8a66\u9a57\uff08Performance Verification Testing\uff0cPVT\uff09\u662f\u5426\u70ba\u5fc5\u9808\u7684\u3002\u85c9\u4ee5\u5c0d\u6eb6\u96e2\u8a2d\u5099\u7684\u6821\u9a57\u8207\u6027\u80fd\u9a57\u8b49\uff0c\u78ba\u8a8d\u6eb6\u96e2\u8a2d\u5099\u4e4b\u9069\u7528\u6027\uff0c\u7dad\u6301\u6a5f\u53f0\u904b\u4f5c\u7684\u54c1\u8cea\u53ca\u7a69\u5b9a\u6027\uff0c\u5f97\u5230\u6210\u529f\u7684\u85e5\u7269\u6eb6\u96e2\u8a66\u9a57\u7d50\u679c\u3002<\/p>\n

\u5100\u5668\u7684\u7269\u6027\u6821\u9a57\u2500\u85e5\u7269\u6eb6\u96e2\u6a5f\u9069\u7528\u6027\u78ba\u8a8d<\/h3>\n

\u5728\u9032\u884c\u6eb6\u96e2\u8a66\u9a57\u4e4b\u524d\uff0c\u5fc5\u9808\u9032\u884c\u6eb6\u96e2\u6a5f\u7684\u7269\u7406\u53c3\u6578\u9a57\u8b49\uff0c\u6b64\u7a31\u4e4b\u70ba\u7269\u6027\u6821\u9a57MQ\uff08Maintenance Qualification\uff09\uff0c\u53ef\u9075\u5faa\u7684\u898f\u7bc4\u5305\u542b\u4ee5\u4e0b\uff0c\u4e26\u65bc\u88681\u5206\u5225\u5217\u51faASTM\u8207USP\u5c0d\u65bcMQ\u7684\u5404\u9a57\u8b49\u9805\u76ee\u4e4b\u898f\u7bc4\uff1a<\/p>\n

    \n
  1. \u7f8e\u570b\u85e5\u5178 USP Dissolution Toolkit Procedure for Mechanical Calibration and Performance Verification Test \uff1a\u5efa\u8b70\u6eb6\u96e2\u8a2d\u5099\u9032\u884c\u5b8c\u7269\u6027\u6821\u9a57 MQ \u5f8c\uff0c\u8981\u9032\u884c\u6027\u80fd\u78ba\u8a8d\u8a66\u9a57 PVT\u3002<\/li>\n
  2. \u7f8e\u570b FDA \u59d4\u8a17 ASTM \uff08American Society for Testing and Materials\uff1b\u7f8e\u570b\u6821\u6e96\u6750\u6599\u6aa2\u9a57\u5c40\uff09\u91dd\u5c0d\u7269\u6027\u6821\u9a57 MQ \u63d0\u51fa\u6a5f\u68b0\u8a8d\u8b49\uff08ASTM E2503\uff09\uff0cASTM \u898f\u7bc4\u7684\u786c\u9ad4\u6e2c\u8a66\u6a19\u6e96\u66f4\u70ba\u56b4\u683c\uff0c\u4f46\u4e0d\u9808\u9032\u884c\u6027\u80fd\u78ba\u8a8d\u8a66\u9a57 PVT \u3002<\/li>\n<\/ol>\n
    \n
    \u88681. \u85e5\u7269\u6eb6\u96e2\u6a5f\u7269\u6027\u6821\u9a57MQ\u64cd\u4f5c\u9805\u76ee\u6e05\u55ae<\/h6><\/div>\n \n \n \n \n \n <\/colgroup>\n \n\n \n\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n
    \u9a57\u8b49\u9805\u76ee<\/th>ASTM E2503\u898f\u7bc4<\/th>USP TOOLKIT\u898f\u7bc4<\/th><\/tr>\n<\/thead>\n
    Basket\u3001Paddle \u74f6\u5e95\u8ddd\u96e2\u9a57\u8b49<\/td>25 \u00b1 2 mm (or < 8% of desired height)<\/td>25mm \u00b1 2mm<\/td> <\/tr>\n
    \u8f49\u901f\u9a57\u8b49<\/td>\u00b1 2 rpm or within 2% of target speed<\/td>\u00b11 RPM at set value<\/td> <\/tr>\n
    Shaft \u6643\u52d5\u5ea6\u9a57\u8b49<\/td>\u2264 1.0 mm total runout<\/td>\u2264 1.0 mm total wobble<\/td> <\/tr>\n
    Basket \u6643\u52d5\u5ea6\u9a57\u8b49<\/td>\u2264 1.0 mm total runout<\/td>\u2264 1.0 mm total wobble<\/td> <\/tr>\n
    Vessel \/ Shaft \u4e2d\u5fc3\u9ede\u9a57\u8b49<\/td>\u2264 1.0 mm from centerline<\/td>NMT 2.0mm for 360\u00ba rotation<\/td> <\/tr>\n
    Shaft \u5782\u76f4\u5ea6\u9a57\u8b49<\/td>NMT 0.5\u00ba from vertical<\/td>NMT 0.5\u00ba from vertical<\/td> <\/tr>\n
    Vessel \u5782\u76f4\u5ea6\u9a57\u8b49<\/td>\u22641\u00ba from vertical measured at 2 points 90\u00ba apart<\/td>NMT 0.5\u00ba from vertical<\/td> <\/tr>\n
    Vessel plate \u6c34\u5e73\u9a57\u8b49<\/td>Not measured<\/td>NMT 0.5\u00ba from horizontal<\/td> <\/tr>\n
    \u8868\u9762\u6c34\u5e73\u9a57\u8b49<\/td>Not measured<\/td>NMT 1\u00ba surface inclination<\/td> <\/tr>\n
    \u6eb6\u96e2\u8a2d\u5099\u9707\u52d5\u5ea6\u9a57\u8b49<\/td>No significant vibration in\n the apparatus or medium<\/td>Should be limited by a high inertial \nmass of the bench top<\/td> <\/tr>\n
    \u6eab\u5ea6<\/td>\u5404\u6eb6\u96e2\u676f\u7684\u8a2d\u5b9a\u6eab\u5ea6 \u00b10.5\u2103<\/td>\u6700\u9ad8\u8207\u6700\u4f4e\u6eab\u5ea6\u5dee\u5728 0.4\u2103\u4ee5\u5167<\/td> <\/tr>\n
    PVT \u6821\u9a57<\/td>Not required<\/td>USP Prednisone Tablets RS<\/td> <\/tr>\n
    Vessel\u3001Basket\u3001Paddle \u5e8f\u865f\u7d00\u9304<\/td><\/td><\/td> <\/tr>\n
    \u6c34\u6d74\u69fd\u6eab\u5ea6\u6821\u6b63\/\u78ba\u6548<\/td><\/td><\/td> <\/tr>\n
    \u52a0\u71b1\u5668\u6eab\u5ea6\u6821\u6b63\/\u78ba\u6548<\/td><\/td><\/td> <\/tr>\n <\/tbody>\n <\/table>\n