{"id":15770,"date":"2025-06-27T12:18:17","date_gmt":"2025-06-27T04:18:17","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=15770"},"modified":"2025-06-27T12:18:17","modified_gmt":"2025-06-27T04:18:17","slug":"%e5%8c%bb%e8%8d%af%e7%ba%a7%e4%b8%8d%e9%94%88%e9%92%a2%e9%ab%98%e6%95%88%e8%bf%87%e6%bb%a4%e5%99%a8%e7%9a%84%e8%ae%be%e8%ae%a1%e8%a7%84%e8%8c%83%e4%b8%8egmp%e5%90%88%e8%a7%84%e6%80%a7%e8%a6%81","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=15770","title":{"rendered":"\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u8bbe\u8ba1\u89c4\u8303\u4e0eGMP\u5408\u89c4\u6027\u8981\u6c42"},"content":{"rendered":"

\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u8bbe\u8ba1\u89c4\u8303\u4e0eGMP\u5408\u89c4\u6027\u8981\u6c42<\/h1>\n

\u4e00\u3001\u5f15\u8a00<\/h2>\n

\u5728\u533b\u836f\u5236\u9020\u9886\u57df\uff0c\u4ea7\u54c1\u7684\u7eaf\u5ea6\u4e0e\u5b89\u5168\u6027\u81f3\u5173\u91cd\u8981\u3002\u4e3a\u786e\u4fdd\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4e0d\u53d7\u5230\u5fae\u751f\u7269\u3001\u9897\u7c92\u7269\u53ca\u5176\u4ed6\u6c61\u67d3\u7269\u7684\u6c61\u67d3\uff0c\u8fc7\u6ee4\u6280\u672f\u88ab\u5e7f\u6cdb\u5e94\u7528\u4e8e\u539f\u6599\u5904\u7406\u3001\u4e2d\u95f4\u4f53\u51c0\u5316\u3001\u6700\u7ec8\u4ea7\u54c1\u9664\u83cc\u7b49\u591a\u4e2a\u73af\u8282\u3002\u5176\u4e2d\uff0c\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668<\/strong>\u56e0\u5176\u4f18\u5f02\u7684\u8010\u8150\u8680\u6027\u80fd\u3001\u826f\u597d\u7684\u673a\u68b0\u5f3a\u5ea6\u4ee5\u53ca\u53ef\u91cd\u590d\u4f7f\u7528\u6027\uff0c\u5728\u5236\u836f\u5de5\u4e1a\u4e2d\u5360\u636e\u91cd\u8981\u5730\u4f4d\u3002<\/p>\n

\u672c\u6587\u5c06\u7cfb\u7edf\u9610\u8ff0\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u8bbe\u8ba1\u89c4\u8303\u53ca\u5176\u4e0e\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08Good Manufacturing Practice, GMP\uff09\u4e4b\u95f4\u7684\u5408\u89c4\u6027\u8981\u6c42\uff0c\u5e76\u7ed3\u5408\u56fd\u5185\u5916\u76f8\u5173\u6807\u51c6\u53ca\u6587\u732e\u8d44\u6599\uff0c\u5206\u6790\u5176\u5173\u952e\u53c2\u6570\u3001\u7ed3\u6784\u8bbe\u8ba1\u3001\u6750\u6599\u9009\u62e9\u3001\u9a8c\u8bc1\u6d41\u7a0b\u7b49\u65b9\u9762\u7684\u5185\u5bb9\u3002<\/p>\n

\n

\u4e8c\u3001\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u6982\u8ff0<\/h2>\n

2.1 \u5b9a\u4e49\u4e0e\u5206\u7c7b<\/h3>\n

\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668<\/strong>\u662f\u6307\u4e13\u7528\u4e8e\u533b\u836f\u884c\u4e1a\u3001\u91c7\u7528304\u6216316L\u7b49\u533b\u7528\u7ea7\u522b\u4e0d\u9508\u94a2\u6750\u8d28\u5236\u9020\u3001\u5177\u6709\u9ad8\u6548\u622a\u7559\u80fd\u529b\uff08\u901a\u5e38\u4e3a0.1 \u03bcm ~ 0.45 \u03bcm\u5b54\u5f84\uff09\u7684\u8fc7\u6ee4\u88c5\u7f6e\u3002\u6839\u636e\u7528\u9014\u548c\u7ed3\u6784\u5f62\u5f0f\uff0c\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/p>\n\n\n\n\n\n\n\n
\u5206\u7c7b\u65b9\u5f0f<\/th>\n\u7c7b\u578b<\/th>\n\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n
\u6309\u7167\u5b89\u88c5\u65b9\u5f0f<\/td>\n\u5361\u7b8d\u5f0f\u3001\u6cd5\u5170\u5f0f\u3001\u710a\u63a5\u5f0f<\/td>\n\u7ba1\u9053\u8fde\u63a5<\/td>\n<\/tr>\n
\u6309\u7167\u6ee4\u82af\u7ed3\u6784<\/td>\n\u6298\u53e0\u5f0f\u3001\u7194\u55b7\u5f0f\u3001\u70e7\u7ed3\u5f0f<\/td>\n\u4e0d\u540c\u5de5\u827a\u9700\u6c42<\/td>\n<\/tr>\n
\u6309\u7167\u529f\u80fd\u4f5c\u7528<\/td>\n\u9884\u8fc7\u6ee4\u5668\u3001\u7ec8\u7aef\u8fc7\u6ee4\u5668\u3001\u9664\u83cc\u8fc7\u6ee4\u5668<\/td>\n\u8fc7\u6ee4\u7cbe\u5ea6\u9012\u8fdb<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

2.2 \u5e38\u89c1\u578b\u53f7\u4e0e\u53c2\u6570<\/h3>\n

\u4e0b\u8868\u5217\u51fa\u4e86\u51e0\u79cd\u5e38\u89c1\u7684\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u4e3b\u8981\u6280\u672f\u53c2\u6570\uff1a<\/p>\n\n\n\n\n\n\n\n
\u578b\u53f7<\/th>\n\u6750\u8d28<\/th>\n\u5b54\u5f84\uff08\u03bcm\uff09<\/th>\n\u5de5\u4f5c\u6e29\u5ea6\uff08\u2103\uff09<\/th>\n\u8bbe\u8ba1\u538b\u529b\uff08MPa\uff09<\/th>\n\u9002\u7528\u4ecb\u8d28\u7c7b\u578b<\/th>\n\u662f\u5426\u7b26\u5408GMP<\/th>\n<\/tr>\n<\/thead>\n
SFP-316L-0.2<\/td>\n316L\u4e0d\u9508\u94a2<\/td>\n0.2<\/td>\n-20~120<\/td>\n\u22640.6<\/td>\n\u6db2\u4f53\u3001\u6c14\u4f53<\/td>\n\u662f<\/td>\n<\/tr>\n
SFP-304-0.45<\/td>\n304\u4e0d\u9508\u94a2<\/td>\n0.45<\/td>\n-10~80<\/td>\n\u22640.4<\/td>\n\u6c34\u6eb6\u6db2\u3001\u7f13\u51b2\u6db2<\/td>\n\u662f<\/td>\n<\/tr>\n
SFH-316L-HV<\/td>\n316L\u4e0d\u9508\u94a2<\/td>\n0.1<\/td>\n-30~150<\/td>\n\u22641.0<\/td>\n\u6ce8\u5c04\u7528\u6c34\u3001\u57f9\u517b\u57fa<\/td>\n\u662f<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\n

\u8bf4\u660e\uff1a<\/strong> \u8868\u683c\u6570\u636e\u53c2\u8003\u81ea\u4e2d\u56fd\u5236\u836f\u88c5\u5907\u884c\u4e1a\u534f\u4f1a\uff08CPA\uff09\u53d1\u5e03\u7684\u300a\u533b\u836f\u7ea7\u8fc7\u6ee4\u8bbe\u5907\u9009\u578b\u6307\u5357\u300b\uff082021\u5e74\u7248\uff09<\/p>\n<\/blockquote>\n

\n

\u4e09\u3001\u8bbe\u8ba1\u89c4\u8303\u4e0e\u6280\u672f\u8981\u6c42<\/h2>\n

3.1 \u7ed3\u6784\u8bbe\u8ba1\u89c4\u8303<\/h3>\n

\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u7ed3\u6784\u8bbe\u8ba1\u5e94\u9075\u5faa\u4ee5\u4e0b\u51e0\u4e2a\u57fa\u672c\u539f\u5219\uff1a<\/p>\n

    \n
  • \u65e0\u6b7b\u89d2\u8bbe\u8ba1<\/strong>\uff1a\u907f\u514d\u6b8b\u7559\u6db2\u4f53\u6216\u9897\u7c92\u79ef\u805a\uff0c\u4fbf\u4e8e\u6e05\u6d17\u548c\u706d\u83cc\u3002<\/li>\n
  • \u6a21\u5757\u5316\u8bbe\u8ba1<\/strong>\uff1a\u65b9\u4fbf\u66f4\u6362\u6ee4\u82af\u3001\u7ef4\u62a4\u4fdd\u517b\u3002<\/li>\n
  • \u5bc6\u5c01\u6027\u80fd\u826f\u597d<\/strong>\uff1a\u9632\u6b62\u6cc4\u6f0f\uff0c\u786e\u4fdd\u8fc7\u6ee4\u6548\u679c\u3002<\/li>\n
  • \u8010\u9ad8\u6e29\u9ad8\u538b<\/strong>\uff1a\u9002\u7528\u4e8e\u5728\u7ebf\u84b8\u6c7d\u706d\u83cc\uff08SIP\uff09\u548c\u5728\u7ebf\u6e05\u6d17\uff08CIP\uff09\u3002<\/li>\n<\/ul>\n

    \u5178\u578b\u7ed3\u6784\u5982\u56fe\u6240\u793a\uff08\u6587\u5b57\u63cf\u8ff0\uff09\uff1a<\/p>\n

      \n
    • \u5916\u58f3\u91c7\u7528\u65e0\u7f1d\u94a2\u7ba1\u6216\u94f8\u9020\u4e0d\u9508\u94a2\uff1b<\/li>\n
    • \u5185\u90e8\u8bbe\u7f6e\u652f\u6491\u7f51\u677f\u4e0e\u6ee4\u82af\u56fa\u5b9a\u67b6\uff1b<\/li>\n
    • \u6cd5\u5170\u8fde\u63a5\u90e8\u4f4d\u91c7\u7528\u98df\u54c1\u7ea7\u5bc6\u5c01\u5708\uff1b<\/li>\n
    • \u6392\u6c14\u53e3\u4e0e\u6392\u6c61\u53e3\u914d\u7f6e\u81ea\u52a8\u6392\u6c14\u9600\u6216\u624b\u52a8\u9600\u95e8\u3002<\/li>\n<\/ul>\n

      3.2 \u6750\u6599\u9009\u62e9\u6807\u51c6<\/h3>\n

      \u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e3b\u8981\u91c7\u7528\u4ee5\u4e0b\u4e24\u79cd\u6750\u6599\uff1a<\/p>\n\n\n\n\n\n\n
      \u6750\u6599\u4ee3\u53f7<\/th>\n\u56fd\u9645\u6807\u51c6<\/th>\n\u7279\u70b9<\/th>\n\u9002\u7528\u573a\u5408<\/th>\n<\/tr>\n<\/thead>\n
      SUS304\uff0806Cr19Ni10\uff09<\/td>\nASTM A240<\/td>\n\u8010\u8150\u8680\u6027\u8f83\u597d\uff0c\u6210\u672c\u8f83\u4f4e<\/td>\n\u4e00\u822c\u6c34\u5904\u7406\u3001\u975e\u5f3a\u9178\u78b1\u73af\u5883<\/td>\n<\/tr>\n
      SUS316L\uff0806Cr17Ni12Mo2\uff09<\/td>\nASTM A240<\/td>\n\u542b\u94bc\u5143\u7d20\uff0c\u6297\u6c2f\u79bb\u5b50\u8150\u8680\u80fd\u529b\u5f3a<\/td>\n\u5f3a\u9178\u78b1\u3001\u9ad8\u76d0\u5206\u73af\u5883\uff0c\u6ce8\u5c04\u5242\u751f\u4ea7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
      \n

      \u5f15\u7528\u6807\u51c6\uff1a<\/strong><\/p>\n

        \n
      • GB\/T 20878-2007\u300a\u4e0d\u9508\u94a2\u51b7\u8f67\u94a2\u677f\u548c\u94a2\u5e26\u300b<\/li>\n
      • ASME BPE-2020\u300a\u751f\u7269\u5236\u836f\u8bbe\u5907\u6807\u51c6\u300b<\/li>\n<\/ul>\n<\/blockquote>\n

        3.3 \u6027\u80fd\u6307\u6807\u8981\u6c42<\/h3>\n\n\n\n\n\n\n\n\n\n
        \u6027\u80fd\u9879\u76ee<\/th>\n\u8981\u6c42\u503c<\/th>\n\u6d4b\u8bd5\u65b9\u6cd5<\/th>\n<\/tr>\n<\/thead>\n
        \u8fc7\u6ee4\u6548\u7387<\/td>\n\u226599.9% @ 0.2 \u03bcm<\/td>\n\u7ec6\u83cc\u6311\u6218\u8bd5\u9a8c\uff08ASTM F838\uff09<\/td>\n<\/tr>\n
        \u538b\u5dee\u635f\u5931<\/td>\n\u22640.2 MPa<\/td>\n\u538b\u529b\u964d\u6d4b\u8bd5<\/td>\n<\/tr>\n
        \u6700\u5927\u5de5\u4f5c\u6e29\u5ea6<\/td>\n\u2264150\u2103<\/td>\n\u70ed\u7a33\u5b9a\u6027\u6d4b\u8bd5<\/td>\n<\/tr>\n
        \u706d\u83cc\u5468\u671f<\/td>\n\u2265100\u6b21<\/td>\nSIP\u5faa\u73af\u6d4b\u8bd5<\/td>\n<\/tr>\n
        \u5fae\u751f\u7269\u622a\u7559\u80fd\u529b<\/td>\n\u901a\u8fc7\u7ec6\u83cc\u7a7f\u900f\u6d4b\u8bd5<\/td>\nPseudomonas diminuta\u6d4b\u8bd5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
        \n

        \u56db\u3001GMP\u5408\u89c4\u6027\u8981\u6c42<\/h2>\n

        4.1 GMP\u5bf9\u8fc7\u6ee4\u5668\u7684\u57fa\u672c\u8981\u6c42<\/h3>\n

        \u6839\u636e\u300a\u4e2d\u56fdGMP\u300b\uff082010\u5e74\u4fee\u8ba2\u7248\uff09\u7b2c7\u7ae0\u201c\u8bbe\u5907\u201d\u4e2d\u7684\u76f8\u5173\u89c4\u5b9a\uff1a<\/p>\n

        \n

        \u7b2c\u4e03\u5341\u4e8c\u6761\uff1a\u8bbe\u5907\u7684\u8bbe\u8ba1\u3001\u5b89\u88c5\u3001\u7ef4\u62a4\u548c\u7ef4\u4fee\u5e94\u7b26\u5408\u751f\u4ea7\u5de5\u827a\u8981\u6c42\uff0c\u4e0d\u5f97\u5bf9\u4ea7\u54c1\u8d28\u91cf\u9020\u6210\u5f71\u54cd\u3002<\/p>\n

        \u7b2c\u4e03\u5341\u4e09\u6761\uff1a\u8bbe\u5907\u5e94\u6613\u4e8e\u6e05\u6d01\u3001\u6d88\u6bd2\u6216\u706d\u83cc\uff0c\u5fc5\u8981\u65f6\u5e94\u8fdb\u884c\u9a8c\u8bc1\u3002<\/p>\n<\/blockquote>\n

        \u56e0\u6b64\uff0c\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u5728\u8bbe\u8ba1\u4e0e\u4f7f\u7528\u8fc7\u7a0b\u4e2d\u5fc5\u987b\u6ee1\u8db3\u4ee5\u4e0bGMP\u6838\u5fc3\u8981\u6c42\uff1a<\/p>\n

          \n
        • \u53ef\u6e05\u6d01\u6027\u4e0e\u53ef\u706d\u83cc\u6027<\/strong>\uff1a\u652f\u6301CIP\/SIP\u64cd\u4f5c\uff0c\u4e0d\u7559\u76f2\u533a\u3002<\/li>\n
        • \u53ef\u9a8c\u8bc1\u6027<\/strong>\uff1a\u5177\u5907\u5b8c\u6574\u6027\u6d4b\u8bd5\u8bb0\u5f55\u3001\u706d\u83cc\u9a8c\u8bc1\u62a5\u544a\u3002<\/li>\n
        • \u6750\u8d28\u5408\u89c4\u6027<\/strong>\uff1a\u7b26\u5408FDA\u3001ASME BPE\u7b49\u56fd\u9645\u6807\u51c6\u3002<\/li>\n
        • \u8fc7\u7a0b\u63a7\u5236\u6587\u4ef6\u9f50\u5168<\/strong>\uff1a\u5305\u62ecDQ\/IQ\/OQ\/PQ\u9a8c\u8bc1\u6587\u6863\u3002<\/li>\n<\/ul>\n

          4.2 \u8bbe\u5907\u9a8c\u8bc1\uff08DQ\/IQ\/OQ\/PQ\uff09<\/h3>\n\n\n\n\n\n\n\n\n
          \u9a8c\u8bc1\u9636\u6bb5<\/th>\n\u82f1\u6587\u5168\u79f0<\/th>\n\u4e2d\u6587\u89e3\u91ca<\/th>\n\u4e3b\u8981\u5185\u5bb9<\/th>\n<\/tr>\n<\/thead>\n
          DQ<\/td>\nDesign Qualification<\/td>\n\u8bbe\u8ba1\u786e\u8ba4<\/td>\n\u786e\u8ba4\u8bbe\u8ba1\u7b26\u5408\u7528\u6237\u9700\u6c42<\/td>\n<\/tr>\n
          IQ<\/td>\nInstallation Qualification<\/td>\n\u5b89\u88c5\u786e\u8ba4<\/td>\n\u6838\u5b9e\u8bbe\u5907\u5b89\u88c5\u6b63\u786e<\/td>\n<\/tr>\n
          OQ<\/td>\nOperational Qualification<\/td>\n\u8fd0\u884c\u786e\u8ba4<\/td>\n\u6d4b\u8bd5\u8bbe\u5907\u5728\u5404\u79cd\u8fd0\u884c\u6761\u4ef6\u4e0b\u7684\u8868\u73b0<\/td>\n<\/tr>\n
          PQ<\/td>\nPerformance Qualification<\/td>\n\u6027\u80fd\u786e\u8ba4<\/td>\n\u9a8c\u8bc1\u8bbe\u5907\u5728\u5b9e\u9645\u751f\u4ea7\u6761\u4ef6\u4e0b\u7a33\u5b9a\u53ef\u9760<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
          \n

          \u53c2\u8003\u6765\u6e90\uff1a<\/strong><\/p>\n

            \n
          • FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories<\/li>\n
          • ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients<\/li>\n<\/ul>\n<\/blockquote>\n

            4.3 \u6e05\u6d01\u4e0e\u706d\u83cc\u7a0b\u5e8f\uff08CIP\/SIP\uff09<\/h3>\n\n\n\n\n\n\n
            \u9879\u76ee<\/th>\n\u65b9\u6cd5<\/th>\n\u53c2\u6570<\/th>\n\u76ee\u6807<\/th>\n<\/tr>\n<\/thead>\n
            CIP<\/td>\n\u5728\u7ebf\u5316\u5b66\u6e05\u6d17<\/td>\nNaOH 0.5%\uff0cpH >12\uff0c\u6e29\u5ea660~80\u2103<\/td>\n\u53bb\u9664\u6709\u673a\u6b8b\u7559<\/td>\n<\/tr>\n
            SIP<\/td>\n\u5728\u7ebf\u84b8\u6c7d\u706d\u83cc<\/td>\n121\u2103\uff0c30\u5206\u949f\uff0c\u9971\u548c\u84b8\u6c7d<\/td>\n\u5b9e\u73b0\u5fae\u751f\u7269\u6740\u706d<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
            \n

            \u4e94\u3001\u56fd\u5185\u5916\u76f8\u5173\u6807\u51c6\u4e0e\u6cd5\u89c4\u5bf9\u6bd4<\/h2>\n

            5.1 \u56fd\u5185\u4e3b\u8981\u6807\u51c6<\/h3>\n\n\n\n\n\n\n\n
            \u6807\u51c6\u7f16\u53f7<\/th>\n\u540d\u79f0<\/th>\n\u53d1\u5e03\u673a\u6784<\/th>\n<\/tr>\n<\/thead>\n
            GB\/T 20878-2007<\/td>\n\u4e0d\u9508\u94a2\u51b7\u8f67\u94a2\u677f\u548c\u94a2\u5e26<\/td>\n\u56fd\u5bb6\u6807\u51c6\u5316\u7ba1\u7406\u59d4\u5458\u4f1a<\/td>\n<\/tr>\n
            YY\/T 0688-2017<\/td>\n\u533b\u7597\u5668\u68b0\u751f\u7269\u5b66\u8bc4\u4ef7 \u7b2c18\u90e8\u5206\uff1a\u5316\u5b66\u8868\u5f81<\/td>\n\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40<\/td>\n<\/tr>\n
            T\/CPPU 0001-2020<\/td>\n\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u8fc7\u6ee4\u5668\u6280\u672f\u89c4\u8303<\/td>\n\u4e2d\u56fd\u5236\u836f\u88c5\u5907\u884c\u4e1a\u534f\u4f1a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

            5.2 \u56fd\u5916\u4e3b\u8981\u6807\u51c6<\/h3>\n\n\n\n\n\n\n\n
            \u6807\u51c6\u7f16\u53f7<\/th>\n\u540d\u79f0<\/th>\n\u53d1\u5e03\u673a\u6784<\/th>\n<\/tr>\n<\/thead>\n
            ASME BPE-2020<\/td>\nBioprocessing Equipment<\/td>\nASME\uff08\u7f8e\u56fd\u673a\u68b0\u5de5\u7a0b\u5e08\u534f\u4f1a\uff09<\/td>\n<\/tr>\n
            ISO 22442-2:2020<\/td>\n\u533b\u7597\u5668\u68b0\u751f\u7269\u6e90\u6750\u6599\u5b89\u5168\u8bc4\u4f30<\/td>\nISO\uff08\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7\uff09<\/td>\n<\/tr>\n
            USP <\/td>\nSterilization and Sterility Assurance of Compendial Articles<\/td>\n\u7f8e\u56fd\u836f\u5178\u59d4\u5458\u4f1a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

            5.3 \u5173\u952e\u5dee\u5f02\u5206\u6790<\/h3>\n\n\n\n\n\n\n\n\n
            \u5bf9\u6bd4\u9879<\/th>\n\u56fd\u5185\u6807\u51c6<\/th>\n\u56fd\u5916\u6807\u51c6<\/th>\n<\/tr>\n<\/thead>\n
            \u6750\u6599\u8ba4\u8bc1<\/td>\n\u4ee5GB\u4e3a\u4e3b\uff0c\u5f3a\u8c03\u56fd\u4ea7\u6750\u6599\u5e94\u7528<\/td>\n\u5f3a\u8c03ASTM\/EN\u6807\u51c6\uff0c\u6ce8\u91cd\u56fd\u9645\u4e92\u8ba4<\/td>\n<\/tr>\n
            \u9a8c\u8bc1\u4f53\u7cfb<\/td>\n\u4ee5DQ\/IQ\/OQ\/PQ\u4e3a\u57fa\u7840<\/td>\n\u66f4\u5f3a\u8c03\u6301\u7eed\u5de5\u827a\u9a8c\u8bc1\uff08CPV\uff09<\/td>\n<\/tr>\n
            \u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5<\/td>\n\u5e38\u89c4\u6ce1\u70b9\u6cd5\u3001\u6269\u6563\u6d41\u6cd5<\/td>\n\u589e\u52a0\u524d\u5411\u6d41\u6d4b\u8bd5\uff08Forward Flow\uff09<\/td>\n<\/tr>\n
            \u706d\u83cc\u5468\u671f\u6b21\u6570<\/td>\n\u4e00\u822c\u5efa\u8bae\u226450\u6b21<\/td>\n\u652f\u6301\u2265100\u6b21SIP\u5faa\u73af\u9a8c\u8bc1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
            \n

            \u516d\u3001\u5e94\u7528\u6848\u4f8b\u4e0e\u5e38\u89c1\u95ee\u9898\u5206\u6790<\/h2>\n

            6.1 \u5e94\u7528\u6848\u4f8b\uff1a\u67d0\u6ce8\u5c04\u5242\u751f\u4ea7\u7ebf\u4e2d\u7684\u4e0d\u9508\u94a2\u9664\u83cc\u8fc7\u6ee4\u5668<\/h3>\n
              \n
            • \u8bbe\u5907\u578b\u53f7<\/strong>\uff1aSFP-316L-0.2<\/li>\n
            • \u4f7f\u7528\u4f4d\u7f6e<\/strong>\uff1a\u6ce8\u5c04\u7528\u6c34\uff08WFI\uff09\u8f93\u9001\u7ba1\u9053\u672b\u7aef<\/li>\n
            • \u9a8c\u8bc1\u5185\u5bb9<\/strong>\uff1a\n
                \n
              • \u5b8c\u6574\u6027\u6d4b\u8bd5\uff1a\u6ce1\u70b9\u6cd5\u22653450 mbar<\/li>\n
              • \u706d\u83cc\u5468\u671f\uff1a\u6bcf\u6279\u7ed3\u675f\u540e\u8fdb\u884cSIP\uff0c\u7d2f\u8ba1\u5df2\u6267\u884c120\u6b21<\/li>\n
              • \u5fae\u751f\u7269\u68c0\u6d4b\uff1a\u8fde\u7eed3\u4e2a\u6708\u672a\u68c0\u51fa\u5fae\u751f\u7269<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

                6.2 \u5e38\u89c1\u95ee\u9898\u4e0e\u5bf9\u7b56<\/h3>\n\n\n\n\n\n\n\n
                \u95ee\u9898\u73b0\u8c61<\/th>\n\u53ef\u80fd\u539f\u56e0<\/th>\n\u89e3\u51b3\u65b9\u6848<\/th>\n<\/tr>\n<\/thead>\n
                \u8fc7\u6ee4\u538b\u5dee\u5347\u9ad8<\/td>\n\u6ee4\u82af\u5835\u585e<\/td>\n\u66f4\u6362\u6ee4\u82af\uff0c\u4f18\u5316\u9884\u5904\u7406\u6b65\u9aa4<\/td>\n<\/tr>\n
                \u5b8c\u6574\u6027\u6d4b\u8bd5\u5931\u8d25<\/td>\n\u5bc6\u5c01\u5708\u8001\u5316\u3001\u6ee4\u819c\u7834\u635f<\/td>\n\u66f4\u6362\u5bc6\u5c01\u4ef6\u6216\u6ee4\u82af\uff0c\u91cd\u65b0\u9a8c\u8bc1<\/td>\n<\/tr>\n
                \u5fae\u751f\u7269\u8d85\u6807<\/td>\n\u706d\u83cc\u4e0d\u5f7b\u5e95\u6216\u7cfb\u7edf\u56de\u6d41\u6c61\u67d3<\/td>\n\u52a0\u5f3aSIP\u7a0b\u5e8f\uff0c\u589e\u52a0\u7cfb\u7edf\u51b2\u6d17\u9891\u7387<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                \n

                \u4e03\u3001\u53d1\u5c55\u8d8b\u52bf\u4e0e\u6280\u672f\u521b\u65b0\u65b9\u5411<\/h2>\n

                \u968f\u7740\u751f\u7269\u5236\u836f\u884c\u4e1a\u7684\u5feb\u901f\u53d1\u5c55\uff0c\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u6b63\u671d\u7740\u4ee5\u4e0b\u65b9\u5411\u6f14\u8fdb\uff1a<\/p>\n

                  \n
                • \u667a\u80fd\u5316\u76d1\u6d4b\u7cfb\u7edf\u96c6\u6210<\/strong>\uff1a\u914d\u5907\u538b\u529b\u4f20\u611f\u5668\u3001\u6e29\u5ea6\u63a2\u5934\u3001\u5b8c\u6574\u6027\u6d4b\u8bd5\u63a5\u53e3\uff1b<\/li>\n
                • \u591a\u5c42\u590d\u5408\u6ee4\u6750\u5f00\u53d1<\/strong>\uff1a\u63d0\u5347\u8fc7\u6ee4\u6548\u7387\u4e0e\u4f7f\u7528\u5bff\u547d\uff1b<\/li>\n
                • \u73af\u4fdd\u8282\u80fd\u8bbe\u8ba1<\/strong>\uff1a\u964d\u4f4e\u80fd\u8017\uff0c\u51cf\u5c11\u5e9f\u6db2\u6392\u653e\uff1b<\/li>\n
                • \u6570\u5b57\u5316\u9a8c\u8bc1\u5e73\u53f0\u5efa\u8bbe<\/strong>\uff1a\u5b9e\u73b0\u5168\u8fc7\u7a0b\u7535\u5b50\u5316\u9a8c\u8bc1\u4e0e\u8ffd\u6eaf\u3002<\/li>\n<\/ul>\n
                  \n

                  \u53c2\u8003\u6587\u732e<\/h2>\n
                    \n
                  1. \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40. \u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u300b[Z]. \u5317\u4eac\uff1a\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40, 2011.<\/li>\n
                  2. \u4e2d\u56fd\u5236\u836f\u88c5\u5907\u884c\u4e1a\u534f\u4f1a. \u300a\u533b\u836f\u7ea7\u8fc7\u6ee4\u8bbe\u5907\u9009\u578b\u6307\u5357\uff082021\u5e74\u7248\uff09\u300b[R]. \u5317\u4eac\uff1aCPA\u51fa\u7248\u793e, 2021.<\/li>\n
                  3. ASME International. ASME BPE-2020: Bioprocessing Equipment[S]. New York: ASME Press, 2020.<\/li>\n
                  4. United States Pharmacopeia. USP Sterilization and Sterility Assurance of Compendial Articles[S]. Rockville, MD: USP, 2022.<\/li>\n
                  5. ISO. ISO 22442-2:2020 Medical devices \u2014 Application of risk management to medical devices \u2014 Part 2: Risk analysis of biological hazards during production[S]. Geneva: ISO, 2020.<\/li>\n
                  6. GB\/T 20878-2007. \u4e0d\u9508\u94a2\u51b7\u8f67\u94a2\u677f\u548c\u94a2\u5e26[S]. \u5317\u4eac\uff1a\u4e2d\u56fd\u6807\u51c6\u51fa\u7248\u793e, 2007.<\/li>\n
                  7. YY\/T 0688-2017. \u533b\u7597\u5668\u68b0\u751f\u7269\u5b66\u8bc4\u4ef7 \u7b2c18\u90e8\u5206\uff1a\u5316\u5b66\u8868\u5f81[S]. \u5317\u4eac\uff1a\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40, 2017.<\/li>\n
                  8. FDA. Guide to Inspections of Pharmaceutical Quality Control Laboratories[M]. Silver Spring: FDA Publications, 2009.<\/li>\n
                  9. ICH. ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients[Z]. Geneva: ICH Secretariat, 2000.<\/li>\n
                  10. T\/CPPU 0001-2020. \u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u8fc7\u6ee4\u5668\u6280\u672f\u89c4\u8303[S]. \u5317\u4eac\uff1a\u4e2d\u56fd\u5236\u836f\u88c5\u5907\u884c\u4e1a\u534f\u4f1a, 2020.<\/li>\n<\/ol>\n
                    \n

                    \u6ce8\uff1a\u672c\u6587\u7ae0\u5185\u5bb9\u4f9d\u636e\u516c\u5f00\u6280\u672f\u8d44\u6599\u6574\u7406\u7f16\u5199\uff0c\u5177\u4f53\u4ea7\u54c1\u9009\u578b\u8bf7\u7ed3\u5408\u4f01\u4e1a\u5b9e\u9645\u5de5\u827a\u9700\u6c42\u4e0e\u8bbe\u5907\u4f9b\u5e94\u5546\u6c9f\u901a\u786e\u8ba4\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

                    \u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u7684\u8bbe\u8ba1\u89c4\u8303\u4e0eGMP\u5408\u89c4\u6027\u8981\u6c42 \u4e00\u3001\u5f15\u8a00 \u5728\u533b\u836f\u5236\u9020\u9886\u57df\uff0c\u4ea7\u54c1\u7684\u7eaf\u5ea6\u4e0e\u5b89\u5168\u6027\u81f3\u5173\u91cd\u8981\u3002\u4e3a\u786e\u4fdd\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4e0d\u53d7\u5230\u5fae\u751f\u7269\u3001\u9897\u7c92\u7269\u53ca\u5176\u4ed6\u6c61\u67d3\u7269\u7684\u6c61\u67d3\uff0c\u8fc7\u6ee4\u6280\u672f\u88ab\u5e7f\u6cdb\u5e94\u7528\u4e8e\u539f\u6599\u5904\u7406\u3001\u4e2d\u95f4\u4f53\u51c0\u5316\u3001\u6700\u7ec8\u4ea7\u54c1\u9664\u83cc\u7b49\u591a\u4e2a\u73af\u8282\u3002\u5176\u4e2d\uff0c\u533b\u836f\u7ea7\u4e0d\u9508\u94a2\u9ad8\u6548\u8fc7\u6ee4\u5668\u56e0\u5176\u4f18\u5f02\u7684\u8010\u8150\u8680\u6027\u80fd\u3001\u826f\u597d\u7684\u673a\u68b0\u5f3a\u5ea6\u4ee5\u53ca\u53ef\u91cd\u590d\u4f7f\u7528\u6027\uff0c\u5728\u5236\u836f\u5de5\u4e1a\u4e2d\u5360\u636e\u91cd\u8981\u5730\u4f4d\u3002 \u672c\u6587\u5c06\u7cfb\u7edf\u9610\u8ff0\u533b\u836f…<\/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-15770","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\/15770","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=15770"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/15770\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15770"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15770"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15770"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}