{"id":697,"date":"2026-04-29T05:43:15","date_gmt":"2026-04-29T05:43:15","guid":{"rendered":"https:\/\/isbm-blow-molding.com\/?p=697"},"modified":"2026-04-29T05:43:15","modified_gmt":"2026-04-29T05:43:15","slug":"korean-pharmaceutical-isbm-production-complete-industry-guide","status":"publish","type":"post","link":"https:\/\/isbm-blow-molding.com\/zh\/korean-pharmaceutical-isbm-production-complete-industry-guide\/","title":{"rendered":"\u97e9\u56fd\u5236\u836fISBM\u751f\u4ea7\uff1a\u5b8c\u6574\u884c\u4e1a\u6307\u5357"},"content":{"rendered":"
\n
\n

\u884c\u4e1a\u5782\u76f4\u6307\u5357<\/p>\n

\u97e9\u56fd\u5236\u836fISBM\u751f\u4ea7\uff1a2026\u5e74\u5b8c\u6574\u884c\u4e1a\u6307\u5357<\/h1>\n

\u53d7\u4eba\u53e3\u8001\u9f84\u5316\u548c\u6162\u6027\u75c5\u9ad8\u53d1\u7684\u5f71\u54cd\uff0c\u97e9\u56fd\u533b\u836f\u5305\u88c5\u5e02\u573a\u9884\u8ba1\u5c06\u4ece15\u4ebf\u81f330\u4ebf\u97e9\u56fd\u5143\u589e\u957f\u81f32033\u5e74\u768415\u4ebf\u81f330\u4ebf\u97e9\u56fd\u5143\uff0c\u5e74\u590d\u5408\u589e\u957f\u7387\u8fbe7.41\u4ebf\u81f33\u4e07\u4ebf\u7f8e\u5143\u3002\u533b\u836f\u5305\u88c5\u74f6\u7684\u751f\u4ea7\u4e0e\u996e\u6599\u548c\u5316\u5986\u54c1\u5305\u88c5\u6709\u7740\u672c\u8d28\u533a\u522b\uff0c\u5176\u91c7\u8d2d\u903b\u8f91\u4ee5\u5408\u89c4\u6027\u4e3a\u5148\u3002\u672c\u6307\u5357\u8be6\u7ec6\u9610\u8ff0\u4e86\u4e03\u79cd\u533b\u836f\u5305\u88c5\u74f6\u7c7b\u522b\u7684\u5b8c\u6574\u751f\u4ea7\u6846\u67b6\u3001USP VI\u7ea7\u6750\u200b\u200b\u6599\u8981\u6c42\u3001K-GMP\u6cd5\u89c4\u9075\u4ece\u6027\u4ee5\u53ca\u706d\u83cc\u517c\u5bb9\u6027\u3002<\/p>\n

\u8ba8\u8bba\u836f\u54c1\u751f\u4ea7 \u2192<\/a><\/p>\n<\/div>\n<\/section>\n

<\/p>\n
\n

TL;DR \u2014 \u5feb\u901f\u6982\u8981<\/p>\n

\u97e9\u56fd\u836f\u54c1\u5305\u88c5\u74f6\u7684\u751f\u4ea7\u5206\u4e3a\u4e03\u5927\u7c7b\uff1a\u53e3\u670d\u6db2\uff08\u7cd6\u6d46\uff09\u3001\u7247\u5242\/\u80f6\u56ca\u74f6\u3001\u5a74\u513f\u914d\u65b9\u5976\u7c89\u74f6\u3001\u6ef4\u773c\u6db2\u74f6\u3001\u975e\u5904\u65b9\u836f\u74f6\u3001\u7ef4\u751f\u7d20\/\u8865\u5145\u5242\u74f6\u548c\u6ce8\u5c04\u5242\u74f6\u3002\u5305\u88c5\u6750\u6599\u5fc5\u987b\u7b26\u5408\u7f8e\u56fd\u836f\u5178\uff08USP\uff09VI\u7ea7\u751f\u7269\u76f8\u5bb9\u6027\u6807\u51c6\u3001\u6b27\u76df\u836f\u51783.1.X\u7248\u4ee5\u53ca\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8\uff08MFDS\uff09\u7684\u98df\u54c1\u63a5\u89e6\u7b49\u6548\u6027\u6807\u51c6\u3002Tritan\u6750\u8d28\u4e3b\u8981\u7528\u4e8e\u5a74\u513f\u5976\u74f6\uff08\u7b26\u5408\u4e0d\u542b\u53cc\u915aA\u7684\u6cd5\u89c4\u8981\u6c42\uff09\uff0cPP\u6750\u8d28\u7528\u4e8e\u9ad8\u6e29\u6740\u83cc\u5a74\u513f\u914d\u65b9\u5976\u7c89\uff0cPETG\u6750\u8d28\u7528\u4e8e\u9ad8\u7aef\u6db2\u4f53\u836f\u54c1\uff0cHDPE\u6750\u8d28\u7528\u4e8e\u7247\u5242\u74f6\u3002\u6240\u6709\u836f\u54c1\u5305\u88c5\u4f9b\u5e94\u5546\u90fd\u5fc5\u987b\u9075\u5b88\u97e9\u56fd\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08K-GMP\uff09\uff1b\u7f8e\u56fd\u51fa\u53e3\u53d7\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff0921 CFR\u7b2c11\u90e8\u5206\u76d1\u7ba1\uff1b\u6b27\u76df\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u9644\u4ef611\uff08EU GMP Annex 11\uff09\u76d1\u7ba1\u3002\u91c7\u8d2d\u903b\u8f91\u5df2\u4ece\u201c\u5355\u4f4d\u6210\u672c\u201d\u8f6c\u5411\u201c\u5408\u89c4\u6210\u672c\u201d\u2014\u2014\u5305\u88c5\u7f3a\u9677\u5bfc\u81f4\u7684\u6e17\u6f0f\u3001\u6c34\u5206\u6e17\u5165\u6216\u5e8f\u5217\u53f7\u7f3a\u5931\u7b49\u95ee\u9898\uff0c\u5176\u9020\u6210\u7684\u635f\u5931\u8fdc\u8fdc\u8d85\u8fc7\u4efb\u4f55\u539f\u6750\u6599\u91c7\u8d2d\u6210\u672c\u7684\u8282\u7701\u3002<\/p>\n<\/div>\n

<\/p>\n

\n

\u672c\u6307\u5357<\/h3>\n
    \n
  1. \u533b\u836f\u884c\u4e1a\u80cc\u666f\uff1aISBM\u4e3a\u4f55\u91cd\u8981<\/a><\/li>\n
  2. 2026\u5e74\u97e9\u56fd\u533b\u836f\u5e02\u573a\u5c55\u671b<\/a><\/li>\n
  3. 7 \u79cd\u836f\u54c1\u74f6\u7c7b\u522b\u53ca ISBM \u8981\u6c42<\/a><\/li>\n
  4. \u6750\u6599\u9009\u62e9\uff1aUSP VI\u7ea7\u548c\u836f\u5178<\/a><\/li>\n
  5. ISBM \u5236\u836f\u6807\u51c6\u5904\u7406<\/a><\/li>\n
  6. K-GMP\/FDA\/EMA\u76d1\u7ba1\u6846\u67b6<\/a><\/li>\n
  7. \u706d\u83cc\u517c\u5bb9\u6027<\/a><\/li>\n
  8. \u9009\u62e9\u97e9\u56fd\u5236\u836fISBM\u5408\u4f5c\u4f19\u4f34<\/a><\/li>\n
  9. \u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/a><\/li>\n
  10. \u7ed3\u8bba<\/a><\/li>\n<\/ol>\n<\/div>\n

    <\/p>\n

    1. \u5236\u836f\u884c\u4e1a\u80cc\u666f\uff1aISBM \u7684\u91cd\u8981\u6027<\/h2>\n

    \u836f\u54c1\u5305\u88c5\uff08ISBM\uff09\u7684\u751f\u4ea7\u8fd0\u4f5c\u9075\u5faa\u7740\u4e0e\u996e\u6599\u6216\u5316\u5986\u54c1\u884c\u4e1a\u622a\u7136\u4e0d\u540c\u7684\u7ecf\u6d4e\u903b\u8f91\u3002\u97e9\u56fd\u5236\u836f\u4f01\u4e1a\u8d2d\u4e70\u7684\u5e76\u975e\u74f6\u5b50\uff0c\u800c\u662f\u89c4\u907f\u76d1\u7ba1\u98ce\u9669\u7684\u4fdd\u969c\u3002\u5305\u88c5\u5931\u6548\u9020\u6210\u7684\u635f\u5931\u2014\u2014\u65e0\u8bba\u662f\u5316\u5b66\u7269\u8d28\u6e17\u51fa\u3001\u6c34\u5206\u6e17\u5165\u3001\u5c3a\u5bf8\u4e0d\u7b26\u8fd8\u662f\u5e8f\u5217\u53f7\u7f3a\u5931\u2014\u2014\u90fd\u8fdc\u8fdc\u8d85\u8fc7\u5546\u54c1\u5316\u91c7\u8d2d\u6240\u5e26\u6765\u7684\u6210\u672c\u8282\u7ea6\u3002\u4ec5\u4ec5\u4e00\u6279\u836f\u54c1\u5931\u6548\u5c31\u53ef\u80fd\u9020\u6210\u6570\u767e\u4e07\u97e9\u5143\u7684\u5e93\u5b58\u635f\u5931\u3001\u76d1\u7ba1\u5904\u7f5a\u4ee5\u53ca\u54c1\u724c\u58f0\u8a89\u635f\u5bb3\uff0c\u800c\u8fd9\u79cd\u635f\u5bb3\u7684\u5f71\u54cd\u751a\u81f3\u4f1a\u6301\u7eed\u6570\u5e74\u4e4b\u4e45\u3002<\/p>\n

    \u8fd9\u79cd\u4ee5\u5408\u89c4\u4e3a\u5148\u7684\u91c7\u8d2d\u903b\u8f91\u4ece\u591a\u4e2a\u5c42\u9762\u5851\u9020\u4e86\u97e9\u56fd\u5236\u836f\u4f01\u4e1a\u4e0e\u56fd\u9645\u836f\u54c1\u5236\u9020\u5546\u534f\u4f1a\uff08ISBM\uff09\u7684\u5408\u4f5c\u5173\u7cfb\u3002\u9996\u5148\u662f\u4f9b\u5e94\u5546\u8d44\u8d28\uff1a\u836f\u54c1\u5305\u88c5\u4f9b\u5e94\u5546\u5fc5\u987b\u6301\u6709\u97e9\u56fd\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08K-GMP\uff09\u8ba4\u8bc1\u3001\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u836f\u54c1\u4e3b\u6587\u4ef6\u6ce8\u518c\uff08\u5982\u9002\u7528\uff09\u4ee5\u53ca\u7b26\u5408\u6b27\u76df\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u9644\u4ef611\uff08EU GMP Annex 11\uff09\u7684\u80fd\u529b\uff0c\u4ee5\u6ee1\u8db3\u6b27\u6d32\u51fa\u53e3\u5e02\u573a\u7684\u9700\u6c42\u3002\u5176\u6b21\u662f\u6750\u6599\u89c4\u683c\uff1a\u521d\u7ea7\u5305\u88c5\u4e2d\u4f7f\u7528\u7684\u6bcf\u79cd\u805a\u5408\u7269\u90fd\u5fc5\u987b\u7b26\u5408\u7f8e\u56fd\u836f\u5178\uff08USP\uff09VI\u7ea7\u751f\u7269\u76f8\u5bb9\u6027\u6d4b\u8bd5\u548c\u97e9\u56fd\u836f\u5178\u7684\u8981\u6c42\u3002\u7b2c\u4e09\u662f\u53ef\u8ffd\u6eaf\u6027\uff1a\u6bcf\u4e2a\u6279\u6b21\u90fd\u5fc5\u987b\u652f\u6301\u5b8c\u6574\u7684\u4e0a\u4e0b\u6e38\u8ffd\u6eaf\uff0c\u4ee5\u4fbf\u5728\u51fa\u73b0\u8d28\u91cf\u95ee\u9898\u65f6\u80fd\u591f\u5feb\u901f\u53ec\u56de\u3002<\/p>\n

    \"\u6ce8\u5851\u62c9\u4f38\u5439\u5851\u673a-\u5e94\u75281-2\"<\/p>\n

    \u5bf9\u4e8e\u670d\u52a1\u4e8e\u533b\u836f\u9886\u57df\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\u800c\u8a00\uff0c\u8fd9\u79cd\u76d1\u7ba1\u73af\u5883\u65e2\u6784\u6210\u4e86\u51c6\u5165\u58c1\u5792\uff0c\u4e5f\u5e26\u6765\u4e86\u7ade\u4e89\u4f18\u52bf\u3002\u83b7\u5f97\u533b\u836f\u8ba4\u8bc1\u6240\u9700\u7684\u6295\u8d44\u901a\u5e38\u8d85\u8fc72\u4ebf\u81f34\u4ebf\u97e9\u5143\uff0c\u7528\u4e8e\u521d\u59cb\u6587\u4ef6\u7f16\u5236\u3001\u9a8c\u8bc1\u548c\u6d4b\u8bd5\u57fa\u7840\u8bbe\u65bd\u3002\u4e00\u65e6\u83b7\u5f97\u533b\u836f\u8ba4\u8bc1\uff0c\u5373\u53ef\u83b7\u5f97\u6ea2\u4ef7\u5229\u6da6\uff08\u901a\u5e38\u6bd4\u540c\u7b49\u5546\u54c1\u996e\u6599\u9ad8\u51fa40\u81f380\u4e07\u97e9\u5143\uff09\uff0c\u5e76\u5efa\u7acb\u4ee5\u5341\u5e74\u800c\u975e\u51e0\u5e74\u4e3a\u5355\u4f4d\u7684\u6301\u4e45\u5ba2\u6237\u5173\u7cfb\u3002\u4ee5\u4e0b\u6846\u67b6\u6db5\u76d6\u4e86\u533b\u836f\u54c1\u7c7b\u7ec4\u5408\u7684\u8981\u6c42\u548c\u4f9b\u5e94\u5546\u8bc4\u4f30\u6807\u51c6\u3002<\/p>\n

    <\/p>\n

    2. 2026\u5e74\u97e9\u56fd\u533b\u836f\u5e02\u573a\u5c55\u671b<\/h2>\n

    \u97e9\u56fd\u836f\u54c1\u5305\u88c5\u5e02\u573a\u9884\u8ba1\u5c06\u4ece2023\u5e74\u76841.4\u4e07\u4ebf\u97e9\u5143\u589e\u957f\u52302033\u5e74\u76841.4\u4e07\u4ebf\u97e9\u5143\uff0c\u590d\u5408\u5e74\u589e\u957f\u7387\u8fbe7.41\u4e07\u4ebf\u97e9\u5143\u3002\u8fd9\u4e00\u589e\u957f\u4e3b\u8981\u53d7\u5f71\u54cd\u97e9\u56fd\u533b\u7597\u4fdd\u5065\u9700\u6c42\u7684\u4e09\u5927\u4eba\u53e3\u548c\u4e34\u5e8a\u8d8b\u52bf\u9a71\u52a8\u3002<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n
    \u9700\u6c42\u9a71\u52a8\u56e0\u7d20<\/th>\n\u8d8b\u52bf<\/th>\n\u5305\u88c5\u7684\u5f71\u54cd<\/th>\n<\/tr>\n<\/thead>\n
    \u4eba\u53e3\u8001\u9f84\u5316<\/td>\n\u52302030\u5e74\uff0c21%\u8d85\u8fc765\u5c81<\/td>\n\u66f4\u591a\u6162\u6027\u75c5\u836f\u7269\u74f6<\/td>\n<\/tr>\n
    \u6162\u6027\u75be\u75c5\u7684\u751f\u957f<\/td>\n\u7cd6\u5c3f\u75c5 +15% \/ \u5341\u5e74<\/td>\n\u957f\u671f\u7528\u836f\u5305\u88c5<\/td>\n<\/tr>\n
    \u5065\u5eb7\u4e0e\u4fdd\u5065<\/td>\n\u7ef4\u751f\u7d20\/\u8865\u5145\u5242 +8% CAGR<\/td>\n\u9ad8\u7ea7\u74f6\u8eab\u7f8e\u5b66<\/td>\n<\/tr>\n
    K-pharma\u51fa\u53e3<\/td>\n\u751f\u7269\u7c7b\u4f3c\u836f + \u4eff\u5236\u836f<\/td>\n\u591a\u53f8\u6cd5\u7ba1\u8f96\u533a\u5408\u89c4\u6027<\/td>\n<\/tr>\n
    \u751f\u7269\u5236\u5242\u6269\u5f20<\/td>\n\u52302036\u5e74\uff0c\u5168\u7403\u5e74\u590d\u5408\u589e\u957f\u7387\u5c06\u8fbe\u52305%\uff0c\u8fbe\u5230$449\u4ebf\u7f8e\u5143\u3002<\/td>\n\u6ea2\u4ef7\u58c1\u5792\u8981\u6c42<\/td>\n<\/tr>\n
    \u5e8f\u5217\u5316\u8981\u6c42<\/td>\nDSCSA\uff08\u7f8e\u56fd\uff09+ FMD\uff08\u6b27\u76df\uff09<\/td>\n\u8ffd\u8e2a\u6eaf\u6e90\u6574\u5408<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \u5851\u6599\u74f6\u662f\u97e9\u56fd\u836f\u54c1\u5305\u88c5\u9886\u57df\u6700\u5927\u7684\u7ec6\u5206\u5e02\u573a\uff0c\u7ea6\u5360\u5e02\u573a\u603b\u6536\u5165\u768428%\u3002\u5851\u6599\u74f6\u7684\u4e3b\u5bfc\u5730\u4f4d\u6e90\u4e8e\u5176\u8f7b\u4fbf\u3001\u517c\u5bb9\u513f\u7ae5\u5b89\u5168\u76d6\u3001\u9632\u7be1\u6539\u5bc6\u5c01\u4ee5\u53ca\u89c4\u6a21\u5316\u751f\u4ea7\u65f6\u7684\u6210\u672c\u6548\u76ca\u7b49\u4f18\u52bf\u3002\u73bb\u7483\u74f6\u5728\u5316\u5b66\u60f0\u6027\u81f3\u5173\u91cd\u8981\u7684\u9ad8\u4ef7\u503c\u6ce8\u5c04\u5242\u5e94\u7528\u4e2d\u4ecd\u662f\u9996\u9009\uff0c\u4f46\u5851\u6599\u74f6\u51ed\u501f\u963b\u9694\u6280\u672f\u7684\u8fdb\u6b65\u548c\u76d1\u7ba1\u65b9\u9762\u7684\u8ba4\u53ef\uff0c\u5e02\u573a\u4efd\u989d\u6301\u7eed\u589e\u957f\u3002<\/p>\n

    \u97e9\u56fd\u836f\u54c1\u5305\u88c5\u884c\u4e1a\u7684\u4e3b\u8981\u53c2\u4e0e\u8005\u5305\u62ec\u56fd\u9645\u4f01\u4e1a\uff08\u5982CCL Industries\u3001West Pharmaceutical Services\u3001Berry Global\u3001Catalent\u3001Gerresheimer\u3001SCHOTT\u3001Amcor\u3001Aptar\u3001Nipro\u548cBD\uff09\u4ee5\u53ca\u670d\u52a1\u4e8e\u97e9\u56fd\u5236\u836f\u884c\u4e1a\u7684\u97e9\u56fd\u672c\u571f\u751f\u4ea7\u5546\u3002\u6fc0\u70c8\u7684\u5e02\u573a\u7ade\u4e89\u6709\u5229\u4e8e\u80fd\u591f\u63d0\u4f9b\u672c\u5730\u8ba4\u8bc1\u3001\u5feb\u901f\u5468\u8f6c\u548c\u7efc\u5408\u76d1\u7ba1\u652f\u6301\u7684\u97e9\u56fd\u751f\u4ea7\u5546\uff0c\u4ee5\u4fc3\u8fdb\u97e9\u56fd\u5236\u836f\u51fa\u53e3\u7684\u6269\u5f20\u3002\u97e9\u56fd\u5236\u836f\u5bf9\u7f8e\u56fd\u3001\u6b27\u76df\u3001\u4e2d\u56fd\u3001\u65e5\u672c\u548c\u4e1c\u5357\u4e9a\u65b0\u5174\u5e02\u573a\u7684\u51fa\u53e3\u6301\u7eed\u589e\u957f\uff0c\u8fd9\u4e3a\u5177\u5907\u591a\u53f8\u6cd5\u7ba1\u8f96\u533a\u5408\u89c4\u80fd\u529b\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\u521b\u9020\u4e86\u673a\u9047\u3002<\/p>\n

    <\/p>\n

    3. 7 \u79cd\u836f\u54c1\u74f6\u5206\u7c7b\u53ca ISBM \u8981\u6c42<\/h2>\n
    \"\u74f6-3\"
    \n\u97e9\u56fd\u836f\u54c1\u751f\u4ea7\u6db5\u76d6\u4e03\u79cd\u4e0d\u540c\u7684\u74f6\u5b50\u7c7b\u522b\uff0c\u6bcf\u79cd\u7c7b\u522b\u90fd\u6709\u5176\u7279\u5b9a\u7684\u6750\u8d28\u3001\u5c3a\u5bf8\u548c\u76d1\u7ba1\u8981\u6c42\u3002<\/figcaption><\/figure>\n

    \u97e9\u56fd\u5236\u836f\u7528ISBM\uff08\u74f6\u88c5\u6db2\u4f53\u50a8\u5b58\u5bb9\u5668\uff09\u7684\u751f\u4ea7\u5206\u4e3a\u4e03\u5927\u7c7b\u3002\u6bcf\u4e00\u7c7b\u90fd\u6709\u7279\u5b9a\u7684\u6750\u8d28\u3001\u5c3a\u5bf8\u548c\u76d1\u7ba1\u8981\u6c42\uff0c\u4ece\u800c\u51b3\u5b9a\u4e86ISBM\u7684\u751f\u4ea7\u89c4\u8303\u3002<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n\n
    \u7c7b\u522b<\/th>\n\u5bb9\u91cf<\/th>\n\u521d\u7ea7\u6750\u6599<\/th>\n\u5173\u952e\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n
    1. \u53e3\u670d\u6db2\uff08\u7cd6\u6d46\uff09<\/td>\n60-250\u6beb\u5347<\/td>\nPET\/PETG\/\u7425\u73c0\u8272PET<\/td>\n\u5149\u5c4f\u969c\uff0c\u9632\u7be1\u6539<\/td>\n<\/tr>\n
    2. \u7247\u5242\/\u80f6\u56ca<\/td>\n30-500\u6beb\u5347<\/td>\n\u9ad8\u5bc6\u5ea6\u805a\u4e59\u70ef\/\u805a\u5bf9\u82ef\u4e8c\u7532\u9178\u4e59\u4e8c\u9187\u916f<\/td>\n\u9632\u6f6e\u5c42\uff0c\u513f\u7ae5\u5b89\u5168<\/td>\n<\/tr>\n
    3. \u5a74\u513f\u914d\u65b9\u5976\u7c89<\/td>\n120-300\u6beb\u5347<\/td>\nTritan \/ PP \/ PPSU<\/td>\n\u4e0d\u542b\u53cc\u915aA\uff0c\u53ef\u8010\u53d7\u6d88\u6bd2<\/td>\n<\/tr>\n
    4. \u773c\u836f\u6c34\/\u9f3b\u55b7\u96fe\u5242<\/td>\n5-30\u6beb\u5347<\/td>\n\u4f4e\u5bc6\u5ea6\u805a\u4e59\u70ef\/\u805a\u4e59\u70ef<\/td>\n\u65e0\u83cc\uff0c\u53ef\u914d\u5408\u6ef4\u7ba1\u4f7f\u7528<\/td>\n<\/tr>\n
    5. \u975e\u5904\u65b9\u836f<\/td>\n50-500\u6beb\u5347<\/td>\nPET\/HDPE<\/td>\n\u9632\u7be1\u6539\u3001\u513f\u7ae5\u5b89\u5168<\/td>\n<\/tr>\n
    6. \u7ef4\u751f\u7d20\/\u8865\u5145\u5242<\/td>\n100-1000\u6beb\u5347<\/td>\nPET\/PETG\/HDPE<\/td>\n\u9ad8\u7ea7\u7f8e\u5b66\uff0c\u6c27\u6c14\u963b\u9694<\/td>\n<\/tr>\n
    7. \u6ce8\u5c04\u5242\u5bb9\u5668<\/td>\n\u591a\u53d8\u7684<\/td>\n\u7279\u79cd\u7b49\u7ea7<\/td>\n\u65e0\u83cc\u3001\u4f4e\u8403\u53d6\u7269<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \u5bf9\u4e8e\u97e9\u56fd\u5a74\u5e7c\u513f\u914d\u65b9\u5976\u7c89\u751f\u4ea7\u5546\u800c\u8a00\uff0c\u6709\u4e09\u7c7b\u836f\u54c1\u9700\u8981\u7279\u522b\u5173\u6ce8\u5176\u6218\u7565\u5730\u4f4d\u3002\u9996\u5148\uff0c\u7531\u4e8e\u76d1\u7ba1\u90e8\u95e8\u8981\u6c42\u4e0d\u542b\u53cc\u915aA\uff08BPA\uff09\uff0c\u5a74\u5e7c\u513f\u914d\u65b9\u5976\u7c89\u74f6\u5fc5\u987b\u4f7f\u7528Tritan\u3001PP\u6216PPSU\u6750\u6599\uff0c\u800c\u9ad8\u7aef\u914d\u65b9\u5976\u7c89\u4ea7\u54c1\u4e5f\u8d8a\u6765\u8d8a\u503e\u5411\u4e8e\u91c7\u7528\u9ad8\u6e29\u9ad8\u538b\u706d\u83cc\uff08104\u00b0C\u9ad8\u538b\u706d\u83cc\uff09\u3002\u6709\u5173\u5a74\u5e7c\u513f\u5582\u517b\u6750\u6599\u7684\u5b8c\u6574\u5206\u6790\uff0c\u8bf7\u53c2\u9605\u2026\u2026 Tritan \u4e0e PC \u5a74\u513f\u5976\u74f6\u5bf9\u6bd4\u6307\u5357<\/a>.<\/p>\n

    \u5176\u6b21\uff0c\u7ef4\u751f\u7d20\/\u8425\u517b\u8865\u5145\u5242\u74f6\u662f\u533b\u836f\u5305\u88c5\u9886\u57df\u4e2dISBM\u5e94\u7528\u589e\u957f\u6700\u5feb\u7684\u9886\u57df\u3002\u97e9\u56fdK-wellness\u54c1\u724c\u5728\u5168\u7403\u7684\u6269\u5f20\u63a8\u52a8\u4e86\u5bf9\u4f18\u8d28PETG\u74f6\u7684\u9700\u6c42\uff0c\u8fd9\u4e9b\u74f6\u5b50\u65e2\u80fd\u652f\u6301\u54c1\u724c\u5dee\u5f02\u5316\uff0c\u53c8\u80fd\u6ee1\u8db3\u533b\u836f\u7ea7\u5408\u89c4\u8981\u6c42\u3002\u7b2c\u4e09\uff0c\u53e3\u670d\u6db2\u7cd6\u6d46\u74f6\u8d8a\u6765\u8d8a\u591a\u5730\u4f7f\u7528\u7425\u73c0\u8272PET\u6765\u4fdd\u62a4\u5149\u654f\u6d3b\u6027\u6210\u5206\uff1b\u8fd9\u79cd\u7279\u6b8a\u6750\u6599\u6bd4\u540c\u7b49\u89c4\u683c\u7684\u900f\u660ePET\u6210\u672c\u9ad8\u51fa\u7ea615-25%\u3002<\/p>\n

    <\/p>\n

    4. \u6750\u6599\u9009\u62e9\uff1aUSP VI\u7ea7\u548c\u836f\u5178<\/h2>\n

    \u836f\u54c1\u5305\u88c5\u6750\u6599\u7684\u9009\u62e9\u6d89\u53ca\u996e\u6599\u548c\u5316\u5986\u54c1\u5e94\u7528\u9886\u57df\u6240\u6ca1\u6709\u7684\u76d1\u7ba1\u5408\u89c4\u6027\u95ee\u9898\u3002\u7528\u4e8e\u836f\u54c1\u521d\u7ea7\u5305\u88c5\u7684\u6bcf\u79cd\u805a\u5408\u7269\u90fd\u5fc5\u987b\u901a\u8fc7\u4e3b\u8981\u836f\u5178\u89c4\u5b9a\u7684\u6807\u51c6\u5316\u6d4b\u8bd5\u65b9\u6848\u6765\u8bc1\u660e\u5176\u751f\u7269\u76f8\u5bb9\u6027\u3002<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n
    \u5408\u89c4\u6807\u51c6<\/th>\n\u7ba1\u8f96\u6743<\/th>\n\u6d4b\u8bd5\u9700\u6c42<\/th>\n<\/tr>\n<\/thead>\n
    USP \u516d\u7ea7<\/td>\n\u7f8e\u56fd\uff08FDA\u53c2\u8003\uff09<\/td>\n\u6025\u6027\u5168\u8eab\u6bd2\u6027\uff0c\u76ae\u5185\uff0c\u690d\u5165<\/td>\n<\/tr>\n
    \u6b27\u76df\u836f\u5178 3.1.X<\/td>\n\u6b27\u76df\uff08EMA \u53c2\u8003\uff09<\/td>\n\u6750\u6599\u4e13\u8457<\/td>\n<\/tr>\n
    \u97e9\u56fd\u836f\u5178<\/td>\n\u97e9\u56fd\uff08MFDS\uff09<\/td>\n\u751f\u7269\u76f8\u5bb9\u6027 + \u53ef\u8403\u53d6\u7269<\/td>\n<\/tr>\n
    ISO 10993<\/td>\n\u56fd\u9645\u7684<\/td>\n\u751f\u7269\u5b66\u8bc4\u4ef7<\/td>\n<\/tr>\n
    \u65e5\u672c\u836f\u5178\uff08JP\uff09<\/td>\n\u65e5\u672c\uff08PMDA\uff09<\/td>\n\u5bb9\u5668\u7279\u5b9a\u6d4b\u8bd5<\/td>\n<\/tr>\n
    \u4e2d\u56fd\u836f\u5178<\/td>\n\u4e2d\u56fd\uff08NMPA\uff09<\/td>\n\u76f4\u63a5\u98df\u54c1\u63a5\u89e6\u7b49\u6548\u6027<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    USP VI\u7ea7\u4ee3\u8868\u4e86\u836f\u5178\u6846\u67b6\u4e2d\u6700\u4e25\u683c\u7684\u751f\u7269\u76f8\u5bb9\u6027\u6807\u51c6\u3002VI\u7ea7\u6d4b\u8bd5\u65b9\u6848\u5305\u62ec\u6025\u6027\u5168\u8eab\u6bd2\u6027\u8bd5\u9a8c\u3001\u76ae\u5185\u523a\u6fc0\u8bd5\u9a8c\u548c\u52a8\u7269\u6a21\u578b\u690d\u5165\u8bd5\u9a8c\u3002\u7b26\u5408VI\u7ea7\u6807\u51c6\u7684\u6750\u6599\u901a\u5e38\u53ef\u4ee5\u901a\u8fc7\u516c\u8ba4\u7684\u7b49\u6548\u9014\u5f84\u6ee1\u8db3\u5176\u4ed6\u836f\u5178\u8981\u6c42\u3002\u5bf9\u4e8e\u670d\u52a1\u4e8e\u5168\u7403\u533b\u836f\u5e02\u573a\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\u800c\u8a00\uff0cUSP VI\u7ea7\u6750\u200b\u200b\u6599\u8ba4\u8bc1\u4e3a\u5176\u63d0\u4f9b\u4e86\u6700\u5e7f\u6cdb\u7684\u5e02\u573a\u51c6\u5165\u57fa\u7840\u3002<\/p>\n

    \u7528\u4e8e\u533b\u836f\u884c\u4e1a\u7684\u6750\u6599\u7b49\u7ea7\u5177\u6709\u7279\u5b9a\u7684\u6807\u8bc6\uff0c\u4ee5\u533a\u522b\u4e8e\u98df\u54c1\u63a5\u89e6\u7ea7\u6216\u5de5\u4e1a\u7ea7\u6750\u6599\u3002\u533b\u836f\u7ea7PET\u3001PP\u3001HDPE\u3001LDPE\u548cTritan\u5747\u5728\u4e25\u683c\u7684GMP\u6761\u4ef6\u4e0b\u751f\u4ea7\uff0c\u5e76\u5177\u6709\u5b8c\u6574\u7684\u6279\u6b21\u8ffd\u6eaf\u6027\u548c\u4f9b\u5e94\u5546\u8d44\u8d28\u6587\u4ef6\u3002\u533b\u836f\u7ea7\u6750\u6599\u7684\u4ef7\u683c\u901a\u5e38\u6bd4\u540c\u7b49\u89c4\u683c\u7684\u98df\u54c1\u63a5\u89e6\u7ea7\u6750\u6599\u9ad8\u51fa20-50%\uff0c\u8fd9\u53cd\u6620\u4e86\u5176\u989d\u5916\u7684\u6587\u6863\u548c\u8d28\u91cf\u63a7\u5236\u4f53\u7cfb\u3002\u5bf9\u4e8e\u97e9\u56fd\u751f\u4ea7\u5546\u800c\u8a00\uff0c\u91c7\u8d2d\u533b\u836f\u7ea7\u6750\u6599\u901a\u5e38\u9700\u8981\u81f3\u5c116\u4e2a\u6708\u7684\u8d44\u8d28\u8ba4\u8bc1\u6d41\u7a0b\u624d\u80fd\u542f\u52a8\u751f\u4ea7\u3002<\/p>\n

    \"15\u6beb\u5347ISBM\u6a21\u5177\u7ec6\u82821\"<\/p>\n

    <\/p>\n

    5. ISBM \u5236\u836f\u6807\u51c6\u5904\u7406<\/h2>\n
    \"HGY200-V4-B
    <\/figcaption><\/figure>\n

    \u533b\u836fISBM\u751f\u4ea7\u5bf9\u8d28\u91cf\u6807\u51c6\u7684\u8981\u6c42\u5728\u5408\u89c4\u6027\u65b9\u9762\u9ad8\u4e8e\u97e9\u5986\u9ad8\u7aef\u4ea7\u54c1\uff0c\u4f46\u5728\u7eaf\u7cb9\u7684\u5ba1\u7f8e\u65b9\u9762\u901a\u5e38\u4f4e\u4e8e\u97e9\u5986\u3002\u533b\u836f\u751f\u4ea7\u4e0e\u5176\u4ed6ISBM\u5e94\u7528\u76f8\u6bd4\uff0c\u6709\u4e09\u4e2a\u533b\u836f\u7279\u6709\u7684\u8d28\u91cf\u7ef4\u5ea6\u3002<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n
    \u8d28\u91cf\u7ef4\u5ea6<\/th>\n\u533b\u836f\u6807\u51c6<\/th>\n\u9a8c\u8bc1\u65b9\u6cd5<\/th>\n<\/tr>\n<\/thead>\n
    \u9897\u7c92\u7269<\/td>\n\u7b26\u5408\u7f8e\u56fd\u836f\u5178<\/td>\n\u5149\u7ebf\u906e\u853d\u8ba1\u6570<\/td>\n<\/tr>\n
    \u53ef\u8403\u53d6\u7269\/\u53ef\u6d78\u51fa\u7269<\/td>\n\u7f8e\u56fd\u836f\u5178 \/<\/td>\n\u6c14\u76f8\u8272\u8c31-\u8d28\u8c31\u8054\u7528\/\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u5206\u6790<\/td>\n<\/tr>\n
    \u5fae\u751f\u7269\u63a7\u5236<\/td>\n\u7b26\u5408\u7f8e\u56fd\u836f\u5178\/\u89c4\u5b9a<\/td>\n\u751f\u7269\u8d1f\u8377\u68c0\u6d4b<\/td>\n<\/tr>\n
    \u5c3a\u5bf8\u4e00\u81f4\u6027<\/td>\n\u00b10.5-1.0%<\/td>\nSPC\u6587\u6863<\/td>\n<\/tr>\n
    \u58c1\u9762\u5747\u5300\u6027<\/td>\n\u00b15%<\/td>\n\u5c3a\u5bf8\u68c0\u9a8c<\/td>\n<\/tr>\n
    \u6279\u6b21\u8ffd\u6eaf\u6027<\/td>\n100% \u6279\u6b21\u6c34\u5e73<\/td>\n\u5e8f\u5217\u5316\u96c6\u6210<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \u5bf9\u4e8e\u836f\u54c1ISBM\u7684\u751f\u4ea7\u800c\u8a00\uff0c\u9897\u7c92\u7269\u63a7\u5236\u5c24\u4e3a\u91cd\u8981\u3002\u7f8e\u56fd\u836f\u5178\u6807\u51c6\u5bf9\u836f\u54c1\u5bb9\u5668\u4e2d\u7684\u9897\u7c92\u7269\u6570\u91cf\u6709\u9650\u5236\uff0c\u5e76\u5bf9\u5927\u4e8e10\u5fae\u7c73\u548c25\u5fae\u7c73\u7684\u9897\u7c92\u7269\u8bbe\u5b9a\u4e86\u5177\u4f53\u7684\u9608\u503c\u3002\u4e3a\u8fbe\u5230\u5408\u89c4\u8981\u6c42\uff0c\u9700\u8981\u5728\u53d7\u63a7\u73af\u5883\u4e0b\u8fdb\u884cISBM\u751f\u4ea7\uff08\u901a\u5e38\u76f8\u5f53\u4e8e\u836f\u54c1\u5e94\u7528\u7684ISO 8\u7ea7\u6d01\u51c0\u5ba4\uff09\uff0c\u5b9a\u671f\u8fdb\u884c\u53d6\u6837\u548c\u68c0\u6d4b\uff0c\u5e76\u5b8c\u6574\u8bb0\u5f55\u6240\u6709\u8d85\u51fa\u89c4\u683c\u7684\u60c5\u51b5\u3002\u97e9\u56fd\u7684\u836f\u54c1\u751f\u4ea7\u5546\u901a\u5e38\u4f1a\u4e13\u95e8\u914d\u5907\u53d7\u63a7\u73af\u5883\u57fa\u7840\u8bbe\u65bd\u7684ISBM\u5e73\u53f0\u7528\u4e8e\u836f\u54c1\u751f\u4ea7\u3002<\/p>\n

    \u6709\u5173\u652f\u6301\u5236\u836f\u8d28\u91cf\u6807\u51c6\u7684\u9884\u9632\u6027\u7ef4\u62a4\u548c\u64cd\u4f5c\u89c4\u8303\uff0c\u8bf7\u53c2\u89c1 \u7ef4\u62a4\u68c0\u67e5\u6e05\u5355\u6846\u67b6<\/a>\u7531\u4e8e\u76d1\u7ba1\u8981\u6c42\u5bf9\u9884\u9632\u6027\u63aa\u65bd\u8fdb\u884c\u8bb0\u5f55\uff0c\u5236\u836f\u4f01\u4e1a\u901a\u5e38\u4f1a\u6267\u884c\u66f4\u9891\u7e41\u7684\u7ef4\u62a4\u8ba1\u5212\uff08\u4e09\u7ea7\u6708\u5ea6\u4efb\u52a1\u6bcf 3 \u5468\u6267\u884c\u4e00\u6b21\uff0c\u56db\u7ea7\u5b63\u5ea6\u4efb\u52a1\u6bcf 10 \u5468\u6267\u884c\u4e00\u6b21\uff09\u3002<\/p>\n

    <\/p>\n

    6. K-GMP \/ FDA \/ EMA \u76d1\u7ba1\u6846\u67b6<\/h2>\n

    \u97e9\u56fd\u836f\u54c1\u5305\u88c5\u4f9b\u5e94\u5546\u53d7\u591a\u79cd\u91cd\u53e0\u7684\u76d1\u7ba1\u6846\u67b6\u7ea6\u675f\u3002\u97e9\u56fd\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303 (K-GMP) \u89c4\u8303\u97e9\u56fd\u56fd\u5185\u836f\u54c1\u751f\u4ea7\uff1b\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) 21 CFR \u7b2c 11 \u90e8\u5206\u89c4\u8303\u7f8e\u56fd\u51fa\u53e3\uff1b\u6b27\u76df\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u9644\u4ef6 11 \u89c4\u8303\u6b27\u6d32\u51fa\u53e3\uff1b\u65e5\u672c (PMDA) \u548c\u4e2d\u56fd (NMPA) \u4e5f\u5206\u522b\u6709\u76f8\u5e94\u7684\u76d1\u7ba1\u6846\u67b6\u3002\u5bf9\u4e8e\u670d\u52a1\u4e8e\u51fa\u53e3\u5e02\u573a\u7684\u97e9\u56fd\u56fd\u9645\u6807\u51c6\u836f\u54c1\u5305\u88c5 (ISBM) \u751f\u4ea7\u5546\u800c\u8a00\uff0c\u9075\u5b88\u591a\u53f8\u6cd5\u7ba1\u8f96\u533a\u7684\u6cd5\u89c4\u662f\u5f3a\u5236\u6027\u7684\uff0c\u800c\u975e\u53ef\u9009\u9879\u3002<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n
    \u76d1\u7ba1\u6846\u67b6<\/th>\n\u6743\u5a01<\/th>\n\u5173\u952e\u9700\u6c42<\/th>\n<\/tr>\n<\/thead>\n
    K-GMP<\/td>\n\u97e9\u56fdMFDS<\/td>\n\u6309\u4ea7\u54c1\u6309\u5de5\u5382\u8ba4\u8bc1<\/td>\n<\/tr>\n
    FDA 21 CFR \u7b2c 11 \u90e8\u5206<\/td>\n\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40<\/td>\n\u7535\u5b50\u8bb0\u5f55\u9a8c\u8bc1<\/td>\n<\/tr>\n
    \u6b27\u76dfGMP\u9644\u4ef611<\/td>\n\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40<\/td>\n\u8ba1\u7b97\u673a\u7cfb\u7edf<\/td>\n<\/tr>\n
    DSCSA<\/td>\n\u7f8e\u56fd\uff08\u836f\u54c1\u4f9b\u5e94\u94fe\u5b89\u5168\u6cd5\uff09<\/td>\n\u5e8f\u5217\u5316\u5230\u5355\u5143\u7ea7\u522b<\/td>\n<\/tr>\n
    \u6b27\u76df\u9632\u536b\u6307\u4ee4<\/td>\n\u6b27\u76df\uff08\u5047\u836f\u6307\u4ee4\uff09<\/td>\n\u4e8c\u7ef4\u6761\u5f62\u7801 + \u9632\u7be1\u6539<\/td>\n<\/tr>\n
    ISO 15378<\/td>\n\u56fd\u9645\u7684<\/td>\n\u521d\u7ea7\u5305\u88c5\u7b26\u5408GMP\u89c4\u8303<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \u97e9\u56fd\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8\uff08MFDS\uff09\u5bf9\u5916\u56fd\u836f\u54c1\u7684\u5ba1\u6279\u6d41\u7a0b\u8981\u6c42\u6307\u5b9a\u4e00\u540d\u672c\u5730\u4ee3\u8868\uff08ICC\uff09\uff0c\u8d1f\u8d23\u4ea7\u54c1\u6ce8\u518c\u548c\u6301\u7eed\u5408\u89c4\u4e8b\u5b9c\u3002MFDS\u63a5\u53d7\u901a\u7528\u6280\u672f\u6587\u4ef6\uff08CTD\uff09\u683c\u5f0f\u7684\u7533\u8bf7\u6587\u4ef6\uff0c\u4f46\u90e8\u5206\u7ae0\u8282\u9700\u8981\u97e9\u8bed\u7ffb\u8bd1\u3002\u5305\u62ecGIFT\uff08\u5168\u7403\u521b\u65b0\u4ea7\u54c1\u5feb\u901f\u901a\u9053\uff09\u8ba1\u5212\u5728\u5185\u7684\u5feb\u901f\u5ba1\u6279\u9014\u5f84\uff0c\u53ef\u52a0\u5feb\u5b64\u513f\u836f\u548c\u5371\u53ca\u751f\u547d\u75be\u75c5\u6cbb\u7597\u836f\u7269\u7684\u5ba1\u6279\u901f\u5ea6\u3002\u5bf9\u4e8e\u836f\u54c1\u5305\u88c5\u4f9b\u5e94\u5546\uff0cK-GMP\u8ba4\u8bc1\u6309\u4ea7\u54c1\u548c\u5de5\u5382\u8fdb\u884c\uff0c\u56e0\u6b64\u591a\u4ea7\u54c1\u8fd0\u8425\u9700\u8981\u5b8c\u5584\u7684\u6587\u6863\u4f53\u7cfb\u3002<\/p>\n

    \u9664\u4e86\u836f\u5178\u548cGMP\u6846\u67b6\u4e4b\u5916\uff0cISO 15378\u4e13\u95e8\u9488\u5bf9\u836f\u54c1\u521d\u7ea7\u5305\u88c5\u7684\u751f\u4ea7\u3002ISO 15378\u5c06GMP\u539f\u5219\u878d\u5165\u521d\u7ea7\u5305\u88c5\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u63d0\u4f9b\u56fd\u9645\u8ba4\u53ef\u7684\u8ba4\u8bc1\u6846\u67b6\u3002\u83b7\u5f97ISO 15378\u8ba4\u8bc1\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\u901a\u5e38\u80fd\u591f\u83b7\u5f97\u66f4\u9ad8\u7684\u5b9a\u4ef7\uff0c\u5e76\u4e0e\u62d3\u5c55\u5168\u7403\u5e02\u573a\u7684\u97e9\u56fd\u5236\u836f\u4f01\u4e1a\u5efa\u7acb\u957f\u671f\u7a33\u5b9a\u7684\u5ba2\u6237\u5173\u7cfb\u3002ISO 15378\u4e0eISO 9001\uff08\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff09\u548cISO 14001\uff08\u73af\u5883\u7ba1\u7406\u4f53\u7cfb\uff09\u5171\u540c\u6784\u6210\u4e86\u97e9\u56fd\u5177\u5907\u5236\u836f\u80fd\u529b\u7684ISBM\u751f\u4ea7\u5546\u7684\u6807\u51c6\u8ba4\u8bc1\u4e09\u90e8\u66f2\u3002<\/p>\n

    <\/p>\n

    7. \u706d\u83cc\u517c\u5bb9\u6027<\/h2>\n
    \"\u97e9\u56fd\u836f\u54c1\u5305\u88c5\u8ba4\u8bc1\uff0c\u5305\u62ec
    <\/figcaption><\/figure>\n

    \u836f\u54c1\u5305\u88c5\u5fc5\u987b\u80fd\u591f\u627f\u53d7\u4e0e\u5176\u5185\u5bb9\u7269\u548c\u6700\u7ec8\u7528\u9014\u76f8\u9002\u5e94\u7684\u706d\u83cc\u5de5\u827a\u3002\u76ee\u524d\uff0c\u836f\u54c1\u5305\u88c5\u5e94\u7528\u4e3b\u8981\u91c7\u7528\u4e09\u79cd\u4e3b\u8981\u7684\u706d\u83cc\u65b9\u6cd5\uff0c\u6bcf\u79cd\u65b9\u6cd5\u5bf9\u6750\u6599\u7684\u76f8\u5bb9\u6027\u8981\u6c42\u5404\u4e0d\u76f8\u540c\u3002<\/p>\n

    \n\n\n\n\n\n\n\n\n\n
    \u706d\u83cc\u65b9\u6cd5<\/th>\n\u72b6\u51b5<\/th>\n\u517c\u5bb9\u6750\u6599<\/th>\n<\/tr>\n<\/thead>\n
    \u84b8\u6c7d\u9ad8\u538b\u91dc<\/td>\n121\u00b0C\uff0c15\u5206\u949f<\/td>\nPP\u3001PPSU\u3001\u73bb\u7483<\/td>\n<\/tr>\n
    \u73af\u6c27\u4e59\u70f7\uff08EtO\uff09<\/td>\n38-55\u00b0C\uff0c\u6c14\u4f53\u66b4\u9732<\/td>\nPE\u3001PET\u3001PETG\u3001PP\u3001Tritan<\/td>\n<\/tr>\n
    \u4f3d\u9a6c\u5c04\u7ebf\u7167\u5c04<\/td>\n25-50 kGy\u5242\u91cf<\/td>\nPE\u3001PET\u3001PETG\uff08\u542b\u7a33\u5b9a\u5242\uff09<\/td>\n<\/tr>\n
    \u8fc7\u6c27\u5316\u6c22\uff08VHP\uff09<\/td>\n25-40\u00b0C\uff0c\u84b8\u6c7d<\/td>\n\u5927\u591a\u6570\u5851\u6599<\/td>\n<\/tr>\n
    \u65e0\u83cc\u704c\u88c5<\/td>\n\u74f6\u5b50\u5df2\u9884\u5148\u6d88\u6bd2<\/td>\n\u6240\u6709\u533b\u836f\u6750\u6599<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \u5bf9\u4e8e\u9700\u8981\u8fdb\u884c\u9ad8\u6e29\u9ad8\u538b\u706d\u83cc\uff08104\u00b0C\u4ee5\u4e0a\uff09\u7684\u97e9\u56fd\u5a74\u5e7c\u513f\u914d\u65b9\u5976\u7c89\u751f\u4ea7\u5546\u800c\u8a00\uff0cPP\u805a\u4e19\u70ef\u662f\u6807\u51c6\u6750\u6599\u4e4b\u9009\u3002PET\u65e0\u6cd5\u627f\u53d7\u9ad8\u6e29\u9ad8\u538b\u706d\u83cc\uff0c\u800cTritan\u5728109\u00b0C\u65f6\u5c31\u5f00\u59cb\u63a5\u8fd1\u5176\u5de5\u4f5c\u6e29\u5ea6\u4e0a\u9650\u3002PPSU\u5177\u6709\u66f4\u4f18\u5f02\u7684\u8010\u9ad8\u6e29\u706d\u83cc\u6027\u80fd\uff0c\u53ef\u8010\u53d7180\u00b0C\u4ee5\u4e0a\u7684\u9ad8\u6e29\uff0c\u4f46\u6210\u672c\u8f83\u9ad8\uff0c\u4ec5\u9002\u7528\u4e8e\u9ad8\u7aef\u533b\u7597\u5e94\u7528\u3002\u6709\u5173\u6b64\u7c7b\u522b\u7684\u5168\u9762\u6750\u6599\u9009\u62e9\uff0c\u8bf7\u53c2\u9605 PP \u4e0e PET \u5bf9\u6bd4\u6307\u5357<\/a>.<\/p>\n

    \u4f3d\u9a6c\u5c04\u7ebf\u8f90\u7167\u9700\u8981\u4f7f\u7528\u7279\u5b9a\u7b49\u7ea7\u7684\u6750\u6599\uff0c\u8fd9\u4e9b\u6750\u6599\u4e2d\u6dfb\u52a0\u4e86\u7a33\u5b9a\u5242\uff0c\u4ee5\u9632\u6b62\u805a\u5408\u7269\u5728\u7535\u79bb\u8f90\u5c04\u7167\u5c04\u4e0b\u53d1\u751f\u964d\u89e3\u3002\u6807\u51c6PET\u5728\u5178\u578b\u7684\u836f\u7528\u4f3d\u9a6c\u5c04\u7ebf\u5242\u91cf\uff0825-50 kGy\uff09\u4e0b\u4f1a\u53d1\u751f\u5206\u5b50\u91cf\u964d\u4f4e\u548c\u989c\u8272\u53d8\u5316\uff1b\u800c\u7ecf\u4f3d\u9a6c\u5c04\u7ebf\u7a33\u5b9a\u5904\u7406\u7684PET\u6750\u6599\u5219\u80fd\u627f\u53d7\u8fd9\u4e9b\u6761\u4ef6\uff0c\u540c\u65f6\u4fdd\u6301\u5176\u673a\u68b0\u6027\u80fd\u548c\u963b\u9694\u6027\u80fd\u3002\u4e3a\u4f3d\u9a6c\u5c04\u7ebf\u706d\u83cc\u5e94\u7528\u63d0\u4f9b\u4ea7\u54c1\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\u5fc5\u987b\u91c7\u8d2d\u4e13\u95e8\u7684\u7a33\u5b9a\u5316\u6811\u8102\uff0c\u5e76\u5728\u76d1\u7ba1\u6587\u4ef6\u4e2d\u8bb0\u5f55\u5176\u7a33\u5b9a\u5242\u4f53\u7cfb\u3002<\/p>\n

    <\/p>\n

    8. \u9009\u62e9\u97e9\u56fd\u5236\u836fISBM\u5408\u4f5c\u4f19\u4f34<\/h2>\n

    \u97e9\u56fd\u5236\u836f\u54c1\u724c\u5728\u9009\u62e9ISBM\u5408\u4f5c\u4f19\u4f34\u65f6\uff0c\u66f4\u6ce8\u91cd\u5408\u89c4\u6027\u548c\u8fd0\u8425\u89c4\u8303\uff0c\u800c\u975e\u8d44\u672c\u6210\u672c\u4f18\u5316\u3002\u97e9\u56fd\u5236\u836f\u54c1\u724c\u901a\u5e38\u4f1a\u6839\u636e\u4e03\u9879\u6807\u51c6\u8bc4\u4f30\u4f9b\u5e94\u5546\uff0c\u8fd9\u4f53\u73b0\u4e86\u5408\u89c4\u4f18\u5148\u7684\u91c7\u8d2d\u7406\u5ff5\u3002<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n\n
    \u8bc4\u4ef7\u6807\u51c6<\/th>\n\u5173\u952e\u6307\u6807<\/th>\n<\/tr>\n<\/thead>\n
    1. \u8d28\u91cf\u8ba4\u8bc1\u5957\u4ef6<\/td>\nISO 15378 + ISO 9001 + K-GMP<\/td>\n<\/tr>\n
    2. \u6750\u6599\u8d44\u8d28<\/td>\nUSP VI\u7ea7\u836f\u6750\u5e93\u5b58\u5145\u8db3<\/td>\n<\/tr>\n
    3. \u591a\u53f8\u6cd5\u7ba1\u8f96\u533a\u5408\u89c4\u6027<\/td>\n\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u3001\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u3001\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8\uff08MFDS\uff09\u548c\u65e5\u672c\u836f\u54c1\u7ba1\u7406\u5c40\uff08JP\uff09\u3002<\/td>\n<\/tr>\n
    4. \u6587\u6863\u57fa\u7840\u8bbe\u65bd<\/td>\nDMF + DoC + CoA \u80fd\u529b<\/td>\n<\/tr>\n
    5. \u706d\u83cc\u517c\u5bb9\u6027<\/td>\n\u591a\u65b9\u6cd5\u9a8c\u8bc1<\/td>\n<\/tr>\n
    6. \u5e8f\u5217\u5316\u652f\u6301<\/td>\nDSCSA + \u6b27\u76df FMD \u51c6\u5907\u5c31\u7eea<\/td>\n<\/tr>\n
    7. \u5ba1\u8ba1\u80fd\u529b<\/td>\n\u5ba2\u6237\u5ba1\u8ba1\u8ba1\u5212<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \u6587\u6863\u57fa\u7840\u8bbe\u65bd\u662f\u4f9b\u5e94\u5546\u80fd\u529b\u4e2d\u6700\u5bb9\u6613\u88ab\u4f4e\u4f30\u7684\u65b9\u9762\uff0c\u56e0\u6b64\u503c\u5f97\u7279\u522b\u5173\u6ce8\u3002\u836f\u54c1\u5305\u88c5\u9879\u76ee\u9700\u8981\u5168\u9762\u7684\u6587\u6863\uff0c\u5305\u62ec\u7269\u6599\u7684\u836f\u54c1\u4e3b\u6587\u4ef6 (DMF)\u3001\u7b26\u5408\u6027\u58f0\u660e (DoC)\u3001\u6bcf\u6279\u6b21\u7684\u5206\u6790\u8bc1\u4e66 (CoA) \u4ee5\u53ca\u4efb\u4f55\u53d8\u66f4\u7684\u7279\u5b9a\u53d8\u66f4\u63a7\u5236\u7a0b\u5e8f\u3002\u97e9\u56fd\u7684ISBM\u751f\u4ea7\u5546\uff0c\u5373\u4f7f\u5177\u5907\u5b9e\u9645\u751f\u4ea7\u80fd\u529b\uff0c\u5982\u679c\u6ca1\u6709\u5b8c\u5584\u7684\u6587\u6863\u57fa\u7840\u8bbe\u65bd\uff0c\u901a\u5e38\u4e5f\u65e0\u6cd5\u901a\u8fc7\u5236\u836f\u5ba2\u6237\u7684\u5ba1\u6838\u3002\u6587\u6863\u7cfb\u7edf\u9700\u89816-12\u4e2a\u6708\u7684\u5f00\u53d1\u65f6\u95f4\uff0c\u624d\u80fd\u4f7f\u5236\u836f\u4f01\u4e1a\u5177\u5907\u76f8\u5e94\u7684\u751f\u4ea7\u80fd\u529b\u3002<\/p>\n

    \u5ba2\u6237\u5ba1\u6838\u80fd\u529b\u662f\u533a\u5206\u7ecf\u9a8c\u4e30\u5bcc\u7684\u5236\u836f\u4f9b\u5e94\u5546\u548c\u5bf9\u5236\u836f\u884c\u4e1a\u611f\u5174\u8da3\u7684\u4f9b\u5e94\u5546\u7684\u5173\u952e\u3002\u6210\u719f\u7684\u5236\u836f\u5305\u88c5\u4f9b\u5e94\u5546\u62e5\u6709\u4e13\u95e8\u7684\u5ba1\u6838\u54cd\u5e94\u673a\u5236\uff0c\u5236\u5b9a\u6b63\u5f0f\u7684\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b (SOP)\uff0c\u5e76\u6bcf\u5e74\u5e94\u5bf9 2-4 \u6b21\u5ba2\u6237\u5ba1\u6838\u3002\u800c\u65b0\u6210\u7acb\u7684\u5236\u836f\u4f9b\u5e94\u5546\u901a\u5e38\u9700\u8981 18-24 \u4e2a\u6708\u7684\u5ba1\u6838\u51c6\u5907\u6295\u5165\uff0c\u624d\u80fd\u81ea\u4fe1\u5730\u652f\u6301\u4e0e\u5927\u578b\u5236\u836f\u5ba2\u6237\u7684\u5408\u4f5c\u5173\u7cfb\u3002\u5bf9\u4e8e\u6b63\u5728\u6784\u5efa\u5236\u836f\u80fd\u529b\u7684\u97e9\u56fd ISBM \u751f\u4ea7\u5546\u800c\u8a00\uff0c\u5ba1\u6838\u51c6\u5907\u5de5\u4f5c\u5e94\u5728\u9996\u6b21\u4e0e\u5ba2\u6237\u63a5\u6d3d\u524d\u89c4\u5212\u4e3a\u4e00\u4e2a\u4e3a\u671f 12 \u4e2a\u6708\u7684\u51c6\u5907\u9879\u76ee\u3002\u6709\u5173\u4e94\u677e\u3001\u5927\u7530\u548c\u5fe0\u5dde\u751f\u4ea7\u57fa\u5730\u7684\u97e9\u56fd\u5236\u836f GMP \u74f6\u751f\u4ea7\u89c4\u8303\u7684\u8be6\u7ec6\u4fe1\u606f\uff0c\u8bf7\u53c2\u9605[\u6b64\u5904]\u3002 \u836f\u54c1GMP\u74f6\u751f\u4ea7\u6307\u5357<\/a>.<\/p>\n

    <\/p>\n

    9. \u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/h2>\n
    \n
    \n

    \u95ee\uff1a\u98df\u54c1\u63a5\u89e6\u7ea7\u6750\u6599\u548c\u533b\u836f\u7ea7\u6750\u6599\u6709\u4ec0\u4e48\u533a\u522b\uff1f<\/p>\n

    \u98df\u54c1\u63a5\u89e6\u6750\u6599\u5fc5\u987b\u8bc1\u660e\u5728\u6b63\u5e38\u5904\u7406\u548c\u98df\u7528\u8fc7\u7a0b\u4e2d\u4e0e\u98df\u54c1\u610f\u5916\u63a5\u89e6\u65f6\u65e0\u6bd2\u3002\u533b\u836f\u7ea7\u6750\u6599\u8fd8\u5fc5\u987b\u8bc1\u660e\u5176\u5177\u6709\u751f\u7269\u76f8\u5bb9\u6027\uff0c\u80fd\u591f\u957f\u671f\u63a5\u89e6\uff08\u53ef\u80fd\u5b58\u653e\u6570\u5e74\uff09\uff0c\u4e0d\u4f1a\u53d1\u751f\u5316\u5b66\u7269\u8d28\u8fc1\u79fb\u5230\u4ea7\u54c1\u4e2d\uff08\u53ef\u8403\u53d6\u7269\/\u53ef\u6d78\u51fa\u7269\uff09\uff0c\u9897\u7c92\u7269\u63a7\u5236\u826f\u597d\uff0c\u5e76\u5177\u5907\u5b8c\u6574\u7684\u6279\u6b21\u53ef\u8ffd\u6eaf\u6027\u4ee5\u53ca\u7b26\u5408GMP\u89c4\u8303\u7684\u6587\u4ef6\u3002\u533b\u836f\u7ea7\u6750\u6599\u7684\u8ba4\u8bc1\u901a\u5e38\u9700\u898112-24\u4e2a\u6708\u7684\u6d4b\u8bd5\u548c\u6587\u4ef6\u7f16\u5236\uff0c\u800c\u98df\u54c1\u63a5\u89e6\u7ea7\u6750\u6599\u7684\u8ba4\u8bc1\u4ec5\u97003-6\u4e2a\u6708\u3002\u533b\u836f\u7ea7\u6750\u6599\u7684\u4ef7\u683c\u901a\u5e38\u6bd4\u666e\u901a\u6750\u6599\u9ad8\u51fa20-50%\u3002<\/p>\n<\/div>\n

    \n

    \u95ee\uff1a\u5e8f\u5217\u5316\u5982\u4f55\u5f71\u54cdISBM\u74f6\u7684\u751f\u4ea7\uff1f<\/p>\n

    \u5e8f\u5217\u5316\u901a\u5e38\u5e94\u7528\u4e8e\u704c\u88c5\/\u8d34\u6807\u9636\u6bb5\uff0c\u800c\u975e\u74f6\u5b50\u751f\u4ea7\u9636\u6bb5\u3002ISBM\uff08\u74f6\u88c5\u72ec\u7acb\u5305\u88c5\uff09\u751f\u4ea7\u5546\u5fc5\u987b\u901a\u8fc7\u786e\u4fdd\u74f6\u5b50\u5c3a\u5bf8\u7684\u4e00\u81f4\u6027\u6765\u652f\u6301\u4e0b\u6e38\u5e8f\u5217\u5316\uff0c\u4ece\u800c\u5b9e\u73b0\u53ef\u9760\u7684\u6807\u7b7e\u7c98\u8d34\u548c\u5370\u5237\u3002\u5177\u4f53\u7684\u8bbe\u8ba1\u63aa\u65bd\u5305\u62ec\uff1a\u91c7\u7528\u66f2\u7387\u53ef\u63a7\u7684\u5e73\u9762\u6807\u7b7e\u9762\u677f\u4ee5\u4fdd\u8bc1\u53ef\u5370\u5237\u8868\u9762\u7684\u5e73\u6574\u5ea6\uff1b\u74f6\u9888\u5c3a\u5bf8\u7cbe\u5ea6\u9700\u7b26\u5408\u8981\u6c42\uff0c\u4ee5\u652f\u6301\u74f6\u76d6\u548c\u5bc6\u5c01\u4f20\u611f\u5668\uff1b\u4ee5\u53ca\u5177\u5907\u5168\u74f6\u68c0\u6d4b\u80fd\u529b\uff0c\u80fd\u591f\u8bc6\u522b\u53ef\u80fd\u5e72\u6270\u4e0b\u6e38\u5e8f\u5217\u5316\u8bbe\u5907\u7684\u5c3a\u5bf8\u5f02\u5e38\u3002\u4e0d\u7b26\u5408\u5c3a\u5bf8\u89c4\u683c\u7684\u74f6\u5b50\u4f1a\u5bfc\u81f4\u4e0b\u6e38\u5e8f\u5217\u5316\u8bbe\u5907\u5835\u585e\uff0c\u4ece\u800c\u5bf9\u704c\u88c5\u7ebf\u9020\u6210\u5de8\u5927\u7684\u6210\u672c\u5f71\u54cd\u3002<\/p>\n<\/div>\n

    \n

    \u95ee\uff1a\u540c\u4e00\u4e2aISBM\u5e73\u53f0\u80fd\u5426\u751f\u4ea7\u836f\u54c1\u548c\u975e\u836f\u54c1\uff1f<\/p>\n

    \u4ece\u6280\u672f\u4e0a\u8bb2\uff0c\u901a\u8fc7\u4e25\u683c\u7684\u5207\u6362\u6d41\u7a0b\u662f\u53ef\u884c\u7684\uff0c\u4f46\u901a\u5e38\u4e0d\u5efa\u8bae\u6210\u719f\u7684\u5236\u836f\u4f01\u4e1a\u91c7\u7528\u8fd9\u79cd\u65b9\u5f0f\u3002\u97e9\u56fd\u5236\u836f\u4f01\u4e1a\u901a\u5e38\u4f1a\u5c06\u7279\u5b9a\u7684ISBM\u5e73\u53f0\u4e13\u95e8\u7528\u4e8e\u836f\u54c1\u751f\u4ea7\uff0c\u4ee5\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\u98ce\u9669\u5e76\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u76d1\u7ba1\u6587\u4ef6\u7684\u590d\u6742\u6027\u3002\u89c4\u6a21\u8f83\u5c0f\u7684\u751f\u4ea7\u5546\u5982\u679c\u5c1d\u8bd5\u5171\u4eab\u5e73\u53f0\uff0c\u5219\u5fc5\u987b\u5b9e\u65bd\u5168\u9762\u7684\u6e05\u6d01\u9a8c\u8bc1\u3001\u53c2\u6570\u5e93\u9694\u79bb\u548c\u4e25\u683c\u7684\u7269\u6599\u5904\u7406\u89c4\u8303\u3002\u5171\u4eab\u5e73\u53f0\u4e0a\u7684\u4ea4\u53c9\u6c61\u67d3\u4e8b\u4ef6\u53ef\u80fd\u5bfc\u81f4\u76d1\u7ba1\u673a\u6784\u91c7\u53d6\u5305\u62ec\u6682\u505c\u751f\u4ea7\u5728\u5185\u7684\u63aa\u65bd\uff0c\u56e0\u6b64\u5e73\u53f0\u4e13\u7528\u662f\u4e00\u79cd\u66f4\u4e3a\u7a33\u59a5\u7684\u8fd0\u8425\u9009\u62e9\u3002<\/p>\n<\/div>\n

    \n

    \u95ee\uff1aK-GMP\u8ba4\u8bc1\u7684\u5178\u578b\u65f6\u95f4\u8868\u662f\u4ec0\u4e48\uff1f<\/p>\n

    \u97e9\u56fd\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303 (K-GMP) \u8ba4\u8bc1\u6309\u4ea7\u54c1\u548c\u8bbe\u65bd\u8fdb\u884c\uff0c\u521d\u59cb\u8ba4\u8bc1\u901a\u5e38\u9700\u8981\u4ece\u9879\u76ee\u542f\u52a8\u5230\u5b8c\u6210\u7684 12-18 \u4e2a\u6708\u3002\u8ba4\u8bc1\u6d41\u7a0b\u5305\u62ec\u8bbe\u65bd\u8bc4\u4f30\u3001\u6587\u4ef6\u4f53\u7cfb\u5f00\u53d1\u3001\u9a8c\u8bc1\u65b9\u6848\u6267\u884c\u3001\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8 (MFDS\u200b\u200b) \u73b0\u573a\u68c0\u67e5\u4ee5\u53ca\u68c0\u67e5\u540e\u6574\u6539\u3002\u8ba4\u8bc1\u5468\u671f\u901a\u5e38\u4e3a 3 \u5e74\uff0c\u4e24\u6b21\u8ba4\u8bc1\u4e4b\u95f4\u4f1a\u8fdb\u884c\u5b9a\u671f\u76d1\u7763\u5ba1\u6838\u3002\u5bf9\u4e8e\u4ece\u57fa\u7840\u98df\u54c1\u63a5\u89e6\u751f\u4ea7\u8d77\u6b65\uff0c\u9010\u6b65\u6784\u5efa\u5236\u836f\u80fd\u529b\u7684\u97e9\u56fd\u539f\u7814\u836f\u751f\u4ea7\u5546\u800c\u8a00\uff0c\u8981\u5efa\u7acb\u8d77\u5b8c\u6574\u7684\u591a\u4ea7\u54c1 K-GMP \u80fd\u529b\uff0c\u901a\u5e38\u9700\u8981 24-36 \u4e2a\u6708\u7684\u603b\u6295\u8d44\u5468\u671f\uff0c\u624d\u80fd\u6700\u7ec8\u5b9e\u73b0\u7ecf\u6d4e\u53ef\u884c\u7684\u5236\u836f\u8fd0\u8425\u3002<\/p>\n<\/div>\n

    \n

    \u95ee\uff1a\u4e0d\u542b\u53cc\u915aA\u7684\u5a74\u513f\u5976\u74f6\u8981\u6c42\u4e0e\u836f\u54c1\u5305\u88c5\u5408\u89c4\u6027\u4e4b\u95f4\u6709\u4f55\u5173\u8054\uff1f<\/p>\n

    \u4e0d\u542b\u53cc\u915aA\uff08BPA\uff09\u7684\u5a74\u513f\u5976\u74f6\u8981\u6c42\uff08\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8\u3001\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u3001\u6b27\u6d32\u98df\u54c1\u5b89\u5168\u5c40\u7b49\uff09\u4e0e\u6807\u51c6\u836f\u54c1\u5305\u88c5\u5408\u89c4\u6027\u6709\u91cd\u53e0\u4e4b\u5904\uff0c\u4f46\u53c8\u6709\u6240\u6269\u5c55\u3002\u836f\u54c1\u5408\u89c4\u6027\u4fa7\u91cd\u4e8e\u6210\u4eba\u60a3\u8005\u7684\u751f\u7269\u76f8\u5bb9\u6027\uff0c\u800c\u5a74\u513f\u5976\u74f6\u5408\u89c4\u6027\u5219\u4e13\u95e8\u9488\u5bf9\u5a74\u513f\u7684\u53d1\u80b2\u548c\u6fc0\u7d20\u5f71\u54cd\u3002\u7b26\u5408\u836f\u54c1\u5305\u88c5\u8981\u6c42\u7684\u6750\u6599\u53ef\u80fd\u672a\u7ecf\u989d\u5916\u7684\u5a74\u513f\u4e13\u7528\u6d4b\u8bd5\uff0c\u56e0\u6b64\u4e0d\u4e00\u5b9a\u9002\u7528\u4e8e\u5a74\u513f\u5976\u74f6\u3002Tritan\u3001PP \u548c PPSU \u662f\u7b26\u5408\u836f\u54c1\u548c\u5a74\u513f\u4e13\u7528\u8981\u6c42\u7684\u4e09\u79cd\u6807\u51c6\u5a74\u513f\u5976\u74f6\u6750\u6599\u3002\u6709\u5173\u5a74\u513f\u5976\u74f6\u6750\u6599\u7684\u5168\u9762\u9009\u62e9\uff0c\u8bf7\u53c2\u9605\u2026\u2026 Tritan \u4e0e PC \u5a74\u513f\u5976\u74f6\u5bf9\u6bd4\u6307\u5357<\/a>.<\/p>\n<\/div>\n<\/div>\n

    <\/p>\n

    10. \u7ed3\u8bba<\/h2>\n

    \u97e9\u56fd\u5236\u836f\u539f\u6599\u836f\u7684\u751f\u4ea7\u9075\u5faa\u5408\u89c4\u4f18\u5148\u7684\u91c7\u8d2d\u903b\u8f91\uff0c\u8fd9\u4f7f\u5176\u4e0e\u996e\u6599\u548c\u5316\u5986\u54c1\u5e94\u7528\u9886\u57df\u6709\u7740\u672c\u8d28\u533a\u522b\u3002\u5e02\u573a\u589e\u957f\u8f68\u8ff9\uff08\u52302033\u5e74\uff0c\u5e02\u573a\u89c4\u6a21\u5c06\u4ece10\u4ebf\u81f330\u4ebf\uff0c\u5e74\u590d\u5408\u589e\u957f\u7387\u8fbe7.41\u4ebf\u81f33\u4e07\u4ebf\u7f8e\u5143\uff09\u4e3a\u613f\u610f\u6295\u8d44\u76d1\u7ba1\u57fa\u7840\u8bbe\u65bd\u7684\u97e9\u56fd\u539f\u6599\u836f\u751f\u4ea7\u5546\u521b\u9020\u4e86\u5de8\u5927\u7684\u673a\u9047\uff0c\u8fd9\u4e9b\u57fa\u7840\u8bbe\u65bd\u5305\u62ec\uff1aK-GMP\u8ba4\u8bc1\u3001ISO 15378\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\u3001USP VI\u7ea7\u539f\u6599\u836f\u8d44\u8d28\u8ba4\u8bc1\u4ee5\u53ca\u9762\u5411\u97e9\u56fd\u5236\u836f\u51fa\u53e3\u5e02\u573a\u7684\u591a\u53f8\u6cd5\u7ba1\u8f96\u533a\u5408\u89c4\u652f\u6301\u3002<\/p>\n

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    \"\u6ce8\u5851\u62c9\u4f38\u5439\u5851\u6210\u578b\u5e94\u7528-6\"<\/p>\n

    <\/p>\n

    \n

    \u51c6\u5907\u597d\u89c4\u5212\u836f\u54c1\u751f\u4ea7\u4e86\u5417\uff1f<\/h3>\n

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    \u8ba8\u8bba\u5236\u836f\u9879\u76ee \u2192<\/a><\/p>\n<\/div>\n

    <\/p>\n

    \u7f16\u8f91\uff1aCxm<\/p>\n<\/article>","protected":false},"excerpt":{"rendered":"

    INDUSTRY VERTICAL GUIDE Korean Pharmaceutical ISBM Production: Complete 2026 Industry Guide South Korea’s pharmaceutical packaging market is projected to grow from $1.5 billion to $3.0 billion by 2033 at 7.4% CAGR, driven by aging population and chronic disease prevalence. Pharmaceutical ISBM production differs fundamentally from beverage and cosmetic applications through its compliance-first procurement logic. This […]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[26],"tags":[],"class_list":["post-697","post","type-post","status-publish","format-standard","hentry","category-application-of-isbm"],"_links":{"self":[{"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/posts\/697","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/comments?post=697"}],"version-history":[{"count":2,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/posts\/697\/revisions"}],"predecessor-version":[{"id":699,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/posts\/697\/revisions\/699"}],"wp:attachment":[{"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/media?parent=697"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/categories?post=697"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/tags?post=697"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}