{"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\/ko\/korean-pharmaceutical-isbm-production-complete-industry-guide\/","title":{"rendered":"\ud55c\uad6d \uc81c\uc57d ISBM \uc0dd\uc0b0: \uc0b0\uc5c5 \uc804\ubc18\uc5d0 \uac78\uce5c \uc885\ud569 \uac00\uc774\ub4dc"},"content":{"rendered":"
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\n

\uc0b0\uc5c5\ubcc4 \uc218\uc9c1 \uac00\uc774\ub4dc<\/p>\n

\ud55c\uad6d \uc81c\uc57d ISBM \uc0dd\uc0b0: 2026\ub144 \uc0b0\uc5c5 \uc885\ud569 \uac00\uc774\ub4dc<\/h1>\n

\ud55c\uad6d\uc758 \uc758\uc57d\ud488 \ud3ec\uc7a5 \uc2dc\uc7a5\uc740 \uace0\ub839\ud654\uc640 \ub9cc\uc131 \uc9c8\ud658 \uc720\ubcd1\ub960 \uc99d\uac00\uc5d0 \ud798\uc785\uc5b4 2033\ub144\uae4c\uc9c0 \uc5f0\ud3c9\uade0 74\uc5b5 1\ucc9c\ub9cc \ub2ec\ub7ec\uc5d0\uc11c 30\uc5b5 \ub2ec\ub7ec\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc758\uc57d\ud488 ISBM(\ud1b5\ud569 \ud3ec\uc7a5 \ubcd1) \uc0dd\uc0b0\uc740 \uaddc\uc815 \uc900\uc218\ub97c \ucd5c\uc6b0\uc120\uc73c\ub85c \ud558\ub294 \uc870\ub2ec \ub17c\ub9ac\ub97c \ud2b9\uc9d5\uc73c\ub85c \ud55c\ub2e4\ub294 \uc810\uc5d0\uc11c \uc74c\ub8cc \ubc0f \ud654\uc7a5\ud488 \ubd84\uc57c\uc640 \uadfc\ubcf8\uc801\uc73c\ub85c \ub2e4\ub985\ub2c8\ub2e4. \ubcf8 \uac00\uc774\ub4dc\ub294 7\uac00\uc9c0 \uc758\uc57d\ud488 \ubcd1 \uc720\ud615\uc5d0 \uac78\uce5c \uc644\ubcbd\ud55c \uc0dd\uc0b0 \ud504\ub808\uc784\uc6cc\ud06c, USP Class VI \uc7ac\uc9c8 \uc694\uac74, K-GMP \uaddc\uc815 \uc900\uc218 \ubc0f \uba78\uade0 \ud638\ud658\uc131\uc5d0 \ub300\ud574 \uc124\uba85\ud569\ub2c8\ub2e4.<\/p>\n

\uc81c\uc57d \uc0dd\uc0b0\uc5d0 \ub300\ud574 \ud1a0\ub860\ud574 \ubcf4\uc138\uc694 \u2192<\/a><\/p>\n<\/div>\n<\/section>\n

<\/p>\n
\n

\uc694\uc57d \u2014 \ube60\ub978 \uc694\uc57d<\/p>\n

\ud55c\uad6d\uc758 ISBM(\ud1b5\ud569 \uc758\uc57d\ud488 \ud3ec\uc7a5) \uc0dd\uc0b0\uc740 \ud06c\uac8c 7\uac00\uc9c0 \ubcd1 \uc885\ub958\ub85c \ub098\ub269\ub2c8\ub2e4: \uacbd\uad6c\uc6a9 \uc561\uc81c(\uc2dc\ub7fd), \uc815\uc81c\/\ucea1\uc290 \uc6a9\uae30, \ubd84\uc720\ubcd1, \uc548\uc57d\ubcd1, \uc77c\ubc18\uc758\uc57d\ud488\ubcd1, \ube44\ud0c0\ubbfc\/\uac74\uac15\ubcf4\uc870\uc2dd\ud488\ubcd1, \uc8fc\uc0ac\uc81c \uc6a9\uae30. \ubaa8\ub4e0 \ud3ec\uc7a5\uc7ac\ub294 USP Class VI \uc0dd\uccb4 \uc801\ud569\uc131 \uae30\uc900, EU \uc57d\uc804 3.1.X \uae30\uc900, \uadf8\ub9ac\uace0 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98\uc758 \uc2dd\ud488 \uc811\ucd09 \ub3d9\ub4f1\uc131 \uae30\uc900\uc744 \ucda9\uc871\ud574\uc57c \ud569\ub2c8\ub2e4. \ubd84\uc720\ubcd1\uc5d0\ub294 \ud2b8\ub77c\uc774\ud0c4(BPA-free \uaddc\uc81c \uc694\uac74 \ucda9\uc871), \ub808\ud1a0\ub974\ud2b8 \ubd84\uc720\uc5d0\ub294 PP, \uace0\uae09 \uc561\uc0c1 \uc758\uc57d\ud488\uc5d0\ub294 PETG, \uc815\uc81c \uc6a9\uae30\uc5d0\ub294 HDPE\uac00 \uc8fc\ub85c \uc0ac\uc6a9\ub429\ub2c8\ub2e4. \ubaa8\ub4e0 \uc81c\uc57d \ud3ec\uc7a5\uc7ac \uacf5\uae09\uc5c5\uccb4\ub294 K-GMP(\ud55c\uad6d \uc758\uc57d\ud488 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900)\ub97c \uc900\uc218\ud574\uc57c \ud558\uba70, \ubbf8\uad6d \uc218\ucd9c\uc5d0\ub294 FDA 21 CFR Part 11, \uc720\ub7fd \uc218\ucd9c\uc5d0\ub294 EU GMP Annex 11\uc774 \uc801\uc6a9\ub429\ub2c8\ub2e4. \uc870\ub2ec \ubc29\uc2dd\uc740 \"\ub2e8\uc704\ub2f9 \ube44\uc6a9\"\uc5d0\uc11c \"\uaddc\uc81c \uc900\uc218 \ube44\uc6a9\"\uc73c\ub85c \uc804\ud658\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \ud3ec\uc7a5\uc7ac \ubd88\ub7c9\uc73c\ub85c \uc778\ud55c \uc6a9\ucd9c, \uc218\ubd84 \uce68\ud22c, \ub610\ub294 \uc81c\ud488 \uc77c\ub828\ubc88\ud638 \ub204\ub77d \ub4f1\uc758 \ubb38\uc81c\ub294 \uc6d0\uc790\uc7ac \ube44\uc6a9 \uc808\uac10 \ud6a8\uacfc\ub97c \ud6e8\uc52c \ub2a5\uac00\ud558\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4.<\/p>\n<\/div>\n

<\/p>\n

\n

\uc774 \uac00\uc774\ub4dc\uc5d0\uc11c<\/h3>\n
    \n
  1. \uc81c\uc57d \uc0b0\uc5c5 \ub9e5\ub77d: ISBM\uc774 \uc911\uc694\ud55c \uc774\uc720<\/a><\/li>\n
  2. 2026\ub144 \ud55c\uad6d \uc81c\uc57d \uc2dc\uc7a5 \uc804\ub9dd<\/a><\/li>\n
  3. 7\uac00\uc9c0 \uc81c\uc57d\uc6a9 \ubcd1 \uc885\ub958 \ubc0f ISBM \uc694\uad6c\uc0ac\ud56d<\/a><\/li>\n
  4. \uc7ac\ub8cc \uc120\ud0dd: USP Class VI \ubc0f \uc57d\uc804<\/a><\/li>\n
  5. \uc81c\uc57d \ud45c\uc900\uc744 \uc704\ud55c ISBM \ucc98\ub9ac<\/a><\/li>\n
  6. K-GMP\/FDA\/EMA \uaddc\uc81c \ud504\ub808\uc784\uc6cc\ud06c<\/a><\/li>\n
  7. \uba78\uade0 \ud638\ud658\uc131<\/a><\/li>\n
  8. \ud55c\uad6d \uc81c\uc57d\ud68c\uc0ac ISBM \ud30c\ud2b8\ub108 \uc120\uc815<\/a><\/li>\n
  9. \uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38<\/a><\/li>\n
  10. \uacb0\ub860<\/a><\/li>\n<\/ol>\n<\/div>\n

    <\/p>\n

    1. \uc81c\uc57d \uc0b0\uc5c5 \ud658\uacbd: ISBM\uc774 \uc911\uc694\ud55c \uc774\uc720<\/h2>\n

    \uc81c\uc57d ISBM \uc0dd\uc0b0\uc740 \uc74c\ub8cc\ub098 \ud654\uc7a5\ud488 \ubd84\uc57c\uc640\ub294 \uadfc\ubcf8\uc801\uc73c\ub85c \ub2e4\ub978 \uacbd\uc81c\uc801 \ub17c\ub9ac\uc5d0 \ub530\ub77c \uc6b4\uc601\ub429\ub2c8\ub2e4. \ud55c\uad6d \uc81c\uc57d \ud68c\uc0ac\ub4e4\uc740 \ub2e8\uc21c\ud788 \ubcd1\uc744 \uad6c\ub9e4\ud558\ub294 \uac83\uc774 \uc544\ub2c8\ub77c, \uaddc\uc81c \uc704\ubc18\uc5d0 \ub300\ud55c \uc704\ud5d8\uc744 \uc644\ud654\ud558\ub294 \uc194\ub8e8\uc158\uc744 \uad6c\ub9e4\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. \ud654\ud559 \ubb3c\uc9c8 \uc6a9\ucd9c, \uc2b5\uae30 \uce68\ud22c, \uce58\uc218 \ubd88\uc77c\uce58, \ub610\ub294 \uc77c\ub828\ubc88\ud638 \ub204\ub77d\uacfc \uac19\uc740 \ud3ec\uc7a5 \uacb0\ud568\uc73c\ub85c \uc778\ud55c \uc190\uc2e4 \ube44\uc6a9\uc740 \uc77c\ubc18\uc801\uc778 \uc790\uc7ac \uc870\ub2ec\uc744 \ud1b5\ud574 \uc5bb\uc744 \uc218 \uc788\ub294 \uc808\uac10 \ud6a8\uacfc\ub97c \ud6e8\uc52c \ub2a5\uac00\ud569\ub2c8\ub2e4. \ub2e8 \ud55c \ubc88\uc758 \uc81c\uc57d \uc81c\ud488 \uc0dd\uc0b0 \uc2e4\ud328\ub85c\ub3c4 \uc7ac\uace0 \ud3d0\uae30, \uaddc\uc81c \uc704\ubc18\uc5d0 \ub530\ub978 \ubc8c\uae08, \uadf8\ub9ac\uace0 \ube0c\ub79c\ub4dc \uc774\ubbf8\uc9c0 \uc190\uc0c1\uc73c\ub85c \uc218\ubc31\ub9cc \uc6d0\uc758 \uc190\uc2e4\uc774 \ubc1c\uc0dd\ud560 \uc218 \uc788\uc73c\uba70, \uc774\ub7ec\ud55c \uc190\uc2e4\uc740 \uc0ac\uac74 \ubc1c\uc0dd \uc9c1\ud6c4\ub97c \ub118\uc5b4 \uc218\ub144\uac04 \uc9c0\uc18d\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

    \uc774\ub7ec\ud55c \uaddc\uc815 \uc900\uc218 \uc6b0\uc120 \uc870\ub2ec \ub17c\ub9ac\ub294 \ud55c\uad6d \uc81c\uc57d ISBM(\uad6d\uc81c \ud1b5\ud569 \uc81c\ud488 \uad00\ub9ac) \uad00\uacc4\ub97c \uc5ec\ub7ec \uce21\uba74\uc5d0\uc11c \ud615\uc131\ud569\ub2c8\ub2e4. \uccab\uc9f8, \uacf5\uae09\uc5c5\uccb4 \uc790\uaca9: \uc81c\uc57d \ud3ec\uc7a5\uc7ac \uacf5\uae09\uc5c5\uccb4\ub294 K-GMP \uc778\uc99d, \ud574\ub2f9\ub418\ub294 \uacbd\uc6b0 FDA \uc758\uc57d\ud488 \ub9c8\uc2a4\ud130 \ud30c\uc77c(DMF) \ub4f1\ub85d, \uadf8\ub9ac\uace0 \uc720\ub7fd \uc218\ucd9c \uc2dc\uc7a5\uc758 \uacbd\uc6b0 EU GMP Annex 11 \uc900\uc218 \uc5ed\ub7c9\uc744 \ubcf4\uc720\ud574\uc57c \ud569\ub2c8\ub2e4. \ub458\uc9f8, \uc7ac\ub8cc \uaddc\uaca9: 1\ucc28 \ud3ec\uc7a5\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ubaa8\ub4e0 \uace0\ubd84\uc790\ub294 USP Class VI \uc0dd\uccb4 \uc801\ud569\uc131 \uc2dc\ud5d8 \ubc0f \ud55c\uad6d \uc57d\uc804 \uc694\uac74\uc744 \ucda9\uc871\ud574\uc57c \ud569\ub2c8\ub2e4. \uc14b\uc9f8, \ucd94\uc801\uc131: \ubaa8\ub4e0 \ubc30\uce58(batch)\ub294 \ud488\uc9c8 \ubb38\uc81c\uac00 \ubc1c\uc0dd\ud560 \uacbd\uc6b0 \uc2e0\uc18d\ud55c \ud68c\uc218\uac00 \uac00\ub2a5\ud558\ub3c4\ub85d \uc804\uccb4 \uacf5\uae09\ub9dd \ucd94\uc801\uc744 \uc9c0\uc6d0\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

    \"\uc0ac\ucd9c<\/p>\n

    \uc81c\uc57d \ubd84\uc57c\uc5d0 \uc81c\ud488\uc744 \uacf5\uae09\ud558\ub294 \ud55c\uad6d ISBM(\ud1b5\ud569 \uc74c\ub8cc \uc81c\uc870 \ubc0f \uc720\ud1b5) \uc5c5\uccb4\uc5d0\uac8c \uc774\ub7ec\ud55c \uaddc\uc81c \ud658\uacbd\uc740 \uc9c4\uc785 \uc7a5\ubcbd\uc778 \ub3d9\uc2dc\uc5d0 \uacbd\uc7c1 \uc6b0\uc704 \uc694\uc18c\ub85c \uc791\uc6a9\ud569\ub2c8\ub2e4. \uc81c\uc57d \ubd84\uc57c \uc778\uc99d \ud68d\ub4dd\uc5d0 \ud544\uc694\ud55c \ucd08\uae30 \uc11c\ub958 \uc791\uc5c5, \uac80\uc99d \ubc0f \uc2dc\ud5d8 \uc778\ud504\ub77c \uad6c\ucd95\uc5d0 \uc77c\ubc18\uc801\uc73c\ub85c 2\uc5b5~4\uc5b5 \uc6d0 \uc774\uc0c1\uc758 \ud22c\uc790\uac00 \uc694\uad6c\ub429\ub2c8\ub2e4. \ud558\uc9c0\ub9cc \uc77c\ub2e8 \uc778\uc99d\uc744 \ud68d\ub4dd\ud558\uba74 \ud504\ub9ac\ubbf8\uc5c4 \ub9c8\uc9c4(\uc77c\ubc18 \uc74c\ub8cc \ub300\ube44 40~80% \ub192\uc740 \uac00\uaca9)\uacfc \uc218\uc2ed \ub144\uc5d0 \uac78\uccd0 \uc9c0\uc18d\ub420 \uc218 \uc788\ub294 \uacac\uace0\ud55c \uace0\uac1d \uad00\uacc4\ub97c \uad6c\ucd95\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc544\ub798 \ud504\ub808\uc784\uc6cc\ud06c\ub294 \uc81c\uc57d \ubd84\uc57c \ud3ec\ud2b8\ud3f4\ub9ac\uc624 \uc804\ubc18\uc5d0 \uac78\uce5c \uc694\uad6c \uc0ac\ud56d\uacfc \uacf5\uae09\uc5c5\uccb4 \ud3c9\uac00 \uae30\uc900\uc744 \ub2e4\ub8f9\ub2c8\ub2e4.<\/p>\n

    <\/p>\n

    2. 2026\ub144 \ud55c\uad6d \uc81c\uc57d \uc2dc\uc7a5 \uc804\ub9dd<\/h2>\n

    \ud55c\uad6d\uc758 \uc758\uc57d\ud488 \ud3ec\uc7a5 \uc2dc\uc7a5\uc740 2023\ub144 14\uc870 15\uc5b5 \ub2ec\ub7ec\uc5d0\uc11c 2033\ub144 14\uc870 30\uc5b5 \ub2ec\ub7ec\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub418\uba70, \uc774\ub294 \uc5f0\ud3c9\uade0 74\uc5b5 1\ucc9c\ub9cc \ub2ec\ub7ec\uc758 \ubcf5\ud569 \uc131\uc7a5\ub960\uc5d0 \ud574\ub2f9\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc131\uc7a5\uc740 \ud55c\uad6d \uc758\ub8cc \uc218\uc694\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \uc138 \uac00\uc9c0 \uc778\uad6c \ud1b5\uacc4\ud559\uc801 \ubc0f \uc784\uc0c1\uc801 \ucd94\uc138\uc5d0 \uc758\ud574 \uc8fc\ub3c4\ub429\ub2c8\ub2e4.<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n
    \uc218\uc694 \ub3d9\uc778<\/th>\n\uacbd\ud5a5<\/th>\n\ud3ec\uc7a5 \uc601\ud5a5<\/th>\n<\/tr>\n<\/thead>\n
    \uace0\ub839\ud654 \uc778\uad6c<\/td>\n2030\ub144\uae4c\uc9c0 65\uc138 \uc774\uc0c1 \uc778\uad6c\uac00 21%\uc5d0 \ub2ec\ud560 \uc804\ub9dd<\/td>\n\ub9cc\uc131 \uc9c8\ud658 \uc57d\ubcd1 \ub354 \ubcf4\uae30<\/td>\n<\/tr>\n
    \ub9cc\uc131 \uc9c8\ud658 \uc131\uc7a5<\/td>\n\ub2f9\ub1e8\ubcd1 +15% \/ 10\ub144<\/td>\n\uc7a5\uae30 \ubcf5\uc6a9 \uc758\uc57d\ud488 \ud3ec\uc7a5<\/td>\n<\/tr>\n
    \uac74\uac15 \ubc0f \uc6f0\ube59<\/td>\n\ube44\ud0c0\ubbfc\/\ubcf4\ucda9\uc81c +8% CAGR<\/td>\n\uace0\uae09\uc2a4\ub7ec\uc6b4 \ubcd1 \ub514\uc790\uc778<\/td>\n<\/tr>\n
    K-\ud30c\ub9c8 \uc218\ucd9c<\/td>\n\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec + \uc81c\ub124\ub9ad<\/td>\n\ub2e4\uad6d\uc801 \uaddc\uc815 \uc900\uc218<\/td>\n<\/tr>\n
    \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \ud655\ub300<\/td>\n\uc804 \uc138\uacc4\uc801\uc73c\ub85c \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960(CAGR) 5%\uac00 2036\ub144\uae4c\uc9c0 $449\uc5b5\uc73c\ub85c \uc99d\uac00\ud560 \uc804\ub9dd\uc785\ub2c8\ub2e4.<\/td>\n\ud504\ub9ac\ubbf8\uc5c4 \uc7a5\ubcbd \uc694\uac74<\/td>\n<\/tr>\n
    \uc9c1\ub82c\ud654 \ud544\uc218 \uc0ac\ud56d<\/td>\nDSCSA(\ubbf8\uad6d) + FMD(\uc720\ub7fd)<\/td>\n\ucd94\uc801 \ubc0f \ucd94\uc801 \ud1b5\ud569<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \ud50c\ub77c\uc2a4\ud2f1 \uc6a9\uae30\ub294 \ud55c\uad6d \uc758\uc57d\ud488 \ud3ec\uc7a5 \uc2dc\uc7a5\uc5d0\uc11c \uc57d 2,813\uc870 \uc6d0(T)\uc758 \ucd1d \ub9e4\ucd9c\uc744 \ucc28\uc9c0\ud558\uba70 \uac00\uc7a5 \ud070 \ube44\uc911\uc744 \ucc28\uc9c0\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ud50c\ub77c\uc2a4\ud2f1 \uc6a9\uae30\uac00 \uc2dc\uc7a5\uc744 \uc8fc\ub3c4\ud558\ub294 \uc774\uc720\ub294 \uac00\ubcbc\uc6b4 \ubb34\uac8c, \uc5b4\ub9b0\uc774 \ubcf4\ud638 \ucea1\uacfc\uc758 \ud638\ud658\uc131, \uac1c\ubd09 \uc5ec\ubd80\ub97c \ud655\uc778\ud560 \uc218 \uc788\ub294 \ubc00\ubd09 \uae30\ub2a5, \uadf8\ub9ac\uace0 \ub300\ub7c9 \uc0dd\uc0b0 \uc2dc \ube44\uc6a9 \ud6a8\uc728\uc131 \ub4f1\uc758 \uc7a5\uc810\uc744 \uac16\ucd94\uace0 \uc788\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4. \ud654\ud559\uc801 \ubd88\ud65c\uc131\uc774 \ub9e4\uc6b0 \uc911\uc694\ud55c \uace0\uac00\uc758 \uc8fc\uc0ac\uc81c \uc6a9\ub3c4\uc5d0\ub294 \uc5ec\uc804\ud788 \uc720\ub9ac \uc6a9\uae30\uac00 \uc120\ud638\ub418\uc9c0\ub9cc, \ud50c\ub77c\uc2a4\ud2f1 \uc6a9\uae30\ub294 \ucc28\ub2e8 \uae30\uc220\uc758 \ubc1c\uc804\uacfc \uaddc\uc81c \uc218\uc6a9\ub3c4 \ud5a5\uc0c1\uc5d0 \ud798\uc785\uc5b4 \uc2dc\uc7a5 \uc810\uc720\uc728\uc744 \uafb8\uc900\ud788 \ud655\ub300\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

    \ud55c\uad6d \uc81c\uc57d \ud3ec\uc7a5 \uc2dc\uc7a5\uc758 \uc8fc\uc694 \ucc38\uc5ec \uc5c5\uccb4\ub85c\ub294 CCL Industries, West Pharmaceutical Services, Berry Global, Catalent, Gerresheimer, SCHOTT, Amcor, Aptar, Nipro, BD\uc640 \uac19\uc740 \uad6d\uc81c \uae30\uc5c5\uacfc K-\uc81c\uc57d \ubd80\ubb38\uc5d0 \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud558\ub294 \uad6d\ub0b4 \uc81c\uc870\uc5c5\uccb4\ub4e4\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uce58\uc5f4\ud55c \uacbd\uc7c1 \uc18d\uc5d0\uc11c \uad6d\ub0b4 \uc778\uc99d, \ube60\ub978 \ub0a9\uae30, \ud1b5\ud569\uc801\uc778 \uaddc\uc81c \uc9c0\uc6d0\uc744 \ud1b5\ud574 K-\uc81c\uc57d \uc218\ucd9c \ud655\ub300\ub97c \ub3c4\ubaa8\ud558\ub294 \ud55c\uad6d \uc81c\uc870\uc5c5\uccb4\ub4e4\uc774 \uc720\ub9ac\ud55c \uc704\uce58\ub97c \ucc28\uc9c0\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ubbf8\uad6d, \uc720\ub7fd\uc5f0\ud569, \uc911\uad6d, \uc77c\ubcf8 \ubc0f \ub3d9\ub0a8\uc544\uc2dc\uc544 \uc2e0\ud765 \uc2dc\uc7a5\uc73c\ub85c\uc758 K-\uc81c\uc57d \uc218\ucd9c\uc740 \uc9c0\uc18d\uc801\uc73c\ub85c \uc99d\uac00\ud558\uace0 \uc788\uc73c\uba70, \uc774\ub294 \ub2e4\uad6d\uc801 \uaddc\uc81c \uc900\uc218 \uc5ed\ub7c9\uc744 \uac16\ucd98 \ud55c\uad6d ISBM(\ud1b5\ud569 \ud3ec\uc7a5 \uc81c\uc870) \uc5c5\uccb4\ub4e4\uc5d0\uac8c \uc0c8\ub85c\uc6b4 \uae30\ud68c\ub97c \uc81c\uacf5\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

    <\/p>\n

    3. 7\uac00\uc9c0 \uc81c\uc57d\uc6a9 \ubcd1 \uc885\ub958 \ubc0f ISBM \uc694\uad6c\uc0ac\ud56d<\/h2>\n
    \"\ubcd1-3\"
    \n\ud55c\uad6d\uc758 \uc758\uc57d\ud488 \uc0dd\uc0b0\uc740 \uc7ac\uc9c8, \ud06c\uae30, \uaddc\uc81c \uc694\uac74\uc774 \uac01\uac01 \ub2e4\ub978 7\uac00\uc9c0 \ubcd1 \uc885\ub958\ub85c \ub098\ub269\ub2c8\ub2e4.<\/figcaption><\/figure>\n

    \ud55c\uad6d \uc81c\uc57d\ud68c\uc0ac\uc758 ISBM(\ub2e8\uc77c \ubcd1 \uc81c\uc870 \uc6a9\uae30) \uc0dd\uc0b0\uc740 \ud06c\uac8c 7\uac00\uc9c0 \uc8fc\uc694 \uc6a9\uae30 \uc720\ud615\uc73c\ub85c \ub098\ub269\ub2c8\ub2e4. \uac01 \uc720\ud615\uc740 \uc7ac\uc9c8, \ud06c\uae30, \uaddc\uc81c \uc694\uac74 \ub4f1\uc5d0\uc11c \ucc28\uc774\ub97c \ubcf4\uc774\uba70, \uc774\ub7ec\ud55c \uc694\uac74\uc5d0 \ub530\ub77c ISBM \uc0dd\uc0b0 \uc0ac\uc591\uc774 \uacb0\uc815\ub429\ub2c8\ub2e4.<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n\n
    \ubc94\uc8fc<\/th>\n\uc6a9\ub7c9<\/th>\n\uc8fc\uc694 \uc7ac\ub8cc<\/th>\n\ud544\uc218 \uc694\uad6c\uc0ac\ud56d<\/th>\n<\/tr>\n<\/thead>\n
    1. \uacbd\uad6c\uc6a9 \uc561\uc81c(\uc2dc\ub7fd)<\/td>\n60-250ml<\/td>\n\ud3ab \/ \ud3abG \/ \uc570\ubc84 \ud3ab<\/td>\n\uad11\uc804\uc2dd, \ubcc0\uc870 \ubc29\uc9c0<\/td>\n<\/tr>\n
    2. \uc815\uc81c\/\ucea1\uc290<\/td>\n30-500ml<\/td>\nHDPE \/ PET<\/td>\n\uc2b5\uae30 \ucc28\ub2e8, \uc5b4\ub9b0\uc774 \ubcf4\ud638 \uae30\ub2a5<\/td>\n<\/tr>\n
    3. \uc720\uc544\uc6a9 \uc870\uc81c\ubd84\uc720<\/td>\n120-300ml<\/td>\n\ud2b8\ub9ac\ud0c4 \/ PP \/ PPSU<\/td>\nBPA \ubb34\ud568\uc720, \uc0b4\uade0 \uac00\ub2a5<\/td>\n<\/tr>\n
    4. \uc548\uc57d\/\ucf54 \uc2a4\ud504\ub808\uc774<\/td>\n5-30ml<\/td>\nLDPE \/ PE<\/td>\n\uba78\uade0 \ucc98\ub9ac, \uc2a4\ud3ec\uc774\ub4dc \ud638\ud658<\/td>\n<\/tr>\n
    5. \uc77c\ubc18\uc758\uc57d\ud488<\/td>\n50-500ml<\/td>\nPET\/HDPE<\/td>\n\uac1c\ubd09 \ud754\uc801 \ubc29\uc9c0 \ubc0f \uc5b4\ub9b0\uc774 \ubcf4\ud638 \uae30\ub2a5<\/td>\n<\/tr>\n
    6. \ube44\ud0c0\ubbfc\/\ubcf4\ucda9\uc81c<\/td>\n100-1000ml<\/td>\nPET\/PETG\/HDPE<\/td>\n\ud504\ub9ac\ubbf8\uc5c4 \uc2ec\ubbf8\uc131, \uc0b0\uc18c \ucc28\ub2e8 \uae30\ub2a5<\/td>\n<\/tr>\n
    7. \uc8fc\uc0ac\uc81c \uc6a9\uae30<\/td>\n\ubcc0\ud558\uae30 \uc26c\uc6b4<\/td>\n\ud2b9\uc218 \ub4f1\uae09<\/td>\n\ubb34\uade0, \ucd94\ucd9c\ubb3c \ud568\ub7c9 \ub0ae\uc74c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \ud55c\uad6d\uc758 ISBM(\uc720\uc544\uc6a9 \ubd84\uc720) \uc81c\uc870\uc5c5\uccb4\ub294 \uc804\ub7b5\uc801\uc73c\ub85c \ud2b9\ubcc4\ud788 \uc9d1\uc911\ud574\uc57c \ud560 \uc138 \uac00\uc9c0 \uc758\uc57d\ud488 \uce74\ud14c\uace0\ub9ac\uac00 \uc788\uc2b5\ub2c8\ub2e4. \uccab\uc9f8, \ubd84\uc720\ubcd1\uc740 BPA \ubb34\ud568\uc720 \uaddc\uc81c \uc694\uac74\uc73c\ub85c \uc778\ud574 \ud2b8\ub77c\uc774\ud0c4, PP \ub610\ub294 PPSU \uc18c\uc7ac\ub97c \uc0ac\uc6a9\ud574\uc57c \ud558\uba70, \uace0\uae09 \ubd84\uc720 \uc81c\ud488\uc758 \uacbd\uc6b0 \ub808\ud1a0\ub974\ud2b8 \uba78\uade0(104\u00b0C \uc624\ud1a0\ud074\ub808\uc774\ube0c)\uc774 \uc810\uc810 \ub354 \ubcf4\ud3b8\ud654\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc720\uc544\uc6a9 \uc2dd\ud488 \uc18c\uc7ac\uc5d0 \ub300\ud55c \uc885\ud569\uc801\uc778 \ubd84\uc11d\uc740 \ub2e4\uc74c\uc744 \ucc38\uc870\ud558\uc2ed\uc2dc\uc624. \ud2b8\ub77c\uc774\ud0c4 \uc816\ubcd1\uacfc PC \uc816\ubcd1 \ube44\uad50 \uac00\uc774\ub4dc<\/a>.<\/p>\n

    \ub458\uc9f8, \ube44\ud0c0\ubbfc\/\ubcf4\ucda9\uc81c \uc6a9\uae30\ub294 \uc81c\uc57d \ud3ec\uc7a5 \ubd84\uc57c\uc5d0\uc11c ISBM \uc801\uc6a9\uc774 \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud558\ub294 \ubd84\uc57c\uc785\ub2c8\ub2e4. \ud55c\uad6d\uc758 K-\uc6f0\ub2c8\uc2a4 \ube0c\ub79c\ub4dc\uac00 \uc804 \uc138\uacc4\uc801\uc73c\ub85c \ud655\uc7a5\ub428\uc5d0 \ub530\ub77c \ube0c\ub79c\ub4dc \ucc28\ubcc4\ud654\ub97c \uc9c0\uc6d0\ud558\uba74\uc11c \uc81c\uc57d \ub4f1\uae09\uc758 \uaddc\uc815\uc744 \uc900\uc218\ud558\ub294 \ud504\ub9ac\ubbf8\uc5c4 PETG \uc6a9\uae30\uc5d0 \ub300\ud55c \uc218\uc694\uac00 \uc99d\uac00\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc14b\uc9f8, \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc2dc\ub7fd \uc6a9\uae30\ub294 \uad11\ubbfc\uac10\uc131 \ud65c\uc131 \uc131\ubd84\uc758 \ube5b \ucc28\ub2e8\uc744 \uc704\ud574 \ud638\ubc15\uc0c9 PET\ub97c \uc810\uc810 \ub354 \ub9ce\uc774 \uc0ac\uc6a9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774 \ud2b9\uc218 \uc18c\uc7ac\ub294 \ud22c\uba85 PET\uc5d0 \ube44\ud574 \uc57d 15~25%\uc758 \uc18c\uc7ac \ube44\uc6a9\uc774 \ucd94\uac00\ub429\ub2c8\ub2e4.<\/p>\n

    <\/p>\n

    4. \uc7ac\ub8cc \uc120\ud0dd: USP 6\uae09 \ubc0f \uc57d\uc804<\/h2>\n

    \uc758\uc57d\ud488 \uc18c\uc7ac \uc120\uc815\uc5d0\ub294 \uc74c\ub8cc \ubc0f \ud654\uc7a5\ud488 \ubd84\uc57c\uc5d0\ub294 \uc5c6\ub294 \uaddc\uc81c \uc900\uc218 \uad00\ub828 \uc0ac\ud56d\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uc758\uc57d\ud488 1\ucc28 \ud3ec\uc7a5\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ubaa8\ub4e0 \uace0\ubd84\uc790\ub294 \uc8fc\uc694 \uc57d\uc804\uc5d0\uc11c \uc815\uc758\ud55c \ud45c\uc900\ud654\ub41c \uc2dc\ud5d8 \ud504\ub85c\ud1a0\ucf5c\uc744 \ud1b5\ud574 \uc0dd\uccb4 \uc801\ud569\uc131\uc744 \uc785\uc99d\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n
    \uc900\uc218 \uae30\uc900<\/th>\n\uad00\ud560\uad8c<\/th>\n\ud14c\uc2a4\ud2b8 \uc694\uad6c \uc0ac\ud56d<\/th>\n<\/tr>\n<\/thead>\n
    USP 6\uae09<\/td>\n\ubbf8\uad6d (FDA \ucc38\uc870)<\/td>\n\uae09\uc131 \uc804\uc2e0 \ub3c5\uc131, \ud53c\ud558 \uc8fc\uc785, \uc774\uc2dd<\/td>\n<\/tr>\n
    EU \uc57d\uc804 3.1.X<\/td>\nEU (EMA \ucc38\uc870)<\/td>\n\uc7ac\ub8cc\ubcc4 \ubaa8\ub178\uadf8\ub798\ud504<\/td>\n<\/tr>\n
    \ub300\ud55c\uc57d\uc804<\/td>\n\ub300\ud55c\ubbfc\uad6d (\uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98)<\/td>\n\uc0dd\uccb4 \uc801\ud569\uc131 + \ucd94\ucd9c\ubb3c<\/td>\n<\/tr>\n
    ISO 10993<\/td>\n\uad6d\uc81c\uc801\uc778<\/td>\n\uc0dd\ubb3c\ud559\uc801 \ud3c9\uac00<\/td>\n<\/tr>\n
    \uc77c\ubcf8 \uc57d\uc804(JP)<\/td>\n\uc77c\ubcf8 \uc758\uc57d\ud488\uc758\uc57d\uad6d(PMDA)<\/td>\n\ucee8\ud14c\uc774\ub108\ubcc4 \ud14c\uc2a4\ud2b8<\/td>\n<\/tr>\n
    \uc911\uad6d \uc57d\uc804<\/td>\n\uc911\uad6d (NMPA)<\/td>\n\uc9c1\uc811 \uc2dd\ud488 \uc811\ucd09 \ub3d9\ub4f1\uc131<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    USP Class VI\ub294 \uc57d\uc804 \uccb4\uacc4 \uc911 \uac00\uc7a5 \uc5c4\uaca9\ud55c \uc0dd\uccb4 \uc801\ud569\uc131 \uae30\uc900\uc744 \ub098\ud0c0\ub0c5\ub2c8\ub2e4. Class VI \uc2dc\ud5d8 \ud504\ub85c\ud1a0\ucf5c\uc5d0\ub294 \uae09\uc131 \uc804\uc2e0 \ub3c5\uc131 \uc2dc\ud5d8, \ud53c\ub0b4 \uc790\uadf9 \uc2dc\ud5d8 \ubc0f \ub3d9\ubb3c \ubaa8\ub378 \uc774\uc2dd \uc2dc\ud5d8\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. Class VI \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294 \uc7ac\ub8cc\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc778\uc815\ub41c \ub3d9\ub4f1\uc131 \uacbd\ub85c\ub97c \ud1b5\ud574 \ub2e4\ub978 \uc57d\uc804 \uc694\uac74\ub3c4 \ucda9\uc871\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uae00\ub85c\ubc8c \uc81c\uc57d \uc2dc\uc7a5\uc5d0 \uc9c4\ucd9c\ud558\ub294 \ud55c\uad6d ISBM \uc81c\uc870\uc5c5\uccb4\uc5d0\uac8c USP Class VI \uc7ac\ub8cc \uc778\uc99d\uc740 \uac00\uc7a5 \ud3ed\ub113\uc740 \uc2dc\uc7a5 \uc9c4\ucd9c \uae30\ubc18\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n

    \uc758\uc57d\ud488 \uc6a9\ub3c4\ub85c \uc801\ud569\ud55c \uc18c\uc7ac \ub4f1\uae09\uc740 \uc2dd\ud488 \uc811\ucd09\uc6a9 \ub610\ub294 \uc0b0\uc5c5\uc6a9 \ub4f1\uae09\uacfc \uad6c\ubcc4\ub418\ub294 \ud2b9\uc815 \uba85\uce6d\uc744 \uc0ac\uc6a9\ud569\ub2c8\ub2e4. \uc758\uc57d\ud488 \ub4f1\uae09 PET, PP, HDPE, LDPE \ubc0f Tritan\uc740 GMP(\uc6b0\uc218 \uc758\uc57d\ud488 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900)\uc5d0 \ub530\ub77c \uc5c4\uaca9\ud55c \uc0dd\uc0b0 \uacf5\uc815\uc744 \uac70\uccd0 \uc0dd\uc0b0\ub418\uba70, \ubaa8\ub4e0 \ubc30\uce58\uc5d0 \ub300\ud55c \ucd94\uc801\uc131\uacfc \uacf5\uae09\uc5c5\uccb4 \uc778\uc99d \uc11c\ub958\uac00 \uc644\ube44\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. \uc758\uc57d\ud488 \ub4f1\uae09 \uc18c\uc7ac\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc2dd\ud488 \uc811\ucd09\uc6a9 \uc18c\uc7ac\ubcf4\ub2e4 20~50% \ub192\uc740 \uac00\uaca9\uc5d0 \ud310\ub9e4\ub418\ub294\ub370, \uc774\ub294 \ucd94\uac00\uc801\uc778 \uc11c\ub958 \uc791\uc5c5\uacfc \ud488\uc9c8 \uad00\ub9ac \uc778\ud504\ub77c \uad6c\ucd95\uc5d0 \ub530\ub978 \ube44\uc6a9 \uc99d\uac00\ub97c \ubc18\uc601\ud55c \u200b\u200b\uac83\uc785\ub2c8\ub2e4. \ud55c\uad6d \uc81c\uc870\uc5c5\uccb4\uc758 \uacbd\uc6b0, \uc758\uc57d\ud488 \ub4f1\uae09 \uc18c\uc7ac\ub97c \ud655\ubcf4\ud558\uae30 \uc704\ud574\uc11c\ub294 \uc0dd\uc0b0 \uac1c\uc2dc \uc804 \ucd5c\uc18c 6\uac1c\uc6d4\uc758 \uc778\uc99d \uc808\ucc28\ub97c \uac70\uccd0\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

    \"15ml<\/p>\n

    <\/p>\n

    5. \uc81c\uc57d \ud45c\uc900\uc744 \uc704\ud55c ISBM \ucc98\ub9ac<\/h2>\n
    \"HGY200-V4-B
    <\/figcaption><\/figure>\n

    \uc81c\uc57d ISBM \uc0dd\uc0b0\uc740 \uaddc\uc815 \uc900\uc218 \uce21\uba74\uc5d0\uc11c K-\ubdf0\ud2f0 \ud504\ub9ac\ubbf8\uc5c4 \uc0dd\uc0b0\uc744 \ub2a5\uac00\ud558\ub294 \ud488\uc9c8 \uae30\uc900\uc744 \uc694\uad6c\ud558\uc9c0\ub9cc, \uc21c\uc218 \ubbf8\uc6a9\uc801 \uce21\uba74\uc5d0\uc11c\ub294 \uc77c\ubc18\uc801\uc73c\ub85c K-\ubdf0\ud2f0\ubcf4\ub2e4 \ub5a8\uc5b4\uc9d1\ub2c8\ub2e4. \uc81c\uc57d \uc0dd\uc0b0\uc744 \ub2e4\ub978 ISBM \uc751\uc6a9 \ubd84\uc57c\uc640 \uad6c\ubcc4\ud558\ub294 \uc138 \uac00\uc9c0 \uc81c\uc57d \ud2b9\uc720\uc758 \ud488\uc9c8 \uae30\uc900\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n
    \ud488\uc9c8 \ucc28\uc6d0<\/th>\n\ud30c\ub9c8 \uc2a4\ud0e0\ub2e4\ub4dc<\/th>\n\uac80\uc99d \ubc29\ubc95<\/th>\n<\/tr>\n<\/thead>\n
    \ubbf8\uc138\uba3c\uc9c0<\/td>\nUSP \uc900\uc218<\/td>\n\ube5b \uac00\ub9bc \uacc4\uc218<\/td>\n<\/tr>\n
    \ucd94\ucd9c\ubb3c\/\uc6a9\ucd9c\ubb3c<\/td>\n\ubbf8\uad6d \ud2b9\ud5c8 \/<\/td>\nGC-MS\/HPLC \ubd84\uc11d<\/td>\n<\/tr>\n
    \ubbf8\uc0dd\ubb3c\ud559\uc801 \uc81c\uc5b4<\/td>\nUSP \/ \uc900\uc218<\/td>\n\ubbf8\uc0dd\ubb3c \uc624\uc5fc\ub3c4 \uac80\uc0ac<\/td>\n<\/tr>\n
    \ucc28\uc6d0\uc801 \uc77c\uad00\uc131<\/td>\n\u00b10.5-1.0%<\/td>\nSPC \ubb38\uc11c<\/td>\n<\/tr>\n
    \ubcbd\uba74 \uade0\uc77c\uc131<\/td>\n\u00b15%<\/td>\n\uce58\uc218 \uac80\uc0ac<\/td>\n<\/tr>\n
    \ubc30\uce58 \ucd94\uc801\uc131<\/td>\n100% \ub85c\ud2b8 \ub808\ubca8<\/td>\n\uc9c1\ub82c\ud654 \ud1b5\ud569<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \uc758\uc57d\ud488 ISBM \uc0dd\uc0b0\uc5d0\uc11c \uc785\uc790\uc0c1 \ubb3c\uc9c8 \uad00\ub9ac\ub294 \ud2b9\ud788 \uc911\uc694\ud569\ub2c8\ub2e4. USP \ud45c\uc900\uc740 \uc758\uc57d\ud488 \uc6a9\uae30 \ub0b4 \uc785\uc790\uc0c1 \ubb3c\uc9c8 \uc218\ub97c \uc81c\ud55c\ud558\uba70, 10\ubbf8\ud06c\ub860 \ubc0f 25\ubbf8\ud06c\ub860 \ucd08\uacfc \uc785\uc790\uc5d0 \ub300\ud55c \ud2b9\uc815 \uae30\uc900\uce58\ub97c \uaddc\uc815\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uae30\uc900\uc744 \ucda9\uc871\ud558\ub824\uba74 \uc81c\uc5b4\ub41c \ud658\uacbd\uc758 ISBM \uc0dd\uc0b0(\uc77c\ubc18\uc801\uc73c\ub85c \uc758\uc57d\ud488 \ubd84\uc57c\uc5d0\uc11c\ub294 ISO 8 \ud074\ub9b0\ub8f8\uc5d0 \uc900\ud558\ub294 \ud658\uacbd)\uacfc \uc815\uae30\uc801\uc778 \uc0d8\ud50c\ub9c1 \ubc0f \ud14c\uc2a4\ud2b8, \uadf8\ub9ac\uace0 \uae30\uc900\uce58 \ubbf8\ub2ec \uc0ac\ub840\uc5d0 \ub300\ud55c \uc644\ubcbd\ud55c \ubb38\uc11c\ud654\uac00 \ud544\uc218\uc801\uc785\ub2c8\ub2e4. \uc81c\uc57d \ubd84\uc57c\uc5d0 \uc81c\ud488\uc744 \uacf5\uae09\ud558\ub294 \ud55c\uad6d \uc81c\uc870\uc5c5\uccb4\ub4e4\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \uc81c\uc5b4\ub41c \ud658\uacbd \uc778\ud504\ub77c\ub97c \uac16\ucd98 \uc804\uc6a9 ISBM \ud50c\ub7ab\ud3fc\uc744 \uc758\uc57d\ud488 \uc0dd\uc0b0\uc5d0 \ud65c\uc6a9\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

    \uc81c\uc57d \ud488\uc9c8 \uae30\uc900\uc744 \ub4b7\ubc1b\uce68\ud558\ub294 \uc608\ubc29 \uc815\ube44 \ubc0f \uc6b4\uc601 \uaddc\uc728\uc5d0 \ub300\ud574\uc11c\ub294 \ub2e4\uc74c\uc744 \ucc38\uc870\ud558\uc2ed\uc2dc\uc624. \uc720\uc9c0\ubcf4\uc218 \uccb4\ud06c\ub9ac\uc2a4\ud2b8 \ud504\ub808\uc784\uc6cc\ud06c<\/a>\uc81c\uc57d \ud68c\uc0ac\uc758 \uc6b4\uc601\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \uc608\ubc29\uc801 \uc870\uce58\uc5d0 \ub300\ud55c \ubb38\uc11c\ud654\ub41c \uae30\ub85d \uc694\uac74 \ub54c\ubb38\uc5d0 \ub354 \ube48\ubc88\ud55c \uc720\uc9c0 \ubcf4\uc218 \uc77c\uc815(3\uc8fc\ub9c8\ub2e4 \uc218\ud589\ub418\ub294 3\ub2e8\uacc4 \uc6d4\uac04 \uc791\uc5c5, 10\uc8fc\ub9c8\ub2e4 \uc218\ud589\ub418\ub294 4\ub2e8\uacc4 \ubd84\uae30\ubcc4 \uc791\uc5c5)\uc744 \uc2e4\ud589\ud569\ub2c8\ub2e4.<\/p>\n

    <\/p>\n

    6. K-GMP\/FDA\/EMA \uaddc\uc81c \uccb4\uacc4<\/h2>\n

    \ud55c\uad6d\uc758 \uc758\uc57d\ud488 \ud3ec\uc7a5 \uacf5\uae09\uc5c5\uccb4\ub4e4\uc740 \uc5ec\ub7ec \uac1c\uc758 \uc911\ucca9\ub41c \uaddc\uc81c \uccb4\uacc4 \ud558\uc5d0\uc11c \uc6b4\uc601\ub429\ub2c8\ub2e4. \ud55c\uad6d \uc758\uc57d\ud488 \uc81c\uc870\uc5d0\ub294 K-GMP(\ud55c\uad6d \uc758\uc57d\ud488 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900)\uac00 \uc801\uc6a9\ub418\uace0, \ubbf8\uad6d \uc218\ucd9c\uc5d0\ub294 FDA 21 CFR Part 11\uc774, \uc720\ub7fd \uc218\ucd9c\uc5d0\ub294 EU GMP Annex 11\uc774 \uc801\uc6a9\ub429\ub2c8\ub2e4. \uc77c\ubcf8(PMDA)\uacfc \uc911\uad6d(NMPA)\uc5d0\ub3c4 \uc720\uc0ac\ud55c \uaddc\uc81c \uccb4\uacc4\uac00 \uc874\uc7ac\ud569\ub2c8\ub2e4. \uc218\ucd9c \uc2dc\uc7a5\uc744 \ub300\uc0c1\uc73c\ub85c \ud558\ub294 \ud55c\uad6d\uc758 ISBM(\ud1b5\ud569 \uc758\uc57d\ud488 \ud3ec\uc7a5) \uc81c\uc870\uc5c5\uccb4\uc5d0\uac8c \uc788\uc5b4, \uc5ec\ub7ec \uad00\ud560\uad8c\uc758 \uaddc\uc81c \uc900\uc218\ub294 \uc120\ud0dd \uc0ac\ud56d\uc774 \uc544\ub2cc \ud544\uc218 \uc0ac\ud56d\uc785\ub2c8\ub2e4.<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n
    \uaddc\uc81c \uccb4\uacc4<\/th>\n\uad8c\ud55c<\/th>\n\ud544\uc218 \uc694\uad6c\uc0ac\ud56d<\/th>\n<\/tr>\n<\/thead>\n
    K-GMP<\/td>\n\ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98<\/td>\n\uc81c\ud488\ubcc4, \uc2dc\uc124\ubcc4 \uc778\uc99d<\/td>\n<\/tr>\n
    FDA 21 CFR \ud30c\ud2b8 11<\/td>\n\ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)<\/td>\n\uc804\uc790 \uae30\ub85d \uac80\uc99d<\/td>\n<\/tr>\n
    EU GMP \ubd80\ub85d 11<\/td>\n\uc720\ub7fd \u200b\u200bEMA<\/td>\n\ucef4\ud4e8\ud130 \uc2dc\uc2a4\ud15c<\/td>\n<\/tr>\n
    \ub514\uc2a4\uce74\uc0ac<\/td>\n\ubbf8\uad6d (\uc758\uc57d\ud488 \uacf5\uae09\ub9dd \ubcf4\uc548\ubc95)<\/td>\n\ub2e8\uc704 \ub808\ubca8\ub85c \uc9c1\ub82c\ud654<\/td>\n<\/tr>\n
    EU FMD<\/td>\nEU (\uc704\uc870 \uc758\uc57d\ud488 \uc9c0\uce68)<\/td>\n2D \ubc14\ucf54\ub4dc + \u200b\u200b\uc704\uc870 \ubc29\uc9c0<\/td>\n<\/tr>\n
    ISO 15378<\/td>\n\uad6d\uc81c\uc801\uc778<\/td>\n1\ucc28 \ud3ec\uc7a5 GMP<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(MFDS)\uc758 \uc678\uad6d \uc758\uc57d\ud488 \uc2b9\uc778 \uc808\ucc28\ub294 \ud604\uc9c0 \ub4f1\ub85d \ubc0f \uc9c0\uc18d\uc801\uc778 \uaddc\uc815 \uc900\uc218\ub97c \ub2f4\ub2f9\ud558\ub294 \ud604\uc9c0 \ub300\ub9ac\uc778(ICC) \uc9c0\uc815\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4. MFDS\ub294 \uacf5\ud1b5\uae30\uc220\ubb38\uc11c(CTD) \ud615\uc2dd\uc758 \uc11c\ub958\ub97c \uc811\uc218\ud558\uba70, \uc77c\ubd80 \ud56d\ubaa9\uc740 \ud55c\uad6d\uc5b4 \ubc88\uc5ed\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. GIFT(Global Innovative Product on Fast Track) \ud504\ub85c\uadf8\ub7a8\uc744 \ud3ec\ud568\ud55c \uc2e0\uc18d \uc2ec\uc0ac \uc81c\ub3c4\ub97c \ud1b5\ud574 \ud76c\uadc0 \uc758\uc57d\ud488 \ubc0f \uc0dd\uba85\uc744 \uc704\ud611\ud558\ub294 \uc9c8\ud658 \uce58\ub8cc\uc81c\uc758 \uc2b9\uc778\uc774 \uac00\uc18d\ud654\ub429\ub2c8\ub2e4. \uc758\uc57d\ud488 \ud3ec\uc7a5\uc7ac \uacf5\uae09\uc5c5\uccb4\uc758 \uacbd\uc6b0, K-GMP \uc778\uc99d\uc740 \uc81c\ud488\ubcc4, \uc2dc\uc124\ubcc4\ub85c \ubd80\uc5ec\ub418\ubbc0\ub85c \ub2e4\uc218\uc758 \uc81c\ud488\uc744 \ucde8\uae09\ud558\ub294 \ub370 \ud544\uc694\ud55c \uc0c1\ub2f9\ud55c \uaddc\ubaa8\uc758 \ubb38\uc11c \uc778\ud504\ub77c\ub97c \uad6c\ucd95\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

    \uc57d\uc804 \ubc0f GMP \ud504\ub808\uc784\uc6cc\ud06c\ub97c \ub118\uc5b4, ISO 15378\uc740 \uc758\uc57d\ud488 1\ucc28 \ud3ec\uc7a5 \uc81c\uc870\uc5d0 \ud2b9\ud654\ub41c \ud45c\uc900\uc785\ub2c8\ub2e4. ISO 15378\uc740 GMP \uc6d0\uce59\uc744 1\ucc28 \ud3ec\uc7a5 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc5d0 \ud1b5\ud569\ud558\uc5ec \uad6d\uc81c\uc801\uc73c\ub85c \uc778\uc815\ubc1b\ub294 \uc778\uc99d \uccb4\uacc4\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. ISO 15378 \uc778\uc99d\uc744 \ud68d\ub4dd\ud55c \ud55c\uad6d ISBM(\uc758\uc57d\ud488 \ud3ec\uc7a5 \uc81c\uc870) \uc5c5\uccb4\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \ub192\uc740 \uac00\uaca9 \uacbd\uc7c1\ub825\uc744 \ud655\ubcf4\ud558\uace0, \uae00\ub85c\ubc8c \uc2dc\uc7a5\uc73c\ub85c \uc9c4\ucd9c\ud558\ub294 \ud55c\uad6d \uc81c\uc57d \ud68c\uc0ac\ub4e4\uacfc\uc758 \uc9c0\uc18d\uc801\uc778 \uace0\uac1d \uad00\uacc4\ub97c \uad6c\ucd95\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. ISO 9001(\uc77c\ubc18 \ud488\uc9c8 \uad00\ub9ac) \ubc0f ISO 14001(\ud658\uacbd \uad00\ub9ac)\uacfc \ud568\uaed8 ISO 15378\uc740 \uc81c\uc57d \uc2dc\uc7a5\uc5d0 \uc9c4\ucd9c\ud560 \uc218 \uc788\ub294 \ud55c\uad6d ISBM \uc5c5\uccb4\uc5d0\uac8c \ud544\uc218\uc801\uc778 \uc778\uc99d 3\uc911\uc8fc\ub97c \uad6c\uc131\ud569\ub2c8\ub2e4.<\/p>\n

    <\/p>\n

    7. \uc0b4\uade0 \ud638\ud658\uc131<\/h2>\n
    \"ISO
    <\/figcaption><\/figure>\n

    \uc758\uc57d\ud488 \ud3ec\uc7a5\uc740 \ub0b4\uc6a9\ubb3c \ubc0f \ucd5c\uc885 \uc6a9\ub3c4\uc5d0 \uc801\ud569\ud55c \uba78\uade0 \uacf5\uc815\uc744 \uacac\ub38c\uc57c \ud569\ub2c8\ub2e4. \uc758\uc57d\ud488 \ud3ec\uc7a5 \uba78\uade0\uc5d0\ub294 \uc8fc\ub85c \uc138 \uac00\uc9c0 \uc8fc\uc694 \ubc29\ubc95\uc774 \uc0ac\uc6a9\ub418\uba70, \uac01 \ubc29\ubc95\ub9c8\ub2e4 \uace0\uc720\ud55c \uc7ac\ub8cc \ud638\ud658\uc131 \uc694\uad6c \uc0ac\ud56d\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

    \n\n\n\n\n\n\n\n\n\n
    \uba78\uade0 \ubc29\ubc95<\/th>\n\uc815\ud669<\/th>\n\ud638\ud658 \uac00\ub2a5\ud55c \uc7ac\ub8cc<\/th>\n<\/tr>\n<\/thead>\n
    \uc99d\uae30 \uc624\ud1a0\ud074\ub808\uc774\ube0c<\/td>\n121\u00b0C, 15\ubd84<\/td>\nPP, PPSU, \uc720\ub9ac<\/td>\n<\/tr>\n
    \uc5d0\ud2f8\ub80c\uc625\uc0ac\uc774\ub4dc(EtO)<\/td>\n38-55\u00b0C, \uac00\uc2a4 \ub178\ucd9c<\/td>\nPE, PET, PETG, PP, \ud2b8\ub77c\uc774\ud0c4<\/td>\n<\/tr>\n
    \uac10\ub9c8\uc120 \uc870\uc0ac<\/td>\n25-50 kGy \uc120\ub7c9<\/td>\nPE, PET, PETG (\uc548\uc815\uc81c \ucca8\uac00)<\/td>\n<\/tr>\n
    \uacfc\uc0b0\ud654\uc218\uc18c(VHP)<\/td>\n25-40\u00b0C, \uc99d\uae30<\/td>\n\ub300\ubd80\ubd84\uc758 \ud50c\ub77c\uc2a4\ud2f1<\/td>\n<\/tr>\n
    \ubb34\uade0 \ucda9\uc804<\/td>\n\uc816\ubcd1\uc740 \ubbf8\ub9ac \uc0b4\uade0 \ucc98\ub9ac\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/td>\n\ubaa8\ub4e0 \uc81c\uc57d \uc7ac\ub8cc<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \ub808\ud1a0\ub974\ud2b8 \uba78\uade0(104\u00b0C \uc774\uc0c1\uc758 \uc624\ud1a0\ud074\ub808\uc774\ube0c \ucc98\ub9ac)\uc774 \ud544\uc694\ud55c \ud55c\uad6d \uc720\uc544\uc6a9 \uc870\uc81c\ubd84\uc720 \uc81c\uc870\uc5c5\uccb4\uc758 \uacbd\uc6b0, PP \ud3f4\ub9ac\ud504\ub85c\ud544\ub80c\uc774 \ud45c\uc900 \uc18c\uc7ac\ub85c \uc0ac\uc6a9\ub429\ub2c8\ub2e4. PET\ub294 \uc624\ud1a0\ud074\ub808\uc774\ube0c \uc628\ub3c4\uc5d0 \uacac\ub51c \uc218 \uc5c6\uc73c\uba70, \ud2b8\ub77c\uc774\ud0c4\uc740 109\u00b0C\ubd80\ud130 \uc0ac\uc6a9 \uac00\ub2a5 \uc628\ub3c4 \ud55c\uacc4\uc5d0 \ub3c4\ub2ec\ud558\uae30 \uc2dc\uc791\ud569\ub2c8\ub2e4. PPSU\ub294 180\u00b0C \uc774\uc0c1\uc758 \uc6b0\uc218\ud55c \uba78\uade0 \ub0b4\uc131\uc744 \uc81c\uacf5\ud558\uc9c0\ub9cc \uac00\uaca9\uc774 \uc0c1\ub2f9\ud788 \ub192\uc544 \uace0\uae09 \uc758\ub8cc\uc6a9\uc73c\ub85c\ub9cc \uc801\ud569\ud569\ub2c8\ub2e4. \uc774 \ubc94\uc8fc\uc758 \uc18c\uc7ac \uc120\ud0dd\uc5d0 \ub300\ud55c \uc790\uc138\ud55c \ub0b4\uc6a9\uc740 \ub2e4\uc74c\uc744 \ucc38\uc870\ud558\uc2ed\uc2dc\uc624. PP\uc640 PET \ube44\uad50 \uac00\uc774\ub4dc<\/a>.<\/p>\n

    \uac10\ub9c8\uc120 \uc870\uc0ac\uc5d0\ub294 \uc774\uc628\ud654 \ubc29\uc0ac\uc120 \ub178\ucd9c \uc2dc \uace0\ubd84\uc790 \ubd84\ud574\ub97c \ubc29\uc9c0\ud558\ub294 \uc548\uc815\uc81c\uac00 \ud568\uc720\ub41c \ud2b9\uc815 \ub4f1\uae09\uc758 \uc7ac\ub8cc\uac00 \ud544\uc694\ud569\ub2c8\ub2e4. \uc77c\ubc18 PET\ub294 \uc77c\ubc18\uc801\uc778 \uc758\uc57d\ud488 \uac10\ub9c8\uc120 \uc870\uc0ac\ub7c9(25~50kGy)\uc5d0\uc11c \ubd84\uc790\ub7c9 \uac10\uc18c \ubc0f \uc0c9\uc0c1 \ubcc0\ud654\ub97c \uacaa\uc9c0\ub9cc, \uac10\ub9c8\uc120 \uc548\uc815\ud654 PET \ub4f1\uae09\uc740 \uc774\ub7ec\ud55c \uc870\uac74\uc5d0\uc11c\ub3c4 \uae30\uacc4\uc801 \ud2b9\uc131 \ubc0f \ucc28\ub2e8\uc131\uc744 \uc720\uc9c0\ud569\ub2c8\ub2e4. \uac10\ub9c8\uc120 \uba78\uade0 \uc6a9\ub3c4\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ud55c\uad6d ISBM \uc81c\uc870\uc5c5\uccb4\ub294 \uc774\ub7ec\ud55c \ud2b9\uc218 \uc548\uc815\ud654 \uc218\uc9c0 \ub4f1\uae09\uc744 \uacf5\uae09\ubc1b\uc544\uc57c \ud558\uba70, \uaddc\uc81c \uae30\uad00 \uc81c\ucd9c \uc11c\ub958\uc5d0 \uc548\uc815\ud654 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc815\ubcf4\ub97c \uba85\uc2dc\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

    <\/p>\n

    8. \ud55c\uad6d \uc81c\uc57d\ud68c\uc0ac ISBM \ud30c\ud2b8\ub108 \uc120\uc815<\/h2>\n

    \uc81c\uc57d ISBM \ud30c\ud2b8\ub108 \uc120\uc815\uc740 \uc790\ubcf8 \ube44\uc6a9 \ucd5c\uc801\ud654\ubcf4\ub2e4\ub294 \uaddc\uc81c \uc900\uc218 \ubc0f \uc6b4\uc601 \uaddc\uc728\uc744 \uc911\uc2dc\ud569\ub2c8\ub2e4. \ud55c\uad6d \uc81c\uc57d \ube0c\ub79c\ub4dc\ub4e4\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \uaddc\uc81c \uc900\uc218\ub97c \ucd5c\uc6b0\uc120\uc73c\ub85c \ud558\ub294 \uc870\ub2ec \ub17c\ub9ac\ub97c \ubc18\uc601\ud558\uc5ec 7\uac00\uc9c0 \uae30\uc900\uc5d0 \ub530\ub77c \uacf5\uae09\uc5c5\uccb4\ub97c \ud3c9\uac00\ud569\ub2c8\ub2e4.<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n\n
    \ud3c9\uac00 \uae30\uc900<\/th>\n\uc911\uc694 \uc9c0\ud45c<\/th>\n<\/tr>\n<\/thead>\n
    1. \ud488\uc9c8 \uc778\uc99d \uc81c\ud488\uad70<\/td>\nISO 15378 + ISO 9001 + K-GMP<\/td>\n<\/tr>\n
    2. \uc7ac\ub8cc \ud488\uc9c8 \uc778\uc99d<\/td>\nUSP 6\uae09 \ub4f1\uae09 \uc7ac\uace0 \ubcf4\uc720<\/td>\n<\/tr>\n
    3. \ub2e4\uc911 \uad00\ud560\uad8c \uaddc\uc815 \uc900\uc218<\/td>\nFDA + EMA + MFDS + JP<\/td>\n<\/tr>\n
    4. \ubb38\uc11c\ud654 \uc778\ud504\ub77c<\/td>\nDMF + DoC + CoA \uae30\ub2a5<\/td>\n<\/tr>\n
    5. \uc0b4\uade0 \ud638\ud658\uc131<\/td>\n\ub2e4\uc911 \ubc29\ubc95 \uac80\uc99d\ub428<\/td>\n<\/tr>\n
    6. \uc9c1\ub82c\ud654 \uc9c0\uc6d0<\/td>\nDSCSA + EU FMD \uc900\ube44 \uc644\ub8cc<\/td>\n<\/tr>\n
    7. \uac10\uc0ac \uae30\ub2a5<\/td>\n\uace0\uac1d \uac10\uc0ac \ud504\ub85c\uadf8\ub7a8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

    \uacf5\uae09\uc5c5\uccb4 \uc5ed\ub7c9 \uc911 \uac00\uc7a5 \uacfc\uc18c\ud3c9\uac00\ub418\ub294 \ubd80\ubd84\uc740 \ubc14\ub85c \ubb38\uc11c \uc778\ud504\ub77c\uc785\ub2c8\ub2e4. \uc81c\uc57d \ud3ec\uc7a5 \ud504\ub85c\uc81d\ud2b8\uc5d0\ub294 \uc6d0\uc7ac\ub8cc\uc5d0 \ub300\ud55c \uc758\uc57d\ud488 \ub9c8\uc2a4\ud130 \ud30c\uc77c(DMF), \uc801\ud569\uc131 \uc120\uc5b8\uc11c(DoC), \ubc30\uce58\ubcc4 \ubd84\uc11d \uc99d\uba85\uc11c(CoA), \uadf8\ub9ac\uace0 \ubaa8\ub4e0 \ubcc0\uacbd \uc0ac\ud56d\uc5d0 \ub300\ud55c \uad6c\uccb4\uc801\uc778 \ubcc0\uacbd \uad00\ub9ac \uc808\ucc28\ub97c \ud3ec\ud568\ud55c \ud3ec\uad04\uc801\uc778 \ubb38\uc11c\uac00 \ud544\uc694\ud569\ub2c8\ub2e4. \uc81c\ub300\ub85c \ub41c \ubb38\uc11c \uc778\ud504\ub77c\uac00 \uad6c\ucd95\ub418\uc9c0 \uc54a\uc740 \ud55c\uad6d\uc758 ISBM(\ud1b5\ud569 \ud3ec\uc7a5 \uc81c\uc870 \ubc0f \ud3ec\uc7a5) \uc5c5\uccb4\ub294 \ubb3c\ub9ac\uc801 \uc0dd\uc0b0 \ub2a5\ub825\uacfc \uad00\uacc4\uc5c6\uc774 \uc81c\uc57d \uace0\uac1d\uc758 \uc2ec\uc0ac\ub97c \ud1b5\uacfc\ud558\uc9c0 \ubabb\ud558\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc2b5\ub2c8\ub2e4. \uc81c\uc57d \uc5c5\uacc4\uc5d0\uc11c \ud65c\uc6a9 \uac00\ub2a5\ud55c \ubb38\uc11c \uc2dc\uc2a4\ud15c\uc744 \uad6c\ucd95\ud558\ub294 \ub370\uc5d0\ub294 6~12\uac1c\uc6d4\uc758 \uc2dc\uac04\uc774 \uc18c\uc694\ub429\ub2c8\ub2e4.<\/p>\n

    \uace0\uac1d \uac10\uc0ac \uc5ed\ub7c9\uc740 \uc81c\uc57d \uc5c5\uacc4 \uacbd\ud5d8\uc774 \ud48d\ubd80\ud55c \uacf5\uae09\uc5c5\uccb4\uc640 \uc774\uc81c \ub9c9 \uad00\uc2ec\uc744 \uac16\uae30 \uc2dc\uc791\ud55c \uacf5\uae09\uc5c5\uccb4\ub97c \uad6c\ubd84\ud558\ub294 \uc911\uc694\ud55c \uc694\uc18c\uc785\ub2c8\ub2e4. \uae30\uc874\uc758 \uc81c\uc57d \ud3ec\uc7a5 \uacf5\uae09\uc5c5\uccb4\ub294 \uac10\uc0ac \ub300\uc751\uc744 \uc704\ud55c \uc804\uc6a9 \uc778\ud504\ub77c\ub97c \uad6c\ucd95\ud558\uace0, \uacf5\uc2dd\uc801\uc778 \ud45c\uc900 \uc6b4\uc601 \uc808\ucc28(SOP)\ub97c \ub9c8\ub828\ud558\uba70, \uc5f0\uac04 2~4\ud68c\uc758 \uace0\uac1d \uac10\uc0ac\ub97c \uc218\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ubc18\uba74, \uc2e0\uaddc \uc81c\uc57d \uacf5\uae09\uc5c5\uccb4\ub294 \uc8fc\uc694 \uc81c\uc57d \uace0\uac1d\uacfc\uc758 \uad00\uacc4\ub97c \uc548\uc815\uc801\uc73c\ub85c \uc720\uc9c0\ud558\uae30 \uc704\ud574 \uc77c\ubc18\uc801\uc73c\ub85c 18~24\uac1c\uc6d4\uc758 \uac10\uc0ac \uc900\ube44 \ud22c\uc790 \uae30\uac04\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uc81c\uc57d \uc5c5\uacc4 \uc9c4\ucd9c \uc5ed\ub7c9\uc744 \uad6c\ucd95\ud558\ub824\ub294 \ud55c\uad6d\uc758 ISBM(\uad6d\uc81c \ud45c\uc900 \ubcd1\uc785 \ud3ec\uc7a5) \uc0dd\uc0b0\uc5c5\uccb4\ub294 \uccab \uace0\uac1d\uacfc\uc758 \uc811\ucd09 \uc804\uc5d0 12\uac1c\uc6d4\uc758 \uc900\ube44 \uae30\uac04\uc744 \ub450\uace0 \uac10\uc0ac \uc900\ube44\ub97c \uacc4\ud68d\ud574\uc57c \ud569\ub2c8\ub2e4. \uc624\uc1a1, \ub300\uc804, \ucda9\uc8fc \uc0dd\uc0b0 \uc2dc\uc124\uc758 \ud3ec\uad04\uc801\uc778 \ud55c\uad6d \uc81c\uc57d GMP \ubcd1 \uc0dd\uc0b0 \uc0ac\uc591\uc740 \ub2e4\uc74c\uc744 \ucc38\uc870\ud558\uc2ed\uc2dc\uc624. \uc81c\uc57d GMP \ubcd1 \uc0dd\uc0b0 \uac00\uc774\ub4dc<\/a>.<\/p>\n

    <\/p>\n

    9. \uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38<\/h2>\n
    \n
    \n

    \uc9c8\ubb38: \uc2dd\ud488 \uc811\ucd09 \uc7ac\ub8cc \uc801\uaca9\uc131 \ud3c9\uac00\uc640 \uc758\uc57d\ud488 \ub4f1\uae09 \uc7ac\ub8cc \uc801\uaca9\uc131 \ud3c9\uac00\uc758 \ucc28\uc774\uc810\uc740 \ubb34\uc5c7\uc778\uac00\uc694?<\/p>\n

    \uc2dd\ud488 \uc811\ucd09 \uc7ac\ub8cc\ub294 \uc77c\ubc18\uc801\uc778 \ucde8\uae09 \ubc0f \uc12d\ucde8 \uacfc\uc815\uc5d0\uc11c \uc2dd\ud488\uacfc \uc6b0\ubc1c\uc801\uc73c\ub85c \uc811\ucd09\ud558\ub354\ub77c\ub3c4 \ub3c5\uc131\uc774 \uc5c6\uc74c\uc744 \uc785\uc99d\ud574\uc57c \ud569\ub2c8\ub2e4. \uc81c\uc57d \ub4f1\uae09 \uc7ac\ub8cc\ub294 \ucd94\uac00\uc801\uc73c\ub85c \uc7a5\uae30\uac04 \uc811\ucd09(\uc7a0\uc7ac\uc801\uc73c\ub85c \uc218\ub144\uac04 \ubcf4\uad00)\uc5d0 \ub300\ud55c \uc0dd\uccb4 \uc801\ud569\uc131, \uc81c\ud488\uc73c\ub85c\uc758 \ud654\ud559 \ubb3c\uc9c8 \uc774\ub3d9(\ucd94\ucd9c\ubb3c\/\uc6a9\ucd9c\ubb3c) \uc5c6\uc74c, \ubbf8\ub9bd\uc790 \ubb3c\uc9c8 \uad00\ub9ac, \uadf8\ub9ac\uace0 GMP \ubb38\uc11c\ud654\ub97c \ud1b5\ud55c \uc644\ubcbd\ud55c \ubc30\uce58 \ucd94\uc801\uc131\uc744 \uc785\uc99d\ud574\uc57c \ud569\ub2c8\ub2e4. \uc81c\uc57d \ub4f1\uae09 \uc778\uc99d\uc740 \uc77c\ubc18\uc801\uc73c\ub85c 12~24\uac1c\uc6d4\uc758 \uc2dc\ud5d8 \ubc0f \ubb38\uc11c\ud654 \uae30\uac04\uc774 \uc18c\uc694\ub418\ub294 \ubc18\uba74, \uc2dd\ud488 \uc811\ucd09 \ub4f1\uae09 \uc778\uc99d\uc740 3~6\uac1c\uc6d4\uc774 \uc18c\uc694\ub429\ub2c8\ub2e4. \uac00\uaca9 \ucc28\uc774\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc81c\uc57d \ub4f1\uae09 \uc7ac\ub8cc\uc5d0 \ub300\ud574 20~50%\uc758 \ud504\ub9ac\ubbf8\uc5c4\uc774 \ubd99\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n

    \n

    \uc9c8\ubb38: \uc2dc\ub9ac\uc5bc \ubc88\ud638 \ubd80\uc5ec\ub294 ISBM \ubcd1 \uc0dd\uc0b0\uc5d0 \uc5b4\ub5a4 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\uae4c?<\/p>\n

    \uc2dc\ub9ac\uc5bc \ubc88\ud638 \ubd80\uc5ec\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \ubcd1 \uc0dd\uc0b0 \ub2e8\uacc4\ubcf4\ub2e4\ub294 \ucda9\uc804\/\ub77c\ubca8\ub9c1 \ub2e8\uacc4\uc5d0\uc11c \uc801\uc6a9\ub429\ub2c8\ub2e4. ISBM(\ud1b5\ud569 \ubcd1 \uc81c\uc870) \uc5c5\uccb4\ub294 \uc548\uc815\uc801\uc778 \ub77c\ubca8 \ubd80\ucc29 \ubc0f \uc778\uc1c4\ub97c \uc704\ud574 \ubcd1\uc758 \uce58\uc218 \uc77c\uad00\uc131\uc744 \uc720\uc9c0\ud568\uc73c\ub85c\uc368 \ud6c4\uc18d \uacf5\uc815\uc5d0\uc11c \uc2dc\ub9ac\uc5bc \ubc88\ud638 \ubd80\uc5ec\ub97c \uc9c0\uc6d0\ud574\uc57c \ud569\ub2c8\ub2e4. \uad6c\uccb4\uc801\uc778 \uc124\uacc4 \uace0\ub824 \uc0ac\ud56d\uc5d0\ub294 \uc778\uc1c4\uba74\uc744 \uc704\ud55c \uace1\ub960\uc744 \uc81c\uc5b4\ud55c \ud3c9\uba74 \ub77c\ubca8 \ud328\ub110, \ucea1\uc564\uc530 \uc13c\uc11c\ub97c \uc9c0\uc6d0\ud558\ub294 \uc815\ubc00\ud55c \ubcd1\ubaa9 \ub9c8\uac10 \uce58\uc218, \uadf8\ub9ac\uace0 \ud6c4\uc18d \uc2dc\ub9ac\uc5bc \ubc88\ud638 \ubd80\uc5ec \uc7a5\ube44\uc5d0 \ubb38\uc81c\ub97c \uc77c\uc73c\ud0ac \uc218 \uc788\ub294 \uce58\uc218 \uc774\uc0c1\uce58\ub97c \uac10\uc9c0\ud558\ub294 \uc804\uccb4 \ubcd1 \uac80\uc0ac \uae30\ub2a5\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uce58\uc218 \uaddc\uaca9\uc744 \ucda9\uc871\ud558\uc9c0 \ubabb\ud558\ub294 \ubcd1\uc740 \ud6c4\uc18d \uc2dc\ub9ac\uc5bc \ubc88\ud638 \ubd80\uc5ec \uc7a5\ube44\uc758 \uc791\ub3d9 \uc911\ub2e8\uc744 \ucd08\ub798\ud558\uc5ec \ucda9\uc804 \ub77c\uc778\uc5d0 \uc0c1\ub2f9\ud55c \ube44\uc6a9 \uc190\uc2e4\uc744 \ubc1c\uc0dd\uc2dc\ud0ac \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n

    \n

    \uc9c8\ubb38: \ub3d9\uc77c\ud55c ISBM \ud50c\ub7ab\ud3fc\uc73c\ub85c \uc758\uc57d\ud488\uacfc \ube44\uc758\uc57d\ud488 \uc81c\ud488\uc744 \ubaa8\ub450 \uc0dd\uc0b0\ud560 \uc218 \uc788\uc2b5\ub2c8\uae4c?<\/p>\n

    \uc5c4\uaca9\ud55c \uc804\ud658 \ud504\ub85c\ud1a0\ucf5c\uc744 \uc900\uc218\ud55c\ub2e4\uba74 \uae30\uc220\uc801\uc73c\ub85c\ub294 \uac00\ub2a5\ud558\uc9c0\ub9cc, \uae30\uc874 \uc81c\uc57d \uc0dd\uc0b0 \uc2dc\uc124\uc5d0\uc11c\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uad8c\uc7a5\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ud55c\uad6d\uc758 \uc81c\uc57d \ud68c\uc0ac\ub4e4\uc740 \uad50\ucc28 \uc624\uc5fc \uc704\ud5d8\uc744 \ubc29\uc9c0\ud558\uace0 \uaddc\uc81c \ubb38\uc11c\uc758 \ubcf5\uc7a1\uc131\uc744 \ucd5c\uc18c\ud654\ud558\uae30 \uc704\ud574 \uc77c\ubc18\uc801\uc73c\ub85c \ud2b9\uc815 ISBM \ud50c\ub7ab\ud3fc\uc744 \uc758\uc57d\ud488 \uc0dd\uc0b0 \uc804\uc6a9\uc73c\ub85c \uc0ac\uc6a9\ud569\ub2c8\ub2e4. \ud50c\ub7ab\ud3fc \uacf5\uc720\ub97c \uc2dc\ub3c4\ud558\ub294 \uc18c\uaddc\ubaa8 \uc5c5\uccb4\ub294 \ud3ec\uad04\uc801\uc778 \uc138\ucc99 \uac80\uc99d, \ud30c\ub77c\ubbf8\ud130 \ub77c\uc774\ube0c\ub7ec\ub9ac \ubd84\ub9ac, \uc790\uc7ac \ucde8\uae09 \uaddc\uc728\uc744 \uc2dc\ud589\ud574\uc57c \ud569\ub2c8\ub2e4. \uacf5\uc720 \ud50c\ub7ab\ud3fc\uc5d0\uc11c \uad50\ucc28 \uc624\uc5fc \uc0ac\uace0\uac00 \ubc1c\uc0dd\ud558\uba74 \uc0dd\uc0b0 \uc911\ub2e8 \ub4f1 \uaddc\uc81c \uc870\uce58\uac00 \ucde8\ud574\uc9c8 \uc218 \uc788\uc73c\ubbc0\ub85c, \ud50c\ub7ab\ud3fc \uc804\uc6a9 \uc0ac\uc6a9\uc774 \uac00\uc7a5 \ubcf4\uc218\uc801\uc778 \uc6b4\uc601 \ubc29\uc2dd\uc785\ub2c8\ub2e4.<\/p>\n<\/div>\n

    \n

    Q: K-GMP \uc778\uc99d\uc744 \ubc1b\ub294 \ub370 \uc77c\ubc18\uc801\uc73c\ub85c \uc5bc\ub9c8\ub098 \uac78\ub9ac\ub098\uc694?<\/p>\n

    K-GMP \uc778\uc99d\uc740 \uc81c\ud488\ubcc4, \uc2dc\uc124\ubcc4\ub85c \ubd80\uc5ec\ub418\uba70, \ucd5c\ucd08 \uc778\uc99d\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \ud504\ub85c\uc81d\ud2b8 \ucc29\uc218 \ud6c4 12~18\uac1c\uc6d4\uc774 \uc18c\uc694\ub429\ub2c8\ub2e4. \uc778\uc99d \uacfc\uc815\uc5d0\ub294 \uc2dc\uc124 \ud3c9\uac00, \ubb38\uc11c \uc2dc\uc2a4\ud15c \uac1c\ubc1c, \uac80\uc99d \ud504\ub85c\ud1a0\ucf5c \uc2e4\ud589, \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(MFDS) \ud604\uc7a5 \uc2e4\uc0ac \ubc0f \uc0ac\ud6c4 \uac1c\uc120 \uc870\uce58\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uac31\uc2e0 \uc8fc\uae30\ub294 \uc77c\ubc18\uc801\uc73c\ub85c 3\ub144\uc774\uba70, \uac31\uc2e0 \uae30\uac04 \ub3d9\uc548 \uc815\uae30\uc801\uc778 \uc0ac\ud6c4 \uc2ec\uc0ac\uac00 \uc9c4\ud589\ub429\ub2c8\ub2e4. \uc2dd\ud488 \uc811\ucd09 \uc81c\ud488 \uc0dd\uc0b0\uc744 \uae30\ubc18\uc73c\ub85c \uc758\uc57d\ud488 \uc0dd\uc0b0 \uc5ed\ub7c9\uc744 \uad6c\ucd95\ud558\ub294 \ud55c\uad6d\uc758 ISBM(\ud1b5\ud569 \uc758\uc57d\ud488 \uc81c\uc870 \ubc0f \uc720\ud1b5) \uc5c5\uccb4\uc758 \uacbd\uc6b0, \uacbd\uc81c\uc801\uc73c\ub85c \uc2e4\ud589 \uac00\ub2a5\ud55c \uc758\uc57d\ud488 \uc0dd\uc0b0 \uc2dc\uc124\uc744 \uc124\ub9bd\ud558\uae30\uae4c\uc9c0 \ub2e4\ud488\ubaa9 K-GMP \uc778\uc99d \uc5ed\ub7c9\uc744 \ud655\ubcf4\ud558\ub294 \ub370 \ucd1d 24~36\uac1c\uc6d4\uc758 \ud22c\uc790 \uae30\uac04\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

    \n

    \uc9c8\ubb38: BPA\uac00 \ud568\uc720\ub418\uc9c0 \uc54a\uc740 \uc816\ubcd1\uc5d0 \ub300\ud55c \uc694\uad6c \uc0ac\ud56d\uc740 \uc81c\uc57d \ud3ec\uc7a5 \uaddc\uc815 \uc900\uc218\uc640 \uc5b4\ub5bb\uac8c \uc5f0\uad00\ub429\ub2c8\uae4c?<\/p>\n

    BPA \ubb34\ud568\uc720 \uc816\ubcd1 \uc694\uac74(\ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98, \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d, \uc720\ub7fd\uc2dd\ud488\uc548\uc804\ucc98 \ub4f1)\uc740 \uc77c\ubc18 \uc758\uc57d\ud488 \ud3ec\uc7a5\uc7ac \uaddc\uc815\uacfc \uc77c\ubd80 \uacb9\uce58\uc9c0\ub9cc \uadf8 \uc774\uc0c1\uc758 \uae30\uc900\uc744 \ud3ec\ud568\ud569\ub2c8\ub2e4. \uc758\uc57d\ud488 \uaddc\uc815\uc740 \uc131\uc778 \ud658\uc790 \uc9d1\ub2e8\uc5d0 \ub300\ud55c \uc0dd\uccb4 \uc801\ud569\uc131\uc744 \ub2e4\ub8e8\ub294 \ubc18\uba74, \uc816\ubcd1 \uaddc\uc815\uc740 \uc601\uc720\uc544\uc758 \ubc1c\ub2ec \ubc0f \ud638\ub974\ubaac\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5\uc744 \uad6c\uccb4\uc801\uc73c\ub85c \ub2e4\ub8f9\ub2c8\ub2e4. \uc758\uc57d\ud488 \ud3ec\uc7a5\uc7ac\uc5d0 \uc801\ud569\ud55c \uc7ac\ub8cc\ub77c\uace0 \ud574\uc11c \ubc18\ub4dc\uc2dc \uc816\ubcd1\uc5d0\ub3c4 \uc801\ud569\ud55c \uac83\uc740 \uc544\ub2c8\uba70, \ucd94\uac00\uc801\uc778 \uc601\uc720\uc544 \ub9de\ucda4\ud615 \ud14c\uc2a4\ud2b8\ub97c \uac70\uccd0\uc57c \ud569\ub2c8\ub2e4. \ud2b8\ub77c\uc774\ud0c4, PP, PPSU\ub294 \uc758\uc57d\ud488 \ubc0f \uc601\uc720\uc544 \ub9de\ucda4\ud615 \uc694\uac74\uc744 \ubaa8\ub450 \ucda9\uc871\ud558\ub294 \ub300\ud45c\uc801\uc778 \uc816\ubcd1 \uc7ac\ub8cc\uc785\ub2c8\ub2e4. \uc816\ubcd1 \uc7ac\ub8cc \uc120\ud0dd\uc5d0 \ub300\ud55c \uc790\uc138\ud55c \ub0b4\uc6a9\uc740 \ub2e4\uc74c\uc744 \ucc38\uc870\ud558\uc2ed\uc2dc\uc624. \ud2b8\ub77c\uc774\ud0c4 \uc816\ubcd1\uacfc PC \uc816\ubcd1 \ube44\uad50 \uac00\uc774\ub4dc<\/a>.<\/p>\n<\/div>\n<\/div>\n

    <\/p>\n

    10. \uacb0\ub860<\/h2>\n

    \ud55c\uad6d\uc758 ISBM(\ud1b5\ud569 \uc758\uc57d\ud488 \uc81c\uc870 \ubc0f \uc720\ud1b5) \uc0dd\uc0b0\uc740 \uc74c\ub8cc \ubc0f \ud654\uc7a5\ud488 \ubd84\uc57c\uc640\ub294 \uadfc\ubcf8\uc801\uc73c\ub85c \ub2e4\ub978, \uaddc\uc815 \uc900\uc218\ub97c \ucd5c\uc6b0\uc120\uc73c\ub85c \ud558\ub294 \uc870\ub2ec \ub17c\ub9ac\uc5d0 \ub530\ub77c \uc6b4\uc601\ub429\ub2c8\ub2e4. \uc2dc\uc7a5 \uc131\uc7a5 \ucd94\uc138(2033\ub144\uae4c\uc9c0 1\uc870 4\ucc9c\uc5b5 \ub2ec\ub7ec\uc5d0\uc11c 1\uc870 4\ucc9c\uc5b5 \ub2ec\ub7ec 30\uc5b5 \ub2ec\ub7ec\ub85c, \uc5f0\ud3c9\uade0 7.41\uc870 3\ucc9c\uc5b5 \ub2ec\ub7ec \uc131\uc7a5\ub960)\ub294 \uaddc\uc81c \uc778\ud504\ub77c\uc5d0 \ud22c\uc790\ud558\uace0\uc790 \ud558\ub294 \ud55c\uad6d ISBM \uc0dd\uc0b0\uc5c5\uccb4\uc5d0\uac8c \uc0c1\ub2f9\ud55c \uae30\ud68c\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc778\ud504\ub77c\uc5d0\ub294 K-GMP \uc778\uc99d, ISO 15378 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c, USP Class VI \ubb3c\uc9c8 \uc778\uc99d, \uadf8\ub9ac\uace0 K-\uc81c\uc57d \uc218\ucd9c \uc2dc\uc7a5\uc744 \uc704\ud55c \ub2e4\uad6d\uc801 \uaddc\uc81c \uc900\uc218 \uc9c0\uc6d0\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n

    \ud55c\uad6d \uc81c\uc57d \ube0c\ub79c\ub4dc\uc758 \uacbd\uc6b0, ISBM \ud30c\ud2b8\ub108 \uc120\uc815 \uc2dc \ud488\uc9c8 \uc778\uc99d \uc81c\ud488\uad70, \uc6d0\ub8cc \uac80\uc99d \uc5ed\ub7c9, \ub2e4\uad6d\uc801 \uaddc\uc81c \uc900\uc218 \ub2a5\ub825, \ubb38\uc11c \uc778\ud504\ub77c, \uba78\uade0 \ud638\ud658\uc131, \uc2dc\ub9ac\uc5bc \ubc88\ud638 \ubd80\uc5ec \uc900\ube44 \uc0c1\ud0dc, \uace0\uac1d \uac10\uc0ac \uc5ed\ub7c9 \ub4f1\uc744 \uc6b0\uc120\uc801\uc73c\ub85c \uace0\ub824\ud574\uc57c \ud569\ub2c8\ub2e4. \uc81c\uc57d \ubd84\uc57c \uacbd\ud5d8\uc774 \ud48d\ubd80\ud55c \uacf5\uae09\uc5c5\uccb4\uc640 \uc81c\uc57d \ubd84\uc57c\uc5d0 \ub300\ud55c \uad00\uc2ec\uc774 \ub0ae\uc740 \uacf5\uae09\uc5c5\uccb4 \uac04\uc758 \uc5ed\ub7c9 \uaca9\ucc28\ub294 \uc0c1\ub2f9\ud569\ub2c8\ub2e4. \uc790\ubcf8 \ube44\uc6a9 \ucd5c\uc801\ud654\ub97c \uae30\uc900\uc73c\ub85c \ud30c\ud2b8\ub108\ub97c \uc120\ud0dd\ud558\ub294 \ube0c\ub79c\ub4dc\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc870\ub2ec \ube44\uc6a9 \uc808\uac10 \ud6a8\uacfc\ub97c \uc0c1\ud68c\ud558\ub294 \ud488\uc9c8 \ubc0f \uaddc\uc81c \ubb38\uc81c\uc5d0 \uc9c1\uba74\ud558\uac8c \ub429\ub2c8\ub2e4. \uaddc\uc81c \uc900\uc218\ub97c \ucd5c\uc6b0\uc120\uc73c\ub85c \ud558\ub294 \uc811\uadfc \ubc29\uc2dd\uc740 \uc2dd\ud488 \uc811\ucd09 \ubd84\uc57c\uc5d0\uc11c \uae30\uc874 \uc0ac\uc5c5 \uc601\uc5ed\uc744 \ud655\uc7a5\ud558\ub824\ub294 \uc2e0\uaddc \uc5c5\uccb4\ubcf4\ub2e4\ub294 \uc81c\uc57d \ubd84\uc57c\uc5d0\uc11c \uac80\uc99d\ub41c \uc2e4\uc801\uc744 \ubcf4\uc720\ud55c \ud55c\uad6d\uc758 \uae30\uc874 \uc0dd\uc0b0 \uc5c5\uccb4\ub97c \uc120\ud638\ud569\ub2c8\ub2e4.<\/p>\n

    7\uac00\uc9c0 \uc81c\uc57d \uce74\ud14c\uace0\ub9ac \uc804\ubc18\uc5d0 \uac78\uce5c \uc18c\uc7ac \uc120\uc815\uc5d0\ub294 \uc0dd\uccb4 \uc801\ud569\uc131(USP Class VI), \uba78\uade0 \uc801\ud569\uc131(\uc99d\uae30, \uc5d0\ud2f8\ub80c \uc625\uc0ac\uc774\ub4dc, \uac10\ub9c8\uc120), \uadf8\ub9ac\uace0 \uce74\ud14c\uace0\ub9ac\ubcc4 \uc694\uad6c \uc0ac\ud56d(\uc816\ubcd1\uc758 \uacbd\uc6b0 BPA \ubb34\ud568\uc720, \uc2dc\ub7fd\uc758 \uacbd\uc6b0 \uad11 \ucc28\ub2e8, \uc77c\ubc18 \uc758\uc57d\ud488\uc758 \uacbd\uc6b0 \uc5b4\ub9b0\uc774 \ubcf4\ud638 \uae30\ub2a5)\uc744 \uc885\ud569\uc801\uc73c\ub85c \uace0\ub824\ud55c \uc758\uc0ac\uacb0\uc815\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \ud3ec\uad04\uc801\uc778 \uc81c\uc57d \ud3ec\ud2b8\ud3f4\ub9ac\uc624\ub97c \uc81c\uacf5\ud558\ub294 \ud55c\uad6d\uc758 ISBM(\ud1b5\ud569 \uc0b4\uade0 \ubc0f \uc81c\uc870 \uc6a9\uae30) \uc81c\uc870\uc5c5\uccb4\ub4e4\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \uad50\ucc28 \uc624\uc5fc \uc704\ud5d8\uacfc \uaddc\uc81c \ubb38\uc11c\uc758 \ubcf5\uc7a1\uc131\uc744 \ucd5c\uc18c\ud654\ud558\uae30 \uc704\ud574 \uc18c\uc7ac \uacc4\uc5f4\ubcc4\ub85c \uc804\uc6a9 \ud50c\ub7ab\ud3fc\uc744 \uc6b4\uc601\ud569\ub2c8\ub2e4. \uc81c\uc57d \ub4f1\uae09 \uc778\ud504\ub77c\uc5d0 \ub300\ud55c \ud22c\uc790\ub294 \uc218\uc2ed \ub144\uc5d0 \uac78\uce5c \uace0\uac1d \uad00\uacc4\uc640 \uc77c\ubc18 \uc74c\ub8cc \ub300\ube44 40~80%\uc758 \ub192\uc740 \ub9c8\uc9c4\uc744 \ud1b5\ud574 \uc9c0\uc18d\uc801\uc778 \uacbd\uc7c1 \uc6b0\uc704\ub97c \ucc3d\ucd9c\ud569\ub2c8\ub2e4.<\/p>\n

    \"\uc0ac\ucd9c-\uc5f0\uc2e0-\ube14\ub85c\uc6b0-\uc131\ud615<\/p>\n

    <\/p>\n

    \n

    \uc81c\uc57d \uc0dd\uc0b0 \uacc4\ud68d\uc744 \uc138\uc6b8 \uc900\ube44\uac00 \ub418\uc168\uc2b5\ub2c8\uae4c?<\/h3>\n

    \uadc0\uc0ac\uc758 \uc758\uc57d\ud488 \uc885\ub958, \ubaa9\ud45c \uc0dd\uc0b0\ub7c9, \uc6d0\ub8cc \uc694\uad6c\uc0ac\ud56d(USP Class VI), \uba78\uade0 \ubc29\ubc95 \ubc0f \uc218\ucd9c \uc2dc\uc7a5 \ud3ec\ud2b8\ud3f4\ub9ac\uc624\ub97c \uacf5\uc720\ud574 \uc8fc\uc2ed\uc2dc\uc624. \uc800\ud76c \ud55c\uad6d \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \ud300\uc774 5\uc601\uc5c5\uc77c \uc774\ub0b4\uc5d0 ISBM \ud50c\ub7ab\ud3fc \ucd94\ucc9c, \uc6d0\ub8cc \uac80\uc99d \ub85c\ub4dc\ub9f5, \uc778\uc99d \uc77c\uc815 \ubc0f \uaddc\uc81c \ubb38\uc11c \uc791\uc131 \uc9c0\uc6d0\uc744 \uc81c\uacf5\ud574 \ub4dc\ub9bd\ub2c8\ub2e4.<\/p>\n

    \uc81c\uc57d \ud504\ub85c\uc81d\ud2b8\uc5d0 \ub300\ud574 \ud1a0\ub860\ud574 \ubcf4\uc138\uc694 \u2192<\/a><\/p>\n<\/div>\n

    <\/p>\n

    \ud3b8\uc9d1\uc790: Cxm<\/p>\n<\/article>","protected":false},"excerpt":{"rendered":"

    \uc0b0\uc5c5\ubcc4 \uac00\uc774\ub4dc - \ud55c\uad6d \uc81c\uc57d ISBM \uc0dd\uc0b0: 2026\ub144 \uc885\ud569 \uc0b0\uc5c5 \uac00\uc774\ub4dc \ud55c\uad6d\uc758 \uc81c\uc57d \ud3ec\uc7a5 \uc2dc\uc7a5\uc740 \uace0\ub839\ud654\uc640 \ub9cc\uc131 \uc9c8\ud658 \uc720\ubcd1\ub960 \uc99d\uac00\uc5d0 \ud798\uc785\uc5b4 2033\ub144\uae4c\uc9c0 \uc5f0\ud3c9\uade0 74\uc5b5 1\ucc9c\ub9cc \ub2ec\ub7ec\uc5d0\uc11c 30\uc5b5 \ub2ec\ub7ec\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc81c\uc57d ISBM \uc0dd\uc0b0\uc740 \uaddc\uc815 \uc900\uc218\ub97c \ucd5c\uc6b0\uc120\uc73c\ub85c \ud558\ub294 \uc870\ub2ec \ub17c\ub9ac\ub97c \ud2b9\uc9d5\uc73c\ub85c \ud55c\ub2e4\ub294 \uc810\uc5d0\uc11c \uc74c\ub8cc \ubc0f \ud654\uc7a5\ud488 \ubd84\uc57c\uc640 \uadfc\ubcf8\uc801\uc73c\ub85c \ub2e4\ub985\ub2c8\ub2e4. \uc774 \uac00\uc774\ub4dc\ub294 [\u2026]<\/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\/ko\/wp-json\/wp\/v2\/posts\/697","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/comments?post=697"}],"version-history":[{"count":2,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/posts\/697\/revisions"}],"predecessor-version":[{"id":699,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/posts\/697\/revisions\/699"}],"wp:attachment":[{"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/media?parent=697"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/categories?post=697"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/tags?post=697"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}