{"id":937,"date":"2026-05-19T07:51:41","date_gmt":"2026-05-19T07:51:41","guid":{"rendered":"https:\/\/isbm-blow-molding.com\/?p=937"},"modified":"2026-05-19T07:51:41","modified_gmt":"2026-05-19T07:51:41","slug":"isbm-korean-pharma-oral-liquid-syrup-bottle-guide","status":"publish","type":"post","link":"https:\/\/isbm-blow-molding.com\/ko\/isbm-korean-pharma-oral-liquid-syrup-bottle-guide\/","title":{"rendered":"ISBM \ud55c\uad6d \uc81c\uc57d \uacbd\uad6c\uc6a9: \uc561\uc0c1 \uc2dc\ub7fd \ubcd1 \uac00\uc774\ub4dc"},"content":{"rendered":"
\n
\n
\n

ISBM \uc801\uc6a9 \u00b7 \ud55c\uad6d \uc81c\uc57d \uacbd\uad6c\uc6a9 \uc561\uc0c1\uc81c \u00b7 2026<\/p>\n

ISBM \ud55c\uad6d \uc81c\uc57d \uacbd\uad6c
\n\uc561\uc0c1 \uc2dc\ub7fd \ubcd1 \uc0ac\uc6a9 \uc124\uba85\uc11c<\/h1>\n

\ud55c\uad6d\uc758 \uacbd\uad6c\uc6a9\uc561 \uc758\uc57d\ud488 \uc2dc\uc7a5(\uc2dc\ub7fd, \ud604\ud0c1\uc561, \uacbd\uad6c\uc6a9\uc561)\uc740 5,800\uc5b5 \uc6d0 \uaddc\ubaa8\uc774\uba70, \uc774 \uc2dc\uc7a5\uc5d0\uc11c \ud3ec\uc7a5\uc740 \ub2e8\uc21c\ud55c \uc0c1\ud488\uc774 \uc544\ub2c8\ub77c \uc784\uc0c1\uc801\uc73c\ub85c \uc815\ubc00\ud55c \uae30\uae30\uc785\ub2c8\ub2e4. ISBM PET \ubc0f PP \uc7ac\uc9c8\uc758 \uacbd\uad6c\uc6a9\uc561 \uc6a9\uae30\ub294 \uc18c\ube44\uc7ac \uc74c\ub8cc\uc640 \ub3d9\uc77c\ud55c \uc0dd\uc0b0 \uaddc\ubaa8\uc5d0\uc11c \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \uc758\uc57d\ud488 \uc6a9\uae30 \uae30\uc900, \uc5b4\ub9b0\uc774 \ubcf4\ud638 \ub9c8\uac1c \uad00\ub828 \ubc95\uaddc, \uc815\ud655\ud55c \uc6a9\ub7c9 \ud45c\uc2dc, GMP \ucd94\uc801\uc131 \uc694\uac74\uc744 \ubaa8\ub450 \ucda9\uc871\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

5,800\uc5b5 \uc6d0 \uaddc\ubaa8\uc758 \uacbd\uad6c\uc6a9 \uc758\uc57d\ud488 \uc2dc\uc7a5<\/span>
\nKFDA \uac1c\uc815 \u5bb9\u5668 \uaddc\uc815 \uc900\uc218<\/span>
\nCRC \uc544\ub3d9\uc548\uc804\ud3ec\uc7a5\ubc95 \ud544\uc218<\/span><\/div>\n

\uc5d0\ubc84\ud30c\uc6cc \ud55c\uad6d \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \ub370\uc2a4\ud06c \u00b7 \uc548\uc0b0\uc2dc \u00b7 2026\ub144 5\uc6d4<\/p>\n<\/div>\n<\/header>\n

 <\/p>\n

<\/p>\n

\n
\n

580\uc6d0<\/p>\n

2025\ub144 \ud55c\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \uc2dc\uc7a5<\/p>\n<\/div>\n

\n

PET\/PP<\/p>\n

\ud55c\uad6d\uc0b0 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \ud3ec\uc7a5\uc7ac\uc6a9 \uc8fc\uc694 ISBM \uc218\uc9c0<\/p>\n<\/div>\n

\n

CRC<\/p>\n

\ud55c\uad6d\uc5d0\uc11c \ucc98\ubc29\ub418\ub294 \uacbd\uad6c\uc6a9 \uc561\uc81c\uc5d0\ub294 \uc5b4\ub9b0\uc774 \ubcf4\ud638\uc6a9 \ub69c\uaed1\uc774 \ud544\uc218\uc785\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

60~500ml<\/p>\n

\ud55c\uad6d \ud45c\uc900 \uacbd\uad6c\uc6a9\uc561 \uc6a9\uae30 \uc6a9\ub7c9 \ubc94\uc704<\/p>\n<\/div>\n

\n

55~120\uc6d0<\/p>\n

\ud504\ub9ac\ubbf8\uc5c4 \uacbd\uad6c\uc6a9 \uc561\uc0c1 ISBM \ubcd1 \uc704\ud0c1 \uac00\uaca9 (100~200ml)<\/p>\n<\/div>\n<\/div>\n

<\/p>\n

1. \ud55c\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \uc2dc\uc7a5 \ubc0f ISBM \ud3ec\uc7a5 \uae30\ud68c<\/h2>\n

\uc18c\uc544\uc6a9 \ud56d\uc0dd\uc81c, \uc5b4\ub9b0\uc774\uc6a9 \uae30\uce68 \uc2dc\ub7fd, \uc77c\ubc18\uc758\uc57d\ud488 \uc81c\uc0b0\uc81c, \ucca0\ubd84 \ubcf4\ucda9\uc81c, \ucc98\ubc29 \uacbd\uad6c\uc6a9\uc561 \ub4f1 \ud55c\uad6d\uc758 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488\uc740 \ud55c\uad6d \uc758\uc57d\ud488\uc548\uc804\ud3ec\uc7a5\uae30\uc900(KFDA Pharmaceutical Affairs Act)\uacfc \uc544\ub3d9\uc548\uc804\ud3ec\uc7a5\ub300\uc0c1\uae30\uc900(Child Safety Packaging Target Reform Design)\uc774\ub77c\ub294 \ub450 \uac00\uc9c0 \uaddc\uc81c \uccb4\uacc4\ub97c \ub3d9\uc2dc\uc5d0 \ucda9\uc871\ud574\uc57c \ud558\ubbc0\ub85c \ud55c\uad6d ISBM \ud3ec\uc7a5 \uc801\uc6a9 \ubd84\uc57c\uc5d0\uc11c \uae30\uc220\uc801\uc73c\ub85c \uac00\uc7a5 \uae4c\ub2e4\ub85c\uc6b4 \ud488\ubaa9 \uc911 \ud558\ub098\uc785\ub2c8\ub2e4. \ud574\ub2f9 \uc6a9\uae30\ub294 \uc2dd\ud488 \uc811\ucd09 \ud3ec\uc7a5\ubcf4\ub2e4 \uc5c4\uaca9\ud55c \uc57d\ubb3c \uc6a9\ucd9c \uc2dc\ud5d8\uc744 \ud1b5\uacfc\ud574\uc57c \ud558\uace0, \uc5b4\ub9b0\uc774 \ubcf4\ud638\uc6a9 \uc7a0\uae08\uc7a5\uce58(CRC)\ub97c \uc7a5\ucc29\ud574\uc57c \ud558\ubbc0\ub85c \uc6a9\uae30 \ubaa9 \ubd80\ubd84\uc758 \uc124\uacc4\uac00 \ub354\uc6b1 \ubcf5\uc7a1\ud574\uc9c0\uba70, \ud55c\uad6d\uc758 \uc57d\uc0ac\ub098 \ubcf4\ud638\uc790\uac00 \uc815\ud655\ud55c \uc6a9\ub7c9 \uce21\uc815\uc744 \uc704\ud574 \uc0ac\uc6a9\ud560 \uc218 \uc788\ub294 \ub208\uae08 \ud45c\uc2dc\uac00 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

\ud55c\uad6d\uc758 ISBM \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc81c\ud615 \ubcd1 \uc0dd\uc0b0\uc740 \ud55c\uad6d \uc81c\uc57d ISBM \uc2dc\uc7a5 \uc804\ubc18(\uc815\uc81c\/\ucea1\uc290 \uc81c\ud615 \ubc0f \uc815\ub9e5\uc8fc\uc0ac\uc81c \ud3ec\uc7a5\uc5d0 \uc911\uc810)\uacfc\ub294 \uad6c\ubcc4\ub429\ub2c8\ub2e4. \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc81c\ud615\uc740 \ubcc4\ub3c4\uc758 \uaddc\uc81c \uc900\uc218 \uacbd\ub85c\uc640 ISBM \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \uc694\uad6c \uc0ac\ud56d\uc744 \uac00\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ud55c\uad6d\uc758 \uc804\uccb4 \uc81c\uc57d GMP \ud3ec\uc7a5 \ud504\ub808\uc784\uc6cc\ud06c\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. \ud55c\uad6d \uc758\uc57d\ud488 GMP \ubcd1 \uc0dd\uc0b0 \uac00\uc774\ub4dc<\/a>.<\/p>\n

<\/p>\n

2. \ud55c\uad6d\uc0b0 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \uc6a9\uae30\uc6a9 PET \ubc0f PP \uc7ac\uc9c8<\/h2>\n
\"\uc0ac\ucd9c
\nISBM\uc758 \ud55c\uad6d\uc0b0 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \uc6a9\uae30 \uc81c\ud488\uad70\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. \ud22c\uba85 PET \uc7ac\uc9c8\uc758 100ml \uc18c\uc544\uc6a9 \ud56d\uc0dd\uc81c \uc2dc\ub7fd \uc6a9\uae30(\ud22c\uba85\ud558\uc5ec \uc81c\ud488 \uc0c9\uc0c1\uc774 \uc798 \ubcf4\uc784, CRC \ud478\uc2dc\uc564\ud134 \ucea1 \uc801\uc6a9), \ud638\ubc15\uc0c9 PET \uc7ac\uc9c8\uc758 200ml \ucca0\ubd84 \ubcf4\ucda9\uc81c \uacbd\uad6c\uc6a9\uc561 \uc6a9\uae30(\ucca0\uc5fc \uad11\ubd84\ud574 \ubc29\uc9c0\ub97c \uc704\ud55c \uc790\uc678\uc120 \ucc28\ub2e8 \uae30\ub2a5 \ud3ec\ud568), \ud770\uc0c9 PP \uc7ac\uc9c8\uc758 120ml \uc81c\uc0b0\uc81c \ud604\ud0c1\uc561 \uc6a9\uae30(\uc218\uc0b0\ud654\ub9c8\uadf8\ub124\uc298 \ud604\ud0c1\uc561\uc758 \ube5b \ucc28\ub2e8\uc744 \uc704\ud55c \ubd88\ud22c\uba85 \uc6a9\uae30), \uadf8\ub9ac\uace0 \ud55c\uad6d \uc57d\uad6d \uc870\uc81c\uc6a9 PETG \uc7ac\uc9c8\uc758 60ml \uc815\ubc00 \uacbd\uad6c\uc6a9 \uc810\uc801\uae30 \uc6a9\uae30\uc785\ub2c8\ub2e4.<\/figcaption><\/figure>\n

\ud55c\uad6d\uc758 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \uc6a9\uae30 \uc218\uc9c0 \uc120\ud0dd\uc740 \ud65c\uc131 \uc758\uc57d\ud488 \uc131\ubd84(API)\uc758 \ud654\ud559\uc801 \ud2b9\uc131\uacfc \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \uc758\uc57d\ud488 \uc6a9\uae30 \ud5c8\uc6a9 \ubaa9\ub85d\uc5d0 \ub530\ub77c \uacb0\uc815\ub429\ub2c8\ub2e4. \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \uc6a9\uae30\uc758 \uacbd\uc6b0, PET\ub294 \uc218\uc6a9\uc131 \uacbd\uad6c\uc6a9\uc561(\uc2dc\ub7fd, \uacbd\uad6c\uc6a9\uc561), \uc54c\ucf54\uc62c \ud568\uc720 \uacbd\uad6c\uc6a9\uc561(\uc5d0\ud0c4\uc62c 5~15%\ub97c \ud568\uc720\ud55c \ud55c\uad6d\uc0b0 \uc77c\ubc18\uc758\uc57d\ud488 \uae30\uce68\uc57d), \ucca0\ubd84 \ubcf4\ucda9\uc81c \uacbd\uad6c\uc6a9\uc561(\ud669\uc0b0\uc81c\uc77c\ucca0, \uad6c\uc5f0\uc0b0\uc81c\uc774\uc554\ubaa8\ub284)\uc5d0 \uc0ac\uc6a9 \uac00\ub2a5\ud569\ub2c8\ub2e4. \uc570\ubc84 \ub9c8\uc2a4\ud130\ubc30\uce58(\uc0b0\ud654\ucca0)\uac00 \ucca8\uac00\ub41c PET\ub294 \ud55c\uad6d\uc758 \uac10\uad11\uc131 \uacbd\uad6c\uc6a9\uc561(\ucca0\ubd84 \ubcf4\ucda9\uc81c, \ube44\ud0c0\ubbfc A, \ub9ac\ubcf4\ud50c\ub77c\ube48)\uc5d0 \ud544\uc218\uc801\uc774\uba70, 400nm\uc5d0\uc11c \uc790\uc678\uc120 \ud22c\uacfc\uc728\uc774 \u226410%\uc5ec\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

\uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc81c\ud488\uc5d0 PP\uac00 \ud544\uc694\ud55c \uacbd\uc6b0: \ud55c\uad6d \uc81c\uc0b0\uc81c \ud604\ud0c1\uc561(\uc218\uc0b0\ud654\ub9c8\uadf8\ub124\uc298, \uc218\uc0b0\ud654\uc54c\ub8e8\ubbf8\ub284, pH 8.5~10.5 - PET\uc758 \uad8c\uc7a5 pH \uc0c1\ud55c\uc120\uc778 9 \uc774\uc0c1)\uc5d0 \ud544\uc694\ud568; \ud55c\uad6d \uc774\ubd80\ud504\ub85c\ud39c \uacbd\uad6c\uc6a9 \ud604\ud0c1\uc561(\uc774\ubd80\ud504\ub85c\ud39c\uc740 \uce5c\uc720\uc131 \uc57d\ubb3c\ub85c \ud2b9\uc815 \uace0\ubd84\uc790 \ud761\ucc29 \uac70\ub3d9\uc744 \ubcf4\uc5ec \ud55c\uad6d \uc57d\uc804 \uaddc\uc815 \uc900\uc218\ub97c \uc704\ud574 PET\ubcf4\ub2e4 PP\uac00 \ud544\uc694\ud568)\uc5d0 \ud544\uc694\ud568; \uadf8\ub9ac\uace0 \ud55c\uad6d \uce74\uc62c\ub9b0-\ud399\ud2f4 \ud604\ud0c1\uc561(\ubd88\ud22c\uba85 \uc785\uc790 \ud604\ud0c1\uc561\uc73c\ub85c \uc81c\ud488 \uc678\uad00\uc758 \uc77c\uad00\uc131\uc744 \uc704\ud574 \ud770\uc0c9 PP\uac00 \ud544\uc694\ud568)\uc5d0 \ud544\uc694\ud568. \ud55c\uad6d \uc758\uc57d\ud488 \uc6a9\uae30\uc758 PET\uc640 PP \uc218\uc9c0 \uc120\ud0dd\uc5d0 \ub300\ud55c \uad8c\uc7a5 \ubaa9\ub85d\uc740 \uccb4\uacc4\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc744 \ub530\ub985\ub2c8\ub2e4. PET \uc218\uc9c0\uc640 PETG \uc218\uc9c0 \uc120\ud0dd \uac00\uc774\ub4dc<\/a>.<\/p>\n

<\/p>\n

3. \ud55c\uad6d\uc0b0 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488\uc758 \uc5b4\ub9b0\uc774 \ubcf4\ud638 \ub69c\uaed1 \uc124\uacc4<\/h2>\n

\ud55c\uad6d \uc544\ub3d9\ubcf4\ud638\ud3ec\uc7a5\uae30\uc900\uc740 \ubaa8\ub4e0 \uc18c\uc544\uc6a9 \ucc98\ubc29 \uc561\uc0c1 \uc758\uc57d\ud488\uacfc \ud2b9\uc815 \ub18d\ub3c4 \uc774\uc0c1\uc758 \ud65c\uc131 \uc131\ubd84(API)\uc744 \ud568\uc720\ud558\ub294 \ud2b9\uc815 \uc77c\ubc18\uc758\uc57d\ud488(OTC)(\uc5b4\ub9b0\uc774\uc6a9 \uc9c4\ud1b5\uc81c, \ud56d\ud788\uc2a4\ud0c0\ubbfc\uc81c, \ucca0\ubd84 \ubcf4\ucda9\uc81c)\uc5d0 \uc5b4\ub9b0\uc774 \ubcf4\ud638 \ub69c\uaed1(CRC) \uc0ac\uc6a9\uc744 \uc758\ubb34\ud654\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ud55c\uad6d\uc758 CRC \uc900\uc218 \uc694\uac74\uc740 \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc5d0\uc11c \uc9c0\uc815\ud55c CRC \uc131\ub2a5 \uc2dc\ud5d8\uc744 \ud1b5\uacfc\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. \uc989, \uc2dc\ud5d8 \ub300\uc0c1 \uc5b4\ub9b0\uc774(42~51\uac1c\uc6d4)\ub97c \ub300\uc0c1\uc73c\ub85c 5\ubd84 \uc774\ub0b4\uc5d0 \ub69c\uaed1\uc774 \uc5f4\ub9ac\uc9c0 \uc54a\ub294 \uacbd\uc6b0\uac00 85% \uc774\uc0c1\uc774\uace0, \uc131\uc778(50~70\uc138)\uc744 \ub300\uc0c1\uc73c\ub85c 5\ubd84 \uc774\ub0b4\uc5d0 \ub69c\uaed1\uc774 \uc131\uacf5\uc801\uc73c\ub85c \uc5f4\ub9ac\ub294 \uacbd\uc6b0\uac00 90% \uc774\uc0c1\uc774\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

\ud55c\uad6d ISBM \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30\uc758 CRC \ud638\ud658\uc131\uc744 \uc704\ud55c \ubcd1\ubaa9 \ub9c8\uac10: \ubcd1\ubaa9 \ud504\ub85c\ud30c\uc77c\uc740 \ud55c\uad6d \uc81c\uc57d \ube0c\ub79c\ub4dc\uc5d0\uc11c \uc9c0\uc815\ud55c \ud2b9\uc815 CRC \uc7a0\uae08 \uba54\ucee4\ub2c8\uc998\uc5d0 \uc801\ud569\ud574\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30\uc758 \uc77c\ubc18\uc801\uc778 CRC \uba54\ucee4\ub2c8\uc998\uc740 \ub450 \uac00\uc9c0\uc785\ub2c8\ub2e4. (1) \ud478\uc2dc \uc564 \ud134(P&T) CRC: \uc18c\ube44\uc790\uac00 \ucea1\uc744 \ub204\ub974\uba74\uc11c \ub3cc\ub824\uc57c \ud569\ub2c8\ub2e4. \ucea1\uc758 \ub204\ub984 \ub798\uce6b \ud1b1\ub2c8\uc5d0 \ub9de\ubb3c\ub9ac\ub294 \ud2b9\uc815 \uc5b4\uae68 \ud504\ub85c\ud30c\uc77c\uc744 \uac00\uc9c4 \ubcd1\ubaa9 \ub9c8\uac10\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uc77c\uad00\ub41c \ub798\uce6b \ub9de\ubb3c\ub9bc\ub825\uc744 \ubcf4\uc7a5\ud558\uae30 \uc704\ud574 \ubcd1\ubaa9 \uc678\uacbd \uacf5\ucc28\ub294 \u00b10.03mm(\ud45c\uc900 \uc81c\uc57d \uaddc\uaca9 \u00b10.04mm\ubcf4\ub2e4 \uc5c4\uaca9\ud568)\uc785\ub2c8\ub2e4. (2) \uc2a4\ud034\uc988 \uc564 \ud134(S&T) CRC(\uc18c\ud615 \ud55c\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30(60~100ml)\uc6a9): \uc18c\ube44\uc790\uac00 \ub3cc\ub9ac\uba74\uc11c \ub204\ub974\ub294 \ubcd1\ubaa9 \uc911\uac04 \ubd80\ubd84\uc5d0 \ud0c0\uc6d0\ud615 \ubcc0\ud615 \uc601\uc5ed\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \ubcd1\ubaa9\uc758 CRC \ub9de\ubb3c\ub9bc \uc601\uc5ed\uc740 \ud0c0\uc6d0\ud615 \ub2e8\uba74\uc774\uc5b4\uc57c \ud569\ub2c8\ub2e4(\ud0c0\uc6d0\ud615 \ud3b8\ucc28 \uacf5\ucc28 \u00b10.02mm). \ub450 \uac00\uc9c0 CRC \ub125 \uc720\ud615 \ubaa8\ub450 ISBM \ub125 \uc778\uc11c\ud2b8\ub97c CRC \uacf5\uae09\uc5c5\uccb4\uc758 \uc0c1\uc138 \uce58\uc218 \ub3c4\uba74\uc744 \uae30\ubc18\uc73c\ub85c \uc124\uacc4\ud574\uc57c \ud569\ub2c8\ub2e4. \uc77c\ubc18\uc801\uc778 \ub125 \uc778\uc11c\ud2b8 \uc124\uacc4\ub294 CRC \uc131\ub2a5 \ud14c\uc2a4\ud2b8\uc758 \ud569\uaca9\ub960\uc744 \uc548\uc815\uc801\uc73c\ub85c \ub2ec\uc131\ud558\uc9c0 \ubabb\ud558\ub294\ub370, \uc774\ub294 \ud14c\uc2a4\ud2b8\uc758 \"\ud558\uc704 \uacb0\ud568\" \uae30\uc900\uc774 \ub798\uce6b \uccb4\uacb0 \ud504\ub85c\ud30c\uc77c\uc758 \u00b10.05mm \ubcc0\ub3d9\uc5d0 \ubbfc\uac10\ud558\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4.<\/p>\n

CRC \ud638\ud658\uc131\uc744 \uc704\ud55c \ub125 \uc778\uc11c\ud2b8 \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \uc815\ubc00\ub3c4 \uc694\uad6c \uc0ac\ud56d(2316 \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc778\uc11c\ud2b8 \uc0ac\uc591 \ubc0f \ub798\uce6b \uccb4\uacb0 \uc601\uc5ed\uc758 \ub2e4\uc774\uc544\ubaac\ub4dc \ub798\ud551 \ub9c8\uac10 \ud3ec\ud568)\uc740 \ud329\ud130 3(\ub125 \uc778\uc11c\ud2b8 \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1) \ubc94\uc704\uc5d0 \ud3ec\ud568\ub429\ub2c8\ub2e4. 9\uac00\uc9c0 \uc694\uc18c\ub97c \uace0\ub824\ud55c \ud55c\uad6d\uc0b0 ISBM \uae08\ud615 \uc120\uc815 \uac00\uc774\ub4dc<\/a>.<\/p>\n

<\/p>\n

4. \ud55c\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 ISBM\uc5d0 \ub300\ud55c KFDA \uc758\uc57d\ud488 \uc6a9\uae30 \uaddc\uc815 \uc900\uc218<\/h2>\n
\"\ud55c\uad6d
\ud55c\uad6d ISBM \uc81c\uc57d\uc0ac\uc758 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30 \uc815\ubc00 \uae08\ud615 \uc0c1\uc138\ub3c4 - \ud478\uc2dc \uc564 \ud134 \ubc29\uc2dd\uc758 CRC \ub125 \ud504\ub85c\ud30c\uc77c(\ub798\uce6b \uccb4\uacb0\uc744 \uc704\ud55c \uc678\uacbd \u00b10.03mm), \ub208\uae08 \ud45c\uc2dc \ucc3d \uc601\uc5ed(\uc815\ud655\ud55c \ub77c\ubca8 \uc778\uc1c4 \ub208\uae08\uc744 \uc704\ud55c \ud3c9\uba74 \ud328\ub110 \u00b10.15mm), \uadf8\ub9ac\uace0 \uac10\uad11\uc131 \ud55c\uad6d\uc0b0 \ucca0\ubd84 \ubcf4\ucda9\uc81c \uacbd\uad6c\uc6a9\uc561\uc6a9 \ud638\ubc15\uc0c9 \ub9c8\uc2a4\ud130\ubc30\uce58 \uac8c\uc774\ud2b8. \uc774 \uc138 \uac00\uc9c0 \ud2b9\uc9d5 \ubaa8\ub450 \ub3d9\uc77c\ud55c ISBM \uc6a9\uae30\uc5d0\uc11c \ub3c5\ub9bd\uc801\uc778 \uc815\ubc00 \uc0ac\uc591\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4.<\/figcaption><\/figure>\n

\uacbd\uad6c\uc6a9 \uc561\uc0c1 ISBM \ubcd1\uc5d0 \ub300\ud55c \ud55c\uad6d \uc758\uc57d\ud488 \uc6a9\uae30 \uaddc\uaca9 \uc900\uc218\ub294 \ud55c\uad6d\uc57d\uc804 \uc6a9\uae30 \uaddc\uaca9 \ubc0f \ud55c\uad6d \uc758\uc57d\ud488 \uc6a9\uae30 \uc548\uc804 \uaddc\uaca9\uc744 \ub530\ub985\ub2c8\ub2e4. \ud55c\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 ISBM \ubcd1 \uc758\uc57d\ud488 \ub4f1\ub85d\uc5d0 \ud544\uc694\ud55c \uc11c\ub958 \uc694\uac74\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. (1) \uc6a9\uae30 \uc7ac\uc9c8 \uae0d\uc815 \ubaa9\ub85d \ud655\uc778 - PET\uc640 PP\ub294 \ubaa8\ub450 \ud55c\uad6d\uc57d\uc804 \uc6a9\uae30 \uc7ac\uc9c8 \uae0d\uc815 \ubaa9\ub85d\uc5d0 \ub4f1\uc7ac\ub418\uc5b4 \uc788\uc73c\uba70, \ud2b9\uc815 \uc774\ud589 \ud55c\ub3c4\uac00 \uba85\uc2dc\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. (2) \ucd94\ucd9c \uc2dc\ud5d8 - \ubcd1 \uc7ac\uc9c8\uc758 \uc218\uc6a9\uc561\uc744 70\u00b0C\uc5d0\uc11c 1\uc2dc\uac04 \ub3d9\uc548 \ucd94\ucd9c\ud558\uc5ec \uc911\uae08\uc18d(\u22641 ppm), \uc0b0\ud654\uc131 \ubb3c\uc9c8(\u22640.5 mg\/L KMnO\u2084 \uc0c1\ub2f9\ub7c9), \ube44\ud718\ubc1c\uc131 \uc794\ub958\ubb3c(\u226450 mg\/L)\uc744 \uce21\uc815\ud569\ub2c8\ub2e4. (3) \uc57d\ubb3c \uc801\ud569\uc131 \uc2dc\ud5d8 - \ud2b9\uc815 \uacbd\uad6c\uc6a9 \uc561\uc0c1 API\ub294 \uc0dd\uc0b0 \ubcd1\uc5d0\uc11c \ud55c\uad6d \uac00\uc18d \uc548\uc815\uc131 \uc800\uc7a5 \uc870\uac74(40\u00b0C\/75%RH)\uc5d0\uc11c 6\uac1c\uc6d4 \ud6c4 \u22645% \ub18d\ub3c4 \uc190\uc2e4 \ubc0f \u22640.05% \uc911\ud569\uccb4 \ubd84\ud574 \uc0dd\uc131\ubb3c \uc0dd\uc131\uc744 \ubcf4\uc5ec\uc57c \ud569\ub2c8\ub2e4. (4) CRC \uc131\ub2a5 \ud14c\uc2a4\ud2b8 \uc778\uc99d(CRC\uac00 \ud544\uc694\ud55c \uacbd\uc6b0) - \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98 \uaddc\uaca9\uc5d0 \ub530\ub978 \uc81c3\uc790 CRC \ud14c\uc2a4\ud2b8(\ud14c\uc2a4\ud2b8 \uc5b4\ub9b0\uc774 \ud3ec\ud568).<\/p>\n

ISBM \uc6a9\uae30\uc758 \ubcbd \ub450\uaed8 \ubd84\ud3ec, \uc989 \ucd94\ucd9c\ubb3c \uc2dc\ud5d8 \uacb0\uacfc\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \ud45c\uba74\uc801 \ub300 \ubd80\ud53c \ube44\uc728\uc744 \uacb0\uc815\ud558\ub294 \ud504\ub9ac\ud3fc \uc124\uacc4\ub294 \ud55c\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488\uc758 ISBM \uaddc\uc815 \uc900\uc218\uc5d0 \uc788\uc5b4 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. \uad00\ub828 \uc6d0\uce59\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. ISBM \uc0ac\uc804 \uc124\uacc4 \uae30\ucd08 \uac00\uc774\ub4dc<\/a>.<\/p>\n

<\/p>\n

5. \ud22c\uc57d\ub7c9 \ub208\uae08 \ud45c\uc2dc \ubc0f \ub77c\ubca8 \ud328\ub110 \uc124\uacc4<\/h2>\n

\ud55c\uad6d\uc5d0\uc11c \uc0ac\uc6a9\ub418\ub294 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \uc6a9\uae30\ub294 \uc57d\uc0ac, \ud658\uc790 \ubc0f \ubcf4\ud638\uc790\uac00 \uc815\ud655\ud55c \uc6a9\ub7c9\uc744 \uce21\uc815\ud560 \uc218 \uc788\ub3c4\ub85d \ub208\uae08 \ud45c\uc2dc\uac00 \ub418\uc5b4 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \uc6a9\ub7c9 \uce21\uc815 \ub208\uae08 \uae30\uc900\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. 60~150ml \uc6a9\uae30\ub294 2.5ml \ubc0f 5ml \uac04\uaca9\uc73c\ub85c, 150~500ml \uc6a9\uae30\ub294 10ml \uac04\uaca9\uc73c\ub85c \ub208\uae08\uc774 \ud45c\uc2dc\ub418\uc5b4\uc57c \ud558\uba70, \ub208\uae08 \uc815\ud655\ub3c4\ub294 20\u00b0C\uc5d0\uc11c \ud45c\uc2dc\ub41c \uc6a9\ub7c9\uc758 \u00b15% \uc774\ub0b4\uc5ec\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d ISBM(\uc758\uc57d\ud488 \ud488\uc9c8\uad00\ub9ac \uae30\uc900)\uc758 \uc6a9\uae30 \ub77c\ubca8 \ud328\ub110 \uc124\uacc4\ub294 \ub208\uae08 \uc815\ud655\ub3c4\ub97c \uc704\ud574 \ub208\uae08\uc744 \ub77c\ubca8\uc5d0 \uc778\uc1c4\ud558\ub294 \ubc29\uc2dd\uc744 \ucc44\ud0dd\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4(\uc6a9\uae30 \ubcbd\uba74\uc5d0 \ubab0\ub529\ud558\ub294 \ubc29\uc2dd\uc740 \ud55c\uad6d \uc758\uc57d\ud488 \ub77c\ubca8\ub9c1\uc5d0\uc11c \ud5c8\uc6a9\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ubab0\ub529\ub41c \ub208\uae08\uc740 \uc0dd\uc0b0 \ud6c4 GMP \uc7ac\uac80\uc99d\uc774 \ubd88\uac00\ub2a5\ud558\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4). \ud55c\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \ub208\uae08 \ud45c\uc2dc\uac00 \uc788\ub294 \ub77c\ubca8 \ud328\ub110\uc740 \ud3c9\ud3c9\ud574\uc57c \ud558\uace0(\ud3c9\ud0c4\ub3c4 \u00b10.15mm), \uce58\uc218\uac00 \uade0\uc77c\ud574\uc57c \ud569\ub2c8\ub2e4(\uc678\uacbd \u00b10.20mm). \uc774\ub294 \ub77c\ubca8\uc758 \ub208\uae08 \uc704\uce58\uac00 \ud45c\uc2dc\ub41c \ub208\uae08\uc120\uc5d0\uc11c\uc758 \uc815\ud655\ud55c \ucda9\uc804\ub7c9\uacfc \uc77c\uce58\ud558\ub3c4\ub85d \ud558\uae30 \uc704\ud568\uc785\ub2c8\ub2e4. \ub208\uae08 \ud45c\uc2dc \ubd80\ubd84\uc758 \uc678\uacbd(OD) \ud3b8\ucc28\uac00 \u00b10.4mm\uc778 \ud55c\uad6d\uc0b0 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc870\uc81c \uc6a9\uae30\ub294 \uc6a9\uae30 \ubcf8\uccb4\uc758 \ub208\uae08 \ud45c\uc2dc\uc5d0 \uc57d \u00b13%\uc758 \uc624\ucc28\ub97c \ubc1c\uc0dd\uc2dc\ud0a4\ub294\ub370, \uc774\ub294 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \u00b15% \uc815\ud655\ub3c4 \uc694\uad6c \uae30\uc900\uc744 \uc544\uc2ac\uc544\uc2ac\ud558\uac8c \ucda9\uc871\ud558\ub294 \uc218\uc900\uc774\uba70, \ub77c\ubca8 \uc778\uc1c4 \uc815\ub82c \uc624\ucc28\uc5d0 \ub300\ud55c \uc548\uc804 \uc5ec\uc720\uac00 \uc5c6\uc2b5\ub2c8\ub2e4. \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \ube0c\ub79c\ub4dc\uc5d0 \uc81c\ud488\uc744 \uacf5\uae09\ud558\ub294 \ud55c\uad6d ISBM(Integrated Solid-Public Binding Medication) \uc81c\uc870\uc5c5\uccb4\ub294 \ubcf4\uc815\ub41c \ubdf0\ub81b\uc744 \uc0ac\uc6a9\ud558\uc5ec \uac01 \ub208\uae08\uae4c\uc9c0 20\uac1c\uc758 \uc0dd\uc0b0 \uc6a9\uae30\ub97c \ucc44\uc6b0\uace0 \ucda9\uc804\ub7c9\uacfc \ud45c\uc2dc\ub41c \uc6a9\ub7c9\uc744 \ube44\uad50\ud558\uc5ec \ub208\uae08 \uc815\ud655\ub3c4\ub97c \uac80\uc99d\ud574\uc57c \ud558\uba70, \uc774 \uac80\uc99d \uacb0\uacfc\ub294 \ud55c\uad6d \uc81c\uc57d \ube0c\ub79c\ub4dc\uc5d0 \uc81c\ucd9c\ud558\ub294 \ucd5c\ucd08 \uc81c\ud488 \ubcf4\uace0\uc11c\uc5d0 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

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

6. \ud55c\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \ube0c\ub79c\ub4dc \ud604\ud669<\/h2>\n
\"\ud55c\uad6d\uc0b0
\ud55c\uad6d\uc0b0 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \ubcd1 \uc0dd\uc0b0\uc744 \uc704\ud55c \uc5d0\ubc84\ud30c\uc6cc HGY150-V4 \uc815\ubc00 \ud50c\ub7ab\ud3fc - 10\ucd08 \uc0ac\uc774\ud074\ub85c 4\uce90\ube44\ud2f0 100ml CRC \uc18c\uc544\uc6a9 \uc2dc\ub7fd \ubcd1 \uc0dd\uc0b0 (\uc644\ubcbd\ud55c CRC \ub125 \ud504\ub85c\ud30c\uc77c \ud615\uc131\uc744 \uc704\ud55c \ud55c\uad6d \uc81c\uc57d \ub4f1\uae09 \ube14\ub85c\uc6b0 \ub4dc\ub808\uc77c \uc801\uc6a9) - \ub3d9\uc544, \uc720\ud55c\uc591, \ud55c\ubbf8 \ubc0f 80\uac1c \uc774\uc0c1\uc758 \ud55c\uad6d \uc81c\ub124\ub9ad \uc81c\uc57d\uc0ac\uc758 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc704\ud0c1 \uacf5\uae09\uc744 \uc704\ud574 16\uc2dc\uac04 \uc0ac\uc774\ud074\ub85c \uc5f0\uac04 1,640\ub9cc \ubcd1 \uc0dd\uc0b0.<\/figcaption><\/figure>\n

\ud55c\uad6d\uc0b0 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 ISBM \ud3ec\uc7a5\uc740 \uc138 \uac00\uc9c0 \ube0c\ub79c\ub4dc \ub4f1\uae09\uc73c\ub85c \uacf5\uae09\ub429\ub2c8\ub2e4. \ud55c\uad6d \ube0c\ub79c\ub4dc \uc804\ubb38\uc758\uc57d\ud488(\ub3d9\uc544\uc81c\uc57d, \uc720\ud55c\uc591\ud589, \ud55c\ubbf8\uc57d\ud488, \ubcf4\ub839\uc81c\uc57d \ub4f1): \ucd5c\uace0 \uc218\uc900\uc758 \uaddc\uc815 \uc900\uc218 \uc694\uac74\uc744 \ucda9\uc871\ud558\uba70, 24~36\uac1c\uc6d4\uc758 \uacf5\uae09\uc5c5\uccb4 \uc790\uaca9 \uc2ec\uc0ac, ISBM \uc2dc\uc124\uc5d0 \ub300\ud55c \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \ud604\uc7a5 GMP \uc2ec\uc0ac, \uc5f0\uac04 \uc7ac\uc778\uc99d\uc744 \uac70\uce69\ub2c8\ub2e4. 100~200ml \ud504\ub9ac\ubbf8\uc5c4 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488\uc740 CRC \uc778\uc99d\uc744 \ubc1b\uc544 \ubcd1\ub2f9 75~120\uc6d0\uc785\ub2c8\ub2e4. \ud55c\uad6d \uc81c\ub124\ub9ad\/OTC \uc758\uc57d\ud488(\ud55c\uad6d \uc81c\ub124\ub9ad \ud56d\uc0dd\uc81c, \ud55c\uad6d OTC \uc81c\uc0b0\uc81c, \ud55c\uad6d \uc885\ud569 \ube44\ud0c0\ubbfc \uc561\uc0c1 \ube0c\ub79c\ub4dc): \ud45c\uc900 KFDA \uc758\uc57d\ud488 \uc6a9\uae30 \uae30\uc900\uc744 \uc900\uc218\ud558\uba70, 12~18\uac1c\uc6d4\uc758 \uc790\uaca9 \uc2ec\uc0ac\ub97c \uac70\uccd0 \ubcd1\ub2f9 42~75\uc6d0\uc785\ub2c8\ub2e4. \ud55c\uad6d \ubcd1\uc6d0\/\uae30\uad00 \uc57d\uad6d \uc870\uc81c\uc6a9 \uc6a9\uae30 \uacf5\uae09(\ud55c\uad6d \ubcd1\uc6d0 \uc57d\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc870\uc81c \uc6a9\uae30 - \uc57d\uc0ac \uc870\uc81c\uc6a9\uc73c\ub85c \uae68\ub057\ud558\uc9c0\ub9cc GMP \uae30\uc900\uc740 \ucda9\uc871\ud558\uc9c0 \uc54a\ub294 \uc6a9\uae30): \uac00\uc7a5 \uac04\ud3b8\ud55c \uaddc\uc815 \uc900\uc218 \uacbd\ub85c(\uc2dd\ud488 \uc811\ucd09\uc6a9 PET \uc7ac\uc9c8\uc758 \uc870\uc81c \uc6a9\uae30 \uc0ac\uc6a9 \uac00\ub2a5), 3~6\uac1c\uc6d4 \uac80\uc99d \uae30\uac04, \ud45c\uc900 PET \uc6a9\uae30 \uae30\uc900 \ubcd1\ub2f9 28~42\uc6d0. \ud55c\uad6d \uc81c\uc57d \uacbd\uad6c\uc6a9 \uc561\uc0c1 ISBM(\ud1b5\ud569 \uc758\uc57d\ud488 \uc81c\uc870 \ubc0f \uc720\ud1b5 \uc13c\ud130) \uc6a9\ub7c9 \uacc4\ud68d - \uac01 \uc81c\uc57d \ube0c\ub79c\ub4dc \ub4f1\uae09\ubcc4 \uc5f0\uac04 \ud310\ub9e4\ub7c9\uc5d0 \ub530\ub978 \ucd5c\uc801\uc758 \uc6a9\uae30 \uac1c\uc218 \uacb0\uc815 - \uc5d0 \ub300\ud55c \ub0b4\uc6a9\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. \ud55c\uad6d ISBM \ucda9\uce58 \uac1c\uc218 \uacc4\uc0b0\uae30<\/a>.<\/p>\n

<\/p>\n

7. \ud55c\uad6d\uc0b0 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \uc6a9\uae30 \uaddc\uaca9<\/h2>\n
\n\n\n\n\n\n\n\n\n\n
\uc81c\ud488<\/th>\n\uc6a9\ub7c9<\/th>\n\uc218\uc9c0<\/th>\n\ubaa9\/\uc7a0\uae08<\/th>\n\uc8fc\uc694 \uaddc\uc815 \uc900\uc218<\/th>\n<\/tr>\n<\/thead>\n
\uc18c\uc544\uc6a9 \ud56d\uc0dd\uc81c \uc2dc\ub7fd<\/td>\n60~100ml<\/td>\n\ud22c\uba85 PET<\/td>\n28mm P&T CRC<\/td>\nCRC \ud544\uc218; GMP \uae30\uc900\uc5d0 \ubd80\ud569\ud558\ub294 \uccad\uacb0\ud55c \ub0b4\ubd80 \ud658\uacbd; \uc57d\uc804 \ucd94\ucd9c\ubb3c \uc2dc\ud5d8; \uc57d\ubb3c \ud638\ud658\uc131 \uc2dc\ud5d8<\/td>\n<\/tr>\n
\uacbd\uad6c\uc6a9 \ucca0\ubd84 \ubcf4\ucda9\uc81c<\/td>\n100~200ml<\/td>\n\uc570\ubc84 \ud3ab<\/td>\n28mm CRC<\/td>\nUV \u226410% (400nm); \ucca0\uc5fc \ud638\ud658\uc131; \ub208\uae08 \u00b15%<\/td>\n<\/tr>\n
\uc81c\uc0b0\uc81c \ud604\ud0c1\uc561<\/td>\n120~200ml<\/td>\n\ud654\uc774\ud2b8 PP<\/td>\n38mm \ud50c\ub9bd \ub610\ub294 CRC<\/td>\npH 9~10.5\uc5d0 \uc801\ud569\ud55c PP \uc7ac\uc9c8\uc774\uba70, MgOH \ud604\ud0c1\uc561\uc5d0\ub294 \ubd88\ud22c\uba85\ud558\uace0, \uc810\uc131 \uc6a9\uc561\uc744 \ub530\ub974\uae30 \uc27d\ub3c4\ub85d \uc785\uad6c\uac00 \ub113\uc2b5\ub2c8\ub2e4.<\/td>\n<\/tr>\n
\uc885\ud569 \ube44\ud0c0\ubbfc \uacbd\uad6c\uc6a9 \uc561\uc0c1<\/td>\n100~300ml<\/td>\n\uc570\ubc84 \ud3ab<\/td>\n28mm \ud45c\uc900 \ub610\ub294 CRC<\/td>\n\ub9ac\ubcf4\ud50c\ub77c\ube48\uacfc \ube44\ud0c0\ubbfc A\uc758 \uc790\uc678\uc120 \ucc28\ub2e8 \ud6a8\uacfc; \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uac74\uac15\uae30\ub2a5\uc2dd\ud488 \ubd84\ub958<\/td>\n<\/tr>\n
\uc57d\uad6d \uc870\uc81c\uc6a9 \ubcd1<\/td>\n100~500ml<\/td>\n\ud22c\uba85 PET<\/td>\n28~38mm \ub098\uc0ac<\/td>\n\uae30\uad00\uc6a9; \ub208\uae08 \uc815\ud655\ub3c4; \uc870\uc81c \ub77c\ubca8 \ud638\ud658\uc131; \uac04\uc18c\ud654\ub41c \uaddc\uc815 \uc900\uc218<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

<\/p>\n

8. \ud55c\uad6d \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 ISBM \uc0dd\uc0b0\uacbd\uc81c\uc131<\/h2>\n

\ud55c\uad6d \uc81c\uc57d\ud68c\uc0ac\uc5d0\uc11c \uc0ac\uc6a9\ud558\ub294 HGY150-V4-EV 4\uce90\ube44\ud2f0 100ml CRC \uc18c\uc544\uc6a9 \uc2dc\ub7fd ISBM(\uc644\uc804\ud55c CRC \ub125 \ud504\ub85c\ud30c\uc77c \ud615\uc131\uc5d0 10\ucd08 \uc8fc\uae30)\uc740 \ud558\ub8e8 16\uc2dc\uac04 \uac00\ub3d9 \uc2dc \uc5f0\uac04 \uc57d 1,640\ub9cc \ubcd1\uc744 \uc0dd\uc0b0\ud569\ub2c8\ub2e4. \ud55c\uad6d \ube0c\ub79c\ub4dc \uc804\ubb38\uc758\uc57d\ud488 \uacf5\uae09\uc744 \ubcd1\ub2f9 88\uc6d0\uc73c\ub85c \uac00\uc815\ud558\uba74, \uc774\ub294 \uae30\uacc4\ub2f9 \uc5f0\uac04 14\uc5b5 4\ucc9c\ub9cc \uc6d0\uc758 \ub9e4\ucd9c\uc5d0 \ud574\ub2f9\ud558\uba70, \ud55c\uad6d ISBM \uc5c5\uacc4 \ucd5c\uace0 \uc218\uc900\uc758 \ub9e4\ucd9c\uc744 \uae30\ub85d\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \ud55c\uad6d\uc758 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 ISBM \ud22c\uc790\uc5d0\ub294 \ub2e4\uc74c\uacfc \uac19\uc740 \uaddc\uc81c \uad00\ub828 \ucd94\uac00 \ube44\uc6a9\uc774 \ubc1c\uc0dd\ud569\ub2c8\ub2e4. \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc758\uc57d\ud488 \uc6a9\uae30 \uc2dc\uc124 \ub4f1\ub85d(3~6\uac1c\uc6d4), \uc5f0\uac04 \uc7ac\uc778\uc99d \ube44\uc6a9(1,500\ub9cc~3,500\ub9cc \uc6d0), GMP \ub4f1\uae09 \uc0dd\uc0b0 \ud658\uacbd \uc720\uc9c0(\ubc30\ucd9c \uad6c\uc5ed\uc5d0 \ud074\ub9b0\ub8f8 \ub610\ub294 \ub3d9\ub4f1 \uc2dc\uc124), \uadf8\ub9ac\uace0 CRC \ub125 \uc778\uc11c\ud2b8 \ud504\ub9ac\ubbf8\uc5c4 \uae08\ud615(\ud45c\uc900 \ub125 \uc778\uc11c\ud2b8 \ub300\ube44 \uae08\ud615\ub2f9 1,000\ub9cc~2,000\ub9cc \uc6d0 \ucd94\uac00 \ube44\uc6a9). \ud55c\uad6d ISBM \uc81c\uc870\uc5c5\uccb4\uc758 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \uaddc\uc81c \uc900\uc218 \ud22c\uc790\uc5d0 \ub300\ud55c \ucd1d \ud68c\uc218\uc561: 14\uc5b5 4\ucc9c\ub9cc \uc6d0\uc758 \ub9e4\ucd9c \ub300\ube44 1\uc5b5 8\ucc9c 5\ubc31\ub9cc \uc6d0\uc758 \uae30\uacc4 \ud22c\uc790, 5\ucc9c 5\ubc31\ub9cc \uc6d0\uc758 CRC \ud234\ub9c1, 2\ucc9c 5\ubc31\ub9cc \uc6d0\uc758 \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc778\uc99d \ube44\uc6a9\uc744 \ud569\ud558\uba74 \ucd1d \ud22c\uc790\uc561\uc740 2\uc5b5 6\ucc9c 5\ubc31\ub9cc \uc6d0\uc774\uba70, \ud55c\uad6d \ube0c\ub79c\ub4dc \uc758\uc57d\ud488 \uacf5\uae09 \uc2dc\uc791 \ud6c4 3\uac1c\uc6d4 \ub9cc\uc5d0 \uc804\uc561 \ud68c\uc218\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc774\ub294 \ubaa8\ub4e0 \uc751\uc6a9 \ubd84\uc57c\ub97c \ud1b5\ud2c0\uc5b4 \ud55c\uad6d ISBM \ud22c\uc790 \ub300\ube44 \uc218\uc775\ub960\uc774 \uac00\uc7a5 \ube60\ub978 \uc0ac\ub840 \uc911 \ud558\ub098\uc785\ub2c8\ub2e4.<\/p>\n

\"ISBM\uc758
\ud55c\uad6d ISBM \uc81c\uc57d\uc0ac\uc758 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30 GMP \uc0dd\uc0b0 \ud658\uacbd\uc740 \uccad\uacb0\ud55c \ubc30\ucd9c \uad6c\uc5ed, \ubc30\uce58 \ucd9c\ud558 \uc2b9\uc778 \uc11c\ub958(QP \uc11c\uba85\uc774 \ud3ec\ud568\ub41c CoA), \uadf8\ub9ac\uace0 \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc758\uc57d\ud488 \uc6a9\uae30 \uc801\ud569\uc131 \uc778\uc99d\uc11c\uac00 \uc0dd\uc0b0 \ud604\uc7a5\uc5d0 \ube44\uce58\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. \ud55c\uad6d\uc758 \uc720\uba85 \uc81c\uc57d\uc0ac \uace0\uac1d\uc0ac\ub4e4\uc740 \ub9e4\ub144 \ud604\uc7a5 GMP \uc2ec\uc0ac\ub97c \ud1b5\ud574 \uc774\ub7ec\ud55c \uc0dd\uc0b0 \ud658\uacbd\uc744 \uc9c1\uc811 \ud3c9\uac00\ud569\ub2c8\ub2e4. \uae30\uacc4\uc5d0\uc11c \ud655\uc778\ud560 \uc218 \uc788\ub294 \ubb3c\ub9ac\uc801 \uccad\uacb0\ub3c4\uc640 \ubb38\uc11c \uad00\ub9ac\uc758 \uc6b0\uc218\uc131\uc740 \ubc30\uce58 CoA\uc758 \uce58\uc218 \ub370\uc774\ud130\ub9cc\ud07c\uc774\ub098 \uc911\uc694\ud558\uac8c \uc5ec\uaca8\uc9d1\ub2c8\ub2e4.<\/figcaption><\/figure>\n

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

Q1 \u2014 \ud55c\uad6d API \uce74\ud14c\uace0\ub9ac \uc911 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30\ub85c \uac08\uc0c9 PET \uc6a9\uae30\ub97c \ud56d\uc0c1 \uc0ac\uc6a9\ud574\uc57c \ud558\ub294 \uce74\ud14c\uace0\ub9ac\ub294 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/p>\n

\uad11\ubd84\ud574\uc131\uc774 \uc788\uc5b4 \uac08\uc0c9 PET \ub610\ub294 \uac08\uc0c9 \uc720\ub9ac \uc6a9\uae30\uac00 \ud544\uc694\ud55c \ud55c\uad6d\uc0b0 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6d0\ub8cc\uc758\uc57d\ud488(API)\uc5d0\ub294 \ub2e4\uc74c\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4: \ucca0 \ud654\ud569\ubb3c(\ud669\uc0b0\uc81c\uc77c\ucca0, \uad6c\uc5f0\uc0b0\uc81c\uc774\uc554\ubaa8\ub284, \uae00\ub8e8\ucf58\uc0b0\uc81c\uc77c\ucca0 - \ud45c\uc900 \uc6a9\ub7c9\uc758 \uc790\uc678\uc120\uc5d0 \ub178\ucd9c \uc2dc 48~72\uc2dc\uac04 \uc774\ub0b4\uc5d0 \ubd88\uc6a9\uc131 \uc81c1\ucca0 \uce68\uc804\ubb3c\ub85c \uad11\uc0b0\ud654\ub428); \ub9ac\ubcf4\ud50c\ub77c\ube48(\ube44\ud0c0\ubbfc B2 - 6,000\ub8e9\uc2a4\uc758 \ud22c\uba85 \uc720\ub9ac \uc6a9\uae30\uc5d0\uc11c 400nm\uc5d0\uc11c \uad11\ubd84\ud574\ub418\uba70 \ubc18\uac10\uae30\ub294 2\uc2dc\uac04\uc784); \ube44\ud0c0\ubbfc A \ubc0f D(\uc720\uc911\uc218\ud615 \uc5d0\uba40\uc83c \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc81c\uc81c\uc5d0 \ud568\uc720\ub41c \uc9c0\uc6a9\uc131 \ube44\ud0c0\ubbfc - 320~400nm\uc5d0\uc11c \uad11\uc0b0\ud654\ub418\uba70 \ud22c\uba85 \uc6a9\uae30\uc5d0 \ub2f4\uc544 \uc18c\ub9e4\uc810\uc5d0 4\uc8fc\uac04 \ub178\ucd9c \uc2dc \ud6a8\ub2a5\uc774 20% \uc774\uc0c1 \uac10\uc18c\ud568); \uadf8\ub9ac\uace0 \ud2b9\uc815 \ud55c\uad6d\uc0b0 \ud56d\uc0dd\uc81c \ud604\ud0c1\uc561(\ub3c5\uc2dc\uc0ac\uc774\ud074\ub9b0 \ud788\ud074\ub808\uc774\ud2b8 \uacbd\uad6c\uc6a9 \ud604\ud0c1\uc561 - 350~420nm\uc5d0\uc11c \uad11\ubd84\ud574\ub418\uba70, \ud55c\uad6d \uc57d\uc804\uc5d0\uc11c\ub294 \uac08\uc0c9 \uc6a9\uae30 \uc0ac\uc6a9\uc744 \uc758\ubb34\ud654\ud568). \ud55c\uad6d ISBM \ud638\ubc15\uc0c9 PET \ubcd1\uc758 \uacbd\uc6b0, 400nm\uc5d0\uc11c \uc790\uc678\uc120 \ud22c\uacfc\uc728 \uaddc\uaca9 \u226410%\ub294 \uad11\uac10\uc131 \uacbd\uad6c\uc6a9 \uc561\uc81c \ubcf4\ud638\ub97c \uc704\ud55c \ud55c\uad6d \uc57d\uc804 \uae30\uc900\uc785\ub2c8\ub2e4. \ud45c\uc900 PET \uacbd\uad6c\uc6a9 \uc561\uc81c \ubcd1\ubcbd \ub450\uaed8(0.25~0.30mm)\uc5d0\uc11c 400nm\uc5d0\uc11c \uc790\uc678\uc120 \ud22c\uacfc\uc728 \u226410%\ub97c \ub2ec\uc131\ud558\uae30 \uc704\ud55c \ud55c\uad6d\uc0b0 \ud638\ubc15\uc0c9 \ub9c8\uc2a4\ud130\ubc30\uce58 \uc0b0\ud654\ucca0 \ud568\ub7c9\uc740 PET \ub2f4\uccb4\uc5d0 \uc57d 0.7~1.1%\uc758 LDR \uc0b0\ud654\ucca0 \ub9c8\uc2a4\ud130\ubc30\uce58\uc785\ub2c8\ub2e4. \uc774\ub294 \ud55c\uad6d \uc81c\uc57d \ube0c\ub79c\ub4dc \ucd5c\ucd08 \uc81c\ud488 \ub0a9\ud488 \uc804 \uc0dd\uc0b0 \ubcd1\uc5d0 \ub300\ud55c \uc790\uc678\uc120 \ud22c\uacfc\uc728 \uce21\uc815\uc744 \ud1b5\ud574 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

Q2 \u2014 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc5d0\uc11c \uc758\uc57d\ud488\uc758 \uc0c8\ub85c\uc6b4 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30\ub97c \ub4f1\ub85d\ud558\ub294 \uc808\ucc28\ub294 \ubb34\uc5c7\uc778\uac00\uc694?<\/p>\n

\ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc758\uc57d\ud488 \ub4f1\ub85d\uc5d0\ub294 \uc81c\ud488 \ub4f1\ub85d \uc11c\ub958\uc5d0 \uc8fc\uc694 \uc6a9\uae30\ub97c \uba85\uc2dc\ud574\uc57c \ud569\ub2c8\ub2e4. \uc0c8\ub85c\uc6b4 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc81c\uc81c \uc6a9\uae30\uc758 \uacbd\uc6b0, ISBM \uc6a9\uae30 \uacf5\uae09\uc5c5\uccb4\ub294 \ub2e4\uc74c \uc11c\ub958\ub97c \uc81c\ucd9c\ud574\uc57c \ud569\ub2c8\ub2e4. (1) \uc7ac\uc9c8 \uba85\uc138\uc11c(PET \ub610\ub294 PP \uc218\uc9c0 \ub4f1\uae09, \uc2b9\uc778 \ubaa9\ub85d \ud655\uc778, \uacf5\uae09\uc5c5\uccb4 \uc801\ud569\uc131 \uc120\uc5b8\uc11c); (2) \ucd94\ucd9c\ubb3c \uc2dc\ud5d8 \uacb0\uacfc(\ud55c\uad6d \uc57d\uc804 \uc6a9\uae30 \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294 70\u00b0C\/1\uc2dc\uac04 \uc218\uc6a9\uc561 \ucd94\ucd9c\ubb3c); (3) \uc57d\ubb3c \uc0c1\ud638\uc791\uc6a9 \uc2dc\ud5d8(40\u00b0C\/75%RH\uc5d0\uc11c 6\uac1c\uc6d4 \uac00\uc18d \uc548\uc815\uc131 \uc2dc\ud5d8 \uacb0\uacfc, \ud65c\uc131 \uc131\ubd84 \ub18d\ub3c4 \uc548\uc815\uc131 \ubc0f 0.05% \uc774\uc0c1\uc758 \ubd84\ud574 \uc0dd\uc131\ubb3c \ubd80\uc7ac \ud655\uc778); (4) \uc6a9\uae30 \uba85\uc138\uc11c(\uce58\uc218 \ub3c4\uba74, \uacf5\uce6d \uc6a9\ub7c9, \uc7ac\uc9c8, \ub9c8\uac1c \uc0ac\uc591); (5) CRC \uc131\ub2a5 \uc2dc\ud5d8 \uc778\uc99d\uc11c(CRC\uac00 \ud544\uc694\ud55c \uacbd\uc6b0 - \ud55c\uad6d KFDA \uacf5\uc778 CRC \uc2dc\ud5d8\uae30\uad00 \ubc1c\uae09). \ud55c\uad6d KFDA\uc758 \uc758\uc57d\ud488 \ub4f1\ub85d \uc2ec\uc0ac\ub294 \uc2e0\uaddc NCE(\uc2e0\uaddc \ud654\ud559 \ubb3c\uc9c8) \uc81c\ud488\uc758 \uacbd\uc6b0 12~18\uac1c\uc6d4, \uc6a9\uae30 \uc7ac\uc9c8 \ubc0f \uc6a9\ub7c9\uc774 \uc624\ub9ac\uc9c0\ub110 \uc81c\ud488\uacfc \ub3d9\uc77c\ud55c \uc81c\ub124\ub9ad \uc81c\ud488\uc758 \uacbd\uc6b0 3~6\uac1c\uc6d4\uc774 \uc18c\uc694\ub429\ub2c8\ub2e4. \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \ucd94\ucd9c\ubb3c \uc2dc\ud5d8 \uc778\uc99d\uc11c(3\ub144 \uc720\ud6a8)\ub97c \ud1b5\ud574 PET \ubc0f PP \uc218\uc9c0\uc5d0 \ub300\ud55c \uc0ac\uc804 \uc778\uc99d\uc744 \ubc1b\uc740 \ud55c\uad6d ISBM \uc0dd\uc0b0\uc5c5\uccb4\ub294 \ucd5c\ucd08 \uc81c\ud488 \uc2b9\uc778 \ud6c4 4~8\uc8fc \uc774\ub0b4\uc5d0 \uc81c\uc57d \ube0c\ub79c\ub4dc \uace0\uac1d\uc5d0\uac8c \ud55c\uad6d \uc81c\ud488 \ub4f1\ub85d\uc5d0 \ud544\uc694\ud55c \uc11c\ub958\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub294 \uc2e0\uaddc \uc81c\uc57d \uace0\uac1d\ub9c8\ub2e4 \uc0c8\ub85c\uc6b4 \ucd94\ucd9c\ubb3c \uc2dc\ud5d8\uc744 \uc758\ub8b0\ud574\uc57c \ud558\ub294 \uc0dd\uc0b0\uc5c5\uccb4\uc758 \uacbd\uc6b0 3~6\uac1c\uc6d4\uc774 \uc18c\uc694\ub418\ub294 \uac83\uacfc \ub300\uc870\uc801\uc785\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

Q3 \u2014 \ud55c\uad6d\uc758 ISBM CRC \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30 \uc0dd\uc0b0 \ubc29\uc2dd\uc740 \uc77c\ubc18\uc801\uc778 \uac1c\uc778 \uc704\uc0dd\uc6a9\ud488 \ud38c\ud504 \uc6a9\uae30 \uc0dd\uc0b0 \ubc29\uc2dd\uacfc \uc5b4\ub5bb\uac8c \ub2e4\ub978\uac00\uc694?<\/p>\n

\ud55c\uad6d ISBM CRC \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30 \uc0dd\uc0b0\uc740 \ud37c\uc2a4\ub110 \ucf00\uc5b4 \ud38c\ud504 \uc6a9\uae30 \uc0dd\uc0b0\uacfc \ub2e4\uc12f \uac00\uc9c0 \uce21\uba74\uc5d0\uc11c \ucc28\uc774\uac00 \uc788\uc2b5\ub2c8\ub2e4. \uccab\uc9f8, \ubcd1\ubaa9 \uc815\ubc00\ub3c4: CRC \uc555\ub825-\uc555\ucc29 \uba54\ucee4\ub2c8\uc998\uc740 \ubcd1\ubaa9 \uc678\uacbd \u00b10.03mm\uc758 \uc815\ubc00\ub3c4\ub97c \uc694\uad6c\ud569\ub2c8\ub2e4(\ud55c\uad6d \ud1a0\ub108 \ud38c\ud504\uc640 \ub3d9\uc77c\ud55c \ubb3c\ub9ac\uc801 \uc774\uc720, \uc989 \uc678\uacbd \ubcc0\ud654\uc5d0 \ubbfc\uac10\ud55c \uc555\ub825 \uacb0\ud569 \uba54\ucee4\ub2c8\uc998\uc5d0 \ub300\ud55c \uc694\uad6c \uc0ac\ud56d \ub54c\ubb38). \ubc18\uba74 \ud37c\uc2a4\ub110 \ucf00\uc5b4 \ub85c\uc158 \ud38c\ud504\ub294 \u00b10.04~0.05mm\uc758 \uc815\ubc00\ub3c4\ub97c \uc694\uad6c\ud569\ub2c8\ub2e4. \ub458\uc9f8, \uacf5\uc815 \uac80\uc99d \ubb38\uc11c: CRC \uc6a9\uae30\ub294 \ubaa8\ub4e0 \uce90\ube44\ud2f0\uc640 \ubaa8\ub4e0 \uc0dd\uc0b0 \ub85c\ud2b8\uc5d0\uc11c CRC \uacb0\ud569\ub825\uc774 \uc77c\uad00\uc801\uc784\uc744 \uc785\uc99d\ud558\ub294 \ubb38\uc11c\ud654\ub41c \uacf5\uc815 \uac80\uc99d\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uc774\ub294 \ud37c\uc2a4\ub110 \ucf00\uc5b4 \ud38c\ud504 \uc6a9\uae30\uc5d0\ub294 \uc694\uad6c\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uc14b\uc9f8, CRC \uc131\ub2a5 \ud14c\uc2a4\ud2b8: \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc5d0\uc11c \uc9c0\uc815\ud55c \uc5b4\ub9b0\uc774(42~51\uac1c\uc6d4) \ub300\uc0c1 CRC \ud14c\uc2a4\ud2b8\ub97c \ud55c\uad6d \uc81c\uc57d \ube0c\ub79c\ub4dc\uc758 \uc2e4\uc81c \ub9c8\uac1c\ub97c \uc0ac\uc6a9\ud558\uc5ec \uc0dd\uc0b0 \uc6a9\uae30\uc5d0 \ub300\ud574 \uc2e4\uc2dc\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774 \ud14c\uc2a4\ud2b8\ub294 \ud55c\uad6d KFDA \uacf5\uc778 CRC \ud14c\uc2a4\ud2b8 \uc2dc\uc124\uc5d0\uc11c \uc608\uc57d \ubc0f \uc644\ub8cc\ud558\ub294 \ub370 3~4\uac1c\uc6d4\uc774 \uc18c\uc694\ub429\ub2c8\ub2e4. \ub137\uc9f8, \uc0dd\uc0b0 \ud658\uacbd: \ud55c\uad6d \uc81c\uc57d\ud68c\uc0ac\uc5d0\uc11c \uc0dd\uc0b0\ud558\ub294 \uacbd\uad6c\uc6a9 CRC \uc6a9\uc561\uc740 GMP \uae30\uc900\uc5d0 \ubd80\ud569\ud558\ub294 \uc0dd\uc0b0 \ud658\uacbd(\uccad\uc815\uad6c\uc5ed \ubd84\ub958, \uc591\uc555 \uc720\uc9c0, \uc9c1\uc6d0 \uc704\uc0dd \uae30\uc900 \uc900\uc218)\uc744 \ud544\uc694\ub85c \ud558\uc9c0\ub9cc, \uac1c\uc778 \uc704\uc0dd\uc6a9\ud488 \ud38c\ud504 \uc6a9\uae30\ub294 \uc774\ub7ec\ud55c \uc694\uac74\uc774 \uc801\uc6a9\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ub2e4\uc12f\uc9f8, \ub85c\ud2b8 \ucd9c\ud558 \uc2b9\uc778: \ud55c\uad6d \uc81c\uc57d\ud68c\uc0ac\uc5d0\uc11c \uc0dd\uc0b0\ud558\ub294 \uacbd\uad6c\uc6a9 CRC \uc6a9\uc561\uc740 \ud55c\uad6d \uc81c\uc57d \ube0c\ub79c\ub4dc\uc5d0 \ub0a9\ud488\ub418\uae30 \uc804\uc5d0 \ub85c\ud2b8 \ucd9c\ud558 \uc2b9\uc778 \uc808\ucc28(\uc0d8\ud50c \ubcf4\uad00, \ubd84\uc11d\uc99d\uba85\uc11c \ubc1c\uae09, \ud488\uc9c8\ubcf4\uc99d \ub2f4\ub2f9\uc790 \uc11c\uba85)\ub97c \uac70\uce58\ub294 \ubc18\uba74, \uac1c\uc778 \uc704\uc0dd\uc6a9\ud488 \ud38c\ud504 \uc6a9\uae30\ub294 \ud45c\uc900 \uaddc\uaca9\uc758 \ubd84\uc11d\uc99d\uba85\uc11c\ub9cc \uc81c\ucd9c\ud558\uba74 \ub0a9\ud488\ub429\ub2c8\ub2e4. \ud55c\uad6d\uc0b0 \uacbd\uad6c\uc6a9 CRC \uc6a9\uc561\uc758 \uacc4\uc57d \uac00\uaca9\uc774 \ub3d9\uae09 \uac1c\uc778 \uc704\uc0dd\uc6a9\ud488 \ud38c\ud504 \uc6a9\uae30\ubcf4\ub2e4 3~4\ubc30 \ub192\uc740 \uac83\uc740 \uc774\ub7ec\ud55c \ub2e4\uc12f \uac00\uc9c0 \ucd94\uac00\uc801\uc778 \ud488\uc9c8 \uad00\ub9ac \uc694\uac74\uc744 \ubc18\uc601\ud55c \uacb0\uacfc\uc785\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

Q4 \u2014 \ud55c\uad6d ISBM \uacf5\uc815 \ub9e4\uac1c\ubcc0\uc218 \uc911 CRC \ub798\uce6b \uccb4\uacb0\ub825 \uc77c\uad00\uc131\uc5d0 \uac00\uc7a5 \ud070 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \uac83\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/p>\n

\ud55c\uad6d ISBM CRC \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30 \ub798\uce6b \uccb4\uacb0\ub825(\ud68c\uc804\uc774 \uac00\ub2a5\ud574\uc9c0\uae30 \uc804\uc5d0 P&T CRC \ub798\uce6b\uc744 \uccb4\uacb0\ud558\ub294 \ub370 \ud544\uc694\ud55c \ub204\ub974\ub294 \ud798)\uc758 \uc77c\uad00\uc131\uc740 \ubcd1\ubaa9 \uc678\uacbd \ubcc0\ud654\uc5d0 \uac00\uc7a5 \ubbfc\uac10\ud569\ub2c8\ub2e4. CRC \ub798\uce6b \uccb4\uacb0\ub825\uc740 \ubcd1\ubaa9 \uc678\uacbd\uc5d0 \ub300\ub7b5\uc801\uc73c\ub85c \uc120\ud615 \ube44\ub840\ud569\ub2c8\ub2e4. \uc989, \ubcd1\ubaa9 \uc678\uacbd\uc774 0.04mm \uc99d\uac00\ud558\uba74 \ud45c\uc900 \ud55c\uad6d P&T CRC \uc2a4\ud504\ub9c1 \uc0c1\uc218\uc5d0\uc11c \ub798\uce6b \uccb4\uacb0\ub825\uc774 \uc57d 12~18% \uc99d\uac00\ud569\ub2c8\ub2e4. \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 CRC \uaddc\uaca9\uc5d0 \ub530\ub974\uba74 \ub178\uc778\uc774 90%\uc758 \ud798\uc73c\ub85c \uc6a9\uae30\ub97c \uc131\uacf5\uc801\uc73c\ub85c \uc5f4 \uc218 \uc788\uc5b4\uc57c \ud558\ub294\ub370, \uc774\ub54c \uac1c\ubc29 \ud1a0\ud06c\ub294 \ud55c\uad6d \ub178\uc778\uc758 \uc545\ub825 \uae30\uc900\uce58(\uc57d 25N\u00b7cm)\ub97c \ucd08\uacfc\ud574\uc11c\ub294 \uc548 \ub429\ub2c8\ub2e4. \uc774\ub294 \uccb4\uacb0\ub825\uc774 \ub178\uc778\uc758 \uac1c\ubc29 \ub2a5\ub825\uc744 \ucd08\uacfc\ud558\uae30 \uc804\uc5d0 \ud5c8\uc6a9\ub418\ub294 \ucd5c\ub300 \ubcd1\ubaa9 \uc678\uacbd \ubcc0\ud654\ub7c9\uc744 \uc124\uc815\ud569\ub2c8\ub2e4. \ub530\ub77c\uc11c \ud55c\uad6d ISBM CRC\uc758 \ubcd1\ubaa9 \uc678\uacbd\uc740 \ucd5c\uc18c\ud55c\uc758 \uae30\ub2a5\uc801 \uccb4\uacb0(\uc5b4\ub9b0\uc774 \uc811\uadfc \ubc29\uc9c0)\ubfd0\ub9cc \uc544\ub2c8\ub77c \ucd5c\ub300 \uae30\ub2a5\uc801 \ud55c\uacc4(\ub178\uc778 \uc811\uadfc \ud5c8\uc6a9)\uc5d0\uc11c\ub3c4 \u00b10.03mm \uc774\ub0b4\ub85c \uc720\uc9c0\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d ISBM \uacf5\uc815\uc5d0\uc11c \ub125 \uc678\uacbd \uc77c\uad00\uc131\uc744 \uac00\uc7a5 \uc9c1\uc811\uc801\uc73c\ub85c \uacb0\uc815\ud558\ub294 \ub9e4\uac1c\ubcc0\uc218\ub294 \ub125 \uc601\uc5ed\uc758 \ucee8\ub514\uc154\ub2dd \uc2a4\ud14c\uc774\uc158 \uc628\ub3c4 \uade0\uc77c\uc131\uc785\ub2c8\ub2e4. \ub125 \uc601\uc5ed\uc5d0\uc11c \u00b11\u00b0C\uc758 \ucee8\ub514\uc154\ub2dd \uc628\ub3c4 \ubcc0\ud654\ub294 \uc57d \u00b10.025mm\uc758 \ub125 \uc678\uacbd \ubcc0\ud654\ub97c \ubc1c\uc0dd\uc2dc\ud0a4\ub294\ub370, \uc774\ub294 \u00b10.03mm \ud5c8\uc6a9 \uc624\ucc28 \ubc94\uc704 \ub0b4\uc5d0 \uc788\uc73c\uba70 0.005mm\uc758 \uc548\uc804 \uc5ec\uc720\uac00 \uc788\uc9c0\ub9cc, \ud55c\uad6d CRC\uc758 \uc77c\uad00\ub41c \uc131\ub2a5\uc744 \uc704\ud574\uc11c\ub294 \u2264\u00b11\u00b0C\uc758 \ucee8\ub514\uc154\ub2dd \uc815\ubc00\ub3c4\uac00 \ud544\uc218\uc801\uc785\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

Q5 - \ud55c\uad6d\uc758 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 ISBM \ubcd1 \uc0dd\uc0b0\uc740 GMP \uae30\uc900\uc5d0 \ub530\ub77c \uc5b4\ub5bb\uac8c \uac80\uc99d\ub429\ub2c8\uae4c?<\/p>\n

\ud55c\uad6d ISBM \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \ubcd1 \uc0dd\uc0b0 GMP \uac80\uc99d\uc740 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \uc758\uc57d\ud488 1\ucc28 \ud3ec\uc7a5\uc7ac \uc81c\uc870 GMP \uac00\uc774\ub4dc\ub77c\uc778(\uc6d0\ub8cc \uc6a9\uae30\u00b7\ud3ec\uc7a5\uc7ac GMP)\uc744 \uc900\uc218\ud569\ub2c8\ub2e4. \uac80\uc99d \ud504\ub85c\uadf8\ub7a8\uc740 \uc138 \ub2e8\uacc4\uc758 \uc801\uaca9\uc131 \ud3c9\uac00\ub85c \uad6c\uc131\ub429\ub2c8\ub2e4. IQ(\uc124\uce58 \uc801\uaca9\uc131 \ud3c9\uac00): ISBM \uae30\uacc4 \uc124\uce58(\uc804\uae30, \uae30\uacc4, \uc555\ucd95 \uacf5\uae30)\uac00 \uc0ac\uc591\uc744 \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778\ud558\uace0, \uc8fc\uc694 \uacc4\uce21\uae30(\uc628\ub3c4 \uc13c\uc11c, \uc555\ub825\uacc4, \uc0ac\uc774\ud074 \ud0c0\uc774\uba38)\ub97c \uad50\uc815\ud558\uba70, \uc801\uaca9\uc790\uac00 \uc11c\uba85\ud55c \ud55c\uad6d ISBM \uae30\uacc4 \uc801\uaca9\uc131 \ud3c9\uac00 IQ \ud504\ub85c\ud1a0\ucf5c\uc744 \ubb38\uc11c\ud654\ud569\ub2c8\ub2e4. OQ(\uc6b4\uc601 \uc801\uaca9\uc131 \ud3c9\uac00): 3\ud68c\uc758 \uac1c\ubcc4 \uc2e4\ud589\uc744 \ud1b5\ud574 ISBM \uae30\uacc4\uac00 \uac80\uc99d\ub41c \uc791\ub3d9 \ubc94\uc704 \ub0b4\uc5d0\uc11c \uc791\ub3d9\ud558\ub294\uc9c0 \uc785\uc99d\ud558\uace0, \uc8fc\uc694 \ud488\uc9c8 \ud2b9\uc131(\ubaa9 \uc678\uacbd, \ubb34\uac8c, \ubcbd \ub450\uaed8, CRC \uacb0\ud569\ub825)\uc744 3\uac00\uc9c0 \uadf9\ub2e8\uc801\uc778 \uac12(\uc815\uc0c1, \uc800, \uace0)\uc5d0\uc11c \uce21\uc815\ud558\uba70, \uc815\uc0c1 \ubc0f \uc800\uadf9\ub2e8 \uc870\uac74\uc5d0\uc11c CRC \uc131\ub2a5 \ud14c\uc2a4\ud2b8\ub97c \ud1b5\uacfc\ud588\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4. PQ(\uc131\ub2a5 \uc801\uaca9\uc131 \ud3c9\uac00): \ud55c\uad6d GMP \uc0dd\uc0b0 \uc870\uac74\uc5d0\uc11c 3\uac1c\uc758 \uc5f0\uc18d \uc0dd\uc0b0 \ub85c\ud2b8\ub97c \uac80\uc99d\ud558\uace0, 100% \uacf5\uc815 \uc911 \uc721\uc548 \uac80\uc0ac \uae30\ub85d\uc744 \uc791\uc131\ud558\uba70, \uac01 \ub85c\ud2b8\uc5d0 \ub300\ud55c \uce58\uc218 \ubd84\uc11d \uc99d\uba85\uc11c(CoA)\ub97c \uc791\uc131\ud569\ub2c8\ub2e4. \uc0d8\ud50c \ubcf4\uad00(\ub85c\ud2b8\ub2f9 10\ubcd1, 1\ub144 + \uc720\ud6a8\uae30\uac04 \ubcf4\uad00); \uc8fc\uc694 \uc18d\uc131\uc5d0 \ub300\ud55c \uacf5\uc815 \ub2a5\ub825 Cpk \u2265 1.33. \ucd1d 150~250\ud398\uc774\uc9c0 \ubd84\ub7c9\uc758 \ud55c\uad6d GMP IQ\/OQ\/PQ \uac80\uc99d \ubb38\uc11c\ub294 \ud55c\uad6d \ube0c\ub79c\ub4dc \uc758\uc57d\ud488 \uacbd\uad6c\uc6a9 \uc561\uc0c1 ISBM \uacf5\uae09\uc758 \uae30\ubcf8 \uc870\uac74\uc785\ub2c8\ub2e4. GMP \uac80\uc99d \uacbd\ud5d8\uc774 \uc5c6\ub294 \ud55c\uad6d ISBM \uc81c\uc870\uc5c5\uccb4\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \ud55c\uad6d \uc81c\uc57d \uac80\uc99d \ucee8\uc124\ud305 \uc5c5\uccb4(GMP Compliance Group, \ub300\ud55c\uc81c\uc57d\ud611\ud68c \uac80\uc99d \uc11c\ube44\uc2a4)\uc5d0 \uc758\ub8b0\ud558\uc5ec \uccab \ubc88\uc9f8 \ud55c\uad6d \uc758\uc57d\ud488 \uacbd\uad6c\uc6a9 \uc561\uc0c1 GMP \uac80\uc99d\uc744 \uc9c4\ud589\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

Q6 \u2014 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc758\uc57d\ud488 \uc6a9\uae30 \uaddc\uc815 \uc900\uc218\uc640 ISBM\uc758 \ud55c\uad6d \uc2dd\ud488 \uc811\ucd09 \uaddc\uc815 \uc900\uc218\uc758 \ucc28\uc774\uc810\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/p>\n

\ud55c\uad6d \uc758\uc57d\ud488 \uc6a9\uae30\u00b7\ud3ec\uc7a5 \uae30\uc900\uacfc \ud55c\uad6d \uc2dd\ud488 \uc811\ucd09 \uae30\uc900\uc740 \ubaa8\ub450 PET \ubc0f PP ISBM \ubcd1\uc744 \uaddc\uc81c\ud558\uc9c0\ub9cc, \ub2e4\uc12f \uac00\uc9c0 \uc8fc\uc694 \uce21\uba74\uc5d0\uc11c \ucc28\uc774\uac00 \uc788\uc2b5\ub2c8\ub2e4. \uc6a9\ucd9c \ud55c\uacc4: \ud55c\uad6d \uc758\uc57d\ud488 \uae30\uc900\uc740 \ub3d9\uc77c\ud55c \ubb3c\uc9c8\uc5d0 \ub300\ud574 \ud55c\uad6d \uc2dd\ud488 \uc811\ucd09 \uae30\uc900\ubcf4\ub2e4 \uc57d 2\ubc30 \ub354 \uc5c4\uaca9\ud569\ub2c8\ub2e4(\uc608: \ube44\ud718\ubc1c\uc131 \uc794\ub958\ubb3c \ud55c\uacc4: \uc758\uc57d\ud488 50mg\/L, \uc2dd\ud488 \uc811\ucd09 \uae30\uc900 200mg\/L). \uc2dc\ud5d8 \uc628\ub3c4: \ud55c\uad6d \uc758\uc57d\ud488 \ucd94\ucd9c \uc2dc\ud5d8\uc740 70\u00b0C\uc5d0\uc11c 1\uc2dc\uac04 \ub3d9\uc548 \uc9c4\ud589\ub418\ub294 \ubc18\uba74, \ud55c\uad6d \uc2dd\ud488 \uc811\ucd09 \uc2dc\ud5d8\uc740 60\u00b0C\uc5d0\uc11c 30\ubd84 \ub3d9\uc548 \uc9c4\ud589\ub429\ub2c8\ub2e4. \uc758\uc57d\ud488 \uc2dc\ud5d8\uc758 \ub192\uc740 \uc628\ub3c4\ub294 \uc6a9\ucd9c\uc131 \ubb3c\uc9c8\uc758 \ucd94\ucd9c\uc744 \uac00\uc18d\ud654\ud558\uc5ec \ubcf8\uc9c8\uc801\uc73c\ub85c \ub354 \ub192\uc740 \ubbfc\uac10\ub3c4\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \ud5c8\uc6a9 \ubaa9\ub85d \ubc94\uc704: \ud55c\uad6d \uc758\uc57d\ud488 \uc6a9\uae30 \ud5c8\uc6a9 \ubaa9\ub85d\uc5d0\ub294 \ud55c\uad6d \uc2dd\ud488 \uc811\ucd09 \ubaa9\ub85d\uc5d0 \uc788\uc9c0\ub9cc \ub3d9\uc77c \ub18d\ub3c4\uc5d0\uc11c \ud55c\uad6d \uc758\uc57d\ud488 \uc6a9\uae30\uc5d0\uc11c\ub294 \uae08\uc9c0\ub41c \ubb3c\uc9c8(UV \uc548\uc815\uc81c, \ud2b9\uc815 \ud56d\uc0b0\ud654\uc81c)\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. \ub530\ub77c\uc11c \ud55c\uad6d ISBM \uc758\uc57d\ud488 \uc81c\uc870\uc5c5\uccb4\ub294 \ud45c\uc900 PET \uc218\uc9c0 \uc2dd\ud488 \ub4f1\uae09 \ucca8\uac00\uc81c \ud3ec\uc7a5\uc5d0 \ud55c\uad6d \uc758\uc57d\ud488 \uc6a9\uae30 \uae08\uc9c0 \ubaa9\ub85d\uc5d0 \uc788\ub294 \ubb3c\uc9c8\uc774 \ud3ec\ud568\ub418\uc5b4 \uc788\uc9c0 \uc54a\uc74c\uc744 \uc785\uc99d\ud574\uc57c \ud569\ub2c8\ub2e4. GMP \uc0dd\uc0b0 \ud658\uacbd: \ud55c\uad6d \uc758\uc57d\ud488 \uc6a9\uae30\ub294 GMP \uc778\uc99d\uc744 \ubc1b\uc740 \uc0dd\uc0b0 \ud658\uacbd\uc5d0\uc11c \uc0dd\uc0b0\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d\uc758 \uc2dd\ud488 \uc811\ucd09\uc6a9 ISBM\uc740 GMP \uc0dd\uc0b0 \uc694\uac74\uacfc \ub3d9\ub4f1\ud55c \uae30\uc900\uc744 \uc694\uad6c\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. CRC \uc900\uc218: \ud55c\uad6d\uc758 \uc758\uc57d\ud488 \uc6a9\uae30\ub294 CRC(\ud2b9\uc815 \uc758\uc57d\ud488 \uc885\ub958\uc5d0 \ub300\ud55c \ubc95\uc801 \uc694\uac74)\ub97c \uc694\uad6c\ud560 \uc218 \uc788\uc9c0\ub9cc, \uc2dd\ud488 \uc6a9\uae30\ub294 CRC\ub97c \uc694\uad6c\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. PET \ub610\ub294 PP ISBM \uc6a9\uae30\uc5d0 \ub300\ud574 \ud55c\uad6d\uc758 \uc2dd\ud488 \uc811\ucd09 \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294 \ud55c\uad6d ISBM \uc81c\uc870\uc5c5\uccb4\ub77c\uace0 \ud574\uc11c \uc790\ub3d9\uc73c\ub85c \ud55c\uad6d \uc758\uc57d\ud488 \uc6a9\uae30 \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294 \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4. \uc758\uc57d\ud488 \uae30\uc900\uc744 \ucda9\uc871\ud558\uae30 \uc704\ud574\uc11c\ub294 \ubcc4\ub3c4\uc758 \uc2dc\ud5d8 \ubc0f \uad00\ub828 \uc11c\ub958\ub97c \uc81c\ucd9c\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n

\n

\uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc758\uc57d\ud488 \ud3ec\uc7a5 \uc9c0\uc6d0<\/p>\n

GMP \uc778\uc99d\uc744 \ubc1b\uc740 CRC \uacbd\uad6c\uc6a9 \uc561\uc0c1 ISBM \ubcd1\uc774 \ud544\uc694\ud55c \ud55c\uad6d \uc81c\uc57d \ube0c\ub79c\ub4dc\ub97c \ucc3e\uace0 \uacc4\uc2ed\ub2c8\uae4c?<\/h2>\n

\ud55c\uad6d\uc758 Ever-Power\ub294 \ud55c\uad6d \ube0c\ub79c\ub4dc \uacbd\uad6c\uc6a9 \uc561\uc0c1 ISBM \uacf5\uae09\uc744 \uc704\ud574 KFDA \uc758\uc57d\ud488 \ucd94\ucd9c\ubb3c \uc2dc\ud5d8, CRC P&T \ub125 \uc815\ubc00\ub3c4 \u00b10.03mm, GMP IQ\/OQ\/PQ \uac80\uc99d \ubb38\uc11c, \uc570\ubc84 UV \ub9c8\uc2a4\ud130\ubc30\uce58 \ubc0f HGY150-V4-EV \ud50c\ub7ab\ud3fc\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n

\uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc81c\ud615 \uad00\ub828 \uc0c1\ub2f4\uc744 \uc694\uccad\ud558\uc138\uc694<\/a><\/p>\n<\/div>\n

\n

\uad00\ub828 \uc790\ub8cc<\/p>\n


\n\uc81c\uc57d \ud50c\ub7ab\ud3fc<\/span>
\n\ud55c\uad6d\uc0b0 Ever-Power HGY150-V4-EV<\/span>
\nEV \uc11c\ubcf4 \uc815\ubc00\ub3c4\ub85c CRC \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30 \ubaa9 \ubd80\ubd84 \uc678\uacbd \u00b10.03mm\ub97c \uad6c\ud604\ud588\uc73c\uba70, GMP \uc778\uc99d \uc0dd\uc0b0 \ud658\uacbd\uc5d0 \ud1b5\ud569\ub418\uc5b4 \ud55c\uad6d GMP \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294 4\uad6c 100ml \uc18c\uc544\uc6a9 \uc758\uc57d\ud488 \uc6a9\uae30\uc785\ub2c8\ub2e4.<\/span>
\n<\/a>
\n

\n\uae30\uacc4 \ubc94\uc704<\/span>
\n4\uac1c \uc2a4\ud14c\uc774\uc158 ISBM \uc0ac\uaca9\uc7a5<\/span>
\nHGY150-V4-EV\ub294 \uc18c\uc544\uc6a9 \ub300\uc7a5\uc554 \uce58\ub8cc\uc81c 60~100ml \uc6a9\ub7c9\uc5d0, HGY200-V4-EV\ub294 \uc131\uc778\uc6a9 \uacbd\uad6c \uc561\uc0c1 \uc81c\uc81c 200~500ml \uc6a9\ub7c9 \ubc0f \uae30\uad00 \uc870\uc81c\uc6a9 \uc81c\ud615\uc5d0 \uc0ac\uc6a9\ub429\ub2c8\ub2e4.<\/span>
\n<\/a>
\n

\nCRC \uc81c\uc57d \ud234\ub9c1<\/span>
\n\ub9de\ucda4\ud615 ISBM \uae08\ud615 \uc124\uacc4<\/span>
\n\ud55c\uad6d \uc81c\uc57d\ud68c\uc0ac CRC \uacbd\uad6c \uc561\uc0c1 \ubab0\ub4dc - \ube0c\ub79c\ub4dc \ub9c8\uac1c \uacf5\uae09\uc5c5\uccb4\uc5d0\uc11c \uc81c\uacf5\ud558\ub294 P&T \ubc0f S&T \ub125 \uc778\uc11c\ud2b8 \uc778\uc1c4, \ub208\uae08 \ud328\ub110 \ud3c9\ud0c4\ub3c4 \u00b10.15mm, \uc570\ubc84 \ub9c8\uc2a4\ud130\ubc30\uce58 UV \uc801\ud569\uc131 \uac80\uc99d.<\/span>
\n<\/a><\/div>\n<\/section>\n

 <\/p>\n