{"id":408,"date":"2026-04-24T08:01:44","date_gmt":"2026-04-24T08:01:44","guid":{"rendered":"https:\/\/onestepblowmachine.com\/?p=408"},"modified":"2026-04-24T08:01:44","modified_gmt":"2026-04-24T08:01:44","slug":"isbm-%ea%b8%b0%ea%b3%84%ea%b0%80-fda-%eb%b0%8f-gmp-%ea%b8%b0%ec%a4%80%ec%9d%84-%ec%b6%a9%ec%a1%b1%ed%95%98%eb%8a%94-%ec%a0%9c%ec%95%bd-%ed%8f%ac%ec%9e%a5%ec%97%90-%ec%96%b4%eb%96%bb%ea%b2%8c-%ec%82%ac","status":"publish","type":"post","link":"https:\/\/onestepblowmachine.com\/ko\/%ec%95%a0%ed%94%8c%eb%a6%ac%ec%bc%80%ec%9d%b4%ec%85%98\/isbm-%ea%b8%b0%ea%b3%84%ea%b0%80-fda-%eb%b0%8f-gmp-%ea%b8%b0%ec%a4%80%ec%9d%84-%ec%b6%a9%ec%a1%b1%ed%95%98%eb%8a%94-%ec%a0%9c%ec%95%bd-%ed%8f%ac%ec%9e%a5%ec%97%90-%ec%96%b4%eb%96%bb%ea%b2%8c-%ec%82%ac\/","title":{"rendered":"ISBM \uae30\uacc4\ub294 \uc81c\uc57d \ud3ec\uc7a5\uc5d0 \uc5b4\ub5bb\uac8c \ud65c\uc6a9\ub420\uae4c\uc694? FDA \ubc0f GMP \uae30\uc900 \ucda9\uc871"},"content":{"rendered":"
\n

ISBM \uae30\uacc4\ub294 \uc81c\uc57d \ud3ec\uc7a5\uc5d0 \uc5b4\ub5bb\uac8c \ud65c\uc6a9\ub420\uae4c\uc694? FDA \ubc0f GMP \uae30\uc900 \ucda9\uc871<\/h2>\n

\ucf5c\ub86c\ube44\uc544 \uc81c\uc57d \uc81c\uc870\uc5c5\uccb4\uac00 INVIMA, FDA \ubc0f GMP \uaddc\uc815 \uc900\uc218\ub97c \uc704\ud574 \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \ub3c4\uc785 \ubc29\uc548\uc744 \uac80\ud1a0\ud560 \ub54c \ucc38\uace0\ud560 \uc218 \uc788\ub294 \uc2e4\uc6a9\uc801\uc778 \uac00\uc774\ub4dc\uc785\ub2c8\ub2e4.<\/p>\n<\/div>\n

1. \uae30\uacc4 \uae30\uc220 \uc0ac\uc591 \u2014 \uc81c\uc57d \ub4f1\uae09 \uad6c\uc131<\/h2>\n

\uc544\ub798 \ub9e4\uac1c\ubcc0\uc218\ub294 20ml\ubd80\ud130 2,500ml\uae4c\uc9c0\uc758 \uc758\uc57d\ud488 \ubcd1 \uc0dd\uc0b0\uc5d0 \ub9de\uac8c \uad6c\uc131\ub41c \uc77c\ubc18\uc801\uc778 3\uc2a4\ud14c\uc774\uc158 \uc644\uc804 \uc804\uae30 \ud50c\ub7ab\ud3fc(\ucc38\uc870 \ubaa8\ub378 HGY50-V3-EV)\uc744 \uc124\uba85\ud569\ub2c8\ub2e4. HGY150-V4, HGY200-V4 \ubc0f HGY250-V4 \uc81c\ud488\uad70\uc758 \ub300\ud615 \uc7a5\ube44\ub294 \uae30\ubcf8 GMP \uce5c\ud654\uc801 \uc544\ud0a4\ud14d\ucc98\ub97c \ubcc0\uacbd\ud558\uc9c0 \uc54a\uace0 \uc6a9\ub7c9\uc744 \ube44\ub840\uc801\uc73c\ub85c \ud655\uc7a5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\ub9e4\uac1c\ubcc0\uc218<\/th>\n\uac12\/\ubc94\uc704<\/th>\n<\/tr>\n
\uae30\uacc4 \uc774\ub984<\/td>\n\uc6d0\uc2a4\ud15d \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30(3\uc2a4\ud14c\uc774\uc158)<\/td>\n<\/tr>\n
\ucc38\uc870 \ubaa8\ub378<\/td>\nHGY50-V3-EV (\uc644\uc804 \uc804\uae30\ucc28)<\/td>\n<\/tr>\n
\uc801\uc6a9 \uac00\ub2a5\ud55c \uc7ac\ub8cc<\/td>\nPET, PETG, PP, PPSU, PC, \ud2b8\ub77c\uc774\ud0c4, PCTG, PLA<\/td>\n<\/tr>\n
\ub098\uc0ac \uc9c1\uacbd<\/td>\n40 \/ 50 \/ 55 mm (\uc120\ud0dd \uc0ac\ud56d)<\/td>\n<\/tr>\n
\uc774\ub860\uc801 \uc8fc\uc785\ub7c9<\/td>\n239 \/ 315 \/ 442 cm\u00b3<\/td>\n<\/tr>\n
\uc0ac\ucd9c \ud074\ub7a8\ud551\ub825<\/td>\n50kN<\/td>\n<\/tr>\n
\uc1a1\ud48d \ud074\ub7a8\ud551\ub825<\/td>\n100kN<\/td>\n<\/tr>\n
\ubaa8\ud130 \ucd9c\ub825<\/td>\n34.8kW (\uc11c\ubcf4 \uad6c\ub3d9 \ubc29\uc2dd)<\/td>\n<\/tr>\n
\ub09c\ubc29 \ucd9c\ub825<\/td>\n10.4kW (\ub098\ub178 \uc6d0\uc801\uc678\uc120)<\/td>\n<\/tr>\n
\ucd1d \uc124\uce58 \uc804\ub825<\/td>\n45.2kW<\/td>\n<\/tr>\n
\uc1a1\ud48d \uacf5\uae30\uc555<\/td>\n2.0 \u2013 3.5 MPa<\/td>\n<\/tr>\n
\ub0c9\uac01\uc218 \uc555\ub825<\/td>\n0.4 \u2013 0.6 MPa<\/td>\n<\/tr>\n
\uc791\ub3d9 \uc804\uc555<\/td>\n370~400V<\/td>\n<\/tr>\n
\uae30\uacc4 \uc124\uce58 \uacf5\uac04 (\uae38\uc774 \u00d7 \ub108\ube44 \u00d7 \ub192\uc774)<\/td>\n3.8 \u00d7 1.2 \u00d7 2.5 \ubbf8\ud130<\/td>\n<\/tr>\n
\uae30\uacc4 \ubb34\uac8c<\/td>\n3.5\ud1a4<\/td>\n<\/tr>\n
\ucd5c\ub300 \ubcd1 \uc6a9\ub7c9 \ubc94\uc704<\/td>\n20ml \u2013 2,500ml<\/td>\n<\/tr>\n
\uc0ac\uc774\ud074\ub2f9 \ucd5c\ub300 \ucda9\uce58 \uac1c\uc218<\/td>\n\ucd5c\ub300 6\uac1c<\/td>\n<\/tr>\n
\ubcbd \ub450\uaed8 \uade0\uc77c\uc131<\/td>\n\u00b15% \uc77c\ubc18\uc801\uc778<\/td>\n<\/tr>\n
\ud638\ud658\uc131<\/td>\nASB \ubc0f AOKI \ud234\ub9c1 \uc81c\ud488\uad70\uc758 \uc644\ubcbd\ud55c \ub300\uccb4\ud488<\/td>\n<\/tr>\n
\uc81c\uc5b4 \uc2dc\uc2a4\ud15c<\/td>\nInovance\/MiRLE PLC\uc758 \ub808\uc2dc\ud53c \uad00\ub9ac \uae30\ub2a5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
<\/div>\n
\"\uc6d0\uc2a4\ud15d<\/div>\n
\n

2. \uc11c\ub860: \uc758\uc57d\ud488 \ud3ec\uc7a5 \ubc0f \uc6d0\uc2a4\ud15d \uacf5\uc815<\/h2>\n

\ubcf4\uace0\ud0c0, \uba54\ub370\uc778, \uce7c\ub9ac, \uadf8\ub9ac\uace0 \ubc14\ub791\ud0a4\uc57c \uc778\uadfc \uce74\ub9ac\ube0c\ud574 \uc5f0\uc548 \uc9c0\uc5ed\uc5d0\uc11c \ud65c\ub3d9\ud558\ub294 \uc81c\uc57d \uc81c\uc870\uc5c5\uccb4\ub4e4\uc740 \uc810\uc810 \ub354 \uc5c4\uaca9\ud574\uc9c0\ub294 \uaddc\uc81c \ud658\uacbd\uc5d0 \uc9c1\uba74\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. INVIMA\uc758 \uac80\uc0ac\uac00 \uac15\ud654\ub418\uc5c8\uace0, \ubd81\ubbf8 \uc218\ucd9c\ud488\uc5d0 \ub300\ud55c FDA\uc758 \uc2ec\uc0ac\uac00 \uc2ec\ud654\ub418\uc5c8\uc73c\uba70, \uc774\uc81c \uc804 \uc138\uacc4 \uace0\uac1d\ub4e4\uc740 \ucd9c\ud558\ub418\ub294 \ubaa8\ub4e0 1\ucc28 \uc6a9\uae30\uc5d0 \ub300\ud574 ISO 15378 \ucd94\uc801\uc131\uc744 \uc694\uad6c\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ubc30\uacbd \uc18d\uc5d0\uc11c \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub294 \uacbd\uad6c\uc6a9 \uc561\uc0c1 \uc6a9\uae30, \uc2dc\ub7fd \uc6a9\uae30, \uc810\uc548\uc561 \uc6a9\uae30, \ube44\uac15 \uc2a4\ud504\ub808\uc774 \ubcf8\uccb4, \uc18c\ud615 \uc8fc\uc785\uc81c \ud3ec\uc7a5\uc7ac \uc0dd\uc0b0\uc5d0 \uc788\uc5b4 \ud575\uc2ec\uc801\uc778 \ud50c\ub7ab\ud3fc\uc73c\ub85c \uc790\ub9ac \uc7a1\uc558\uc2b5\ub2c8\ub2e4. \ud504\ub9ac\ud3fc\uc744 \ubcf4\uad00\ud558\uace0 \uc8fc\ubcc0 \ud658\uacbd \uc624\uc5fc\uc5d0 \ub178\ucd9c\uc2dc\ud0a4\ub294 2\ub2e8\uacc4 \uacf5\uc815\uacfc \ub2ec\ub9ac, \uc6d0\uc2a4\ud15d \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub294 \uc0ac\ucd9c, \ucee8\ub514\uc154\ub2dd, \uc2a4\ud2b8\ub808\uce58, \ube14\ub85c\uc6b0, \uadf8\ub9ac\uace0 \uc6a9\uae30 \ubc30\ucd9c\uae4c\uc9c0 \ubaa8\ub4e0 \uacf5\uc815\uc744 \ud558\ub098\uc758 \ubc00\ud3d0\ub41c \uacf5\uac04 \ub0b4\uc5d0\uc11c \uc644\ub8cc\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ub2e8\uc77c \uacf5\uc815 \uad6c\uc870 \ub355\ubd84\uc5d0 \uaddc\uc81c \ub2f9\uad6d\uacfc \ud488\uc9c8 \uad00\ub9ac\ud300\uc740 \uc644\uc81c\ud488\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ubaa8\ub4e0 \uc81c\ud488\uc5d0 \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub97c \uc120\ud638\ud569\ub2c8\ub2e4. \uc774 \uae00\uc5d0\uc11c\ub294 \ucf5c\ub86c\ube44\uc544\uc758 \uaddc\uc81c \ud658\uacbd\uacfc \uc804 \uc138\uacc4\uc801\uc73c\ub85c \uc911\uc694\ud55c GMP \uac00\uc774\ub4dc\ub77c\uc778\uc744 \uad6c\uccb4\uc801\uc73c\ub85c \uc0b4\ud3b4\ubcf4\uba74\uc11c \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\uc758 \uc7a5\uc810\uacfc \uc7a5\uc810\uc744 \ubd84\uc11d\ud569\ub2c8\ub2e4.<\/p>\n

\"\uc6d0\uc2a4\ud15d<\/div>\n<\/div>\n
\n

3. \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\uac00 \uc81c\uc57d \uc0b0\uc5c5\uc5d0 \uc801\ud569\ud55c \uc774\uc720<\/h2>\n

\uc758\uc57d\ud488 1\ucc28 \ud3ec\uc7a5 \uc694\uac74\uc740 \uc11c\ub958\uc0c1\uc73c\ub85c\ub294 \uac04\ub2e8\ud574 \ubcf4\uc785\ub2c8\ub2e4. \uae68\ub057\ud558\uace0, \uce58\uc218 \uc7ac\ud604\uc131\uc774 \ub6f0\uc5b4\ub098\uba70, \ub0b4\uc6a9\ubb3c\uc5d0 \ub300\ud574 \ud654\ud559\uc801\uc73c\ub85c \ubd88\ud65c\uc131\uc774\uace0, \uac80\uc99d\ub41c \uc0dd\uc0b0 \ub85c\ud2b8\uae4c\uc9c0 \ucd94\uc801 \uac00\ub2a5\ud55c \uc6a9\uae30\ub97c \uc81c\uacf5\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. \ud558\uc9c0\ub9cc \uc2e4\uc81c\ub85c\ub294 \uc774 \ub124 \uac00\uc9c0 \uc870\uac74\uc744 \ubaa8\ub450 \ucda9\uc871\ud558\uae30\ub294 \uc5b4\ub835\uc2b5\ub2c8\ub2e4. \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615 \uacf5\uc815\uc740 \ubd84\uc790 \ubc30\ud5a5\uc744 \ud1b5\ud574 \uc774\ub97c \ub2ec\uc131\ud569\ub2c8\ub2e4. \ud504\ub9ac\ud3fc\uc744 \uc720\ub9ac \uc804\uc774 \uc628\ub3c4 \uc774\uc0c1\uc5d0\uc11c \uc774\ucd95 \ubc29\ud5a5\uc73c\ub85c \ub298\ub824 \ud3f4\ub9ac\uba38 \uc0ac\uc2ac\uc744 \ucd95 \ubc29\ud5a5\uacfc \uc6d0\uc8fc \ubc29\ud5a5\uc73c\ub85c \uc815\ub82c\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ubc30\ud5a5\uc740 \ucc28\ub2e8 \uc131\ub2a5\uc744 \ud5a5\uc0c1\uc2dc\ud0a4\uace0, \ud30c\uc5f4 \uac15\ub3c4\ub97c \ub192\uc774\uba70, \ubc00\ubd09 \ubb34\uacb0\uc131\uc774 \ubcf4\uc7a5\ub418\uc5b4\uc57c \ud558\ub294 \ubcd1\ubaa9 \ubd80\uadfc\uc758 \uc6a9\uc811\uc120\uc744 \uc81c\uac70\ud569\ub2c8\ub2e4. \ucf5c\ub86c\ube44\uc544\uc758 \ud55c \uc704\ud0c1 \uc81c\uc870\uc5c5\uccb4\ub294 \uacbd\uad6c\uc6a9\uc561\uc774\ub098 \uad6d\uc18c \uc81c\uc81c\ub97c \uc0dd\uc0b0\ud558\ub294\ub370, \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub97c \uc0ac\uc6a9\ud558\uba74 \ubcbd \ub450\uaed8 \ud3b8\ucc28\uac00 \u00b15% \uc774\ub0b4\uc774\uace0, \ubcd1\ubaa9 \ub9c8\uac10\uc740 \uc0ac\ucd9c \uc131\ud615\uc758 \uc815\ubc00\ub3c4\ub97c \uc720\uc9c0\ud558\uba70, \ub0b4\ubd80 \ud45c\uba74\uc740 \uc0ac\ub78c\uc758 \uc190\uae38\uc774 \uc804\ud600 \ub2ff\uc9c0 \uc54a\uc740 \ubcd1\uc744 \uc5bb\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\uac83\uc774 \ubc14\ub85c INVIMA, FDA, ANVISA, COFEPRIS\uc640 \uac19\uc740 \uaddc\uc81c \uae30\uad00\uc5d0\uc11c \uc6d0\uc2a4\ud15d \uc0dd\uc0b0 \ubc29\uc2dd\uc744 \ub2e4\ub978 \ubc29\uc2dd\ubcf4\ub2e4 \uc704\ud5d8\ub3c4\uac00 \ub0ae\ub2e4\uace0 \ud310\ub2e8\ud558\ub294 \ud575\uc2ec \uc774\uc720\uc785\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

4. \uc791\ub3d9 \uc6d0\ub9ac: 4\ub2e8\uacc4 \uc0ac\uc774\ud074<\/h2>\n

\uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615 \uacf5\uc815\uc740 \ud68c\uc804\uc2dd \ud134\ud14c\uc774\ube14\uc5d0 \ubc30\uc5f4\ub41c \ub124 \uac1c\uc758 \uac1c\ubcc4 \uc2a4\ud14c\uc774\uc158\uc73c\ub85c \uad6c\uc131\ub429\ub2c8\ub2e4. \uccab \ubc88\uc9f8 \uc2a4\ud14c\uc774\uc158\uc740 \uc0ac\ucd9c \ub2e8\uacc4\ub85c, \uc6a9\uc735\ub41c PET, PETG, PPSU, PP, PC, Tritan, PCTG \ub610\ub294 PLA\uac00 \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc2a4\ud2f8 \ucf54\uc5b4 \ud540 \uc8fc\uc704\ub85c \uc0ac\ucd9c\ub418\uc5b4 \ubaa9 \ubd80\ubd84\uacfc \ub098\uc0ac\uc0b0\uc774 \uc644\uc131\ub41c \ud504\ub9ac\ud3fc\uc744 \ud615\uc131\ud569\ub2c8\ub2e4. \ub450 \ubc88\uc9f8 \uc2a4\ud14c\uc774\uc158\uc740 \uc5f4\ucc98\ub9ac \ub2e8\uacc4\ub85c, \ud504\ub9ac\ud3fc\uc774 \uc628\ub3c4 \uc870\uc808 \ubc30\ub7f4\uc744 \ud1b5\uacfc\ud558\uba74\uc11c \ubcf8\uccb4 \uc7ac\uc9c8\uc740 \ucda9\ubd84\ud788 \ub728\uac70\uc6cc\uc838 \ub298\uc5b4\ub098\uc9c0\ub9cc \ubaa9 \ubd80\ubd84\uc740 \ub2e8\ub2e8\ud558\uac8c \uc720\uc9c0\ub418\ub3c4\ub85d \ud504\ub85c\ud30c\uc77c\uc774 \ubbf8\uc138 \uc870\uc815\ub429\ub2c8\ub2e4. \uc11c\ubcf4 \ubc0f \uc644\uc804 \uc804\uae30\uc2dd \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\uc5d0\uc11c\ub294 \uc774 \ub2e8\uacc4\uc5d0\uc11c \uc11c\ubcf4 \ud14c\uc77c \ucee4\ud130\uac00 \uac8c\uc774\ud2b8 \uc794\uc5ec\ubb3c\uc744 \uae54\ub054\ud558\uac8c \uc81c\uac70\ud569\ub2c8\ub2e4. \uc138 \ubc88\uc9f8 \uc2a4\ud14c\uc774\uc158\uc740 \uc5f0\uc2e0 \ubc0f \ube14\ub85c\uc6b0 \ub2e8\uacc4\ub85c, \uae08\ud615\uc774 \uc5f4\ucc98\ub9ac\ub41c \ud504\ub9ac\ud3fc \uc8fc\uc704\ub85c \ub2eb\ud788\uace0, \uc5f0\uc2e0 \ub85c\ub4dc\uac00 \uc544\ub798\ucabd\uc73c\ub85c \uc774\ub3d9\ud558\uc5ec \ucd95 \ubc29\ud5a5\uc73c\ub85c \uc5f0\uc2e0\ub418\uba70, 2.0~3.5MPa\uc758 \uacf5\uae30\uac00 \ud504\ub9ac\ud3fc\uc744 \uce90\ube44\ud2f0 \ubcbd\uba74 \ucabd\uc73c\ub85c \ubc29\uc0ac\ud615\uc73c\ub85c \ud33d\ucc3d\uc2dc\ud0b5\ub2c8\ub2e4. \ub124 \ubc88\uc9f8 \uc2a4\ud14c\uc774\uc158\uc740 \ubc30\ucd9c \ub2e8\uacc4\ub85c, \ub0c9\uac01\ub41c \ubcd1\uc774 \ucee8\ubca0\uc774\uc5b4\ub85c \ubc30\ucd9c\ub418\uace0 \ucf54\uc5b4 \ud540\uc740 \uccab \ubc88\uc9f8 \uc2a4\ud14c\uc774\uc158\uc73c\ub85c \ub3cc\uc544\uac11\ub2c8\ub2e4. \uc0ac\uc774\ud074 \uc2dc\uac04\uc740 \uce90\ube44\ud2f0 \uac1c\uc218\uc640 \uc218\uc9c0 \uc885\ub958\uc5d0 \ub530\ub77c \uc77c\ubc18\uc801\uc73c\ub85c 10~30\ucd08 \uc815\ub3c4 \uc18c\uc694\ub429\ub2c8\ub2e4.<\/p>\n

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

5. \uc758\uc57d\ud488 \ud3ec\uc7a5\uc758 5\uac00\uc9c0 \ud575\uc2ec \uc774\uc810<\/h2>\n
\n

1. \ud3d0\uc1c4 \ub8e8\ud504 \uccad\uc815\uc131<\/h3>\n

\ud504\ub9ac\ud3fc\uc740 \uc0ac\ucd9c\uacfc \ube14\ub85c\uc6b0 \uc131\ud615 \uc0ac\uc774\uc5d0\uc11c \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \ubc16\uc73c\ub85c \uc808\ub300 \ub098\uac00\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ubc00\ud3d0\ub41c \uc6a9\uae30 \uc548\uc5d0\uc11c \ud68c\uc804\ud558\ub294 \ucf54\uc5b4 \ud540\uc744 \ub530\ub77c \uc774\ub3d9\ud558\ubbc0\ub85c \uc791\uc5c5\uc790\uc640\uc758 \uc811\ucd09, \uacf5\uae30 \uc911 \uc624\uc5fc \uac00\ub2a5\uc131, \uc911\uac04 \ubcf4\uad00 \ub2e8\uacc4\uac00 \ubaa8\ub450 \uc81c\uac70\ub429\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ub2e8\uc77c \uad6c\uc870\uc801 \uc124\uacc4 \ub355\ubd84\uc5d0 GMP \uc2ec\uc0ac\uad00\ub4e4\uc740 \uc7ac\uac00\uc5f4 \uacf5\uc815\ubcf4\ub2e4 \ubb34\uade0 \ucda9\uc804 \ubc0f \ubbf8\uc0dd\ubb3c \uc624\uc5fc\ub3c4\uac00 \ub0ae\uc740 \uc81c\ud615\uc5d0 \ub300\ud574 \uc6d0\uc2a4\ud15d \uc0dd\uc0b0 \ubc29\uc2dd\uc744 \ub354 \uc27d\uac8c \uc778\uc815\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

2. \ucea1\ud551 \ubb34\uacb0\uc131\uc744 \uc704\ud55c \uce58\uc218 \ubc18\ubcf5\uc131<\/h3>\n

\ubcd1\ubaa9 \ub9c8\uac10\uc740 \ube14\ub85c\uc6b0 \uc131\ud615\uc774 \uc544\ub2cc \uc0ac\ucd9c \uc131\ud615 \ubc29\uc2dd\uc73c\ub85c \uc774\ub8e8\uc5b4\uc838 \ub098\uc0ac\uc0b0 \ud615\uc0c1\uc774 \ubaa8\ub4e0 \ubcd1\uc5d0\uc11c \uae08\ud615 \uc218\uc900\uc758 \uc815\ubc00\ub3c4\ub97c \uc720\uc9c0\ud569\ub2c8\ub2e4. \uc790\ub3d9 \ucea1\ud551 \uc2dc \ud1a0\ud06c \ubc18\ubcf5\uc131\uc774 \ud5a5\uc0c1\ub418\uace0 \ub204\ucd9c\ub960\uc774 \uac10\uc18c\ud558\uba70, INVIMA \ub610\ub294 FDA \uc0ac\uc804 \uc2b9\uc778 \uac80\uc0ac \uc2dc \ub9c8\uac1c \uac80\uc99d \ubb38\uc11c\ub97c \ud6e8\uc52c \uc27d\uac8c \uc785\uc99d\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

3. \uc5d0\ub108\uc9c0 \ubc1c\uc790\uad6d\uc774 \uc57d 40% \uac10\uc18c<\/h3>\n

\ud504\ub9ac\ud3fc\uc740 \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615 \uacfc\uc815\uc5d0\uc11c \uc9c1\uc811 \uc8fc\uc785\ub420 \ub54c \ubc1c\uc0dd\ud558\ub294 \uc7a0\uc5f4\uc744 \uadf8\ub300\ub85c \uc720\uc9c0\ud558\uae30 \ub54c\ubb38\uc5d0 \uc7ac\uac00\uc5f4 \uc624\ube10\uc774 \ud544\uc694\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uc6b4\uc601 \uce21\uba74\uc5d0\uc11c, 24\uc2dc\uac04 \uad50\ub300 \uadfc\ubb34\ub97c \ud558\ub294 \ucf5c\ub86c\ube44\uc544 \uacf5\uc7a5\uc740 \ub3d9\uc77c\ud55c 2\ub2e8\uacc4 \uc0dd\uc0b0 \ubc29\uc2dd\uacfc \ube44\uad50\ud588\uc744 \ub54c \ud0ac\ub85c\uc640\ud2b8\uc2dc \uc18c\ube44\ub7c9\uc744 \ud06c\uac8c \uc904\uc77c \uc218 \uc788\uc744 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc774\ub294 \uc548\ub370\uc2a4 \uc0b0\uc5c5 \uc9c0\uc5ed\uc758 \uc804\uae30 \uc694\uae08\uc774 \uc0c1\uc2b9\ud568\uc5d0 \ub530\ub77c \uc810\uc810 \ub354 \uc911\uc694\ud55c \uc774\uc810\uc774 \ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

4. \ud3ed\ub113\uc740 \uc218\uc9c0 \ud638\ud658\uc131<\/h3>\n

\ud558\ub098\uc758 \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub85c \uacbd\uad6c\uc6a9 \uc6a9\uc561 \ubcd1\uc5d0 \uc0ac\uc6a9\ub418\ub294 PET, \uace0\uc628 \ucda9\uc804 \uc2dc\ub7fd\uc5d0 \uc0ac\uc6a9\ub418\ub294 PP, \uc99d\uae30 \uba78\uade0 \uac00\ub2a5\ud55c \uc9c4\ub2e8 \uc6a9\uae30\uc5d0 \uc0ac\uc6a9\ub418\ub294 PPSU, \uace0\uae09 \ud654\uc7a5\ud488 \ub4f1\uae09 \uad6d\uc18c \ub3c4\ud3ec\uc81c\uc5d0 \uc0ac\uc6a9\ub418\ub294 PCTG, \uadf8\ub9ac\uace0 BPA\uac00 \ud568\uc720\ub418\uc9c0 \uc54a\uc740 \uc18c\uc544\uc6a9 \uc81c\ud488\uc5d0 \uc0ac\uc6a9\ub418\ub294 Tritan\uc744 \uac00\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc18c\uc7ac \ubcc0\uacbd\uc740 \uacf5\uc815 \uc7ac\uac1c\ubc1c\uc774 \uc544\ub2cc \uae08\ud615 \uc81c\uc791 \uc791\uc5c5\uc785\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

5. ASB \ubc0f AOKI \ud234\ub9c1\uacfc\uc758 \ud638\ud658\uc131<\/h3>\n

\ub808\ud37c\ub7f0\uc2a4 \uc11c\ubcf4 \ubaa8\ub378 HGY150-V4, HGY200-V4 \ubc0f HGY250-V4\ub294 ASB-12M, AOKI-250 \ubc0f ASB-70DPH \ud50c\ub7ab\ud3fc\uc6a9\uc73c\ub85c \uc124\uacc4\ub41c \uae08\ud615 \uc138\ud2b8\ub97c \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uae30\uc874 \uc77c\ubcf8\uc0b0 \uae08\ud615\uc744 \uc774\ubbf8 \uc0ac\uc6a9\ud558\uace0 \uc788\ub294 \ucf5c\ub86c\ube44\uc544 \uc778\uc1c4\uc5c5\uccb4\uc758 \uacbd\uc6b0, \uac80\uc99d\ub41c \uae08\ud615 \uc7ac\uace0\ub97c \ud3d0\uae30\ud558\uc9c0 \uc54a\uace0 \ub2e8\uacc4\uc801\uc73c\ub85c \uc804\ud658\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub294 \ube0c\ub85c\uc154\uc5d0\uc11c\ub294 \uc798 \uc5b8\uae09\ub418\uc9c0 \uc54a\ub294 \uc2e4\uc9c8\uc801\uc778 \uad6c\ub9e4 \uc774\uc810\uc785\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n

\n

6. \uc758\uc57d\ud488 \uc6a9\uae30\uc6a9 \uc7ac\ub8cc \uc2dc\uc2a4\ud15c<\/h2>\n

\uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\uc5d0\uc11c \uc7ac\ub8cc \uc120\ud0dd\uc740 \uc81c\ud615\uc758 \ud654\ud559\uc801 \ud2b9\uc131\uacfc \uc801\uc6a9 \uac00\ub2a5\ud55c \uc57d\uc804 \uaddc\uc815\uc5d0 \ub530\ub77c \uacb0\uc815\ub429\ub2c8\ub2e4. PET\ub294 \uacbd\uad6c\uc6a9 \uc561\uc81c, \uc2dc\ub7fd, \uc885\ud569 \ube44\ud0c0\ubbfc \uc6a9\uc561\uc5d0 \ub110\ub9ac \uc0ac\uc6a9\ub418\ub294 \uc7ac\ub8cc\ub85c, USP \ubc0f \uc720\ub7fd \uc57d\uc804 3.1.15\uc758 \ud50c\ub77c\uc2a4\ud2f1 \uc989\uc2dc \uc6a9\uae30 \uae30\uc900\uc744 \ucda9\uc871\ud558\uba70 \uac10\ub9c8\uc120 \uba78\uade0 \uacfc\uc815\uc5d0\uc11c\ub3c4 \uc548\uc815\uc801\uc778 \uac70\ub3d9\uc744 \ubcf4\uc785\ub2c8\ub2e4. PP\ub294 \uc5f4 \ubcc0\ud615 \uc628\ub3c4\uac00 \ub192\uc544 \uace0\uc628 \ucda9\uc804 \ub610\ub294 \uc800\uc628 \uc99d\uae30 \uc0b4\uade0 \uacf5\uc815\uc774 \ud544\uc694\ud55c \uacbd\uc6b0\uc5d0 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. PPSU\ub294 134\u00b0C\uc5d0\uc11c \ubc18\ubcf5\uc801\uc778 \uace0\uc555\uba78\uade0\uc744 \uac70\uce58\ub294 \uc9c4\ub2e8 \uc6a9\uae30\uc5d0 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. PC\ub294 \uc77c\ubd80 \uc2dc\uc7a5\uc5d0\uc11c \ud1f4\ucd9c \uc555\ub825\uc774 \uc788\uc74c\uc5d0\ub3c4 \ubd88\uad6c\ud558\uace0 \uc720\uc544\uc6a9 \uc816\ubcd1 \ubcf8\uccb4\uc5d0 \uc5ec\uc804\ud788 \ub110\ub9ac \uc0ac\uc6a9\ub429\ub2c8\ub2e4. \ud2b8\ub77c\uc774\ud0c4 \ucf54\ud3f4\ub9ac\uc5d0\uc2a4\ud130\ub294 BPA \ubb34\ud568\uc720 \uc81c\ud488\uc73c\ub85c \uc810\uc810 \ub354 \uc120\ud638\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. PCTG\ub294 \uad6d\uc18c \ud53c\ubd80\uacfc \ubc0f \uae30\ub2a5\uc131 \ud654\uc7a5\ud488 \uc81c\uc81c\uc5d0 \uc801\ud569\ud55c \ud22c\uba85\ud558\uace0 \ud654\ud559\uc801\uc73c\ub85c \ub0b4\uc131\uc774 \ub6f0\uc5b4\ub09c \uc18c\uc7ac\uc774\uba70, PLA\ub294 \uc720\ud1b5\uae30\ud55c\uc774 \uc9e7\uc740 \uc81c\ud488\uc758 \uc0dd\ubd84\ud574\uc131 \ud3ec\uc7a5\uc5d0 \uc801\ud569\ud569\ub2c8\ub2e4. \ubaa8\ub4e0 \uc218\uc9c0 \ub4f1\uae09\uc740 INVIMA \ubc0f FDA \uc81c\ucd9c\uc744 \uc9c0\uc6d0\ud558\uae30 \uc704\ud574 DMF \ub610\ub294 III\ud615 \uc758\uc57d\ud488 \ub9c8\uc2a4\ud130 \ud30c\uc77c\uacfc \ud568\uaed8 \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\uc5d0 \ud22c\uc785\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

7. \uad6c\uc870\uc801 \ud2b9\uc9d5 \ubc0f \uad8c\uc7a5 \uad6c\uc131<\/h2>\n

\uc544\ub798 \uc694\uc57d\ud45c\ub294 \uaddc\uc81c\ub41c \uc81c\uc870 \ud658\uacbd\uc5d0\uc11c \uc801\uaca9\uc131 \ud3c9\uac00, \uac80\uc99d \ubc0f \uc7a5\uae30 \uc2e0\ub8b0\uc131\uacfc \uad00\ub828\ub41c 9\uac00\uc9c0 \uce21\uba74\uc5d0 \uac78\uccd0 \uc81c\uc57d \ub4f1\uae09 \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\uc758 \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \ud504\ub85c\ud544\uc744 \uac04\ub7b5\ud558\uac8c \ubcf4\uc5ec\uc90d\ub2c8\ub2e4.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
\uae30\uc778\ud558\ub2e4<\/th>\n\uc124\uba85<\/th>\n<\/tr>\n
\ubaa8\uc158 \ubaa8\ub4dc<\/td>\n\ud68c\uc804\uc2dd 4\uc2a4\ud14c\uc774\uc158 \ub610\ub294 3\uc2a4\ud14c\uc774\uc158 \ud134\ud14c\uc774\ube14; \uc11c\ubcf4 \uad6c\ub3d9\uc2dd \ud074\ub7a8\ud551, \uc2a4\ud2b8\ub808\uce6d \ubc0f \uc778\ucd9c; \uace0\uc555 \ubcf4\uc0c1 \uae30\ub2a5\uc774 \uc788\ub294 \uc774\uc911 \uc11c\ubcf4 \ube14\ub85c\uc6b0 \uc131\ud615 \ud3d0\uc1c4 \uc7a5\uce58<\/td>\n<\/tr>\n
\uad6c\uc870 \uc720\ud615<\/td>\n\uc218\ud3c9 \uc0ac\ucd9c \ubc30\ub7f4\uacfc \uc218\uc9c1 \ud074\ub7a8\ud504\uc758 \uacb0\ud569; \uc0c1\ubd80 \ubc0f \ud558\ubd80 \uae08\ud615 \uc2a4\ud2b8\ub85c\ud06c\ub294 \ub3c5\ub9bd\uc801\uc73c\ub85c \uc81c\uc5b4\ub428; IP \ub4f1\uae09\uc758 \uc678\ud568\uc5d0 \ud1b5\ud569\ub41c \uc81c\uc5b4 \uce90\ube44\ub2db<\/td>\n<\/tr>\n
\uc81c\uc870 \uac74\uc124<\/td>\n\uc6a9\uc811 \ubc0f \uc751\ub825 \uc81c\uac70 \ucc98\ub9ac\ub41c \uac15\ucca0 \ud504\ub808\uc784; S136 \uc2a4\ud14c\uc778\ub9ac\uc2a4\uac15 \uce90\ube44\ud2f0 \uc7ac\uc9c8; NSK \ub9ac\ub4dc \uc2a4\ud06c\ub958; \uc77c\ubcf8 Yaskawa \ub610\ub294 Inovance \uc11c\ubcf4 \ubaa8\ud130 \ubc0f \ub300\ub9cc Tsuntien \uac10\uc18d\uae30<\/td>\n<\/tr>\n
\uc7ac\ub8cc \uc2dc\uc2a4\ud15c<\/td>\nPET, PETG, PP, PPSU, PC, Tritan, PCTG, PS, ABS, PLA; \uc2a4\ud06c\ub958 \ubc0f \uce90\ube44\ud2f0 \uad50\uccb4\ub97c \ud1b5\ud55c \ub2e4\uc911 \uc18c\uc7ac \uc804\ud658 \uac00\ub2a5<\/td>\n<\/tr>\n
\ud45c\uba74 \ucc98\ub9ac<\/td>\n\uce90\ube44\ud2f0 \ud45c\uba74\uc740 \uac70\uc6b8\ucc98\ub7fc \ub9e4\ub044\ub7fd\uac8c \uc5f0\ub9c8\ub418\uc5b4 Ra \u2264 0.8 \u00b5m\uc774\uba70, \uc2a4\ud2b8\ub808\uce58 \ub85c\ub4dc\uc640 \ucf54\uc5b4 \ud540\uc5d0\ub294 \ud06c\ub86c \ub610\ub294 \uc9c8\ud654\ud2f0\ud0c0\ub284 \ub9c8\ubaa8 \ubc29\uc9c0 \ucf54\ud305\uc774 \uc801\uc6a9\ub418\uc5c8\uace0, \uad6c\uc870 \ud504\ub808\uc784\uc740 \ubd84\uccb4 \ub3c4\uc7a5 \ucc98\ub9ac\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/td>\n<\/tr>\n
\ud658\uacbd \ub4f1\uae09<\/td>\nISO 8\/\ud074\ub798\uc2a4 100,000 \ud074\ub9b0\ub8f8 \uc124\uce58\uc5d0 \uc801\ud569\ud558\uba70, ISO 7 \uc5c5\uadf8\ub808\uc774\ub4dc\ub97c \uc704\ud574 \ud14c\uc774\ud06c\uc544\uc6c3 \uad6c\uc5ed\uc5d0 HEPA \uce90\ub178\ud53c\ub97c \uc120\ud0dd\uc801\uc73c\ub85c \uc124\uce58\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc8fc\ubcc0 \uc628\ub3c4\ub294 15~38\u00b0C, \uc2b5\ub3c4\ub294 40~70% RH\uc785\ub2c8\ub2e4.<\/td>\n<\/tr>\n
\uc791\ub3d9 \uc870\uac74<\/td>\n24\uc2dc\uac04 \uc5f0\uc18d \uc791\ub3d9 \uac00\ub2a5; \uc1a1\ud48d \uc555\ub825 2.0~3.5 MPa; \ub0c9\uac01\uc218 \uc555\ub825 0.4~0.6 MPa; \uc555\ucd95 \uacf5\uae30\ub294 \uac74\uc2dd, \ubb34\uc720; \uc804\uc6d0 370~400V 3\uc0c1<\/td>\n<\/tr>\n
\uc77c\ubc18\uc801\uc778 \uace0\uc7a5 \ubaa8\ub4dc<\/td>\n\uc7a5\uc2dc\uac04 \uc6b4\uc804 \ud6c4 \ucf54\uc5b4 \ud540 \ub9c8\ubaa8; \uc2a4\ud2b8\ub808\uce58 \ub85c\ub4dc \uc815\ub82c \ud3b8\ucc28; \ube44\uc804\uae30\uc2dd \ud50c\ub7ab\ud3fc\uc758 \uc720\uc555 \uc530 \ud53c\ub85c; \ud788\ud130 \ubc34\ub4dc \uc18c\uc190; \uc624\uc5fc\ub41c \uacf5\uae30\ub85c \uc778\ud55c \ubc38\ube0c \uace0\ucc29<\/td>\n<\/tr>\n
\uc81c\uc57d \ubd84\uc57c\uc5d0 \uad8c\uc7a5\ub418\ub294 \uad6c\uc131<\/td>\n\uc644\uc804 \uc804\uae30\uc2dd \ub610\ub294 \uc644\uc804 \uc11c\ubcf4 \uad6c\ub3d9 \ubc29\uc2dd; S136 \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uae08\ud615\uac15; \ud30c\ucee4 \uace0\uc555 \ud30c\uc77c\ub7ff \ubc38\ube0c; (\uc720\uc9c0\ub41c \uacbd\uc6b0) \uc720\ucf04 \uc720\uc555 \ubc38\ube0c; \ud1b5\ud569 \uc628\ub3c4 \uc81c\uc5b4; 21 CFR Part 11 \uc900\uc218 \uac10\uc0ac \ucd94\uc801 \uae30\ub2a5\uc744 \uac16\ucd98 PLC<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
\n

8. \uaddc\uc81c \ud658\uacbd: \ucf5c\ub86c\ube44\uc544, FDA \ubc0f \uae00\ub85c\ubc8c GMP<\/h2>\n

\ucf5c\ub86c\ube44\uc544 \uc758\uc57d\ud488 \uaddc\uc81c\uae30\uad00\uc778 INVIMA\ub294 WHO \uc6b0\uc218 \uc758\uc57d\ud488 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900(GMP) \uc9c0\uce68\uc758 \uad6d\uac00\uc801 \uc774\ud589\uc5d0 \uad00\ud55c 2016\ub144 \uacb0\uc758\uc548 1160\ud638\uc640 \uc758\uc57d\ud488 \ub4f1\ub85d \ubc0f \uac80\uc0ac\ub97c \uaddc\uc815\ud558\ub294 1995\ub144 \ubc95\ub839 677\ud638\ub97c \uc2dc\ud589\ud569\ub2c8\ub2e4. \ucf5c\ub86c\ube44\uc544\uc5d0\uc11c 1\ucc28 \ud3ec\uc7a5\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ubaa8\ub4e0 \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub294 \uc774\ub7ec\ud55c \uaddc\uc815\uc5d0 \ubd80\ud569\ud558\ub294 \uac80\uc99d \ubb38\uc11c\ub97c \uac16\ucd94\uc5b4\uc57c \ud569\ub2c8\ub2e4. \ubbf8\uad6d \uc218\ucd9c\uc5c5\uccb4\ub294 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA) 21 CFR 210 \ubc0f 211\ubd80(\uc644\uc81c\ud488 \uc758\uc57d\ud488\uc5d0 \ub300\ud55c \ud604\ud589 GMP), 21 CFR 11\ubd80(\uc804\uc790 \uae30\ub85d \ubc0f \uc11c\uba85), \uadf8\ub9ac\uace0 \uc6a9\uae30-\ubc00\ubd09 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc0b0\uc5c5 \uc9c0\uce68\uc744 \uc804\uc801\uc73c\ub85c \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \uc720\ub7fd \uc2dc\uc7a5\uc5d0\uc11c\ub294 \ubb34\uade0 \uc81c\ud488\uc5d0 \ub300\ud55c EU GMP Annex 1\uacfc 1\ucc28 \ud3ec\uc7a5\uc7ac\uc5d0 \ub300\ud55c ISO 15378\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \uad6d\uc81c \uc57d\uc804\uc73c\ub85c\ub294 \ubbf8\uad6d\uc5d0\uc11c\ub294 USP , , , \uc720\ub7fd\uc5d0\uc11c\ub294 Ph. Eur. 3.1\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \uc77c\ubcf8\uc758 JP \uaddc\uaca9\uc740 \ubaa8\ub4e0 \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\uac00 \ucda9\uc871\ud574\uc57c \ud558\ub294 \ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c \uae30\uc900\uc744 \uc81c\uc2dc\ud569\ub2c8\ub2e4. \uadf8 \uc678 \uad00\ub828 \uaddc\uaca9\uc73c\ub85c\ub294 \ube0c\ub77c\uc9c8 ANVISA RDC 301\/2019, \uba55\uc2dc\ucf54 COFEPRIS NOM-059-SSA1-2015, \uc544\ub974\ud5e8\ud2f0\ub098 ANMAT Disposici\u00f3n 2819\/04, \uce90\ub098\ub2e4 Health Canada GMP Guide GUI-0001 \ub4f1\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uac01 \uaddc\uaca9\uc740 \ubb38\uc11c\ud654\ub41c \uac80\uc99d, \ubcc0\uacbd \uad00\ub9ac \ubc0f \ucd94\uc801\uc131\uc744 \uac15\uc870\ud558\uba70, \ucd5c\uc2e0 \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub294 PLC \uac10\uc0ac \ucd94\uc801 \uae30\ub2a5\uc744 \ud1b5\ud574 \uc774\ub7ec\ud55c \ubaa8\ub4e0 \uae30\ub2a5\uc744 \uae30\ubcf8\uc801\uc73c\ub85c \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

9. \uc81c\uc57d \uc0dd\uc0b0 \ubd84\uc57c\uc5d0\uc11c\uc758 \uc801\uc6a9 \uc2dc\ub098\ub9ac\uc624<\/h2>\n
\n

\uacbd\uad6c\uc6a9 \uc6a9\uc561 \ubc0f \uc2dc\ub7fd \ubcd1<\/h3>\n

30ml\uc5d0\uc11c 500ml\uae4c\uc9c0\uc758 \ud638\ubc15\uc0c9 \ubc0f \ud22c\uba85 PET \ubcd1\uc774 \uac00\uc7a5 \ud070 \ub2e8\uc77c \uc6a9\ub3c4\uc785\ub2c8\ub2e4. \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub294 \uc790\ub3d9 \uacc4\ub7c9\ucef5 \ubc0f \ucf5c\ub86c\ube44\uc544 \uc18c\uc544\uc6a9 \uc758\uc57d\ud488\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc5b4\ub9b0\uc774 \ubcf4\ud638 \ucea1\uacfc \uae54\ub054\ud558\uac8c \uacb0\ud569\ub418\ub294 \uc815\ud655\ud55c \ubaa9 \ubd80\ubd84\uc744 \uac00\uc9c4 \ubcd1\uc744 \uc0dd\uc0b0\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

\uc548\uc57d \ubc0f \ube44\uac15 \uc2a4\ud504\ub808\uc774 \uc6a9\uae30<\/h3>\n

\uc548\uacfc \ubc0f \uc774\ube44\uc778\ud6c4\uacfc \uc81c\ud488\uc5d0 \uc0ac\uc6a9\ub418\ub294 5~30ml \uc18c\ud615 \uc6a9\uae30\ub294 \uc815\ud655\ud55c \uc6a9\ub7c9 \uc870\uc808\uc744 \uc704\ud574 \ubcbd \ub450\uaed8\ub97c \uc815\ubc00\ud558\uac8c \uc81c\uc5b4\ud574\uc57c \ud569\ub2c8\ub2e4. \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\uc758 \ub2e4\uc911 \uce90\ube44\ud2f0 \ud234\ub9c1\uc740 \ud544\uc694\ud55c \ubc18\ubcf5\uc131\uc744 \uc81c\uacf5\ud558\uace0 \uc644\ubcbd\ud55c \uba78\uade0 \ud638\ud658\uc131\uc744 \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

\uace0\ud615 \uc81c\ud615 \ud3ec\uc7a5<\/h3>\n

\uc815\uc81c, \ucea1\uc290 \ubc0f \ubc1c\ud3ec\uc815 \uc81c\ud615\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc785\uad6c\uac00 \ub113\uc740 PET \ubc0f PP \ubcd1. \ub9c8\uac1c \ubd80\ubd84\uc5d0 \uac74\uc870\uc81c\ub97c \ud1b5\ud569\ud558\ub294 \uac83\uc774 \uc77c\ubc18\uc801\uc774\ubbc0\ub85c, \ubcd1 \ubcf8\uccb4 \ud615\uc0c1\ubcf4\ub2e4 \ubaa9 \ubd80\ubd84\uc758 \uce58\uc218 \uc815\ud655\ub3c4(\uc0ac\ucd9c \uc131\ud615\uc744 \ud1b5\ud574\uc11c\ub9cc \ub2ec\uc131 \uac00\ub2a5)\uac00 \ub354 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

\uad6d\uc18c \ud53c\ubd80\uacfc \ubc0f \uc77c\ubc18\uc758\uc57d\ud488<\/h3>\n

PCTG\uc640 PETG\ub294 \uace0\uae09 \uad6d\uc18c \uc81c\uc81c\uc5d0 \uac00\uc7a5 \uc801\ud569\ud55c \uc218\uc9c0\uc785\ub2c8\ub2e4. \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub85c \uc0dd\uc0b0\ub418\ub294 \uc774 \uc218\uc9c0\ub4e4\uc740 \uc790\uc678\uc120 \ucc28\ub2e8\uc81c, \ud749\ud130 \uce58\ub8cc\uc81c, \uae30\ub2a5\uc131 \ud654\uc7a5\ud488 \ube0c\ub79c\ub4dc\uc5d0 \uc801\ud569\ud558\uba70, \uc774\ub7ec\ud55c \ube0c\ub79c\ub4dc\ub4e4\uc740 \uc548\ub370\uc2a4 \u200b\u200b\uc9c0\uc5ed\uc5d0\uc11c \uc810\uc810 \ub354 \ud65c\ubc1c\ud558\uac8c \uc0ac\uc5c5\uc744 \ud655\uc7a5\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

\uc720\uc544 \uc218\uc720 \ubc0f \uc18c\uc544\uc6a9 \uc6a9\uae30<\/h3>\n

PP, PPSU \ubc0f \ud2b8\ub77c\uc774\ud0c4 \uc18c\uc7ac\uc758 \uc816\ubcd1\uc740 \ubc18\ubcf5\uc801\uc778 \uba78\uade0 \ucc98\ub9ac\ub97c \uacac\ub38c\uc57c \ud569\ub2c8\ub2e4. \uc6d0\uc2a4\ud15d \uc0dd\uc0b0 \ubc29\uc2dd\uc758 \uc815\ubc00\ud55c \ubaa9 \ubd80\ubd84 \ub355\ubd84\uc5d0 \uc2e4\ub9ac\ucf58 \uc816\uaf2d\uc9c0 \uc5b4\uc148\ube14\ub9ac \ubc0f \ub098\uc0ac\uc2dd \ud1b5\ud48d \ub9c1\uacfc \uc644\ubcbd\ud558\uac8c \ud638\ud658\ub429\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n

\uc9c4\ub2e8 \ubc0f \uc2e4\ud5d8\uc2e4 \uc7a5\ube44<\/h3>\n

\uc2dc\ub8cc \ucc44\ucde8\uc6a9 \ubc14\uc774\uc54c, \uac80\uccb4 \ucef5, \uc18c\ud615 \uc2dc\uc57d\ubcd1\uc740 \ub3d9\uc77c\ud55c \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \ud50c\ub7ab\ud3fc\uc744 \ud65c\uc6a9\ud558\uba70, \ub300\ud615 HGY200 \ubc0f HGY250 \uc2dc\ub9ac\uc988 \uc7a5\ube44\uc5d0\uc11c\ub294 \uc0ac\uc774\ud074\ub2f9 \ucd5c\ub300 12\uac1c\uc758 \uce90\ube44\ud2f0\ub97c \uc0ac\uc6a9\ud558\ub294 \ub2e4\uc911 \uce90\ube44\ud2f0 \uad6c\uc131\uc73c\ub85c \uc81c\uc791\ub418\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n

<\/div>\n<\/div>\n
\n

\uc791\uc5c5\uc7a5<\/h3>\n
\n
\"ISBM
\n\"\uc0ac\ucd9c
\n\"\uc81c\uc870
\n\"\uc644\uc131\ub41c<\/div>\n<\/div>\n<\/div>\n
\n

10. \ubcf4\uc644 \uc81c\ud488: ISBM \uc2dc\uc2a4\ud15c\uc744 \uc704\ud55c \uc6d0\uc2a4\ud1b1 \uacf5\uae09<\/h2>\n

\ub2f9\uc0ac\ub294 \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \uc790\uccb4\ubfd0\ub9cc \uc544\ub2c8\ub77c \uc0dd\uc0b0 \ub77c\uc778\uc744 \uc644\uc131\ud558\ub294 \ub370 \ud544\uc694\ud55c \ud234\ub9c1, \ubaa8\uc158 \ubc0f \uad6c\ub3d9\uacc4 \ubd80\ud488\uc744 \ud3ec\ud568\ud55c \uc804\uccb4 \uc0dd\ud0dc\uacc4\ub97c \uc81c\uc870 \ubc0f \uacf5\uae09\ud569\ub2c8\ub2e4. \uc774\ub294 \ubaa8\ub4e0 \ud575\uc2ec \ubd80\ud488\uc5d0 \ub300\ud574 \uac80\uc99d\ub41c \ub2e8\uc77c \uacf5\uae09\uc5c5\uccb4\ub97c \uc120\ud638\ud558\ub294 \uc81c\uc57d \uac00\uacf5\uc5c5\uccb4\ub97c \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n

\n
\n

\uac15\uc131 \ucee4\ud50c\ub9c1<\/a> \ub4dc\ub77c\uc774\ube0c \ud1b5\ud569\uc6a9<\/h3>\n

\uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \ud134\ud14c\uc774\ube14 \uad6c\ub3d9\ubd80 \ub0b4\ubd80\uc5d0 \uc11c\ubcf4 \ubaa8\ud130\uc640 \uae30\uc5b4\ubc15\uc2a4\ub97c \ud1b5\ud569\ud558\uae30 \uc704\ud55c \uc815\ubc00 \uac15\uc131 \ucee4\ud50c\ub9c1\uc785\ub2c8\ub2e4. \uace0\uc18d \ud68c\uc804 \uacf5\ucc28\uc5d0 \ub9de\ucdb0 \uade0\ud615\uc744 \ub9de\ucd98 \uc774 \ucee4\ud50c\ub9c1\uc740 \uc2a4\ud14c\uc774\uc158 \uac04 \ube60\ub978 \uc804\ud658 \uc2dc \ubc1c\uc0dd\ud558\ub294 \ube44\ud2c0\ub9bc \uc9c4\ub3d9\uc744 \ucd5c\uc18c\ud654\ud558\uc5ec \ubca0\uc5b4\ub9c1 \uc218\uba85\uc744 \uc5f0\uc7a5\ud558\uace0 \ubcd1 \ud615\uc0c1\uc744 \uacb0\uc815\ud558\ub294 \uc2a4\ud2b8\ub808\uce58 \ub85c\ub4dc \uc815\ub82c\uc744 \ubcf4\ud638\ud569\ub2c8\ub2e4.<\/p>\n

\"\uad6c\ub3d9<\/div>\n<\/div>\n
\n

\uc11c\ubcf4 \ubaa8\ud130 \ubc0f \ub4dc\ub77c\uc774\ube0c \ud328\ud0a4\uc9c0<\/h3>\n

\uc774\ub178\ubc18\uc2a4(Inovance)\uc640 \uc57c\uc2a4\uce74\uc640(Yaskawa) \uc11c\ubcf4 \ubaa8\ud130, \ub300\ub9cc \ucd98\ud2f0\uc5d4(Tsuntien) \uac10\uc18d\uae30, \ud30c\ucee4(Parker) \uace0\uc555 \ud30c\uc77c\ub7ff \ubc38\ube0c, \uadf8\ub9ac\uace0 \uc720\ucf04(YUKEN) \uc720\uc555 \uc81c\uc5b4 \ubd80\ud488\uc774 \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \ud50c\ub7ab\ud3fc\uc5d0 \ub9de\ucdb0 \uc138\ud2b8\ub85c \uacf5\uae09\ub429\ub2c8\ub2e4. \ubaa8\uc158 \uc2a4\ud0dd\uacfc \uae30\uacc4\ub97c \ud55c \uacf3\uc5d0\uc11c \uad6c\ub9e4\ud568\uc73c\ub85c\uc368 \uc608\ube44 \ubd80\ud488 \uacc4\ud68d \ubc0f \uaddc\uc81c \uad00\ub828 \uc11c\ub958 \uc791\uc5c5\uc774 \uac04\uc18c\ud654\ub429\ub2c8\ub2e4.<\/p>\n

<\/div>\n<\/div>\n<\/div>\n<\/div>\n
\n

\uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38<\/h2>\n
\nQ1. \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \uc81c\uc870\uc5c5\uccb4\ub294 FDA \uaddc\uc81c \uc218\ucd9c\uc744 \uc704\ud55c \uac80\uc99d \ubb38\uc11c \ud328\ud0a4\uc9c0\uc5d0 \ubb34\uc5c7\uc744 \ud3ec\ud568\ud569\ub2c8\uae4c?<\/summary>\n

A2. \uc644\uc804\ud55c \ud328\ud0a4\uc9c0\uc5d0\ub294 \uc124\uacc4 \uc801\uaca9\uc131 \ud3c9\uac00, \uacf5\uc7a5 \uc778\uc218 \uc2dc\ud5d8 \uae30\ub85d, \uc124\uce58 \uc801\uaca9\uc131 \ud3c9\uac00 \ud504\ub85c\ud1a0\ucf5c, \uc6b4\uc601 \uc801\uaca9\uc131 \ud3c9\uac00 \uc2a4\ud06c\ub9bd\ud2b8, 21 CFR Part 11\uc5d0 \ub530\ub978 PLC \uac10\uc0ac \ucd94\uc801 \uad6c\uc131, \uc811\ucd09 \ubd80\ud488\uc6a9 \uc790\uc7ac DMF, \ubaa8\ub4e0 \uc911\uc694 \uc13c\uc11c\uc5d0 \ub300\ud55c \uad50\uc815 \uc778\uc99d\uc11c\uac00 \ud3ec\ud568\ub418\uba70, \uc7a5\ube44 \ucd9c\ud558\uc77c \uc774\uc804\uc5d0 \uc81c\uacf5\ub429\ub2c8\ub2e4.<\/p>\n<\/details>\n

\nQ2. \uc548\ub370\uc2a4 \uc9c0\uc5ed\uc5d0\uc11c \uc758\uc57d\ud488 \uac80\uc99d\uc744 \uc704\ud55c \ud604\uc7a5 \uc2dc\uc6b4\uc804 \uc9c0\uc6d0\uc744 \uc81c\uacf5\ud558\ub294 \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \uacf5\uae09\uc5c5\uccb4\ub294 \uc5b4\ub514\uc785\ub2c8\uae4c?<\/summary>\n

A3. \uad6d\uc81c \uc11c\ube44\uc2a4 \ud300\uc744 \ubcf4\uc720\ud55c \uacf5\uae09\uc5c5\uccb4\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc124\uce58\ub97c \uc704\ud574 5~10\uc77c(\uc601\uc5c5\uc77c \uae30\uc900) \ub3d9\uc548 \uc2dc\uc6b4\uc804 \uc5d4\uc9c0\ub2c8\uc5b4\ub97c \ud30c\uacac\ud558\uc5ec \uae30\uacc4 \uc124\uc815, \uacf5\uc815 \uc2dc\ud5d8, \uc6b4\uc601\uc790 \uad50\uc721 \ubc0f IQ \ubb38\uc11c \uc138\ud2b8 \uc778\uc218\uc778\uacc4\ub97c \uc9c0\uc6d0\ud569\ub2c8\ub2e4. \uc6d0\uaca9 PLC \uc9c4\ub2e8\uc740 \uc804\uccb4 \ubcf4\uc99d \uae30\uac04\uc740 \ubb3c\ub860 \uadf8 \uc774\ud6c4\uae4c\uc9c0 \uc9c0\uc6d0\uc744 \ud655\ub300\ud569\ub2c8\ub2e4.<\/p>\n<\/details>\n

\nQ3. \ucf5c\ub86c\ube44\uc544 \uacbd\uad6c\uc6a9\uc561 \uc81c\uc870\uc5d0 \uc788\uc5b4 \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615 \uacf5\uc815\uc740 \uc5b4\ub5bb\uac8c \ubb34\uade0\uc131 \uae30\uc900\uc744 \ucda9\uc871\ud569\ub2c8\uae4c?<\/summary>\n

A4. \ubc00\ud3d0\ud615 \uc6d0\uc2a4\ud15d \uad6c\uc870\ub294 \uc0ac\ucd9c\uacfc \ube14\ub85c\uc6b0 \uc131\ud615 \uc0ac\uc774\uc5d0\uc11c \ud504\ub9ac\ud3fc\uc744 \uace0\uc628 \ucda9\uc804 \uc628\ub3c4 \ubc94\uc704 \ub0b4\uc5d0 \uc720\uc9c0\ud558\uc5ec \ubbf8\uc0dd\ubb3c \uc99d\uc2dd\uc744 \uc5b5\uc81c\ud569\ub2c8\ub2e4. \ubcd1\uc740 \ub0b4\ubd80 \ud45c\uba74\uc774 \uacf5\uae30\uc5d0 \uc804\ud600 \ub2ff\uc9c0 \uc54a\uc740 \uc0c1\ud0dc\ub85c \ucd9c\uace0\ub418\ubbc0\ub85c WHO TRS \ubd80\ub85d 2\uc5d0 \ubd80\ud569\ud558\ub294 \ub0ae\uc740 \ubbf8\uc0dd\ubb3c \uc624\uc5fc\ub3c4 \uae30\uc900\uc744 \ucda9\uc871\ud569\ub2c8\ub2e4.<\/p>\n<\/details>\n

\nQ4. \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \uad50\uccb4 \uad6c\ub9e4\ub97c \uc7ac\uac00\uc5f4 2\ub2e8\uacc4 \ub77c\uc778\uacfc \ube44\uad50\ud558\uc5ec \ud3c9\uac00\ud560 \ub54c \ube44\uc6a9 \ud0c0\ub2f9\uc131 \ubd84\uc11d \ud504\ub808\uc784\uc6cc\ud06c\ub294 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/summary>\n

A5. \ucd1d \uc18c\uc720 \ube44\uc6a9 \ubd84\uc11d\uc5d0\ub294 \uc804\uae30\ub8cc \uc808\uac10(1\ub2e8\uacc4 \uacf5\uc815\uc5d0\uc11c \uc57d 40% \uc808\uac10), \ud504\ub9ac\ud3fc \ucde8\uae09 \uc778\uac74\ube44 \uac10\uc18c, \ub125 \uc815\ubc00\ub3c4 \uad00\ub828 \ubd88\ub7c9\ub960 \uac10\uc18c, \ud504\ub9ac\ud3fc \ubcf4\uad00 \ubc0f \uac80\uc0ac \ube44\uc6a9 \uc808\uac10 \ub4f1\uc774 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc81c\uc57d \uac00\uacf5\uc5c5\uccb4\uc758 \uacbd\uc6b0 \ud22c\uc790 \ud68c\uc218 \uae30\uac04\uc740 \uc77c\ubc18\uc801\uc73c\ub85c 2~3\ub144\uc785\ub2c8\ub2e4.<\/p>\n<\/details>\n

\nQ5. \ucf5c\ub86c\ube44\uc544 \uc81c\uc57d \uacf5\uc7a5\uc5d0\uc11c \uc2e0\uaddc \uc124\ube44\ub97c \ub3c4\uc785\ud560 \ub54c \uc77c\ubc18\uc801\uc73c\ub85c \uac00\uc7a5 \uba3c\uc800 \uac80\uc99d\ub418\ub294 \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615 \uc81c\ud488\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/summary>\n

A7. 1\ucc28 \uac80\uc99d\uc5d0\uc11c\ub294 \uc77c\ubc18\uc801\uc73c\ub85c 60ml, 120ml, 240ml \uaddc\uaca9\uc758 \ud45c\uc900 \uacbd\uad6c\uc6a9 PET \ubcd1\uc744 \ub300\uc0c1\uc73c\ub85c \ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ubcd1\uc740 \uc2e0\ucd95\uc131 \ube44\uc728\uc774 \uc798 \uc54c\ub824\uc838 \uc788\uace0 \uc57d\uc804 \uc2dc\ud5d8 \uc774\ub825\uc774 \ud655\ub9bd\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. PPSU \uc9c4\ub2e8\uc6a9 \ubc14\uc774\uc54c\uc774\ub098 PCTG \ud53c\ubd80\uacfc\uc6a9 \uc6a9\uae30\uc640 \uac19\uc740 \ud2b9\uc218 \uc81c\ud488\uc740 \ud6c4\uc18d \uac80\uc99d \ub2e8\uacc4\uc5d0\uc11c \ub2e4\ub8e8\uc5b4\uc9d1\ub2c8\ub2e4.<\/p>\n<\/details>\n

\nQ6. \uc6d0\uc2a4\ud15d \uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub294 \ub2e4\uc911 \uc81c\ud488 \uc81c\uc57d \uc2dc\uc124\uc5d0\uc11c \uc218\uc9c0 \uad50\uccb4\ub97c \uc5b4\ub5bb\uac8c \ucc98\ub9ac\ud569\ub2c8\uae4c?<\/summary>\n

A8. PET, PETG, PP \ubc0f PPSU \uac04 \uc804\ud658\uc5d0\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc804\ud658 \uc218\uc9c0\ub97c \uc0ac\uc6a9\ud55c \uc2a4\ud06c\ub958 \ud37c\uc9d5, \uce90\ube44\ud2f0 \uad50\uccb4, \ud788\ud130 \uc874 \ub808\uc2dc\ud53c \ubd88\ub7ec\uc624\uae30 \ubc0f \uc7ac\uc778\uc99d \uc804 \uc9e7\uc740 \uc2dc\ud5d8 \uc0dd\uc0b0 \uacfc\uc815\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. Inovance \ub610\ub294 MiRLE PLC\uc758 \ub808\uc2dc\ud53c \uad00\ub9ac \uae30\ub2a5\uc744 \uc0ac\uc6a9\ud558\uba74 \ub300\ubd80\ubd84\uc758 \uc81c\ud488\uad70\uc5d0 \ub300\ud574 \uc804\uccb4 \uc804\ud658 \uc2dc\uac04\uc744 2~4\uc2dc\uac04\uc73c\ub85c \ub2e8\ucd95\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/details>\n

\nQ7. \ucf5c\ub86c\ube44\uc544 \uc81c\uc57d \uac00\uacf5\uc5c5\uccb4\ub4e4\uc740 \ucd5c\uc2e0 \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \ud50c\ub7ab\ud3fc\uc5d0\uc11c ASB \ubc0f AOKI \ud234\ub9c1 \uc9c0\uc6d0\uc744 \uc5b4\ub5bb\uac8c \ub300\uccb4\ud560 \uc218 \uc788\uc744 \uac83\uc73c\ub85c \uae30\ub300\ud560 \uc218 \uc788\uc2b5\ub2c8\uae4c?<\/summary>\n

A10. \ucc38\uc870 \uc7a5\ube44\uc778 HGY150-V4\ub294 ASB-12M \ud234\ub9c1\uc5d0 \ub9e4\ud551\ub418\uace0, HGY200-V4\ub294 AOKI 250\uc5d0 \ub9e4\ud551\ub418\uba70, HGY250-V4\ub294 ASB-70DPH \uc138\ud2b8\ub97c \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub4dc\ub86d\uc778 \ud638\ud658\uc131\uc744 \ud1b5\ud574 \uae30\uc874 \uce90\ube44\ud2f0 \ub9e4\ubab0\uc7ac\ub97c \ubcf4\uc874\ud558\uace0 INVIMA \ub610\ub294 FDA \uc0ac\uc804 \uc2b9\uc778 \uac80\uc0ac\ub97c \uc774\ubbf8 \ud1b5\uacfc\ud55c \ubcd1 \ud615\uc0c1\uc5d0 \ub300\ud55c \uc7ac\uac80\uc99d \uc808\ucc28\ub97c \ud53c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/details>\n

\nQ8. ISO 15378 \uaddc\uaca9\uc744 \ucda9\uc871\ud558\ub294 \uc758\uc57d\ud488 1\ucc28 \ud3ec\uc7a5\uc7ac\uc6a9 ASB \uc0ac\ucd9c \uc131\ud615\uae30 \ub300\uccb4 \uc7a5\ube44\ub97c \uc5b4\ub5bb\uac8c \ud65c\uc6a9\ud560 \uc218 \uc788\uc744\uae4c\uc694?<\/summary>\n

A11. ISO 15378 \uc900\uc218\ub294 \ubb38\uc11c\ud654\ub41c \ubcc0\uacbd \uad00\ub9ac, \uac80\uc99d\ub41c \uc138\ucc99 \uc808\ucc28, \uc5f4 \ubc88\ud638\uae4c\uc9c0\uc758 \uc7ac\ub8cc \ucd94\uc801\uc131, \uadf8\ub9ac\uace0 \uc778\uc99d\ub41c \uc811\ucd09 \ubd80\ud488 \ub9c8\uac10 \ucc98\ub9ac\ub97c \ud1b5\ud574 \ub2ec\uc131\ub429\ub2c8\ub2e4. \ucd5c\uc2e0 \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30\ub294 S136 \uc2a4\ud14c\uc778\ub9ac\uc2a4\uac15 \uae08\ud615, \uad50\uc815\ub41c \uc13c\uc11c \ub85c\uae45, \uadf8\ub9ac\uace0 \uc644\ubcbd\ud55c \ubc30\uce58 \uae30\ub85d \ud1b5\ud569\uc744 \ud1b5\ud574 \uc774\ub97c \ub4b7\ubc1b\uce68\ud569\ub2c8\ub2e4.<\/p>\n<\/details>\n

\nQ9. \uc0ac\ucd9c \ube14\ub85c\uc6b0 \uc131\ud615\uacfc \uc6d0\uc2a4\ud15d \uc0ac\ucd9c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 \uacf5\uc815 \uac04\uc758 \ub125 \uc815\ubc00\ub3c4 \ucc28\uc774\ub97c \uac00\uc7a5 \uc798 \ubcf4\uc5ec\uc8fc\ub294 \ube14\ub85c\uc6b0 \uc131\ud615 \ub3d9\uc601\uc0c1\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/summary>\n

A12. \uc720\uc0ac\ud55c \uc0ac\uc774\ud074 \ud0c0\uc784\uc5d0\uc11c \ub125 \ub9c8\uac10 \ub514\ud14c\uc77c\uc744 \ub098\ub780\ud788 \ube44\uad50\ud55c \uadfc\uc811 \uc601\uc0c1\uc774 \uac00\uc7a5 \ud6a8\uacfc\uc801\uc785\ub2c8\ub2e4. 1\ub2e8\uacc4 \uc0ac\ucd9c \uc131\ud615\uc73c\ub85c \uc81c\uc791\ub41c \ub098\uc0ac\uc0b0 \ud615\uc0c1\uc740 \ub3d9\uc77c\ud55c \uc555\ucd9c \ube14\ub85c\uc6b0 \ub610\ub294 2\ub2e8\uacc4 \uc7ac\uac00\uc5f4 \uacf5\uc815\uc73c\ub85c \uc81c\uc791\ub41c \ub098\uc0ac\uc0b0 \ud615\uc0c1\ubcf4\ub2e4 \ub354\uc6b1 \uc120\uba85\ud55c \ud574\uc0c1\ub3c4\uc640 \uc815\ubc00\ud55c \uce58\uc218 \uacf5\ucc28\ub97c \ubcf4\uc5ec\uc8fc\uba70, \uc774\ub294 \ubc00\ud3d0\uc131 \ud14c\uc2a4\ud2b8 \uacb0\uacfc \ud5a5\uc0c1\uc73c\ub85c \uc9c1\uacb0\ub429\ub2c8\ub2e4.<\/p>\n<\/details>\n<\/div>\n

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

How ISBM Machines Are Used in Pharmaceutical Packaging: Meeting FDA and GMP Standards A practical guide for Colombian pharmaceutical manufacturers evaluating the injection stretch blow moulding machine route to INVIMA, FDA, and GMP compliance. 1. Machine Technical Specifications \u2014 Pharma-Grade Configuration The parameters below describe a typical 3-station fully electric platform (reference model HGY50-V3-EV) configured […]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[22],"tags":[],"class_list":["post-408","post","type-post","status-publish","format-standard","hentry","category-isbm-machine"],"_links":{"self":[{"href":"https:\/\/onestepblowmachine.com\/ko\/wp-json\/wp\/v2\/posts\/408","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/onestepblowmachine.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/onestepblowmachine.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/onestepblowmachine.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/onestepblowmachine.com\/ko\/wp-json\/wp\/v2\/comments?post=408"}],"version-history":[{"count":2,"href":"https:\/\/onestepblowmachine.com\/ko\/wp-json\/wp\/v2\/posts\/408\/revisions"}],"predecessor-version":[{"id":410,"href":"https:\/\/onestepblowmachine.com\/ko\/wp-json\/wp\/v2\/posts\/408\/revisions\/410"}],"wp:attachment":[{"href":"https:\/\/onestepblowmachine.com\/ko\/wp-json\/wp\/v2\/media?parent=408"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/onestepblowmachine.com\/ko\/wp-json\/wp\/v2\/categories?post=408"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/onestepblowmachine.com\/ko\/wp-json\/wp\/v2\/tags?post=408"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}