{"id":53103,"date":"2026-02-23T09:56:43","date_gmt":"2026-02-23T09:56:43","guid":{"rendered":"https:\/\/www.globalresearch.co.kr\/insight\/sterility-testing-market-mordor\/"},"modified":"2026-09-25T17:02:01","modified_gmt":"2026-09-25T08:02:01","slug":"sterility-testing-market-mordor","status":"publish","type":"post","link":"https:\/\/www.globalresearch.co.kr\/insight\/sterility-testing-market-mordor\/","title":{"rendered":"\uc138\uacc4\uc758 \ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc810\uc720\uc728 \ubd84\uc11d &#8211; \uc131\uc7a5 \ub3d9\ud5a5 \ubc0f \uc804\ub9dd (2026-2031\ub144)"},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/www.globalresearch.co.kr\/insight\/wp-content\/uploads\/2026\/02\/sterility-testing-market_1646030969023_Sterility_Testing_Market.webp\" alt=\"Chart\" class=\"aligncenter size-full\" \/><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/www.globalresearch.co.kr\/insight\/wp-content\/uploads\/2026\/02\/sterility-testing-market-size-image-1770826950385.webp\" alt=\"Chart\" class=\"aligncenter size-full\" \/><\/p>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-0\">1. \uc11c\ub860<\/p>\n<ul>\n<li class=\"toc-level-2\">1.1 \uc5f0\uad6c \uac00\uc815 \ubc0f \uc2dc\uc7a5 \uc815\uc758<\/li>\n<li class=\"toc-level-2\">1.2 \uc5f0\uad6c \ubc94\uc704<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-1\">2. \uc5f0\uad6c \ubc29\ubc95\ub860<\/p>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-2\">3. \uc694\uc57d<\/p>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-3\">4. \uc2dc\uc7a5 \ud658\uacbd<\/p>\n<ul>\n<li class=\"toc-level-2\">4.1 \uc2dc\uc7a5 \uac1c\uc694<\/li>\n<li class=\"toc-level-2\">4.2 \uc2dc\uc7a5 \ub3d9\uc778\n<ul>\n<li class=\"toc-level-3\">4.2.1 \ucca8\ub2e8 \ubc14\uc774\uc624\uc758\uc57d\ud488 \ud30c\uc774\ud504\ub77c\uc778\uc5d0 \ub300\ud55c \uc5c4\uaca9\ud55c GMP \uc5c5\uadf8\ub808\uc774\ub4dc<\/li>\n<li class=\"toc-level-3\">4.2.2 \uc2e0\uc18d \ubc29\ucd9c \ubb34\uade0 \uc2dc\ud5d8\uc774 \ud544\uc694\ud55c \uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c \uc0c1\uc5c5\uc6a9 \ubc30\uce58 \uc99d\uac00<\/li>\n<li class=\"toc-level-3\">4.2.3 \uc790\uccb4 QC\uc5d0\uc11c \uc544\uc6c3\uc18c\uc2f1 CDMO \ubb34\uade0 \uc11c\ube44\uc2a4\ub85c\uc758 \uc804\ud658<\/li>\n<li class=\"toc-level-3\">4.2.4 \uc704\uc591\uc131\ub960\uc744 \ub0ae\ucd94\ub294 \ubaa8\ub4c8\ud615 \uc544\uc774\uc194\ub808\uc774\ud130 \uc2dc\uc2a4\ud15c \ucc44\ud0dd<\/li>\n<li class=\"toc-level-3\">4.2.5 \uac80\uc99d\ub41c \uc2e0\uc18d \ubbf8\uc0dd\ubb3c\ud559\uc801 \ubc29\ubc95\uc5d0 \ub300\ud55c \uaddc\uc81c \uac15\ud654<\/li>\n<li class=\"toc-level-3\">4.2.6 \uc77c\ud68c\uc6a9 \uae30\uc220 \ud638\ud658 \ud14c\uc2a4\ud2b8 \ud0a4\ud2b8\uc5d0 \ub300\ud55c \uc218\uc694 \uc99d\uac00<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">4.3 \uc2dc\uc7a5 \uc81c\uc57d\n<ul>\n<li class=\"toc-level-3\">4.3.1 B\ub4f1\uae09 \uc544\uc774\uc194\ub808\uc774\ud130 \uc778\ud504\ub77c\uc758 \ub192\uc740 \ucd08\uae30 \ud22c\uc790 \ube44\uc6a9<\/li>\n<li class=\"toc-level-3\">4.3.2 \uacf5\uc815\uc11c \uc2dc\ud5d8 \ud45c\uc900\uc758 \uc81c\ud55c\uc801\uc778 \uae00\ub85c\ubc8c \uc870\ud654<\/li>\n<li class=\"toc-level-3\">4.3.3 \uc2e0\ud765 \uc2dc\uc7a5\uc758 \uc219\ub828\ub41c \ubbf8\uc0dd\ubb3c\ud559\uc790 \ubd80\uc871 \uc2ec\ud654<\/li>\n<li class=\"toc-level-3\">4.3.4 \uc9c1\uc811 \uc811\uc885 \uc2dc\ud5d8\uc758 \uc704\uc591\uc131 \uc704\ud5d8\uc73c\ub85c \uc778\ud55c \ucd9c\uc2dc \uc9c0\uc5f0<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">4.4 \uacf5\uae09\ub9dd \ubd84\uc11d<\/li>\n<li class=\"toc-level-2\">4.5 \uaddc\uc81c \ud658\uacbd<\/li>\n<li class=\"toc-level-2\">4.6 \uae30\uc220 \uc804\ub9dd<\/li>\n<li class=\"toc-level-2\">4.7 \ud3ec\ud130\uc758 5\uac00\uc9c0 \uacbd\uc7c1 \uc694\uc778 \ubd84\uc11d\n<ul>\n<li class=\"toc-level-3\">4.7.1 \uc2e0\uaddc \uc9c4\uc785\uc790\uc758 \uc704\ud611<\/li>\n<li class=\"toc-level-3\">4.7.2 \uad6c\ub9e4\uc790\uc758 \uad50\uc12d\ub825<\/li>\n<li class=\"toc-level-3\">4.7.3 \uacf5\uae09\uc790\uc758 \uad50\uc12d\ub825<\/li>\n<li class=\"toc-level-3\">4.7.4 \ub300\uccb4\uc7ac\uc758 \uc704\ud611<\/li>\n<li class=\"toc-level-3\">4.7.5 \uacbd\uc7c1 \uac15\ub3c4<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-4\">5. \uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc131\uc7a5 \uc608\uce21 (\uac00\uce58)<\/p>\n<ul>\n<li class=\"toc-level-2\">5.1 \uc81c\ud488 \uc720\ud615\ubcc4\n<ul>\n<li class=\"toc-level-3\">5.1.1 \uae30\uae30<\/li>\n<li class=\"toc-level-3\">5.1.2 \ud0a4\ud2b8 \ubc0f \uc2dc\uc57d<\/li>\n<li class=\"toc-level-3\">5.1.3 \uc11c\ube44\uc2a4<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">5.2 \ud14c\uc2a4\ud2b8 \uc720\ud615\ubcc4\n<ul>\n<li class=\"toc-level-3\">5.2.1 \ub9c9 \uc5ec\uacfc<\/li>\n<li class=\"toc-level-3\">5.2.2 \uc9c1\uc811 \uc811\uc885<\/li>\n<li class=\"toc-level-3\">5.2.3 \uc2e0\uc18d \ubb34\uade0 \ud14c\uc2a4\ud2b8<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">5.3 \uc560\ud50c\ub9ac\ucf00\uc774\uc158\ubcc4\n<ul>\n<li class=\"toc-level-3\">5.3.1 \uc81c\uc57d \ubc0f \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uc81c\uc870<\/li>\n<li class=\"toc-level-3\">5.3.2 \uc758\ub8cc \uae30\uae30 \uc81c\uc870<\/li>\n<li class=\"toc-level-3\">5.3.3 \uae30\ud0c0<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">5.4 \ubaa8\ub4dc\ubcc4\n<ul>\n<li class=\"toc-level-3\">5.4.1 \uc790\uccb4 \ud14c\uc2a4\ud2b8<\/li>\n<li class=\"toc-level-3\">5.4.2 \uc544\uc6c3\uc18c\uc2f1\/\uacc4\uc57d \ud14c\uc2a4\ud2b8<\/li>\n<\/ul>\n<\/li>\n<li class=\"toc-level-2\">5.5 \uc9c0\uc5ed\ubcc4\n<ul>\n<li class=\"toc-level-3\">5.5.1 \ubd81\ubbf8<\/li>\n<li class=\"toc-level-4\">5.5.1.1 \ubbf8\uad6d<\/li>\n<li class=\"toc-level-4\">5.5.1.2 \uce90\ub098\ub2e4<\/li>\n<li class=\"toc-level-4\">5.5.1.3 \uba55\uc2dc\ucf54<\/li>\n<li class=\"toc-level-3\">5.5.2 \uc720\ub7fd<\/li>\n<li class=\"toc-level-4\">5.5.2.1 \ub3c5\uc77c<\/li>\n<li class=\"toc-level-4\">5.5.2.2 \uc601\uad6d<\/li>\n<li class=\"toc-level-4\">5.5.2.3 \ud504\ub791\uc2a4<\/li>\n<li class=\"toc-level-4\">5.5.2.4 \uc774\ud0c8\ub9ac\uc544<\/li>\n<li class=\"toc-level-4\">5.5.2.5 \uc2a4\ud398\uc778<\/li>\n<li class=\"toc-level-4\">5.5.2.6 \uc720\ub7fd \uae30\ud0c0 \uc9c0\uc5ed<\/li>\n<li class=\"toc-level-3\">5.5.3 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591<\/li>\n<li class=\"toc-level-4\">5.5.3.1 \uc911\uad6d<\/li>\n<li class=\"toc-level-4\">5.5.3.2 \uc77c\ubcf8<\/li>\n<li class=\"toc-level-4\">5.5.3.3 \uc778\ub3c4<\/li>\n<li class=\"toc-level-4\">5.5.3.4 \ub300\ud55c\ubbfc\uad6d<\/li>\n<li class=\"toc-level-4\">5.5.3.5 \ud638\uc8fc<\/li>\n<li class=\"toc-level-4\">5.5.3.6 \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uae30\ud0c0 \uc9c0\uc5ed<\/li>\n<li class=\"toc-level-3\">5.5.4 \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74<\/li>\n<li class=\"toc-level-4\">5.5.4.1 GCC<\/li>\n<li class=\"toc-level-4\">5.5.4.2 \ub0a8\uc544\ud504\ub9ac\uce74<\/li>\n<li class=\"toc-level-4\">5.5.4.3 \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74 \uae30\ud0c0 \uc9c0\uc5ed<\/li>\n<li class=\"toc-level-3\">5.5.5 \ub0a8\ubbf8<\/li>\n<li class=\"toc-level-4\">5.5.5.1 \ube0c\ub77c\uc9c8<\/li>\n<li class=\"toc-level-4\">5.5.5.2 \uc544\ub974\ud5e8\ud2f0\ub098<\/li>\n<li class=\"toc-level-4\">5.5.5.3 \ub0a8\ubbf8 \uae30\ud0c0 \uc9c0\uc5ed<\/li>\n<li class=\"toc-level-5\">5.5.5.3.1 \uc0ac\uc6b0\ub514\uc544\ub77c\ube44\uc544<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-5\">6. \uacbd\uc7c1 \ud658\uacbd<\/p>\n<ul>\n<li class=\"toc-level-2\">6.1 \uc2dc\uc7a5 \uc9d1\uc911\ub3c4<\/li>\n<li class=\"toc-level-2\">6.2 \uc2dc\uc7a5 \uc810\uc720\uc728 \ubd84\uc11d<\/li>\n<li class=\"toc-level-2\">6.3 \ud68c\uc0ac \ud504\ub85c\ud544 (\uae00\ub85c\ubc8c \uac1c\uc694, \uc2dc\uc7a5 \uac1c\uc694, \ud575\uc2ec \ubd80\ubb38, \uc7ac\ubb34 \uc815\ubcf4(\uac00\ub2a5\ud55c \uacbd\uc6b0), \uc804\ub7b5 \uc815\ubcf4, \uc8fc\uc694 \uae30\uc5c5\uc758 \uc2dc\uc7a5 \uc21c\uc704\/\uc810\uc720\uc728, \uc81c\ud488 \ubc0f \uc11c\ube44\uc2a4, \ucd5c\uadfc \uac1c\ubc1c \ud3ec\ud568)\n<ul>\n<li class=\"toc-level-3\">6.3.1 bioMerieux SA<\/li>\n<li class=\"toc-level-3\">6.3.2 Charles River Laboratories<\/li>\n<li class=\"toc-level-3\">6.3.3 Merck KGaA<\/li>\n<li class=\"toc-level-3\">6.3.4 Sartorius AG<\/li>\n<li class=\"toc-level-3\">6.3.5 SGS SA<\/li>\n<li class=\"toc-level-3\">6.3.6 Sotera Health (Nelson Laboratories)<\/li>\n<li class=\"toc-level-3\">6.3.7 STERIS Plc<\/li>\n<li class=\"toc-level-3\">6.3.8 Thermo Fisher Scientific<\/li>\n<li class=\"toc-level-3\">6.3.9 Laboratory Corporation of America Holdings<\/li>\n<li class=\"toc-level-3\">6.3.10 WuXi AppTec<\/li>\n<li class=\"toc-level-3\">6.3.11 Rapid Micro Biosystems Inc.<\/li>\n<li class=\"toc-level-3\">6.3.12 Pace Analytical<\/li>\n<li class=\"toc-level-3\">6.3.13 Eurofins Scientific<\/li>\n<li class=\"toc-level-3\">6.3.14 Pacific BioLabs<\/li>\n<li class=\"toc-level-3\">6.3.15 Lonza Group<\/li>\n<li class=\"toc-level-3\">6.3.16 Boston Analytical<\/li>\n<li class=\"toc-level-3\">6.3.17 Bio-Outsource (SGS)<\/li>\n<li class=\"toc-level-3\">6.3.18 Toxikon Europe<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p class=\"toc-level-1 toc-content-heading\" id=\"toc-content-heading-6\">7. \uc2dc\uc7a5 \uae30\ud68c \ubc0f \ubbf8\ub798 \uc804\ub9dd<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5 \uaddc\ubaa8 \ubc0f \uc810\uc720\uc728 \ubd84\uc11d \u2013 \uc131\uc7a5 \ub3d9\ud5a5 \ubc0f \uc608\uce21 (2026-2031)<\/p>\n<p>1. \uc2dc\uc7a5 \uac1c\uc694 \ubc0f \uc8fc\uc694 \uc218\uce58<\/p>\n<p>\ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5\uc740 2025\ub144 15\uc5b5 9\ucc9c\ub9cc \ub2ec\ub7ec\ub85c \ud3c9\uac00\ub418\uc5c8\uc73c\uba70, 2026\ub144 17\uc5b5 6\ucc9c\ub9cc \ub2ec\ub7ec\uc5d0\uc11c 2031\ub144 29\uc5b5 6\ucc9c\ub9cc \ub2ec\ub7ec\uc5d0 \uc774\ub97c \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc608\uce21 \uae30\uac04(2026-2031) \ub3d9\uc548 \uc5f0\ud3c9\uade0 \uc131\uc7a5\ub960(CAGR)\uc740 10.92%\ub97c \uae30\ub85d\ud560 \uac83\uc73c\ub85c \uc804\ub9dd\ub429\ub2c8\ub2e4. \ubcf8 \uc2dc\uc7a5\uc740 \uc81c\ud488 \uc720\ud615(\uc7a5\ube44, \ud0a4\ud2b8 \ubc0f \uc2dc\uc57d \ub4f1), \uc2dc\ud5d8 \uc720\ud615(\uba64\ube0c\ub808\uc778 \uc5ec\uacfc, \uc9c1\uc811 \uc811\uc885 \ub4f1), \uc801\uc6a9 \ubd84\uc57c(\uc81c\uc57d \ubc0f \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uc81c\uc870 \ub4f1), \uc6b4\uc601 \ubc29\uc2dd(\uc790\uccb4 \uc2dc\ud5d8 \ubc0f \uc544\uc6c3\uc18c\uc2f1\/\uc704\ud0c1 \uc2dc\ud5d8), \uadf8\ub9ac\uace0 \uc9c0\uc5ed(\ubd81\ubbf8, \uc720\ub7fd, \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \ub4f1)\ubcc4\ub85c \uc138\ubd84\ud654\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc8fc\uc694 \uc2dc\uc7a5 \uc9c0\ud45c\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4:<br \/>\n*   \uc5f0\uad6c \uae30\uac04: 2020\ub144 \u2013 2031\ub144<br \/>\n*   2026\ub144 \uc2dc\uc7a5 \uaddc\ubaa8: 17\uc5b5 6\ucc9c\ub9cc \ub2ec\ub7ec<br \/>\n*   2031\ub144 \uc2dc\uc7a5 \uaddc\ubaa8: 29\uc5b5 6\ucc9c\ub9cc \ub2ec\ub7ec<br \/>\n*   \uc131\uc7a5\ub960 (2026-2031): 10.92% CAGR<br \/>\n*   \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud558\ub294 \uc2dc\uc7a5: \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591<br \/>\n*   \uac00\uc7a5 \ud070 \uc2dc\uc7a5: \ubd81\ubbf8<br \/>\n*   \uc2dc\uc7a5 \uc9d1\uc911\ub3c4: \uc911\uac04<\/p>\n<p>2. \uc2dc\uc7a5 \ubd84\uc11d \ubc0f \uc8fc\uc694 \ub3d9\uc778<\/p>\n<p>\ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5\uc758 \uc131\uc7a5\uc740 EU GMP Annex 1\uc758 \ubb34\uade0 \ud658\uacbd\uc5d0 \ub300\ud55c &#8216;\uc81c\ub85c CFU(Colony Forming Unit)&#8217; \uc694\uad6c\uc0ac\ud56d \uac15\ud654, \ubcf5\uc7a1\ud55c \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \ud30c\uc774\ud504\ub77c\uc778\uc758 \uc0c1\uc5c5\ud654, \uadf8\ub9ac\uace0 \uc758\uc57d\ud488 \ucd9c\uc2dc \uae30\uac04\uc744 \ub2e8\ucd95\ud558\ub294 \uc2e0\uc18d \ubc29\ucd9c(rapid-release) \ubc29\ubc95\uc758 \ub3c4\uc785\uc774 \ubcf5\ud569\uc801\uc73c\ub85c \uc791\uc6a9\ud55c \uacb0\uacfc\uc785\ub2c8\ub2e4. \uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc \ubd84\uc57c\uc5d0 \ub300\ud55c \ubca4\ucc98 \uce90\ud53c\ud0c8\uc758 \uc9c0\uc18d\uc801\uc778 \uc720\uc785, \uacf5\uacf5 \ubd80\ubb38\uc758 \ubc31\uc2e0 \uc870\ub2ec \uc99d\uac00, \uadf8\ub9ac\uace0 \ubb34\uade0 \ucda9\uc804-\ub9c8\uac10(sterile fill-finish) \uc5ed\ub7c9\uc774 \uc704\ud0c1 \ud30c\ud2b8\ub108\ub85c \uc774\uc804\ub418\ub294 \ucd94\uc138 \ub610\ud55c \uc2dc\uc7a5 \uc218\uc694\ub97c \ucd09\uc9c4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uba64\ube0c\ub808\uc778 \uc5ec\uacfc\ubc95\uc740 \uc5ec\uc804\ud788 \ud655\uace0\ud55c \uc785\uc9c0\ub97c \uc720\uc9c0\ud558\uace0 \uc788\uc9c0\ub9cc, \uc2e0\uc18d \ubbf8\uc0dd\ubb3c \uac80\ucd9c \ud50c\ub7ab\ud3fc\uc740 \uaddc\uc81c \ub2f9\uad6d\uc758 \uc120\ud638\ub97c \uc5bb\uc73c\uba70 \uba87 \uc8fc\uac00 \uac78\ub9ac\ub358 \ubc30\uce58(batch) \ucc98\ub9ac\ub97c \uba87 \uc2dc\uac04 \ub0b4\ub85c \ub2e8\ucd95\uc2dc\ud0a4\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ubd81\ubbf8\ub294 \uc815\uad50\ud55c \uaddc\uc81c \uc0dd\ud0dc\uacc4\ub97c \ubc14\ud0d5\uc73c\ub85c \uc2dc\uc7a5\uc744 \uc120\ub3c4\ud558\uace0 \uc788\uc73c\uba70, \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591\uc740 \uc2e0\ud765 \ub300\uaddc\ubaa8 \uc0dd\uc0b0 \uc2dc\uc124, \uc6b0\ub300 \uc138\uae08 \uc81c\ub3c4, \uadf8\ub9ac\uace0 \uc57d\uc804(pharmacopeia) \uc5c5\ub370\uc774\ud2b8\uc758 \uc870\ud654\ub97c \ud1b5\ud574 \uac00\uc7a5 \ub192\uc740 \uc9c0\uc5ed\ubcc4 CAGR\uc744 \uae30\ub85d\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc8fc\uc694 \uc131\uc7a5 \ub3d9\uc778\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4:<br \/>\n*   \ucca8\ub2e8 \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \ud30c\uc774\ud504\ub77c\uc778\uc5d0 \ub300\ud55c \uc5c4\uaca9\ud55c GMP \uc5c5\uadf8\ub808\uc774\ub4dc: EU GMP Annex 1 \uac1c\uc815\uc73c\ub85c \ubb34\uade0 \ud658\uacbd\uc758 &#8216;\uc81c\ub85c CFU&#8217; \ud5c8\uc6a9 \uae30\uc900\uc774 \uacf5\uc2dd\ud654\ub418\uc5c8\uc73c\uba70, \uc774\ub294 \uc544\uc774\uc194\ub808\uc774\ud130, \uc0dd\uc874 \ubbf8\uc0dd\ubb3c \ubaa8\ub2c8\ud130\ub9c1, \uba78\uade0 \uc804\ud6c4 \ubb34\uacb0\uc131 \uc2dc\ud5d8(PUPSIT) \ub4f1\uc5d0 \ub300\ud55c \uc790\ubcf8 \uc9c0\ucd9c \uc99d\uac00\ub85c \uc774\uc5b4\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4. EMA\uc640 FDA \uac04\uc758 \uc870\ud654\ub294 \ub2e4\uad6d\uc801 \uc81c\uc870\uc0ac\ub4e4\uc774 \uac80\uc99d \ub9c8\uc2a4\ud130 \ud50c\ub79c\uc744 \ud45c\uc900\ud654\ud558\uace0 \ub85c\ud2b8(lot) \ucd9c\uc2dc \uacb0\uc815\uc744 \uac00\uc18d\ud654\ud558\ub294 \ub370 \uae30\uc5ec\ud569\ub2c8\ub2e4.<br \/>\n*   \uc2e0\uc18d \ubc29\ucd9c \ubb34\uade0 \uc2dc\ud5d8\uc774 \ud544\uc694\ud55c \uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c \uc0c1\uc5c5 \ubc30\uce58 \uc99d\uac00: 1,200\uac1c \uc774\uc0c1\uc758 \ubbf8\uad6d \uc784\uc0c1 \uc5f0\uad6c\uc640 \uc790\uac00(autologous) \uce58\ub8cc\uc81c \uc2b9\uc778 \uc99d\uac00\ub294 \uc0b4\uc544\uc788\ub294 \uc138\ud3ec\uc758 \ud6a8\ub2a5\uc744 \ubcf4\ud638\ud558\uae30 \uc704\ud574 4\uc2dc\uac04 \uc774\ub0b4\uc758 \ubb34\uade0 \ud655\uc778 \ud544\uc694\uc131\uc744 \uc99d\ub300\uc2dc\ud0a4\uace0 \uc788\uc2b5\ub2c8\ub2e4. bioM\u00e9rieux\uc758 SCANRDI\uc640 \uac19\uc740 \uae30\uc220\uc740 \uacb0\uacfc \ub3c4\ucd9c \uc2dc\uac04\uc744 14\uc77c\uc5d0\uc11c 150\ubd84 \ubbf8\ub9cc\uc73c\ub85c \ub2e8\ucd95\uc2dc\ud0a4\uba70 USP <1223> \uae30\uc900\uc744 \ucda9\uc871\ud569\ub2c8\ub2e4.<br \/>\n*   \uc790\uccb4 QC\uc5d0\uc11c CDMO \ubb34\uade0 \uc11c\ube44\uc2a4 \uc544\uc6c3\uc18c\uc2f1\uc73c\ub85c\uc758 \uc804\ud658: \uc81c\uc57d \ubd80\ubb38\uc774 \ub300\uaddc\ubaa8 \ubb34\uade0 \ubd84\uc11d\uc744 \uc704\ud574 \uc804\ubb38 \ud30c\ud2b8\ub108\uc5d0 \uc758\uc874\ud558\ub294 \uacbd\ud5a5\uc774 \ucee4\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4. Eurofins\uc640 \uac19\uc740 CDMO\ub294 \ubb34\uade0, \uc5d4\ub3c4\ud1a1\uc2e0, \ubbf8\ub9bd\uc790 \uc2dc\ud5d8\uc744 \ud1b5\ud569\ud55c GMP \uc5f0\uad6c\uc18c\ub97c \uc6b4\uc601\ud558\uc5ec \uae00\ub85c\ubc8c \ubc30\uce58 \ucd9c\uc2dc\ub97c \uc704\ud55c \uc6d0\uc2a4\ud1b1 \ud5c8\ube0c\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc774\ub294 \uc758\uc57d\ud488 \uc18c\uc720\uc790\ub4e4\uc774 \uc219\ub828\ub41c \uc778\ub825 \ubd80\uc871 \ubb38\uc81c\ub97c \ud574\uacb0\ud558\uace0 \ub300\ub959 \uc804\ubc18\uc5d0 \uac78\uccd0 24\uc2dc\uac04 \uc911\ubcf5\uc131\uc744 \ud655\ubcf4\ud558\ub294 \ub370 \ub3c4\uc6c0\uc744 \uc90d\ub2c8\ub2e4.<br \/>\n*   \uc704\uc591\uc131(false positive)\uc744 \uc5b5\uc81c\ud558\ub294 \ubaa8\ub4c8\ud615 \uc544\uc774\uc194\ub808\uc774\ud130 \uc2dc\uc2a4\ud15c \ub3c4\uc785: \ubaa8\ub4c8\ud615 \uc544\uc774\uc194\ub808\uc774\ud130\ub294 ISO 14644-7 \uaddc\uc815\uc744 \uc900\uc218\ud558\uace0 Grade A \ub2e8\ubc29\ud5a5 \uacf5\uae30 \ud750\ub984\uc744 \uc720\uc9c0\ud558\uba70, \uc774\uc804\uc5d0 \uc704\uc591\uc131 \uc870\uc0ac\uc758 35%\ub97c \ucc28\uc9c0\ud588\ub358 \uc791\uc5c5\uc790 \uc720\ubc1c \uc774\ud0c8\uc744 \uc904\uc785\ub2c8\ub2e4. IonHP+ \uc624\uc5fc \uc81c\uac70 \uc8fc\uae30\ub294 15\ubd84 \uc774\ub0b4\uc5d0 6-\ub85c\uadf8 \uc774\uc0c1\uc758 \ubbf8\uc0dd\ubb3c \uac10\uc18c\ub97c \ub2ec\uc131\ud569\ub2c8\ub2e4.<br \/>\n*   \uac80\uc99d\ub41c \uc2e0\uc18d \ubbf8\uc0dd\ubb3c\ud559\uc801 \ubc29\ubc95(RMM)\uc5d0 \ub300\ud55c \uaddc\uc81c \uac15\ud654: EU GMP Annex 1\uc740 \uc2e0\uc18d \ubbf8\uc0dd\ubb3c\ud559\uc801 \ubc29\ubc95 \ucc44\ud0dd\uc758 \ucd09\ub9e4\uc81c \uc5ed\ud560\uc744 \ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n*   \uc77c\ud68c\uc6a9 \uae30\uc220 \ud638\ud658 \ud14c\uc2a4\ud2b8 \ud0a4\ud2b8 \uc218\uc694 \uc99d\uac00: \uc804 \uc138\uacc4 \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \ud5c8\ube0c\uc5d0\uc11c \uc77c\ud68c\uc6a9 \uae30\uc220\uacfc \ud638\ud658\ub418\ub294 \ud14c\uc2a4\ud2b8 \ud0a4\ud2b8\uc5d0 \ub300\ud55c \uc218\uc694\uac00 \uc99d\uac00\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>3. \uc2dc\uc7a5 \uc131\uc7a5 \uc800\ud574 \uc694\uc778<\/p>\n<p>\ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5\uc758 \uc131\uc7a5\uc744 \uc800\ud574\ud558\ub294 \uc8fc\uc694 \uc694\uc778\ub4e4\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4:<br \/>\n*   Class B \uc544\uc774\uc194\ub808\uc774\ud130 \uc778\ud504\ub77c\uc758 \ub192\uc740 \ucd08\uae30 \ud22c\uc790 \ube44\uc6a9: \uc790\ub3d9 \ub204\ucd9c \ud14c\uc2a4\ud2b8 \ubaa8\ub4c8\uc744 \uac16\ucd98 \uc774\uc911 \ucc54\ubc84 \uc544\uc774\uc194\ub808\uc774\ud130\ub294 \uac80\uc99d \ubc0f \uc5f0\uac04 \uc11c\ube44\uc2a4 \uacc4\uc57d\uc744 \uc81c\uc678\ud558\uace0\ub3c4 30\ub9cc \ub2ec\ub7ec \uc774\uc0c1\uc758 \ube44\uc6a9\uc774 \uc18c\uc694\ub429\ub2c8\ub2e4. \uc774\ub294 \ud2b9\ud788 \uc2e0\ud765 \uc2dc\uc7a5\uc5d0 \ud070 \ubd80\ub2f4\uc73c\ub85c \uc791\uc6a9\ud558\uba70, \uacfc\uc18c \ud22c\uc790 \uc2dc \ub370\uc774\ud130 \ubb34\uacb0\uc131 \ubb38\uc81c \ubc1c\uc0dd \uc704\ud5d8\uc744 \ub192\uc785\ub2c8\ub2e4.<br \/>\n*   \uacf5\uc815\uc11c \uc2dc\ud5d8 \ud45c\uc900\uc758 \uc81c\ud55c\uc801\uc778 \uae00\ub85c\ubc8c \uc870\ud654: USP, EP, JP, \uc911\uad6d \uc57d\uc804 \uac04\uc758 \ubd88\uc77c\uce58\ub294 \uc911\ubcf5 \uac80\uc99d, \uc18c\ubaa8\ud488 \uc7ac\uace0 \uc99d\uac00, \uadf8\ub9ac\uace0 \ub2e4\uad6d\uc801 \uae30\uc5c5\uc774 \ube44\ub3d9\uae30\uc801\uc778 \uac1c\uc815\uc5d0 \ub178\ucd9c\ub418\ub294 \uacb0\uacfc\ub97c \ucd08\ub798\ud569\ub2c8\ub2e4. \uc911\uad6d\uc758 YY 1001-2024 \uc720\ub9ac \uc8fc\uc0ac\uae30 \ud45c\uc900\uacfc \uac19\uc740 \uc9c0\uc5ed\ubcc4 \uaddc\uc815\uc740 \ubd84\uc11d \uc77c\uc815\uc744 \uc5f0\uc7a5\ud558\uace0 \uaddc\uc815 \uc900\uc218 \ube44\uc6a9\uc744 \uc99d\uac00\uc2dc\ud0b5\ub2c8\ub2e4.<br \/>\n*   \uc2e0\ud765 \uc2dc\uc7a5\uc758 \uc219\ub828\ub41c \ubbf8\uc0dd\ubb3c\ud559\uc790 \ubd80\uc871: \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591, \ub77c\ud2f4 \uc544\uba54\ub9ac\uce74, \uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74 \uc9c0\uc5ed\uc5d0\uc11c \uc219\ub828\ub41c \ubbf8\uc0dd\ubb3c\ud559\uc790 \ubd80\uc871\uc740 \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uc800\ud574\ud558\ub294 \uc8fc\uc694 \uc694\uc778\uc785\ub2c8\ub2e4.<br \/>\n*   \uc9c1\uc811 \uc811\uc885 \uc2dc\ud5d8\uc758 \uc704\uc591\uc131 \uc704\ud5d8: \uc9c1\uc811 \uc811\uc885 \uc2dc\ud5d8\uc740 \uc18c\ub7c9 \uc561\uccb4\uc5d0 \uac04\ub2e8\ud558\uc9c0\ub9cc, \ubcf5\uc7a1\ud55c \ubd80\ud615\uc81c\ub294 \ud0c1\ub3c4 \ud574\uc11d\uc744 \ubc29\ud574\ud558\uace0 \uc704\uc591\uc131 \uc704\ud5d8\uc744 \ub192\uc5ec \uc81c\ud488 \ucd9c\uc2dc\ub97c \uc9c0\uc5f0\uc2dc\ud0ac \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>4. \uc138\uadf8\uba3c\ud2b8\ubcc4 \ubd84\uc11d<\/p>\n<p>4.1. \uc81c\ud488 \uc720\ud615\ubcc4: \uc11c\ube44\uc2a4 \ubd80\ubb38\uc758 \uc131\uc7a5\uacfc \ud0a4\ud2b8 \ubc0f \uc2dc\uc57d\uc758 \uc9c0\uc18d\uc801\uc778 \uc911\uc694\uc131<\/p>\n<p>*   \uc11c\ube44\uc2a4: 2031\ub144\uae4c\uc9c0 10.48%\uc758 CAGR\uc744 \ubcf4\uc774\uba70, \ubbf8\uc0dd\ubb3c\ud559\uc790 \ubd80\uc871 \uc2ec\ud654\ub85c \uc778\ud574 \uc815\uad50\ud55c \ubd84\uc11d\uc744 \uc544\uc6c3\uc18c\uc2f1\ud558\ub824\ub294 \uc5c5\uacc4\uc758 \uc758\uc9c0\ub97c \ubc18\uc601\ud569\ub2c8\ub2e4. \uc120\ub3c4\uc801\uc778 CDMO\ub4e4\uc740 \ubb34\uade0 \ucda9\uc804 \ub77c\uc778 \uc606\uc5d0 QC \uc2a4\uc704\ud2b8\ub97c \ud1b5\ud569\ud558\uc5ec \ubb3c\ub958 \uc9c0\uc5f0\uc744 \uc904\uc774\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n*   \ud0a4\ud2b8 \ubc0f \uc2dc\uc57d: 2025\ub144 \uc2dc\uc7a5 \uc810\uc720\uc728 50.12%\ub97c \ucc28\uc9c0\ud558\uba70, \uc911\uc18c \uc81c\uc870\uc5c5\uccb4\uc758 \ubd84\uc0b0\ub41c \ud488\uc9c8 \uad00\ub9ac \uc9c0\uc810\uc5d0\uc11c \uc911\uc694\ud55c \uc5ed\ud560\uc744 \ud569\ub2c8\ub2e4. \uc77c\ud68c\uc6a9 \ub9e4\ub2c8\ud3f4\ub4dc, \uc0c9\uc0c1 \ubcc0\ud654 \ubc30\uc9c0, \uae30\uc131\ud488 0.45 \u00b5m \uce5c\uc218\uc131 PVDF \uba64\ube0c\ub808\uc778 \ub4f1\uc774 \uc5ec\uc804\ud788 \uc911\uc694\ud569\ub2c8\ub2e4. \uc544\uac00 \ud50c\ub808\uc774\ud2b8\uc758 \uc0c1\ud488\ud654\ub294 \ud0a4\ud2b8 \ub9c8\uc9c4\uc5d0 \uc555\ub825\uc744 \uac00\ud558\uba70, \uacf5\uae09\uc5c5\uccb4\ub4e4\uc740 \ud074\ub77c\uc6b0\ub4dc \uae30\ubc18 \ubd84\uc11d \ubc0f \ucd94\uc801\uc131 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \ubc88\ub4e4\ub85c \uc81c\uacf5\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n*   \uc7a5\ube44: \uac00\uc7a5 \uc791\uc740 \ub9e4\ucd9c \ube44\uc911\uc744 \ucc28\uc9c0\ud558\uc9c0\ub9cc \ud601\uc2e0 \uc9c0\uc218\uac00 \uac00\uc7a5 \ub192\uc2b5\ub2c8\ub2e4. Growth Direct \ubaa8\ub4c8\uc740 126\uac1c\uc758 \uce74\uc138\ud2b8\ub97c \ub3d9\uc2dc\uc5d0 \ubc30\uc591\ud558\uace0 AI \uc774\ubbf8\uc9c0 \ubd84\uc11d\uc744 \ud1b5\ud569\ud558\uc5ec 48\uc2dc\uac04 \uc774\ub0b4\uc5d0 \ub192\uc740 \uc2e0\ub8b0\ub3c4\ub85c \uacf5\uc2dd \ubb34\uade0 \ud310\ub3c5\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n<p>\uc11c\ube44\uc2a4 \uacf5\uae09\uc5c5\uccb4\ub4e4\uc740 \ucee8\uc124\ud305 \uc804\ubb38 \uc9c0\uc2dd\uc744 \ud65c\uc6a9\ud558\uc5ec \ud3b8\ucc28 \uc870\uc0ac, \uc624\uc5fc\uc6d0 \ub9e4\ud551, \uc0ac\uc804 \uc2b9\uc778 \uac80\uc0ac\ub97c \uc704\ud55c \uc815\ud655\ud55c \ubb38\uc11c\ud654\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. Jabil\uc758 Pii \ucea0\ud37c\uc2a4 \uc0ac\ub840\ub294 \ubb34\uade0 \ucda9\uc804-\ub9c8\uac10\uacfc \ud604\uc7a5 \ubbf8\uc0dd\ubb3c\ud559 \uc5f0\uad6c\uc18c\ub97c \ud1b5\ud569\ud558\uc5ec \uc0d8\ud50c\uc744 \ucea0\ud37c\uc2a4 \ub0b4\uc5d0 \uc720\uc9c0\ud558\uace0 \ubcf4\uad00 \uc0ac\uc2ac \uc704\ud5d8\uc744 \uc904\uc774\ub294 \uc218\ud3c9\uc801 \ud655\uc7a5\uc744 \ubcf4\uc5ec\uc90d\ub2c8\ub2e4.<\/p>\n<p>4.2. \uc2dc\ud5d8 \uc720\ud615\ubcc4: \uba64\ube0c\ub808\uc778 \uc5ec\uacfc\uc758 \uc9c0\ubc30\ub825\uacfc \uc2e0\uc18d \uc2dc\ud5d8\uc758 \ubd80\uc0c1<\/p>\n<p>*   \uba64\ube0c\ub808\uc778 \uc5ec\uacfc: 2025\ub144 \ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5\uc758 70.85%\ub97c \ucc28\uc9c0\ud558\uba70, \uc800\uc810\ub3c4 \uc8fc\uc0ac\uc81c \ubc0f \uc548\uacfc\uc6a9 \uc81c\ud488\uc5d0 \uc120\ud638\ub429\ub2c8\ub2e4. \ud655\uace0\ud55c \uc57d\uc804 \uae30\ubc18, \uac04\ub2e8\ud55c \uc18c\ubaa8\ud488, 0.45 \u00b5m \uacf5\uadf9 \ud06c\uae30\ub294 \uc77c\uad00\ub41c \uac80\uc99d\uc744 \uc6a9\uc774\ud558\uac8c \ud569\ub2c8\ub2e4. \uadf8\ub7ec\ub098 14\uc77c\uc758 \ubc30\uc591 \uae30\uac04\uc740 \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c\uc758 \uc720\ud6a8 \uae30\uac04\uacfc \uc0c1\ucda9\ub429\ub2c8\ub2e4.<br \/>\n*   \uc2e0\uc18d \ubb34\uade0 \uc2dc\ud5d8: USP <71> \ub300\uccb4 \ubc29\ubc95 \uc5b8\uc5b4\uc5d0 \ub530\ub77c \uac80\uc99d\ub41c \uc2e0\uc18d \ubb34\uade0 \uc2dc\ud5d8\uc740 2031\ub144\uae4c\uc9c0 14.45%\uc758 CAGR\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. Nelson Labs\uc758 6\uc77c \ud6c4 \ubc1c\uad11 \ud310\ub3c5\uc740 \uc644\uc81c\ud488 \ucd9c\uc2dc\ub97c \uc704\ud55c EP Chapter 2.6.1 \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\ud558\uc5ec \uc7ac\uace0 \uc720\uc9c0 \ube44\uc6a9\uc744 \uc808\uac10\ud569\ub2c8\ub2e4.<br \/>\n*   \uc9c1\uc811 \uc811\uc885: \uc18c\ub7c9 \uc561\uccb4\uc5d0 \uac04\ub2e8\ud558\uc9c0\ub9cc, \ubcf5\uc7a1\ud55c \ubd80\ud615\uc81c\ub294 \ud0c1\ub3c4 \ud574\uc11d\uc744 \ubc29\ud574\ud558\uace0 \uc704\uc591\uc131 \uc704\ud5d8\uc744 \ub192\uc5ec \uc810\uc810 \ub354 \uba74\ubc00\ud55c \uc870\uc0ac\ub97c \ubc1b\uace0 \uc788\uc2b5\ub2c8\ub2e4. Redberry\uc758 \uad11\ud559 \ubc00\ub3c4 \uc5c6\ub294 \ud615\uad11 \uacc4\uc218\ub294 4\uc77c \uc774\ub0b4\uc5d0 \ubd88\ud22c\uba85 \ub9e4\ud2b8\ub9ad\uc2a4\uc5d0\uc11c \ub2e8\uc77c \uc720\uae30\uccb4\ub97c \uac10\uc9c0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n\uaddc\uc81c \ub2f9\uad6d\uc740 \uc5ec\uc804\ud788 \uae30\uc874 \ubc29\ubc95\uacfc \ub300\uccb4 \ubc29\ubc95 \ubaa8\ub450\uc5d0 \ub300\ud55c \uc774\uc911 \uac80\uc99d\uc744 \uc694\uad6c\ud558\uc5ec \uc804\ud658 \uae30\uac04\uc774 \uae38\uc5b4\uc9c0\uace0 \uc788\uc2b5\ub2c8\ub2e4. AI \uae30\ubc18 \ub514\uc9c0\ud138 \ucf5c\ub85c\ub2c8 \uce74\uc6b4\ud130\uac00 510(k) \uc2b9\uc778\uc744 \ubc1b\uc73c\uba74\uc11c, \uba64\ube0c\ub808\uc778 \uc5ec\uacfc\uac00 \ub300\ub7c9 \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c\ub97c \uc9c0\ubc30\ud558\uace0 \uc2e0\uc18d \uc2dc\ud5d8\uc774 \uc138\ud3ec \uce58\ub8cc\uc81c \ub85c\ud2b8\ub97c \ucf5c\ub4dc \uccb4\uc778 \ubcd1\ubaa9 \ud604\uc0c1\uc5d0\uc11c \ud574\ubc29\uc2dc\ud0a4\ub294 \uc810\uc9c4\uc801\uc778 \ud63c\ud569\uc774 \uc608\uc0c1\ub429\ub2c8\ub2e4.<\/p>\n<p>4.3. \uc6b4\uc601 \ubc29\uc2dd\ubcc4: \uc544\uc6c3\uc18c\uc2f1\uc73c\ub85c\uc758 \ud328\ub7ec\ub2e4\uc784 \uc804\ud658<\/p>\n<p>*   \uc544\uc6c3\uc18c\uc2f1\/\uc704\ud0c1 \uc2dc\ud5d8: 2025\ub144 \ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5 \uc810\uc720\uc728\uc758 56.84%\ub97c \ucc28\uc9c0\ud588\uc73c\uba70, \ub9cc\uc131\uc801\uc778 \uc778\ub825 \ubd80\uc871\uc73c\ub85c \uc778\ud574 \uc544\uc6c3\uc18c\uc2f1\uc73c\ub85c\uc758 \uad6c\uc870\uc801 \uc804\ud658\uc774 \uac00\uc18d\ud654\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc5c5\uacc4 \uc870\uc0ac\uc5d0 \ub530\ub974\uba74 \uc2e0\uaddc \uc608\uc0b0 \ucc44\uc6a9\uc758 34%\uac00 QC \ubbf8\uc0dd\ubb3c\ud559\uc744 \ubaa9\ud45c\ub85c \ud558\uc9c0\ub9cc, \ucc44\uc6a9\ub960\uc740 66%\uc5d0 \ubd88\uacfc\ud569\ub2c8\ub2e4. CDMO\ub294 \uc911\uc559 \uc9d1\uc911\uc2dd \uad50\uc721 \uc544\uce74\ub370\ubbf8\uc640 \ub85c\ubd07 \uc6cc\ud06c\ud50c\ub85c\uc6b0\ub97c \ud1b5\ud574 \uc778\ub825 \ubd80\uc871\uc744 \uc0c1\uc1c4\ud569\ub2c8\ub2e4.<br \/>\n*   \uc790\uccb4 \uc2dc\ud5d8: \uc544\uc774\uc194\ub808\uc774\ud130 \uac1c\uc870, Annex 1 \uc900\uc218 HVAC \uc7ac\uc778\uc99d, \uc804\uc790 \ubc30\uce58 \uae30\ub85d \ud1b5\ud569 \ub4f1 \ub9c9\ub300\ud55c \uc790\ubcf8 \uc9c0\ucd9c\uc5d0 \uc9c1\uba74\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uacb0\uacfc\uc801\uc73c\ub85c \ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5\uc740 \uc11c\ube44\uc2a4 \ub9e4\ucd9c\uc774 \ub450 \uc790\ub9bf\uc218 \uc131\uc7a5\uc744 \uae30\ub85d\ud558\ub294 \ubc18\uba74, \uc790\uccb4 \ud0a4\ud2b8 \uc18c\ube44\ub294 \ud55c \uc790\ub9bf\uc218 \uc911\ubc18 \uc131\uc7a5\uc5d0 \uadf8\uce58\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uaddc\uc81c \ub2f9\uad6d\uc774 GAMP 5 \ubc0f ALCOA+ \uc6d0\uce59\uc744 \ud1b5\ud574 \ub370\uc774\ud130 \ubb34\uacb0\uc131\uc744 \uc639\ud638\ud568\uc5d0 \ub530\ub77c, \uc911\uc18c\uae30\uc5c5\ub4e4\uc740 \uc544\uc6c3\uc18c\uc2f1\uc774 \uae30\uc220\uc801 \uae4a\uc774\uc640 \uaddc\uc815 \uc900\uc218 \uac10\uc0ac \uc900\ube44\ub97c \ubaa8\ub450 \uc81c\uacf5\ud55c\ub2e4\ub294 \uc810\uc744 \uc778\uc815\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>5. \uc9c0\uc5ed\ubcc4 \ubd84\uc11d<\/p>\n<p>*   \ubd81\ubbf8: 2025\ub144 \uc804 \uc138\uacc4 \ub9e4\ucd9c\uc758 41.86%\ub97c \ucc28\uc9c0\ud588\uc2b5\ub2c8\ub2e4. \uc774\ub294 \ubc00\uc9d1\ub41c \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \ud5c8\uac00 \ud30c\uc774\ud504\ub77c\uc778, \uacf5\uaca9\uc801\uc778 \ubca4\ucc98 \uc790\uae08 \uc870\ub2ec, \uadf8\ub9ac\uace0 \uc2e0\uc18d \ubc29\ubc95\uc758 \uc870\uae30 \ucc44\ud0dd\uc744 \uc7a5\ub824\ud558\ub294 FDA\uc758 \uba85\ud655\ud55c \ubb34\uade0 \uc9c0\uce68\uc5d0 \uae30\uc778\ud569\ub2c8\ub2e4. STERIS\ub294 2024\ub144\uc5d0 \ub9e4\uc0ac\ucd94\uc138\uce20\uc640 \uce98\ub9ac\ud3ec\ub2c8\uc544\uc5d0 \ub450 \uac1c\uc758 \uc0c8\ub85c\uc6b4 \uac80\uc99d \uc5f0\uad6c\uc18c\ub97c \uc124\ub9bd\ud558\uc5ec \ub2f9\uc77c \uba64\ube0c\ub808\uc778 \uc5ec\uacfc \uc124\uc815\uc744 \uc81c\uacf5\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n*   \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591: 2026\ub144\ubd80\ud130 2031\ub144\uae4c\uc9c0 9.58%\uc758 CAGR\ub85c \ubaa8\ub4e0 \uc9c0\uc5ed \uc911 \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc774\ub294 \uc815\ucc45 \uc778\uc13c\ud2f0\ube0c, \ub300\uaddc\ubaa8 \ubc31\uc2e0 \ucea0\ud398\uc778, \uadf8\ub9ac\uace0 \ub2e4\uc911 \ud14c\ub10c\ud2b8 \ubc14\uc774\uc624\ud30c\ud06c\uc5d0 \ub300\ud55c \uc0ac\ubaa8 \ud380\ub4dc \uc790\uae08 \uc870\ub2ec\uc5d0 \uc758\ud574 \uc8fc\ub3c4\ub429\ub2c8\ub2e4. \uc911\uad6d\uc758 PIC\/S\uc640 \uad6d\ub0b4 \uc2dc\ud5d8 \ud45c\uc900\uc744 \uc77c\uce58\uc2dc\ud0a4\ub824\ub294 \ucd5c\uadfc\uc758 \uc758\ubb34\ud654\ub294 Annex 1 \ub4f1\uae09 \uc544\uc774\uc194\ub808\uc774\ud130\uc5d0 \ub300\ud55c \uc218\uc694\ub97c \uc99d\uac00\uc2dc\ud0a4\uace0 \uc788\uc2b5\ub2c8\ub2e4.<br \/>\n*   \uc720\ub7fd: 2023\ub144 8\uc6d4 Annex 1\uc758 \uc804\uba74 \uc2dc\ud589\uc5d0 \ud798\uc785\uc5b4 \uc548\uc815\uc801\uc778 \uc804\ub9dd\uc744 \uc720\uc9c0\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ub3c5\uc77c, \uc601\uad6d, \ud504\ub791\uc2a4\ub294 \uc544\uc774\uc194\ub808\uc774\ud130 \uac1c\uc870\ub97c \uc8fc\ub3c4\ud558\uace0 \uc788\uc73c\uba70, \uc18c\uaddc\ubaa8 \ubc30\uce58 \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uacf5\uc7a5\uc740 \uc644\uc804\ud788 \ud1b5\ud569\ub41c HEPA \ud544\ud130 \uc7a5\ubcbd \uc2dc\uc2a4\ud15c\uc73c\ub85c \uc5c5\uadf8\ub808\uc774\ub4dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. EU\uc758 Fit-for-55 \ud0c4\uc18c \ubaa9\ud45c\ub294 \uacf5\uae09\uc5c5\uccb4\ub4e4\uc774 \uc800\uc5d0\ub108\uc9c0 \uae30\ud654 \uc218\uc18c \uacfc\uc0b0\ud654\ubb3c(VHP) \uc0ac\uc774\ud074\uc744 \uac1c\ubc1c\ud558\ub3c4\ub85d \ucd09\uc9c4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>6. \uacbd\uc7c1 \ud658\uacbd \ubc0f \uc8fc\uc694 \uae30\uc5c5<\/p>\n<p>\ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5\uc740 \uc911\uac04 \uc815\ub3c4\uc758 \ud30c\ud3b8\ud654\ub97c \ubcf4\uc785\ub2c8\ub2e4. \uc8fc\uc694 \uae30\uc5c5\ub4e4\uc740 \uae30\uc220 \ud601\uc2e0, \uc778\uc218\ud569\ubcd1, \uc11c\ube44\uc2a4 \ud655\uc7a5\uc744 \ud1b5\ud574 \uacbd\uc7c1 \uc6b0\uc704\ub97c \ud655\ubcf4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>*   bioM\u00e9rieux: \uc2a4\ub9c8\ud2b8 \ud50c\ub808\uc774\ud2b8, \uc790\ub3d9\ud654\ub41c \ubc30\uc591, \uc2e4\uc2dc\uac04 \ucf5c\ub85c\ub2c8 \uacc4\uc218\ub97c \ud1b5\ud569\ud55c 3P ENTERPRISE\ub97c \ud1b5\ud574 \uc791\uc5c5\uc790\uc758 \uc8fc\uad00\uc801\uc778 \ud50c\ub808\uc774\ud2b8 \ud310\ub3c5 \ubd80\ub2f4\uc744 \uc904\uc774\uace0 \uac10\uc0ac \uc900\ube44\uac00 \ub41c \ub370\uc774\ud130 \uc138\ud2b8\ub97c LIMS\uc5d0 \uc81c\uacf5\ud569\ub2c8\ub2e4.<br \/>\n*   Thermo Fisher Scientific: Solventum\uc758 \uc815\uc81c \ubc0f \uc5ec\uacfc \uc0ac\uc5c5\ubd80\ub97c 41\uc5b5 \ub2ec\ub7ec\uc5d0 \uc778\uc218\ud558\uc5ec \uc0c1\ub958 \uc5ec\uacfc \ubc0f \ud558\ub958 QC \uc804\ubc18\uc73c\ub85c \uc5ed\ub7c9\uc744 \ud655\uc7a5\ud558\uace0, \uba78\uade0 \ub4f1\uae09 \ud544\ud130\uc640 \uba64\ube0c\ub808\uc778 \uc5ec\uacfc \uac80\uc99d \ub514\uc2a4\ud06c\ub97c \uacb0\ud569\ud55c \ubc88\ub4e4 \uc81c\ud488\uc744 \uc81c\uacf5\ud560 \uc608\uc815\uc785\ub2c8\ub2e4.<br \/>\n*   Charles River Laboratories: ATP-\uc0dd\ubb3c\ubc1c\uad11\uacfc \ucd9c\ucc98 \ucd94\uc801 \ubc14\ucf54\ub4dc\ub97c \ud1b5\ud569\ud55c Celsis \ud50c\ub7ab\ud3fc\uc744 \ud655\uc7a5\ud558\uc5ec Annex 1\uc758 \uc624\uc5fc \uc81c\uc5b4 \uc804\ub7b5 \ubb38\uc11c\ud654 \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\ud569\ub2c8\ub2e4.<br \/>\n*   KBI Biopharma: Argonaut Manufacturing Services\uc640 \ud611\ub825\ud558\uc5ec \uc0c1\ub958 \uc138\ud3ec \ubc30\uc591 \ubd84\uc11d\uacfc \ubb34\uade0 \ucda9\uc804-\ub9c8\uac10\uc744 \uc5f0\uacb0\ud569\ub2c8\ub2e4.<br \/>\n*   Syntegon: \ubaa8\ub4c8\ud615 \ucda9\uc804\uae30\uc5d0 \uc138\ud2c0 \ud50c\ub808\uc774\ud2b8 \uad50\ud658\uae30\ub97c \ub0b4\uc7a5\ud558\uc5ec \uc218\ub3d9 \uc0dd\uc874 \ubbf8\uc0dd\ubb3c \ubaa8\ub2c8\ud130\ub9c1 \ub2e8\uacc4\uc758 80%\ub97c \uc790\ub3d9\ud654\ud569\ub2c8\ub2e4.<br \/>\n*   St\u00e4ubli (Sterimove): \uc790\uc728\uc801\uc778 Grade A\/B \ud398\uc774\ub85c\ub4dc(payload) \uc774\uc1a1\uc744 \ucd94\uc9c4\ud558\uc5ec \uac00\uc6b4 \ucc29\uc6a9\uc73c\ub85c \uc778\ud55c \uc624\uc5fc \uc704\ud5d8\uc744 \uc904\uc785\ub2c8\ub2e4.<\/p>\n<p>\uc2e0\ud765 \uc2dc\uc7a5\uc758 \uacbd\uc6b0, \uacf5\uae09\uc5c5\uccb4\ub4e4\uc740 \uc6d0\uaca9 \uc720\uc9c0\ubcf4\uc218 \ubaa8\ub4c8\uacfc \uc99d\uac15 \ud604\uc2e4 \ubb38\uc81c \ud574\uacb0 \uae30\ub2a5\uc744 \ub0b4\uc7a5\ud558\uc5ec \ud604\uc9c0 \uc778\ub825 \ubd80\uc871\uc744 \uc0c1\uc1c4\ud558\ub294 \ub370 \ub3c4\uc6c0\uc744 \uc90d\ub2c8\ub2e4. \ud654\uc774\ud2b8 \uc2a4\ud398\uc774\uc2a4 \uae30\ud68c\ub294 \uad50\uc721 \ubc0f \ub514\uc9c0\ud138\ud654\uc5d0 \uc9d1\uc911\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. \uac00\uc0c1 \ud604\uc2e4 \ubb34\uade0 \uacf5\uc815 \uc2dc\ubbac\ub808\uc774\uc158 \ubc0f AI \uae30\ubc18 \uadfc\ubcf8 \uc6d0\uc778 \ubd84\uc11d\uc744 \uc81c\uacf5\ud558\ub294 \uae30\uc5c5\ub4e4\uc740 \uc790\uc6d0 \uc81c\uc57d\uc774 \uc788\ub294 \uc81c\uc870\uc5c5\uccb4\ub4e4 \uc0ac\uc774\uc5d0\uc11c \ucda9\uc131\ub3c4\ub97c \ub192\uc774\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc8fc\uc694 \uc0b0\uc5c5 \ub9ac\ub354:<br \/>\n*   Charles River Laboratories<br \/>\n*   bioM\u00e9rieux SA<br \/>\n*   Merck KGaA<br \/>\n*   SGS SA<br \/>\n*   Sotera Health (Nelson Laboratories, LLC)<\/p>\n<p>7. \ucd5c\uadfc \uc0b0\uc5c5 \ub3d9\ud5a5<\/p>\n<p>*   2025\ub144 2\uc6d4: Thermo Fisher Scientific\uc740 Solventum\uc758 \uc815\uc81c \ubc0f \uc5ec\uacfc \uc0ac\uc5c5\ubd80\ub97c 41\uc5b5 \ub2ec\ub7ec\uc5d0 \uc778\uc218\ud558\uae30\ub85c \ud569\uc758\ud588\uc73c\uba70, 2025\ub144\uae4c\uc9c0 \uac70\ub798\ub97c \uc644\ub8cc\ud558\uace0 \uc790\uc0ac\uc758 \uc0dd\uba85 \uacfc\ud559 \uc194\ub8e8\uc158 \ubd80\ubb38\uc5d0 \ud1b5\ud569\ud560 \uc608\uc815\uc785\ub2c8\ub2e4.<br \/>\n*   2025\ub144 2\uc6d4: Jabil\uc740 Pharmaceutics International Inc. \uc778\uc218\ub97c \uc644\ub8cc\ud558\uc5ec \uba54\ub9b4\ub79c\ub4dc\uc5d0 360,000\ud3c9\ubc29\ud53c\ud2b8 \uaddc\ubaa8\uc758 \ubb34\uade0 \uc0dd\uc0b0 \uc5ed\ub7c9\uc744 \uc81c\uc57d \uc194\ub8e8\uc158 \ud3ec\ud2b8\ud3f4\ub9ac\uc624\uc5d0 \ucd94\uac00\ud588\uc2b5\ub2c8\ub2e4.<br \/>\n*   2025\ub144 1\uc6d4: bioM\u00e9rieux\ub294 Neoprospecta\ub97c \uc778\uc218\ud558\uae30 \uc704\ud55c \ucd5c\uc885 \uacc4\uc57d\uc744 \uccb4\uacb0\ud558\uc5ec \uc2dd\ud488 \ubc0f \uc81c\uc57d \ud488\uc9c8 \ud504\ub85c\uadf8\ub7a8\uc5d0 \ub300\ud55c \uc720\uc804\uccb4 \uc624\uc5fc \uc81c\uc5b4 \ud234\ud0b7\uc744 \uac15\ud654\ud588\uc2b5\ub2c8\ub2e4.<br \/>\n*   2024\ub144 11\uc6d4: bioM\u00e9rieux\ub294 SMART PLATES, CONNECT \uc18c\ud504\ud2b8\uc6e8\uc5b4, STATION \ud558\ub4dc\uc6e8\uc5b4\ub97c \uacb0\ud569\ud55c 3P ENTERPRISE\ub97c \ucd9c\uc2dc\ud558\uc5ec \ud578\uc988\ud504\ub9ac \ud658\uacbd \ubaa8\ub2c8\ud130\ub9c1\uc744 \uac00\ub2a5\ud558\uac8c \ud588\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ubcf8 \ubcf4\uace0\uc11c\ub294 \uc644\uc81c \uc758\uc57d\ud488, \ubc14\uc774\uc624 \uc758\uc57d\ud488 \ubc0f \uc758\ub8cc \uae30\uae30 \ubc30\uce58 \ucd9c\ud558 \uc804 \ubbf8\uc0dd\ubb3c \ubd80\uc7ac\ub97c \ud655\uc778\ud558\ub294 \ub370 \uc0ac\uc6a9\ub418\ub294 \ud0a4\ud2b8, \uc2dc\uc57d, \uc7a5\ube44 \ubc0f \uc544\uc6c3\uc18c\uc2f1 \uc2e4\ud5d8\uc2e4 \uc11c\ube44\uc2a4\uc5d0\uc11c \ubc1c\uc0dd\ud558\ub294 \uc218\uc775\uc73c\ub85c \uc815\uc758\ub418\ub294 \ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5\uc5d0 \ub300\ud55c \uc2ec\uce35 \ubd84\uc11d\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \ubcf8 \uc5f0\uad6c\ub294 17\uac1c\uad6d\uc744 \ub300\uc0c1\uc73c\ub85c \ud558\uba70, \ud658\uacbd \ubaa8\ub2c8\ud130\ub9c1 \uc18c\ubaa8\ud488 \ubc0f \uc0dd\uc0b0 \uacf5\uc815 \uc911 \uc0dd\ubb3c \ubd80\ud558 \ud14c\uc2a4\ud2b8\ub294 \ubc94\uc704\uc5d0\uc11c \uc81c\uc678\ub429\ub2c8\ub2e4.<\/p>\n<p>\ubcf4\uace0\uc11c\uc5d0 \ub530\ub974\uba74, \ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5\uc740 2026\ub144 17\uc5b5 6\ucc9c\ub9cc \ub2ec\ub7ec\uc5d0\uc11c 2031\ub144\uae4c\uc9c0 29\uc5b5 6\ucc9c\ub9cc \ub2ec\ub7ec \uaddc\ubaa8\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc804\ub9dd\ub429\ub2c8\ub2e4. \ud2b9\ud788 \uc544\uc6c3\uc18c\uc2f1 \uc11c\ube44\uc2a4 \ubd80\ubb38\uc740 \uc81c\uc57d\uc0ac\ub4e4\uc774 \uc804\ubb38\uc131\uc744 \uc704\ud574 CDMO(\uc704\ud0c1\uac1c\ubc1c\uc0dd\uc0b0\uae30\uad00)\ub85c \uc804\ud658\ud568\uc5d0 \ub530\ub77c 2031\ub144\uae4c\uc9c0 \uc5f0\ud3c9\uade0 10.48%\uc758 \uac00\uc7a5 \ube60\ub978 \uc131\uc7a5\ub960\uc744 \ubcf4\uc77c \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc9c0\uc5ed\ubcc4\ub85c\ub294 \ubd81\ubbf8\uac00 41.86%\ub85c \uac00\uc7a5 \ud070 \uc2dc\uc7a5 \uc810\uc720\uc728\uc744 \ucc28\uc9c0\ud558\uace0 \uc788\uc73c\uba70, \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \uc9c0\uc5ed\uc740 2031\ub144\uae4c\uc9c0 \uc5f0\ud3c9\uade0 9.58%\ub85c \uac00\uc7a5 \ube60\ub974\uac8c \uc131\uc7a5\ud558\ub294 \uc9c0\uc5ed\uc73c\ub85c \uc608\uce21\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc2dc\uc7a5 \uc131\uc7a5\uc744 \uacac\uc778\ud558\ub294 \uc8fc\uc694 \uc694\uc778\uc73c\ub85c\ub294 \ucca8\ub2e8 \ubc14\uc774\uc624 \uc758\uc57d\ud488 \ud30c\uc774\ud504\ub77c\uc778\uc5d0 \ub300\ud55c \uc5c4\uaca9\ud55c GMP(\uc6b0\uc218 \uc758\uc57d\ud488 \uc81c\uc870 \ubc0f \ud488\uc9c8 \uad00\ub9ac \uae30\uc900) \uc5c5\uadf8\ub808\uc774\ub4dc, \uc720\ud1b5 \uae30\ud55c\uc774 \uc9e7\uc740 \uc138\ud3ec \ubc0f \uc720\uc804\uc790 \uce58\ub8cc\uc81c \uc0c1\uc5c5\uc6a9 \ubc30\uce58 \uc99d\uac00\uc5d0 \ub530\ub978 \uc2e0\uc18d \ubc29\ucd9c \ubb34\uade0 \uc2dc\ud5d8\uc758 \ud544\uc694\uc131 \uc99d\ub300, \uc0ac\ub0b4 QC(\ud488\uc9c8 \uad00\ub9ac)\uc5d0\uc11c \uc544\uc6c3\uc18c\uc2f1 CDMO \ubb34\uade0 \uc11c\ube44\uc2a4\ub85c\uc758 \uc804\ud658 \uac00\uc18d\ud654\uac00 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c, \uc624\ub958 \uc591\uc131\ub960\uc744 \ub0ae\ucd94\ub294 \ubaa8\ub4c8\ud615 \uc544\uc774\uc194\ub808\uc774\ud130 \uc2dc\uc2a4\ud15c \ucc44\ud0dd, \uac80\uc99d\ub41c \uc2e0\uc18d \ubbf8\uc0dd\ubb3c\ud559\uc801 \ubc29\ubc95\uc5d0 \ub300\ud55c \uaddc\uc81c \ub2f9\uad6d\uc758 \uc7a5\ub824, \uc77c\ud68c\uc6a9 \uae30\uc220 \ud638\ud658 \ud14c\uc2a4\ud2b8 \ud0a4\ud2b8\uc5d0 \ub300\ud55c \uc218\uc694 \uc99d\uac00\ub3c4 \uc911\uc694\ud55c \ub3d9\ub825\uc785\ub2c8\ub2e4. \ud2b9\ud788 EU GMP Annex 1\uc758 &#8216;\uc81c\ub85c CFU(\uc9d1\ub77d \ud615\uc131 \ub2e8\uc704)&#8217; \uc694\uad6c\uc0ac\ud56d\uc740 \uc544\uc774\uc194\ub808\uc774\ud130 \uc5c5\uadf8\ub808\uc774\ub4dc, PUPSIT(Pre-Use Post-Sterilization Integrity Testing) \ucc44\ud0dd, \ucca8\ub2e8 \ud658\uacbd \ubaa8\ub2c8\ud130\ub9c1 \uc2dc\uc2a4\ud15c \uc124\uce58\ub97c \uc758\ubb34\ud654\ud558\uc5ec \uad00\ub828 \uc7a5\ube44 \ubc0f \uc11c\ube44\uc2a4 \uacc4\uc57d \uc218\uc694\ub97c \uc99d\ub300\uc2dc\ud0a4\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ubc18\uba74, \uc2dc\uc7a5 \uc131\uc7a5\uc744 \uc800\ud574\ud558\ub294 \uc694\uc778\uc73c\ub85c\ub294 Class B \uc544\uc774\uc194\ub808\uc774\ud130 \uc778\ud504\ub77c \uad6c\ucd95\uc758 \ub192\uc740 \ucd08\uae30 \ud22c\uc790 \ube44\uc6a9, \uacf5\uc815\uc11c \uc2dc\ud5d8 \ud45c\uc900\uc758 \uc81c\ud55c\uc801\uc778 \uae00\ub85c\ubc8c \uc870\ud654, \uc2e0\ud765 \uc2dc\uc7a5\uc758 \uc219\ub828\ub41c \ubbf8\uc0dd\ubb3c\ud559\uc790 \ubd80\uc871, \uadf8\ub9ac\uace0 \uc9c1\uc811 \uc811\uc885 \uc2dc\ud5d8\uc758 \uc624\ub958 \uc591\uc131 \uc704\ud5d8 \ubc0f \uc774\ub85c \uc778\ud55c \uc81c\ud488 \ucd9c\uc2dc \uc9c0\uc5f0 \uac00\ub2a5\uc131\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ubcf8 \ubcf4\uace0\uc11c\ub294 \uc81c\ud488 \uc720\ud615(\uc7a5\ube44, \ud0a4\ud2b8 \ubc0f \uc2dc\uc57d, \uc11c\ube44\uc2a4), \uc2dc\ud5d8 \uc720\ud615(\ub9c9 \uc5ec\uacfc, \uc9c1\uc811 \uc811\uc885, \uc2e0\uc18d \ubb34\uade0 \uc2dc\ud5d8), \uc801\uc6a9 \ubd84\uc57c(\uc81c\uc57d \ubc0f \ubc14\uc774\uc624 \uc758\uc57d\ud488 \uc81c\uc870, \uc758\ub8cc \uae30\uae30 \uc81c\uc870 \ub4f1), \uc2dc\ud5d8 \ubc29\uc2dd(\uc0ac\ub0b4 \uc2dc\ud5d8, \uc544\uc6c3\uc18c\uc2f1\/\uc704\ud0c1 \uc2dc\ud5d8), \uadf8\ub9ac\uace0 \ubd81\ubbf8, \uc720\ub7fd, \uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591 \ub4f1 \uc8fc\uc694 \uc9c0\uc5ed\ubcc4\ub85c \uc2dc\uc7a5\uc744 \uc138\ubd84\ud654\ud558\uc5ec \ubd84\uc11d\ud569\ub2c8\ub2e4. \uacbd\uc7c1 \ud658\uacbd \ubd84\uc11d\uc5d0\ub294 \uc2dc\uc7a5 \uc9d1\uc911\ub3c4, \uc2dc\uc7a5 \uc810\uc720\uc728 \ubd84\uc11d, \uadf8\ub9ac\uace0 bioMerieux SA, Charles River Laboratories, Merck KGaA, Thermo Fisher Scientific \ub4f1 \uc8fc\uc694 18\uac1c \uae30\uc5c5\uc758 \uc0ac\uc5c5 \uac1c\uc694, \uc7ac\ubb34, \uc81c\ud488 \ubc0f \uc804\ub7b5, \ucd5c\uadfc \uac1c\ubc1c \uc0ac\ud56d \ub4f1\uc774 \uc0c1\uc138\ud788 \ub2e4\ub8e8\uc5b4\uc9d1\ub2c8\ub2e4.<\/p>\n<p>\ubcf4\uace0\uc11c\ub294 \ud488\uc9c8 \uad00\ub9ac\uc790, \uacc4\uc57d \uc2e4\ud5d8\uc2e4 \uc774\uc0ac, \uc2dc\uc57d \uc720\ud1b5\uc5c5\uccb4\uc640\uc758 \uc778\ud130\ubdf0\ub97c \ud1b5\ud55c 1\ucc28 \uc5f0\uad6c, \uacf5\uc815\uc11c \ubc0f \ubb34\uc5ed \ub370\uc774\ud130 \ubd84\uc11d\uc744 \ud1b5\ud55c 2\ucc28 \uc5f0\uad6c, \uadf8\ub9ac\uace0 \uc0c1\ud5a5\uc2dd \ubc0f \ud558\ud5a5\uc2dd \ubaa8\ub378\uc744 \uacb0\ud569\ud55c \uc2dc\uc7a5 \uaddc\ubaa8 \uc0b0\uc815 \ubc0f \uc608\uce21 \ub4f1 \uc5c4\uaca9\ud55c \uc5f0\uad6c \ubc29\ubc95\ub860\uc744 \ud1b5\ud574 \uc2e0\ub8b0\uc131\uc744 \ud655\ubcf4\ud569\ub2c8\ub2e4. \ub370\uc774\ud130\ub294 3\ub2e8\uacc4 \uac80\uc99d \uacfc\uc815\uc744 \uac70\uce58\uba70, \ubbf8\ub798 \uc804\ub9dd \uc139\uc158\uc5d0\uc11c\ub294 \uc2dc\uc7a5 \uae30\ud68c\uc640 \ubbf8\ucda9\uc871 \uc218\uc694\uc5d0 \ub300\ud55c \ud3c9\uac00\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n<p>\uacb0\ub860\uc801\uc73c\ub85c, \ubb34\uade0 \uc2dc\ud5d8 \uc2dc\uc7a5\uc740 \uc5c4\uaca9\ud55c \uaddc\uc81c \ud658\uacbd, \ucca8\ub2e8 \uce58\ub8cc\ubc95\uc758 \ubc1c\uc804, \uadf8\ub9ac\uace0 \uc544\uc6c3\uc18c\uc2f1 \ucd94\uc138\uc5d0 \ud798\uc785\uc5b4 \uc9c0\uc18d\uc801\uc778 \uc131\uc7a5\uc774 \uc608\uc0c1\ub429\ub2c8\ub2e4. \uae30\uc220 \ud601\uc2e0\uc744 \ud1b5\ud55c \uc624\ub958 \uc591\uc131\ub960 \uac10\uc18c \ub178\ub825\uacfc \uc9c0\uc5ed\ubcc4 \uc131\uc7a5 \ub3d9\ub825\uc740 \uc2dc\uc7a5 \ucc38\uc5ec\uc790\ub4e4\uc5d0\uac8c \uc911\uc694\ud55c \uae30\ud68c\ub97c \uc81c\uacf5\ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-53103","post","type-post","status-publish","format-standard","hentry","category-market-reports"],"_links":{"self":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/posts\/53103"}],"collection":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/comments?post=53103"}],"version-history":[{"count":0,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/posts\/53103\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/media?parent=53103"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/categories?post=53103"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.globalresearch.co.kr\/insight\/wp-json\/wp\/v2\/tags?post=53103"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}