{"id":229,"date":"2026-07-10T05:28:01","date_gmt":"2026-07-10T05:28:01","guid":{"rendered":"https:\/\/industrialelectricmotor.net\/?p=229"},"modified":"2026-07-10T05:28:01","modified_gmt":"2026-07-10T05:28:01","slug":"stainless-steel-motor-for-pharmaceutical-gmp-manufacturing","status":"publish","type":"post","link":"https:\/\/industrialelectricmotor.net\/ko\/stainless-steel-motor-for-pharmaceutical-gmp-manufacturing\/","title":{"rendered":"\uc81c\uc57d GMP \uc81c\uc870\uc6a9 \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc2a4\ud2f8 \ubaa8\ud130"},"content":{"rendered":"
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\ud55c\uad6d \uc5d0\ubc84\ud30c\uc6cc \u00b7 BXG \uc2dc\ub9ac\uc988 \u00b7 \uc81c\uc57d GMP \ub4dc\ub77c\uc774\ube0c \uac00\uc774\ub4dc<\/span><\/p>\n

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\uc81c\uc57d GMP \uc81c\uc870\uc6a9 \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc2a4\ud2f8 \ubaa8\ud130:
\nFDA 21 CFR, EU GMP \ubc0f EHEDG \uc900\uc218 \uac00\uc774\ub4dc<\/span><\/h1>\n

\uc6b0\uc218 \uc758\uc57d\ud488 \uc81c\uc870 \uae30\uc900(GMP) \uaddc\uc815\uc5d0 \ub530\ub77c \uc6b4\uc601\ub418\ub294 \uc758\uc57d\ud488 \uc81c\uc870 \uc2dc\uc124\uc740 \uc81c\ud488\uacfc \uc811\ucd09\ud558\uac70\ub098 \uc81c\ud488 \uc811\ucd09\uba74 \uc704\uc5d0 \uc788\ub294 \ubaa8\ub4e0 \uc7a5\ube44\uac00 \uc758\uc57d\ud488 \uc624\uc5fc\uc744 \ubc29\uc9c0\ud558\ub3c4\ub85d \uc124\uacc4\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. GMP \uad6c\uc5ed\uc5d0 \uc124\uce58\ub418\ub294 \ubaa8\ud130\ub294 \ud45c\uba74\uc774 \ub9e4\ub044\ub7fd\uace0 \ub0b4\uc2dd\uc131\uc774 \uc788\uc73c\uba70 \uc138\ucc99\uc774 \uc6a9\uc774\ud574\uc57c \ud558\uace0, \uc785\uc790\ub098 \uc561\uccb4\uac00 \uace0\uc77c \uc218 \uc788\ub294 \uc218\ud3c9 \ub3cc\ucd9c\ubd80\uac00 \uc5c6\uc5b4\uc57c \ud558\uba70, \ubbf8\uc0dd\ubb3c \uc624\uc5fc\uc744 \uc720\ubc1c\ud560 \uc218 \uc788\ub294 \ud2c8\uc0c8\uac00 \uc5c6\uc5b4\uc57c \ud558\uace0, \uc138\ucc99 \ubc0f \uac80\uc0ac \uc808\ucc28\uac00 \ubb38\uc11c\ud654\ub418\uc5b4 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774 \uac00\uc774\ub4dc\ub294 \ud55c\uad6d \uc5d0\ubc84\ud30c\uc6cc(Ever-Power) BXG \uc2a4\ud14c\uc778\ub9ac\uc2a4\uac15 \uc2dc\ub9ac\uc988\ub97c \uc0ac\uc6a9\ud558\ub294 GMP \uc6d0\ub8cc\uc758\uc57d\ud488 \ubc0f \uc644\uc81c\ud488 \uc81c\uc870\uc6a9 \ubaa8\ud130 \uc0ac\uc591\uc744 \ub2e4\ub8f9\ub2c8\ub2e4.<\/p>\n

FDA 21 CFR \ud30c\ud2b8 211<\/span>
\nEU GMP \ubd80\ub85d 1\/2<\/span>
\nIP69K SS316L<\/span>
\nRa \u2264 0.8 \u03bcm<\/span>
\n\ud074\ub9b0\ub8f8 \ud638\ud658 \uac00\ub2a5<\/span><\/div>\n<\/div>\n<\/div>\n

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316L<\/div>\n
\ubaa8\ub4e0 \uc678\ubd80 \ud45c\uba74<\/div>\n<\/div>\n
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IP69K<\/div>\n
\uc81c\uc57d \ubd84\uc57c WIP<\/div>\n<\/div>\n
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FDA<\/div>\n
21 CFR \ud30c\ud2b8 211<\/div>\n<\/div>\n
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EU GMP<\/div>\n
\ubd80\ub85d 1 \ubc0f \ubd80\ub85d 2<\/div>\n<\/div>\n
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Ra 0.8<\/div>\n
\u03bcm \ucd5c\ub300 \ud45c\uba74 \ub9c8\uac10<\/div>\n<\/div>\n
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H1<\/div>\n
NSF H1 \uc81c\uc57d \uadf8\ub9ac\uc2a4<\/div>\n<\/div>\n<\/div>\n

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\"\uc2a4\ud14c\uc778\ub9ac\uc2a4\uac15<\/p>\n
\ud55c\uad6d Ever-Power BXG \uc2dc\ub9ac\uc988 \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc2a4\ud2f8 \ubaa8\ud130 - IP69K \uc778\uc99d, AISI 316L \uc678\uc7a5 \uad6c\uc870, Ra \u2264 0.8 \u03bcm \ud328\uc2dc\ubca0\uc774\uc158 \ucc98\ub9ac \ud45c\uba74. GMP \uc0dd\uc0b0 \uad6c\uc5ed\uc758 \uc758\uc57d\ud488 \uc81c\uc870 \uc124\ube44\uc5d0 \ub300\ud55c FDA 21 CFR Part 211 \ubc0f EU GMP Annex 2\uc758 \uc7a5\ube44 \uc704\uc0dd \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub3c4\ub85d \uc124\uacc4\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/div>\n<\/div>\n

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\ub0b4\uc6a9\ubb3c<\/div>\n
1. \ubaa8\ud130\uc5d0 \ub300\ud55c GMP \uaddc\uc81c \uc694\uac74<\/a>
\n2. GMP \uad6c\uc5ed \ubd84\ub958<\/a>
\n3. \uc81c\uc57d WIP \ubc0f CIP<\/a>
\n4. GMP \ud45c\uba74 \ubc0f \ud2c8\uc0c8 \uc694\uad6c\uc0ac\ud56d<\/a>
\n5. IQ\/OQ\/PQ \uc790\uaca9 \uc778\uc99d \uc11c\ub958<\/a>
\n6. BXG GMP \ub4dc\ub77c\uc774\ube0c \uc0ac\uc591<\/a>
\n7. \uc81c\uc57d GMP \uc801\uc6a9 \ubd84\uc57c<\/a>
\n8. \uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38<\/a><\/div>\n<\/div>\n

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1. \uc81c\uc57d \uc81c\uc870\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ubaa8\ud130\uc5d0 \ub300\ud55c GMP \uaddc\uc81c \uc694\uac74<\/h2>\n

\ubbf8\uad6d\uacfc \uc720\ub7fd\uc758 \uc6b0\uc218 \uc758\uc57d\ud488 \uc81c\uc870 \uad00\ub9ac \uae30\uc900(GMP) \uaddc\uc815\uc740 \uc81c\uc57d \uc81c\uc870 \ud604\uc7a5\uc5d0 \uc124\uce58\ub418\ub294 \ubaa8\ub4e0 \uc7a5\ube44, \ud2b9\ud788 \ubbf9\uc11c, \ucee8\ubca0\uc774\uc5b4, \ucf54\ud305\uae30, \uacfc\ub9bd\uae30\ub97c \uad6c\ub3d9\ud558\ub294 \ubaa8\ud130\uc5d0 \ub300\ud574 \ud2b9\uc815 \uc694\uad6c \uc0ac\ud56d\uc744 \ubd80\uacfc\ud569\ub2c8\ub2e4. GMP \ud604\uc7a5\uc758 \ubaa8\ud130\ub294 \uc804\uae30 \ud45c\uc900\ubfd0\ub9cc \uc544\ub2c8\ub77c \uc81c\uc57d \uc7a5\ube44 \uc704\uc0dd \ud45c\uc900\ub3c4 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

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FDA 21 CFR Part 211 (\ubbf8\uad6d)<\/div>\n

21 CFR 211.65\ub294 \uad6c\uc131 \uc694\uc18c, \uc758\uc57d\ud488 \uc81c\uc870 \uacf5\uc815 \uc911 \ubb3c\uc9c8 \ub610\ub294 \uc758\uc57d\ud488\uacfc \uc811\ucd09\ud558\ub294 \uc7a5\ube44 \ud45c\uba74\uc774 \ud655\ub9bd\ub41c \uc694\uad6c \uc0ac\ud56d\uc744 \ub118\uc5b4 \uc548\uc804\uc131, \uc815\uccb4\uc131, \ud6a8\ub2a5, \ud488\uc9c8 \ub610\ub294 \uc21c\ub3c4\ub97c \ubcc0\ud654\uc2dc\ud0ac \uc218 \uc788\ub294 \ubc18\uc751\uc131, \ucca8\uac00\uc131 \ub610\ub294 \ud761\uc218\uc131\uc744 \uac16\uc9c0 \uc54a\uc544\uc57c \ud55c\ub2e4\uace0 \uaddc\uc815\ud569\ub2c8\ub2e4. 21 CFR 211.67\uc740 \uc7a5\ube44\ub97c \uc801\uc808\ud55c \uac04\uaca9\uc73c\ub85c \uc138\ucc99 \ubc0f \uc720\uc9c0 \uad00\ub9ac\ud574\uc57c \ud55c\ub2e4\uace0 \uaddc\uc815\ud569\ub2c8\ub2e4. \uc758\uc57d\ud488 \uac00\uacf5 \uc6a9\uae30 \uc704\uc5d0 \uc788\ub294 \ubaa8\ud130\uc758 \ud45c\uba74\uc774 \ubd80\uc2dd\ub418\uc5c8\uac70\ub098 \uac70\uce60\uba74 \ud45c\uba74 \uc785\uc790 \ub610\ub294 \ubd80\uc2dd \uc0dd\uc131\ubb3c\uc774 \uc544\ub798\ucabd\uc758 \uc758\uc57d\ud488 \ubb3c\uc9c8\uc744 \uc624\uc5fc\uc2dc\ud0ac \uc218 \uc788\uc73c\ubbc0\ub85c 211.65 \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\uc9c0 \ubabb\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

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EU GMP \ubd80\ub85d 2(\uc0dd\ubb3c\ud559\uc801 \uc758\uc57d\ud488)<\/div>\n

EU GMP \ubd80\ub85d 2(2020\ub144 \uac1c\uc815\ud310)\ub294 \uc0dd\ubb3c\ud559\uc801 \uc6d0\ub8cc\uc758\uc57d\ud488(API) \ubc0f \uc644\uc81c\ud488 \uc758\uc57d\ud488 \uc81c\uc870\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc7a5\ube44\uac00 \uc138\ucc99 \ubc0f \uba78\uade0\uc774 \uc6a9\uc774\ud558\ub3c4\ub85d \uc124\uacc4 \ubc0f \uc81c\uc791\ub418\uc5b4\uc57c \ud55c\ub2e4\uace0 \uaddc\uc815\ud569\ub2c8\ub2e4. \uc81c\ud488\uacfc \uc811\ucd09\ud558\uac70\ub098 \uc81c\ud488 \uadfc\ucc98\uc5d0 \uc788\ub294 \ubaa8\ub4e0 \ud45c\uba74\uc740 \ub9e4\ub044\ub7fd\uace0 \ud2c8\uc0c8\ub098 \ubaa8\uc11c\ub9ac\uac00 \uc5c6\uc5b4\uc57c \ud558\uba70, \uc138\ucc99\uc774 \uc6a9\uc774\ud558\uace0 \uc0ac\uc6a9\ub418\ub294 \uc138\ucc99 \ubc0f \uba78\uade0\uc81c\uc5d0 \ub0b4\uc131\uc774 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4. C\ub4f1\uae09 \ubc0f D\ub4f1\uae09 \ud074\ub9b0\ub8f8\uc5d0 \uc124\uce58\ub418\ub294 \ubaa8\ud130\ub294 \uc774\ub7ec\ud55c \uc7ac\uc9c8 \ubc0f \ud45c\uba74 \uc694\uac74\uc744 \ucda9\uc871\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

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EU GMP \ubd80\ub85d 1 (\uba78\uade0 \uc758\uc57d\ud488)<\/div>\n

EU GMP Annex 1(2022\ub144 \uac1c\uc815)\uc740 \ubb34\uade0 \uc758\uc57d\ud488\uc5d0 \ub300\ud574 A\/B \ub4f1\uae09 \ud074\ub9b0\ub8f8(\ubb34\uade0 \ucda9\uc804 \uad6c\uc5ed)\uc5d0 \ucd5c\uace0 \uc218\uc900\uc758 \uc7a5\ube44 \uc704\uc0dd \uae30\uc900\uc744 \uc801\uc6a9\ud569\ub2c8\ub2e4. A \ubc0f B \ub4f1\uae09 \uad6c\uc5ed\uc758 \uc7a5\ube44\ub294 \ud604\uc7a5 \uba78\uade0(SIP) \ubc0f \ud604\uc7a5 \uc138\ucc99(CIP)\uc774 \uac00\ub2a5\ud558\ub3c4\ub85d \uc124\uacc4\ub418\uc5b4\uc57c \ud558\uba70, \uc624\ud1a0\ud074\ub808\uc774\ube0c \uba78\uade0 \uc628\ub3c4 \ubc0f \uc0ac\uc6a9\ub418\ub294 \ubaa8\ub4e0 \uc138\ucc99\uc81c\uc5d0 \ub0b4\uc131\uc774 \uc788\ub294 \ub9e4\ub044\ub7fd\uace0 \ube44\ubd84\ub9ac\uc131 \ud45c\uba74\uc744 \uac16\ucd94\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uad6c\uc5ed\uc758 \ubaa8\ud130\ub294 \ud074\ub9b0\ub8f8 \uc124\uacc4\uc758 \uc77c\ubd80\ub85c \ud2b9\ubcc4\ud788 \uac80\uc99d\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. A\/B \ub4f1\uae09 \ud658\uacbd\uc5d0 \ub300\ud55c BXG \uc0ac\uc591\uc740 \ud55c\uad6d \uc5d0\ubc84\ud30c\uc6cc\uc5d0 \ubb38\uc758\ud558\uc2ed\uc2dc\uc624.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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2. GMP \uad6c\uc5ed \ubd84\ub958 \ubc0f \ubaa8\ud130 \uc0ac\uc591<\/h2>\n
\n\n\n\n\n\n\n\n\n\n
GMP \ub4f1\uae09<\/th>\n\uc81c\ud488 \uc601\uc5ed<\/th>\n\ubaa8\ud130 \uc7ac\ub8cc \uc694\uad6c \uc0ac\ud56d<\/th>\nBXG\uc5d0 \uc801\ud569\ud569\ub2c8\uae4c?<\/th>\n<\/tr>\n<\/thead>\n
A\ub4f1\uae09<\/td>\n\ubb34\uade0 \ucda9\uc804, \ubc14\uc774\uc54c \ub9c8\uac1c \ub2eb\uae30, \uac1c\ubd09 \uc6a9\uae30 \uc704\ud5d8<\/td>\nSIP\/CIP \ud638\ud658, SS316L \uc7ac\uc9c8, \uc77c\ubd80 \uc801\uc6a9 \ubd84\uc57c\uc5d0\uc11c Ra \u2264 0.4 \u03bcm<\/td>\n\ucf54\ub9ac\uc544 \uc5d0\ubc84\ud30c\uc6cc\uc5d0 \ubb38\uc758\ud558\uc138\uc694<\/td>\n<\/tr>\n
B\ub4f1\uae09<\/td>\nA\ub4f1\uae09\uc6a9 \ubc30\uacbd \uc601\uc5ed; \ubc14\uc774\uc54c \uc138\ucc99, \uad6c\uc131 \uc694\uc18c \uc900\ube44<\/td>\nSS316L, Ra \u2264 0.8 \u03bcm, CIP \ud638\ud658, \ud0c8\uc0c9 \uc5c6\uc74c<\/td>\n\uc608 \u2014 BXG \ud45c\uc900<\/td>\n<\/tr>\n
C\ub4f1\uae09<\/td>\n\ub300\ub7c9 \ucda9\uc804, \uacfc\ub9bd\ud654, \uc815\uc81c \uc555\ucd95, \ucf54\ud305<\/td>\nSS316L \ub610\ub294 \ub3d9\ub4f1 \uc7ac\uc9c8, \uc138\ucc99 \uac00\ub2a5\ud558\uace0 \ubd80\uc2dd\ub418\uc9c0 \uc54a\uc74c<\/td>\n\uc608 \u2014 BXG \ud45c\uc900<\/td>\n<\/tr>\n
D\ub4f1\uae09<\/td>\n\uc77c\ubc18 \uc81c\uc870 \uc9c0\uc6d0, \ubd80\ud488 \uad00\ub9ac<\/td>\n\ub9e4\ub044\ub7fd\uace0 \uc138\ucc99\uc774 \uc6a9\uc774\ud558\uba70 \ubd80\uc2dd\uc5d0 \uac15\ud569\ub2c8\ub2e4. SS316L \uc7ac\uc9c8\uc744 \uad8c\uc7a5\ud569\ub2c8\ub2e4.<\/td>\n\uc608 \u2014 BXG \ud45c\uc900<\/td>\n<\/tr>\n
\ube44GMP<\/td>\n\ucc3d\uace0, \uacf5\uacf5\uc2dc\uc124, \ube44\ubd84\ub958 \uad6c\uc5ed<\/td>\n\ud45c\uc900 Y2 \ubaa8\ud130 \uc0ac\uc6a9 \uac00\ub2a5<\/td>\nY2 \ud45c\uc900 \ubaa8\ud130<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n

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3. \uc81c\uc57d WIP \ubc0f CIP \uc138\ucc99\uc81c<\/h2>\n

\uc81c\uc57d \uc81c\uc870 \uc124\ube44\ub294 \uac80\uc99d\ub41c \uc138\ucc99 \uc808\ucc28\ub97c \uc0ac\uc6a9\ud558\uc5ec \uc138\ucc99\ub418\uba70, \uc5ec\uae30\uc5d0\ub294 \uc2a4\ud504\ub808\uc774 \ud5e4\ub4dc \ub610\ub294 \uc218\ub3d9 \uc138\ucc99\uc744 \uc774\uc6a9\ud55c \ud604\uc7a5 \uc138\ucc99(WIP)\uacfc \uc5f0\uacb0\ub41c \uacf5\uc815 \uc124\ube44\uc5d0 \ub300\ud55c \ud604\uc7a5 \uc138\ucc99(CIP)\uc774 \ud3ec\ud568\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc81c\uc57d GMP\uc5d0\uc11c \uc0ac\uc6a9\ub418\ub294 \uc138\ucc99\uc81c\ub294 \uc2dd\ud488 \uc0b0\uc5c5\uc758 CIP\uc640 \ub2ec\ub9ac \uc218\uc131 \uc138\ucc99\uc81c \uc678\uc5d0\ub3c4 \uc720\uae30 \uc6a9\ub9e4 \ub9b0\uc2a4, \ud2b9\uc218 \uc138\uc81c \ubc0f \uc0b4\uade0 \uc6a9\uc561\uc744 \ud3ec\ud568\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

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\n
\uc218\uc131 \uc138\ucc99(C\/D \ub4f1\uae09)<\/div>\n

\ud45c\uc900 \uc81c\uc57d GMP \uc138\ucc99\uc5d0\uc11c\ub294 \uc815\uc81c\uc218(PW) \ub610\ub294 \uc8fc\uc0ac\uc6a9\uc218(WFI)\ub97c \uc6a9\ub9e4\ub85c \uc0ac\uc6a9\ud558\uace0 \uc54c\uce7c\ub9ac\uc131 \uc138\uc81c(NaOH 0.5~2%, pH 11~13)\uc640 \uc0b0\uc131 \ud5f9\uad7c\uc561(\uc778\uc0b0 \ub610\ub294 \uad6c\uc5f0\uc0b0 0.5~1%)\uc744 \uc0ac\uc6a9\ud569\ub2c8\ub2e4. BXG SS316L\uc740 \uc774\ub7ec\ud55c \uc138\ucc99\uc81c\uc5d0 \uc644\ubcbd\ud558\uac8c \ub0b4\uc131\uc744 \uac16\uc2b5\ub2c8\ub2e4. \ubaa8\ud130 \uc138\ucc99\uc740 PW\/WFI\ub97c \uc801\uc2e0 \uae68\ub057\ud55c \ucc9c\uc73c\ub85c \uc190\uc73c\ub85c \ub2e6\uac70\ub098 \ubd84\ubb34\ud558\uc5ec \uc218\ud589\ud558\uba70, IP69K \uc778\uc99d\uc740 \uace0\uc555 \ubd84\ubb34 \uc138\ucc99\uc5d0 \ub300\ud55c \ub0b4\uc131\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

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\uc54c\ucf54\uc62c \uc18c\ub3c5 (B\/C \ub4f1\uae09)<\/div>\n

\uc81c\uc57d \ud074\ub9b0\ub8f8\uc5d0\uc11c\ub294 \uc0dd\uc0b0 \ubc30\uce58 \uac04 \ud45c\uba74 \uc18c\ub3c5\uc744 \uc704\ud574 70% \uc774\uc18c\ud504\ub85c\ud544 \uc54c\ucf54\uc62c(IPA) \ub610\ub294 70% \uc5d0\ud0c4\uc62c \uc2a4\ud504\ub808\uc774\ub97c \uc0ac\uc6a9\ud569\ub2c8\ub2e4. BXG SS316L \ubaa8\ud130 \ud45c\uba74\uc740 \uc774\ub7ec\ud55c \ub18d\ub3c4\uc758 IPA \ubc0f \uc5d0\ud0c4\uc62c\uc5d0 \ub300\ud574 \uc644\ubcbd\ud55c \ub0b4\uc131\uc744 \uac16\uc2b5\ub2c8\ub2e4. FDA \uc2b9\uc778 \uc2e4\ub9ac\ucf58 \uc0e4\ud504\ud2b8 \uc530\uacfc NSF H1 \uc778\uc99d \ubca0\uc5b4\ub9c1 \uadf8\ub9ac\uc2a4 \ub610\ud55c \uc81c\uc57d \uc6a9\ub3c4 \ub18d\ub3c4\uc758 \uc54c\ucf54\uc62c \uc18c\ub3c5\uc5d0 \uc801\ud569\ud569\ub2c8\ub2e4. IPA \uc2a4\ud504\ub808\uc774 \uc18c\ub3c5\uc740 BXG IP69K \ub4f1\uae09\uc758 \uc548\uc804\uc131\uc744 \uc800\ud574\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n
VHP \uba78\uade0 \ucc98\ub9ac(A\/B \ub4f1\uae09)<\/div>\n

150~750ppm H\u2082O\u2082 \ub18d\ub3c4\uc758 \uae30\ud654 \uacfc\uc0b0\ud654\uc218\uc18c(VHP)\ub294 A\/B \ub4f1\uae09 \ud074\ub9b0\ub8f8\uc758 \uc720\uc9c0\ubcf4\uc218 \ub610\ub294 \uc81c\ud488 \uad50\uccb4 \ud6c4 \uc81c\uc5fc \uacfc\uc815\uc5d0 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. VHP\ub294 \uc81c\uc57d \uba78\uade0 \ub18d\ub3c4\uc5d0\uc11c SS316L \ubc0f \ubaa8\ub4e0 BXG \uc530 \ubc0f \uadf8\ub9ac\uc2a4 \uc7ac\uc9c8\uacfc \ud638\ud658\ub429\ub2c8\ub2e4. VHP \ub178\ucd9c\uc774 \ud544\uc694\ud55c A\/B \ub4f1\uae09 \ubaa8\ud130\uc758 \uacbd\uc6b0, \ubaa8\ud130 \uad00\ub828 \ubb38\uc11c \ubc0f \uc7ac\uc9c8 \uc778\uc99d\uc11c\ub97c \ud55c\uad6d \uc5d0\ubc84\ud30c\uc6cc\uc5d0 \ud655\uc778\ud558\uc2ed\uc2dc\uc624.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

4. GMP \ud45c\uba74, \ud2c8\uc0c8 \ubc0f \ubc30\uc218\uad6c \uc124\uacc4 \uc694\uad6c\uc0ac\ud56d<\/h2>\n
\n
\n
Ra \u2264 0.8 \u03bcm \u2014 \ubbf8\uc0dd\ubb3c \uc81c\uc5b4<\/div>\n

EU GMP \ubc0f FDA \uc9c0\uce68 \ubaa8\ub450 \ud6a8\uacfc\uc801\uc778 \uc138\ucc99\uc131\uc744 \uc704\ud55c \uae30\uc900\uc73c\ub85c EHEDG \ud45c\uba74 \uac70\uce60\uae30 \ud45c\uc900\uc778 Ra \u2264 0.8 \u03bcm\ub97c \ucc38\uc870\ud569\ub2c8\ub2e4. \uc774 \uac70\uce60\uae30 \uc774\ud558\uc5d0\uc11c\ub294 \uc138\uade0 \ubd80\ucc29 \ubc0f \ubc14\uc774\uc624\ud544\ub984 \ud615\uc131\uc774 \ud604\uc800\ud788 \uac10\uc18c\ud558\uba70, \uc77c\ubc18 \uc138\uc81c\ub97c \uc0ac\uc6a9\ud55c \ud45c\uba74 \uc138\ucc99\ub9cc\uc73c\ub85c\ub3c4 \uc81c\uc57d GMP\uc5d0 \ud544\uc694\ud55c \ubbf8\uc0dd\ubb3c \uac10\uc18c\ub97c \ub2ec\uc131\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. BXG \ubaa8\ud130\ub294 \ucd9c\uace0 \uc2dc \ubaa8\ub4e0 \uc678\ubd80 \ud45c\uba74\uc774 Ra \u2264 0.8 \u03bcm\ub85c \ub9c8\uac10 \ucc98\ub9ac\ub418\uc5c8\uc73c\uba70, SS316L \uc7ac\uc9c8\uc740 \uc77c\ubc18\uc801\uc778 GMP \uc138\ucc99 \uc8fc\uae30 \ub3d9\uc548 \uac70\uce60\uc5b4\uc9c0\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. IQ \ub2e8\uacc4\uc5d0\uc11c \ud45c\uba74 \ub9c8\uac10\uc744 \ud655\uc778\ud558\uace0, \ud604\uc7a5 \ubcc0\uacbd \uad00\ub9ac \uc808\ucc28\uc5d0 \ub530\ub77c \uc8fc\uae30\uc801\uc778 \uc7ac\uc778\uc99d \uae30\uac04\ub9c8\ub2e4 \uc7ac\ud655\uc778\ud558\uc2ed\uc2dc\uc624.<\/p>\n<\/div>\n

\n
\ub2e4\ub9ac\uac00 \ub9c9\ud788\uac70\ub098, \ud2c8\uc0c8\uac00 \uc788\uac70\ub098, \uc218\ud3c9\uc73c\ub85c \ud280\uc5b4\ub098\uc628 \ubd80\ubd84\uc774 \uc5c6\uc2b5\ub2c8\ub2e4.<\/div>\n

GMP(\uc6b0\uc218 \uc81c\uc870 \uae30\uc900)\ub294 \uc81c\ud488, \uc138\ucc99\uc561 \ub610\ub294 \ubbf8\uc0dd\ubb3c \uc624\uc5fc \ubb3c\uc9c8\uc774 \uc138\ucc99 \uc808\ucc28\ub85c \uc81c\uac70\ub418\uc9c0 \uc54a\uace0 \ucd95\uc801\ub420 \uc218 \uc788\ub294 \ubaa8\ud130 \ud45c\uba74\uc758 \uc601\uc5ed\uc744 \uc81c\uac70\ud558\ub3c4\ub85d \uc694\uad6c\ud569\ub2c8\ub2e4. BXG \ud504\ub808\uc784\uc740 \uc790\uc720\ub85c\uc6b4 \ubc30\uc218\ub97c \uc704\ud55c \uacbd\uc0ac\uc9c4 \ub0c9\uac01 \ud540, \ubcfc\ub85d\ud55c \ub2e8\uc790\ud568 \ub36e\uac1c(\ud3c9\ud3c9\ud55c \uc218\ud3c9\uba74 \uc5c6\uc74c), \uae30\uacc4\uc801\uc73c\ub85c \uc811\ud569\ub41c \ud328\ub110 \ub300\uc2e0 \ub9e4\ub044\ub7ec\uc6b4 \uc6a9\uc811 \uad6c\uc870, \uadf8\ub9ac\uace0 \uc785\uc790 \ud3ec\uc9d1 \uc9c0\uc810\uc744 \ub9cc\ub4dc\ub294 \uc2ed\uc790\ud615 \ub610\ub294 \uc721\uac01 \uc18c\ucf13 \ud328\uc2a4\ub108 \ub300\uc2e0 \ub9e4\ub044\ub7ec\uc6b4 \uc18c\ucf13 \ucea1 \ud328\uc2a4\ub108\ub85c \uc124\uacc4\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc124\uacc4 \ud2b9\uc9d5\uc740 GMP \uc7a5\ube44 \uc778\uc99d\uc5d0 \ud3ec\ud568\ub418\ub3c4\ub85d BXG \uae30\uc220 \ud30c\uc77c\uc5d0 \ubb38\uc11c\ud654\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

5. GMP \uc2dc\uc124\uc5d0\uc11c\uc758 BXG\uc5d0 \ub300\ud55c IQ\/OQ\/PQ \uc801\uaca9\uc131 \ud3c9\uac00 \ubb38\uc11c<\/h2>\n

FDA 21 CFR Part 211 \ubc0f EU GMP\ub294 \uc758\uc57d\ud488 \uc81c\uc870\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc7a5\ube44\uac00 \uc0dd\uc0b0\uc5d0 \uc0ac\uc6a9\ud558\uae30 \uc804\uc5d0 \uc801\uaca9\uc131 \ud3c9\uac00\ub97c \uac70\uccd0\uc57c \ud55c\ub2e4\uace0 \uaddc\uc815\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ubaa8\ud130\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc7a5\ube44 \uc2dc\uc2a4\ud15c \uc801\uaca9\uc131 \ud3c9\uac00(\ubaa8\ud130\uac00 \ud3ec\ud568\ub41c \uacfc\ub9bd\uae30, \ucf54\ud305\uae30 \ub610\ub294 \ucee8\ubca0\uc774\uc5b4)\uc758 \uc77c\ubd80\ub85c \uc801\uaca9\uc131 \ud3c9\uac00\ub97c \ubc1b\uc9c0\ub9cc, \ucd5c\uc18c\ud55c \uc124\uce58 \uc801\uaca9\uc131 \ud3c9\uac00(IQ)\ub97c \ub4b7\ubc1b\uce68\ud560 \uc218 \uc788\ub3c4\ub85d \ubaa8\ud130 \uad00\ub828 \ubb38\uc11c \ud328\ud0a4\uc9c0\uac00 \uc81c\uacf5\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

\n
\n
IQ \ubb38\uc11c\ud654<\/div>\n

\ubaa8\ud130 \ubaa8\ub378 \ubc0f \uc77c\ub828\ubc88\ud638; \uc81c\uc870\uc0ac \uc801\ud569\uc131 \uc778\uc99d\uc11c; SS316L \ud504\ub808\uc784 \uc7ac\uc9c8 \uc778\uc99d\uc11c(EN 10204 Type 3.1 \uc7ac\uc9c8 \uc2dc\ud5d8 \uc778\uc99d\uc11c); \ud45c\uba74 \uc870\ub3c4 \uce21\uc815 \ubcf4\uace0\uc11c(Ra \u2264 0.8 \u03bcm); IP69K \uc2dc\ud5d8 \uc778\uc99d\uc11c; \uc530 \ubc0f \uadf8\ub9ac\uc2a4\uc5d0 \ub300\ud55c FDA 21 CFR \uc7ac\uc9c8 \uc900\uc218 \uc9c4\uc220\uc11c; \ubca0\uc5b4\ub9c1 \uadf8\ub9ac\uc2a4\uc5d0 \ub300\ud55c NSF H1 \uc778\uc99d\uc11c.<\/p>\n<\/div>\n

\n
OQ \ubb38\uc11c<\/div>\n

\uc124\uce58 \uc2dc \ubaa8\ud130 \uc815\uaca9 \uc18d\ub3c4, \ud1a0\ud06c \ubc0f \ucd9c\ub825; \uc2dc\uc6b4\uc804 \uc2dc \uc9c4\ub3d9 \ud2b9\uc131; \ubaa8\ud130 \ubcf4\ud638 \uacc4\uc804\uae30 \uc124\uc815 \uae30\ub85d; \ud2b9\uc815 \uc704\uce58\uc5d0 \uc124\uce58\ub41c \ubaa8\ud130\uc5d0 \ub300\ud55c \uc138\ucc99 \uc808\ucc28 \uc801\uaca9\uc131 \ud3c9\uac00; \uc138\ucc99\uc81c \ud638\ud658\uc131 \ud655\uc778; \ucd5c\ucd08 \uc124\uce58 \ud6c4 \uac80\uc0ac \uae30\ub85d.<\/p>\n<\/div>\n

\n
PQ \ubc0f \uc7ac\uc790\uaca9<\/div>\n

PQ\ub294 \uc0c1\uc6a9 \uc0dd\uc0b0 \uacfc\uc815\uc5d0\uc11c \uc0dd\uc0b0 \uc124\ube44\uc758 \uc77c\ubd80\ub85c\uc11c \ubaa8\ud130\uac00 \uc815\uc0c1\uc801\uc73c\ub85c \uc791\ub3d9\ud558\ub294\uc9c0 \ud655\uc778\ud558\ub294 \uc808\ucc28\uc785\ub2c8\ub2e4. \uc7ac\uac80\uc99d\uc740 \ubaa8\ud130 \uad50\uccb4, \ubaa8\ud130 \uc218\ub9ac, \uc138\ucc99\uc81c \ubcc0\uacbd \ub610\ub294 \uc124\ube44 \uc7ac\uad6c\uc131 \ub4f1\uc758 \ubcc0\uacbd \uad00\ub9ac \uc774\ubca4\ud2b8 \ubc1c\uc0dd \uc2dc \uc9c4\ud589\ub429\ub2c8\ub2e4. \ud55c\uad6d \uc5d0\ubc84\ud30c\uc6cc\ub294 \uc81c\uc57d \uace0\uac1d\uc0ac\uc5d0\uac8c \ubaa8\ub4e0 BXG \uc8fc\ubb38 \uc2dc \ud544\uc694\ud55c IQ \ubb38\uc11c\ub97c \ud568\uaed8 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n

\n

\ud55c\uad6d\uc758 \uc5d0\ubc84\ud30c\uc6cc\ub294 \uc81c\uc57d GMP \uc560\ud50c\ub9ac\ucf00\uc774\uc158\uc6a9 BXG \ubaa8\ud130\ub97c \uacf5\uae09\ud558\uba70, \uc81c\uc870\uc0ac \uc801\ud569\uc131 \uc120\uc5b8\uc11c, \uc7ac\ub8cc \uc2dc\ud5d8 \uc131\uc801\uc11c(EN 10204 3.1), \ud45c\uba74 \uc870\ub3c4 \uc2dc\ud5d8 \ubcf4\uace0\uc11c, IP69K \uc778\uc99d\uc11c, FDA 21 CFR \uc900\uc218 \uba85\uc138\uc11c, NSF H1 \uc724\ud65c\uc720 \uc778\uc99d\uc11c, \ubcc0\uacbd \ud1b5\uc9c0 \uc808\ucc28 \ub4f1 \ud3ec\uad04\uc801\uc778 \ubb38\uc11c \ud328\ud0a4\uc9c0\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc774 \ubb38\uc11c \ud328\ud0a4\uc9c0\ub294 \uc81c\uc57d \ud68c\uc0ac\uac00 \ucd94\uac00 \uc2dc\ud5d8 \uc5c6\uc774 \uc7a5\ube44 \uac80\uc99d\uc758 IQ \ub2e8\uacc4\ub97c \uc644\ub8cc\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n

<\/p>\n

\n

6. \ud55c\uad6d\uc758 Ever-Power BXG, \uc81c\uc57d GMP \ucd94\uc9c4 \uc194\ub8e8\uc158<\/h2>\n
\n
\n

\ud55c\uad6d \uc5d0\ubc84\ud30c\uc6cc BXG \uc2dc\ub9ac\uc988\ub294 GMP B, C, D \ub4f1\uae09 \uc81c\uc57d \uc81c\uc870 \uc2dc\uc124\uc5d0 \ud544\uc694\ud55c \ubaa8\ub4e0 \ubaa8\ud130 \uc0ac\uc591\uc744 \uac16\ucd94\uace0 \uc788\uc2b5\ub2c8\ub2e4. IP69K \ubc29\uc218 \ub4f1\uae09\uacfc SS316L \ub0b4\uc0b0\/\ub0b4\uc54c\uce7c\ub9ac\uc131 \uad6c\uc870, Ra \u2264 0.8 \u03bcm\uc758 \uc704\uc0dd\uc801\uc778 \u200b\u200b\ud45c\uba74 \ub9c8\uac10, FDA \uc778\uc99d \uc2e4\ub9ac\ucf58 \uc0e4\ud504\ud2b8 \uc530, NSF H1 \uc81c\uc57d \ub4f1\uae09 \ubca0\uc5b4\ub9c1 \uadf8\ub9ac\uc2a4, \uadf8\ub9ac\uace0 H\uae09 \uc808\uc5f0\uc744 \uc801\uc6a9\ud588\uc2b5\ub2c8\ub2e4. BXG \uae30\uc220 \uc790\ub8cc\uc5d0\ub294 \uc81c\uc57d \uc7a5\ube44 IQ\uc5d0 \ud544\uc694\ud55c \ubaa8\ub4e0 \ubb38\uc11c\uac00 \ud3ec\ud568\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. \uc804\uccb4 \uc81c\ud488\uad70\uc740 \ub2e4\uc74c\uc5d0\uc11c \ud655\uc778\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc2a4\ud14c\uc778\ub9ac\uc2a4\uac15 \ubaa8\ud130 \uc81c\ud488 \uc139\uc158<\/a>A\/B \ub4f1\uae09 \ubb34\uade0 \uc81c\uc870 \ud658\uacbd \uc0ac\uc591 \ub610\ub294 \uc758\uc57d\ud488 \uac80\uc99d \uc9c0\uc6d0\uc5d0 \ub300\ud574\uc11c\ub294 \ub2e4\uc74c \uc5f0\ub77d\ucc98\ub85c \ubb38\uc758\ud558\uc2ed\uc2dc\uc624. \ud55c\uad6d \uc5d0\ubc84\ud30c\uc6cc \uae30\uc220\ud300<\/a>.<\/p>\n<\/div>\n

\n
\n
BXG \u2014 \uc81c\uc57d GMP \ub370\uc774\ud130<\/div>\n\n\n\n\n\n\n\n\n\n\n
\ud504\ub808\uc784 \uc18c\uc7ac<\/td>\nAISI 316L \uc678\ubd80 \ubd80\ud488<\/td>\n<\/tr>\n
\ud45c\uba74 \ub9c8\uac10<\/td>\nRa \u2264 0.8 \u03bcm (\uc778\uc99d\ub428)<\/td>\n<\/tr>\n
IP \ub4f1\uae09<\/td>\nIP69K<\/td>\n<\/tr>\n
\uc0e4\ud504\ud2b8 \uc530<\/td>\nFDA 21 CFR 177.2600 \uc2e4\ub9ac\ucf58<\/td>\n<\/tr>\n
\uc720\uc9c0<\/td>\nNSF H1 \uc758\uc57d\ud488 \ub4f1\uae09<\/td>\n<\/tr>\n
\uaca9\ub9ac<\/td>\nH\uae09<\/td>\n<\/tr>\n
\uc804\ub825 \ubc94\uc704<\/td>\n0.18~11kW<\/td>\n<\/tr>\n
IQ \ubb38\uc11c<\/td>\n\uae30\ubcf8 \uad6c\uc131\ud488\uc740 \ubaa8\ub450 \ud3ec\ud568\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

7. \uc81c\uc57d GMP \uc81c\uc870 \uc751\uc6a9 \ubd84\uc57c<\/h2>\n\n\n\n
\"\uc2a4\ud14c\uc778\ub9ac\uc2a4\uac15<\/p>\n
\n
\uc815\uc81c \uacfc\ub9bd\uae30 \ubc0f \uc815\uc81c \ud504\ub808\uc2a4<\/div>\n

C\ub4f1\uae09 \uc815\uc81c \uc81c\uc870 \uad6c\uc5ed\uc5d0\ub294 \uace0\uc804\ub2e8 \uc2b5\uc2dd \uacfc\ub9bd\uae30 \ubc0f \ub864\ub7ec \uc555\ucd95 \uacfc\ub9bd\uae30\uac00 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. BXG 1.1~5.5kW 4\uadf9 \ubaa8\ud130\uac00 \ubc00\ud3d0\ud615 \uae30\uc5b4\ubc15\uc2a4\ub97c \ud1b5\ud574 \uc784\ud3a0\ub7ec\uc640 \ubd84\uc1c4\uae30 \uc0e4\ud504\ud2b8\ub97c \uad6c\ub3d9\ud569\ub2c8\ub2e4. C\ub4f1\uae09 \uacfc\ub9bd\uc2e4\uc5d0\uc11c\ub294 \ubaa8\ub4e0 \ub178\ucd9c\ub41c \ubaa8\ud130 \ud45c\uba74\uc774 SS316L \uc7ac\uc9c8\uc774\uc5b4\uc57c \ud558\uba70, IPA \ubc0f \uc218\uc131 \uc138\ucc99\uc81c\ub85c \uc138\ucc99 \uac00\ub2a5\ud558\uace0 \uc218\ud3c9 \ub2e8\ucc28\uac00 \uc5c6\uc5b4\uc57c \ud569\ub2c8\ub2e4. C\ub4f1\uae09 \uc0dd\uc0b0\uc2e4\uc758 \uc815\uc81c \ud504\ub808\uc2a4 \uad6c\ub3d9 \ubaa8\ud130\ub294 \ud130\ub9bf \uc778\ub371\uc2f1 \ubc0f \ud504\ub808\uc2a4 \uc555\ub825 \uad6c\ub3d9\uc6a9\uc73c\ub85c BXG 0.75~2.2kW\ub97c \uc0ac\uc6a9\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/td>\n

\"\uc2a4\ud14c\uc778\ub9ac\uc2a4<\/p>\n
\n
\uc81c\uc57d \ucee8\ubca0\uc774\uc5b4 \ubc0f \uc774\uc1a1 \uc2dc\uc2a4\ud15c<\/div>\n

C\ub4f1\uae09 \ubc0f D\ub4f1\uae09 \uc81c\uc57d \uc81c\uc870 \uad6c\uc5ed\uc5d0\uc11c \uc6d0\ub8cc \uc758\uc57d\ud488, \uc644\uc81c\ud488 \ud63c\ud569\ubb3c, \ucda9\uc804\ub41c 1\ucc28 \uc6a9\uae30\ub97c \uacf5\uc815 \ub2e8\uacc4 \uac04\uc5d0 \uc774\uc1a1\ud558\ub294 \ucee8\ubca0\uc774\uc5b4 \uc2dc\uc2a4\ud15c. \ucee8\ubca0\uc774\uc5b4 \uc139\uc158 \uad6c\ub3d9\uc5d0\ub294 BXG 0.18~1.5kW 4\uadf9 \ubaa8\ud130\uac00 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. GMP \uad6c\uc5ed \ub0b4 \ubaa8\ub4e0 \ubaa8\ud130 \ud45c\uba74\uc740 Ra \u2264 0.8\u03bcm\uc778 SS316L \uc7ac\uc9c8\uc774\uc5b4\uc57c \ud569\ub2c8\ub2e4. \ucee8\ubca0\uc774\uc5b4 \ubaa8\ud130 \uc138\ucc99\uc740 \ucee8\ubca0\uc774\uc5b4 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uac80\uc99d\ub41c \uc138\ucc99 \uc808\ucc28\uc5d0 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\n
\n
\ucf54\ud305 \ud32c \ub4dc\ub77c\uc774\ube0c<\/div>\n

C\ub4f1\uae09\uc2e4\uc758 \uc815\uc81c \ucf54\ud305 \ud32c\uc740 \uc815\uc81c\uce35 \ud140\ube14\ub9c1\uc744 \uc704\ud574 3~25rpm\uc73c\ub85c \ud68c\uc804\ud569\ub2c8\ub2e4. BXG 0.75~2.2kW 4\uadf9 \ubaa8\ud130\uc640 40:1~100:1\uc758 NMRV \uae30\uc5b4\ubc15\uc2a4\uac00 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. \ud32c \ub0b4\ubd80\ub294 \uc758\uc57d\ud488\uacfc \uc9c1\uc811 \uc811\ucd09\ud569\ub2c8\ub2e4. \ud32c \uc678\ubd80\uc5d0 \uc788\ub294 BXG \ubaa8\ud130\ub294 \ud32c \ub0b4\ubd80 \uc138\ucc99\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ub3d9\uc77c\ud55c \uc138\ucc99\uc81c\ub85c \uc138\ucc99 \uac00\ub2a5\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n
\uc0dd\ubb3c\ubc18\uc751\uae30 \uad50\ubc18\uae30 \uad6c\ub3d9 \uc7a5\uce58<\/div>\n

C\ub4f1\uae09 \uc0dd\ubb3c\ud559\uc801 \uc81c\uc870 \uc2dc\uc124\uc758 \uc0dd\ubb3c\ubc18\uc751\uae30 \ubc0f \ubc1c\ud6a8 \uc6a9\uae30\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc678\ubd80 \uad50\ubc18\uae30 \uad6c\ub3d9 \ubaa8\ud130\ub294 BXG\uc0ac\uc758 0.37~2.2kW, 20:1~60:1 NMRV \uae30\uc5b4 \ubaa8\ud130\uc785\ub2c8\ub2e4. \ubaa8\ud130\ub294 \uc6a9\uae30 \uc678\ubd80\uc5d0 \uc124\uce58\ub418\uc9c0\ub9cc C\ub4f1\uae09 \uae30\uc900 \ub0b4\uc5d0 \uc788\uc73c\uba70, \uc77c\ubc18\uc801\uc73c\ub85c IPA\ub97c \uc774\uc6a9\ud55c \uc77c\uc77c \uc138\ucc99\uacfc \uac00\uc131\uc18c\ub2e4 \uc6a9\uc561\uc744 \uc774\uc6a9\ud55c \uc8fc\uac04 \uc138\ucc99\uc774 \uc774\ub8e8\uc5b4\uc9d1\ub2c8\ub2e4. BXG\uc0ac\uc758 SS316L \ubc0f FDA \uc778\uc99d \uc2e4\ub9ac\ucf58 \uc530\uc740 \uc774\ub7ec\ud55c \uc138\ucc99 \ud658\uacbd\uc5d0\uc11c\ub3c4 \uc131\ub2a5 \uc800\ud558 \uc5c6\uc774 \uacac\ub51c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n
\ub3d9\uacb0\uac74\uc870\uae30 \ub85c\ub529 \uc2dc\uc2a4\ud15c<\/div>\n

A\ub4f1\uae09 \ubb34\uade0 \ucda9\uc804 \uad6c\uc5ed\uc5d0 \uc778\uc811\ud55c B\ub4f1\uae09 \uad6c\uc5ed\uc5d0 \uc124\uce58\ub418\ub294 \ub3d9\uacb0\uac74\uc870\uae30(\ub3d9\uacb0\uac74\uc870\uae30)\uc6a9 \uc790\ub3d9 \ubc14\uc774\uc54c \uc801\uc7ac \ubc0f \ud558\uc5ed \uc2dc\uc2a4\ud15c. \ubc14\uc774\uc54c \uc774\uc1a1 \ucee8\ubca0\uc774\uc5b4 \uad6c\ub3d9\uc5d0\ub294 BXG 0.18~0.75kW \uc81c\ud488\uc774 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. \ub3d9\uacb0\uac74\uc870\uae30 \uc801\uc7ac \uad6c\uc5ed\uc740 \uc801\uc7ac \uc791\uc5c5 \uc911\uc5d0\ub294 B\ub4f1\uae09\uc73c\ub85c \uc720\uc9c0\ub418\uba70, BXG VHP \uc81c\ud488\uc740 GMP \uc81c\uc5fc \uc8fc\uae30 \ub3d9\uc548 \uc0ac\uc6a9 \uac00\ub2a5\ud55c \uac83\uc73c\ub85c \ud655\uc778\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n

\n
WFI \ub8e8\ud504 \ud38c\ud504<\/div>\n

\uc81c\uc57d\uc6a9\uc218 \uc2dc\uc2a4\ud15c\uc758 \uc8fc\uc0ac\uc6a9\uc218(WFI) \ubd84\ubc30 \ub8e8\ud504 \ud38c\ud504 \uad6c\ub3d9 \uc7a5\uce58\uc785\ub2c8\ub2e4. \ubaa8\ud130\ub294 \uc77c\ubc18\uc801\uc73c\ub85c GMP\uc2e4 \uc678\ubd80\uc758 \uc124\ube44 \uacf5\uac04\uc5d0 \uc124\uce58\ub418\uc9c0\ub9cc, \uc720\uc9c0\ubcf4\uc218 \uc911 WFI \ubd84\ubb34\uc5d0 \ub178\ucd9c\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. BXG 0.75~3.0kW, 2\uadf9 \ubaa8\ud130\ub294 \uace0\uc21c\ub3c4 \uc6a9\uc218 \ubc0f \ud38c\ud504\uc2e4\uc758 \uc2a4\ud300 \uc138\ucc99\uc5d0 \ub300\ud55c \ub0b4\uc2dd\uc131\uc774 \uc694\uad6c\ub418\ub294 WFI \ud38c\ud504 \uad6c\ub3d9 \uc7a5\uce58\uc5d0 \uc801\ud569\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n
\n

\"\ud55c\uad6d<\/p>\n

GMP \ubaa8\ud130 \uc0dd\uc0b0<\/div>\n<\/div>\n
\n

\"\ud55c\uad6d<\/p>\n

Ra \uce21\uc815<\/div>\n<\/div>\n
\n

\"\ud55c\uad6d<\/p>\n

CE \ubc0f ISO<\/div>\n<\/div>\n
\n

\"\ud55c\uad6d<\/p>\n

\uc218\ucd9c \ud3ec\uc7a5<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

8. \uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38<\/h2>\n
\n
\n
\n
BXG \ubaa8\ud130\ub97c \ub3d9\uc77c \ubaa8\ub378 \ubc88\ud638\uc758 \uc0c8 BXG \ubaa8\ud130\ub85c \uad50\uccb4\ud560 \uacbd\uc6b0 \uc7ac\uc778\uc99d\uc744 \ubc1b\uc544\uc57c \ud569\ub2c8\uae4c?<\/div>\n<\/div>\n
\n

\uc778\uc99d\ub41c \uc81c\uc57d \uc7a5\ube44\uc758 \ubaa8\ud130 \uad50\uccb4\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \ucd5c\uc18c\ud55c IQ \uc7ac\uac80\uc99d(\uc0c8 \ubaa8\ud130\uac00 \uae30\uc874 \uc778\uc99d \ubaa8\ud130\uc640 \ub3d9\uc77c\ud55c \uc0ac\uc591\uc744 \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778) \ubc0f OQ \uc7ac\uac80\uc99d(\uc0c8 \ubaa8\ud130 \uc124\uce58 \ud6c4 \uc7a5\ube44\uac00 \uc0ac\uc591\ub300\ub85c \uc791\ub3d9\ud558\ub294\uc9c0 \ud655\uc778)\uc774 \ud544\uc694\ud55c \ubcc0\uacbd \uad00\ub9ac \uc774\ubca4\ud2b8\uc785\ub2c8\ub2e4. \uad50\uccb4 \ubaa8\ud130\uac00 \ub3d9\uc77c\ud55c BXG \ubaa8\ub378 \ubc0f \uc815\uaca9 \ucd9c\ub825, \uadf8\ub9ac\uace0 \ub3d9\ub4f1\ud55c \ubb38\uc11c \ud328\ud0a4\uc9c0\ub97c \uac16\ucd98 \uacbd\uc6b0, \uc804\uccb4 \uc7ac\uc778\uc99d \uc808\ucc28 \uc5c6\uc774 IQ \uac80\uc99d \ubc0f \uac04\ub2e8\ud55c OQ \uae30\ub2a5 \ud14c\uc2a4\ud2b8\ub9cc\uc73c\ub85c \uad50\uccb4\uac00 \uac00\ub2a5\ud55c \ub3d9\uc885 \uad50\uccb4\ub85c \ubd84\ub958\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc778\uc99d\ub41c \uc81c\uc57d \uc7a5\ube44\uc758 \ubaa8\ud130\ub97c \uad50\uccb4\ud558\uae30 \uc804\uc5d0 \ud574\ub2f9 \uc0ac\uc5c5\uc7a5\uc758 \ubcc0\uacbd \uad00\ub9ac \uc808\ucc28\ub97c \ud655\uc778\ud558\uace0 \ud488\uc9c8 \uad00\ub9ac\ud300\uacfc \ud611\uc758\ud558\uc2ed\uc2dc\uc624. \ucf54\ub9ac\uc544 \uc5d0\ubc84\ud30c\uc6cc\ub294 \uad50\uccb4 BXG \ubaa8\ud130\uac00 \uae30\uc874 \uc778\uc99d \ubaa8\ud130\uc640 \ub3d9\uc77c\ud55c \uc0ac\uc591 \ubc0f \uc7ac\uc9c8\uc784\uc744 \ud655\uc778\ud558\ub294 \ubcc0\uacbd \uad00\ub9ac \uc9c0\uc6d0\uc11c\ub97c \uc81c\uacf5\ud558\uc5ec \ub3d9\uc885 \uad50\uccb4\uc5d0 \ud544\uc694\ud55c \uc778\uc99d \ub178\ub825\uc744 \uc904\uc77c \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n

\n
\n
\uc81c\uc57d GMP \uad6c\uc5ed\uc5d0\uc11c BXG \ubaa8\ud130\uc758 \ucd5c\uc18c \uccad\uc18c \ube48\ub3c4\ub294 \uc5bc\ub9c8\uc785\ub2c8\uae4c?<\/div>\n<\/div>\n
\n

\uc138\ucc99 \ube48\ub3c4\ub294 \ud2b9\uc815 \ubaa8\ud130 \uc704\uce58\uc758 \uc624\uc5fc \uc704\ud5d8\ub3c4, \uc81c\uc870\ub418\ub294 \uc81c\ud488, \uc138\ucc99\uc81c\uc758 \ud6a8\uacfc\ub97c \uace0\ub824\ud558\uc5ec \uac80\uc99d\ub41c \uc138\ucc99 \uc808\ucc28\uc5d0 \ub530\ub77c \uacb0\uc815\ud574\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d \uc5d0\ubc84\ud30c\uc6cc\ub294 \uc138\ucc99 \ube48\ub3c4\ub97c \ub530\ub85c \uc9c0\uc815\ud558\uc9c0 \uc54a\uc73c\uba70, \uc774\ub294 \uc81c\uc57d\ud68c\uc0ac\uc758 \ud488\uc9c8 \ubc0f \uac80\uc99d \uacb0\uc815 \uc0ac\ud56d\uc785\ub2c8\ub2e4. \ucd5c\uc18c\ud55c \ubaa8\ud130\ub294 \uc124\uce58\ub41c GMP \uad6c\uc5ed\uc758 \uc2e4\ub0b4 \uc138\ucc99 \uc808\ucc28\uc5d0 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. C\ub4f1\uae09 \uad6c\uc5ed\uc5d0\uc11c\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uac01 \uc0dd\uc0b0 \ubc30\uce58 \uc804\ud6c4\uc5d0 IPA(\uc774\uc18c\ud504\ub85c\ud544 \uc54c\ucf54\uc62c)\ub85c \uc138\ucc99\ud569\ub2c8\ub2e4. D\ub4f1\uae09 \uad6c\uc5ed\uc5d0\uc11c\ub294 \uc218\uc131 \uc138\ucc99\uc561\uc744 \uc774\uc6a9\ud55c \ub9e4\uc77c \uc138\ucc99\uc774 \uac80\uc99d\ub41c \uc808\ucc28\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc138\ucc99 \uc808\ucc28\ub294 \uc9c0\uc815\ub41c \uc138\ucc99\uc81c, \uc6a9\ub7c9 \ubc0f \ubc29\ubc95\uc744 \uc0ac\uc6a9\ud558\uc5ec \uc124\uce58\ub41c \uc704\uce58\uc758 BXG \ubaa8\ud130 \ud45c\uba74\uc744 \uc694\uad6c\ub418\ub294 \ubbf8\uc0dd\ubb3c \ubc0f \ud654\ud559 \uc794\ub958\ubb3c \ud55c\ub3c4\uae4c\uc9c0 \uc138\ucc99\ud560 \uc218 \uc788\uc74c\uc744 \uc785\uc99d\ud558\ub3c4\ub85d \uac80\uc99d\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n

\n
\n
BXG \ubaa8\ud130\ub294 \uc138\ud3ec\ub3c5\uc131(OEB 4\/5) \uc758\uc57d\ud488 \uc81c\uc870 \ubd84\uc57c\uc5d0\uc11c \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\uae4c?<\/div>\n<\/div>\n
\n

\uc791\uc5c5 \ub178\ucd9c \ub4f1\uae09 4 \uc774\uc0c1\uc778 \uc138\ud3ec\ub3c5\uc131 \ubc0f \uace0\ud6a8\ub2a5 \ud65c\uc131 \uc758\uc57d\ud488 \uc131\ubd84(HPAPI) \uc81c\uc870 \uad6c\uc5ed\uc5d0\uc11c\ub294 \uc791\uc5c5\uc790\ub97c \uc81c\ud488 \ub178\ucd9c\ub85c\ubd80\ud130 \ubcf4\ud638\ud558\uae30 \uc704\ud574 \uc544\uc774\uc194\ub808\uc774\ud130 \ub610\ub294 \ucc28\ub2e8\ub9c9 \uae30\uc220\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uc544\uc774\uc194\ub808\uc774\ud130 \ub610\ub294 RABS(\uc81c\ud55c \uc811\uadfc \ucc28\ub2e8 \uc2dc\uc2a4\ud15c) \ub0b4\uc5d0\uc11c \ubaa8\ud130\ub294 \uac00\ub2a5\ud55c \ud55c \ucc28\ub2e8\ub9c9 \ubcbd\uc744 \uad00\ud1b5\ud558\uc5ec \uc544\uc774\uc194\ub808\uc774\ud130 \uacbd\uacc4 \uc678\ubd80\uc5d0 \uc124\uce58\ud574\uc57c \ud569\ub2c8\ub2e4. \ubaa8\ud130\ub97c \uc544\uc774\uc194\ub808\uc774\ud130 \ub0b4\ubd80\uc5d0 \uc124\uce58\ud574\uc57c \ud558\ub294 \uacbd\uc6b0, \uc77c\ubc18\uc801\uc73c\ub85c \uc544\uc774\uc194\ub808\uc774\ud130 \ub0b4\ubd80\uc640\uc758 \uc624\uc5fc \uc81c\uc5b4 \uc778\ud130\ud398\uc774\uc2a4\uac00 \uc815\uc758\ub41c \ub9de\ucda4\ud615 \ud558\uc6b0\uc9d5 \ub0b4\ubd80\uc5d0 \ubc00\ubd09\ub429\ub2c8\ub2e4. BXG \ubaa8\ud130 \ubcf8\uccb4\uc640 IP69K \uc778\uc99d\uc740 VHP \uc81c\uc5fc\uc744 \uc0ac\uc6a9\ud558\ub294 \uc81c\uc5fc \uac00\ub2a5\ud55c \uc544\uc774\uc194\ub808\uc774\ud130 \ub0b4\ubd80\uc5d0 \uc124\uce58\ud558\uae30\uc5d0 \uc801\ud569\ud569\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \ubaa8\ud130\uc758 \uc544\uc774\uc194\ub808\uc774\ud130 \ud1b5\ud569\uc740 \uaca9\ub9ac \uacbd\uacc4, \uc81c\uc5fc \ud504\ub85c\ud1a0\ucf5c, \ubaa8\ud130 \uac80\uc0ac \ubc0f \uc720\uc9c0 \ubcf4\uc218 \uc811\uadfc \uc808\ucc28\ub97c \uc815\uc758\ud558\uae30 \uc704\ud574 \uc544\uc774\uc194\ub808\uc774\ud130 \uc124\uacc4\uc790 \ubc0f \uc81c\uc57d \ud488\uc9c8 \ud300\uacfc \uae34\ubc00\ud788 \ud611\ub825\ud574\uc57c \ud569\ub2c8\ub2e4. BXG \uc544\uc774\uc194\ub808\uc774\ud130 \ud1b5\ud569 \u200b\u200b\uc9c0\uc6d0 \ubb38\uc11c\ub294 \ud55c\uad6d \uc5d0\ubc84\ud30c\uc6cc\uc5d0 \ubb38\uc758\ud558\uc2ed\uc2dc\uc624.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n
<\/div>\n

 <\/p>\n

\n
\ud55c\uad6d \uc5d0\ubc84\ud30c\uc6cc \u00b7 BXG \uc2dc\ub9ac\uc988 \u00b7 IP69K SS316L \uc81c\uc57d GMP \ubaa8\ud130<\/div>\n

\uadc0\uc0ac\uc758 \uc81c\uc57d \uc2dc\uc124\uc5d0 GMP \uaddc\uc815\uc744 \uc900\uc218\ud558\uace0 IQ \ubb38\uc11c\ud654\uac00 \uac00\ub2a5\ud55c \ubaa8\ud130\uac00 \ud544\uc694\ud558\uc2ed\ub2c8\uae4c?<\/h2>\n

\ud55c\uad6d Ever-Power BXG: AISI 316L \uc7ac\uc9c8, IP69K \ub4f1\uae09, Ra \u2264 0.8 \u03bcm, FDA 21 CFR \uc778\uc99d \uc530, NSF H1 \uadf8\ub9ac\uc2a4, Class H \ub4f1\uae09, 0.18\u201311 kW \ucd9c\ub825. \ubaa8\ub4e0 IQ \ubb38\uc11c \ud328\ud0a4\uc9c0\uac00 \uae30\ubcf8\uc73c\ub85c \uc81c\uacf5\ub429\ub2c8\ub2e4.<\/p>\n

BXG \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc81c\ud488\uad70 \ubcf4\uae30<\/a><\/p>\n<\/div>\n<\/div>\n

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

Korea Ever-Power \u00b7 BXG Series \u00b7 Pharmaceutical GMP Drive Guide Stainless Steel Motor for Pharmaceutical GMP Manufacturing: FDA 21 CFR, EU GMP and EHEDG Compliance Guide Pharmaceutical manufacturing facilities operating under Good Manufacturing Practice (GMP) regulations must ensure that all equipment in contact with or above product and product-contact surfaces is constructed to prevent contamination […]<\/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":[28],"tags":[],"class_list":["post-229","post","type-post","status-publish","format-standard","hentry","category-industrial-electric-motor"],"_links":{"self":[{"href":"https:\/\/industrialelectricmotor.net\/ko\/wp-json\/wp\/v2\/posts\/229","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/industrialelectricmotor.net\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/industrialelectricmotor.net\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/ko\/wp-json\/wp\/v2\/comments?post=229"}],"version-history":[{"count":1,"href":"https:\/\/industrialelectricmotor.net\/ko\/wp-json\/wp\/v2\/posts\/229\/revisions"}],"predecessor-version":[{"id":230,"href":"https:\/\/industrialelectricmotor.net\/ko\/wp-json\/wp\/v2\/posts\/229\/revisions\/230"}],"wp:attachment":[{"href":"https:\/\/industrialelectricmotor.net\/ko\/wp-json\/wp\/v2\/media?parent=229"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/ko\/wp-json\/wp\/v2\/categories?post=229"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/ko\/wp-json\/wp\/v2\/tags?post=229"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}