{"id":7549,"date":"2026-04-20T04:24:14","date_gmt":"2026-04-20T04:24:14","guid":{"rendered":"https:\/\/melchersvietnam.com\/?p=7549"},"modified":"2026-04-20T07:24:42","modified_gmt":"2026-04-20T07:24:42","slug":"eu-gmp-annex-1-bfs-bottle-inspection-ccit","status":"publish","type":"post","link":"https:\/\/melchersvietnam.com\/vn\/eu-gmp-annex-1-bfs-bottle-inspection-ccit\/","title":{"rendered":"Ki\u1ec3m Tra Chai BFS Tu\u00e2n Th\u1ee7 EU GMP Annex 1"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"7549\" class=\"elementor elementor-7549\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-62bcf41b e-flex e-con-boxed e-con e-parent\" data-id=\"62bcf41b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2e015b4d elementor-widget elementor-widget-text-editor\" data-id=\"2e015b4d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\n<p class=\"wp-block-heading\"><strong>EU GMP Annex 1 l\u00e0 g\u00ec?<\/strong><\/p>\n\n<p class=\"translation-block\">EU GMP Annex 1, do C\u01a1 quan D\u01b0\u1ee3c ph\u1ea9m Ch\u00e2u \u00c2u (EMA) ban h\u00e0nh, l\u00e0 t\u00e0i li\u1ec7u quy \u0111\u1ecbnh li\u00ean quan \u0111\u1ebfn s\u1ea3n xu\u1ea5t thu\u1ed1c v\u00f4 tr\u00f9ng. Phi\u00ean b\u1ea3n c\u1eadp nh\u1eadt m\u1edbi nh\u1ea5t \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 n\u0103m 2022 v\u00e0 ch\u00ednh th\u1ee9c c\u00f3 hi\u1ec7u l\u1ef1c t\u1eeb 25 th\u00e1ng 8 n\u0103m 2023.<\/p>\n\n<p class=\"translation-block\">Quy \u0111\u1ecbnh n\u00e0y \u0111\u1eb7c bi\u1ec7t \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c \u0111\u00f3ng k\u00edn b\u1eb1ng ph\u01b0\u01a1ng ph\u00e1p h\u00e0n nhi\u1ec7t, ch\u1eb3ng h\u1ea1n nh\u01b0 chai BFS (Blow-Fill-Seal), y\u00eau c\u1ea7u ki\u1ec3m so\u00e1t nghi\u00eam ng\u1eb7t h\u01a1n v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 \u0111\u1ed9 k\u00edn.<\/p>\n\n<p class=\"wp-block-heading\"><strong>Y\u00eau C\u1ea7u Annex 1 \u0110\u1ed1i V\u1edbi Chai BFS<\/strong><\/p>\n\n<p class=\"translation-block\">Theo EU GMP Annex 1, c\u00e1c bao b\u00ec \u0111\u01b0\u1ee3c \u0111\u00f3ng k\u00edn b\u1eb1ng ph\u01b0\u01a1ng ph\u00e1p h\u00e0n nhi\u1ec7t nh\u01b0 chai BFS ph\u1ea3i th\u1ef1c hi\u1ec7n:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Ki\u1ec3m tra \u0111\u1ed9 to\u00e0n v\u1eb9n bao b\u00ec 100% (CCIT \u2013 Container Closure Integrity Testing)<\/strong><\/li>\n\n<li class=\"translation-block\">S\u1eed d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh (validated method)<\/li>\n<\/ul>\n\n<p>Quy \u0111\u1ecbnh cu\u1ed1i c\u00f9ng bao g\u1ed3m:<\/p>\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">\u00c1p d\u1ee5ng cho bao b\u00ec dung t\u00edch \u2264 100 mL (SVP \u2013 Small Volume Parenterals)<\/li>\n\n<li class=\"translation-block\">Bao g\u1ed3m c\u00e1c \u0111\u01a1n v\u1ecb BFS<\/li>\n<\/ul>\n\n<p class=\"translation-block\">\u0110i\u1ec1u n\u00e0y khi\u1ebfn CCIT cho chai BFS tr\u1edf th\u00e0nh y\u1ebfu t\u1ed1 b\u1eaft bu\u1ed9c \u0111\u1ec3 tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh.<\/p>\n\n<p class=\"wp-block-heading\"><strong>T\u1ea1i Sao CCIT Quan Tr\u1ecdng V\u1edbi Ki\u1ec3m Tra Chai BFS?<\/strong><\/p>\n\n<p class=\"translation-block\">C\u00f4ng ngh\u1ec7 BFS \u0111\u1ea3m b\u1ea3o v\u00f4 tr\u00f9ng trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t, nh\u01b0ng r\u1ee7i ro sau khi chi\u1ebft r\u00f3t v\u1eabn t\u1ed3n t\u1ea1i, \u0111\u1eb7c bi\u1ec7t l\u00e0 sau c\u00f4ng \u0111o\u1ea1n ti\u1ec7t tr\u00f9ng.<\/p>\n\n<p class=\"wp-block-heading\"><strong>C\u00e1c th\u00e1ch th\u1ee9c trong ki\u1ec3m tra chai BFS:<\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">Ti\u1ec7t tr\u00f9ng b\u1eb1ng autoclave (\u2265121\u00b0C, \u00e1p su\u1ea5t l\u00ean \u0111\u1ebfn 2 bar)<\/li>\n\n<li><strong>Bi\u1ebfn d\u1ea1ng h\u00ecnh d\u1ea1ng chai sau ti\u1ec7t tr\u00f9ng<\/strong><\/li>\n\n<li>S\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa h\u00ecnh d\u1ea1ng \u201cthi\u1ebft k\u1ebf ban \u0111\u1ea7u\u201d v\u00e0 h\u00ecnh d\u1ea1ng th\u1ef1c t\u1ebf<\/li>\n<\/ul>\n\n<p class=\"translation-block\">Nh\u1eefng y\u1ebfu t\u1ed1 n\u00e0y l\u00e0m t\u0103ng nhu c\u1ea7u v\u1ec1 h\u1ec7 th\u1ed1ng ki\u1ec3m tra r\u00f2 r\u1ec9 c\u00f3 \u0111\u1ed9 ch\u00ednh x\u00e1c cao.<\/p>\n\n<p class=\"wp-block-heading\"><strong>Ph\u01b0\u01a1ng Ph\u00e1p Ki\u1ec3m Tra R\u00f2 R\u1ec9 Chai BFS \u0110\u1ed9 Ch\u00ednh X\u00e1c Cao\u00a0<\/strong><\/p>\n\n<p>Vi\u1ec7c l\u1ef1a ch\u1ecdn c\u00f4ng ngh\u1ec7 ph\u00f9 h\u1ee3p l\u00e0 y\u1ebfu t\u1ed1 then ch\u1ed1t \u0111\u1ec3 \u0111\u00e1p \u1ee9ng Annex 1.<\/p>\n\n<p class=\"translation-block\">Ph\u01b0\u01a1ng ph\u00e1p WILCO LFC\u00ae mang l\u1ea1i:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>\u0110\u1ed9 ch\u00ednh x\u00e1c \u0111o l\u01b0\u1eddng cao<\/strong><\/li>\n\n<li><strong>Ki\u1ec3m tra to\u00e0n b\u1ed9 chai trong m\u1ed9t l\u1ea7n \u0111o<\/strong><\/li>\n\n<li>Kh\u1ea3 n\u0103ng ph\u00e1t hi\u1ec7n c\u00e1c r\u00f2 r\u1ec9 c\u1ef1c nh\u1ecf<\/li>\n<\/ul>\n\n<p class=\"translation-block\">\u0110\u00e2y l\u00e0 gi\u1ea3i ph\u00e1p l\u00fd t\u01b0\u1edfng cho ki\u1ec3m tra CCIT chai BFS theo EU GMP Annex 1.<\/p>\n\n<p class=\"wp-block-heading\"><strong>Gi\u1ea3i Ph\u00e1p Ph\u00e1t Hi\u1ec7n R\u00f2 R\u1ec9 100% \u0110\u00e1ng Tin C\u1eady <\/strong><\/p>\n<p class=\"wp-block-heading translation-block\">Thi\u1ebft b\u1ecb R DPPB leak tester \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 x\u1eed l\u00fd c\u00e1c th\u00e1ch th\u1ee9c th\u1ef1c t\u1ebf:<\/p>\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">B\u00f9 tr\u1eeb bi\u1ebfn d\u1ea1ng chai sau ti\u1ec7t tr\u00f9ng<\/li>\n\n<li class=\"translation-block\">\u0110\u1ea3m b\u1ea3o v\u1eadn chuy\u1ec3n \u1ed5n \u0111\u1ecbnh qua h\u1ec7 th\u1ed1ng ki\u1ec3m tra<\/li>\n\n<li class=\"translation-block\">H\u1ed7 tr\u1ee3 ki\u1ec3m tra inline 100%<\/li>\n<\/ul>\n\n<p class=\"translation-block\">S\u1eed d\u1ee5ng c\u00f4ng ngh\u1ec7 ch\u00e2n kh\u00f4ng s\u00e2u (deep vacuum), h\u1ec7 th\u1ed1ng \u0111\u1ea1t:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>\u0110\u1ed9 nh\u1ea1y c\u1ef1c cao<\/strong><\/li>\n\n<li class=\"translation-block\">Ph\u00e1t hi\u1ec7n r\u00f2 r\u1ec9 \u1edf c\u1ea3 ph\u1ea7n ch\u1ee9a dung d\u1ecbch v\u00e0 kho\u1ea3ng kh\u00f4ng (headspace)<\/li>\n<\/ul>\n<p>\u00a0<\/p>\n\n<p class=\"wp-block-heading\"><strong>C\u00f4ng Ngh\u1ec7 Ki\u1ec3m Tra BFS Ti\u00ean Ti\u1ebfn <\/strong><\/p>\n<p class=\"wp-block-heading translation-block\">C\u00f4ng ngh\u1ec7 ki\u1ec3m tra \u00e1p su\u1ea5t vi sai (differential pressure) \u0111\u1ed9c quy\u1ec1n c\u1ee7a WILCO cho ph\u00e9p:<\/p>\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">Ki\u1ec3m tra to\u00e0n b\u1ed9 chai trong m\u1ed9t l\u1ea7n \u0111o<\/li>\n\n<li class=\"translation-block\">\u0110\u1ea3m b\u1ea3o k\u1ebft qu\u1ea3 \u1ed5n \u0111\u1ecbnh v\u1edbi nhi\u1ec1u k\u00edch th\u01b0\u1edbc v\u00e0 h\u00ecnh d\u1ea1ng kh\u00e1c nhau<\/li>\n\n<li class=\"translation-block\">T\u00edch h\u1ee3p giao di\u1ec7n MAVIS\u2122 HMI d\u1ec5 s\u1eed d\u1ee5ng<\/li>\n<\/ul>\n\n<p class=\"translation-block\">\u0110i\u1ec1u n\u00e0y \u0111\u1ea3m b\u1ea3o quy tr\u00ecnh ki\u1ec3m tra BFS hi\u1ec7u qu\u1ea3, tu\u00e2n th\u1ee7 v\u00e0 c\u00f3 kh\u1ea3 n\u0103ng m\u1edf r\u1ed9ng.<\/p>\n\n<p class=\"wp-block-heading\"><strong>L\u1ee3i \u00cdch C\u1ee7a Gi\u1ea3i Ph\u00e1p Ki\u1ec3m Tra Chai BFS <\/strong><\/p>\n<p class=\"wp-block-heading\">\u0110\u1ed9 nh\u1ea1y cao v\u1edbi ph\u01b0\u01a1ng ph\u00e1p LFC\u00ae<\/p>\n\n<ul class=\"wp-block-list\">\n<li>\u0110\u1ed9 nh\u1ea1y cao v\u1edbi ph\u01b0\u01a1ng ph\u00e1p LFC\u00ae <strong>LFC method\u00ae<\/strong><\/li>\n\n<li class=\"translation-block\">Ki\u1ec3m tra to\u00e0n b\u1ed9 chai trong m\u1ed9t l\u1ea7n \u0111o<\/li>\n\n<li class=\"translation-block\">Ph\u00f9 h\u1ee3p v\u1edbi nhi\u1ec1u h\u00ecnh d\u1ea1ng v\u00e0 k\u00edch th\u01b0\u1edbc<\/li>\n\n<li class=\"translation-block\">Ph\u01b0\u01a1ng ph\u00e1p kh\u00f4ng ph\u00e1 h\u1ee7y, mang t\u00ednh x\u00e1c \u0111\u1ecbnh (USP )<\/li>\n\n<li class=\"translation-block\">\u00c1p d\u1ee5ng cho ch\u1ea5t l\u1ecfng d\u1ea7u v\u00e0 kh\u00f4ng d\u1eabn \u0111i\u1ec7n<\/li>\n\n<li class=\"translation-block\">Hi\u1ec7u qu\u1ea3 v\u1edbi th\u1ec3 t\u00edch chi\u1ebft r\u00f3t th\u1ea5p<\/li>\n<\/ul>\n<p>\u00a0<\/p>\n\n<p class=\"wp-block-heading\"><strong>Melchers Vietnam \u2013 \u0110\u1ed1i T\u00e1c \u0110\u1ecba Ph\u01b0\u01a1ng Cho Tu\u00e2n Th\u1ee7 Annex 1 <\/strong><\/p>\n<p class=\"wp-block-heading translation-block\">Melchers Vietnam l\u00e0 \u0111\u1ed1i t\u00e1c uy t\u00edn cung c\u1ea5p c\u00e1c gi\u1ea3i ph\u00e1p ki\u1ec3m tra v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng ti\u00ean ti\u1ebfn cho ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m, ph\u00f9 h\u1ee3p v\u1edbi y\u00eau c\u1ea7u c\u1ee7a EU GMP Annex 1.<\/p>\n\n<p class=\"translation-block\">Th\u00f4ng qua h\u1ee3p t\u00e1c v\u1edbi c\u00e1c nh\u00e0 cung c\u1ea5p c\u00f4ng ngh\u1ec7 h\u00e0ng \u0111\u1ea7u nh\u01b0 WILCO, Melchers Vietnam mang \u0111\u1ebfn:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>H\u1ec7 th\u1ed1ng CCIT hi\u1ec7n \u0111\u1ea1i cho chai BFS<\/strong><\/li>\n\n<li>D\u1ecbch v\u1ee5 t\u01b0 v\u1ea5n v\u00e0 h\u1ed7 tr\u1ee3 k\u1ef9 thu\u1eadt t\u1ea1i Vi\u1ec7t Nam<\/li>\n\n<li class=\"translation-block\">Kh\u1ea3 n\u0103ng t\u00edch h\u1ee3p v\u00e0o d\u00e2y chuy\u1ec1n chi\u1ebft r\u00f3t \u2013 \u0111\u00f3ng g\u00f3i (fill-finish)<\/li>\n\n<li class=\"translation-block\">Gi\u1ea3i ph\u00e1p ph\u00f9 h\u1ee3p v\u1edbi m\u00f4i tr\u01b0\u1eddng ph\u00e1p l\u00fd t\u1ea1i Vi\u1ec7t Nam v\u00e0 \u0110\u00f4ng Nam \u00c1<\/li>\n<\/ul>\n\n<p class=\"translation-block\">Melchers Vietnam gi\u00fap doanh nghi\u1ec7p \u0111\u1ea9y nhanh qu\u00e1 tr\u00ecnh tu\u00e2n th\u1ee7 \u0111\u1ed3ng th\u1eddi t\u1ed1i \u01b0u hi\u1ec7u qu\u1ea3 v\u1eadn h\u00e0nh.<\/p>\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n<p class=\"wp-block-heading\"><strong>K\u1ebft Lu\u1eadn: \u0110\u1ea3m B\u1ea3o Tu\u00e2n Th\u1ee7 EU GMP Annex 1\u00a0<\/strong><\/p>\n\n<p class=\"translation-block\">\u0110\u1ec3 tu\u00e2n th\u1ee7 EU GMP Annex 1, c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m c\u1ea7n tri\u1ec3n khai ki\u1ec3m tra CCIT 100% cho chai BFS.<\/p>\n\n<p class=\"translation-block\">V\u1edbi c\u00f4ng ngh\u1ec7 ti\u00ean ti\u1ebfn v\u00e0 s\u1ef1 h\u1ed7 tr\u1ee3 t\u1eeb Melchers Vietnam, doanh nghi\u1ec7p c\u00f3 th\u1ec3 \u0111\u1ea3m b\u1ea3o:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh<\/li>\n\n<li>\u0110\u1ea3m b\u1ea3o \u0111\u1ed9 v\u00f4 tr\u00f9ng s\u1ea3n ph\u1ea9m<\/li>\n\n<li>An to\u00e0n cho b\u1ec7nh nh\u00e2n<\/li>\n\n<li>Hi\u1ec7u qu\u1ea3 v\u1eadn h\u00e0nh d\u00e0i h\u1ea1n<\/li>\n<\/ul>\n\n<figure class=\"wp-block-video\"><\/figure>\n\n<p>\u00a0<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-015c5d1 e-flex e-con-boxed e-con 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Phi\u00ean b\u1ea3n c\u1eadp nh\u1eadt m\u1edbi nh\u1ea5t \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 n\u0103m 2022 v\u00e0 ch\u00ednh th\u1ee9c c\u00f3 hi\u1ec7u l\u1ef1c t\u1eeb 25 th\u00e1ng 8 n\u0103m 2023.<\/p>","protected":false},"author":12,"featured_media":7550,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[51],"tags":[],"class_list":["post-7549","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-technology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EU GMP Annex 1 BFS Bottle Inspection &amp; CCIT Guide<\/title>\n<meta name=\"description\" content=\"Learn how EU GMP Annex 1 impacts BFS bottle inspection and why 100% CCIT is essential for compliance, sterility, and product safety.\" \/>\n<meta name=\"robots\" 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