{"id":14075,"date":"2026-10-19T13:10:53","date_gmt":"2026-10-19T06:10:53","guid":{"rendered":"https:\/\/sepro.vn\/?p=14075"},"modified":"2026-10-19T13:10:53","modified_gmt":"2026-10-19T06:10:53","slug":"ethanol-phong-sach-yeu-cau-gmp-eu","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/","title":{"rendered":"Ethanol Ph\u00f2ng S\u1ea1ch: Y\u00eau C\u1ea7u K\u1ef9 Thu\u1eadt V\u00e0 C\u00e1ch L\u1ef1a Ch\u1ecdn"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_62 ez-toc-wrap-center counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title \" >Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/#Ethanol_phong_sach_la_gi_Khac_gi_voi_con_thong_thuong\" title=\"Ethanol ph\u00f2ng s\u1ea1ch l\u00e0 g\u00ec? Kh\u00e1c g\u00ec v\u1edbi c\u1ed3n th\u00f4ng th\u01b0\u1eddng?\">Ethanol ph\u00f2ng s\u1ea1ch l\u00e0 g\u00ec? Kh\u00e1c g\u00ec v\u1edbi c\u1ed3n th\u00f4ng th\u01b0\u1eddng?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/#Thanh_phan_va_tieu_chuan_nguyen_lieu_cua_Ethanol_phong_sach\" title=\"Th\u00e0nh ph\u1ea7n v\u00e0 ti\u00eau chu\u1ea9n nguy\u00ean li\u1ec7u c\u1ee7a Ethanol ph\u00f2ng s\u1ea1ch\">Th\u00e0nh ph\u1ea7n v\u00e0 ti\u00eau chu\u1ea9n nguy\u00ean li\u1ec7u c\u1ee7a Ethanol ph\u00f2ng s\u1ea1ch<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/#Yeu_cau_vo_trung_va_SAL_10%E2%81%BB%E2%81%B6_doi_voi_Ethanol_phong_sach\" title=\"Y\u00eau c\u1ea7u v\u00f4 tr\u00f9ng v\u00e0 SAL 10\u207b\u2076 \u0111\u1ed1i v\u1edbi Ethanol ph\u00f2ng s\u1ea1ch\">Y\u00eau c\u1ea7u v\u00f4 tr\u00f9ng v\u00e0 SAL 10\u207b\u2076 \u0111\u1ed1i v\u1edbi Ethanol ph\u00f2ng s\u1ea1ch<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/#Kiem_soat_endotoxin_va_du_luong_sau_bay_hoi_cua_Ethanol_phong_sach\" title=\"Ki\u1ec3m so\u00e1t endotoxin v\u00e0 d\u01b0 l\u01b0\u1ee3ng sau bay h\u01a1i c\u1ee7a Ethanol ph\u00f2ng s\u1ea1ch\">Ki\u1ec3m so\u00e1t endotoxin v\u00e0 d\u01b0 l\u01b0\u1ee3ng sau bay h\u01a1i c\u1ee7a Ethanol ph\u00f2ng s\u1ea1ch<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/#Bao_bi_bao_quan_va_truy_xuat_nguon_goc_Ethanol_phong_sach\" title=\"Bao b\u00ec, b\u1ea3o qu\u1ea3n v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c Ethanol ph\u00f2ng s\u1ea1ch\">Bao b\u00ec, b\u1ea3o qu\u1ea3n v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c Ethanol ph\u00f2ng s\u1ea1ch<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/#Hieu_luc_khu_khuan_cua_Ethanol_70_va_gioi_han_su_dung\" title=\"Hi\u1ec7u l\u1ef1c kh\u1eed khu\u1ea9n c\u1ee7a Ethanol 70% v\u00e0 gi\u1edbi h\u1ea1n s\u1eed d\u1ee5ng\">Hi\u1ec7u l\u1ef1c kh\u1eed khu\u1ea9n c\u1ee7a Ethanol 70% v\u00e0 gi\u1edbi h\u1ea1n s\u1eed d\u1ee5ng<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/#Checklist_lua_chon_Ethanol_phong_sach_theo_yeu_cau_QAQC\" title=\"Checklist l\u1ef1a ch\u1ecdn Ethanol ph\u00f2ng s\u1ea1ch theo y\u00eau c\u1ea7u QA\/QC\">Checklist l\u1ef1a ch\u1ecdn Ethanol ph\u00f2ng s\u1ea1ch theo y\u00eau c\u1ea7u QA\/QC<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/#Ket_luan\" title=\"K\u1ebft lu\u1eadn\">K\u1ebft lu\u1eadn<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/#FAQ\" title=\"FAQ\">FAQ<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/#Nguon_tham_khao_va_tai_lieu_ky_thuat\" title=\"Ngu\u1ed3n tham kh\u1ea3o v\u00e0 t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt\">Ngu\u1ed3n tham kh\u1ea3o v\u00e0 t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt<\/a><\/li><\/ul><\/nav><\/div>\n<p><span style=\"font-weight: 400;\">Trong m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m, \u0111\u1eb7c bi\u1ec7t t\u1ea1i c\u00e1c khu v\u1ef1c c\u00f3 y\u00eau c\u1ea7u ki\u1ec3m so\u00e1t nhi\u1ec5m nghi\u00eam ng\u1eb7t, c\u1ed3n Ethanol 70% th\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 kh\u1eed khu\u1ea9n b\u1ec1 m\u1eb7t v\u00e0 thi\u1ebft b\u1ecb. Tuy nhi\u00ean, c\u00f9ng n\u1ed3ng \u0111\u1ed9 70% kh\u00f4ng c\u00f3 ngh\u0129a c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u1ec1u ph\u00f9 h\u1ee3p v\u1edbi m\u1ecdi khu v\u1ef1c ph\u00f2ng s\u1ea1ch. Ngo\u00e0i n\u1ed3ng \u0111\u1ed9 c\u1ed3n, vi\u1ec7c l\u1ef1a ch\u1ecdn c\u00f2n ph\u1ee5 thu\u1ed9c v\u00e0o ch\u1ea5t l\u01b0\u1ee3ng nguy\u00ean li\u1ec7u, n\u01b0\u1edbc pha ch\u1ebf, tr\u1ea1ng th\u00e1i v\u00f4 tr\u00f9ng, hi\u1ec7u l\u1ef1c kh\u1eed khu\u1ea9n v\u00e0 h\u1ed3 s\u01a1 ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a s\u1ea3n ph\u1ea9m. \u0110\u1eb7c bi\u1ec7t, EU GMP Annex 1 y\u00eau c\u1ea7u ch\u1ea5t kh\u1eed khu\u1ea9n s\u1eed d\u1ee5ng t\u1ea1i Grade A\/B ph\u1ea3i v\u00f4 tr\u00f9ng tr\u01b0\u1edbc khi d\u00f9ng. V\u1eady Ethanol s\u1eed d\u1ee5ng trong ph\u00f2ng s\u1ea1ch c\u1ea7n \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 theo nh\u1eefng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt n\u00e0o? B\u00e0i vi\u1ebft s\u1ebd l\u00e0m r\u00f5 c\u00e1c ti\u00eau ch\u00ed quan tr\u1ecdng v\u00e0 c\u00e1ch ki\u1ec3m tra h\u1ed3 s\u01a1 \u0111\u1ec3 l\u1ef1a ch\u1ecdn s\u1ea3n ph\u1ea9m ph\u00f9 h\u1ee3p v\u1edbi t\u1eebng khu v\u1ef1c v\u00e0 quy tr\u00ecnh s\u1eed d\u1ee5ng<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Ethanol_phong_sach_la_gi_Khac_gi_voi_con_thong_thuong\"><\/span><b>Ethanol ph\u00f2ng s\u1ea1ch l\u00e0 g\u00ec? Kh\u00e1c g\u00ec v\u1edbi c\u1ed3n th\u00f4ng th\u01b0\u1eddng?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">C\u1ed3n Ethanol s\u1eed d\u1ee5ng trong ph\u00f2ng s\u1ea1ch l\u00e0 dung d\u1ecbch ch\u1ee9a Ethanol \u0111\u01b0\u1ee3c l\u1ef1a ch\u1ecdn \u0111\u1ec3 kh\u1eed khu\u1ea9n b\u1ec1 m\u1eb7t, thi\u1ebft b\u1ecb v\u00e0 v\u1eadt d\u1ee5ng trong m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t c\u00f3 ki\u1ec3m so\u00e1t. Kh\u00e1c v\u1edbi c\u1ed3n th\u00f4ng th\u01b0\u1eddng, s\u1ea3n ph\u1ea9m d\u00f9ng trong ph\u00f2ng s\u1ea1ch d\u01b0\u1ee3c ph\u1ea9m c\u1ea7n \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 d\u1ef1a tr\u00ean y\u00eau c\u1ea7u ki\u1ec3m so\u00e1t nhi\u1ec5m c\u1ee7a t\u1eebng khu v\u1ef1c v\u00e0 quy tr\u00ecnh s\u1ea3n xu\u1ea5t.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">S\u1ef1 kh\u00e1c bi\u1ec7t kh\u00f4ng ch\u1ec9 n\u1eb1m \u1edf n\u1ed3ng \u0111\u1ed9 c\u1ed3n 70%. Hai s\u1ea3n ph\u1ea9m c\u00f9ng n\u1ed3ng \u0111\u1ed9 c\u00f3 th\u1ec3 kh\u00e1c nhau v\u1ec1 th\u00e0nh ph\u1ea7n, ch\u1ea5t l\u01b0\u1ee3ng n\u01b0\u1edbc pha ch\u1ebf, t\u1ea1p ch\u1ea5t, tr\u1ea1ng th\u00e1i v\u00f4 tr\u00f9ng, bao b\u00ec v\u00e0 h\u1ed3 s\u01a1 ki\u1ec3m nghi\u1ec7m. Theo EU GMP Annex 1, m\u1ee5c 4.35, ch\u1ea5t kh\u1eed khu\u1ea9n d\u00f9ng t\u1ea1i Grade A\/B ph\u1ea3i v\u00f4 tr\u00f9ng tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng; t\u1ea1i Grade C\/D, y\u00eau c\u1ea7u v\u00f4 tr\u00f9ng \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh theo chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t nhi\u1ec5m (CCS).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">V\u00ec v\u1eady, vi\u1ec7c l\u1ef1a ch\u1ecdn ethanol ph\u00f2ng s\u1ea1ch c\u1ea7n d\u1ef1a tr\u00ean h\u1ed3 s\u01a1 ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 m\u1ee9c \u0111\u1ed9 ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng. \u0110\u1ec3 t\u00ecm hi\u1ec3u ri\u00eang v\u1ec1 \u0111i\u1ec3m kh\u00e1c bi\u1ec7t gi\u1eefa hai lo\u1ea1i c\u1ed3n, c\u00f3 th\u1ec3 tham kh\u1ea3o b\u00e0i<\/span><a href=\"https:\/\/sepro.vn\/vi\/ipa-va-ethanol-trong-duoc-pham-dau-la-lua-chon-phu-hop\/\"> <span style=\"font-weight: 400;\">IPA v\u00e0 Ethanol trong d\u01b0\u1ee3c ph\u1ea9m<\/span><\/a><span style=\"font-weight: 400;\"> c\u1ee7a SEPRO.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Thanh_phan_va_tieu_chuan_nguyen_lieu_cua_Ethanol_phong_sach\"><\/span><b>Th\u00e0nh ph\u1ea7n v\u00e0 ti\u00eau chu\u1ea9n nguy\u00ean li\u1ec7u c\u1ee7a Ethanol ph\u00f2ng s\u1ea1ch<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_14082\" aria-describedby=\"caption-attachment-14082\" style=\"width: 847px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-14082 size-large\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-70-usp-wfi-1024x640.png\" alt=\"S\u01a1 \u0111\u1ed3 th\u00e0nh ph\u1ea7n QT 70 SDA g\u1ed3m 70% c\u1ed3n bi\u1ebfn t\u00ednh v\u00e0 30% USP WFI\" width=\"847\" height=\"529\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-70-usp-wfi-1024x640.png 1024w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-70-usp-wfi-300x188.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-70-usp-wfi-768x480.png 768w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-70-usp-wfi-1536x961.png 1536w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-70-usp-wfi-80x50.png 80w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-70-usp-wfi-600x375.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-70-usp-wfi.png 1586w\" sizes=\"(max-width: 847px) 100vw, 847px\" \/><figcaption id=\"caption-attachment-14082\" class=\"wp-caption-text\">Infographic minh h\u1ecda t\u1ef7 l\u1ec7 th\u00e0nh ph\u1ea7n 70% Specially Denatured Alcohol v\u00e0 30% USP Water for Injection theo TDS QuantumTec<\/figcaption><\/figure>\n<h3><b>Th\u00e0nh ph\u1ea7n Ethanol 70% v\u00e0 Ethanol bi\u1ebfn t\u00ednh (SDA)<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Ethanol 70% l\u00e0 dung d\u1ecbch ch\u1ee9a Ethanol v\u00e0 n\u01b0\u1edbc theo t\u1ef7 l\u1ec7 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh; tuy nhi\u00ean, c\u00e1c s\u1ea3n ph\u1ea9m mang t\u00ean c\u1ed3n 70% kh\u00f4ng nh\u1ea5t thi\u1ebft c\u00f3 th\u00e0nh ph\u1ea7n nh\u01b0 nhau. M\u1ed9t s\u1ed1 d\u00f2ng d\u00e0nh cho ph\u00f2ng s\u1ea1ch s\u1eed d\u1ee5ng Specially Denatured Alcohol (SDA), ethanol \u0111\u01b0\u1ee3c b\u1ed5 sung ch\u1ea5t bi\u1ebfn t\u00ednh theo m\u1ed9t c\u00f4ng th\u1ee9c x\u00e1c \u0111\u1ecbnh.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">QuantumTec c\u00f3 c\u00e1c phi\u00ean b\u1ea3n QT SDA bi\u1ebfn t\u00ednh b\u1eb1ng Isopropyl Alcohol (IPA) ho\u1eb7c Methanol. TDS c\u1ee7a h\u00e3ng m\u00f4 t\u1ea3 c\u00f4ng th\u1ee9c 70% SDA v\u00e0 30% USP Water for Injection (WFI). C\u1ea7n ph\u00e2n bi\u1ec7t t\u1ef7 l\u1ec7 SDA trong c\u00f4ng th\u1ee9c v\u1edbi h\u00e0m l\u01b0\u1ee3ng Ethanol nguy\u00ean ch\u1ea5t. SDS c\u1ee7a t\u1eebng d\u00f2ng n\u00eau r\u00f5 ch\u1ea5t bi\u1ebfn t\u00ednh v\u00e0 kho\u1ea3ng h\u00e0m l\u01b0\u1ee3ng th\u00e0nh ph\u1ea7n; v\u00ec v\u1eady kh\u00f4ng n\u00ean xem hai c\u00f4ng th\u1ee9c l\u00e0 gi\u1ed1ng nhau.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Khi \u0111\u00e1nh gi\u00e1, QA\/QC c\u1ea7n \u0111\u1ed1i chi\u1ebfu TDS, SDS v\u00e0 CoA \u0111\u1ec3 x\u00e1c minh th\u00e0nh ph\u1ea7n, n\u1ed3ng \u0111\u1ed9, \u0111\u01a1n v\u1ecb n\u1ed3ng \u0111\u1ed9, y\u00eau c\u1ea7u an to\u00e0n v\u00e0 t\u00ednh ph\u00f9 h\u1ee3p v\u1edbi quy tr\u00ecnh. \u0110\u1eb7c bi\u1ec7t, s\u1ea3n ph\u1ea9m ch\u1ee9a Methanol c\u1ea7n \u0111\u01b0\u1ee3c xem x\u00e9t k\u1ef9 v\u1ec1 nguy c\u01a1 ph\u01a1i nhi\u1ec5m v\u00e0 ph\u1ea1m vi \u1ee9ng d\u1ee5ng theo SDS.<\/span><\/p>\n<h3><b>V\u00ec sao WFI \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 pha ch\u1ebf Ethanol ph\u00f2ng s\u1ea1ch?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">N\u01b0\u1edbc pha lo\u00e3ng c\u00f3 th\u1ec3 l\u00e0 ngu\u1ed3n \u0111\u01b0a th\u00eam vi sinh v\u1eadt, n\u1ed9i \u0111\u1ed9c t\u1ed1 v\u00e0 t\u1ea1p ch\u1ea5t v\u00e0o dung d\u1ecbch. WFI l\u00e0 l\u1ef1a ch\u1ecdn c\u00f3 c\u01a1 s\u1edf k\u1ef9 thu\u1eadt cho c\u00f4ng th\u1ee9c kh\u1eed khu\u1ea9n s\u1eed d\u1ee5ng t\u1ea1i m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m v\u00f4 tr\u00f9ng. EU GMP Annex 1, m\u1ee5c 6.7 y\u00eau c\u1ea7u h\u1ec7 th\u1ed1ng n\u01b0\u1edbc s\u1ea3n xu\u1ea5t \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t nh\u1eb1m gi\u1ea3m thi\u1ec3u nguy c\u01a1 ti\u1ec3u ph\u00e2n, vi sinh v\u00e0 endotoxin\/pyrogen.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Theo chuy\u00ean lu\u1eadn Water for Injections (0169) c\u1ee7a D\u01b0\u1ee3c \u0111i\u1ec3n ch\u00e2u \u00c2u, WFI c\u00f3 gi\u1edbi h\u1ea1n n\u1ed9i \u0111\u1ed9c t\u1ed1 vi khu\u1ea9n d\u01b0\u1edbi 0,25 IU\/mL. Vi\u1ec7c d\u00f9ng WFI gi\u00fap ki\u1ec3m so\u00e1t nguy c\u01a1 t\u1eeb n\u01b0\u1edbc \u0111\u1ea7u v\u00e0o, nh\u01b0ng kh\u00f4ng t\u1ef1 \u0111\u1ed9ng ch\u1ee9ng minh dung d\u1ecbch Ethanol th\u00e0nh ph\u1ea9m \u0111\u1ea1t c\u00f9ng gi\u1edbi h\u1ea1n endotoxin. Ch\u1ec9 ti\u00eau cu\u1ed1i c\u00f9ng c\u1ea7n \u0111\u01b0\u1ee3c \u0111\u1ed1i chi\u1ebfu v\u1edbi specification v\u00e0 k\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m c\u1ee7a \u0111\u00fang s\u1ea3n ph\u1ea9m, l\u00f4 h\u00e0ng<\/span><a href=\"https:\/\/www.edqm.eu\/documents\/52006\/0\/2024%2BBio%2BTraining%2BModule%2B4%2B-%2Bpresentations-web.pdf\/4dd00e74-b2f0-9c97-043e-ddac702683b8\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/a><b>Ki\u1ec3m so\u00e1t ti\u1ec3u ph\u00e2n v\u00e0 quy tr\u00ecnh l\u1ecdc Ethanol ph\u00f2ng s\u1ea1ch<\/b><\/p>\n<p><span style=\"font-weight: 400;\">B\u00ean c\u1ea1nh nguy\u00ean li\u1ec7u v\u00e0 n\u01b0\u1edbc pha ch\u1ebf, c\u00f4ng \u0111o\u1ea1n l\u1ecdc, chi\u1ebft r\u00f3t v\u00e0 \u0111\u00f3ng g\u00f3i \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn kh\u1ea3 n\u0103ng ki\u1ec3m so\u00e1t nhi\u1ec5m. C\u1ea7n ph\u00e2n bi\u1ec7t vai tr\u00f2 c\u1ee7a b\u01b0\u1edbc l\u1ecdc v\u1edbi b\u1eb1ng ch\u1ee9ng b\u1ea3o \u0111\u1ea3m v\u00f4 tr\u00f9ng c\u1ee7a th\u00e0nh ph\u1ea9m.<\/span><\/p>\n<h3><b>Vai tr\u00f2 c\u1ee7a m\u00e0ng l\u1ecdc 0,22 \u00b5m trong s\u1ea3n xu\u1ea5t Ethanol ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">M\u00e0ng l\u1ecdc c\u00f3 k\u00edch th\u01b0\u1edbc l\u1ed7 danh \u0111\u1ecbnh 0,22 \u00b5m th\u01b0\u1eddng \u0111\u01b0\u1ee3c d\u00f9ng \u0111\u1ec3 lo\u1ea1i gi\u1eef vi sinh v\u1eadt trong m\u1ed9t quy tr\u00ecnh l\u1ecdc \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf v\u00e0 x\u00e1c nh\u1eadn ph\u00f9 h\u1ee3p; kh\u1ea3 n\u0103ng lo\u1ea1i gi\u1eef ti\u1ec3u ph\u00e2n c\u00f2n ph\u1ee5 thu\u1ed9c \u0111\u1eb7c t\u00ednh m\u00e0ng v\u00e0 \u0111i\u1ec1u ki\u1ec7n l\u1ecdc. TDS QuantumTec c\u00f4ng b\u1ed1 QT SDA \u0111\u01b0\u1ee3c l\u1ecdc qua m\u00e0ng 0,22 \u00b5m.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">EU GMP Annex 1, m\u1ee5c 8.79 n\u00eau y\u00eau c\u1ea7u v\u1ec1 m\u00e0ng l\u1ecdc c\u1ea5p ti\u1ec7t tr\u00f9ng t\u1ed1i \u0111a 0,22 \u00b5m \u0111\u1ed1i v\u1edbi c\u00e1c dung d\u1ecbch thu\u1ed1c v\u00f4 tr\u00f9ng kh\u00f4ng th\u1ec3 ti\u1ec7t tr\u00f9ng trong bao b\u00ec cu\u1ed1i. \u0110\u00e2y l\u00e0 c\u0103n c\u1ee9 tham kh\u1ea3o v\u1ec1 nguy\u00ean l\u00fd ki\u1ec3m so\u00e1t l\u1ecdc, kh\u00f4ng ph\u1ea3i quy \u0111\u1ecbnh ri\u00eang b\u1eaft bu\u1ed9c cho m\u1ecdi Ethanol kh\u1eed khu\u1ea9n b\u1ec1 m\u1eb7t.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">M\u1ed9t b\u01b0\u1edbc l\u1ecdc 0,22 \u00b5m kh\u00f4ng t\u1ef1 \u0111\u1ed9ng lo\u1ea1i b\u1ecf endotoxin ho\u1eb7c t\u1ea5t c\u1ea3 t\u1ea1p ch\u1ea5t h\u00f2a tan, c\u0169ng kh\u00f4ng \u0111\u1ee7 \u0111\u1ec3 k\u1ebft lu\u1eadn s\u1ea3n ph\u1ea9m th\u00e0nh ph\u1ea9m v\u00f4 tr\u00f9ng. C\u1ea7n xem x\u00e9t to\u00e0n b\u1ed9 quy tr\u00ecnh s\u1ea3n xu\u1ea5t v\u00e0 c\u00e1c b\u01b0\u1edbc ki\u1ec3m so\u00e1t ti\u1ebfp theo.<\/span><\/p>\n<h3><b>Ki\u1ec3m so\u00e1t m\u00f4i tr\u01b0\u1eddng chi\u1ebft r\u00f3t v\u00e0 bao b\u00ec sau l\u1ecdc<\/b><\/h3>\n<figure id=\"attachment_14084\" aria-describedby=\"caption-attachment-14084\" style=\"width: 847px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-large wp-image-14084\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-loc-022-micron-gamma-sal-10-6-1024x640.png\" alt=\"S\u01a1 \u0111\u1ed3 l\u1ecdc m\u00e0ng 0,22 \u00b5m, chi\u1ebfu x\u1ea1 Gamma 25\u201345 kGy v\u00e0 m\u1ee9c b\u1ea3o \u0111\u1ea3m v\u00f4 tr\u00f9ng SAL 10\u207b\u2076 c\u1ee7a QT 70 SDA\" width=\"847\" height=\"529\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-loc-022-micron-gamma-sal-10-6-1024x640.png 1024w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-loc-022-micron-gamma-sal-10-6-300x188.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-loc-022-micron-gamma-sal-10-6-768x480.png 768w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-loc-022-micron-gamma-sal-10-6-1536x961.png 1536w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-loc-022-micron-gamma-sal-10-6-80x50.png 80w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-loc-022-micron-gamma-sal-10-6-600x375.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/qt-sda-loc-022-micron-gamma-sal-10-6.png 1586w\" sizes=\"(max-width: 847px) 100vw, 847px\" \/><figcaption id=\"caption-attachment-14084\" class=\"wp-caption-text\">Infographic minh h\u1ecda c\u00e1c th\u00f4ng s\u1ed1 ki\u1ec3m so\u00e1t v\u00f4 tr\u00f9ng c\u1ee7a QT 70 SDA<\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">Sau l\u1ecdc, s\u1ea3n ph\u1ea9m c\u00f3 th\u1ec3 t\u00e1i nhi\u1ec5m t\u1eeb thi\u1ebft b\u1ecb, kh\u00f4ng kh\u00ed ho\u1eb7c b\u1ed9 ph\u1eadn ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp v\u1edbi dung d\u1ecbch. Do \u0111\u00f3, m\u00f4i tr\u01b0\u1eddng chi\u1ebft r\u00f3t v\u00e0 x\u1eed l\u00fd bao b\u00ec ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh theo quy tr\u00ecnh s\u1ea3n xu\u1ea5t v\u00e0 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro. C\u00e1c quy \u0111\u1ecbnh v\u1ec1 c\u1ea5p s\u1ea1ch trong s\u1ea3n xu\u1ea5t thu\u1ed1c v\u00f4 tr\u00f9ng c\u1ee7a EU GMP Annex 1 c\u00f3 th\u1ec3 l\u00e0m c\u01a1 s\u1edf tham kh\u1ea3o, nh\u01b0ng kh\u00f4ng th\u1ec3 m\u1eb7c \u0111\u1ecbnh d\u00e2y chuy\u1ec1n Ethanol c\u1ee7a QuantumTec chi\u1ebft r\u00f3t t\u1ea1i ISO Class 5 hay khu v\u1ef1c n\u1ec1n ISO Class 7 n\u1ebfu thi\u1ebfu h\u1ed3 s\u01a1 tr\u1ef1c ti\u1ebfp c\u1ee7a h\u00e3ng.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">C\u1ea5u h\u00ecnh bao b\u00ec v\u00e0 ph\u01b0\u01a1ng ph\u00e1p c\u1ea5p ph\u00e1t c\u0169ng g\u00f3p ph\u1ea7n h\u1ea1n ch\u1ebf nguy c\u01a1 t\u00e1i nhi\u1ec5m. QuantumTec c\u00f3 phi\u00ean b\u1ea3n d\u00f9ng h\u1ec7 th\u1ed1ng Bag-in-Bottle k\u00edn v\u00e0 \u0111\u00f3ng t\u00fai k\u00e9p cho s\u1ea3n ph\u1ea9m v\u00f4 tr\u00f9ng; c\u1ea5u h\u00ecnh v\u00e0 quy c\u00e1ch bao b\u00ec c\u1ea7n \u0111\u01b0\u1ee3c ki\u1ec3m tra theo t\u1eebng m\u00e3 s\u1ea3n ph\u1ea9m.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Yeu_cau_vo_trung_va_SAL_10%E2%81%BB%E2%81%B6_doi_voi_Ethanol_phong_sach\"><\/span><b>Y\u00eau c\u1ea7u v\u00f4 tr\u00f9ng v\u00e0 SAL 10\u207b\u2076 \u0111\u1ed1i v\u1edbi Ethanol ph\u00f2ng s\u1ea1ch<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u0110\u1ed1i v\u1edbi Ethanol d\u00f9ng trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m v\u00f4 tr\u00f9ng, c\u1ea7n x\u00e1c \u0111\u1ecbnh tr\u1ea1ng th\u00e1i v\u00f4 tr\u00f9ng theo c\u1ea5p s\u1ea1ch, m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 b\u1eb1ng ch\u1ee9ng b\u1ea3o \u0111\u1ea3m v\u00f4 tr\u00f9ng c\u1ee7a t\u1eebng s\u1ea3n ph\u1ea9m.<\/span><\/p>\n<h3><b>Y\u00eau c\u1ea7u v\u00f4 tr\u00f9ng \u0111\u1ed1i v\u1edbi Ethanol theo EU GMP Annex 1<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">EU GMP Annex 1, m\u1ee5c 4.35 quy \u0111\u1ecbnh ch\u1ea5t kh\u1eed khu\u1ea9n v\u00e0 ch\u1ea5t t\u1ea9y r\u1eeda s\u1eed d\u1ee5ng t\u1ea1i Grade A\/B ph\u1ea3i v\u00f4 tr\u00f9ng tr\u01b0\u1edbc khi d\u00f9ng. V\u1edbi Grade C\/D, ch\u1ea5t kh\u1eed khu\u1ea9n c\u0169ng c\u00f3 th\u1ec3 c\u1ea7n v\u00f4 tr\u00f9ng n\u1ebfu CCS x\u00e1c \u0111\u1ecbnh y\u00eau c\u1ea7u n\u00e0y. \u0110\u1ed1i v\u1edbi dung d\u1ecbch pha s\u1eb5n (ready-made), k\u1ebft qu\u1ea3 tr\u00ean CoA ho\u1eb7c Certificate of Conformance c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn sau khi \u0111\u00e1nh gi\u00e1 nh\u00e0 cung c\u1ea5p ph\u00f9 h\u1ee3p.<\/span><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf\" target=\"_blank\" rel=\"noopener\">\u00a0<\/a><\/p>\n<p><span style=\"font-weight: 400;\">V\u00ec v\u1eady, QA\/QC c\u1ea7n x\u00e1c \u0111\u1ecbnh \u0111\u00fang phi\u00ean b\u1ea3n Sterile ho\u1eb7c Non-Sterile, ki\u1ec3m tra m\u00e3 h\u00e0ng, ch\u1ee9ng t\u1eeb li\u00ean quan v\u00e0 s\u1ef1 ph\u00f9 h\u1ee3p v\u1edbi SOP. Kh\u00f4ng th\u1ec3 suy ra v\u00f4 tr\u00f9ng ch\u1ec9 t\u1eeb n\u1ed3ng \u0111\u1ed9 70% hay th\u00f4ng tin l\u1ecdc 0,22 \u00b5m.<\/span><\/p>\n<h3><b>Chi\u1ebfu x\u1ea1 Gamma, SAL 10\u207b\u2076 v\u00e0 h\u1ed3 s\u01a1 ch\u1ee9ng nh\u1eadn v\u00f4 tr\u00f9ng<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Chi\u1ebfu x\u1ea1 Gamma l\u00e0 m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p ti\u1ec7t tr\u00f9ng b\u1eb1ng b\u1ee9c x\u1ea1 ion h\u00f3a cho c\u00e1c s\u1ea3n ph\u1ea9m v\u00e0 v\u1eadt li\u1ec7u bao g\u00f3i t\u01b0\u01a1ng th\u00edch. Theo TDS, QT SDA phi\u00ean b\u1ea3n v\u00f4 tr\u00f9ng c\u1ee7a QuantumTec \u0111\u01b0\u1ee3c chi\u1ebfu x\u1ea1 Gamma trong d\u1ea3i li\u1ec1u 25\u201345 kGy nh\u1eb1m \u0111\u1ea1t m\u1ee9c b\u1ea3o \u0111\u1ea3m v\u00f4 tr\u00f9ng SAL 10\u207b\u2076. \u0110\u00e2y l\u00e0 th\u00f4ng s\u1ed1 nh\u00e0 s\u1ea3n xu\u1ea5t c\u00f4ng b\u1ed1, kh\u00f4ng ph\u1ea3i d\u1ea3i li\u1ec1u b\u1eaft bu\u1ed9c cho m\u1ecdi Ethanol ph\u00f2ng s\u1ea1ch.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">SAL 10\u207b\u2076 th\u1ec3 hi\u1ec7n x\u00e1c su\u1ea5t l\u00fd thuy\u1ebft kh\u00f4ng qu\u00e1 m\u1ed9t ph\u1ea7n tri\u1ec7u \u0111\u1ec3 m\u1ed9t \u0111\u01a1n v\u1ecb s\u1ea3n ph\u1ea9m v\u1eabn c\u00f2n vi sinh v\u1eadt s\u1ed1ng sau quy tr\u00ecnh ti\u1ec7t tr\u00f9ng \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh. M\u1ed9t th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng tr\u00ean s\u1ed1 m\u1eabu gi\u1edbi h\u1ea1n kh\u00f4ng th\u1ec3 t\u1ef1 n\u00f3 ch\u1ee9ng minh m\u1ee9c SAL.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">V\u00ed d\u1ee5, CoA c\u00f4ng khai c\u1ee7a QT SDA v\u00f4 tr\u00f9ng m\u00e3 QT2514-128, l\u00f4 30000822 ghi nh\u1eadn li\u1ec1u chi\u1ebfu x\u1ea1 th\u1ef1c t\u1ebf 26,0\u201329,4 kGy, n\u1eb1m trong d\u1ea3i quy \u0111\u1ecbnh 25\u201345 kGy; th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng kh\u00f4ng ph\u00e1t hi\u1ec7n t\u0103ng tr\u01b0\u1edfng. T\u00e0i li\u1ec7u c\u0169ng n\u00eau ph\u01b0\u01a1ng ph\u00e1p VDmax25 theo ISO EN 11137-2 trong h\u1ed3 s\u01a1 x\u00e1c l\u1eadp li\u1ec1u. \u0110\u00e2y l\u00e0 v\u00ed d\u1ee5 theo m\u1ed9t l\u00f4 l\u1ecbch s\u1eed, kh\u00f4ng ph\u1ea3i ch\u1ee9ng nh\u1eadn cho nh\u1eefng l\u00f4 kh\u00e1c.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Khi ti\u1ebfp nh\u1eadn h\u00e0ng, QA\/QC \u0111\u1ed1i chi\u1ebfu CoA, Certificate of Irradiation (COI) n\u1ebfu c\u00f3 x\u1eed l\u00fd chi\u1ebfu x\u1ea1, s\u1ed1 l\u00f4, h\u1ea1n s\u1eed d\u1ee5ng v\u00e0 th\u00f4ng tin v\u1ec1 quy tr\u00ecnh \u0111\u00e3 th\u1ea9m \u0111\u1ecbnh khi c\u1ea7n thi\u1ebft. CoA ph\u1ea3n \u00e1nh k\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m; COI ghi nh\u1eadn x\u1eed l\u00fd chi\u1ebfu x\u1ea1; h\u1ed3 s\u01a1 th\u1ea9m \u0111\u1ecbnh l\u00e0 c\u01a1 s\u1edf \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 m\u1ee9c SAL c\u00f4ng b\u1ed1.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Kiem_soat_endotoxin_va_du_luong_sau_bay_hoi_cua_Ethanol_phong_sach\"><\/span><b>Ki\u1ec3m so\u00e1t endotoxin v\u00e0 d\u01b0 l\u01b0\u1ee3ng sau bay h\u01a1i c\u1ee7a Ethanol ph\u00f2ng s\u1ea1ch<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">V\u00f4 tr\u00f9ng, endotoxin th\u1ea5p v\u00e0 d\u01b0 l\u01b0\u1ee3ng th\u1ea5p l\u00e0 c\u00e1c \u0111\u1eb7c t\u00ednh ch\u1ea5t l\u01b0\u1ee3ng kh\u00e1c nhau. Khi \u0111\u00e1nh gi\u00e1 Ethanol ph\u00f2ng s\u1ea1ch, QA\/QC c\u1ea7n x\u00e1c \u0111\u1ecbnh ch\u1ec9 ti\u00eau n\u00e0o \u00e1p d\u1ee5ng cho quy tr\u00ecnh v\u00e0 b\u1eb1ng ch\u1ee9ng n\u00e0o ch\u1ee9ng minh ch\u1ec9 ti\u00eau \u0111\u00f3.<\/span><\/p>\n<h3><b>Gi\u1edbi h\u1ea1n endotoxin trong Ethanol ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Endotoxin l\u00e0 th\u00e0nh ph\u1ea7n lipopolysaccharide (LPS) c\u1ee7a m\u00e0ng ngo\u00e0i vi khu\u1ea9n Gram \u00e2m v\u00e0 c\u00f3 th\u1ec3 t\u1ed3n t\u1ea1i sau khi vi khu\u1ea9n b\u1ecb ti\u00eau di\u1ec7t. V\u00ec v\u1eady, m\u1ed9t dung d\u1ecbch v\u00f4 tr\u00f9ng kh\u00f4ng \u0111\u1ed3ng ngh\u0129a \u0111\u00e3 \u0111\u01b0\u1ee3c lo\u1ea1i b\u1ecf endotoxin. EU GMP Annex 1, m\u1ee5c 2.1(iv) \u0111\u1eb7t ra nguy\u00ean t\u1eafc ki\u1ec3m so\u00e1t bioburden v\u00e0 endotoxin\/pyrogen t\u1eeb nguy\u00ean li\u1ec7u, v\u1eadt li\u1ec7u bao g\u00f3i trong s\u1ea3n xu\u1ea5t thu\u1ed1c v\u00f4 tr\u00f9ng<\/span><\/p>\n<p><span style=\"font-weight: 400;\">WFI c\u00f3 gi\u1edbi h\u1ea1n endotoxin d\u01b0\u1edbi 0,25 IU\/mL theo Ph. Eur. 0169, c\u00f2n m\u1ee9c endotoxin ch\u1ea5p nh\u1eadn c\u1ee7a dung d\u1ecbch kh\u1eed khu\u1ea9n th\u00e0nh ph\u1ea9m ph\u1ea3i c\u0103n c\u1ee9 v\u00e0o specification t\u01b0\u01a1ng \u1ee9ng. V\u00ed d\u1ee5, CoA QT SDA 70% v\u00f4 tr\u00f9ng, m\u00e3 QT2514-128, l\u00f4 30000822 c\u00f4ng b\u1ed1 specification v\u00e0 k\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m d\u01b0\u1edbi 0,25 EU\/mL. \u0110\u00e2y l\u00e0 d\u1eef li\u1ec7u c\u1ee7a l\u00f4 \u0111\u01b0\u1ee3c ki\u1ec3m nghi\u1ec7m, kh\u00f4ng ph\u1ea3i gi\u1edbi h\u1ea1n m\u1eb7c \u0111\u1ecbnh cho m\u1ecdi Ethanol<\/span><\/p>\n<p><span style=\"font-weight: 400;\">QA\/QC c\u1ea7n ki\u1ec3m tra ch\u1ec9 ti\u00eau, ph\u01b0\u01a1ng ph\u00e1p th\u1eed v\u00e0 k\u1ebft qu\u1ea3 c\u1ee7a \u0111\u00fang m\u00e3\/l\u00f4, kh\u00f4ng ch\u1ec9 d\u1ef1a v\u00e0o ch\u1ea5t l\u01b0\u1ee3ng WFI \u0111\u1ea7u v\u00e0o.<\/span><\/p>\n<h3><b>D\u01b0 l\u01b0\u1ee3ng sau bay h\u01a1i (ROE) v\u00e0 y\u00eau c\u1ea7u ki\u1ec3m so\u00e1t b\u1ec1 m\u1eb7t<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Residue on Evaporation (ROE), hay d\u01b0 l\u01b0\u1ee3ng sau bay h\u01a1i, l\u00e0 l\u01b0\u1ee3ng ch\u1ea5t c\u00f2n l\u1ea1i khi dung m\u00f4i bay h\u01a1i theo \u0111i\u1ec1u ki\u1ec7n th\u1eed x\u00e1c \u0111\u1ecbnh. D\u01b0 l\u01b0\u1ee3ng c\u00f3 th\u1ec3 xu\u1ea5t ph\u00e1t t\u1eeb t\u1ea1p ch\u1ea5t kh\u00f4ng bay h\u01a1i trong nguy\u00ean li\u1ec7u, n\u01b0\u1edbc pha ch\u1ebf ho\u1eb7c c\u00e1c th\u00e0nh ph\u1ea7n c\u1ee7a c\u00f4ng th\u1ee9c. Ki\u1ec3m so\u00e1t ROE\/NVR c\u00f3 \u00fd ngh\u0129a khi s\u1eed d\u1ee5ng tr\u00ean b\u1ec1 m\u1eb7t inox, k\u00ednh v\u00e0 thi\u1ebft b\u1ecb c\u00f3 y\u00eau c\u1ea7u v\u1ec7 sinh nghi\u00eam ng\u1eb7t.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Trong chuy\u00ean lu\u1eadn Alcohol c\u1ee7a USP Herbal Medicines Compendium, ph\u00e9p th\u1eed Limit of Nonvolatile Residue c\u00f3 gi\u1edbi h\u1ea1n kh\u00f4ng qu\u00e1 2,5 mg t\u1eeb 100 mL m\u1eabu Alcohol. \u0110\u00e2y l\u00e0 v\u00ed d\u1ee5 v\u1ec1 gi\u1edbi h\u1ea1n c\u1ee7a nguy\u00ean li\u1ec7u thu\u1ed9c ph\u1ea1m vi chuy\u00ean lu\u1eadn, kh\u00f4ng ph\u1ea3i gi\u1edbi h\u1ea1n b\u1eaft bu\u1ed9c chung c\u1ee7a dung d\u1ecbch QT SDA 70% th\u00e0nh ph\u1ea9m.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">EU GMP Annex 1, m\u1ee5c 4.33 y\u00eau c\u1ea7u ch\u01b0\u01a1ng tr\u00ecnh v\u1ec7 sinh lo\u1ea1i b\u1ecf hi\u1ec7u qu\u1ea3 d\u01b0 l\u01b0\u1ee3ng ch\u1ea5t kh\u1eed khu\u1ea9n. QuantumTec m\u00f4 t\u1ea3 QT SDA c\u00f3 \u0111\u1eb7c t\u00ednh \u00edt \u0111\u1ec3 l\u1ea1i c\u1eb7n sau bay h\u01a1i; tuy nhi\u00ean, ch\u01b0a c\u00f3 t\u00e0i li\u1ec7u \u0111\u01b0\u1ee3c x\u00e1c minh ch\u1ee9ng minh gi\u1edbi h\u1ea1n ROE d\u01b0\u1edbi 0,01% w\/v ri\u00eang cho QT SDA. N\u1ebfu quy tr\u00ecnh y\u00eau c\u1ea7u gi\u1edbi h\u1ea1n \u0111\u1ecbnh l\u01b0\u1ee3ng, QA\/QC c\u1ea7n \u0111\u1ed1i chi\u1ebfu specification, ph\u01b0\u01a1ng ph\u00e1p th\u1eed, k\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m v\u00e0 SOP v\u1ec7 sinh c\u1ee7a nh\u00e0 m\u00e1y<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Bao_bi_bao_quan_va_truy_xuat_nguon_goc_Ethanol_phong_sach\"><\/span><b>Bao b\u00ec, b\u1ea3o qu\u1ea3n v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c Ethanol ph\u00f2ng s\u1ea1ch<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_14076\" aria-describedby=\"caption-attachment-14076\" style=\"width: 847px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-large wp-image-14076\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/bao-bi-qt-70-sda-quantumtec-san-pham-thuc-1024x819.png\" alt=\"C\u00e1c d\u1ea1ng bao b\u00ec QT 70 SDA QuantumTec g\u1ed3m can, chai x\u1ecbt, chai n\u1eafp v\u1eb7n v\u00e0 kh\u0103n lau t\u1ea9m s\u1eb5n\" width=\"847\" height=\"677\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/bao-bi-qt-70-sda-quantumtec-san-pham-thuc-1024x819.png 1024w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/bao-bi-qt-70-sda-quantumtec-san-pham-thuc-300x240.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/bao-bi-qt-70-sda-quantumtec-san-pham-thuc-768x614.png 768w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/bao-bi-qt-70-sda-quantumtec-san-pham-thuc-80x64.png 80w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/bao-bi-qt-70-sda-quantumtec-san-pham-thuc-600x480.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/bao-bi-qt-70-sda-quantumtec-san-pham-thuc.png 1200w\" sizes=\"(max-width: 847px) 100vw, 847px\" \/><figcaption id=\"caption-attachment-14076\" class=\"wp-caption-text\">H\u00ecnh \u1ea3nh minh h\u1ecda h\u1ec7 th\u1ed1ng bao b\u00ec s\u1ea3n ph\u1ea9m s\u1eed d\u1ee5ng trong m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch.<\/figcaption><\/figure>\n<h3><b>H\u1ec7 th\u1ed1ng bao b\u00ec v\u00e0 ki\u1ec3m so\u00e1t nhi\u1ec5m khi \u0111\u01b0a Ethanol v\u00e0o ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Theo EU GMP Annex 1, m\u1ee5c 4.11\u20134.12, chuy\u1ec3n v\u1eadt t\u01b0 v\u00e0o Grade A\/B c\u1ea7n \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u0111\u1ec3 gi\u1ea3m nguy c\u01a1 \u0111\u01b0a vi sinh v\u1eadt v\u00e0 ti\u1ec3u ph\u00e2n t\u1eeb b\u00ean ngo\u00e0i v\u00e0o. \u0110\u1ed1i v\u1edbi QT SDA v\u00f4 tr\u00f9ng, QuantumTec c\u00f4ng b\u1ed1 \u0111\u00f3ng t\u00fai k\u00e9p (double-bagged) b\u1eb1ng t\u00fai poly h\u00e0n k\u00edn, h\u1ed7 tr\u1ee3 th\u00e1o l\u1ea7n l\u01b0\u1ee3t c\u00e1c l\u1edbp bao b\u00ec t\u1ea1i \u0111i\u1ec3m chuy\u1ec3n giao theo quy tr\u00ecnh \u0111\u00e3 ph\u00ea duy\u1ec7t. Vi\u1ec7c \u0111\u00f3ng t\u00fai k\u00e9p kh\u00f4ng thay th\u1ebf SOP kh\u1eed khu\u1ea9n bao b\u00ec ho\u1eb7c quy tr\u00ecnh chuy\u1ec3n v\u1eadt t\u01b0 c\u1ee7a nh\u00e0 m\u00e1y<\/span><\/p>\n<p><span style=\"font-weight: 400;\">V\u1edbi m\u1ed9t s\u1ed1 quy c\u00e1ch, h\u1ec7 th\u1ed1ng Bag-in-Bottle l\u00e0 c\u01a1 c\u1ea5u c\u1ea5p ph\u00e1t k\u00edn gi\u00fap h\u1ea1n ch\u1ebf kh\u00f4ng kh\u00ed b\u00ean ngo\u00e0i \u0111i ng\u01b0\u1ee3c v\u00e0o chai. Tuy nhi\u00ean, kh\u00f4ng ph\u1ea3i t\u1ea5t c\u1ea3 QT SDA \u0111\u1ec1u d\u00f9ng Bag-in-Bottle: TDS c\u00f2n li\u1ec7t k\u00ea Trigger Spray v\u00e0 Screw Cap. Tr\u1ea1ng th\u00e1i v\u00f4 tr\u00f9ng, c\u1ea5u h\u00ecnh \u0111\u00f3ng g\u00f3i v\u00e0 m\u00e3 SKU ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m tra ri\u00eang<\/span><\/p>\n<h3><b>\u0110i\u1ec1u ki\u1ec7n b\u1ea3o qu\u1ea3n, h\u1ea1n s\u1eed d\u1ee5ng v\u00e0 truy xu\u1ea5t theo l\u00f4<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Ethanol l\u00e0 ch\u1ea5t d\u1ec5 ch\u00e1y. Theo SDS QuantumTec, QT SDA c\u1ea7n l\u01b0u t\u1ea1i n\u01a1i m\u00e1t, kh\u00f4, th\u00f4ng tho\u00e1ng, tr\u00e1nh \u00e1nh n\u1eafng, ngu\u1ed3n nhi\u1ec7t, ngu\u1ed3n g\u00e2y ch\u00e1y v\u00e0 ch\u1ea5t kh\u00f4ng t\u01b0\u01a1ng th\u00edch. SDS kh\u00f4ng x\u00e1c nh\u1eadn gi\u1edbi h\u1ea1n chung 18\u201325\u00b0C ho\u1eb7c 40\u201360% RH cho c\u00e1c quy c\u00e1ch \u0111\u01b0\u1ee3c xem x\u00e9t; v\u00ec v\u1eady kh\u00f4ng \u0111\u01b0a c\u00e1c kho\u1ea3ng n\u00e0y th\u00e0nh y\u00eau c\u1ea7u m\u1eb7c \u0111\u1ecbnh.<\/span><a href=\"https:\/\/quantumtec.com.my\/wp-content\/uploads\/2023\/06\/PMA-QT-Safety-Data-Sheet-70-SDA-Jun-2023-EN-QT2500-0I.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">\u00a0<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">TDS QuantumTec c\u00f4ng b\u1ed1 shelf life 36 th\u00e1ng \u0111\u1ed1i v\u1edbi nhi\u1ec1u m\u00e3 QT SDA d\u1ea1ng chai, nh\u01b0 Bag-in-Bottle 473 mL\/946 mL, Trigger Spray v\u00e0 Screw Cap 1 gallon; th\u1eddi h\u1ea1n c\u1ee5 th\u1ec3 ph\u1ea3i c\u0103n c\u1ee9 \u0111\u00fang SKU v\u00e0 nh\u00e3n l\u00f4. Shelf life ch\u01b0a m\u1edf kh\u00f4ng \u0111\u1ed3ng ngh\u0129a th\u1eddi h\u1ea1n s\u1eed d\u1ee5ng sau m\u1edf (in-use shelf life). Ch\u1ec9 s\u1eed d\u1ee5ng th\u1eddi h\u1ea1n sau m\u1edf khi c\u00f3 d\u1eef li\u1ec7u ph\u00f9 h\u1ee3p v\u00e0 SOP ph\u00ea duy\u1ec7t.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Khi ti\u1ebfp nh\u1eadn, QA\/QC ki\u1ec3m tra m\u00e3 h\u00e0ng, tr\u1ea1ng th\u00e1i bao b\u00ec, s\u1ed1 l\u00f4, h\u1ea1n d\u00f9ng v\u00e0 h\u1ed3 s\u01a1 t\u01b0\u01a1ng \u1ee9ng. Kh\u1ea3 n\u0103ng truy xu\u1ea5t theo l\u00f4 h\u1ed7 tr\u1ee3 x\u1eed l\u00fd sai l\u1ec7ch, \u0111\u00e1nh gi\u00e1 nh\u00e0 cung c\u1ea5p v\u00e0 thanh tra GMP.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Hieu_luc_khu_khuan_cua_Ethanol_70_va_gioi_han_su_dung\"><\/span><b>Hi\u1ec7u l\u1ef1c kh\u1eed khu\u1ea9n c\u1ee7a Ethanol 70% v\u00e0 gi\u1edbi h\u1ea1n s\u1eed d\u1ee5ng<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_14080\" aria-describedby=\"caption-attachment-14080\" style=\"width: 847px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-large wp-image-14080\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/lau-khu-khuan-be-mat-inox-phong-sach-1024x576.png\" alt=\"Nh\u00e2n vi\u00ean ph\u00f2ng s\u1ea1ch s\u1eed d\u1ee5ng kh\u0103n lau v\u1ec7 sinh b\u1ec1 m\u1eb7t thi\u1ebft b\u1ecb inox\" width=\"847\" height=\"476\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/lau-khu-khuan-be-mat-inox-phong-sach-1024x576.png 1024w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/lau-khu-khuan-be-mat-inox-phong-sach-300x169.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/lau-khu-khuan-be-mat-inox-phong-sach-768x432.png 768w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/lau-khu-khuan-be-mat-inox-phong-sach-80x45.png 80w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/lau-khu-khuan-be-mat-inox-phong-sach-600x338.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/10\/lau-khu-khuan-be-mat-inox-phong-sach.png 1200w\" sizes=\"(max-width: 847px) 100vw, 847px\" \/><figcaption id=\"caption-attachment-14080\" class=\"wp-caption-text\">\u1ea2nh minh h\u1ecda thao t\u00e1c lau v\u1ec7 sinh thi\u1ebft b\u1ecb inox trong ph\u00f2ng s\u1ea1ch d\u01b0\u1ee3c ph\u1ea9m<\/figcaption><\/figure>\n<h3><b>C\u01a1 ch\u1ebf kh\u1eed khu\u1ea9n, n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Ethanol t\u00e1c \u0111\u1ed9ng ch\u1ee7 y\u1ebfu th\u00f4ng qua bi\u1ebfn t\u00ednh protein, l\u00e0m gi\u00e1n \u0111o\u1ea1n ho\u1ea1t \u0111\u1ed9ng thi\u1ebft y\u1ebfu c\u1ee7a t\u1ebf b\u00e0o. CDC ghi nh\u1eadn c\u00e1c dung d\u1ecbch alcohol trong kho\u1ea3ng 60\u201390% v\/v c\u00f3 hi\u1ec7u l\u1ef1c di\u1ec7t khu\u1ea9n t\u1ed1t \u0111\u1ed1i v\u1edbi nhi\u1ec1u vi khu\u1ea9n sinh d\u01b0\u1ee1ng; n\u01b0\u1edbc h\u1ed7 tr\u1ee3 qu\u00e1 tr\u00ecnh bi\u1ebfn t\u00ednh protein, v\u00ec v\u1eady Ethanol tuy\u1ec7t \u0111\u1ed1i kh\u00f4ng m\u1eb7c nhi\u00ean di\u1ec7t khu\u1ea9n t\u1ed1t h\u01a1n. Khi so s\u00e1nh v\u1edbi QT SDA, c\u1ea7n \u0111\u1ed1i chi\u1ebfu \u0111\u01a1n v\u1ecb n\u1ed3ng \u0111\u1ed9 v\u00e0 c\u00f4ng th\u1ee9c trong SDS\/specification, kh\u00f4ng \u0111\u1ed3ng nh\u1ea5t t\u1ef7 l\u1ec7 SDA v\u1edbi ph\u1ea7n tr\u0103m Ethanol nguy\u00ean ch\u1ea5t<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ethanol c\u00f3 hi\u1ec7u l\u1ef1c \u0111\u1ed1i v\u1edbi nhi\u1ec1u virus, \u0111\u1eb7c bi\u1ec7t nh\u00f3m c\u00f3 v\u1ecf b\u1ecdc lipid; \u0111\u00e1p \u1ee9ng \u0111\u1ed1i v\u1edbi virus kh\u00f4ng c\u00f3 v\u1ecf c\u00f3 th\u1ec3 kh\u00e1c nhau. Th\u1eddi gian ti\u1ebfp x\u00fac (contact time) v\u00e0 th\u1eddi gian b\u1ec1 m\u1eb7t c\u00f2n \u01b0\u1edbt ph\u1ea3i \u0111\u01b0\u1ee3c xem x\u00e9t v\u00ec Ethanol bay h\u01a1i nhanh. Kh\u00f4ng th\u1ec3 \u00e1p d\u1ee5ng chung m\u1ed9t th\u1eddi gian nh\u01b0 30 gi\u00e2y ho\u1eb7c 1 ph\u00fat n\u1ebfu ch\u01b0a c\u00f3 th\u1eed nghi\u1ec7m hi\u1ec7u l\u1ef1c c\u1ee7a \u0111\u00fang s\u1ea3n ph\u1ea9m, vi sinh v\u1eadt m\u1ee5c ti\u00eau v\u00e0 lo\u1ea1i b\u1ec1 m\u1eb7t.<\/span><\/p>\n<h3><b>Gi\u1edbi h\u1ea1n di\u1ec7t b\u00e0o t\u1eed v\u00e0 vai tr\u00f2 c\u1ee7a Sporicide trong ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Ethanol 70% kh\u00f4ng c\u00f3 hi\u1ec7u l\u1ef1c di\u1ec7t b\u00e0o t\u1eed vi khu\u1ea9n \u0111\u00e1ng tin c\u1eady trong \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng th\u00f4ng th\u01b0\u1eddng. Do \u0111\u00f3, Ethanol kh\u00f4ng thay th\u1ebf \u0111\u01b0\u1ee3c ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed chuy\u00ean d\u1ee5ng (Sporicide) trong ch\u01b0\u01a1ng tr\u00ecnh v\u1ec7 sinh c\u1ea7n ki\u1ec3m so\u00e1t nguy c\u01a1 b\u00e0o t\u1eed<\/span><\/p>\n<p><span style=\"font-weight: 400;\">EU GMP Annex 1, m\u1ee5c 4.33\u20134.34 y\u00eau c\u1ea7u s\u1eed d\u1ee5ng nhi\u1ec1u t\u00e1c nh\u00e2n kh\u1eed khu\u1ea9n c\u00f3 c\u01a1 ch\u1ebf ph\u00f9 h\u1ee3p v\u00e0 \u0111\u1ecbnh k\u1ef3 \u00e1p d\u1ee5ng ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed; quy tr\u00ecnh ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh theo c\u00e1ch d\u00f9ng v\u00e0 v\u1eadt li\u1ec7u b\u1ec1 m\u1eb7t th\u1ef1c t\u1ebf. T\u1ea7n su\u1ea5t, lo\u1ea1i t\u00e1c nh\u00e2n v\u00e0 \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng c\u1ea7n do CCS\/SOP c\u1ee7a nh\u00e0 m\u00e1y x\u00e1c \u0111\u1ecbnh. C\u00f3 th\u1ec3 xem th\u00eam b\u00e0i<\/span><a href=\"https:\/\/sepro.vn\/vi\/hoa-chat-khu-khuan-phong-sach-theo-gmp-eu\/\"> <span style=\"font-weight: 400;\">H\u00f3a ch\u1ea5t kh\u1eed khu\u1ea9n ph\u00f2ng s\u1ea1ch theo GMP \u2013 EU<\/span><\/a><span style=\"font-weight: 400;\"> \u0111\u1ec3 hi\u1ec3u ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n \u1edf c\u1ea5p \u0111\u1ed9 t\u1ed5ng th\u1ec3.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Checklist_lua_chon_Ethanol_phong_sach_theo_yeu_cau_QAQC\"><\/span><b>Checklist l\u1ef1a ch\u1ecdn Ethanol ph\u00f2ng s\u1ea1ch theo y\u00eau c\u1ea7u QA\/QC<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u0110\u1ec3 chuy\u1ec3n c\u00e1c ti\u00eau ch\u00ed k\u1ef9 thu\u1eadt th\u00e0nh b\u01b0\u1edbc \u0111\u00e1nh gi\u00e1 c\u1ee5 th\u1ec3, QA\/QC n\u00ean x\u00e1c \u0111\u1ecbnh y\u00eau c\u1ea7u khu v\u1ef1c tr\u01b0\u1edbc, sau \u0111\u00f3 \u0111\u1ed1i chi\u1ebfu th\u00f4ng s\u1ed1 v\u00e0 h\u1ed3 s\u01a1 nh\u00e0 s\u1ea3n xu\u1ea5t.<\/span><\/p>\n<h3><b>X\u00e1c \u0111\u1ecbnh y\u00eau c\u1ea7u theo khu v\u1ef1c v\u00e0 m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Tr\u01b0\u1edbc khi xem TDS, h\u00e3y x\u00e1c \u0111\u1ecbnh Grade A\/B\/C\/D, b\u1ec1 m\u1eb7t c\u1ea7n x\u1eed l\u00fd, ph\u01b0\u01a1ng ph\u00e1p c\u1ea5p ph\u00e1t, vi sinh v\u1eadt m\u1ee5c ti\u00eau, contact time v\u00e0 y\u00eau c\u1ea7u trong CCS. V\u1edbi Grade A\/B, tr\u1ea1ng th\u00e1i v\u00f4 tr\u00f9ng tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng l\u00e0 y\u00eau c\u1ea7u theo EU GMP Annex 1, m\u1ee5c 4.35. \u0110\u1ed3ng th\u1eddi, m\u1ee5c 4.34 y\u00eau c\u1ea7u th\u1ea9m \u0111\u1ecbnh hi\u1ec7u l\u1ef1c theo \u0111i\u1ec1u ki\u1ec7n v\u00e0 v\u1eadt li\u1ec7u b\u1ec1 m\u1eb7t s\u1eed d\u1ee5ng.<\/span><\/p>\n<h3><b>Checklist ki\u1ec3m tra th\u00f4ng s\u1ed1 v\u00e0 h\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt Ethanol<\/b><\/h3>\n<table>\n<tbody>\n<tr>\n<td><b>Nh\u00f3m \u0111\u00e1nh gi\u00e1<\/b><\/td>\n<td><b>C\u1ea7n \u0111\u1ed1i chi\u1ebfu<\/b><\/td>\n<td><b>H\u1ed3 s\u01a1<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Th\u00e0nh ph\u1ea7n<\/span><\/td>\n<td><span style=\"font-weight: 400;\">N\u1ed3ng \u0111\u1ed9 Ethanol\/SDA, lo\u1ea1i ch\u1ea5t bi\u1ebfn t\u00ednh, \u0111\u01a1n v\u1ecb n\u1ed3ng \u0111\u1ed9<\/span><\/td>\n<td><span style=\"font-weight: 400;\">TDS, SDS, CoA<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Nguy\u00ean li\u1ec7u<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Ti\u00eau chu\u1ea9n nguy\u00ean li\u1ec7u, n\u01b0\u1edbc pha ch\u1ebf\/WFI n\u1ebfu \u00e1p d\u1ee5ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">TDS, Specification<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">V\u00f4 tr\u00f9ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Sterile\/Non-Sterile theo SKU; l\u1ecdc, Gamma, SAL n\u1ebfu \u00e1p d\u1ee5ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">TDS, CoA, COI<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Ch\u1ec9 ti\u00eau ch\u1ea5t l\u01b0\u1ee3ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Endotoxin, ROE\/NVR n\u1ebfu c\u00f3 y\u00eau c\u1ea7u v\u00e0 gi\u1edbi h\u1ea1n \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Specification, CoA<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Hi\u1ec7u l\u1ef1c<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Vi sinh v\u1eadt m\u1ee5c ti\u00eau, contact time, \u0111i\u1ec1u ki\u1ec7n th\u1eed, b\u1ec1 m\u1eb7t<\/span><\/td>\n<td><span style=\"font-weight: 400;\">B\u00e1o c\u00e1o hi\u1ec7u l\u1ef1c, validation<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Bao b\u00ec<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u1ea5u h\u00ecnh b\u00ecnh, \u0111\u00f3ng t\u00fai, t\u00ednh to\u00e0n v\u1eb9n, quy tr\u00ecnh chuy\u1ec3n v\u1eadt t\u01b0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">TDS, nh\u00e3n, SOP<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">B\u1ea3o qu\u1ea3n<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u0110i\u1ec1u ki\u1ec7n l\u01b0u kho, h\u1ea1n ch\u01b0a m\u1edf v\u00e0 sau m\u1edf<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SDS, nh\u00e3n, IFU\/SOP<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Truy xu\u1ea5t<\/span><\/td>\n<td><span style=\"font-weight: 400;\">M\u00e3 h\u00e0ng, s\u1ed1 l\u00f4, ng\u00e0y h\u1ebft h\u1ea1n, ch\u1ee9ng t\u1eeb ph\u00f9 h\u1ee3p<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Nh\u00e3n, CoA, COI<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">Nh\u1eefng ch\u1ec9 ti\u00eau nh\u01b0 WFI, Gamma 25\u201345 kGy ho\u1eb7c SAL 10\u207b\u2076 ph\u1ea3i \u0111\u1ed1i chi\u1ebfu v\u1edbi \u0111\u00fang s\u1ea3n ph\u1ea9m v\u00e0 phi\u00ean b\u1ea3n. V\u1edbi h\u00f3a ch\u1ea5t pha s\u1eb5n, EU GMP Annex 1, m\u1ee5c 4.35 cho ph\u00e9p xem x\u00e9t CoA\/ch\u1ee9ng nh\u1eadn ph\u00f9 h\u1ee3p sau khi \u0111\u00e1nh gi\u00e1 nh\u00e0 cung c\u1ea5p th\u00edch h\u1ee3p. <\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Ket_luan\"><\/span><b>K\u1ebft lu\u1eadn<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">L\u1ef1a ch\u1ecdn Ethanol ph\u00f2ng s\u1ea1ch kh\u00f4ng ch\u1ec9 d\u1ef1a v\u00e0o n\u1ed3ng \u0111\u1ed9 c\u1ed3n 70% m\u00e0 c\u00f2n c\u1ea7n \u0111\u00e1nh gi\u00e1 th\u00e0nh ph\u1ea7n nguy\u00ean li\u1ec7u, tr\u1ea1ng th\u00e1i v\u00f4 tr\u00f9ng, hi\u1ec7u l\u1ef1c kh\u1eed khu\u1ea9n, d\u01b0 l\u01b0\u1ee3ng v\u00e0 h\u1ed3 s\u01a1 ch\u1ea5t l\u01b0\u1ee3ng. \u0110\u1eb7c bi\u1ec7t, t\u1ea1i Grade A\/B, ch\u1ea5t kh\u1eed khu\u1ea9n ph\u1ea3i \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u v\u00f4 tr\u00f9ng theo EU GMP Annex 1<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u0110\u1ed1i chi\u1ebfu y\u00eau c\u1ea7u s\u1eed d\u1ee5ng v\u1edbi TDS, SDS, specification, CoA v\u00e0 d\u1eef li\u1ec7u th\u1ea9m \u0111\u1ecbnh l\u00e0 c\u01a1 s\u1edf gi\u00fap QA\/QC l\u1ef1a ch\u1ecdn s\u1ea3n ph\u1ea9m ph\u00f9 h\u1ee3p. SEPRO cung c\u1ea5p c\u00e1c d\u00f2ng QT SDA 70% c\u1ee7a QuantumTec cho m\u00f4i tr\u01b0\u1eddng c\u00f3 ki\u1ec3m so\u00e1t. Tham kh\u1ea3o<\/span><a href=\"https:\/\/sepro.vn\/vi\/product-category\/quantumtec-cleanroom-disinfections\/dung-dich-qt-sda\/\"> <span style=\"font-weight: 400;\">danh m\u1ee5c QT SDA t\u1ea1i SEPRO<\/span><\/a><span style=\"font-weight: 400;\"> ho\u1eb7c<\/span><a href=\"https:\/\/sepro.vn\/vi\/product\/qt-sda-70-specially-denatured-ethanol-with-ipa\/\"> <span style=\"font-weight: 400;\">s\u1ea3n ph\u1ea9m QT SDA with IPA<\/span><\/a><span style=\"font-weight: 400;\"> \u0111\u1ec3 t\u00ecm hi\u1ec3u c\u1ea5u h\u00ecnh bao b\u00ec v\u00e0 y\u00eau c\u1ea7u b\u1ed9 h\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt cho \u0111\u00fang m\u00e3 h\u00e0ng.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"FAQ\"><\/span><b>FAQ<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><b>1. Ethanol 70% th\u00f4ng th\u01b0\u1eddng c\u00f3 s\u1eed d\u1ee5ng \u0111\u01b0\u1ee3c trong ph\u00f2ng s\u1ea1ch Grade A\/B kh\u00f4ng?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Kh\u00f4ng th\u1ec3 k\u1ebft lu\u1eadn ch\u1ec9 d\u1ef1a v\u00e0o n\u1ed3ng \u0111\u1ed9 70%. S\u1ea3n ph\u1ea9m c\u1ea7n \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u v\u00f4 tr\u00f9ng tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng t\u1ea1i Grade A\/B v\u00e0 c\u00e1c ti\u00eau ch\u00ed ph\u00f9 h\u1ee3p v\u1edbi quy tr\u00ecnh c\u1ee7a nh\u00e0 m\u00e1y EU GMP Annex 1, m\u1ee5c 4.35 y\u00eau c\u1ea7u ch\u1ea5t kh\u1eed khu\u1ea9n d\u00f9ng t\u1ea1i Grade A\/B ph\u1ea3i v\u00f4 tr\u00f9ng tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng<\/span><\/p>\n<h3><b>2. Ethanol ph\u00f2ng s\u1ea1ch c\u00f3 b\u1eaft bu\u1ed9c pha ch\u1ebf b\u1eb1ng WFI kh\u00f4ng?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Kh\u00f4ng b\u1eaft bu\u1ed9c trong m\u1ecdi tr\u01b0\u1eddng h\u1ee3p. Tuy nhi\u00ean, WFI gi\u00fap ki\u1ec3m so\u00e1t endotoxin t\u1eeb n\u01b0\u1edbc pha ch\u1ebf; Ph. Eur. 0169 quy \u0111\u1ecbnh WFI c\u00f3 endotoxin d\u01b0\u1edbi 0,25 IU\/mL<\/span><\/p>\n<h3><b>3. Ethanol l\u1ecdc qua m\u00e0ng 0,22 \u00b5m \u0111\u00e3 \u0111\u01b0\u1ee3c xem l\u00e0 v\u00f4 tr\u00f9ng ch\u01b0a?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">C\u00e1c h\u00f3a ch\u1ea5t \u0111\u01b0\u1ee3c l\u1ecdc qua m\u00e0ng 0,22\u00b5m ch\u01b0a \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u1ec3 k\u1ebft lu\u1eadn l\u00e0 v\u00f4 tr\u00f9ng. T\u00ednh v\u00f4 tr\u00f9ng ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng minh b\u1eb1ng to\u00e0n b\u1ed9 quy tr\u00ecnh s\u1ea3n xu\u1ea5t v\u00e0 d\u1eef li\u1ec7u b\u1ea3o \u0111\u1ea3m v\u00f4 tr\u00f9ng c\u1ee7a th\u00e0nh ph\u1ea9m.<\/span><\/p>\n<h3><b>4. Ethanol 70% c\u00f3 thay th\u1ebf \u0111\u01b0\u1ee3c Sporicide kh\u00f4ng?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Kh\u00f4ng. Ethanol kh\u00f4ng c\u00f3 hi\u1ec7u l\u1ef1c di\u1ec7t b\u00e0o t\u1eed \u0111\u00e1ng tin c\u1eady trong \u0111i\u1ec1u ki\u1ec7n th\u00f4ng th\u01b0\u1eddng; Annex 1 y\u00eau c\u1ea7u ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n \u0111\u1ecbnh k\u1ef3 d\u00f9ng Sporicide ph\u00f9 h\u1ee3p<\/span><\/p>\n<h3><b>5. Ethanol ph\u00f2ng s\u1ea1ch s\u1eed d\u1ee5ng \u0111\u01b0\u1ee3c bao l\u00e2u sau khi m\u1edf n\u1eafp?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Th\u1eddi h\u1ea1n s\u1eed d\u1ee5ng sau khi m\u1edf ph\u1ee5 thu\u1ed9c v\u00e0o c\u00f4ng th\u1ee9c, thi\u1ebft k\u1ebf bao b\u00ec v\u00e0 d\u1eef li\u1ec7u h\u00e3ng. C\u1ea7n tu\u00e2n th\u1ee7 th\u1eddi h\u1ea1n sau m\u1edf \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 v\u00e0 ph\u00ea duy\u1ec7t trong SOP, kh\u00f4ng l\u1ea5y h\u1ea1n d\u00f9ng ch\u01b0a m\u1edf \u0111\u1ec3 suy ra.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Nguon_tham_khao_va_tai_lieu_ky_thuat\"><\/span><b>Ngu\u1ed3n tham kh\u1ea3o v\u00e0 t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>[1]<\/b><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf\" rel=\"nofollow noopener\" target=\"_blank\"> <span style=\"font-weight: 400;\">European Commission, EU GMP Annex 1 (2022), m\u1ee5c 2.1, 4.11\u20134.12, 4.33\u20134.35, 6.7 v\u00e0 8.79<\/span><\/a><\/p>\n<p><b>[2]<\/b><a href=\"https:\/\/www.edqm.eu\/documents\/52006\/0\/2024%2BBio%2BTraining%2BModule%2B4%2B-%2Bpresentations-web.pdf\/4dd00e74-b2f0-9c97-043e-ddac702683b8\" rel=\"nofollow noopener\" target=\"_blank\"> <span style=\"font-weight: 400;\">EDQM, \u0111\u00e0o t\u1ea1o Ph. Eur. (2024), chuy\u00ean lu\u1eadn Water for Injections 0169, tr. 129<\/span><\/a><\/p>\n<p><b>[3]<\/b><a href=\"https:\/\/www.cdc.gov\/infection-control\/hcp\/disinfection-sterilization\/chemical-disinfectants.html\" rel=\"nofollow noopener\" target=\"_blank\"> <span style=\"font-weight: 400;\">CDC, Guideline for Disinfection and Sterilization, Chemical Disinfectants \u2013 Alcohol<\/span><\/a><\/p>\n<p><b>[4]<\/b><a href=\"https:\/\/hmctest.usp.org\/monograph\/alcohol-0\" rel=\"nofollow noopener\" target=\"_blank\"> <span style=\"font-weight: 400;\">USP Herbal Medicines Compendium, Alcohol, ph\u00e9p th\u1eed Limit of Nonvolatile Residue<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Trong m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m, \u0111\u1eb7c bi\u1ec7t t\u1ea1i c\u00e1c khu v\u1ef1c c\u00f3 y\u00eau c\u1ea7u ki\u1ec3m so\u00e1t nhi\u1ec5m nghi\u00eam ng\u1eb7t, c\u1ed3n Ethanol 70% th\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 kh\u1eed khu\u1ea9n b\u1ec1 m\u1eb7t v\u00e0 thi\u1ebft b\u1ecb. Tuy nhi\u00ean, c\u00f9ng n\u1ed3ng \u0111\u1ed9 70% kh\u00f4ng c\u00f3 ngh\u0129a c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u1ec1u ph\u00f9 h\u1ee3p v\u1edbi m\u1ecdi khu v\u1ef1c &hellip; <a href=\"https:\/\/sepro.vn\/vi\/ethanol-phong-sach-yeu-cau-gmp-eu\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Ethanol Ph\u00f2ng S\u1ea1ch: Y\u00eau C\u1ea7u K\u1ef9 Thu\u1eadt V\u00e0 C\u00e1ch L\u1ef1a Ch\u1ecdn<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":14078,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_daextinma_seo_power":"1000","_daextinma_enable_ail":"","footnotes":""},"categories":[126],"tags":[],"class_list":["post-14075","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"_links":{"self":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/14075","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=14075"}],"version-history":[{"count":5,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/14075\/revisions"}],"predecessor-version":[{"id":14090,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/14075\/revisions\/14090"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/14078"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=14075"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=14075"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=14075"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}