{"id":9216,"date":"2026-02-24T18:51:28","date_gmt":"2026-02-24T18:51:28","guid":{"rendered":"https:\/\/sepro.vn\/?p=9216"},"modified":"2026-06-20T13:28:42","modified_gmt":"2026-06-20T06:28:42","slug":"nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/","title":{"rendered":"N\u01b0\u1edbc WFI L\u00e0 G\u00ec V\u00e0 D\u00f9ng Th\u1ebf N\u00e0o Trong Nh\u00e0 M\u00e1y D\u01b0\u1ee3c GMP"},"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\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#Nuoc_WFI_la_gi_trong_nha_may_duoc\" title=\"N\u01b0\u1edbc WFI l\u00e0 g\u00ec trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c\">N\u01b0\u1edbc WFI l\u00e0 g\u00ec trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c<\/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\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#Nuoc_WFI_la_gi_va_WFI_la_viet_tat_cua_gi\" title=\"N\u01b0\u1edbc WFI l\u00e0 g\u00ec v\u00e0 WFI l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a g\u00ec\">N\u01b0\u1edbc WFI l\u00e0 g\u00ec v\u00e0 WFI l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a g\u00ec<\/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\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#Nuoc_WFI_dung_de_lam_gi_trong_nha_may_duoc\" title=\"N\u01b0\u1edbc WFI d\u00f9ng \u0111\u1ec3 l\u00e0m g\u00ec trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c\">N\u01b0\u1edbc WFI d\u00f9ng \u0111\u1ec3 l\u00e0m g\u00ec trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c<\/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\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#Nuoc_WFI_khac_gi_nuoc_PW\" title=\"N\u01b0\u1edbc WFI kh\u00e1c g\u00ec n\u01b0\u1edbc PW\">N\u01b0\u1edbc WFI kh\u00e1c g\u00ec n\u01b0\u1edbc PW<\/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\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#Yeu_cau_chat_luong_nuoc_WFI_gom_nhung_chi_tieu_nao\" title=\"Y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng n\u01b0\u1edbc WFI g\u1ed3m nh\u1eefng ch\u1ec9 ti\u00eau n\u00e0o\">Y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng n\u01b0\u1edbc WFI g\u1ed3m nh\u1eefng ch\u1ec9 ti\u00eau n\u00e0o<\/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\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#Tan_suat_kiem_nghiem_WFI_theo_khuyen_nghi\" title=\"T\u1ea7n su\u1ea5t ki\u1ec3m nghi\u1ec7m WFI (theo khuy\u1ebfn ngh\u1ecb)\">T\u1ea7n su\u1ea5t ki\u1ec3m nghi\u1ec7m WFI (theo khuy\u1ebfn ngh\u1ecb)<\/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\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#Chien_luoc_lay_mau_theo_rui_ro\" title=\"Chi\u1ebfn l\u01b0\u1ee3c l\u1ea5y m\u1eabu theo r\u1ee7i ro\">Chi\u1ebfn l\u01b0\u1ee3c l\u1ea5y m\u1eabu theo r\u1ee7i ro<\/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\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#He_thong_tao_WFI_va_he_thong_vong_tuan_hoan_luu_tru_phan_phoi\" title=\"H\u1ec7 th\u1ed1ng t\u1ea1o WFI v\u00e0 h\u1ec7 th\u1ed1ng v\u00f2ng tu\u1ea7n ho\u00e0n l\u01b0u tr\u1eef ph\u00e2n ph\u1ed1i\">H\u1ec7 th\u1ed1ng t\u1ea1o WFI v\u00e0 h\u1ec7 th\u1ed1ng v\u00f2ng tu\u1ea7n ho\u00e0n l\u01b0u tr\u1eef ph\u00e2n ph\u1ed1i<\/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\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#Ve_sinh_khu_trung_he_thong_WFI\" title=\"V\u1ec7 sinh kh\u1eed tr\u00f9ng h\u1ec7 th\u1ed1ng WFI\">V\u1ec7 sinh kh\u1eed tr\u00f9ng h\u1ec7 th\u1ed1ng WFI<\/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\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#Lay_mau_nuoc_WFI_dung_cach_va_xu_ly_OOS_OOT\" title=\"L\u1ea5y m\u1eabu n\u01b0\u1edbc WFI \u0111\u00fang c\u00e1ch v\u00e0 x\u1eed l\u00fd OOS OOT\">L\u1ea5y m\u1eabu n\u01b0\u1edbc WFI \u0111\u00fang c\u00e1ch v\u00e0 x\u1eed l\u00fd OOS OOT<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/sepro.vn\/vi\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#FAQ_%E2%80%93_WFI_Water_for_Injection\" title=\"FAQ &#8211; WFI (Water for Injection)\">FAQ &#8211; WFI (Water for Injection)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/sepro.vn\/vi\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/#Tam_Ket\" title=\"T\u1ea1m K\u1ebft\">T\u1ea1m K\u1ebft<\/a><\/li><\/ul><\/nav><\/div>\n<p><span style=\"font-weight: 400;\">C\u00f3 nh\u1eefng ng\u00e0y m\u1ecdi ch\u1ec9 ti\u00eau \u0111\u1ec1u \u0111\u1ea1t, nh\u01b0ng nh\u00ecn bi\u1ec3u \u0111\u1ed3 v\u1eabn th\u1ea5y kh\u00f4ng y\u00ean. WFI l\u00e0 ki\u1ec3u h\u1ec7 th\u1ed1ng nh\u01b0 v\u1eady, nh\u00ecn t\u01b0\u1edfng \u1ed5n m\u00e0 ch\u1ec9 c\u1ea7n m\u1ed9t nh\u00e1nh ch\u1ebft ho\u1eb7c m\u1ed9t thao t\u00e1c l\u1ea5y m\u1eabu l\u1ec7ch l\u00e0 k\u00e9o theo c\u1ea3 chu\u1ed7i \u0111i\u1ec1u tra. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">B\u00e0i n\u00e0y gom l\u1ea1i nh\u1eefng th\u1ee9 c\u1ea7n nh\u1edb, nh\u1eefng m\u1eb9o nh\u1ecf nh\u01b0ng \u0111\u1ee7 \u0111\u1ec3 b\u1ea1n ki\u1ec3m so\u00e1t nh\u1eefng r\u1ee7i ro kh\u00f3 tr\u00e1nh.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Nuoc_WFI_la_gi_trong_nha_may_duoc\"><\/span><b>N\u01b0\u1edbc WFI l\u00e0 g\u00ec trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9219\" aria-describedby=\"caption-attachment-9219\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-9219\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-5.png\" alt=\"nuoc-wfi-la-gi\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-5.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-5-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-5-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-5-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9219\" class=\"wp-caption-text\"><em>N\u01b0\u1edbc WFI l\u00e0 g\u00ec<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">N\u01b0\u1edbc WFI l\u00e0 m\u1ed9t lo\u1ea1i n\u01b0\u1edbc d\u01b0\u1ee3c d\u1ee5ng cho pha ch\u1ebf thu\u1ed1c ti\u00eam v\u00e0 cho c\u00e1c b\u01b0\u1edbc kh\u1eed khu\u1ea9n b\u1ec1 m\u1eb7t thi\u1ebft b\u1ecb, d\u1ee5ng c\u1ee5 y t\u1ebf. <\/span><\/p>\n<p><span style=\"font-weight: 400;\"><strong>\u0110i\u1ec3m c\u1ed1t l\u00f5i \u1edf \u0111\u00e2y l\u00e0 lo\u1ea1i n\u01b0\u1edbc \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ch\u1eb7t v\u1ec1 vi sinh, n\u1ed9i \u0111\u1ed9c t\u1ed1<\/strong> v\u00e0 c\u00e1c ch\u1ec9 ti\u00eau h\u00f3a l\u00fd theo quy tr\u00ecnh c\u1ee7a nh\u00e0 m\u00e1y \u0111\u1ec3 h\u1ea1n ch\u1ebf nhi\u1ec5m b\u1ea9n ng\u01b0\u1ee3c trong v\u1eadn h\u00e0nh.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Nuoc_WFI_la_gi_va_WFI_la_viet_tat_cua_gi\"><\/span><b>N\u01b0\u1edbc WFI l\u00e0 g\u00ec v\u00e0 WFI l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a g\u00ec<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>WFI l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a\u00a0<strong>Water for Injection<\/strong>, hay\u00a0<strong>n\u01b0\u1edbc pha cho ti\u00eam<\/strong>, c\u0169ng g\u1ecdi l\u00e0\u00a0<strong>n\u01b0\u1edbc c\u1ea5t pha ti\u00eam<\/strong>.<\/li>\n<li>\u0110\u00e2y l\u00e0 n\u01b0\u1edbc d\u01b0\u1ee3c d\u1ee5ng th\u01b0\u1eddng d\u00f9ng \u0111\u1ec3 l\u00e0m dung m\u00f4i ho\u1eb7c \u0111\u1ec3 pha lo\u00e3ng trong c\u00e1c c\u00f4ng \u0111o\u1ea1n v\u00f4 tr\u00f9ng n\u00ean y\u00eau c\u1ea7u ki\u1ec3m so\u00e1t r\u1ee7i ro cao h\u01a1n c\u00e1c nh\u00f3m n\u01b0\u1edbc d\u00f9ng cho m\u1ee5c \u0111\u00edch kh\u00f4ng v\u00f4 tr\u00f9ng.<\/li>\n<li><span style=\"font-weight: 400;\"><strong>L\u01b0u \u00fd quan tr\u1ecdng: <\/strong>B\u1ea1n n\u00ean ph\u00e2n bi\u1ec7t r\u00f5 WFI d\u1ea1ng kh\u1ed1i l\u01b0u h\u00e0nh trong h\u1ec7 th\u1ed1ng nh\u00e0 m\u00e1y v\u1edbi n\u01b0\u1edbc d\u00f9ng cho ti\u00eam \u0111\u00e3 ti\u1ec7t khu\u1ea9n v\u00e0 \u0111\u00f3ng g\u00f3i th\u00e0nh ph\u1ea9m, v\u00ec h\u1ed3 s\u01a1 th\u1ea9m \u0111\u1ecbnh v\u00e0 c\u00e1ch qu\u1ea3n tr\u1ecb r\u1ee7i ro c\u1ee7a hai nh\u00f3m n\u00e0y kh\u00f4ng gi\u1ed1ng nhau.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u0110\u1ed1i di\u1ec7n v\u1edbi c\u00e1c c\u00e2u h\u1ecfi \u0111\u1ebfn t\u1eeb nh\u00e0 th\u1ea9m \u0111\u1ecbnh, c\u00e1ch tr\u1ea3 l\u1eddi an to\u00e0n nh\u1ea5t l\u00e0 \u0111i t\u1eeb m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t r\u1ee7i ro, sau \u0111\u00f3 m\u1edbi d\u1eabn sang c\u00e1c ti\u00eau chu\u1ea9n nh\u00e0 m\u00e1y \u0111ang \u00e1p d\u1ee5ng nh\u01b0 <strong>USP (United States Pharmacopeia, D\u01b0\u1ee3c \u0111i\u1ec3n Hoa K\u1ef3) v\u00e0 Ph. Eur. (European Pharmacopoeia, D\u01b0\u1ee3c \u0111i\u1ec3n ch\u00e2u \u00c2u).<\/strong><\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Nuoc_WFI_dung_de_lam_gi_trong_nha_may_duoc\"><\/span><b>N\u01b0\u1edbc WFI d\u00f9ng \u0111\u1ec3 l\u00e0m g\u00ec trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\"><strong>Trong v\u1eadn h\u00e0nh, WFI th\u01b0\u1eddng g\u1eafn v\u1edbi hai nh\u00f3m nhu c\u1ea7u l\u1edbn<\/strong>, v\u1eeba l\u00e0 nguy\u00ean li\u1ec7u cho pha ch\u1ebf h\u00f3a ch\u1ea5t kh\u1eed khu\u1ea9n v\u00f4 tr\u00f9ng v\u1eeba l\u00e0 n\u01b0\u1edbc d\u00f9ng cho b\u01b0\u1edbc v\u1ec7 sinh b\u1ec1 m\u1eb7t thi\u1ebft b\u1ecb, d\u1ee5ng c\u1ee5 ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp s\u1ea3n ph\u1ea9m, v\u00ec \u0111\u00e2y l\u00e0 n\u01a1i r\u1ee7i ro nhi\u1ec5m ng\u01b0\u1ee3c hay xu\u1ea5t hi\u1ec7n n\u1ebfu ch\u1ea5t l\u01b0\u1ee3ng n\u01b0\u1edbc kh\u00f4ng \u1ed5n \u0111\u1ecbnh. <\/span><\/p>\n<p><span style=\"font-weight: 400;\"><strong>\u1ede g\u00f3c \u0111\u1ed9 c\u1ee7a c\u1ea3 QA (Quality Assurance, \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng) v\u00e0 QC (Quality Control, ki\u1ec3m nghi\u1ec7m ch\u1ea5t l\u01b0\u1ee3ng)<\/strong>, m\u1ed7i \u0111i\u1ec3m d\u00f9ng c\u1ea7n c\u00f3 m\u1ee5c \u0111\u00edch r\u00f5 r\u00e0ng \u0111\u1ec3 tr\u00e1nh vi\u1ec7c chi ph\u00ed v\u1eadn h\u00e0nh t\u0103ng nh\u01b0ng hi\u1ec7u qu\u1ea3 v\u1ec7 sinh l\u1ea1i kh\u00f4ng \u0111\u1ea1t y\u00eau c\u1ea7u<\/span><\/p>\n<p><span style=\"font-weight: 400;\">C\u00e1c t\u00ecnh hu\u1ed1ng th\u01b0\u1eddng hay s\u1eed d\u1ee5ng n\u01b0\u1edbc WFI t\u1ea1i c\u00e1c nh\u00e0 m\u00e1y:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Pha dung m\u00f4i, pha lo\u00e3ng ho\u1eb7c v\u1ec7 sinh m\u00f4i tr\u01b0\u1eddng cho thu\u1ed1c ti\u00eam<\/strong> trong khu v\u1ef1c v\u00f4 tr\u00f9ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Tr\u00e1ng l\u1ea1i thi\u1ebft b\u1ecb<\/strong> sau khi v\u1ec7 sinh t\u1ea1i ch\u1ed7 CIP (Clean-In-Place, v\u1ec7 sinh t\u1ea1i ch\u1ed7) tr\u01b0\u1edbc ti\u1ec7t khu\u1ea9n t\u1ea1i ch\u1ed7 SIP (Sterilize-In-Place, ti\u1ec7t khu\u1ea9n t\u1ea1i ch\u1ed7) ho\u1eb7c tr\u01b0\u1edbc khi l\u1eafp r\u00e1p<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>L\u00e0 th\u00e0nh ph\u1ea7n kh\u00f4ng th\u1ec3 thi\u1ebfu<\/strong>, d\u00f9ng c\u00f9ng c\u00e1c dung d\u1ecbch v\u1ec7 sinh, kh\u1eed tr\u00f9ng khi quy tr\u00ecnh l\u00e0m s\u1ea1ch y\u00eau c\u1ea7u n\u01b0\u1edbc \u0111\u1ea1t m\u1ee9c WFI<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>C\u1ea5p n\u01b0\u1edbc cho m\u1ed9t s\u1ed1 thi\u1ebft b\u1ecb c\u00f4ng ngh\u1ec7<\/strong> c\u00f3 y\u00eau c\u1ea7u ki\u1ec3m so\u00e1t n\u1ed9i \u0111\u1ed9c t\u1ed1, t\u00f9y \u0111\u00e1nh gi\u00e1 r\u1ee7i ro v\u00e0 thi\u1ebft k\u1ebf<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">Nhi\u1ec1u nh\u00e0 m\u00e1y hay nh\u1ea7m l\u1eabn \u1edf ch\u1ed7 d\u00f9ng WFI cho m\u1ecdi b\u01b0\u1edbc r\u1eeda t\u1eeb \u0111\u1ea7u v\u1edbi suy ngh\u0129 d\u00f9ng c\u00e0ng nhi\u1ec1u c\u00e0ng s\u1ea1ch, trong khi th\u1ef1c t\u1ebf r\u1ee7i ro th\u1eadt s\u1ef1 n\u1eb1m \u1edf b\u01b0\u1edbc v\u1ec7 sinh cu\u1ed1i v\u1edbi nguy c\u01a1 nhi\u1ec5m ng\u01b0\u1ee3c. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">V\u00ec v\u1eady, ph\u00e2n t\u1ea7ng \u0111\u00fang PW v\u00e0 WFI theo r\u1ee7i ro th\u01b0\u1eddng cho hi\u1ec7u qu\u1ea3 t\u1ed1t h\u01a1n, v\u1eeba ki\u1ec3m so\u00e1t t\u1ed1t v\u1eeba tr\u00e1nh l\u00e3ng ph\u00ed.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Nuoc_WFI_khac_gi_nuoc_PW\"><\/span><b>N\u01b0\u1edbc WFI kh\u00e1c g\u00ec n\u01b0\u1edbc PW<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9221\" aria-describedby=\"caption-attachment-9221\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9221\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-5.png\" alt=\"nghien-cuu-va-kiem-soat-vi-sinh-o-nuoc-wfi\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-5.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-5-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-5-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-5-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9221\" class=\"wp-caption-text\"><em>Nghi\u00ean c\u1ee9u v\u00e0 ki\u1ec3m so\u00e1t vi sinh \u1edf n\u01b0\u1edbc WFI<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\"><strong>WFI kh\u00e1c PW ch\u1ee7 y\u1ebfu n\u1eb1m \u1edf m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 m\u1ee9c ki\u1ec3m so\u00e1t n\u1ed9i \u0111\u1ed9c t\u1ed1<\/strong>, vi sinh v\u00e0 v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng, ch\u1ee9 kh\u00f4ng ch\u1ec9 l\u00e0 t\u1ef7 l\u1ec7 trong COA (Certificate of Analysis, gi\u1ea5y ch\u1ee9ng nh\u1eadn ph\u00e2n t\u00edch) nh\u00ecn th\u1ea5y tr\u00ean gi\u1ea5y. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">N\u00f3i theo ng\u00f4n ng\u1eef v\u1eadn h\u00e0nh th\u00ec :<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"><strong><a href=\"https:\/\/sepro.vn\/vi\/nuoc-pw-purified-water-la-gi\/\">PW th\u01b0\u1eddng d\u00f9ng cho pha ch\u1ebf<\/a><\/strong> kh\u00f4ng v\u00f4 tr\u00f9ng v\u00e0 c\u00e1c b\u01b0\u1edbc v\u1ec7 sinh \u0111\u1ea7u ti\u00ean<\/span><\/li>\n<li><span style=\"font-weight: 400;\"><strong>WFI d\u00f9ng cho pha ch\u1ebf ti\u00eam truy\u1ec1n<\/strong> v\u00e0 b\u01b0\u1edbc tr\u00e1ng cu\u1ed1i li\u00ean quan v\u00f4 tr\u00f9ng v\u00ec y\u00eau c\u1ea7u qu\u1ea3n tr\u1ecb r\u1ee7i ro c\u1ee7a hai nh\u00f3m kh\u00e1c nhau<\/span><\/li>\n<\/ul>\n<h3><b>B\u1ea3ng So S\u00e1nh Chi Ti\u1ebft PW v\u00e0 WFI <a href=\"https:\/\/sepro.vn\/vi\/gmp-eu-annex-1-la-gi\/\">(Theo Ti\u00eau Chu\u1ea9n EU GMP Annex 1)<\/a><\/b><\/h3>\n<table>\n<tbody>\n<tr>\n<td><b>Ti\u00eau ch\u00ed<\/b><\/td>\n<td><b>N\u01b0\u1edbc tinh khi\u1ebft (PW)<\/b><\/td>\n<td><b>N\u01b0\u1edbc c\u1ea5t pha ti\u00eam (WFI)<\/b><\/td>\n<\/tr>\n<tr>\n<td><b>\u1ee8ng d\u1ee5ng ch\u00ednh<\/b><\/td>\n<td><span style=\"font-weight: 400;\">S\u1ea3n xu\u1ea5t thu\u1ed1c kh\u00f4ng v\u00f4 tr\u00f9ng (vi\u00ean n\u00e9n, siro), r\u1eeda thi\u1ebft b\u1ecb ban \u0111\u1ea7u, chu\u1ea9n b\u1ecb thu\u1ed1c th\u1eed<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Dung m\u00f4i thu\u1ed1c ti\u00eam, d\u1ecbch truy\u1ec1n, v\u1eafc-xin, tr\u00e1ng cu\u1ed1i thi\u1ebft b\u1ecb ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp s\u1ea3n ph\u1ea9m v\u00f4 tr\u00f9ng<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>Vi sinh (CFU)<\/b><\/td>\n<td><span style=\"font-weight: 400;\">\u2264100<\/span><b> CFU\/mL<\/b><\/td>\n<td><span style=\"font-weight: 400;\">\u226410<\/span><b> CFU\/100 mL<\/b><\/td>\n<\/tr>\n<tr>\n<td><b>N\u1ed9i \u0111\u1ed9c t\u1ed1 (Endotoxin)<\/b><\/td>\n<td><span style=\"font-weight: 400;\">Kh\u00f4ng quy \u0111\u1ecbnh c\u1ee5 th\u1ec3 trong d\u01b0\u1ee3c \u0111i\u1ec3n.<\/span><\/td>\n<td><span style=\"font-weight: 400;\">&lt;0,25<\/span><b> EU\/mL<\/b><span style=\"font-weight: 400;\">\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>\u0110\u1ed9 d\u1eabn \u0111i\u1ec7n (<\/b><span style=\"font-weight: 400;\">25\u2218C<\/span><b>)<\/b><\/p>\n<p><em><span style=\"font-weight: 400;\">(D\u01b0\u1ee3c \u0111i\u1ec3n quy \u0111\u1ecbnh gi\u1ed1ng nhau nh\u01b0ng th\u1ef1c t\u1ebf ki\u1ec3m so\u00e1t WFI th\u01b0\u1eddng ch\u1eb7t h\u01a1n)<\/span><\/em><\/td>\n<td><span style=\"font-weight: 400;\">\u22641,3\u03bcS\/cm.<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u22641,3\u03bcS\/cm <\/span><\/td>\n<\/tr>\n<tr>\n<td><b>T\u1ed5ng cacbon h\u1eefu c\u01a1 (TOC)<\/b><\/td>\n<td><span style=\"font-weight: 400;\">\u2264500 ppb<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u2264500 ppb<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>C\u00f4ng ngh\u1ec7 s\u1ea3n xu\u1ea5t<\/b><\/td>\n<td><span style=\"font-weight: 400;\">RO, EDI, trao \u0111\u1ed5i ion<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Ch\u01b0ng c\u1ea5t (\u0111a hi\u1ec7u \u1ee9ng\/n\u00e9n h\u01a1i) ho\u1eb7c m\u00e0ng l\u1ecdc (RO 2 c\u1ea5p + EDI + UF) \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh t\u01b0\u01a1ng \u0111\u01b0\u01a1ng<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>Gi\u00e1m s\u00e1t (Monitoring)<\/b><\/td>\n<td><span style=\"font-weight: 400;\">L\u1ea5y m\u1eabu th\u1ee7 c\u00f4ng \u0111\u1ecbnh k\u1ef3 k\u1ebft h\u1ee3p c\u1ea3m bi\u1ebfn online t\u00f9y ch\u1ecdn<\/span><\/td>\n<td><b>B\u1eaft bu\u1ed9c gi\u00e1m s\u00e1t Online li\u00ean t\u1ee5c<\/b><span style=\"font-weight: 400;\"> cho ch\u1ec9 s\u1ed1 TOC v\u00e0 \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>Thi\u1ebft k\u1ebf h\u1ec7 th\u1ed1ng<\/b><\/td>\n<td><span style=\"font-weight: 400;\">Th\u01b0\u1eddng v\u1eadn h\u00e0nh \u1edf nhi\u1ec7t \u0111\u1ed9 th\u01b0\u1eddng (Ambient), kh\u1eed tr\u00f9ng \u0111\u1ecbnh k\u1ef3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Duy tr\u00ec <\/span><b>tu\u1ea7n ho\u00e0n n\u00f3ng li\u00ean t\u1ee5c (<\/b><span style=\"font-weight: 400;\">&gt;70\u2218C<\/span><b> ho\u1eb7c <\/b><span style=\"font-weight: 400;\">&gt;80\u2218C<\/span><b>)<\/b><span style=\"font-weight: 400;\"> \u0111\u1ec3 t\u1ef1 ti\u1ec7t tr\u00f9ng<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>\u0110\u1ed9ng l\u1ef1c h\u1ecdc d\u00f2ng ch\u1ea3y<\/b><\/td>\n<td><span style=\"font-weight: 400;\">Duy tr\u00ec d\u00f2ng ch\u1ea3y r\u1ed1i \u0111\u1ec3 ng\u0103n biofilm<\/span><\/td>\n<td><span style=\"font-weight: 400;\">B\u1eaft bu\u1ed9c d\u00f2ng ch\u1ea3y r\u1ed1i (Re\u22654000), v\u1eadn t\u1ed1c h\u1ed3i l\u01b0u n\u00ean \u0111\u1ea1t \u22651,5<\/span><b> m\/s<\/b><\/td>\n<\/tr>\n<tr>\n<td><b>Ki\u1ec3m so\u00e1t nh\u00e1nh ch\u1ebft<\/b><\/td>\n<td><span style=\"font-weight: 400;\">Khuy\u1ebfn kh\u00edch h\u1ea1n ch\u1ebf<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Tu\u00e2n th\u1ee7 nghi\u00eam ng\u1eb7t <\/span><b>quy t\u1eafc 1.5D<\/b><span style=\"font-weight: 400;\"> (chi\u1ec1u d\u00e0i nh\u00e1nh kh\u00f4ng qu\u00e1 1,5 l\u1ea7n \u0111\u01b0\u1eddng k\u00ednh \u1ed1ng)<\/span><\/td>\n<\/tr>\n<tr>\n<td><b>Thi\u1ebft l\u1eadp gi\u1edbi h\u1ea1n (Limit)<\/b><\/td>\n<td><span style=\"font-weight: 400;\">D\u1ef1a tr\u00ean ph\u00e2n ph\u1ed1i chu\u1ea9n (<\/span><b>Ph\u01b0\u01a1ng ph\u00e1p <\/b><span style=\"font-weight: 400;\">3\u03c3)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">D\u1ef1a tr\u00ean ph\u00e2n ph\u1ed1i phi chu\u1ea9n (<\/span><b>Ph\u01b0\u01a1ng ph\u00e1p ph\u00e2n v\u1ecb &#8211; Percentile 95th\/99th<\/b><span style=\"font-weight: 400;\">) do d\u1eef li\u1ec7u th\u01b0\u1eddng b\u1eb1ng 0<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\"><em>Tham kh\u1ea3o th\u00eam: <strong><a href=\"https:\/\/sepro.vn\/vi\/ema-la-gi-vai-tro-quy-trinh-tra-cuu-thuoc-eu\/\">EMA l\u00e0 g\u00ec<\/a><\/strong> v\u00e0<\/em>\u00a0<strong><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-quality-water-pharmaceutical-use_en.pdf\" target=\"_blank\" rel=\"noopener\">EMA Guideline WFI<\/a><\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">C\u00e1c \u0111i\u1ec3m l\u01b0u \u00fd quan tr\u1ecdng cho QA\/QC:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Ki\u1ec3m so\u00e1t Biofilm:<\/b><span style=\"font-weight: 400;\"> Biofilm l\u00e0 r\u1ee7i ro l\u1edbn nh\u1ea5t g\u00e2y nhi\u1ec5m khu\u1ea9n ch\u00e9o v\u00e0 n\u1ed9i \u0111\u1ed9c t\u1ed1. Annex 1 y\u00eau c\u1ea7u thi\u1ebft k\u1ebf h\u1ec7 th\u1ed1ng ph\u1ea3i h\u01b0\u1edbng t\u1edbi vi\u1ec7c <\/span><b>lo\u1ea1i b\u1ecf ho\u00e0n to\u00e0n kh\u00f4ng gian ch\u1ebft<\/b><span style=\"font-weight: 400;\"> (dead-space-free design).<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Th\u1ea9m \u0111\u1ecbnh h\u1ec7 th\u1ed1ng (PQ):<\/b><span style=\"font-weight: 400;\"> Quy tr\u00ecnh PQ n\u01b0\u1edbc d\u01b0\u1ee3c ph\u1ea9m b\u1eaft bu\u1ed9c th\u1ef1c hi\u1ec7n theo 3 pha:<\/span>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><b>Pha 1 (2-4 tu\u1ea7n):<\/b><span style=\"font-weight: 400;\"> Gi\u00e1m s\u00e1t chuy\u00ean s\u00e2u h\u00e0ng ng\u00e0y t\u1ea5t c\u1ea3 c\u00e1c \u0111i\u1ec3m, n\u01b0\u1edbc ch\u01b0a \u0111\u01b0\u1ee3c d\u00f9ng cho s\u1ea3n xu\u1ea5t th\u01b0\u01a1ng m\u1ea1i.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><b>Pha 2 (4-6 tu\u1ea7n):<\/b><span style=\"font-weight: 400;\"> Ch\u1ee9ng minh s\u1ef1 \u1ed5n \u0111\u1ecbnh d\u01b0\u1edbi \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh ti\u00eau chu\u1ea9n.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><b>Pha 3 (1 n\u0103m):<\/b><span style=\"font-weight: 400;\"> Ch\u1ee9ng minh \u0111\u1ed9 tin c\u1eady l\u00e2u d\u00e0i tr\u01b0\u1edbc bi\u1ebfn \u0111\u1ed9ng theo m\u00f9a c\u1ee7a ngu\u1ed3n n\u01b0\u1edbc th\u00f4 \u0111\u1ea7u v\u00e0o.<\/span><\/li>\n<\/ol>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>X\u1eed l\u00fd sai l\u1ec7ch:<\/b><span style=\"font-weight: 400;\"> M\u1ecdi tr\u01b0\u1eddng h\u1ee3p v\u01b0\u1ee3t gi\u1edbi h\u1ea1n c\u1ea3nh b\u00e1o (Alert) ph\u1ea3i \u0111\u01b0\u1ee3c ghi l\u1ea1i v\u00e0 \u0111\u00e1nh gi\u00e1 xu h\u01b0\u1edbng. N\u1ebfu v\u01b0\u1ee3t gi\u1edbi h\u1ea1n h\u00e0nh \u0111\u1ed9ng (Action), b\u1eaft bu\u1ed9c ph\u1ea3i th\u1ef1c hi\u1ec7n <\/span><b>\u0111i\u1ec1u tra nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 (RCA)<\/b><span style=\"font-weight: 400;\"> v\u00e0 \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng l\u00f4 s\u1ea3n ph\u1ea9m.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>H\u01a1i n\u01b0\u1edbc tinh khi\u1ebft (Pure Steam):<\/b><span style=\"font-weight: 400;\"> \u0110\u1ed1i v\u1edbi c\u00e1c qu\u00e1 tr\u00ecnh ti\u1ec7t tr\u00f9ng (h\u1ea5p n\u00fat cao su, d\u1ee5ng c\u1ee5), n\u01b0\u1edbc ng\u01b0ng c\u1ee7a h\u01a1i n\u01b0\u1edbc tinh khi\u1ebft ph\u1ea3i \u0111\u00e1p \u1ee9ng \u0111\u1ea7y \u0111\u1ee7 ti\u00eau chu\u1ea9n h\u00f3a l\u00fd c\u1ee7a <\/span><b>n\u01b0\u1edbc WFI.<\/b><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Yeu_cau_chat_luong_nuoc_WFI_gom_nhung_chi_tieu_nao\"><\/span><b>Y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng n\u01b0\u1edbc WFI g\u1ed3m nh\u1eefng ch\u1ec9 ti\u00eau n\u00e0o<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><span style=\"font-weight: 400;\">Y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng WFI th\u01b0\u1eddng xoay quanh ba nh\u00f3m, h\u00f3a l\u00fd nh\u01b0 TOC v\u00e0 \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n, n\u1ed9i \u0111\u1ed9c t\u1ed1 nh\u01b0 endotoxin, v\u00e0 vi sinh theo ki\u1ec3m so\u00e1t t\u1ea3i khu\u1ea9n, v\u00ec m\u1ed7i nh\u00f3m ph\u1ea3n \u00e1nh m\u1ed9t ki\u1ec3u r\u1ee7i ro kh\u00e1c nhau trong h\u1ec7 th\u1ed1ng n\u01b0\u1edbc. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u0110i\u1ec3m quan tr\u1ecdng \u1edf \u0111\u00e2y l\u00e0 s\u1ed1 li\u1ec7u \u0111\u1ea1t t\u1eebng l\u1ea7n v\u1eabn c\u00f3 th\u1ec3 b\u1ecb \u0111\u00e1nh l\u1eeba n\u1ebfu b\u1ea1n kh\u00f4ng c\u00f3 theo d\u00f5i xu h\u01b0\u1edbng v\u00e0 gi\u1edbi h\u1ea1n c\u1ea3nh b\u00e1o, h\u00e0nh \u0111\u1ed9ng r\u00f5 r\u00e0ng theo <strong><a href=\"https:\/\/sepro.vn\/vi\/sop-la-gi-trong-nganh-duoc-dinh-nghia\/\">SOP (Standard Operating Procedure, quy tr\u00ecnh thao t\u00e1c chu\u1ea9n)<\/a><\/strong>.<\/span><\/li>\n<\/ul>\n<h3><b>Endotoxin trong n\u01b0\u1edbc WFI l\u00e0 g\u00ec<\/b><\/h3>\n<ul>\n<li><span style=\"font-weight: 400;\"><strong><a href=\"https:\/\/sepro.vn\/vi\/endotoxin-trong-san-xuat-duoc-pham\/\">Endotoxin l\u00e0 n\u1ed9i \u0111\u1ed9c t\u1ed1 t\u1eeb vi khu\u1ea9n Gram \u00e2m<\/a><\/strong>, c\u00f3 th\u1ec3 g\u00e2y ph\u1ea3n \u1ee9ng s\u1ed1t v\u00e0 l\u00e0 r\u1ee7i ro \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng v\u1edbi ch\u1ebf ph\u1ea9m ti\u00eam truy\u1ec1n. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u0110i\u1ec1u d\u1ec5 b\u1ecb b\u1ecf s\u00f3t n\u1eb1m \u1edf l\u1edbp b\u00e1m vi sinh trong \u0111\u01b0\u1eddng \u1ed1ng, v\u00ec endotoxin c\u00f3 th\u1ec3 nh\u00edch l\u00ean theo xu h\u01b0\u1edbng tr\u01b0\u1edbc khi vi sinh t\u0103ng r\u00f5, l\u00e0m OOT (Out of Trend, l\u1ec7ch xu h\u01b0\u1edbng) xu\u1ea5t hi\u1ec7n b\u1ea5t ng\u1edd v\u00e0 h\u1ed3 s\u01a1 \u0111i\u1ec1u tra k\u00e9o d\u00e0i.<\/span><\/li>\n<\/ul>\n<h3><b>TOC v\u00e0 \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n c\u1ee7a n\u01b0\u1edbc WFI<\/b><\/h3>\n<ol>\n<li><span style=\"font-weight: 400;\"><strong>TOC (Total Organic Carbon, t\u1ed5ng carbon h\u1eefu c\u01a1)<\/strong> ph\u1ea3n \u00e1nh \u0111\u1ed9 t\u1ea1p h\u1eefu c\u01a1<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u0110\u1ed9 d\u1eabn \u0111i\u1ec7n ph\u1ea3n \u00e1nh \u0111\u1ed9 t\u1ea1p ion v\u00e0 tr\u1ea1ng th\u00e1i c\u00e2n b\u1eb1ng c\u1ee7a n\u01b0\u1edbc.<\/span><\/li>\n<\/ol>\n<p><strong>Gi\u00e1 tr\u1ecb c\u1ee5 th\u1ec3:<\/strong><\/p>\n<ul>\n<li><strong>TOC:<\/strong>\u00a0Gi\u1edbi h\u1ea1n \u2264 0.5 mg\/L (500 ppb) theo c\u1ea3 USP v\u00e0 Ph. Eur.<\/li>\n<li><strong>\u0110\u1ed9 d\u1eabn \u0111i\u1ec7n:<\/strong>\u00a0Gi\u1edbi h\u1ea1n \u2264 1.3 \u00b5S\/cm (25\u00b0C) theo USP, \u2264 1.3 \u00b5S\/cm (25\u00b0C) theo Ph. Eur. (L\u01b0u \u00fd \u0111i\u1ec1u ch\u1ec9nh theo nhi\u1ec7t \u0111\u1ed9 v\u1eadn h\u00e0nh th\u1ef1c t\u1ebf n\u1ebfu h\u1ec7 ch\u1ea1y n\u00f3ng)<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\"><strong>D\u1ef1a v\u00e0o 2 ch\u1ec9 s\u1ed1<\/strong> n\u00e0y ta c\u00f3 th\u1ec3 ph\u00e1t hi\u1ec7n h\u1ec7 th\u1ed1ng \u0111ang n\u1eb1m \u1edf t\u00ecnh tr\u1ea1ng n\u00e0o.<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><strong>Tr\u00ean th\u1ef1c t\u1ebf v\u1eadn h\u00e0nh, ch\u1ec9 s\u1ed1 TOC s\u1ebd nh\u00edch l\u00ean 1 ch\u00fat sau b\u1ea3o tr\u00ec<\/strong> nh\u01b0ng ch\u01b0a ch\u1eafc do n\u01b0\u1edbc b\u1ea9n, \u0111\u00f4i khi ch\u1ec9 v\u00ec v\u1eadt li\u1ec7u m\u1edbi c\u1ea7n \u0111\u01b0\u1ee3c tr\u00e1ng r\u1eeda v\u00e0 v\u1ec7 sinh \u0111\u1ea7y \u0111\u1ee7 theo quy tr\u00ecnh tr\u01b0\u1edbc khi h\u1ec7 \u1ed5n \u0111\u1ecbnh tr\u1edf l\u1ea1i.<\/span><\/p>\n<h3><b>Ki\u1ec3m nghi\u1ec7m vi sinh n\u01b0\u1edbc WFI v\u00e0 theo d\u00f5i xu h\u01b0\u1edbng<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Ki\u1ec3m nghi\u1ec7m vi sinh WFI kh\u00f4ng ch\u1ec9 l\u00e0 \u0111\u1ebfm khu\u1ea9n, m\u00e0 l\u00e0 qu\u1ea3n tr\u1ecb xu h\u01b0\u1edbng theo \u0111i\u1ec3m l\u1ea5y m\u1eabu, theo th\u1eddi gian v\u00e0 theo m\u1ed1i li\u00ean h\u1ec7 v\u1edbi l\u1ea7n kh\u1eed tr\u00f9ng h\u1ec7 th\u1ed1ng, nhi\u1ec7t \u0111\u1ed9 v\u1eadn h\u00e0nh v\u00e0 t\u1ed1c \u0111\u1ed9 tu\u1ea7n ho\u00e0n, v\u00ec vi sinh th\u01b0\u1eddng t\u0103ng \u00e2m \u1ec9 r\u1ed3i b\u00f9ng l\u00ean. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Khi m\u1ed9t \u0111i\u1ec3m dao \u0111\u1ed9ng nh\u01b0ng to\u00e0n h\u1ec7 v\u1eabn \u1ed5n, k\u1ebft lu\u1eadn t\u1ed1t th\u01b0\u1eddng d\u1ef1a v\u00e0o xu h\u01b0\u1edbng d\u1eef li\u1ec7u v\u00e0 \u0111i\u1ec1u ki\u1ec7n l\u1ea5y m\u1eabu, thay v\u00ec ph\u1ea3n \u1ee9ng theo m\u1ed9t k\u1ebft qu\u1ea3 \u0111\u01a1n l\u1ebb.<\/span><\/p>\n<blockquote><p><strong>Gi\u1edbi h\u1ea1n vi sinh:<\/strong><\/p>\n<p>Theo ti\u00eau chu\u1ea9n, t\u1ed5ng vi sinh hi\u1ebfu kh\u00ed l\u00e0\u00a0<strong>\u2264 10 CFU\/100 mL<\/strong>\u00a0(CFU = Colony Forming Unit, \u0111\u01a1n v\u1ecb t\u1ea1o khu\u1ea9n).<\/p><\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Tan_suat_kiem_nghiem_WFI_theo_khuyen_nghi\"><\/span><strong>T\u1ea7n su\u1ea5t ki\u1ec3m nghi\u1ec7m WFI (theo khuy\u1ebfn ngh\u1ecb)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">L\u1ecbch ki\u1ec3m nghi\u1ec7m WFI kh\u00f4ng ph\u1ea3i &#8220;ki\u1ec3m th\u1ee9 2, ki\u1ec3m th\u1ee9 4&#8221; m\u00e0 ph\u1ea3i d\u1ef1a tr\u00ean r\u1ee7i ro v\u00e0 chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t c\u1ee7a h\u1ec7 th\u1ed1ng.<\/span><\/p>\n<h3><strong>Vi sinh<\/strong><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">M\u1eabu li\u00ean t\u1ee5c (online monitoring): N\u00ean c\u00f3 h\u1ec7 th\u1ed1ng monitoring real-time t\u1ea1i c\u00e1c \u0111i\u1ec3m d\u00f9ng nguy c\u01a1 cao (v\u00ed d\u1ee5 \u0111i\u1ec3m pha ch\u1ebf ti\u00eam)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">M\u1eabu \u0111\u1ecbnh k\u1ef3:<\/span>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u0110i\u1ec3m d\u00f9ng th\u01b0\u1eddng xuy\u00ean (t\u1ea7n su\u1ea5t cao): 1-2 l\u1ea7n\/tu\u1ea7n<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u0110i\u1ec3m d\u00f9ng th\u1ec9nh tho\u1ea3ng (t\u1ea7n su\u1ea5t th\u1ea5p): 2 l\u1ea7n\/th\u00e1ng ho\u1eb7c 1 l\u1ea7n\/th\u00e1ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">B\u1ed3n ch\u1ee9a: 1 l\u1ea7n\/tu\u1ea7n (b\u1ed3n ch\u1ee9a l\u00e0 kho d\u1eef li\u1ec7u, c\u1ea7n monitor ch\u1eb7t)<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ul>\n<h3><strong>Endotoxin<\/strong><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u00cdt h\u01a1n vi sinh v\u00ec endotoxin \u1ed5n \u0111\u1ecbnh h\u01a1n khi h\u1ec7 \u1ed5n \u0111\u1ecbnh<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u1ea7n su\u1ea5t: 1-2 l\u1ea7n\/tu\u1ea7n n\u1ebfu h\u1ec7 \u1ed5n \u0111\u1ecbnh<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u0103ng t\u1ea7n su\u1ea5t l\u00ean 1 l\u1ea7n\/2-3 ng\u00e0y sau:<\/span>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">B\u1ea3o tr\u00ec h\u1ec7 th\u1ed1ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Kh\u1eed tr\u00f9ng \u0111\u1ecbnh k\u1ef3\/b\u1ea5t th\u01b0\u1eddng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Ph\u00e1t hi\u1ec7n OOT \u1edf vi sinh<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3><strong>TOC + \u0110\u1ed9 d\u1eabn \u0111i\u1ec7n<\/strong><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Online monitoring (real-time) t\u1ea1i b\u1ed3n ch\u1ee9a v\u00e0 c\u00e1c \u0111i\u1ec3m d\u00f9ng ch\u00ednh<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">N\u1ebfu kh\u00f4ng c\u00f3 online: H\u00e0ng ng\u00e0y ho\u1eb7c 2-3 l\u1ea7n\/tu\u1ea7n t\u1ea1i c\u00e1c \u0111i\u1ec3m quan tr\u1ecdng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">TOC + \u0111\u1ed9 d\u1eabn l\u00e0 early warning indicators \u2013 ph\u00e1t hi\u1ec7n s\u1edbm gi\u00fap tr\u00e1nh b\u00f9ng ph\u00e1t vi sinh b\u1ea5t ng\u1edd<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Chien_luoc_lay_mau_theo_rui_ro\"><\/span><strong>Chi\u1ebfn l\u01b0\u1ee3c l\u1ea5y m\u1eabu theo r\u1ee7i ro<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Kh\u00f4ng ph\u1ea3i t\u1ea5t c\u1ea3 \u0111i\u1ec3m \u0111\u1ec1u b\u1eb1ng nhau. L\u1ef1a ch\u1ecdn t\u1ea7n su\u1ea5t l\u1ea5y m\u1eabu d\u1ef1a tr\u00ean:<\/span><\/p>\n<h3><strong>V\u1ecb tr\u00ed \u0111i\u1ec3m:<\/strong><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">G\u1ea7n b\u1ed3n ch\u1ee9a: R\u1ee7i ro th\u1ea5p h\u01a1n (n\u01b0\u1edbc m\u1edbi t\u1ea1o, ch\u01b0a c\u00f3 th\u1eddi gian ph\u00e1t tri\u1ec3n vi sinh) \u2192 2 l\u1ea7n\/th\u00e1ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Xa b\u1ed3n ch\u1ee9a: R\u1ee7i ro cao h\u01a1n (l\u1edbp b\u00e1m d\u1ec5 h\u00ecnh th\u00e0nh, nh\u00e1nh ch\u1ebft) \u2192 1-2 l\u1ea7n\/tu\u1ea7n<\/span><\/li>\n<\/ul>\n<h3><strong>T\u1ea7n su\u1ea5t s\u1eed d\u1ee5ng \u0111i\u1ec3m:<\/strong><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110i\u1ec3m r\u1eeda\/pha th\u01b0\u1eddng xuy\u00ean (t\u1ea7n su\u1ea5t cao, nhi\u1ec1u l\u1ea7n\/ng\u00e0y): R\u1ee7i ro cao \u2192 1-2 l\u1ea7n\/tu\u1ea7n<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110i\u1ec3m d\u1ef1 ph\u00f2ng, \u00edt d\u00f9ng: R\u1ee7i ro th\u1ea5p \u2192 2 l\u1ea7n\/th\u00e1ng ho\u1eb7c 1 l\u1ea7n\/th\u00e1ng<\/span><\/li>\n<\/ul>\n<h3><strong>L\u1ecbch s\u1eed d\u1eef li\u1ec7u:<\/strong><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110i\u1ec3m &#8220;b\u00ecnh \u1ed5n&#8221; (6+ th\u00e1ng kh\u00f4ng OOT\/OOS): C\u00f3 th\u1ec3 gi\u1ea3m t\u1ea7n su\u1ea5t<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110i\u1ec3m hay g\u1eb7p OOT\/OOS: T\u0103ng t\u1ea7n su\u1ea5t l\u00ean 1 l\u1ea7n\/2-3 ng\u00e0y cho \u0111\u1ebfn khi \u1ed5n \u0111\u1ecbnh 3 th\u00e1ng<\/span><\/li>\n<\/ul>\n<h3><strong>Lo\u1ea1i kh\u1eed tr\u00f9ng:<\/strong><\/h3>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Sau kh\u1eed tr\u00f9ng h\u00f3a ch\u1ea5t:<\/strong> C\u00f3 th\u1ec3 l\u1ea5y m\u1eabu ngay ho\u1eb7c sau 24 gi\u1edd (theo SOP) \u0111\u1ec3 ki\u1ec3m tra m\u1ee9c \u0111\u1ed9 hi\u1ec7u qu\u1ea3<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><strong>Sau kh\u1eed tr\u00f9ng nhi\u1ec7t:<\/strong> L\u1ea5y m\u1eabu sau khi h\u1ec7 h\u1ea1 nhi\u1ec7t v\u00e0 \u1ed5n \u0111\u1ecbnh<\/span><\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"He_thong_tao_WFI_va_he_thong_vong_tuan_hoan_luu_tru_phan_phoi\"><\/span><b>H\u1ec7 th\u1ed1ng t\u1ea1o WFI v\u00e0 h\u1ec7 th\u1ed1ng v\u00f2ng tu\u1ea7n ho\u00e0n l\u01b0u tr\u1eef ph\u00e2n ph\u1ed1i<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9223\" aria-describedby=\"caption-attachment-9223\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9223\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-5.png\" alt=\"he-thong-tao-wfi-va-he-thong-vong-tuan-hoan-luu-tru-phan-phoi\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-5.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-5-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-5-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-5-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9223\" class=\"wp-caption-text\"><em>H\u1ec7 th\u1ed1ng t\u1ea1o WFI v\u00e0 h\u1ec7 th\u1ed1ng v\u00f2ng tu\u1ea7n ho\u00e0n l\u01b0u tr\u1eef ph\u00e2n ph\u1ed1i<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">H\u1ec7 th\u1ed1ng WFI th\u01b0\u1eddng g\u1ed3m kh\u1ed1i t\u1ea1o n\u01b0\u1edbc, b\u1ed3n ch\u1ee9a, b\u01a1m tu\u1ea7n ho\u00e0n, \u0111\u01b0\u1eddng \u1ed1ng v\u00f2ng v\u00e0 c\u00e1c \u0111i\u1ec3m d\u00f9ng, v\u00e0 ph\u1ea7n n\u00e0y c\u1ea7n \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 h\u1ea1n ch\u1ebf nh\u00e1nh ch\u1ebft v\u00ec nh\u00e1nh ch\u1ebft l\u00e0 n\u01a1i l\u1edbp b\u00e1m vi sinh d\u1ec5 h\u00ecnh th\u00e0nh. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u1ede g\u00f3c qu\u1ea3n tr\u1ecb r\u1ee7i ro, th\u1ee9 c\u1ea7n h\u1ecfi kh\u00f4ng ph\u1ea3i ch\u01b0ng c\u1ea5t hay m\u00e0ng t\u1ed1t h\u01a1n, m\u00e0 l\u00e0 chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t c\u00f3 \u0111\u1ee7 m\u1ea1nh \u0111\u1ec3 gi\u1eef h\u1ec7 \u1ed5n \u0111\u1ecbnh theo th\u1eddi gian, nh\u1ea5t l\u00e0 sau c\u00e1c s\u1ef1 ki\u1ec7n nh\u01b0 b\u1ea3o tr\u00ec, thay v\u1eadt li\u1ec7u ho\u1eb7c thay \u0111\u1ed5i t\u1ea3i d\u00f9ng.<\/span><\/p>\n<h3>C\u1ea5u tr\u00fac h\u1ec7 th\u1ed1ng WFI<\/h3>\n<p>H\u1ec7 th\u1ed1ng WFI th\u01b0\u1eddng g\u1ed3m:<\/p>\n<ol>\n<li><strong>Kh\u1ed1i t\u1ea1o n\u01b0\u1edbc (Water Generator):<\/strong>\n<ul>\n<li>Ch\u01b0ng c\u1ea5t (distillation) \u2013 hi\u1ec7u qu\u1ea3 cao v\u1edbi endotoxin, t\u1ed1n \u0111i\u1ec7n<\/li>\n<li>Ho\u1eb7c RO + EDI + polishing \u2013 ti\u1ebft ki\u1ec7m n\u0103ng l\u01b0\u1ee3ng, c\u1ea7n h\u1ed7 tr\u1ee3 kh\u1eed tr\u00f9ng t\u1ed1t h\u01a1n<\/li>\n<\/ul>\n<\/li>\n<li><strong>B\u1ed3n ch\u1ee9a (Tank):<\/strong>\n<ul>\n<li>Dung t\u00edch: Th\u01b0\u1eddng 50-500 L t\u00f9y nh\u00e0 m\u00e1y<\/li>\n<li>V\u1eadt li\u1ec7u: Inox 316L<\/li>\n<li>C\u00f3 van x\u1ea3 d\u01b0\u1edbi, van l\u1ea5y m\u1eabu<\/li>\n<\/ul>\n<\/li>\n<li><strong>B\u01a1m tu\u1ea7n ho\u00e0n (Circulation Pump):<\/strong>\n<ul>\n<li>Duy tr\u00ec d\u00f2ng ch\u1ea3y li\u00ean t\u1ee5c trong v\u00f2ng<\/li>\n<li>T\u1ed1c \u0111\u1ed9: \u2265 1 m\/s (\u0111\u1ec3 tr\u00e1nh l\u1edbp b\u00e1m vi sinh)<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u0110\u01b0\u1eddng \u1ed1ng v\u00f2ng tu\u1ea7n ho\u00e0n (Distribution Loop):<\/strong>\n<ul>\n<li>V\u1eadt li\u1ec7u: Inox 316L, electropolished (Ra \u2264 0.6 \u00b5m)<\/li>\n<li>\u0110\u1ed9 d\u1ed1c: \u2265 1% (\u0111\u1ec3 tho\u00e1t n\u01b0\u1edbc ho\u00e0n to\u00e0n)<\/li>\n<li>Dead leg: \u2264 1.5D (\u0111\u01b0\u1eddng k\u00ednh \u1ed1ng)<\/li>\n<li>Giao n\u1ed1i: Welded (h\u00e0n), kh\u00f4ng d\u00f9ng threaded (ren)<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u0110i\u1ec3m l\u1ea5y m\u1eabu (Sampling Points):<\/strong>\n<ul>\n<li>N\u1eb1m \u1edf cu\u1ed1i v\u00f2ng, t\u1ea1i c\u00e1c \u0111i\u1ec3m d\u00f9ng ch\u00ednh<\/li>\n<li>C\u1ea7n kh\u1eed tr\u00f9ng tr\u01b0\u1edbc l\u1ea5y m\u1eabu (b\u1eb1ng h\u01a1i n\u01b0\u1edbc ho\u1eb7c alcohol 70%)<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u0110i\u1ec3m d\u00f9ng (End-use Points):<\/strong>\n<ul>\n<li>Pha ch\u1ebf ti\u00eam<\/li>\n<li>R\u1eeda thi\u1ebft b\u1ecb<\/li>\n<li>C\u00e1c thi\u1ebft b\u1ecb kh\u00e1c theo r\u1ee7i ro<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<h3>V\u00f2ng n\u00f3ng vs v\u00f2ng l\u1ea1nh \u2013 \u0110\u00e2u l\u00e0 l\u1ef1a ch\u1ecdn ph\u00f9 h\u1ee3p<\/h3>\n<table>\n<thead>\n<tr>\n<th>Ti\u00eau ch\u00ed<\/th>\n<th>V\u00f2ng n\u00f3ng (Hot Loop)<\/th>\n<th>V\u00f2ng l\u1ea1nh (Cold Loop)<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Nhi\u1ec7t \u0111\u1ed9 v\u1eadn h\u00e0nh<\/strong><\/td>\n<td>65-85\u00b0C (th\u01b0\u1eddng 75-80\u00b0C)<\/td>\n<td>20-25\u00b0C<\/td>\n<\/tr>\n<tr>\n<td><strong>Ki\u1ec3m so\u00e1t vi sinh<\/strong><\/td>\n<td>T\u1ed1t \u2013 nhi\u1ec7t h\u1ea1n ch\u1ebf ph\u00e1t tri\u1ec3n vi sinh<\/td>\n<td>D\u1ef1a v\u00e0o kh\u1eed tr\u00f9ng \u0111\u1ecbnh k\u1ef3 + thi\u1ebft k\u1ebf<\/td>\n<\/tr>\n<tr>\n<td><strong>N\u0103ng l\u01b0\u1ee3ng<\/strong><\/td>\n<td>Cao (t\u1ed1n \u0111i\u1ec7n h\u01a1n 40-50%)<\/td>\n<td>Th\u1ea5p<\/td>\n<\/tr>\n<tr>\n<td><strong>V\u1eadt li\u1ec7u<\/strong><\/td>\n<td>C\u1ea7n ch\u1ecbu nhi\u1ec7t cao, cao su NBR ho\u1eb7c EPDM<\/td>\n<td>Ti\u00eau chu\u1ea9n inox 316L,\u00a0 EPDM<\/td>\n<\/tr>\n<tr>\n<td><strong>R\u1ee7i ro<\/strong><\/td>\n<td>X\u1eed l\u00fd nhi\u1ec7t, gi\u00e3n n\u1edf \u1ed1ng (c\u1ea7n bypass tu\u00e2n)<\/td>\n<td>Vi sinh t\u0103ng nhanh n\u1ebfu ng\u1eebng kh\u1eed tr\u00f9ng; l\u1edbp b\u00e1m ph\u00e1t tri\u1ec3n nhanh<\/td>\n<\/tr>\n<tr>\n<td><strong>Kh\u1eed tr\u00f9ng<\/strong><\/td>\n<td>Online thermal disinfection (~80\u00b0C \u0111\u1ecbnh k\u1ef3 ho\u1eb7c li\u00ean t\u1ee5c)<\/td>\n<td>Chemical disinfection (citric acid, hydrogen peroxide) 6-12 th\u00e1ng\/l\u1ea7n<\/td>\n<\/tr>\n<tr>\n<td><strong>L\u1ef1a ch\u1ecdn khi n\u00e0o<\/strong><\/td>\n<td>\n<ul>\n<li>N\u1ebfu t\u1ea3i d\u00f9ng cao (pha ch\u1ebf li\u00ean t\u1ee5c)<\/li>\n<li>N\u1ebfu chi ph\u00ed n\u0103ng l\u01b0\u1ee3ng kh\u00f4ng ph\u1ea3i r\u00e0ng bu\u1ed9c<\/li>\n<li>N\u1ebfu kh\u00f4ng c\u00f3 kh\u1ea3 n\u0103ng kh\u1eed tr\u00f9ng h\u00f3a ch\u1ea5t t\u1ed1t<\/li>\n<\/ul>\n<\/td>\n<td>\n<ul>\n<li>N\u1ebfu chi ph\u00ed n\u0103ng l\u01b0\u1ee3ng quan tr\u1ecdng<\/li>\n<li>N\u1ebfu c\u00f3 quy tr\u00ecnh kh\u1eed tr\u00f9ng h\u00f3a ch\u1ea5t \u0111\u1ee7 m\u1ea1nh<\/li>\n<li>N\u1ebfu ph\u00e2n t\u00edch d\u1eef li\u1ec7u 6-12 th\u00e1ng cho th\u1ea5y \u1ed5n \u0111\u1ecbnh<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>L\u01b0u \u00fd:<\/strong> L\u1ef1a ch\u1ecdn gi\u1eefa v\u00f2ng n\u00f3ng v\u00e0 v\u00f2ng l\u1ea1nh ph\u1ee5 thu\u1ed9c v\u00e0o \u0111\u00e1nh gi\u00e1 r\u1ee7i ro chi ti\u1ebft v\u00e0 d\u1eef li\u1ec7u v\u1eadn h\u00e0nh c\u1ee7a t\u1eebng nh\u00e0 m\u00e1y. V\u00f2ng n\u00f3ng kh\u00f4ng m\u1eb7c \u0111\u1ecbnh &#8220;t\u1ed1t nh\u1ea5t&#8221; n\u1ebfu x\u00e9t c\u1ea3 n\u0103ng l\u01b0\u1ee3ng, v\u1eadt li\u1ec7u v\u00e0 \u0111\u1ed9 b\u1ec1n v\u1eadn h\u00e0nh.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Ve_sinh_khu_trung_he_thong_WFI\"><\/span><b>V\u1ec7 sinh kh\u1eed tr\u00f9ng h\u1ec7 th\u1ed1ng WFI<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Kh\u1eed tr\u00f9ng h\u1ec7 th\u1ed1ng c\u00f3 th\u1ec3 theo nhi\u1ec7t ho\u1eb7c theo h\u00f3a ch\u1ea5t, v\u00e0 n\u1ebfu d\u00f9ng h\u00f3a ch\u1ea5t th\u00ec SDS (Safety Data Sheet, b\u1ea3ng d\u1eef li\u1ec7u an to\u00e0n h\u00f3a ch\u1ea5t) v\u00e0 PPE (Personal Protective Equipment, ph\u01b0\u01a1ng ti\u1ec7n b\u1ea3o h\u1ed9 c\u00e1 nh\u00e2n) c\u1ea7n \u0111\u01b0\u1ee3c n\u00eau r\u00f5 trong SOP \u0111\u1ec3 tr\u00e1nh r\u1ee7i ro an to\u00e0n v\u00e0 nguy c\u01a1 t\u1ed3n l\u01b0u.<\/p>\n<p><strong>N\u1ebfu ch\u1ec9 ch\u1ea1y kh\u1eed tr\u00f9ng theo l\u1ecbch cho c\u00f3, b\u1ea1n s\u1ebd kh\u00f3 gi\u1ea3i th\u00edch khi xu h\u01b0\u1edbng d\u1eef li\u1ec7u b\u1eaft \u0111\u1ea7u l\u1ec7ch<\/strong>, n\u00ean c\u00e1ch l\u00e0m b\u1ec1n l\u00e0 b\u00e1m xu h\u01b0\u1edbng d\u1eef li\u1ec7u, s\u1ef1 ki\u1ec7n b\u1ea3o tr\u00ec v\u00e0 r\u1ee7i ro theo t\u1eebng \u0111i\u1ec3m d\u00f9ng \u0111\u1ec3 quy\u1ebft \u0111\u1ecbnh th\u1eddi \u0111i\u1ec3m v\u00e0 ph\u01b0\u01a1ng ph\u00e1p ph\u00f9 h\u1ee3p.<\/p>\n<h3>Ph\u01b0\u01a1ng ph\u00e1p kh\u1eed tr\u00f9ng<\/h3>\n<p><strong>1. Kh\u1eed tr\u00f9ng nhi\u1ec7t (Thermal Disinfection)<\/strong><\/p>\n<ul>\n<li><strong>Ph\u01b0\u01a1ng ph\u00e1p:<\/strong>\u00a0N\u00e2ng nhi\u1ec7t \u0111\u1ed9 v\u00f2ng l\u00ean 80-85\u00b0C, gi\u1eef 30-60 ph\u00fat<\/li>\n<li><strong>\u01afu \u0111i\u1ec3m:<\/strong>\u00a0Kh\u00f4ng d\u01b0 l\u01b0\u1ee3ng h\u00f3a ch\u1ea5t, \u0111\u01a1n gi\u1ea3n, hi\u1ec7u qu\u1ea3 cao<\/li>\n<li><strong>Nh\u01b0\u1ee3c \u0111i\u1ec3m:<\/strong> T\u1ed1n \u0111i\u1ec7n, g\u00e2y stress cho v\u1eadt li\u1ec7u<\/li>\n<li><strong>Chu k\u1ef3:<\/strong>\u00a0\u0110\u1ecbnh k\u1ef3 2-4 tu\u1ea7n (v\u00f2ng n\u00f3ng) ho\u1eb7c theo y\u00eau c\u1ea7u khi OOT xu\u1ea5t hi\u1ec7n<\/li>\n<li><strong>SOP ghi:<\/strong>\u00a0Nhi\u1ec7t \u0111\u1ed9 target, th\u1eddi gian gi\u1eef, dung d\u1ecbch cooling sau<\/li>\n<\/ul>\n<p><strong>2. Kh\u1eed tr\u00f9ng h\u00f3a ch\u1ea5t (Chemical Disinfection)<\/strong><\/p>\n<ul>\n<li><strong>H\u00f3a ch\u1ea5t th\u01b0\u1eddng d\u00f9ng:<\/strong>\n<ul>\n<li><strong>Citric acid:<\/strong>\u00a00.5-2% (pH 2-3), \u0111\u1ec3 12-24 gi\u1edd<\/li>\n<li><strong>Hydrogen peroxide:<\/strong>\u00a01-3%, \u0111\u1ec3 2-6 gi\u1edd<\/li>\n<li><strong>Peracetic acid:<\/strong>\u00a00.2-0.5%, \u0111\u1ec3 30-60 ph\u00fat<\/li>\n<\/ul>\n<\/li>\n<li><strong>Quy tr\u00ecnh:<\/strong>\n<ol>\n<li>Chu\u1ea9n b\u1ecb dung d\u1ecbch kh\u1eed tr\u00f9ng<\/li>\n<li>Xoay v\u00f2ng 8-24 gi\u1edd t\u00f9y h\u00f3a ch\u1ea5t<\/li>\n<li>R\u1eeda s\u1ea1ch dung d\u1ecbch b\u1eb1ng WFI (r\u1eeda \u2265 3 l\u1ea7n)<\/li>\n<li>Kh\u1eed tr\u00f9ng l\u1ea1i v\u1edbi n\u01b0\u1edbc c\u1ea5t ho\u1eb7c WFI s\u1ea1ch<\/li>\n<li>L\u1ea5y m\u1eabu ki\u1ec3m nghi\u1ec7m TOC, vi sinh tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng<\/li>\n<\/ol>\n<\/li>\n<li><strong>Chu k\u1ef3:<\/strong>\u00a06-12 th\u00e1ng\/l\u1ea7n, ho\u1eb7c theo d\u1eef li\u1ec7u OOT<\/li>\n<li><strong>SOP ghi r\u00f5:<\/strong>\u00a0H\u00f3a ch\u1ea5t n\u00e0o, n\u1ed3ng \u0111\u1ed9, th\u1eddi gian, PPE (g\u0103ng tay, m\u1eb7t n\u1ea1), c\u00e1ch r\u1eeda s\u1ea1ch<\/li>\n<\/ul>\n<p><strong>3. Kh\u1eed tr\u00f9ng k\u1ebft h\u1ee3p (Hybrid)<\/strong><\/p>\n<ul>\n<li>Kh\u1eed tr\u00f9ng h\u00f3a ch\u1ea5t 1 l\u1ea7n\/6 th\u00e1ng + kh\u1eed tr\u00f9ng nhi\u1ec7t 1 l\u1ea7n\/2 tu\u1ea7n<\/li>\n<li>T\u1ed1i \u01b0u t\u1ed5ng chi ph\u00ed + hi\u1ec7u qu\u1ea3<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Lay_mau_nuoc_WFI_dung_cach_va_xu_ly_OOS_OOT\"><\/span><b>L\u1ea5y m\u1eabu n\u01b0\u1edbc WFI \u0111\u00fang c\u00e1ch v\u00e0 x\u1eed l\u00fd OOS OOT<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9225\" aria-describedby=\"caption-attachment-9225\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9225\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-3.png\" alt=\"kiem-soat-wfi-oos-oot-dung-cach\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-3.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-3-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-3-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-3-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9225\" class=\"wp-caption-text\"><em>Ki\u1ec3m so\u00e1t WFI, OOS, OOT \u0111\u00fang c\u00e1ch<\/em><\/figcaption><\/figure>\n<h3>T\u1ea7m quan tr\u1ecdng c\u1ee7a thao t\u00e1c l\u1ea5y m\u1eabu<\/h3>\n<p>L\u1ea5y m\u1eabu l\u00e0 \u0111i\u1ec3m d\u1ec5 t\u1ea1o sai l\u1ec7ch nh\u1ea5t v\u00ec ch\u1ec9 c\u1ea7n thao t\u00e1c ch\u1ea1m sai v\u00e0o van ho\u1eb7c x\u1ea3 tr\u01b0\u1edbc ch\u01b0a \u0111\u1ee7, k\u1ebft qu\u1ea3 vi sinh v\u00e0 endotoxin c\u00f3 th\u1ec3 t\u0103ng gi\u1ea3, r\u1ed3i c\u1ea3 \u0111\u1ed9i m\u1ea5t th\u1eddi gian \u0111i\u1ec1u tra, x\u1eed l\u00fd v\u00e0 \u0111\u00e1nh gi\u00e1 \u1ea3nh h\u01b0\u1edfng.<\/p>\n<p><strong>N\u1ebfu ph\u1ea3i ch\u1ecdn m\u1ed9t \u0111i\u1ec1u \u0111\u1ec3 nh\u1edb th\u00ec \u0111\u00f3 l\u00e0:<\/strong> D\u1eef li\u1ec7u t\u1ed1t b\u1eaft \u0111\u1ea7u t\u1eeb thao t\u00e1c l\u1ea5y m\u1eabu chu\u1ea9n, n\u00ean ti\u00eau chu\u1ea9n h\u00f3a thao t\u00e1c v\u00e0 ghi nh\u1eadn \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh ngay l\u00fac l\u1ea5y m\u1eabu s\u1ebd gi\u00fap gi\u1ea3m \u0111i\u1ec1u tra kh\u00f4ng c\u1ea7n thi\u1ebft.<\/p>\n<h3>Thao t\u00e1c l\u1ea5y m\u1eabu WFI chu\u1ea9n (Practical Guide)<\/h3>\n<h4><strong>B\u01b0\u1edbc 1: X\u1ea3 tr\u01b0\u1edbc (Pre-flush)<\/strong><\/h4>\n<ul>\n<li><strong>M\u1ee5c \u0111\u00edch:<\/strong>\u00a0L\u00e0m s\u1ea1ch n\u01b0\u1edbc n\u1eb1m trong nh\u00e1nh ch\u1ebft (dead leg), tr\u00e1nh k\u1ebft qu\u1ea3 vi sinh\/endotoxin gi\u1ea3<\/li>\n<li><strong>Thao t\u00e1c:<\/strong>\u00a0M\u1edf van x\u1ea3 l\u1ea5y m\u1eabu\n<ul>\n<li>X\u1ea3\u00a0<strong>30 gi\u00e2y<\/strong>\u00a0(ho\u1eb7c\u00a0<strong>200-300 mL<\/strong>) \u2013 t\u00f9y thi\u1ebft k\u1ebf, ph\u1ea3i ghi trong SOP<\/li>\n<li>Khi n\u01b0\u1edbc ch\u1ea3y \u1ed5n \u0111\u1ecbnh (kh\u00f4ng c\u00f2n b\u1ecdt kh\u00ed)<\/li>\n<\/ul>\n<\/li>\n<li><strong>Ghi nh\u1eadn:<\/strong>\u00a0Th\u1eddi gian x\u1ea3, nhi\u1ec7t \u0111\u1ed9 n\u01b0\u1edbc l\u00fac x\u1ea3<\/li>\n<li><strong>L\u01b0u \u00fd:<\/strong>\n<ul>\n<li>Kh\u00f4ng \u0111\u01b0\u1ee3c m\u1edf van 5 gi\u00e2y r\u1ed3i l\u1ea5y m\u1eabu (n\u01b0\u1edbc v\u1eabn \u0111\u1ecdng t\u1eeb l\u1ea7n l\u1ea5y tr\u01b0\u1edbc)<\/li>\n<li>Ph\u1ea3i x\u1ea3 li\u00ean t\u1ee5c 30 gi\u00e2y, ch\u1ea3y \u0111\u1ec1u, kh\u00f4ng gi\u00e1n \u0111o\u1ea1n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h4><strong>B\u01b0\u1edbc 2: Kh\u1eed tr\u00f9ng van l\u1ea5y m\u1eabu<\/strong><\/h4>\n<ul>\n<li><strong>M\u1ee5c \u0111\u00edch:<\/strong>\u00a0Ti\u00eau di\u1ec7t vi sinh b\u00e1m tr\u00ean van, c\u1ed1c l\u1ea5y m\u1eabu tr\u01b0\u1edbc<\/li>\n<li><strong>Thao t\u00e1c (ch\u1ecdn 1 trong 2):<\/strong>\n<ul>\n<li><strong>C\u00e1ch A &#8211; Alcohol 70% (nhanh):<\/strong>\n<ul>\n<li>Tr\u00e1y cotton x\u1ea7m alcohol 70%, lau van l\u1ea5y m\u1eabu, c\u1ed1c l\u1ea5y m\u1eabu<\/li>\n<li>\u0110\u1ec3 kh\u00f4 (kho\u1ea3ng 30 gi\u00e2y)<\/li>\n<li>T\u1ed1t: nhanh, kh\u00f4ng \u0111\u1ed9c t\u1ed1<\/li>\n<\/ul>\n<\/li>\n<li><strong>C\u00e1ch B &#8211; Steam (t\u1ed1i \u01b0u nh\u1ea5t):<\/strong>\n<ul>\n<li>D\u00f9ng h\u01a1i n\u01b0\u1edbc kh\u1eed tr\u00f9ng van, c\u1ed1c (n\u1ebfu c\u00f3 system tr\u00ean v\u00f2ng)<\/li>\n<li>\u0110\u1ec3 h\u01a1i x\u1ea3 h\u1ebft, t\u1ef1 ng\u01b0ng t\u1ee5, kh\u00f4<\/li>\n<li>T\u1ed1t nh\u1ea5t: hi\u1ec7u qu\u1ea3 100%, kh\u00f4ng h\u00f3a ch\u1ea5t d\u01b0 l\u01b0\u1ee3ng<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li><strong>Ghi nh\u1eadn:<\/strong>\u00a0Ph\u01b0\u01a1ng ph\u00e1p kh\u1eed tr\u00f9ng, ng\u00e0y gi\u1edd<\/li>\n<\/ul>\n<h4><strong>B\u01b0\u1edbc 3: L\u1ea5y m\u1eabu<\/strong><\/h4>\n<ul>\n<li><strong>Thao t\u00e1c:<\/strong>\n<ul>\n<li>Chu\u1ea9n b\u1ecb bao m\u1eabu v\u00f4 tr\u00f9ng (sterilized bag)<\/li>\n<li><strong>Kh\u00f4ng ch\u1ea1m tay v\u00e0o mi\u1ec7ng bao, mi\u1ec7ng van<\/strong><\/li>\n<li>M\u1edf van, m\u1eabu ch\u1ea3y v\u00e0o bao t\u1eeb t\u1eeb (kh\u00f4ng b\u1eafn m\u1ea1nh, tr\u00e1nh bong b\u1ecdt kh\u00ed)<\/li>\n<li>\u0110\u1ea7y bao (th\u01b0\u1eddng 100-200 mL t\u00f9y lo\u1ea1i ki\u1ec3m nghi\u1ec7m: vi sinh 100 mL, endotoxin 10 mL)<\/li>\n<\/ul>\n<\/li>\n<li><strong>Ghi nh\u1eadn:<\/strong>\n<ul>\n<li>Th\u1eddi \u0111i\u1ec3m l\u1ea5y (gi\u1edd, ph\u00fat)<\/li>\n<li>Nhi\u1ec7t \u0111\u1ed9 n\u01b0\u1edbc l\u00fac l\u1ea5y<\/li>\n<li>T\u00ean ng\u01b0\u1eddi l\u1ea5y m\u1eabu<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h4><strong>B\u01b0\u1edbc 4: Ghi nh\u1eadn \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh<\/strong><\/h4>\n<ul>\n<li><strong>B\u1eaft bu\u1ed9c ghi r\u00f5:<\/strong>\n<ul>\n<li>Th\u1eddi gian kh\u1eed tr\u00f9ng g\u1ea7n nh\u1ea5t (ng\u00e0y gi\u1edd)<\/li>\n<li>Lo\u1ea1i kh\u1eed tr\u00f9ng (hot\/chemical)<\/li>\n<li>T\u1ed1c \u0111\u1ed9 tu\u1ea7n ho\u00e0n (m\/s ho\u1eb7c L\/min)<\/li>\n<li>Nhi\u1ec7t \u0111\u1ed9 b\u1ed3n ch\u1ee9a ho\u1eb7c v\u00f2ng tu\u1ea7n ho\u00e0n<\/li>\n<li>B\u1ea5t th\u01b0\u1eddng n\u00e0o g\u1ea7n \u0111\u00e2y (b\u1ea3o tr\u00ec, \u0111i\u1ec1u ch\u1ec9nh, v.v.)<\/li>\n<\/ul>\n<\/li>\n<li><strong>L\u1ee3i \u00edch:<\/strong>\u00a0Khi OOT xu\u1ea5t hi\u1ec7n, d\u1eef li\u1ec7u n\u00e0y gi\u00fap \u0111i\u1ec1u tra nhanh<\/li>\n<\/ul>\n<h4><strong>B\u01b0\u1edbc 5: B\u1ea3o qu\u1ea3n m\u1eabu<\/strong><\/h4>\n<ul>\n<li><strong>Vi sinh:<\/strong>\u00a0Ph\u00e2n t\u00edch\u00a0<strong>trong 2 gi\u1edd<\/strong>\u00a0(ho\u1eb7c 4 gi\u1edd n\u1ebfu b\u1ea3o qu\u1ea3n 4\u00b0C)\n<ul>\n<li>\u0110\u1ec3 l\u00e2u: Vi sinh t\u0103ng gi\u1ea3 t\u1eeb ph\u00e1t tri\u1ec3n trong bao ch\u1ee9 kh\u00f4ng ph\u1ea3i t\u1eeb h\u1ec7 th\u1ed1ng<\/li>\n<\/ul>\n<\/li>\n<li><strong>Endotoxin:<\/strong>\u00a0Ph\u00e2n t\u00edch\u00a0<strong>trong 24 gi\u1edd<\/strong>\u00a0(endotoxin b\u1ec1n h\u01a1n)\n<ul>\n<li>B\u1ea3o qu\u1ea3n nhi\u1ec7t \u0111\u1ed9 ph\u00f2ng<\/li>\n<\/ul>\n<\/li>\n<li><strong>TOC\/\u0110\u1ed9 d\u1eabn:<\/strong>\u00a0Ph\u00e2n t\u00edch\u00a0<strong>trong 4 gi\u1edd<\/strong>\u00a0(ho\u1eb7c online n\u1ebfu c\u00f3)<\/li>\n<\/ul>\n<h3>Ki\u1ec3m so\u00e1t WFI, OOS, OOT \u0111\u00fang c\u00e1ch<\/h3>\n<h4>OOT (Out of Trend \u2013 L\u1ec7ch xu h\u01b0\u1edbng)<\/h4>\n<p><strong>\u0110\u1ecbnh ngh\u0129a:<\/strong>\u00a0K\u1ebft qu\u1ea3 \u0111\u1ea1t ti\u00eau chu\u1ea9n tuy\u1ec7t \u0111\u1ed1i nh\u01b0ng l\u1ec7ch kh\u1ecfi xu h\u01b0\u1edbng d\u1eef li\u1ec7u th\u01b0\u1eddng l\u1ec7.<\/p>\n<p><strong>X\u1eed l\u00fd OOT:<\/strong><\/p>\n<h4><strong>B\u01b0\u1edbc 1: Ki\u1ec3m tra l\u1ea1i thao t\u00e1c l\u1ea5y m\u1eabu (\u01b0u ti\u00ean \u0111\u1ea7u ti\u00ean)<\/strong><\/h4>\n<ul>\n<li>QC l\u1ea5y m\u1eabu sai \u2192 x\u1ea3 tr\u01b0\u1edbc kh\u00f4ng \u0111\u1ee7?<\/li>\n<li>Kh\u1eed tr\u00f9ng van kh\u00f4ng k\u1ef9?<\/li>\n<li>\u0110\u1ec3 l\u00e2u tr\u01b0\u1edbc khi ph\u00e2n t\u00edch?<\/li>\n<li>B\u1ea3o qu\u1ea3n sai (nhi\u1ec7t \u0111\u1ed9, bao m\u1eabu)?<\/li>\n<\/ul>\n<p><strong>N\u1ebfu ph\u00e1t hi\u1ec7n l\u1ed7i thao t\u00e1c:<\/strong>\u00a0\u1ea4n \u0111\u1ecbnh &#8220;L\u1ed7i l\u1ea5y m\u1eabu&#8221;, kh\u00f4ng c\u1ea7n \u0111i\u1ec1u tra h\u1ec7 th\u1ed1ng, hu\u1ea5n luy\u1ec7n QC l\u1ea1i<\/p>\n<h4><strong>B\u01b0\u1edbc 2: Ki\u1ec3m tra \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh l\u00fac l\u1ea5y m\u1eabu<\/strong><\/h4>\n<ul>\n<li>L\u1ea7n kh\u1eed tr\u00f9ng g\u1ea7n nh\u1ea5t c\u00e1ch \u0111\u00e2y bao l\u00e2u? (n\u1ebfu &gt; 4 tu\u1ea7n m\u00e0 v\u00f2ng l\u1ea1nh \u2192 c\u00f3 th\u1ec3 drifting)<\/li>\n<li>Nhi\u1ec7t \u0111\u1ed9 v\u00f2ng \u1ed5n \u0111\u1ecbnh kh\u00f4ng? (n\u1ebfu gi\u1ea3m t\u1eeb 80\u00b0C \u2192 75\u00b0C \u2192 vi sinh t\u0103ng)<\/li>\n<li>C\u00f3 s\u1ef1 ki\u1ec7n b\u1ea3o tr\u00ec g\u1ea7n \u0111\u00e2y kh\u00f4ng? (v\u1eadt li\u1ec7u m\u1edbi)<\/li>\n<li>T\u1ed1c \u0111\u1ed9 tu\u1ea7n ho\u00e0n b\u00ecnh th\u01b0\u1eddng kh\u00f4ng? (n\u1ebfu gi\u1ea3m \u2192 l\u1edbp b\u00e1m d\u1ec5 h\u00ecnh th\u00e0nh)<\/li>\n<\/ul>\n<p><strong>N\u1ebfu ph\u00e1t hi\u1ec7n b\u1ea5t th\u01b0\u1eddng v\u1eadn h\u00e0nh:<\/strong>\u00a0\u0110i\u1ec1u tra nguy\u00ean nh\u00e2n, k\u00edch ho\u1ea1t kh\u1eed tr\u00f9ng b\u1ea5t th\u01b0\u1eddng<\/p>\n<h4><strong>B\u01b0\u1edbc 3: L\u1ea5y m\u1eabu l\u1ea1i (repeat sampling)<\/strong><\/h4>\n<ul>\n<li>Trong 24 gi\u1edd t\u1ea1i c\u00f9ng \u0111i\u1ec3m<\/li>\n<li>V\u1edbi thao t\u00e1c chu\u1ea9n (x\u1ea3 tr\u01b0\u1edbc \u0111\u1ee7, kh\u1eed tr\u00f9ng van)<\/li>\n<li>L\u1ea7n n\u00e0y n\u1ebfu normal \u2192 OOT \u0111\u01b0\u1ee3c gi\u1ea3i th\u00edch b\u1edfi thao t\u00e1c ho\u1eb7c t\u1ea1m th\u1eddi drift<\/li>\n<li>N\u1ebfu l\u1eb7p l\u1ea1i OOT \u2192 nguy c\u01a1 cao h\u1ec7 th\u1ed1ng b\u1eaft \u0111\u1ea7u tr\u01b0\u1ee3t<\/li>\n<\/ul>\n<h4><strong>B\u01b0\u1edbc 4: K\u00edch ho\u1ea1t h\u00e0nh \u0111\u1ed9ng n\u1ebfu OOT l\u1eb7p l\u1ea1i<\/strong><\/h4>\n<ul>\n<li>Kh\u1eed tr\u00f9ng b\u1ea5t th\u01b0\u1eddng<\/li>\n<li>T\u0103ng t\u1ea7n su\u1ea5t l\u1ea5y m\u1eabu t\u1eeb 2 tu\u1ea7n\/l\u1ea7n \u2192 1 tu\u1ea7n\/l\u1ea7n trong 1 th\u00e1ng<\/li>\n<li>Ki\u1ec3m tra h\u1ec7 th\u1ed1ng: nh\u00e1nh ch\u1ebft, t\u1ed1c \u0111\u1ed9, nhi\u1ec7t \u0111\u1ed9<\/li>\n<li>L\u1eadp h\u1ed3 s\u01a1 trend analysis (xem 6-12 th\u00e1ng, OOT c\u00f3 pattern kh\u00f4ng?)<\/li>\n<\/ul>\n<h4>OOS (Out of Specification \u2013 V\u01b0\u1ee3t ti\u00eau chu\u1ea9n)<\/h4>\n<p><strong>\u0110\u1ecbnh ngh\u0129a:<\/strong>\u00a0K\u1ebft qu\u1ea3 v\u01b0\u1ee3t gi\u1edbi h\u1ea1n spec (v\u00ed d\u1ee5 vi sinh &gt; 10 CFU, endotoxin &gt; 0.25 IU\/mL).<\/p>\n<p><strong>X\u1eed l\u00fd OOS (theo GMP):<\/strong><\/p>\n<p><strong>B\u01b0\u1edbc 1: Ki\u1ec3m tra l\u1ea1i k\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m (ngay l\u1eadp t\u1ee9c)<\/strong><\/p>\n<ul>\n<li>Retest c\u00f9ng m\u1eabu l\u1ea1i?<\/li>\n<li>Hay l\u1ea5y m\u1eabu m\u1edbi (repeat sampling) t\u1ea1i c\u00f9ng \u0111i\u1ec3m?<\/li>\n<\/ul>\n<p><strong>N\u00ean l\u1ea5y m\u1eabu m\u1edbi<\/strong>\u00a0(repeat sampling) v\u00ec m\u1eabu c\u0169 c\u00f3 th\u1ec3 b\u1ecb nhi\u1ec5m trong b\u1ea3o qu\u1ea3n<\/p>\n<p><strong>B\u01b0\u1edbc 2: Ki\u1ec3m tra \u0111i\u1ec1u ki\u1ec7n l\u1ea5y m\u1eabu<\/strong><\/p>\n<ul>\n<li>(T\u01b0\u01a1ng t\u1ef1 OOT)<\/li>\n<li>N\u1ebfu ph\u00e1t hi\u1ec7n l\u1ed7i thao t\u00e1c \u2192 h\u1ee7y k\u1ebft qu\u1ea3 OOS, kh\u00f4ng c\u1ea7n \u0111i\u1ec1u tra h\u1ec7<\/li>\n<\/ul>\n<p><strong>B\u01b0\u1edbc 3: \u0110\u00e1nh gi\u00e1 \u1ea3nh h\u01b0\u1edfng t\u1edbi l\u00f4 s\u1ea3n ph\u1ea9m (Impact Assessment)<\/strong><\/p>\n<ul>\n<li><strong>Khi x\u1ea3y ra OOS, c\u1ea7n h\u1ecfi:<\/strong>\n<ul>\n<li>WFI n\u00e0y \u0111\u00e3 d\u00f9ng cho l\u00f4 n\u00e0o?<\/li>\n<li>L\u00f4 s\u1ea3n ph\u1ea9m \u0111\u00f3 \u0111\u00e3 xu\u1ea5t x\u01b0\u1edfng ch\u01b0a?<\/li>\n<li>C\u1ea7n thu h\u1ed3i kh\u00f4ng?<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>B\u01b0\u1edbc 4: K\u00edch ho\u1ea1t h\u1ed3 s\u01a1 Deviation \/ OOS Investigation<\/strong><\/p>\n<ul>\n<li>M\u00f4 t\u1ea3 s\u1ef1 ki\u1ec7n, k\u1ebft qu\u1ea3<\/li>\n<li>Nguy\u00ean nh\u00e2n g\u1ed1c (root cause) \u2013 n\u1ebfu l\u00e0 l\u1ed7i thao t\u00e1c hay v\u1ea5n \u0111\u1ec1 h\u1ec7<\/li>\n<li>H\u00e0nh \u0111\u1ed9ng ngay (immediate action): kh\u1eed tr\u00f9ng, thay \u0111\u1ed5i \u0111i\u1ec1u ki\u1ec7n, hu\u1ea5n luy\u1ec7n<\/li>\n<li>H\u00e0nh \u0111\u1ed9ng d\u00e0i h\u1ea1n (preventive action): c\u1ea3i thi\u1ec7n SOP, upgrade thi\u1ebft b\u1ecb, v.v.<\/li>\n<li>Verify &amp; close<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"FAQ_%E2%80%93_WFI_Water_for_Injection\"><\/span><b>FAQ &#8211; WFI (Water for Injection)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><b>WFI l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a g\u00ec<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">WFI l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a Water for Injection, ngh\u0129a l\u00e0 n\u01b0\u1edbc d\u00f9ng cho ti\u00eam, v\u00e0 trong nh\u00e0 m\u00e1y n\u00f3 th\u01b0\u1eddng t\u1ed3n t\u1ea1i d\u1ea1ng n\u01b0\u1edbc kh\u1ed1i l\u01b0u h\u00e0nh trong h\u1ec7 th\u1ed1ng v\u00f2ng tu\u1ea7n ho\u00e0n \u0111\u1ec3 ph\u1ee5c v\u1ee5 pha ch\u1ebf thu\u1ed1c ti\u00eam truy\u1ec1n v\u00e0 b\u01b0\u1edbc tr\u00e1ng cu\u1ed1i li\u00ean quan v\u00f4 tr\u00f9ng. Khi vi\u1ebft h\u1ed3 s\u01a1, b\u1ea1n n\u00ean \u0111\u1ed1i chi\u1ebfu \u0111\u1ecbnh ngh\u0129a theo d\u01b0\u1ee3c \u0111i\u1ec3n v\u00e0 SOP c\u1ee7a nh\u00e0 m\u00e1y \u0111\u1ec3 tr\u00e1nh nh\u1ea7m v\u1edbi n\u01b0\u1edbc d\u00f9ng cho ti\u00eam \u0111\u00e3 ti\u1ec7t khu\u1ea9n v\u00e0 \u0111\u00f3ng g\u00f3i th\u00e0nh ph\u1ea9m.<\/span><\/p>\n<h3><b>Endotoxin trong n\u01b0\u1edbc WFI l\u00e0 g\u00ec v\u00e0 v\u00ec sao hay b\u1ecb \u0111\u00e1nh gi\u00e1 h\u1ecfi s\u00e2u<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Endotoxin l\u00e0 n\u1ed9i \u0111\u1ed9c t\u1ed1 t\u1eeb vi khu\u1ea9n Gram \u00e2m v\u00e0 li\u00ean quan tr\u1ef1c ti\u1ebfp t\u1edbi y\u00eau c\u1ea7u kh\u00f4ng g\u00e2y s\u1ed1t c\u1ee7a ch\u1ebf ph\u1ea9m ti\u00eam truy\u1ec1n, n\u00ean \u0111o\u00e0n \u0111\u00e1nh gi\u00e1 th\u01b0\u1eddng h\u1ecfi s\u00e2u v\u1ec1 c\u00e1ch ki\u1ec3m so\u00e1t v\u00e0 c\u00e1ch ph\u1ea3n \u1ee9ng khi c\u00f3 t\u00edn hi\u1ec7u b\u1ea5t th\u01b0\u1eddng. H\u1ecd th\u01b0\u1eddng mu\u1ed1n th\u1ea5y xu h\u01b0\u1edbng d\u1eef li\u1ec7u, \u0111\u00e1nh gi\u00e1 nguy\u00ean nh\u00e2n g\u1ed1c v\u00e0 chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t l\u1edbp b\u00e1m vi sinh trong \u0111\u01b0\u1eddng \u1ed1ng, ch\u1ee9 kh\u00f4ng ch\u1ec9 m\u1ed9t k\u1ebft qu\u1ea3 \u0111\u1ea1t t\u1ea1i m\u1ed9t th\u1eddi \u0111i\u1ec3m.<\/span><\/p>\n<h3><b>TOC v\u00e0 \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n c\u1ee7a WFI n\u00f3i l\u00ean \u0111i\u1ec1u g\u00ec<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">TOC ph\u1ea3n \u00e1nh t\u1ea1p h\u1eefu c\u01a1, c\u00f2n \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n ph\u1ea3n \u00e1nh t\u1ea1p ion v\u00e0 tr\u1ea1ng th\u00e1i c\u00e2n b\u1eb1ng c\u1ee7a n\u01b0\u1edbc, v\u00ec v\u1eady hai ch\u1ec9 ti\u00eau n\u00e0y th\u01b0\u1eddng gi\u00fap ph\u00e1t hi\u1ec7n h\u1ec7 th\u1ed1ng b\u1eaft \u0111\u1ea7u tr\u01b0\u1ee3t s\u1edbm h\u01a1n khi vi sinh t\u0103ng r\u00f5. Sau b\u1ea3o tr\u00ec, hai ch\u1ec9 ti\u00eau n\u00e0y c\u00f3 th\u1ec3 nh\u00edch nh\u1eb9 do v\u1eadt li\u1ec7u m\u1edbi ho\u1eb7c \u0111i\u1ec1u ki\u1ec7n tr\u00e1ng r\u1eeda ch\u01b0a \u0111\u1ee7, n\u00ean v\u1eabn c\u1ea7n \u0111i\u1ec1u tra theo SOP thay v\u00ec k\u1ebft lu\u1eadn v\u1ed9i.<\/span><\/p>\n<h3><b>V\u00f2ng n\u00f3ng v\u00e0 v\u00f2ng l\u1ea1nh kh\u00e1c nhau ra sao<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">V\u00f2ng n\u00f3ng v\u1eadn h\u00e0nh \u1edf nhi\u1ec7t \u0111\u1ed9 cao \u0111\u1ec3 h\u1ea1n ch\u1ebf vi sinh, c\u00f2n v\u00f2ng l\u1ea1nh v\u1eadn h\u00e0nh th\u1ea5p h\u01a1n v\u00e0 d\u1ef1a nhi\u1ec1u v\u00e0o kh\u1eed tr\u00f9ng \u0111\u1ecbnh k\u1ef3, thi\u1ebft k\u1ebf v\u00e0 gi\u00e1m s\u00e1t \u0111\u1ec3 gi\u1eef t\u1ea3i khu\u1ea9n \u1ed5n \u0111\u1ecbnh. L\u1ef1a ch\u1ecdn ph\u00f9 h\u1ee3p c\u1ea7n d\u1ef1a tr\u00ean \u0111\u00e1nh gi\u00e1 r\u1ee7i ro v\u00e0 d\u1eef li\u1ec7u v\u1eadn h\u00e0nh c\u1ee7a nh\u00e0 m\u00e1y, v\u00ec v\u00f2ng n\u00f3ng kh\u00f4ng m\u1eb7c \u0111\u1ecbnh t\u1ed1i \u01b0u n\u1ebfu x\u00e9t c\u1ea3 n\u0103ng l\u01b0\u1ee3ng, v\u1eadt li\u1ec7u v\u00e0 \u0111\u1ed9 b\u1ec1n v\u1eadn h\u00e0nh.<\/span><\/p>\n<h3><b>OOS v\u00e0 OOT n\u01b0\u1edbc WFI x\u1eed l\u00fd th\u1ebf n\u00e0o cho \u0111\u00fang<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Khi g\u1eb7p OOT, b\u1ea1n n\u00ean \u01b0u ti\u00ean ki\u1ec3m tra thao t\u00e1c l\u1ea5y m\u1eabu, \u0111i\u1ec1u ki\u1ec7n x\u1ea3 tr\u01b0\u1edbc v\u00e0 t\u00ecnh tr\u1ea1ng kh\u1eed tr\u00f9ng \u0111i\u1ec3m l\u1ea5y m\u1eabu, v\u00ec l\u1ec7ch xu h\u01b0\u1edbng r\u1ea5t th\u01b0\u1eddng \u0111\u1ebfn t\u1eeb thao t\u00e1c ho\u1eb7c \u0111i\u1ec1u ki\u1ec7n l\u1ea5y m\u1eabu kh\u00f4ng nh\u1ea5t qu\u00e1n. Khi g\u1eb7p OOS, c\u1ea7n k\u00edch ho\u1ea1t h\u1ed3 s\u01a1 sai l\u1ec7ch v\u00e0 \u0111\u00e1nh gi\u00e1 \u1ea3nh h\u01b0\u1edfng t\u1edbi l\u00f4 theo SOP, \u0111\u1ed3ng th\u1eddi khoanh v\u00f9ng \u0111i\u1ec3m d\u00f9ng \u0111\u1ec3 ki\u1ec3m so\u00e1t r\u1ee7i ro thay v\u00ec ch\u1ec9 l\u1ea5y m\u1eabu l\u1ea1i nhi\u1ec1u l\u1ea7n.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tam_Ket\"><\/span><b>T\u1ea1m K\u1ebft<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\"><strong>N\u01b0\u1edbc WFI<\/strong> l\u00e0 g\u00ec kh\u00f4ng ch\u1ec9 l\u00e0 \u0111\u1ecbnh ngh\u0129a trong d\u01b0\u1ee3c \u0111i\u1ec3n m\u00e0 c\u00f2n l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng v\u00e0 m\u1ed9t th\u00f3i quen qu\u1ea3n tr\u1ecb r\u1ee7i ro, b\u1eaft \u0111\u1ea7u t\u1eeb thi\u1ebft k\u1ebf v\u00f2ng tu\u1ea7n ho\u00e0n, kh\u1eed tr\u00f9ng, l\u1ea5y m\u1eabu \u0111\u1ebfn theo d\u00f5i xu h\u01b0\u1edbng v\u00e0 ph\u1ea3n \u1ee9ng OOT, OOS theo SOP c\u1ee7a nh\u00e0 m\u00e1y. N\u1ebfu b\u1ea1n \u0111ang r\u00e0 so\u00e1t h\u1ec7 th\u1ed1ng, c\u00e1ch \u0111i hi\u1ec7u qu\u1ea3 th\u01b0\u1eddng l\u00e0 b\u1eaft \u0111\u1ea7u t\u1eeb xu h\u01b0\u1edbng d\u1eef li\u1ec7u v\u00e0 c\u00e1c \u0111i\u1ec3m l\u1ea5y m\u1eabu hay g\u00e2y tranh c\u00e3i r\u1ed3i m\u1edbi quay l\u1ea1i c\u00e2u chuy\u1ec7n c\u00f4ng ngh\u1ec7 t\u1ea1o n\u01b0\u1edbc, v\u00ec d\u1eef li\u1ec7u v\u1eadn h\u00e0nh m\u1edbi l\u00e0 th\u1ee9 tr\u1ea3 l\u1eddi \u0111\u00fang nh\u1ea5t.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>C\u00f3 nh\u1eefng ng\u00e0y m\u1ecdi ch\u1ec9 ti\u00eau \u0111\u1ec1u \u0111\u1ea1t, nh\u01b0ng nh\u00ecn bi\u1ec3u \u0111\u1ed3 v\u1eabn th\u1ea5y kh\u00f4ng y\u00ean. WFI l\u00e0 ki\u1ec3u h\u1ec7 th\u1ed1ng nh\u01b0 v\u1eady, nh\u00ecn t\u01b0\u1edfng \u1ed5n m\u00e0 ch\u1ec9 c\u1ea7n m\u1ed9t nh\u00e1nh ch\u1ebft ho\u1eb7c m\u1ed9t thao t\u00e1c l\u1ea5y m\u1eabu l\u1ec7ch l\u00e0 k\u00e9o theo c\u1ea3 chu\u1ed7i \u0111i\u1ec1u tra. B\u00e0i n\u00e0y gom l\u1ea1i nh\u1eefng th\u1ee9 c\u1ea7n nh\u1edb, nh\u1eefng &hellip; <a href=\"https:\/\/sepro.vn\/vi\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">N\u01b0\u1edbc WFI L\u00e0 G\u00ec V\u00e0 D\u00f9ng Th\u1ebf N\u00e0o Trong Nh\u00e0 M\u00e1y D\u01b0\u1ee3c GMP<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":9227,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[],"class_list":["post-9216","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\/9216","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=9216"}],"version-history":[{"count":17,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9216\/revisions"}],"predecessor-version":[{"id":13647,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9216\/revisions\/13647"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9227"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9216"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9216"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9216"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}