{"id":9461,"date":"2026-03-19T09:36:01","date_gmt":"2026-03-19T09:36:01","guid":{"rendered":"https:\/\/sepro.vn\/?p=9461"},"modified":"2026-03-19T09:36:01","modified_gmt":"2026-03-19T09:36:01","slug":"khi-nao-can-diet-bao-tu-phong-sach-gmp","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/khi-nao-can-diet-bao-tu-phong-sach-gmp\/","title":{"rendered":"Khi N\u00e0o C\u1ea7n Di\u1ec7t B\u00e0o T\u1eed Ph\u00f2ng S\u1ea1ch Theo Chu\u1ea9n GMP EU"},"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\/khi-nao-can-diet-bao-tu-phong-sach-gmp\/#Yeu_Cau_GMP_EU_FDA_Ve_Su_Dung_Sporicide_Diet_Bao_Tu\" title=\"Y\u00eau C\u1ea7u GMP EU &amp; FDA V\u1ec1 S\u1eed D\u1ee5ng Sporicide Di\u1ec7t B\u00e0o T\u1eed\">Y\u00eau C\u1ea7u GMP EU &amp; FDA V\u1ec1 S\u1eed D\u1ee5ng Sporicide Di\u1ec7t B\u00e0o T\u1eed<\/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\/khi-nao-can-diet-bao-tu-phong-sach-gmp\/#Khi_nao_can_su_dung_hoa_chat_diet_bao_tu_%E2%80%94_5_tinh_huong_dien_hinh\" title=\"Khi n\u00e0o c\u1ea7n s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed \u2014 5 t\u00ecnh hu\u1ed1ng \u0111i\u1ec3n h\u00ecnh\">Khi n\u00e0o c\u1ea7n s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed \u2014 5 t\u00ecnh hu\u1ed1ng \u0111i\u1ec3n h\u00ecnh<\/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\/khi-nao-can-diet-bao-tu-phong-sach-gmp\/#Sporicide_Co_Duoc_Dung_Cho_Grade_A_B_C_D_Khong\" title=\"Sporicide C\u00f3 \u0110\u01b0\u1ee3c D\u00f9ng Cho Grade A, B, C, D Kh\u00f4ng?\">Sporicide C\u00f3 \u0110\u01b0\u1ee3c D\u00f9ng Cho Grade A, B, C, D Kh\u00f4ng?<\/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\/khi-nao-can-diet-bao-tu-phong-sach-gmp\/#So_sanh_IPA_70_hydrogen_peroxide_va_hoa_chat_diet_bao_tu_%E2%80%94_lua_chon_theo_muc_dich_su_dung\" title=\"So s\u00e1nh IPA 70%, hydrogen peroxide v\u00e0 h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed \u2014 l\u1ef1a ch\u1ecdn theo m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng\">So s\u00e1nh IPA 70%, hydrogen peroxide v\u00e0 h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed \u2014 l\u1ef1a ch\u1ecdn theo m\u1ee5c \u0111\u00edch 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-5\" href=\"https:\/\/sepro.vn\/vi\/khi-nao-can-diet-bao-tu-phong-sach-gmp\/#Contact_Time_Tan_Suat_%E2%80%94_Lam_Sao_De_Tuan_Thu_Dung\" title=\"Contact Time &amp; T\u1ea7n Su\u1ea5t \u2014 L\u00e0m Sao \u0110\u1ec3 Tu\u00e2n Th\u1ee7 \u0110\u00fang?\">Contact Time &amp; T\u1ea7n Su\u1ea5t \u2014 L\u00e0m Sao \u0110\u1ec3 Tu\u00e2n Th\u1ee7 \u0110\u00fang?<\/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\/khi-nao-can-diet-bao-tu-phong-sach-gmp\/#FAQ_Khi_nao_can_diet_bao_tu_phong_sach\" title=\"FAQ: Khi n\u00e0o c\u1ea7n di\u1ec7t b\u00e0o t\u1eed ph\u00f2ng s\u1ea1ch\">FAQ: Khi n\u00e0o c\u1ea7n di\u1ec7t b\u00e0o t\u1eed 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-7\" href=\"https:\/\/sepro.vn\/vi\/khi-nao-can-diet-bao-tu-phong-sach-gmp\/#Ket_Luan\" title=\"K\u1ebft Lu\u1eadn\">K\u1ebft Lu\u1eadn<\/a><\/li><\/ul><\/nav><\/div>\n<p><span style=\"font-weight: 400;\">Trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c, s\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n hi\u1ec7u qu\u1ea3 v\u00e0 m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh kh\u00f4ng \u0111\u1ea1t ti\u00eau chu\u1ea9n n\u1eb1m \u1edf kh\u1ea3 n\u0103ng <\/span>x\u00e1c \u0111\u1ecbnh \u0111\u00fang th\u1eddi \u0111i\u1ec3m s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t <a href=\"https:\/\/sepro.vn\/khi-nao-can-diet-bao-tu-phong-sach-gmp\/\"><b>b\u00e0o t\u1eed ph\u00f2ng s\u1ea1ch<\/b><\/a><span style=\"font-weight: 400;\">. Tr\u00ean th\u1ef1c t\u1ebf, nhi\u1ec1u nh\u00e2n s\u1ef1 t\u1eeb v\u1ec7 sinh, QA \u0111\u1ebfn qu\u1ea3n l\u00fd s\u1ea3n xu\u1ea5t v\u1eabn c\u00f2n nh\u1ea7m l\u1eabn v\u1ec1 t\u1ea7n su\u1ea5t \u00e1p d\u1ee5ng, ph\u1ea1m vi s\u1eed d\u1ee5ng v\u00e0 vi\u1ec7c c\u00f3 c\u1ea7n tri\u1ec3n khai khi ch\u01b0a ph\u00e1t hi\u1ec7n b\u00e0o t\u1eed hay kh\u00f4ng.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">B\u00e0i vi\u1ebft n\u00e0y l\u00e0m r\u00f5 <\/span><b>th\u1eddi \u0111i\u1ec3m c\u1ea7n s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed trong ph\u00f2ng s\u1ea1ch<\/b><span style=\"font-weight: 400;\">, \u0111\u1ed3ng th\u1eddi ph\u00e2n t\u00edch c\u00e1c k\u1ef3 v\u1ecdng t\u1eeb GMP EU v\u00e0 FDA, v\u00e0 h\u01b0\u1edbng d\u1eabn x\u00e2y d\u1ef1ng chi\u1ebfn l\u01b0\u1ee3c s\u1eed d\u1ee5ng d\u1ef1a tr\u00ean \u0111\u00e1nh gi\u00e1 r\u1ee7i ro th\u1ef1c t\u1ebf t\u1ea1i nh\u00e0 m\u00e1y<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Yeu_Cau_GMP_EU_FDA_Ve_Su_Dung_Sporicide_Diet_Bao_Tu\"><\/span><b>Y\u00eau C\u1ea7u GMP EU &amp; FDA V\u1ec1 S\u1eed D\u1ee5ng Sporicide Di\u1ec7t B\u00e0o T\u1eed<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9470\" aria-describedby=\"caption-attachment-9470\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-9470\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-6.png\" alt=\"yeu-cau-cua-gmp-eu-fda-ve-su-dung-diet-bao-tu-phong-sach\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-6.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-6-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-6-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-6-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9470\" class=\"wp-caption-text\"><em>Y\u00eau C\u1ea7u GMP EU &amp; FDA V\u1ec1 S\u1eed D\u1ee5ng Sporicide Di\u1ec7t B\u00e0o T\u1eed Ph\u00f2ng S\u1ea1ch<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">H\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed kh\u00f4ng ph\u1ea3i l\u00e0 l\u1ef1a ch\u1ecdn t\u00f9y \u00fd m\u00e0 l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c theo c\u00e1c ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">EU GMP Annex 1 ph\u00e1t h\u00e0nh r\u00f5 r\u00e0ng:\u00a0<\/span><\/p>\n<blockquote><p><i><span style=\"font-weight: 400;\">&#8220;Disinfection should include the periodic use of a sporicidal agent.&#8221;\u00a0<\/span><\/i><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec1u n\u00e0y c\u00f3 ngh\u0129a l\u00e0 ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n ph\u00f2ng s\u1ea1ch ph\u1ea3i bao g\u1ed3m vi\u1ec7c s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed theo chu k\u1ef3 \u0111\u1ecbnh k\u1ef3, kh\u00f4ng ph\u1ee5 thu\u1ed9c v\u00e0o vi\u1ec7c \u0111\u00e3 ph\u00e1t hi\u1ec7n b\u00e0o t\u1eed hay ch\u01b0a. Y\u00eau c\u1ea7u n\u00e0y \u00e1p d\u1ee5ng cho t\u1ea5t c\u1ea3 c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m t\u1ea1i EU ho\u1eb7c xu\u1ea5t kh\u1ea9u v\u00e0o th\u1ecb tr\u01b0\u1eddng EU.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Link tham kh\u1ea3o: <\/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\"><span style=\"font-weight: 400;\">https:\/\/health.ec.europa.eu\/document\/download\/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">FDA Aseptic Guidance c\u0169ng nh\u1ea5n m\u1ea1nh:\u00a0<\/span><\/p>\n<blockquote><p><i><span style=\"font-weight: 400;\">&#8220;a sound disinfectant program also includes a sporicidal agent, used according to a written schedule and when environmental data suggest the presence of sporeforming organisms.&#8221;\u00a0<\/span><\/i><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">N\u00f3i c\u00e1ch kh\u00e1c, vi\u1ec7c s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh r\u00f5 trong SOP, bao g\u1ed3m t\u1ea7n su\u1ea5t, khu v\u1ef1c \u00e1p d\u1ee5ng, lo\u1ea1i h\u00f3a ch\u1ea5t v\u00e0 contact time, kh\u00f4ng \u0111\u01b0\u1ee3c tri\u1ec3n khai theo c\u1ea3m t\u00ednh.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Link tham kh\u1ea3o: <\/span><a href=\"https:\/\/www.fda.gov\/files\/drugs\/published\/Sterile-Drug-Products-Produced-by-Aseptic-Processing-%E2%80%94-Current-Good-Manufacturing-Practice.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/files\/drugs\/published\/Sterile-Drug-Products-Produced-by-Aseptic-Processing-%E2%80%94-Current-Good-Manufacturing-Practice.pdf<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">FDA \u0111\u00e3 ghi nh\u1eadn c\u00e1c sai l\u1ec7ch li\u00ean quan \u0111\u1ebfn vi\u1ec7c kh\u00f4ng s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed \u0111\u00fang c\u00e1ch. V\u00ed d\u1ee5, Porton Biopharma b\u1ecb c\u1ea3nh b\u00e1o v\u00ec:<\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">Porton Biopharma b\u1ecb FDA c\u1ea3nh b\u00e1o v\u00ec:<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><i><span style=\"font-weight: 400;\">&#8220;no use of sporicidal disinfectant on surfaces inside aseptic filling room, although your environmental monitoring detected spore-forming organisms there&#8221;<\/span><\/i><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec1u n\u00e0y cho th\u1ea5y c\u01a1 s\u1edf \u0111\u00e3 ph\u00e1t hi\u1ec7n vi sinh t\u1ea1o b\u00e0o t\u1eed nh\u01b0ng kh\u00f4ng tri\u1ec3n khai h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed \u0111\u1ec3 ki\u1ec3m so\u00e1t.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u0110\u1ec3 x\u00e2y d\u1ef1ng ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n to\u00e0n di\u1ec7n \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n GMP EU, xem chi ti\u1ebft t\u1ea1i: <\/span><a href=\"https:\/\/sepro.vn\/hoa-chat-khu-khuan-phong-sach-theo-gmp-eu\/\"><b>H\u00f3a Ch\u1ea5t Kh\u1eed Khu\u1ea9n Ph\u00f2ng S\u1ea1ch Theo GMP EU<\/b><\/a><\/p>\n<p><b>\u0110i\u1ec3m quan tr\u1ecdng<\/b><span style=\"font-weight: 400;\">:\u00a0<\/span><\/p>\n<blockquote>\n<ul>\n<li><span style=\"font-weight: 400;\">N\u1ebfu ph\u00e1t hi\u1ec7n b\u00e0o t\u1eed trong d\u1eef li\u1ec7u gi\u00e1m s\u00e1t vi sinh m\u00e0 kh\u00f4ng c\u00f3 k\u1ebf ho\u1ea1ch s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed, \u0111\u00e2y \u0111\u01b0\u1ee3c xem l\u00e0 sai l\u1ec7ch nghi\u00eam tr\u1ecdng theo cGMP.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Ng\u01b0\u1ee3c l\u1ea1i, vi\u1ec7c t\u0103ng t\u1ea7n su\u1ea5t ho\u1eb7c n\u1ed3ng \u0111\u1ed9 s\u1eed d\u1ee5ng m\u00e0 kh\u00f4ng c\u00f3 b\u1eb1ng ch\u1ee9ng khoa h\u1ecdc (validation) c\u0169ng kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn theo y\u00eau c\u1ea7u c\u1ee7a FDA.<\/span><\/li>\n<\/ul>\n<\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Khi_nao_can_su_dung_hoa_chat_diet_bao_tu_%E2%80%94_5_tinh_huong_dien_hinh\"><\/span><b>Khi n\u00e0o c\u1ea7n s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed \u2014 5 t\u00ecnh hu\u1ed1ng \u0111i\u1ec3n h\u00ecnh<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u0110\u1ec3 x\u00e1c \u0111\u1ecbnh \u0111\u00fang th\u1eddi \u0111i\u1ec3m s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed, c\u1ea7n d\u1ef1a tr\u00ean d\u1eef li\u1ec7u v\u1eadn h\u00e0nh v\u00e0 \u0111\u00e1nh gi\u00e1 r\u1ee7i ro th\u1ef1c t\u1ebf thay v\u00ec \u00e1p d\u1ee5ng theo th\u00f3i quen.<\/span><\/p>\n<h3><b>T\u00ecnh hu\u1ed1ng 1: D\u1eef li\u1ec7u gi\u00e1m s\u00e1t vi sinh ph\u00e1t hi\u1ec7n vi sinh t\u1ea1o b\u00e0o t\u1eed<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Khi k\u1ebft qu\u1ea3 EM ph\u00e1t hi\u1ec7n c\u00e1c ch\u1ee7ng t\u1ea1o b\u00e0o t\u1eed nh\u01b0 Bacillus ho\u1eb7c Clostridium, c\u1ea7n tri\u1ec3n khai h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed ngay. \u0110\u00e2y l\u00e0 d\u1ea5u hi\u1ec7u cho th\u1ea5y ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n hi\u1ec7n t\u1ea1i ch\u01b0a \u0111\u1ee7 hi\u1ec7u l\u1ef1c. Vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c t\u00e1c nh\u00e2n oxy h\u00f3a m\u1ea1nh v\u1edbi th\u1eddi gian ti\u1ebfp x\u00fac ph\u00f9 h\u1ee3p gi\u00fap gi\u1ea3m nhanh t\u1ea3i l\u01b0\u1ee3ng b\u00e0o t\u1eed v\u1ec1 m\u1ee9c ki\u1ec3m so\u00e1t. Sau x\u1eed l\u00fd, c\u1ea7n theo d\u00f5i l\u1ea1i EM trong 24\u201348 gi\u1edd \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3. V\u00ed d\u1ee5: s\u1ea3n ph\u1ea9m nh\u01b0 <\/span><b>STERIS Spor-Klenz<\/b><span style=\"font-weight: 400;\">, <\/span><b>QT Sporicide<\/b><span style=\"font-weight: 400;\">, ho\u1eb7c <\/span><b>VAI\/Veltek DECON-SPORE 200 Plus<\/b><span style=\"font-weight: 400;\"> c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng hi\u1ec7u qu\u1ea3 trong tr\u01b0\u1eddng h\u1ee3p n\u00e0y.\u00a0<\/span><\/p>\n<h3><b>T\u00ecnh Hu\u1ed1ng 2: Ph\u00f2ng S\u1ea1ch Grade A Ho\u1eb7c B Ch\u01b0a Bao Gi\u1edd D\u00f9ng Sporicide<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">N\u1ebfu ph\u00f2ng s\u1ea1ch Grade A (v\u00f4 tr\u00f9ng) ho\u1eb7c Grade B (h\u1ed7 tr\u1ee3 v\u00f4 tr\u00f9ng) ch\u01b0a c\u00f3 ch\u01b0\u01a1ng tr\u00ecnh sporicide \u0111\u1ecbnh k\u1ef3, b\u1ea1n c\u1ea7n b\u1eaft \u0111\u1ea7u ngay. EU GMP y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c. Th\u01b0\u1eddng th\u00ec Grade A c\u1ea7n d\u00f9ng sporicide <\/span><b>h\u00e0ng tu\u1ea7n<\/b><span style=\"font-weight: 400;\"> ho\u1eb7c <\/span><b>2 tu\u1ea7n 1 l\u1ea7n<\/b><span style=\"font-weight: 400;\">, v\u1edbi contact time ng\u1eafn <\/span><b>(10-15 ph\u00fat) <\/b><span style=\"font-weight: 400;\">\u0111\u1ec3 kh\u00f4ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn t\u00ednh v\u00f4 tr\u00f9ng c\u1ee7a kh\u00f4ng kh\u00ed.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Lo\u1ea1i h\u00f3a ch\u1ea5t \u0111\u01b0\u1ee3c ch\u1ecdn ph\u1ea3i l\u00e0 low residue (\u00edt ho\u1eb7c \u0111\u1ec3 l\u1ea1i d\u01b0 l\u01b0\u1ee3ng) v\u00ed d\u1ee5 nh\u01b0 <\/span><b>hydrogen peroxide 6-7.5%<\/b><span style=\"font-weight: 400;\"> ph\u00e2n h\u1ee7y th\u00e0nh n\u01b0\u1edbc + oxy.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">C\u00e1c s\u1ea3n ph\u1ea9m nh\u01b0 STERIS 6% Hydrogen Peroxide WFI, Ecolab Klercide Low Residue Peroxide 6%, ho\u1eb7c <\/span><a href=\"https:\/\/sepro.vn\/product\/6-hydrogen-peroxide-solution\/\"><b>QT Pure Peroxy<\/b><\/a><span style=\"font-weight: 400;\"> \u0111\u1ec1u th\u00edch h\u1ee3p.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ngo\u00e0i ra, peracetic acid + hydrogen peroxide k\u1ebft h\u1ee3p c\u0169ng l\u00e0 l\u1ef1a ch\u1ecdn t\u1ed1t. \u0110i\u1ec1u n\u00e0y \u0111\u1ea3m b\u1ea3o sau khi lau s\u1ea1ch, kh\u00f4ng c\u00f3 ch\u1ea5t \u0111\u1ed9c h\u1ea1i s\u00f3t l\u1ea1i \u00f4 nhi\u1ec5m s\u1ea3n ph\u1ea9m.<\/span><\/p>\n<h3><b>T\u00ecnh Hu\u1ed1ng 3: Sau C\u00e1c S\u1ef1 Ki\u1ec7n B\u1ea3o Tr\u00ec, Thay C\u1ea5u H\u00ecnh \u1ed0ng D\u1eabn, Ho\u1eb7c Nhi\u1ec5m B\u1ea9n<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">C\u00e1c ho\u1ea1t \u0111\u1ed9ng b\u1ea3o tr\u00ec ho\u1eb7c can thi\u1ec7p k\u1ef9 thu\u1eadt l\u00e0m t\u0103ng nguy c\u01a1 \u0111\u01b0a b\u00e0o t\u1eed v\u00e0o m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch. Sau khi l\u00e0m s\u1ea1ch th\u00f4ng th\u01b0\u1eddng b\u1eb1ng dung m\u00f4i ph\u00f9 h\u1ee3p nh\u01b0 IPA 70% \u0111\u1ec3 lau b\u1ec1 m\u1eb7t (v\u00ed d\u1ee5 nh\u01b0 STERIS Septihol WFI, Ecolab Klercide 70|30 IPA, ho\u1eb7c VAI\/Veltek DECON-AHOL WFI). Sau \u0111\u00f3, c\u1ea7n s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed v\u1edbi th\u1eddi gian ti\u1ebfp x\u00fac \u0111\u1ea7y \u0111\u1ee7 tr\u01b0\u1edbc khi \u0111\u01b0a khu v\u1ef1c tr\u1edf l\u1ea1i s\u1ea3n xu\u1ea5t.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Quy tr\u00ecnh ti\u00eau chu\u1ea9n l\u00e0:\u00a0<\/span><\/p>\n<blockquote>\n<ol>\n<li><span style=\"font-weight: 400;\">Lau s\u1ea1ch b\u1eb1ng n\u01b0\u1edbc c\u1ea5t ho\u1eb7c IPA 70%<\/span><\/li>\n<li>\u0110\u1ee3i kh\u00f4<\/li>\n<li>D\u00f9ng sporicide v\u1edbi contact time theo SOP<\/li>\n<li>Lau l\u1ea1i b\u1eb1ng 70% isopropyl alcohol ho\u1eb7c n\u01b0\u1edbc c\u1ea5t \u0111\u1ec3 lo\u1ea1i b\u1ecf d\u01b0 l\u01b0\u1ee3ng<\/li>\n<li>\u0110\u1ec3 kh\u00f4 t\u1ef1 nhi\u00ean ho\u1eb7c s\u1ea5y b\u1eb1ng kh\u00f4ng kh\u00ed s\u1ea1ch.<\/li>\n<\/ol>\n<\/blockquote>\n<p><span style=\"font-weight: 400;\">Khi g\u1eb7p t\u00ecnh hu\u1ed1ng n\u00e0y, vi\u1ec7c t\u00ecm v\u00e0 lo\u1ea1i b\u1ecf ngu\u1ed3n g\u1ed1c nhi\u1ec5m c\u0169ng quan tr\u1ecdng. T\u00ecm hi\u1ec3u th\u00eam: <\/span><a href=\"https:\/\/sepro.vn\/o-nhiem-phong-sach-la-gi-6-nguon-ban-hay-bi-bo-sot\/\"><b>\u00d4 Nhi\u1ec5m Ph\u00f2ng S\u1ea1ch L\u00e0 G\u00ec: 6 Ngu\u1ed3n B\u1ea9n Hay B\u1ecb B\u1ecf S\u00f3t<\/b><\/a><\/p>\n<h3><b>T\u00ecnh hu\u1ed1ng 4: Kh\u00f4ng tu\u00e2n th\u1ee7 t\u1ea7n su\u1ea5t di\u1ec7t b\u00e0o t\u1eed theo SOP<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">N\u1ebfu ch\u01b0\u01a1ng tr\u00ecnh \u0111\u1ecbnh k\u1ef3 kh\u00f4ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u00fang t\u1ea7n su\u1ea5t, nguy c\u01a1 t\u00edch l\u0169y b\u00e0o t\u1eed s\u1ebd t\u0103ng theo th\u1eddi gian. Tr\u01b0\u1eddng h\u1ee3p n\u00e0y c\u1ea7n \u0111\u01b0\u1ee3c kh\u00f4i ph\u1ee5c ngay v\u00e0 ghi nh\u1eadn nh\u01b0 m\u1ed9t sai l\u1ec7ch trong h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng, k\u00e8m theo \u0111\u00e1nh gi\u00e1 v\u00e0 tri\u1ec3n khai CAPA ph\u00f9 h\u1ee3p.<\/span><\/p>\n<h3><b>T\u00ecnh Hu\u1ed1ng 5: S\u1eed D\u1ee5ng Isolator (B\u1ed1c H\u01a1i Kh\u1eed Tr\u00f9ng)<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">EU GMP Annex 1 n\u00eau r\u00f5:\u00a0<\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">&#8220;The bio-decontamination process of the interior should be automated, validated and controlled within defined cycle parameters and should include a sporicidal agent.&#8221;\u00a0<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">Theo EU GMP Annex 1, qu\u00e1 tr\u00ecnh kh\u1eed nhi\u1ec5m trong isolator ph\u1ea3i \u0111\u01b0\u1ee3c t\u1ef1 \u0111\u1ed9ng h\u00f3a, th\u1ea9m \u0111\u1ecbnh v\u00e0 bao g\u1ed3m t\u00e1c nh\u00e2n c\u00f3 kh\u1ea3 n\u0103ng di\u1ec7t b\u00e0o t\u1eed. Th\u1ef1c t\u1ebf v\u1eadn h\u00e0nh th\u01b0\u1eddng s\u1eed d\u1ee5ng hydrogen peroxide d\u1ea1ng h\u01a1i \u1edf n\u1ed3ng \u0111\u1ed9 cao. Hi\u1ec7u l\u1ef1c ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng minh th\u00f4ng qua validation v\u1edbi m\u1ee9c gi\u1ea3m vi sinh ph\u00f9 h\u1ee3p, th\u01b0\u1eddng \u0111\u1ea1t t\u1ed1i thi\u1ec3u 6-log reduction.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Link tham kh\u1ea3o: <\/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\"><span style=\"font-weight: 400;\">https:\/\/health.ec.europa.eu\/document\/download\/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf<\/span><\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Sporicide_Co_Duoc_Dung_Cho_Grade_A_B_C_D_Khong\"><\/span><b>Sporicide C\u00f3 \u0110\u01b0\u1ee3c D\u00f9ng Cho Grade A, B, C, D Kh\u00f4ng?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">C\u00e2u tr\u1ea3 l\u1eddi l\u00e0: T\u1ea5t c\u1ea3 c\u00e1c Grade \u0111\u1ec1u c\u00f3 th\u1ec3 s\u1eed d\u1ee5ng sporicide, nh\u01b0ng t\u1ea7n su\u1ea5t v\u00e0 contact time kh\u00e1c nhau. D\u01b0\u1edbi \u0111\u00e2y l\u00e0 b\u1ea3ng h\u01b0\u1edbng d\u1eabn:<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>Grade<\/b><\/td>\n<td><b>C\u00f3 d\u00f9ng sporicide kh\u00f4ng?<\/b><\/td>\n<td><b>T\u1ea7n su\u1ea5t<\/b><\/td>\n<td><b>Contact time<\/b><\/td>\n<td><b>Ghi ch\u00fa<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Grade A (V\u00f4 tr\u00f9ng)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">B\u1eaft bu\u1ed9c<\/span><\/td>\n<td><span style=\"font-weight: 400;\">H\u00e0ng tu\u1ea7n<\/span><\/td>\n<td><span style=\"font-weight: 400;\">10-15 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Y\u00eau c\u1ea7u d\u01b0 l\u01b0\u1ee3ng th\u1ea5p, kh\u00f4ng \u1ea3nh h\u01b0\u1edfng s\u1ea3n ph\u1ea9m<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Grade B (H\u1ed7 tr\u1ee3 A)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">B\u1eaft bu\u1ed9c<\/span><\/td>\n<td><span style=\"font-weight: 400;\">H\u00e0ng tu\u1ea7n<\/span><\/td>\n<td><span style=\"font-weight: 400;\">10-15 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f9ng y\u00eau c\u1ea7u Grade A<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Grade C (S\u1ea3n xu\u1ea5t)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">2 tu\u1ea7n 1 l\u1ea7n<\/span><\/td>\n<td><span style=\"font-weight: 400;\">20-30 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3 th\u1ec3 d\u00f9ng contact time d\u00e0i h\u01a1n v\u00ec kh\u00f4ng ho\u1ea1t \u0111\u1ed9ng v\u00f4 tr\u00f9ng<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Grade D (Kho l\u01b0u tr\u1eef)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">T\u00f9y tr\u01b0\u1eddng h\u1ee3p<\/span><\/td>\n<td><span style=\"font-weight: 400;\">H\u00e0ng th\u00e1ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">20-30 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">N\u1ebfu \u0111\u1ed9 \u1ea9m &gt; 60% ho\u1eb7c nhi\u1ec7t \u0111\u1ed9 &lt; 20\u00b0C th\u00ec t\u0103ng t\u1ea7n su\u1ea5t<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">Link tham kh\u1ea3o: <\/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\"><span style=\"font-weight: 400;\">https:\/\/health.ec.europa.eu\/document\/download\/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec3m c\u1ed1t l\u00f5i:<\/span><\/p>\n<blockquote>\n<ul>\n<li><span style=\"font-weight: 400;\">\u0110\u1ed1i v\u1edbi Grade A v\u00e0 B, vi\u1ec7c s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c theo GMP nh\u1eb1m ki\u1ec3m so\u00e1t nguy c\u01a1 t\u1eeb vi sinh t\u1ea1o b\u00e0o t\u1eed trong m\u00f4i tr\u01b0\u1eddng v\u00f4 tr\u00f9ng.<\/span><\/li>\n<li>\u0110\u1ed1i v\u1edbi Grade C, vi\u1ec7c s\u1eed d\u1ee5ng mang t\u00ednh ki\u1ec3m so\u00e1t ch\u1ee7 \u0111\u1ed9ng, nh\u1eb1m ng\u0103n ng\u1eeba t\u00edch l\u0169y b\u00e0o t\u1eed theo th\u1eddi gian. T\u1ea7n su\u1ea5t c\u1ea7n \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh d\u1ef1a tr\u00ean d\u1eef li\u1ec7u gi\u00e1m s\u00e1t vi sinh, \u0111\u1eb7c bi\u1ec7t khi xu\u1ea5t hi\u1ec7n xu h\u01b0\u1edbng t\u0103ng c\u1ee7a c\u00e1c ch\u1ee7ng nh\u01b0 Bacillus.<\/li>\n<li>\u0110\u1ed1i v\u1edbi Grade D, vi\u1ec7c \u00e1p d\u1ee5ng ph\u1ee5 thu\u1ed9c v\u00e0o \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh th\u1ef1c t\u1ebf. Trong c\u00e1c m\u00f4i tr\u01b0\u1eddng c\u00f3 \u0111\u1ed9 \u1ea9m cao, t\u1ed3n \u0111\u1ecdng n\u01b0\u1edbc ho\u1eb7c l\u01b0u th\u00f4ng kh\u00f4ng kh\u00ed k\u00e9m, nguy c\u01a1 ph\u00e1t sinh b\u00e0o t\u1eed t\u0103ng l\u00ean v\u00e0 c\u1ea7n t\u0103ng t\u1ea7n su\u1ea5t s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed t\u01b0\u01a1ng \u1ee9ng.<\/li>\n<\/ul>\n<\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"So_sanh_IPA_70_hydrogen_peroxide_va_hoa_chat_diet_bao_tu_%E2%80%94_lua_chon_theo_muc_dich_su_dung\"><\/span><b>So s\u00e1nh IPA 70%, hydrogen peroxide v\u00e0 h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed \u2014 l\u1ef1a ch\u1ecdn theo m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Ba nh\u00f3m h\u00f3a ch\u1ea5t n\u00e0y c\u00f3 vai tr\u00f2 kh\u00e1c nhau trong ch\u01b0\u01a1ng tr\u00ecnh ki\u1ec3m so\u00e1t vi sinh v\u00e0 kh\u00f4ng th\u1ec3 thay th\u1ebf cho nhau.<\/span><\/p>\n<p><b>IPA 70% (Isopropyl Alcohol)<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u00e1c d\u1ee5ng: Di\u1ec7t vi khu\u1ea9n sinh d\u01b0\u1ee1ng nhanh, KH\u00d4NG di\u1ec7t b\u00e0o t\u1eed<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Khi d\u00f9ng: H\u00e0ng ng\u00e0y, \u0111\u1ec3 v\u1ec7 sinh v\u00e0 kh\u1eed khu\u1ea9n nhanh ch\u00f3ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Contact time: 5-10 ph\u00fat<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">H\u1ea1n ch\u1ebf: <\/span><b>KH\u00d4NG <\/b><span style=\"font-weight: 400;\">c\u00f3 kh\u1ea3 n\u0103ng di\u1ec7t b\u00e0o t\u1eed<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">S\u1ea3n ph\u1ea9m v\u00ed d\u1ee5: STERIS Septihol WFI, Ecolab Klercide 70|30 IPA, Contec Sterile 70% IPA, VAI\/Veltek DECON-AHOL WFI<\/span><\/li>\n<\/ul>\n<p><b>Hydrogen Peroxide 6%-7.5%<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u00e1c d\u1ee5ng: Di\u1ec7t b\u00e0o t\u1eed (sporicidal) + vi khu\u1ea9n sinh d\u01b0\u1ee1ng + n\u1ea5m + virus<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Khi d\u00f9ng: \u0110\u1ecbnh k\u1ef3 (tu\u1ea7n\/2 tu\u1ea7n 1 l\u1ea7n), ho\u1eb7c sau b\u1ea3o tr\u00ec<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Contact time: 10-15 ph\u00fat \u1edf n\u1ed3ng \u0111\u1ed9 6%-7.5%<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u01afu \u0111i\u1ec3m: Ph\u00e2n h\u1ee7y th\u00e0nh n\u01b0\u1edbc + oxy, kh\u00f4ng \u0111\u1ec3 l\u1ea1i d\u01b0 l\u01b0\u1ee3ng \u0111\u1ed9c h\u1ea1i. N\u1ed3ng \u0111\u1ed9 v\u1eeba ph\u1ea3i n\u00ean an to\u00e0n cho nh\u00e2n vi\u00ean h\u01a1n n\u1ed3ng \u0111\u1ed9 cao<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">S\u1ea3n ph\u1ea9m v\u00ed d\u1ee5: STERIS 6% Hydrogen Peroxide WFI, Ecolab Klercide Low Residue Peroxide 6%, <\/span><b>QT Pure Peroxy<\/b><span style=\"font-weight: 400;\">, VAI\/Veltek STERI-PEROX 6%<\/span><\/li>\n<\/ul>\n<p><b>Sporicide (Peracetic Acid + Hydrogen Peroxide ho\u1eb7c Peracetic Acid \u0111\u01a1n)<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">T\u00e1c d\u1ee5ng: Di\u1ec7t b\u00e0o t\u1eed m\u1ea1nh h\u01a1n, t\u00e1c d\u1ee5ng nhanh h\u01a1n hydrogen peroxide \u0111\u01a1n<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Khi d\u00f9ng: \u0110\u1ecbnh k\u1ef3 (tu\u1ea7n\/2 tu\u1ea7n 1 l\u1ea7n) ho\u1eb7c khi ph\u00e1t hi\u1ec7n b\u00e0o t\u1eed cao<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Contact time: <\/span><b>10-15 ph\u00fat<\/b><span style=\"font-weight: 400;\"> (t\u00f9y n\u1ed3ng \u0111\u1ed9 <\/span><b>0.2%-0.35%<\/b><span style=\"font-weight: 400;\">) ho\u1eb7c 20-30 ph\u00fat (t\u00f9y bi\u1ebfn th\u1ec3)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u01afu \u0111i\u1ec3m: C\u00f4ng th\u1ee9c t\u1ed1i \u01b0u cho m\u00f4i tr\u01b0\u1eddng ki\u1ec3m so\u00e1t nghi\u00eam ng\u1eb7t, hi\u1ec7u l\u1ef1c di\u1ec7t b\u00e0o t\u1eed cao<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">S\u1ea3n ph\u1ea9m v\u00ed d\u1ee5: STERIS Spor-Klenz, <\/span><a href=\"https:\/\/sepro.vn\/product\/qt-sporicide\/\"><b>QT Sporicide<\/b><\/a><span style=\"font-weight: 400;\">, VAI\/Veltek DECON-SPORE 200 Plus<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">B\u1ea3ng So S\u00e1nh Chi Ti\u1ebft:<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>Ti\u00eau ch\u00ed<\/b><\/td>\n<td><b>IPA 70%<\/b><\/td>\n<td><b>Hydrogen Peroxide 6-7.5%<\/b><\/td>\n<td><b>Sporicide (PAA + H2O2)<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Di\u1ec7t vi khu\u1ea9n sinh d\u01b0\u1ee1ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Di\u1ec7t b\u00e0o t\u1eed<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Kh\u00f4ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">T\u00e1c d\u1ee5ng nhanh<\/span><\/td>\n<td><span style=\"font-weight: 400;\">5-10 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">10-15 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">10-15 ph\u00fat<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Kh\u00f4ng \u0111\u1ec3 l\u1ea1i d\u01b0 l\u01b0\u1ee3ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">An to\u00e0n cho nh\u00e2n vi\u00ean<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Cao<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Cao<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Cao<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">S\u1ea3n ph\u1ea9m ti\u00eau bi\u1ec3u<\/span><\/td>\n<td><span style=\"font-weight: 400;\">STERIS, Ecolab, Contec, VAI\/Veltek<\/span><\/td>\n<td><span style=\"font-weight: 400;\">STERIS, Ecolab, Contec, VAI\/Veltek<\/span><\/td>\n<td><span style=\"font-weight: 400;\">STERIS, Contec, VAI\/Veltek<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">Link tham kh\u1ea3o: <\/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\"><span style=\"font-weight: 400;\">https:\/\/health.ec.europa.eu\/document\/download\/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">K\u1ebft lu\u1eadn:<\/span><\/p>\n<blockquote>\n<ol>\n<li><span style=\"font-weight: 400;\">S\u1eed d\u1ee5ng IPA 70% = v\u1ec7 sinh h\u00e0ng ng\u00e0y (di\u1ec7t vi khu\u1ea9n sinh d\u01b0\u1ee1ng)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">S\u1eed d\u1ee5ng Sporicide = ki\u1ec3m so\u00e1t b\u00e0o t\u1eed \u0111\u1ecbnh k\u1ef3 (b\u00e0o t\u1eed vi khu\u1ea9n)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">C\u1ea7n k\u1ebft h\u1ee3p c\u1ea3 hai, kh\u00f4ng thay th\u1ebf \u0111\u01b0\u1ee3c \u2014 n\u1ebfu ch\u1ec9 d\u00f9ng IPA 70%, b\u00e0o t\u1eed s\u1ebd t\u00edch l\u0169y theo th\u1eddi gian, n\u1ebfu ch\u1ec9 d\u00f9ng sporicide m\u00e0 kh\u00f4ng v\u1ec7 sinh th\u01b0\u1eddng xuy\u00ean, vi khu\u1ea9n sinh d\u01b0\u1ee1ng s\u1ebd ph\u00e1t tri\u1ec3n nhanh<\/span><\/li>\n<\/ol>\n<\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Contact_Time_Tan_Suat_%E2%80%94_Lam_Sao_De_Tuan_Thu_Dung\"><\/span><b>Contact Time &amp; T\u1ea7n Su\u1ea5t \u2014 L\u00e0m Sao \u0110\u1ec3 Tu\u00e2n Th\u1ee7 \u0110\u00fang?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure id=\"attachment_9472\" aria-describedby=\"caption-attachment-9472\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9472\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-6.png\" alt=\"tuan-thu-dung-contact-time-tan-suat-khi-diet-bao-tu-phong-sach\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-6.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-6-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-6-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-6-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9472\" class=\"wp-caption-text\"><em>Tu\u00e2n th\u1ee7 \u0111\u00fang contact time v\u00e0 t\u1ea7n xu\u1ea5t khi di\u1ec7t b\u00e0o t\u1eed ph\u00f2ng s\u1ea1ch<\/em><\/figcaption><\/figure>\n<h3><b>Contact Time L\u00e0 G\u00ec?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Contact time l\u00e0 kho\u1ea3ng th\u1eddi gian m\u00e0 sporicide ph\u1ea3i ti\u1ebfp x\u00fac v\u1edbi b\u1ec1 m\u1eb7t \u0111\u1ec3 \u0111\u1ea1t hi\u1ec7u qu\u1ea3 di\u1ec7t b\u00e0o t\u1eed.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">V\u00ed d\u1ee5: n\u1ebfu SOP quy \u0111\u1ecbnh hydrogen peroxide 6% c\u00f3 contact time 15 ph\u00fat, b\u1ea1n PH\u1ea2I gi\u1eef b\u1ec1 m\u1eb7t \u1ea9m (<\/span><b>wet<\/b><span style=\"font-weight: 400;\">) su\u1ed1t <\/span><b>15 ph\u00fat<\/b><span style=\"font-weight: 400;\">. N\u1ebfu gi\u1ea3m, hi\u1ec7u l\u1ef1c s\u1ebd gi\u1ea3m, b\u00e0o t\u1eed c\u00f3 th\u1ec3 s\u1ed1ng s\u00f3t.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Gi\u00e1 tr\u1ecb contact time kh\u00f4ng ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ecdn t\u00f9y \u00fd m\u00e0 l\u00e0 k\u1ebft qu\u1ea3 c\u1ee7a c\u00e1c th\u1eed nghi\u1ec7m hi\u1ec7u l\u1ef1c kh\u1eed khu\u1ea9n theo ti\u00eau chu\u1ea9n k\u1ef9 thu\u1eadt. Ti\u00eau chu\u1ea9n <\/span><b>ISO 11135<\/b><span style=\"font-weight: 400;\"> quy \u0111\u1ecbnh ph\u01b0\u01a1ng ph\u00e1p x\u00e1c \u0111\u1ecbnh contact time cho c\u00e1c h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA ghi nh\u1eadn: nh\u00e0 m\u00e1y Brigham and Women&#8217;s Hospital kh\u00f4ng tu\u00e2n th\u1ee7 th\u1eddi gian ti\u1ebfp x\u00fac t\u1ed1i thi\u1ec3u cho sporicide, v\u00e0 nh\u00e0 m\u00e1y Greenpark Compounding Pharmacy kh\u00f4ng \u0111\u1ea3m b\u1ea3o th\u1eddi gian ti\u1ebfp x\u00fac \u0111\u1ee7 cho h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed. \u0110\u00e2y l\u00e0 nh\u1eefng vi ph\u1ea1m <\/span><b>cGMP <\/b><span style=\"font-weight: 400;\">nghi\u00eam tr\u1ecdng.<\/span><\/p>\n<blockquote>\n<ol>\n<li><span style=\"font-weight: 400;\">Link tham kh\u1ea3o (Brigham and Women&#8217;s Hospital): <\/span><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/brigham-and-womens-hospital-inc-623476-04112022\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/brigham-and-womens-hospital-inc-623476-04112022<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Link tham kh\u1ea3o (Greenpark Compounding Pharmacy): <\/span><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/greenpark-compounding-pharmacy-566233-10262018\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/greenpark-compounding-pharmacy-566233-10262018<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">Link tham kh\u1ea3o (ISO 11135): <\/span><a href=\"https:\/\/www.fda.gov\/files\/drugs\/published\/Sterile-Drug-Products-Produced-by-Aseptic-Processing-%E2%80%94-Current-Good-Manufacturing-Practice.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/files\/drugs\/published\/Sterile-Drug-Products-Produced-by-Aseptic-Processing-%E2%80%94-Current-Good-Manufacturing-Practice.pdf<\/span><\/a><\/li>\n<\/ol>\n<\/blockquote>\n<h3><b>T\u1ea7n Su\u1ea5t L\u00e0 G\u00ec?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">T\u1ea7n su\u1ea5t l\u00e0 kho\u1ea3ng th\u1eddi gian gi\u1eefa c\u00e1c l\u1ea7n s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed. Kh\u00f4ng t\u1ed3n t\u1ea1i m\u1ed9t m\u1ed1c th\u1eddi gian c\u1ed1 \u0111\u1ecbnh \u00e1p d\u1ee5ng cho m\u1ecdi nh\u00e0 m\u00e1y, t\u1ea7n su\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp d\u1ef1a tr\u00ean d\u1eef li\u1ec7u gi\u00e1m s\u00e1t vi sinh v\u00e0 \u0111\u00e1nh gi\u00e1 r\u1ee7i ro. V\u00ed d\u1ee5:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Grade A\/B: H\u00e0ng tu\u1ea7n ho\u1eb7c 2 tu\u1ea7n 1 l\u1ea7n<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Grade C: H\u00e0ng th\u00e1ng ho\u1eb7c 2 th\u00e1ng 1 l\u1ea7n<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Grade D: H\u00e0ng qu\u00fd (n\u1ebfu \u0111i\u1ec1u ki\u1ec7n \u1ed5n \u0111\u1ecbnh<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">T\u1ea7n su\u1ea5t kh\u00f4ng ph\u1ea3i c\u1ed1 \u0111\u1ecbnh m\u00e0 ph\u1ee5 thu\u1ed9c v\u00e0o d\u1eef li\u1ec7u EM v\u00e0 \u0111\u00e1nh gi\u00e1 r\u1ee7i ro. N\u1ebfu Bacillus li\u00ean t\u1ee5c xu\u1ea5t hi\u1ec7n \u1edf m\u1ee9c cao, t\u1ea7n su\u1ea5t c\u1ea7n t\u0103ng. N\u1ebfu 3-6 th\u00e1ng li\u00ean ti\u1ebfp kh\u00f4ng ph\u00e1t hi\u1ec7n b\u00e0o t\u1eed \u1edf Grade D, t\u1ea7n su\u1ea5t c\u00f3 th\u1ec3 duy tr\u00ec h\u00e0ng qu\u00fd. \u0110\u1ec3 chi ti\u1ebft h\u01a1n v\u1ec1 c\u00e1ch l\u1eadp k\u1ebf ho\u1ea1ch v\u1ec7 sinh v\u00e0 kh\u1eed khu\u1ea9n d\u1ef1a tr\u00ean r\u1ee7i ro, xem: <\/span><a href=\"https:\/\/sepro.vn\/quy-trinh-ve-sinh-nha-may-theo-gmp-eu\/\"><b>Quy Tr\u00ecnh V\u1ec7 Sinh Nh\u00e0 M\u00e1y Theo GMP EU: C\u00e1c B\u01b0\u1edbc, SOP, An To\u00e0n, Nghi\u1ec7m Thu<\/b><\/a><\/p>\n<p><span style=\"font-weight: 400;\">B\u1ea3ng Contact Time Ti\u00eau Bi\u1ec3u:<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>H\u00f3a ch\u1ea5t<\/b><\/td>\n<td><b>N\u1ed3ng \u0111\u1ed9<\/b><\/td>\n<td><b>Contact time<\/b><\/td>\n<td><b>S\u1ea3n ph\u1ea9m v\u00ed d\u1ee5<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Hydrogen Peroxide<\/span><\/td>\n<td><span style=\"font-weight: 400;\">6-7.5%<\/span><\/td>\n<td><span style=\"font-weight: 400;\">10-15 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">STERIS 6% H2O2 WFI, Ecolab Klercide 6%, <\/span><b>QT Pure Peroxy<\/b><span style=\"font-weight: 400;\">, VAI\/Veltek STERI-PEROX 6%<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Hydrogen Peroxide<\/span><\/td>\n<td><span style=\"font-weight: 400;\">35%<\/span><\/td>\n<td><span style=\"font-weight: 400;\">3-10 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">STERIS 35% H2O2 (cho isolator), VAI\/Veltek s\u1ea3n ph\u1ea9m H2O2 n\u1ed3ng \u0111\u1ed9 cao<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Peracetic Acid + H2O2<\/span><\/td>\n<td><span style=\"font-weight: 400;\">0.2-0.35%<\/span><\/td>\n<td><span style=\"font-weight: 400;\">10-15 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">STERIS Spor-Klenz, <\/span><b>QT Sporicide<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Peracetic Acid + H2O2 (kh\u00e1c)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Kh\u00e1c n\u1ed3ng \u0111\u1ed9<\/span><\/td>\n<td><span style=\"font-weight: 400;\">20-30 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">VAI\/Veltek DECON-SPORE 200 Plus<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Glutaraldehyde<\/span><\/td>\n<td><span style=\"font-weight: 400;\">2-3.5%<\/span><\/td>\n<td><span style=\"font-weight: 400;\">3-10 gi\u1edd<\/span><\/td>\n<td><span style=\"font-weight: 400;\">(Hi\u1ebfm d\u00f9ng trong ph\u00f2ng s\u1ea1ch ho\u1ea1t \u0111\u1ed9ng)<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Sodium Hypochlorite<\/span><\/td>\n<td><span style=\"font-weight: 400;\">0.52-5.25%<\/span><\/td>\n<td><span style=\"font-weight: 400;\">10-60 ph\u00fat<\/span><\/td>\n<td><span style=\"font-weight: 400;\">STERIS Hypochlorite WFI, VAI\/Veltek HYPO-CHLOR, Ecolab Klercide Sporicidal Active Chlorine<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">Link tham kh\u1ea3o: <\/span><a href=\"https:\/\/www.fda.gov\/files\/drugs\/published\/Sterile-Drug-Products-Produced-by-Aseptic-Processing-%E2%80%94-Current-Good-Manufacturing-Practice.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/files\/drugs\/published\/Sterile-Drug-Products-Produced-by-Aseptic-Processing-%E2%80%94-Current-Good-Manufacturing-Practice.pdf<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">C\u00e1ch Tu\u00e2n Th\u1ee7 \u0110\u00fang:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ghi ch\u00e9p t\u1eebng l\u1ea7n s\u1eed d\u1ee5ng: Lo\u1ea1i sporicide, n\u1ed3ng \u0111\u1ed9 th\u1ef1c t\u1ebf, ng\u00e0y gi\u1edd, contact time th\u1ef1c t\u1ebf, khu v\u1ef1c \u00e1p d\u1ee5ng, nh\u00e2n vi\u00ean th\u1ef1c hi\u1ec7n. \u0110\u00e2y l\u00e0 b\u1eb1ng ch\u1ee9ng cho FDA n\u1ebfu c\u00f3 thanh tra.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ki\u1ec3m tra n\u1ed3ng \u0111\u1ed9 tr\u01b0\u1edbc s\u1eed d\u1ee5ng: D\u00f9ng que test ho\u1eb7c ph\u01b0\u01a1ng ph\u00e1p <\/span><b>titration (x\u00e1c \u0111\u1ecbnh n\u1ed3ng \u0111\u1ed9 dung d\u1ecbch) <\/b><span style=\"font-weight: 400;\">\u0111\u1ec3 x\u00e1c minh n\u1ed3ng \u0111\u1ed9 \u0111\u00fang. Hydrogen peroxide ho\u1eb7c peracetic acid c\u00f3 th\u1ec3 m\u1ea5t hi\u1ec7u l\u1ef1c theo th\u1eddi gian n\u1ebfu b\u1ea3o qu\u1ea3n kh\u00f4ng \u0111\u00fang, do \u0111\u00f3 ki\u1ec3m tra n\u1ed3ng \u0111\u1ed9 l\u00e0 b\u1eaft bu\u1ed9c.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Gi\u00e1m s\u00e1t k\u1ebft qu\u1ea3 EM sau kh\u1eed khu\u1ea9n: Th\u01b0\u1eddng sau <\/span><b>24-48 gi\u1edd<\/b><span style=\"font-weight: 400;\">, ki\u1ec3m tra xem m\u1ee9c vi sinh v\u1eadt c\u00f3 gi\u1ea3m kh\u00f4ng. N\u1ebfu Bacillus v\u1eabn cao ho\u1eb7c t\u0103ng tr\u1edf l\u1ea1i, \u0111i\u1ec1u ch\u1ec9nh l\u1ea1i lo\u1ea1i sporicide, n\u1ed3ng \u0111\u1ed9, ho\u1eb7c t\u1ea7n su\u1ea5t.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110i\u1ec1u ch\u1ec9nh t\u1ea7n su\u1ea5t d\u1ef1a tr\u00ean xu h\u01b0\u1edbng: Ph\u00e2n t\u00edch d\u1eef li\u1ec7u EM h\u00e0ng th\u00e1ng. N\u1ebfu xu h\u01b0\u1edbng Bacillus gi\u1ea3m v\u00e0 duy tr\u00ec th\u1ea5p, k\u1ebf ho\u1ea1ch hi\u1ec7u qu\u1ea3. N\u1ebfu kh\u00f4ng, \u0111i\u1ec1u ch\u1ec9nh.<\/span><\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"FAQ_Khi_nao_can_diet_bao_tu_phong_sach\"><\/span>FAQ: Khi n\u00e0o c\u1ea7n di\u1ec7t b\u00e0o t\u1eed ph\u00f2ng s\u1ea1ch<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<blockquote>\n<h3><b>N\u1ebfu Ch\u01b0a Ph\u00e1t Hi\u1ec7n B\u00e0o T\u1eed Th\u00ec C\u00f3 C\u1ea7n D\u00f9ng Sporicide Kh\u00f4ng?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">C\u00f3. EU GMP Annex 1 y\u00eau c\u1ea7u s\u1eed d\u1ee5ng sporicide \u0111\u1ecbnh k\u1ef3 \u0111\u1ec3 ki\u1ec3m so\u00e1t d\u1ef1 ph\u00f2ng, kh\u00f4ng ph\u1ea3i ch\u1ec9 khi ph\u00e1t hi\u1ec7n. D\u1eef li\u1ec7u gi\u00e1m s\u00e1t vi sinh c\u00f3 th\u1ec3 ch\u1eadm ph\u00e1t hi\u1ec7n b\u00e0o t\u1eed v\u00ec b\u00e0o t\u1eed c\u00f3 th\u1ec3 s\u00f3t l\u1ea1i \u1edf c\u00e1c \u0111i\u1ec3m kh\u00f3 ti\u1ebfp c\u1eadn. S\u1eed d\u1ee5ng sporicide \u0111\u1ecbnh k\u1ef3 l\u00e0 c\u00e1ch ch\u1ee7 \u0111\u1ed9ng tr\u00e1nh r\u1ee7i ro.<\/span><\/p>\n<h3><b>Sporicide C\u00f3 \u0110\u01b0\u1ee3c D\u00f9ng Cho Grade D (Kho L\u01b0u Tr\u1eef) Kh\u00f4ng?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">T\u00f9y tr\u01b0\u1eddng h\u1ee3p. N\u1ebfu Grade D c\u00f3 \u0111\u1ed9 \u1ea9m cao <\/span><b>(&gt; 60%)<\/b><span style=\"font-weight: 400;\"> ho\u1eb7c nhi\u1ec7t \u0111\u1ed9 th\u1ea5p <\/span><b>(&lt; 20\u00b0C)<\/b><span style=\"font-weight: 400;\">, nguy c\u01a1 b\u00e0o t\u1eed t\u0103ng n\u00ean c\u1ea7n d\u00f9ng sporicide h\u00e0ng th\u00e1ng. N\u1ebfu Grade D \u1ed5n \u0111\u1ecbnh (<\/span><b>\u0111\u1ed9 \u1ea9m 40-60%, nhi\u1ec7t \u0111\u1ed9 20-25\u00b0C)<\/b><span style=\"font-weight: 400;\">, c\u00f3 th\u1ec3 d\u00f9ng \u0111\u1ecbnh k\u1ef3 h\u00e0ng qu\u00fd.<\/span><\/p>\n<h3><b>Lu\u00e2n Phi\u00ean Sporicide L\u00e0 G\u00ec V\u00e0 T\u1ea1i Sao C\u1ea7n Lu\u00e2n Phi\u00ean?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Lu\u00e2n phi\u00ean sporicide c\u00f3 ngh\u0129a l\u00e0 s\u1eed d\u1ee5ng 2-3 lo\u1ea1i h\u00f3a ch\u1ea5t kh\u00e1c nhau theo chu k\u1ef3. V\u00ed d\u1ee5:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">tu\u1ea7n 1-2 s\u1eed d\u1ee5ng peracetic acid + hydrogen peroxide (nh\u01b0 STERIS Spor-Klenz ho\u1eb7c VAI\/Veltek DECON-SPORE 200 Plus)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">tu\u1ea7n 3-4 s\u1eed d\u1ee5ng hydrogen peroxide \u0111\u01a1n 6% (nh\u01b0 <\/span><b>QT Pure Peroxy<\/b><span style=\"font-weight: 400;\"> ho\u1eb7c Ecolab Klercide 6%), r\u1ed3i quay l\u1ea1i peracetic acid.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec1u n\u00e0y ng\u0103n vi khu\u1ea9n, \u0111\u1eb7c bi\u1ec7t l\u00e0 Bacillus, ph\u00e1t tri\u1ec3n kh\u00e1ng t\u00ednh v\u1edbi m\u1ed9t lo\u1ea1i h\u00f3a ch\u1ea5t nh\u1ea5t \u0111\u1ecbnh.<\/span><\/p>\n<h3><b>Contact Time L\u00e0 Bao L\u00e2u N\u1ebfu D\u00f9ng Sporicidal Low Residue?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Sporicidal low residue (v\u00ed d\u1ee5: hydrogen peroxide 6% ho\u1eb7c peracetic acid 0.2%) c\u00f3 contact time t\u1eeb <\/span><b>10-15 ph\u00fat<\/b><span style=\"font-weight: 400;\"> t\u00f9y lo\u1ea1i v\u00e0 n\u1ed3ng \u0111\u1ed9 c\u1ee5 th\u1ec3. S\u1ea3n ph\u1ea9m nh\u01b0 STERIS 6% H2O2, <\/span><b>QT Pure Peroxy<\/b><span style=\"font-weight: 400;\">, ho\u1eb7c STERIS Spor-Klenz th\u01b0\u1eddng c\u00f3 contact time <\/span><b>10-15 ph\u00fat<\/b><span style=\"font-weight: 400;\">. N\u00ean ki\u1ec3m tra SOP ho\u1eb7c h\u01b0\u1edbng d\u1eabn nh\u00e0 s\u1ea3n xu\u1ea5t h\u00f3a ch\u1ea5t \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh contact time ch\u00ednh x\u00e1c cho t\u1eebng s\u1ea3n ph\u1ea9m, v\u00ec c\u00e1c nh\u00e0 cung c\u1ea5p kh\u00e1c nhau c\u00f3 th\u1ec3 c\u00f3 c\u00f4ng th\u1ee9c kh\u00e1c nhau.<\/span><\/p>\n<h3><b>C\u00f3 C\u1ea7n S\u1eed D\u1ee5ng Sporicidal Agent Cho B\u1ea3o Tr\u00ec Thi\u1ebft B\u1ecb Kh\u00f4ng?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">C\u00f3, \u0111\u1eb7c bi\u1ec7t khi b\u1ea3o tr\u00ec \u1edf Grade A ho\u1eb7c B. Sau khi l\u00e0m s\u1ea1ch th\u00f4ng th\u01b0\u1eddng (d\u00f9ng IPA 70% nh\u01b0 STERIS Septihol WFI ho\u1eb7c Contec 70% IPA), c\u1ea7n d\u00f9ng sporicide v\u1edbi contact time \u0111\u1ea7y \u0111\u1ee7 \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o kh\u00f4ng c\u00f2n b\u00e0o t\u1eed s\u00f3t l\u1ea1i tr\u01b0\u1edbc khi ti\u1ebfp t\u1ee5c s\u1ea3n xu\u1ea5t. \u0110\u1ea3m b\u1ea3o to\u00e0n b\u1ed9 nh\u00e2n vi\u00ean tu\u00e2n th\u1ee7 \u0111\u00fang quy tr\u00ecnh: <\/span><a href=\"https:\/\/sepro.vn\/dos-donts-phong-sach-gmp-eu-annex-1\/\"><b>Dos &amp; Don&#8217;ts Trong Ph\u00f2ng S\u1ea1ch: H\u01b0\u1edbng D\u1eabn Chu\u1ea9n GMP<\/b><\/a><\/p>\n<h3><b>Rotational Sporicide L\u00e0 G\u00ec?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Rotational sporicide (lu\u00e2n phi\u00ean sporicide) l\u00e0 chi\u1ebfn l\u01b0\u1ee3c s\u1eed d\u1ee5ng c\u00e1c lo\u1ea1i sporicide kh\u00e1c nhau theo chu k\u1ef3 h\u00e0ng tu\u1ea7n ho\u1eb7c h\u00e0ng th\u00e1ng \u0111\u1ec3 tr\u00e1nh vi khu\u1ea9n ph\u00e1t tri\u1ec3n kh\u00e1ng t\u00ednh v\u00e0 duy tr\u00ec hi\u1ec7u qu\u1ea3 ki\u1ec3m so\u00e1t b\u00e0o t\u1eed d\u00e0i h\u1ea1n. V\u00ed d\u1ee5: <\/span><\/p>\n<ul>\n<li>Tu\u1ea7n 1-2 d\u00f9ng peracetic acid + hydrogen peroxide (STERIS Spor-Klenz)<\/li>\n<li>Tu\u1ea7n 3-4 d\u00f9ng hydrogen peroxide \u0111\u01a1n 6% (<b>QT Pure Peroxy<\/b>)<\/li>\n<li>Tu\u1ea7n 5-6 d\u00f9ng sodium hypochlorite (VAI\/Veltek HYPO-CHLOR 0.52%), r\u1ed3i quay l\u1ea1i chu k\u1ef3 \u0111\u1ea7u<\/li>\n<\/ul>\n<\/blockquote>\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;\">Sporicide di\u1ec7t b\u00e0o t\u1eed l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c theo<\/span><b> GMP EU v\u00e0 FDA<\/b><span style=\"font-weight: 400;\">, kh\u00f4ng ph\u1ea3i l\u1ef1a ch\u1ecdn t\u00f9y \u00fd. <strong><a href=\"https:\/\/sepro.vn\/\">Ch\u00fang t\u00f4i<\/a> <\/strong>hi\u1ec3u r\u1eb1ng nh\u1eefng y\u00eau c\u1ea7u n\u00e0y c\u00f3 v\u1ebb ph\u1ee9c t\u1ea1p, nh\u01b0ng th\u1ef1c ch\u1ea5t r\u1ea5t \u0111\u01a1n gi\u1ea3n: n\u1ebfu ph\u00e1t hi\u1ec7n b\u00e0o t\u1eed trong d\u1eef li\u1ec7u gi\u00e1m s\u00e1t vi sinh m\u00e0 kh\u00f4ng c\u00f3 k\u1ebf ho\u1ea1ch sporicide r\u00f5 r\u00e0ng, b\u1ea1n \u0111ang vi ph\u1ea1m ti\u00eau chu\u1ea9n cGMP. H\u00e0ng lo\u1ea1t nh\u00e0 m\u00e1y d\u01b0\u1ee3c tr\u00ean th\u1ebf gi\u1edbi t\u1eeb Porton Biopharma \u0111\u1ebfn Brigham and Women&#8217;s Hospital \u0111\u00e3 b\u1ecb c\u1ea3nh b\u00e1o v\u00ec l\u1ed7i n\u00e0y, ch\u1ee9ng t\u1ecf \u0111\u00e2y kh\u00f4ng ph\u1ea3i l\u00e0 v\u1ea5n \u0111\u1ec1 nh\u1ecf m\u00e0 l\u00e0 r\u1ee7i ro nghi\u00eam tr\u1ecdng.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Gi\u1ea3i ph\u00e1p kh\u00f4ng ph\u1ee9c t\u1ea1p. Ch\u00fang t\u00f4i khuy\u1ebfn kh\u00edch b\u1ea1n: <\/span><b>x\u00e1c \u0111\u1ecbnh Grade<\/b><span style=\"font-weight: 400;\"> c\u1ee7a t\u1eebng khu v\u1ef1c ph\u00f2ng s\u1ea1ch, <\/span><b>\u0111\u00e1nh gi\u00e1 d\u1eef li\u1ec7u<\/b><span style=\"font-weight: 400;\"> EM \u0111\u1ec3 t\u00ecm xu h\u01b0\u1edbng Bacillus, <\/span><b>ch\u1ecdn h\u00f3a ch\u1ea5t sporicide ph\u00f9 h\u1ee3p<\/b><span style=\"font-weight: 400;\"> v\u1edbi t\u1ea7n su\u1ea5t v\u00e0 m\u1ee5c ti\u00eau c\u1ee7a b\u1ea1n, l\u1eadp k\u1ebf ho\u1ea1ch lu\u00e2n phi\u00ean \u0111\u1ec3 <\/span><b>tr\u00e1nh<\/b><span style=\"font-weight: 400;\"> kh\u00e1ng ho\u1ea1t t\u00ednh s\u1ea3n ph\u1ea9m, v\u00e0 <\/span><b>gi\u00e1m s\u00e1t<\/b><span style=\"font-weight: 400;\"> k\u1ebft qu\u1ea3 h\u00e0ng th\u00e1ng. \u0110\u00f3 l\u00e0 nh\u1eefng \u0111i\u1ec1u m\u00e0 m\u1ecdi nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea3i l\u00e0m \u0111\u1ec3 tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c, s\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n hi\u1ec7u qu\u1ea3 v\u00e0 m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh kh\u00f4ng \u0111\u1ea1t ti\u00eau chu\u1ea9n n\u1eb1m \u1edf kh\u1ea3 n\u0103ng x\u00e1c \u0111\u1ecbnh \u0111\u00fang th\u1eddi \u0111i\u1ec3m s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed ph\u00f2ng s\u1ea1ch. Tr\u00ean th\u1ef1c t\u1ebf, nhi\u1ec1u nh\u00e2n s\u1ef1 t\u1eeb v\u1ec7 sinh, QA \u0111\u1ebfn qu\u1ea3n l\u00fd s\u1ea3n &hellip; <a href=\"https:\/\/sepro.vn\/vi\/khi-nao-can-diet-bao-tu-phong-sach-gmp\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Khi N\u00e0o C\u1ea7n Di\u1ec7t B\u00e0o T\u1eed Ph\u00f2ng S\u1ea1ch Theo Chu\u1ea9n GMP EU<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":9468,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[],"class_list":["post-9461","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\/9461","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=9461"}],"version-history":[{"count":8,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9461\/revisions"}],"predecessor-version":[{"id":9479,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9461\/revisions\/9479"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9468"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9461"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9461"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9461"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}