{"id":9557,"date":"2026-03-31T09:47:55","date_gmt":"2026-03-31T09:47:55","guid":{"rendered":"https:\/\/sepro.vn\/?p=9557"},"modified":"2026-04-01T02:19:36","modified_gmt":"2026-04-01T02:19:36","slug":"nuoc-pw-purified-water-la-gi","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/nuoc-pw-purified-water-la-gi\/","title":{"rendered":"N\u01b0\u1edbc PW (Purified Water) l\u00e0 g\u00ec? Ti\u00eau Chu\u1ea9n v\u00e0 Quy Tr\u00ecnh Ki\u1ec3m Nghi\u1ec7m"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">M\u1ed9t nh\u1ea7m l\u1eabn ph\u1ed5 bi\u1ebfn trong v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng n\u01b0\u1edbc t\u1ea1i c\u00e1c nh\u00e0 m\u00e1y d\u01b0\u1ee3c l\u00e0 xem n\u01b0\u1edbc tinh khi\u1ebft ch\u1ec9 \u0111\u01a1n gi\u1ea3n l\u00e0 n\u01b0\u1edbc m\u00e1y \u0111\u01b0\u1ee3c x\u1eed l\u00fd s\u1ea1ch h\u01a1n.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">T\u1eeb c\u00e1ch hi\u1ec3u n\u00e0y, nhi\u1ec1u ng\u01b0\u1eddi cho r\u1eb1ng h\u1ec7 th\u1ed1ng n\u01b0\u1edbc tinh khi\u1ebft &#8211; <\/span><b>Purified Water (PW)<\/b><span style=\"font-weight: 400;\"> kh\u00f4ng c\u1ea7n \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t nghi\u00eam ng\u1eb7t nh\u01b0 <\/span><a href=\"https:\/\/sepro.vn\/vi\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/\"><b>Water for Injection (WFI)<\/b><\/a><span style=\"font-weight: 400;\">. Tuy nhi\u00ean, nh\u1eadn \u0111\u1ecbnh n\u00e0y c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn nhi\u1ec1u sai l\u1ec7ch trong v\u1eadn h\u00e0nh, nh\u01b0 l\u1ef1a ch\u1ecdn sai c\u1ea5p \u0111\u1ed9 n\u01b0\u1edbc, l\u1ea5y m\u1eabu kh\u00f4ng \u0111\u00fang \u0111i\u1ec3m s\u1eed d\u1ee5ng, di\u1ec5n gi\u1ea3i k\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m thi\u1ebfu b\u1ed1i c\u1ea3nh, ho\u1eb7c \u0111i\u1ec1u tra sai l\u1ec7ch theo h\u01b0\u1edbng \u0111\u1ed1i ph\u00f3 thay v\u00ec t\u00ecm nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">D\u01b0\u1edbi \u0111\u00e2y l\u00e0<\/span> m\u1ed9t g\u00f3c nh\u00ecn c\u1ee7a <strong><a href=\"https:\/\/sepro.vn\/\">Sepro<\/a><\/strong> v\u1ec1 h\u1ec7 th\u1ed1ng n\u01b0\u1edbc tinh khi\u1ebft &#8211; Purified Water (PW) trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c, bao g\u1ed3m b\u1ea3n ch\u1ea5t c\u1ee7a c\u1ea5p n\u01b0\u1edbc n\u00e0y, nguy\u00ean t\u1eafc v\u1eadn h\u00e0nh v\u00e0 ki\u1ec3m nghi\u1ec7m, c\u0169ng nh\u01b0 \u00fd ngh\u0129a c\u1ee7a c\u00e1c sai l\u1ec7ch ph\u00e1t sinh trong h\u1ec7 th\u1ed1ng n\u01b0\u1edbc.<\/p>\n<h2><b>B\u1ea3n Ch\u1ea5t V\u00e0 Chi\u1ebfn L\u01b0\u1ee3c V\u1eadn H\u00e0nh H\u1ec7 Th\u1ed1ng N\u01b0\u1edbc PW (Purified Water)<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Trong m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t theo chu\u1ea9n <\/span><b>Th\u1ef1c h\u00e0nh S\u1ea3n xu\u1ea5t T\u1ed1t (GMP)<\/b><span style=\"font-weight: 400;\">, n\u01b0\u1edbc tinh khi\u1ebft kh\u00f4ng ch\u1ec9 l\u00e0 m\u1ed9t ch\u1ec9 ti\u00eau \u0111\u1ea1t y\u00eau c\u1ea7u tr\u00ean phi\u1ebfu ki\u1ec3m nghi\u1ec7m. Tr\u00ean th\u1ef1c t\u1ebf, \u0111\u00e2y l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng k\u1ef9 thu\u1eadt c\u1ea7n \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf, v\u1eadn h\u00e0nh v\u00e0 gi\u00e1m s\u00e1t c\u00f3 ch\u1ee7 \u0111\u00edch, bao g\u1ed3m ki\u1ec3m so\u00e1t li\u00ean t\u1ee5c, theo d\u00f5i xu h\u01b0\u1edbng d\u1eef li\u1ec7u v\u00e0 \u0111i\u1ec1u tra sai l\u1ec7ch d\u1ef1a tr\u00ean m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng c\u1ee7a t\u1eebng c\u00f4ng \u0111o\u1ea1n.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">C\u00e1c h\u01b0\u1edbng d\u1eabn c\u1ee7a <\/span><a href=\"https:\/\/sepro.vn\/vi\/ema-la-gi-vai-tro-quy-trinh-tra-cuu-thuoc-eu\/\"><b>C\u01a1 quan D\u01b0\u1ee3c ph\u1ea9m Ch\u00e2u \u00c2u (EMA)<\/b><\/a><span style=\"font-weight: 400;\"> c\u0169ng nh\u1ea5n m\u1ea1nh r\u1eb1ng c\u1ea5p \u0111\u1ed9 n\u01b0\u1edbc ph\u1ea3i g\u1eafn tr\u1ef1c ti\u1ebfp v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng th\u1ef1c t\u1ebf v\u00e0 \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd theo c\u00e1ch ti\u1ebfp c\u1eadn d\u1ef1a tr\u00ean r\u1ee7i ro trong chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t t\u1ed5ng th\u1ec3 c\u1ee7a nh\u00e0 m\u00e1y.<\/span><\/p>\n<h2><b>N\u01b0\u1edbc PW (Purified Water)<\/b><b> trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c l\u00e0 g\u00ec?<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">N\u01b0\u1edbc tinh khi\u1ebft, vi\u1ebft t\u1eaft l\u00e0 <\/span><a href=\"https:\/\/sepro.vn\/vi\/nuoc-pw-purified-water-la-gi\/\"><b>PW (Purified Water)<\/b><\/a><span style=\"font-weight: 400;\">, l\u00e0 lo\u1ea1i n\u01b0\u1edbc \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong s\u1ea3n xu\u1ea5t c\u00e1c ch\u1ebf ph\u1ea9m d\u01b0\u1ee3c kh\u00f4ng y\u00eau c\u1ea7u \u0111\u1ed3ng th\u1eddi t\u00ednh v\u00f4 tr\u00f9ng v\u00e0 gi\u1edbi h\u1ea1n n\u1ed9i \u0111\u1ed9c t\u1ed1, tr\u1eeb khi c\u00f3 quy \u0111\u1ecbnh \u0111\u1eb7c bi\u1ec7t kh\u00e1c t\u1eeb quy tr\u00ecnh s\u1ea3n xu\u1ea5t ho\u1eb7c h\u1ed3 s\u01a1 s\u1ea3n ph\u1ea9m.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Tuy nhi\u00ean, \u0111\u1ecbnh ngh\u0129a n\u00e0y ch\u1ec9 ph\u1ea3n \u00e1nh m\u1ed9t ph\u1ea7n b\u1ea3n ch\u1ea5t c\u1ee7a PW. N\u01b0\u1edbc tinh khi\u1ebft kh\u00f4ng \u0111\u01a1n thu\u1ea7n l\u00e0 n\u01b0\u1edbc m\u00e1y \u0111\u01b0\u1ee3c x\u1eed l\u00fd s\u1ea1ch h\u01a1n, m\u00e0 l\u00e0 m\u1ed9t c\u1ea5p n\u01b0\u1edbc ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c<strong> ti\u00eau chu\u1ea9n nghi\u00eam ng\u1eb7t<\/strong> c\u1ee7a c\u00e1c d\u01b0\u1ee3c \u0111i\u1ec3n \u00e1p d\u1ee5ng nh\u01b0 USP, EP ho\u1eb7c JP. Quan tr\u1ecdng h\u01a1n, ch\u1ea5t l\u01b0\u1ee3ng n\u01b0\u1edbc ph\u1ea3i \u0111\u01b0\u1ee3c duy tr\u00ec trong tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t xuy\u00ean su\u1ed1t to\u00e0n b\u1ed9 h\u1ec7 th\u1ed1ng, t\u1eeb kh\u00e2u t\u1ea1o n\u01b0\u1edbc, l\u01b0u tr\u1eef, ph\u00e2n ph\u1ed1i cho \u0111\u1ebfn c\u00e1c \u0111i\u1ec3m s\u1eed d\u1ee5ng cu\u1ed1i c\u00f9ng (points of use).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">C\u00e1c y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd, bao g\u1ed3m FDA, c\u0169ng ch\u1ec9 r\u00f5 r\u1eb1ng n\u01b0\u1edbc d\u00f9ng cho c\u00e1c ho\u1ea1t \u0111\u1ed9ng nh\u01b0 x\u00e1t h\u1ea1t \u01b0\u1edbt, pha ch\u1ebf thu\u1ed1c d\u1ea1ng l\u1ecfng ho\u1eb7c s\u1eed d\u1ee5ng trong ph\u00f2ng th\u00ed nghi\u1ec7m ph\u1ea3i \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n n\u01b0\u1edbc tinh khi\u1ebft c\u1ea3 v\u1ec1 h\u00f3a h\u1ecdc l\u1eabn vi sinh.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u0110i\u1ec3m then ch\u1ed1t trong qu\u1ea3n l\u00fd h\u1ec7 th\u1ed1ng n\u01b0\u1edbc l\u00e0 \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng n\u01b0\u1edbc d\u1ef1a tr\u00ean m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng th\u1ef1c t\u1ebf. D\u00f9 c\u00f9ng l\u00e0 n\u01b0\u1edbc tinh khi\u1ebft, m\u1ee9c \u0111\u1ed9 r\u1ee7i ro v\u00e0 c\u00e1ch di\u1ec5n gi\u1ea3i d\u1eef li\u1ec7u ki\u1ec3m nghi\u1ec7m c\u00f3 th\u1ec3 kh\u00e1c nhau t\u00f9y theo c\u00f4ng \u0111o\u1ea1n s\u1ea3n xu\u1ea5t.\u00a0<\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">V\u00ed d\u1ee5: trong qu\u00e1 tr\u00ecnh x\u00e1t h\u1ea1t \u01b0\u1edbt, n\u01b0\u1edbc tham gia tr\u1ef1c ti\u1ebfp v\u00e0o qu\u00e1 tr\u00ecnh t\u1ea1o h\u1ea1t n\u00ean nh\u00e0 m\u00e1y c\u1ea7n \u0111\u00e1nh gi\u00e1 nghi\u00eam ng\u1eb7t h\u01a1n \u0111\u1ed1i v\u1edbi:<\/span><\/p><\/blockquote>\n<ul>\n<li><span style=\"font-weight: 400;\">T\u00ednh ph\u00f9 h\u1ee3p c\u1ee7a \u0111i\u1ec3m s\u1eed d\u1ee5ng<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Xu h\u01b0\u1edbng vi sinh c\u1ee7a h\u1ec7 th\u1ed1ng<\/span><\/li>\n<li><span style=\"font-weight: 400;\">C\u00e1c ch\u1ec9 s\u1ed1 h\u00f3a l\u00fd<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t t\u1ed5ng th\u1ec3 c\u1ee7a h\u1ec7 th\u1ed1ng n\u01b0\u1edbc.<\/span><\/li>\n<\/ul>\n<h3><b>B\u1ea3ng 1: T\u00ednh ch\u1ea5t v\u1eadt l\u00fd n\u1ec1n c\u1ee7a n\u01b0\u1edbc<\/b><\/h3>\n<p><b>L\u01b0u \u00fd:<\/b><span style=\"font-weight: 400;\"> C\u00e1c th\u00f4ng s\u1ed1 d\u01b0\u1edbi \u0111\u00e2y ch\u1ec9 mang t\u00ednh tham chi\u1ebfu khoa h\u1ecdc, nh\u1eb1m \u0111\u1ecbnh v\u1ecb kh\u00e1i ni\u1ec7m n\u1ec1n t\u1ea3ng c\u1ee7a n\u01b0\u1edbc. Ch\u00fang kh\u00f4ng thay th\u1ebf c\u00e1c ti\u00eau ch\u00ed ch\u1ea5t l\u01b0\u1ee3ng \u00e1p d\u1ee5ng cho n\u01b0\u1edbc tinh khi\u1ebft trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c.<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>Thu\u1ed9c t\u00ednh<\/b><\/td>\n<td><b>Gi\u00e1 tr\u1ecb tham chi\u1ebfu<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">C\u00f4ng th\u1ee9c h\u00f3a h\u1ecdc<\/span><\/td>\n<td><span style=\"font-weight: 400;\">H<\/span><span style=\"font-weight: 400;\">\u2082<\/span><span style=\"font-weight: 400;\">O<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Kh\u1ed1i l\u01b0\u1ee3ng ph\u00e2n t\u1eed<\/span><\/td>\n<td><b>18,015 g\/mol<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u0110i\u1ec3m n\u00f3ng ch\u1ea3y<\/span><\/td>\n<td><b>0 \u00b0C<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u0110i\u1ec3m s\u00f4i<\/span><\/td>\n<td><b>100 \u00b0C<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Kh\u1ed1i l\u01b0\u1ee3ng ri\u00eang<\/span><\/td>\n<td><span style=\"font-weight: 400;\">X\u1ea5p x\u1ec9 <\/span><b>1,000 g\/cm\u00b3<\/b><span style=\"font-weight: 400;\"> \u1edf g\u1ea7n <\/span><b>4 \u00b0C<\/b><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">C\u00e1c gi\u00e1 tr\u1ecb tr\u00ean t\u01b0\u01a1ng \u0111\u1ed1i \u1ed5n \u0111\u1ecbnh v\u1ec1 m\u1eb7t v\u1eadt l\u00fd. Tuy nhi\u00ean, trong v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng n\u01b0\u1edbc d\u01b0\u1ee3c d\u1ee5ng, tr\u1ecdng t\u00e2m ki\u1ec3m so\u00e1t kh\u00f4ng n\u1eb1m \u1edf c\u00e1c \u0111\u1eb7c t\u00ednh c\u01a1 b\u1ea3n n\u00e0y m\u00e0 \u1edf m\u1ee9c \u0111\u1ed9 t\u1ea1p ch\u1ea5t v\u00e0 tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t vi sinh c\u1ee7a h\u1ec7 th\u1ed1ng.<\/span><\/p>\n<h3><b>B\u1ea3ng 2: C\u00e1c nh\u00f3m t\u1ea1p ch\u1ea5t v\u00e0 ch\u1ec9 s\u1ed1 ki\u1ec3m so\u00e1t c\u1ed1t l\u00f5i trong h\u1ec7 th\u1ed1ng<\/b><\/h3>\n<blockquote>\n<h4><b>\u0110\u00e2y m\u1edbi l\u00e0 nh\u1eefng y\u1ebfu t\u1ed1 nh\u00e0 m\u00e1y th\u1ef1c s\u1ef1 c\u1ea7n theo d\u00f5i s\u00e1t sao<\/b><\/h4>\n<\/blockquote>\n<table>\n<tbody>\n<tr>\n<td><b>Nh\u00f3m t\u1ea1p ch\u1ea5t ho\u1eb7c t\u00edn hi\u1ec7u<\/b><\/td>\n<td><b>Ch\u1ec9 s\u1ed1 \/ C\u00e1ch ki\u1ec3m so\u00e1t<\/b><\/td>\n<td><b>Ghi ch\u00fa v\u1eadn h\u00e0nh th\u1ef1c t\u1ebf<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">T\u1ea1p ion v\u00f4 c\u01a1<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u0110\u1ed9 d\u1eabn \u0111i\u1ec7n (Conductivity)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Ph\u1ea3n \u00e1nh l\u01b0\u1ee3ng ion c\u00f2n s\u00f3t l\u1ea1i trong to\u00e0n h\u1ec7 th\u1ed1ng.<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">T\u1ea1p h\u1eefu c\u01a1<\/span><\/td>\n<td><span style=\"font-weight: 400;\">T\u1ed5ng cacbon h\u1eefu c\u01a1 &#8211; Total Organic Carbon (TOC)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Ch\u1ec9 th\u1ecb s\u1ef1 hi\u1ec7n di\u1ec7n c\u1ee7a t\u1ea1p h\u1eefu c\u01a1, c\u00f3 t\u1ea7m quan tr\u1ecdng t\u01b0\u01a1ng \u0111\u01b0\u01a1ng \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n v\u00e0 vi sinh<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Vi sinh t\u1ed5ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Theo d\u00f5i vi sinh \u0111\u1ecbnh k\u1ef3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Ph\u1ea3n \u00e1nh th\u1ef1c tr\u1ea1ng ki\u1ec3m so\u00e1t vi sinh c\u1ee7a to\u00e0n h\u1ec7 th\u1ed1ng.<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Vi sinh v\u1eadt kh\u00f4ng mong mu\u1ed1n<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Nh\u1eadn di\u1ec7n theo \u0111\u00e1nh gi\u00e1 r\u1ee7i ro s\u1ea3n ph\u1ea9m<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Mang \u00fd ngh\u0129a quan tr\u1ecdng h\u01a1n c\u1ea3 vi\u1ec7c ch\u1ec9 \u0111\u1ebfm t\u1ed5ng s\u1ed1 l\u01b0\u1ee3ng.<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Ng\u01b0\u1ee1ng h\u00e0nh \u0111\u1ed9ng vi sinh<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Kh\u00f4ng v\u01b0\u1ee3t qu\u00e1 <\/span><b>100 \u0111\u01a1n v\u1ecb khu\u1ea9n l\u1ea1c tr\u00ean mililit (\u2264 100 CFU\/mL)<\/b><\/td>\n<td><span style=\"font-weight: 400;\">\u0110\u00e2y l\u00e0 k\u1ef3 v\u1ecdng thanh tra c\u1ee7a FDA, kh\u00f4ng ph\u1ea3i m\u1ee9c m\u1eb7c \u0111\u1ecbnh cho m\u1ecdi nh\u00e0 m\u00e1y.<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">Hai ph\u00e9p th\u1eed h\u00f3a l\u00fd quan tr\u1ecdng nh\u1ea5t trong h\u1ec7 th\u1ed1ng n\u01b0\u1edbc tinh khi\u1ebft (PW) th\u01b0\u1eddng l\u00e0 <\/span><b>Total Organic Carbon (TOC)<\/b><span style=\"font-weight: 400;\"> v\u00e0 <\/span><b>\u0111\u1ed9 d\u1eabn \u0111i\u1ec7n (conductivity)<\/b><span style=\"font-weight: 400;\">. \u0110\u1ed1i v\u1edbi vi sinh, FDA th\u01b0\u1eddng xem <\/span><b>100 CFU\/mL<\/b><span style=\"font-weight: 400;\"> l\u00e0 m\u1ee9c t\u1ed1i \u0111a kh\u00f4ng n\u00ean v\u01b0\u1ee3t qu\u00e1 khi thi\u1ebft l\u1eadp h\u1ec7 th\u1ed1ng n\u01b0\u1edbc tinh khi\u1ebft. Tuy nhi\u00ean, c\u00e1c m\u1ee9c c\u1ea3nh b\u00e1o (alert limits) v\u00e0 ng\u01b0\u1ee1ng h\u00e0nh \u0111\u1ed9ng (action limits) c\u1ee5 th\u1ec3 c\u1ea7n \u0111\u01b0\u1ee3c m\u1ed7i nh\u00e0 m\u00e1y t\u1ef1 x\u00e2y d\u1ef1ng d\u1ef1a tr\u00ean d\u1eef li\u1ec7u v\u1eadn h\u00e0nh l\u1ecbch s\u1eed, \u0111\u1eb7c th\u00f9 s\u1ea3n ph\u1ea9m v\u00e0 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro c\u1ee7a t\u1eebng c\u00f4ng \u0111o\u1ea1n s\u1ea3n xu\u1ea5t.<\/span><\/p>\n<h3><b>\u1ee8ng d\u1ee5ng th\u1ef1c t\u1ebf c\u1ee7a n\u01b0\u1edbc tinh khi\u1ebft<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">N\u01b0\u1edbc tinh khi\u1ebft (PW) th\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong c\u00e1c c\u00f4ng \u0111o\u1ea1n s\u1ea3n xu\u1ea5t kh\u00f4ng y\u00eau c\u1ea7u \u0111i\u1ec1u ki\u1ec7n v\u00f4 tr\u00f9ng, bao g\u1ed3m:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Pha ch\u1ebf c\u00e1c ch\u1ebf ph\u1ea9m kh\u00f4ng v\u00f4 tr\u00f9ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">X\u00e1t h\u1ea1t \u01b0\u1edbt (wet granulation)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">S\u1ea3n xu\u1ea5t thu\u1ed1c d\u1ea1ng dung d\u1ecbch khi kh\u00f4ng b\u1eaft bu\u1ed9c s\u1eed d\u1ee5ng WFI<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">S\u1eed d\u1ee5ng trong ph\u00f2ng th\u00ed nghi\u1ec7m<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">R\u1eeda thi\u1ebft b\u1ecb \u1edf c\u00e1c b\u01b0\u1edbc ph\u00f9 h\u1ee3p v\u1edbi m\u1ee9c \u0111\u1ed9 r\u1ee7i ro c\u1ee7a quy tr\u00ecnh<\/span><\/li>\n<\/ul>\n<blockquote><p><span style=\"font-weight: 400;\">Nguy\u00ean t\u1eafc qu\u1ea3n l\u00fd \u1edf \u0111\u00e2y r\u1ea5t \u0111\u01a1n gi\u1ea3n nh\u01b0ng l\u1ea1i hay b\u1ecb ph\u1edbt l\u1edd:\u00a0<\/span><\/p>\n<p><b>D\u00f9ng \u0111\u00fang lo\u1ea1i n\u01b0\u1edbc cho \u0111\u00fang m\u1ee5c \u0111\u00edch s\u1ebd gi\u00fap t\u1ed1i \u01b0u chi ph\u00ed v\u00e0 duy tr\u00ec t\u1ed1t vi\u1ec7c ki\u1ec3m so\u00e1t. N\u1ebfu d\u00f9ng sai, m\u1ecdi kh\u00e2u t\u1eeb ki\u1ec3m nghi\u1ec7m \u0111\u1ebfn \u0111i\u1ec1u tra sai l\u1ec7ch v\u1ec1 sau s\u1ebd tr\u1edf n\u00ean c\u1ef1c k\u1ef3 n\u1eb7ng n\u1ec1 v\u00e0 l\u00e3ng ph\u00ed.<\/b><\/p><\/blockquote>\n<h2><b>\u0110i\u1ec3m kh\u00e1c bi\u1ec7t gi\u1eefa n<\/b><b>\u01b0\u1edbc PW (Purified Water) v\u00e0 <\/b><b>n\u01b0\u1edbc WFI (Water for Injection)<\/b><\/h2>\n<figure id=\"attachment_9628\" aria-describedby=\"caption-attachment-9628\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-9628\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-12.png\" alt=\"diem-khac-biet-giua-nuoc-pw-va-nuoc-wfi\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-12.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-12-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-12-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-12-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9628\" class=\"wp-caption-text\"><em>\u0110i\u1ec3m kh\u00e1c bi\u1ec7t gi\u1eefa n\u01b0\u1edbc PW (Purified Water) v\u00e0 n\u01b0\u1edbc WFI (Water for Injection)<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">S\u1ef1 kh\u00e1c bi\u1ec7t ch\u00ednh gi\u1eefa n\u01b0\u1edbc tinh khi\u1ebft v\u00e0 n\u01b0\u1edbc pha ti\u00eam n\u1eb1m \u1edf m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro c\u1ea7n ki\u1ec3m so\u00e1t. N\u01b0\u1edbc tinh khi\u1ebft (PW) \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho c\u00e1c ch\u1ebf ph\u1ea9m kh\u00f4ng y\u00eau c\u1ea7u \u0111\u1ed3ng th\u1eddi t\u00ednh v\u00f4 tr\u00f9ng v\u00e0 gi\u1edbi h\u1ea1n n\u1ed9i \u0111\u1ed9c t\u1ed1. Ng\u01b0\u1ee3c l\u1ea1i, Water for Injection b\u1eaft bu\u1ed9c \u00e1p d\u1ee5ng cho c\u00e1c s\u1ea3n ph\u1ea9m c\u00f3 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro cao, \u0111\u1eb7c bi\u1ec7t l\u00e0 thu\u1ed1c ti\u00eam.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Trong th\u1ef1c t\u1ebf v\u1eadn h\u00e0nh, hai sai l\u1ec7ch th\u01b0\u1eddng g\u1eb7p l\u00e0:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">S\u1eed d\u1ee5ng PW trong c\u00e1c c\u00f4ng \u0111o\u1ea1n y\u00eau c\u1ea7u s\u1eed d\u1ee5ng <b>n\u01b0\u1edbc WFI (Water for Injection) <\/b><\/span><\/span><span style=\"font-weight: 400;\">\u0111i\u1ec1u n\u00e0y s\u1ebd l\u00e0m t\u0103ng r\u1ee7i ro ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m. <\/span><b>M\u1ed9t s\u1ed1 nh\u00e0 m\u00e1y \u0111\u00e3 t\u1eebng b\u1ecb \u0111i\u1ec1u tra khi s\u1eed d\u1ee5ng PW \u0111\u1ec3 pha ch\u1ebf dung d\u1ecbch ti\u00eam kh\u00f4ng \u0111\u1ea3m b\u1ea3o ki\u1ec3m so\u00e1t n\u1ed9i \u0111\u1ed9c t\u1ed1, d\u1eabn \u0111\u1ebfn y\u00eau c\u1ea7u ph\u1ea3i thay \u0111\u1ed5i c\u1ea5p n\u01b0\u1edbc ho\u1eb7c b\u1ed5 sung ki\u1ec3m so\u00e1t n\u1ed9i \u0111\u1ed9c t\u1ed1 nghi\u00eam ng\u1eb7t h\u01a1n.<\/b><span style=\"font-weight: 400;\"> N\u1ebfu ti\u1ebfp t\u1ee5c s\u1eed d\u1ee5ng PW, nh\u00e0 m\u00e1y c\u1ea7n b\u1ed5 sung ki\u1ec3m so\u00e1t n\u1ed9i \u0111\u1ed9c t\u1ed1 (endotoxin \u2264 0.25 EU\/mL) b\u1eb1ng c\u00e1c bi\u1ec7n ph\u00e1p b\u1ed5 sung nh\u01b0 s\u1eed d\u1ee5ng c\u00e1c ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed nh\u01b0 <\/span><b><a href=\"https:\/\/sepro.vn\/vi\/product\/qt-sporicide\/\">QuantumTec SPORICIDE<\/a> ho\u1eb7c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng (STERIS Spor-Klenz, Contec PeridoxRTU)<\/b><span style=\"font-weight: 400;\"> \u0111\u1ec3 di\u1ec7t b\u00e0o t\u1eed vi khu\u1ea9n Gram \u00e2m, gi\u1ea3m nguy c\u01a1 n\u1ed9i \u0111\u1ed9c t\u1ed1 t\u00edch l\u0169y.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>L\u1ea1m d\u1ee5ng WFI cho m\u1ecdi c\u00f4ng \u0111o\u1ea1n nh\u01b0 m\u1ed9t bi\u1ec7n ph\u00e1p an to\u00e0n<\/b><span style=\"font-weight: 400;\"> \u2014 d\u1eabn \u0111\u1ebfn chi ph\u00ed \u0111\u1ea7u t\u01b0 v\u00e0 v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng kh\u00f4ng c\u1ea7n thi\u1ebft.<\/span><\/li>\n<\/ul>\n<blockquote><p><span style=\"font-weight: 400;\">C\u1ea3 hai c\u00e1ch l\u00e0m n\u00e0y \u0111\u1ec1u d\u00f9ng \u0111\u01b0\u1ee3c nh\u01b0ng kh\u00f4ng th\u1ef1c s\u1ef1 mang l\u1ea1i hi\u1ec7u qu\u1ea3 t\u1ed1i \u01b0u.<\/span><\/p><\/blockquote>\n<h2><b>Ti\u00eau chu\u1ea9n d\u00e0nh cho <\/b><b>N\u01b0\u1edbc PW (Purified Water)<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Qu\u1ea3n l\u00fd h\u1ec7 th\u1ed1ng n\u01b0\u1edbc tinh khi\u1ebft (PW) c\u1ea7n \u0111\u01b0\u1ee3c nh\u00ecn qua ba l\u1edbp ti\u00eau chu\u1ea9n kh\u00e1c nhau: ti\u00eau chu\u1ea9n d\u01b0\u1ee3c \u0111i\u1ec3n, k\u1ef3 v\u1ecdng thanh tra v\u00e0 gi\u1edbi h\u1ea1n ki\u1ec3m so\u00e1t n\u1ed9i b\u1ed9.<\/span><\/p>\n<p><b>L\u1edbp th\u1ee9 nh\u1ea5t:<\/b><span style=\"font-weight: 400;\"> bao g\u1ed3m c\u00e1c chuy\u00ean lu\u1eadn v\u00e0 ti\u00eau ch\u00ed k\u1ef9 thu\u1eadt c\u1ed1t l\u00f5i \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh trong c\u00e1c d\u01b0\u1ee3c \u0111i\u1ec3n nh\u01b0 USP, EP ho\u1eb7c JP.<\/span><\/p>\n<p><b>L\u1edbp th\u1ee9 hai:<\/b><span style=\"font-weight: 400;\"> li\u00ean quan \u0111\u1ebfn c\u00e1ch nh\u00e0 m\u00e1y thi\u1ebft k\u1ebf h\u1ec7 th\u1ed1ng n\u01b0\u1edbc, x\u00e2y d\u1ef1ng ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t, b\u1ed1 tr\u00ed \u0111i\u1ec3m l\u1ea5y m\u1eabu v\u00e0 duy tr\u00ec tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t c\u1ee7a h\u1ec7 th\u1ed1ng.<\/span><\/p>\n<p><b>L\u1edbp th\u1ee9 ba:<\/b><span style=\"font-weight: 400;\"> bao g\u1ed3m c\u00e1c m\u1ee9c c\u1ea3nh b\u00e1o (alert limits), ng\u01b0\u1ee1ng h\u00e0nh \u0111\u1ed9ng (action limits) v\u00e0 c\u00e1c gi\u1edbi h\u1ea1n xu h\u01b0\u1edbng \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp d\u1ef1a tr\u00ean d\u1eef li\u1ec7u v\u1eadn h\u00e0nh th\u1ef1c t\u1ebf. <\/span><b>M\u1ed9t s\u1ed1 nh\u00e0 m\u00e1y \u00e1p d\u1ee5ng m\u00f4 h\u00ecnh r\u00f5 r\u00e0ng h\u01a1n: \u0111\u1eb7t alert limit 50 CFU\/mL v\u00e0 action limit 100 CFU\/mL, coi vi\u1ec7c v\u01b0\u1ee3t 100 CFU\/mL l\u00e0 d\u1ea5u hi\u1ec7u h\u1ec7 th\u1ed1ng m\u1ea5t ki\u1ec3m so\u00e1t c\u1ea7n \u0111i\u1ec1u tra.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">M\u1ed9t k\u1ebft qu\u1ea3 ngo\u00e0i xu h\u01b0\u1edbng (Out of Trend \u2013 OOT) kh\u00f4ng nh\u1ea5t thi\u1ebft \u0111\u1ed3ng ngh\u0129a v\u1edbi vi\u1ec7c v\u01b0\u1ee3t ng\u01b0\u1ee1ng d\u01b0\u1ee3c \u0111i\u1ec3n. \u0110\u00e2y l\u00e0 t\u00edn hi\u1ec7u c\u1ea3nh b\u00e1o s\u1edbm trong n\u1ed9i b\u1ed9, v\u00e0 ch\u1ec9 c\u00f3 \u00fd ngh\u0129a khi c\u00e1c gi\u1edbi h\u1ea1n n\u00e0y \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng d\u1ef1a tr\u00ean d\u1eef li\u1ec7u v\u1eadn h\u00e0nh \u0111\u1ee7 tin c\u1eady.<\/span><\/p>\n<h2><b>H\u1ec7 th\u1ed1ng t\u1ea1o <\/b><b>N\u01b0\u1edbc PW (Purified Water)\u00a0<\/b><b>ho\u1ea1t \u0111\u1ed9ng ra sao?<\/b><\/h2>\n<figure id=\"attachment_9630\" aria-describedby=\"caption-attachment-9630\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9630\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-12.png\" alt=\"he-thong-tao-nuoc-pw-hoat-dong-ra-sao\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-12.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-12-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-12-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-12-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9630\" class=\"wp-caption-text\"><em>H\u1ec7 th\u1ed1ng t\u1ea1o N\u01b0\u1edbc PW (Purified Water)\u00a0ho\u1ea1t \u0111\u1ed9ng ra sao?<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">H\u1ec7 th\u1ed1ng n\u01b0\u1edbc tinh khi\u1ebft (PW) th\u01b0\u1eddng bao g\u1ed3m c\u00e1c b\u01b0\u1edbc x\u1eed l\u00fd nh\u01b0 th\u1ea9m th\u1ea5u ng\u01b0\u1ee3c (Reverse Osmosis \u2013 RO), kh\u1eed ion b\u1eb1ng \u0111i\u1ec7n (Electrodeionization \u2013 EDI), si\u00eau l\u1ecdc (Ultrafiltration \u2013 UF) ho\u1eb7c c\u00e1c c\u00f4ng ngh\u1ec7 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng. Tuy nhi\u00ean, vi\u1ec7c \u0111\u00e1nh gi\u00e1 h\u1ec7 th\u1ed1ng n\u01b0\u1edbc kh\u00f4ng n\u00ean ch\u1ec9 t\u1eadp trung v\u00e0o c\u00f4ng ngh\u1ec7 x\u1eed l\u00fd.<\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">Trong th\u1ef1c t\u1ebf v\u1eadn h\u00e0nh, nhi\u1ec1u v\u1ea5n \u0111\u1ec1 ph\u00e1t sinh kh\u00f4ng n\u1eb1m \u1edf kh\u00e2u t\u1ea1o n\u01b0\u1edbc m\u00e0 \u1edf c\u00e1c ph\u1ea7n l\u01b0u tr\u1eef v\u00e0 ph\u00e2n ph\u1ed1i, bao g\u1ed3m:\u00a0<\/span><\/p>\n<p><b>B\u1ed3n ch\u1ee9a \u2014 H\u1ec7 th\u1ed1ng ph\u00e2n ph\u1ed1i \u2014 B\u01a1m tu\u1ea7n ho\u00e0n \u2014 V\u1ecb tr\u00ed l\u1ea5y m\u1eabu \u2014 Quy tr\u00ecnh kh\u1eed khu\u1ea9n<\/b><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">H\u1ec7 th\u1ed1ng ph\u00e2n ph\u1ed1i th\u01b0\u1eddng \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf tu\u1ea7n ho\u00e0n li\u00ean t\u1ee5c \u0111\u1ec3 h\u1ea1n ch\u1ebf s\u1ef1 ph\u00e1t tri\u1ec3n c\u1ee7a vi sinh. Ng\u01b0\u1ee3c l\u1ea1i, c\u00e1c \u0111o\u1ea1n \u1ed1ng c\u1ee5t kh\u00f4ng tu\u1ea7n ho\u00e0n (dead legs) c\u00f3 th\u1ec3 tr\u1edf th\u00e0nh \u0111i\u1ec3m t\u00edch t\u1ee5 vi sinh v\u1eadt. <\/span><b>M\u1ed9t nh\u00e0 m\u00e1y d\u01b0\u1ee3c ch\u00e2u \u00c2u \u0111\u00e3 ch\u1ee9ng minh vi\u1ec7c t\u1ed1i \u01b0u h\u00f3a dead legs, t\u0103ng t\u1ed1c \u0111\u1ed9 l\u01b0u t\u1ed1c v\u00e0 \u0111i\u1ec1u ch\u1ec9nh t\u1ea7n su\u1ea5t kh\u1eed khu\u1ea9n c\u00f3 th\u1ec3 gi\u1ea3m s\u1ed1 sai l\u1ec7ch vi sinh l\u00ean t\u1edbi 82% trong v\u00e0i th\u00e1ng m\u00e0 kh\u00f4ng ph\u1ea3i \u0111\u1ea7u t\u01b0 l\u1edbn.<\/b><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">K\u1ebft qu\u1ea3 c\u1ee5 th\u1ec3 cho th\u1ea5y: t\u1eeb <\/span><b>11 v\u1ee5\/n\u0103m xu\u1ed1ng c\u00f2n 2 v\u1ee5\/n\u0103m<\/b><span style=\"font-weight: 400;\">, \u0111\u00f3 l\u00e0 b\u1eb1ng ch\u1ee9ng r\u00f5 r\u00e0ng r\u1eb1ng m\u1ed9t k\u1ef9 thu\u1eadt v\u1eadn h\u00e0nh \u0111\u01a1n gi\u1ea3n nh\u01b0ng c\u00f3 chi\u1ebfn l\u01b0\u1ee3c c\u00f3 th\u1ec3 mang l\u1ea1i c\u1ea3i thi\u1ec7n \u0111\u00e1ng k\u1ec3.<\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">M\u1ed9t y\u1ebfu t\u1ed1 quan tr\u1ecdng kh\u00e1c l\u00e0 ph\u01b0\u01a1ng ph\u00e1p l\u1ea5y m\u1eabu. \u0110i\u1ec3m l\u1ea5y m\u1eabu c\u1ea7n ph\u1ea3n \u00e1nh \u0111\u00fang \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng th\u1ef1c t\u1ebf t\u1ea1i \u0111i\u1ec3m d\u00f9ng. <\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">V\u00ed d\u1ee5:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">N\u1ebfu n\u01b0\u1edbc \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng qua \u1ed1ng m\u1ec1m, m\u1eabu c\u1ea7n \u0111\u01b0\u1ee3c l\u1ea5y \u1edf cu\u1ed1i \u0111o\u1ea1n \u1ed1ng<\/span><\/li>\n<li><span style=\"font-weight: 400;\">N\u1ebfu quy tr\u00ecnh y\u00eau c\u1ea7u x\u1ea3 n\u01b0\u1edbc tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng, m\u1eabu ph\u1ea3i \u0111\u01b0\u1ee3c l\u1ea5y sau khi x\u1ea3<\/span><\/li>\n<\/ul>\n<\/blockquote>\n<p><span style=\"font-weight: 400;\">Vi\u1ec7c l\u1ea5y m\u1eabu \u0111\u00fang c\u00e1ch quy\u1ebft \u0111\u1ecbnh li\u1ec7u d\u1eef li\u1ec7u thu \u0111\u01b0\u1ee3c c\u00f3 \u0111\u1ea1i di\u1ec7n cho \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh th\u1ef1c t\u1ebf c\u1ee7a h\u1ec7 th\u1ed1ng hay kh\u00f4ng.<\/span><\/p>\n<h2><b>L\u1ed7i l\u1ea5y m\u1eabu v\u00e0 h\u1ec7 l\u1ee5y sai l\u1ec7ch h\u01b0\u1edbng \u0111i\u1ec1u tra<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">M\u1ed9t k\u1ebft qu\u1ea3 l\u1ea5y m\u1eabu \u0111\u01a1n l\u1ebb kh\u00f4ng nh\u1ea5t thi\u1ebft ph\u1ea3n \u00e1nh ch\u00ednh x\u00e1c tr\u1ea1ng th\u00e1i c\u1ee7a to\u00e0n b\u1ed9 h\u1ec7 th\u1ed1ng n\u01b0\u1edbc. Trong \u0111\u01b0\u1eddng \u1ed1ng ph\u00e2n ph\u1ed1i, vi sinh v\u1eadt th\u01b0\u1eddng kh\u00f4ng ph\u00e2n b\u1ed1 \u0111\u1ed3ng \u0111\u1ec1u. Ch\u00fang c\u00f3 th\u1ec3 h\u00ecnh th\u00e0nh <strong><a href=\"https:\/\/sepro.vn\/vi\/tac-dong-cua-quat-tren-biofilm-va-vi-sinh\/\">m\u00e0ng sinh h\u1ecdc (biofilm)<\/a><\/strong> b\u00e1m tr\u00ean b\u1ec1 m\u1eb7t \u1ed1ng v\u00e0 \u0111\u00f4i khi bong ra t\u1eebng m\u1ea3ng.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">V\u00ec v\u1eady, vi\u1ec7c m\u1ed9t m\u1eabu cho k\u1ebft qu\u1ea3 <\/span><b>10 CFU<\/b><span style=\"font-weight: 400;\"> trong khi m\u1eabu ti\u1ebfp theo t\u0103ng l\u00ean <\/span><b>1.000 CFU<\/b><span style=\"font-weight: 400;\"> v\u1eabn c\u00f3 th\u1ec3 x\u1ea3y ra v\u1ec1 m\u1eb7t k\u1ef9 thu\u1eadt. <\/span><b>C\u00e1c d\u1eef li\u1ec7u ph\u00e2n t\u00edch d\u00e0i h\u1ea1n t\u1ea1i m\u1ed9t c\u01a1 s\u1edf y t\u1ebf \u0111\u00e3 cho th\u1ea5y m\u1eabu vi sinh c\u00f3 th\u1ec3 dao \u0111\u1ed9ng t\u1eeb v\u00e0i CFU\/100 mL l\u00ean h\u00e0ng tr\u0103m do hi\u1ec7n t\u01b0\u1ee3ng bong biofilm t\u1eeb b\u1ec1 m\u1eb7t \u1ed1ng, c\u1ee7ng c\u1ed1 r\u1eb1ng m\u1ed9t m\u1eabu \u0111\u01a1n l\u1ebb kh\u00f4ng \u0111\u1ea1i di\u1ec7n cho to\u00e0n h\u1ec7 th\u1ed1ng.<\/b><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">B\u00e0i h\u1ecdc quan tr\u1ecdng l\u00e0:\u00a0<\/span><\/p>\n<p><b>N\u1ebfu ph\u01b0\u01a1ng ph\u00e1p l\u1ea5y m\u1eabu kh\u00f4ng \u0111\u1ea1i di\u1ec7n cho \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng th\u1ef1c t\u1ebf, qu\u00e1 tr\u00ecnh \u0111i\u1ec1u tra sai l\u1ec7ch c\u00f3 th\u1ec3 \u0111i sai h\u01b0\u1edbng ngay t\u1eeb b\u01b0\u1edbc \u0111\u1ea7u ti\u00ean.<\/b><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">Trong th\u1ef1c t\u1ebf, nhi\u1ec1u nh\u00e0 m\u00e1y \u0111\u00e3 ghi nh\u1eadn k\u1ebft qu\u1ea3 vi sinh bi\u1ebfn thi\u00ean l\u1edbn \u1edf c\u00e1c \u0111i\u1ec3m d\u00f9ng c\u00f3 \u1ed1ng m\u1ec1m, ch\u1ec9 \u0111\u01b0\u1ee3c \u1ed5n \u0111\u1ecbnh khi quy tr\u00ecnh l\u1ea5y m\u1eabu b\u1eaft bu\u1ed9c x\u1ea3 \u0111\u1ee7 th\u1eddi gian <strong>(30-60 gi\u00e2y)<\/strong> v\u00e0 thay \u1ed1ng m\u1ec1m \u0111\u1ecbnh k\u1ef3. S\u1eed d\u1ee5ng c\u00e1c ch\u1ea5t kh\u1eed khu\u1ea9n nh\u01b0 <\/span><a href=\"https:\/\/sepro.vn\/product\/quantumtec-70-ipa-isopropyl-alcohol\/\"><b>QuantumTec 70 IPA<\/b><\/a><span style=\"font-weight: 400;\"> ho\u1eb7c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng c\u1ee7a <\/span><b>STERIS Septihol, Ecolab Klercide<\/b><span style=\"font-weight: 400;\"> \u0111\u1ec3 t\u1ed1i \u01b0u h\u00f3a quy tr\u00ecnh x\u1ea3 n\u01b0\u1edbc tr\u01b0\u1edbc khi l\u1ea5y m\u1eabu c\u0169ng gi\u00fap \u0111\u1ea3m b\u1ea3o vi sinh kh\u00f4ng b\u1ecb bam d\u00ednh tr\u00ean b\u1ec1 m\u1eb7t \u1ed1ng.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">K\u1ebft qu\u1ea3: c\u00e1c m\u1eabu l\u1ec7ch li\u00ean t\u1ee5c cho k\u1ebft qu\u1ea3 <\/span><b>10\u2013100 CFU\/mL<\/b><span style=\"font-weight: 400;\">, nh\u01b0ng sau khi \u0111\u1ed5i quy tr\u00ecnh x\u1ea3 k\u1ebft h\u1ee3p thay \u0111\u1ecbnh k\u1ef3 \u1ed1ng m\u1ec1m, s\u1ed1 vi sinh \u1ed5n \u0111\u1ecbnh d\u01b0\u1edbi <\/span><b>20 CFU\/mL<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><b>Ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m nghi\u1ec7m th\u1ef1c chi\u1ebfn<\/b><\/h2>\n<blockquote><p><strong>Ki\u1ec3m nghi\u1ec7m n\u01b0\u1edbc tinh khi\u1ebft c\u1ea7n \u0111\u01b0\u1ee3c tri\u1ec3n khai \u0111\u1ed3ng th\u1eddi tr\u00ean ba nh\u00f3m ho\u1ea1t \u0111\u1ed9ng ch\u00ednh:<\/strong><\/p>\n<p><b>H\u00f3a l\u00fd:<\/b><span style=\"font-weight: 400;\"> T\u1eadp trung v\u00e0o hai ch\u1ec9 s\u1ed1 c\u1ed1t l\u00f5i l\u00e0 <\/span><b>Total Organic Carbon (TOC)<\/b><span style=\"font-weight: 400;\"> v\u00e0 <\/span><b>\u0111\u1ed9 d\u1eabn \u0111i\u1ec7n (conductivity)<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><b>Vi sinh:<\/b><span style=\"font-weight: 400;\"> Y\u00eau c\u1ea7u ch\u01b0\u01a1ng tr\u00ecnh l\u1ea5y m\u1eabu v\u1edbi t\u1ea7n su\u1ea5t ph\u00f9 h\u1ee3p, bao ph\u1ee7 c\u00e1c \u0111i\u1ec3m r\u1ee7i ro trong h\u1ec7 th\u1ed1ng, \u0111\u1ed3ng th\u1eddi ph\u00f2ng th\u00ed nghi\u1ec7m c\u1ea7n c\u00f3 n\u0103ng l\u1ef1c \u0111\u1ecbnh danh vi sinh v\u1eadt kh\u00f4ng mong mu\u1ed1n.<\/span><\/p>\n<p><b>Theo d\u00f5i xu h\u01b0\u1edbng:<\/b><span style=\"font-weight: 400;\"> Ph\u00e2n t\u00edch xu h\u01b0\u1edbng d\u1eef li\u1ec7u theo th\u1eddi gian \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 li\u1ec7u h\u1ec7 th\u1ed1ng n\u01b0\u1edbc c\u00f3 \u0111ang duy tr\u00ec tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t \u1ed5n \u0111\u1ecbnh hay kh\u00f4ng.<\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">M\u1ed9t h\u1ec7 th\u1ed1ng PW s\u1eed d\u1ee5ng RO\/EDI \u0111\u00e3 t\u1eebng ghi nh\u1eadn TOC t\u0103ng d\u1ea7n nh\u01b0ng ch\u01b0a v\u01b0\u1ee3t gi\u1edbi h\u1ea1n d\u01b0\u1ee3c \u0111i\u1ec3n, ph\u00e2n t\u00edch xu h\u01b0\u1edbng cho th\u1ea5y m\u00e0ng RO b\u1ecb b\u00e1m b\u1ea9n nh\u1eb9, bu\u1ed9c nh\u00e0 m\u00e1y ph\u1ea3i b\u1ea3o tr\u00ec v\u00e0 \u0111i\u1ec1u ch\u1ec9nh v\u1eadn h\u00e0nh tr\u01b0\u1edbc khi x\u1ea3y ra OOS. B\u00e0i h\u1ecdc \u1edf \u0111\u00e2y l\u00e0 kh\u00f4ng n\u00ean ch\u1edd \u0111\u1ebfn khi v\u01b0\u1ee3t ti\u00eau chu\u1ea9n d\u01b0\u1ee3c \u0111i\u1ec3n m\u1edbi h\u00e0nh \u0111\u1ed9ng \u2014 ph\u1ea3i b\u1eaft \u0111\u1ea7u t\u1eeb nh\u1eefng d\u1ea5u hi\u1ec7u OOT s\u1edbm h\u01a1n.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">M\u1ed9t nh\u00e0 m\u00e1y \u0111\u00e3 t\u1eebng ph\u00e1t hi\u1ec7n r\u00f2 r\u1ec9 n\u01b0\u1edbc ngu\u1ed3n b\u1ea9n v\u00e0o \u0111\u1ea7u v\u00e0o RO nh\u1edd xu h\u01b0\u1edbng TOC t\u0103ng d\u1ea7n trong v\u00e0i tu\u1ea7n, cho ph\u00e9p h\u1ec7 th\u1ed1ng \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh tr\u01b0\u1edbc khi OOS th\u1ef1c s\u1ef1 x\u1ea3y ra. \u0110\u00e2y l\u00e0 minh ch\u1ee9ng cho s\u1ee9c m\u1ea1nh c\u1ee7a gi\u00e1m s\u00e1t li\u00ean t\u1ee5c d\u1ef1a tr\u00ean d\u1eef li\u1ec7u.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Vi\u1ec7c qu\u1ea3n l\u00fd n\u01b0\u1edbc tinh khi\u1ebft \u0111\u00f2i h\u1ecfi m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t li\u00ean t\u1ee5c, c\u00f3 c\u1ea5u tr\u00fac v\u00e0 d\u1ef1a tr\u00ean d\u1eef li\u1ec7u, thay v\u00ec ki\u1ec3m tra r\u1eddi r\u1ea1c theo t\u1eebng th\u1eddi \u0111i\u1ec3m.<\/span><\/p>\n<h2><b>X\u1eed l\u00fd k\u1ebft qu\u1ea3 ngo\u00e0i ti\u00eau chu\u1ea9n v\u00e0 ngo\u00e0i xu h\u01b0\u1edbng<\/b><\/h2>\n<figure id=\"attachment_9632\" aria-describedby=\"caption-attachment-9632\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9632\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-10.png\" alt=\"xu-ly-cac-ket-qua-cua-nuoc-pw\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-10.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-10-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-10-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-10-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9632\" class=\"wp-caption-text\"><em>X\u1eed l\u00fd k\u1ebft qu\u1ea3 ngo\u00e0i ti\u00eau chu\u1ea9n v\u00e0 ngo\u00e0i xu h\u01b0\u1edbng<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">Trong ki\u1ec3m nghi\u1ec7m h\u1ec7 th\u1ed1ng n\u01b0\u1edbc, c\u1ea7n ph\u00e2n bi\u1ec7t hai lo\u1ea1i sai l\u1ec7ch:<\/span><\/p>\n<p><b>Ngo\u00e0i ti\u00eau chu\u1ea9n (Out of Specification \u2013 OOS):<\/b><span style=\"font-weight: 400;\"> X\u1ea3y ra khi k\u1ebft qu\u1ea3 v\u01b0\u1ee3t qu\u00e1 gi\u1edbi h\u1ea1n ch\u1ea5t l\u01b0\u1ee3ng \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t ch\u00ednh th\u1ee9c. Tr\u01b0\u1eddng h\u1ee3p n\u00e0y ph\u1ea3i \u0111\u01b0\u1ee3c \u0111i\u1ec1u tra theo quy tr\u00ecnh \u0111i\u1ec1u tra sai l\u1ec7ch (deviation investigation) c\u1ee7a h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng.<\/span><\/p>\n<p><b>Ngo\u00e0i xu h\u01b0\u1edbng (Out of Trend \u2013 OOT):<\/b><span style=\"font-weight: 400;\"> X\u1ea3y ra khi d\u1eef li\u1ec7u l\u1ec7ch kh\u1ecfi xu h\u01b0\u1edbng v\u1eadn h\u00e0nh b\u00ecnh th\u01b0\u1eddng do nh\u00e0 m\u00e1y thi\u1ebft l\u1eadp t\u1eeb d\u1eef li\u1ec7u l\u1ecbch s\u1eed. \u0110\u00e2y l\u00e0 t\u00edn hi\u1ec7u c\u1ea3nh b\u00e1o s\u1edbm, cho ph\u00e9p can thi\u1ec7p tr\u01b0\u1edbc khi s\u1ef1 c\u1ed1 tr\u1edf th\u00e0nh OOS.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Khi ph\u00e1t hi\u1ec7n sai l\u1ec7ch, qu\u00e1 tr\u00ecnh \u0111\u00e1nh gi\u00e1 n\u00ean \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n theo tr\u00ecnh t\u1ef1:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">X\u00e1c nh\u1eadn t\u00ednh \u0111\u1ea1i di\u1ec7n c\u1ee7a m\u1eabu.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0110\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng sai s\u00f3t trong thao t\u00e1c ki\u1ec3m nghi\u1ec7m.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Xem x\u00e9t tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t c\u1ee7a h\u1ec7 th\u1ed1ng n\u01b0\u1edbc.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">N\u1ebfu sai l\u1ec7ch l\u1eb7p l\u1ea1i, xu\u1ea5t hi\u1ec7n vi sinh v\u1eadt kh\u00f4ng mong mu\u1ed1n, ho\u1eb7c d\u1eef li\u1ec7u kh\u00f4ng ph\u1ea3n \u00e1nh \u0111\u00fang \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t th\u1ef1c t\u1ebf, c\u1ea7n ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tra nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 (root cause investigation), \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng \u0111\u1ebfn c\u00e1c l\u00f4 s\u1ea3n ph\u1ea9m li\u00ean quan, v\u00e0 tri\u1ec3n khai h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba (CAPA) ph\u00f9 h\u1ee3p.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">C\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd th\u01b0\u1eddng xem sai l\u1ec7ch vi sinh l\u1eb7p l\u1ea1i l\u00e0 d\u1ea5u hi\u1ec7u cho th\u1ea5y h\u1ec7 th\u1ed1ng n\u01b0\u1edbc kh\u00f4ng c\u00f2n duy tr\u00ec tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t th\u00edch h\u1ee3p. Trong tr\u01b0\u1eddng h\u1ee3p n\u00e0y, vi\u1ec7c di\u1ec5n gi\u1ea3i d\u1eef li\u1ec7u c\u1ea7n d\u1ef1a tr\u00ean b\u1eb1ng ch\u1ee9ng k\u1ef9 thu\u1eadt v\u00e0 ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t h\u1ec7 th\u1ed1ng, thay v\u00ec ch\u1ec9 d\u1ef1a v\u00e0o m\u1ed9t s\u1ed1 k\u1ebft qu\u1ea3 \u0111\u01a1n l\u1ebb \u0111\u1ea1t gi\u1edbi h\u1ea1n.<\/span><\/p>\n<h2><strong>M\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p x\u1ea3y ra trong th\u1ef1c t\u1ebf khi v\u1eadn h\u00e0nh nh\u00e0 m\u00e1y<\/strong><\/h2>\n<h3><b>Tr\u01b0\u1eddng h\u1ee3p Creative Essences, 2025<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">C\u01a1 quan qu\u1ea3n l\u00fd M\u1ef9 y\u00eau c\u1ea7u h\u1ecd ph\u1ea3i x\u00e2y d\u1ef1ng l\u1ea1i to\u00e0n b\u1ed9 quy tr\u00ecnh gi\u00e1m s\u00e1t, thi\u1ebft l\u1eadp c\u00e1c ng\u01b0\u1ee1ng vi sinh v\u00e0 ch\u1ee9ng minh h\u1ec7 th\u1ed1ng ho\u1ea1t \u0111\u1ed9ng \u1ed5n \u0111\u1ecbnh. B\u00e0i h\u1ecdc \u1edf \u0111\u00e2y thu\u1ed9c v\u1ec1 t\u01b0 duy: <\/span><b>\u0111\u1eebng v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng n\u01b0\u1edbc theo ki\u1ec3u th\u1ee5 \u0111\u1ed9ng \u0111\u1ed1i ph\u00f3. H\u00e3y ch\u1ee7 \u0111\u1ed9ng thi\u1ebft k\u1ebf m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t c\u00f3 b\u1eb1ng ch\u1ee9ng li\u00ean t\u1ee5c.<\/b><\/p>\n<p><em><b>Link tham kh\u1ea3o:<\/b> <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/creative-essences-inc-710658-09252025\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/creative-essences-inc-710658-09252025<\/span><\/a><\/em><\/p>\n<p><b>M\u1ed9t \u0111o\u1ea1n tr\u00edch nh\u1ecf trong b\u00e0i:<\/b><\/p>\n<blockquote><p><i><span style=\"font-weight: 400;\">&#8220;A procedure for your water system monitoring that specifies routine microbial testing of water to ensure its acceptability for use in each batch of drug products produced by your firm.&#8221;<\/span><\/i><\/p><\/blockquote>\n<h3><b>Tr\u01b0\u1eddng h\u1ee3p Strukmyer, 2025<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Nh\u00e0 m\u00e1y n\u00e0y b\u1ecb ph\u00e1t hi\u1ec7n c\u00f3 <\/span><b>h\u01a1n 60 l\u1ea7n<\/b><span style=\"font-weight: 400;\"> ph\u00e2n l\u1eadp \u0111\u01b0\u1ee3c vi sinh v\u1eadt l\u1ea1 trong h\u1ec7 th\u1ed1ng n\u01b0\u1edbc. C\u00f3 hai v\u1ea5n \u0111\u1ec1 l\u1edbn \u1edf \u0111\u00e2y: <\/span><b>t\u1ea7n su\u1ea5t l\u1ed7i qu\u00e1 d\u00e0y \u0111\u1eb7c t\u1ef1 n\u00f3 \u0111\u00e3 t\u1ed1 c\u00e1o h\u1ec7 th\u1ed1ng m\u1ea5t ki\u1ec3m so\u00e1t<\/b><span style=\"font-weight: 400;\">\u00a0v\u00e0 vi\u1ec7c v\u1ed9i v\u00e0ng \u0111\u00f3ng \u0111i\u1ec1u tra ch\u1ec9 v\u00ec v\u00e0i m\u1eabu sau \u0111\u00f3 \u0111\u1ea1t chu\u1ea9n l\u00e0 m\u1ed9t sai l\u1ea7m nghi\u00eam tr\u1ecdng. Ch\u1eebng n\u00e0o ch\u01b0a t\u00ecm ra nguy\u00ean nh\u00e2n g\u1ed1c v\u00e0 ch\u01b0a \u0111\u00e1nh gi\u00e1 h\u1ebft t\u00e1c \u0111\u1ed9ng, h\u1ec7 th\u1ed1ng \u0111\u00f3 v\u1eabn ch\u01b0a \u0111\u01b0\u1ee3c xem l\u00e0 an to\u00e0n.<\/span><\/p>\n<p><em><b>Link tham kh\u1ea3o:<\/b> <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/strukmyer-llc-dba-strukmyer-medical-692686-01302025\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/strukmyer-llc-dba-strukmyer-medical-692686-01302025<\/span><\/a><\/em><\/p>\n<p><b>M\u1ed9t \u0111o\u1ea1n tr\u00edch nh\u1ecf trong b\u00e0i:<\/b><\/p>\n<blockquote><p><i><span style=\"font-weight: 400;\">&#8220;Frequent microbiological excursions suggest that your purified water system may not be in an adequate state of control.&#8221;<\/span><\/i><\/p><\/blockquote>\n<h3><b>Th\u00eam Use Case: M\u1ed9t s\u1ed1 nh\u00e0 m\u00e1y \u0111\u00e3 t\u1eebng lo\u1ea1i b\u1ecf dead leg \u2192 gi\u1ea3m vi sinh cho \u0111i\u1ec3m d\u00f9ng cu\u1ed1i<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">M\u1ed9t nh\u00e0 m\u00e1y d\u01b0\u1ee3c sau khi r\u00e0 so\u00e1t to\u00e0n b\u1ed9 h\u1ec7 th\u1ed1ng PW, ph\u00e1t hi\u1ec7n nhi\u1ec1u \u0111o\u1ea1n \u1ed1ng c\u1ee5t (dead legs) ph\u00eda sau c\u00e1c van kh\u00f3a t\u1ea1i \u0111i\u1ec3m d\u00f9ng. <\/span><b>Sau khi lo\u1ea1i b\u1ecf c\u00e1c \u0111o\u1ea1n \u1ed1ng n\u00e0y, t\u0103ng t\u1ed1c \u0111\u1ed9 l\u01b0u tu\u1ea7n ho\u00e0n v\u00e0 m\u1edf r\u1ed9ng t\u1ea7n su\u1ea5t kh\u1eed khu\u1ea9n, vi sinh t\u1ea1i c\u00e1c \u0111i\u1ec3m d\u00f9ng cu\u1ed1i gi\u1ea3m \u0111\u00e1ng k\u1ec3, v\u1edbi t\u1ef7 l\u1ec7 m\u1eabu v\u01b0\u1ee3t 50 CFU\/mL gi\u1ea3m h\u01a1n 70%.<\/b><span style=\"font-weight: 400;\"> M\u1ed9t s\u1ed1 nh\u00e0 m\u00e1y \u0111\u00e3 ghi nh\u1eadn vi\u1ec7c lo\u1ea1i b\u1ecf dead legs v\u00e0 t\u1ed1i \u01b0u h\u00f3a l\u01b0u t\u1ed1c tu\u1ea7n ho\u00e0n l\u00e0m gi\u1ea3m r\u00f5 r\u1ec7t s\u1ed1 m\u1eabu vi sinh v\u01b0\u1ee3t m\u1ee9c c\u1ea3nh b\u00e1o t\u1ea1i c\u00e1c \u0111i\u1ec3m d\u00f9ng cu\u1ed1i.<\/span><\/p>\n<h2><b>FAQ v\u1ec1 <\/b><b>N\u01b0\u1edbc PW (Purified Water)<\/b><\/h2>\n<blockquote>\n<h3><b>PW l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a g\u00ec?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">PW l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a <\/span><b>Purified Water<\/b><span style=\"font-weight: 400;\">, t\u1ee9c n\u01b0\u1edbc tinh khi\u1ebft d\u00f9ng cho c\u00e1c m\u1ee5c \u0111\u00edch ph\u00f9 h\u1ee3p trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m.<\/span><\/p>\n<h3><b>N\u01b0\u1edbc tinh khi\u1ebft d\u00f9ng \u0111\u1ec3 l\u00e0m g\u00ec trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Th\u01b0\u1eddng d\u00f9ng cho pha ch\u1ebf kh\u00f4ng v\u00f4 tr\u00f9ng, x\u00e1t h\u1ea1t \u01b0\u1edbt, ch\u1ebf ph\u1ea9m l\u1ecfng d\u1ea1ng n\u01b0\u1edbc, n\u01b0\u1edbc ph\u00f2ng th\u00ed nghi\u1ec7m v\u00e0 c\u00e1c b\u01b0\u1edbc r\u1eeda thi\u1ebft b\u1ecb ph\u00f9 h\u1ee3p v\u1edbi m\u1ee9c \u0111\u1ed9 r\u1ee7i ro.<\/span><\/p>\n<h3><b>Ch\u1ec9 ti\u00eau ch\u1ea5t l\u01b0\u1ee3ng n\u01b0\u1edbc tinh khi\u1ebft g\u1ed3m nh\u1eefng g\u00ec?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Ba tr\u1ee5c ch\u00ednh l\u00e0 t\u1ed5ng cacbon h\u1eefu c\u01a1, \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n v\u00e0 vi sinh. S\u00e2u h\u01a1n n\u1eefa, nh\u00e0 m\u00e1y c\u1ea7n c\u00f3 m\u1ee9c c\u1ea3nh b\u00e1o, ng\u01b0\u1ee1ng h\u00e0nh \u0111\u1ed9ng v\u00e0 gi\u1edbi h\u1ea1n xu h\u01b0\u1edbng t\u1ef1 x\u00e2y d\u1ef1ng.<\/span><\/p>\n<h3><b>Gi\u1edbi h\u1ea1n vi sinh n\u01b0\u1edbc tinh khi\u1ebft l\u00e0 bao nhi\u00eau?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">C\u01a1 quan qu\u1ea3n l\u00fd M\u1ef9 kh\u00f4ng ch\u1ea5p nh\u1eadn ng\u01b0\u1ee1ng h\u00e0nh \u0111\u1ed9ng l\u1edbn h\u01a1n <\/span><b>100 \u0111\u01a1n v\u1ecb khu\u1ea9n l\u1ea1c tr\u00ean mililit<\/b><span style=\"font-weight: 400;\">. Tuy nhi\u00ean, con s\u1ed1 th\u1ef1c t\u1ebf \u00e1p d\u1ee5ng t\u1ea1i nh\u00e0 m\u00e1y ph\u1ea3i d\u1ef1a tr\u00ean m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, r\u1ee7i ro s\u1ea3n ph\u1ea9m v\u00e0 d\u1eef li\u1ec7u l\u1ecbch s\u1eed.<\/span><\/p>\n<h3><b>L\u1ea5y m\u1eabu n\u01b0\u1edbc tinh khi\u1ebft \u0111\u00fang c\u00e1ch l\u00e0 nh\u01b0 th\u1ebf n\u00e0o?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">L\u1ea5y \u0111\u00fang \u0111i\u1ec3m s\u1eed d\u1ee5ng, \u0111\u00fang \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh th\u1ef1c t\u1ebf. N\u1ebfu quy tr\u00ecnh y\u00eau c\u1ea7u x\u1ea3 n\u01b0\u1edbc tr\u01b0\u1edbc khi d\u00f9ng, ph\u1ea3i l\u1ea5y m\u1eabu sau khi x\u1ea3. N\u1ebfu x\u00e0i qua \u1ed1ng d\u1eabn, ph\u1ea3i h\u1ee9ng m\u1eabu \u1edf cu\u1ed1i \u1ed1ng.<\/span><\/p>\n<h3><b>C\u00e1ch x\u1eed l\u00fd k\u1ebft qu\u1ea3 ngo\u00e0i ti\u00eau chu\u1ea9n v\u00e0 ngo\u00e0i xu h\u01b0\u1edbng?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">\u0110\u1ea7u ti\u00ean ph\u1ea3i x\u00e1c nh\u1eadn t\u00ednh \u0111\u1ea1i di\u1ec7n c\u1ee7a m\u1eabu v\u00e0 t\u00ednh ch\u00ednh x\u00e1c c\u1ee7a ph\u00e9p th\u1eed. Sau \u0111\u00f3 m\u1edbi m\u1edf \u0111i\u1ec1u tra h\u1ec7 th\u1ed1ng. N\u1ebfu l\u1ed7i l\u1eb7p l\u1ea1i ho\u1eb7c c\u00f3 vi sinh v\u1eadt l\u1ea1, ph\u1ea3i t\u00ecm ra nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 v\u00e0 \u0111\u01b0a ra bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c tri\u1ec7t \u0111\u1ec3.<\/span><\/p><\/blockquote>\n<h2><b>L\u1eddi k\u1ebft<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">N\u01b0\u1edbc tinh khi\u1ebft tuy\u1ec7t \u0111\u1ed1i kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t ti\u1ec7n \u00edch ph\u1ee5 tr\u1ee3 \u0111\u1ee9ng ngo\u00e0i l\u1ec1. N\u00f3 l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng v\u1eadn h\u00e0nh c\u1ea7n \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf c\u1ea9n th\u1eadn, theo d\u00f5i s\u00e1t sao v\u00e0 \u0111i\u1ec1u tra \u0111\u1ebfn n\u01a1i \u0111\u1ebfn ch\u1ed1n.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u0110\u1ec3 hi\u1ec3u \u0111\u00fang h\u1ec7 n\u01b0\u1edbc tinh khi\u1ebft, c\u00f3 n\u0103m \u0111i\u1ec3m c\u1ea7n gi\u1eef v\u1eefng:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>M\u1ed9t:<\/b><span style=\"font-weight: 400;\"> b\u1eaft \u0111\u1ea7u t\u1eeb m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, kh\u00f4ng b\u1eaft \u0111\u1ea7u t\u1eeb th\u00f3i quen.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Hai:<\/b><span style=\"font-weight: 400;\"> lu\u00f4n t\u00e1ch ba l\u1edbp th\u00f4ng tin \u2014 d\u01b0\u1ee3c \u0111i\u1ec3n, k\u1ef3 v\u1ecdng thanh tra v\u00e0 gi\u1edbi h\u1ea1n n\u1ed9i b\u1ed9 c\u1ee7a c\u01a1 s\u1edf.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Ba:<\/b><span style=\"font-weight: 400;\"> \u0111\u1eb7t t\u1ed5ng cacbon h\u1eefu c\u01a1, \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n v\u00e0 vi sinh ngang h\u00e0ng nhau khi \u0111\u1ecdc tr\u1ea1ng th\u00e1i h\u1ec7.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>B\u1ed1n:<\/b><span style=\"font-weight: 400;\"> xem l\u1ea5y m\u1eabu l\u00e0 m\u1ed9t ph\u1ea7n c\u1ee7a chi\u1ebfn l\u01b0\u1ee3c \u0111i\u1ec1u tra, kh\u00f4ng ph\u1ea3i \u0111\u1ed9ng t\u00e1c k\u1ef9 thu\u1eadt \u0111\u01a1n thu\u1ea7n.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>N\u0103m:<\/b><span style=\"font-weight: 400;\"> khi h\u1ec7 n\u01b0\u1edbc tinh khi\u1ebft c\u00f3 sai l\u1ec7ch l\u1eb7p l\u1ea1i, \u0111\u1eebng \u0111\u00f3ng \u0111i\u1ec1u tra ch\u1ec9 v\u00ec v\u00e0i m\u1eabu ti\u1ebfp theo c\u00f2n \u0111\u1ea1t. Trong c\u00e1ch \u0111\u00e1nh gi\u00e1 c\u1ee7a C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3, \u0111\u00f3 c\u00f3 th\u1ec3 \u0111\u00e3 l\u00e0 d\u1ea5u hi\u1ec7u r\u00f5 r\u00e0ng r\u1eb1ng h\u1ec7 th\u1ed1ng kh\u00f4ng c\u00f2n \u1edf tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t ph\u00f9 h\u1ee3p.<\/span><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>M\u1ed9t nh\u1ea7m l\u1eabn ph\u1ed5 bi\u1ebfn trong v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng n\u01b0\u1edbc t\u1ea1i c\u00e1c nh\u00e0 m\u00e1y d\u01b0\u1ee3c l\u00e0 xem n\u01b0\u1edbc tinh khi\u1ebft ch\u1ec9 \u0111\u01a1n gi\u1ea3n l\u00e0 n\u01b0\u1edbc m\u00e1y \u0111\u01b0\u1ee3c x\u1eed l\u00fd s\u1ea1ch h\u01a1n. T\u1eeb c\u00e1ch hi\u1ec3u n\u00e0y, nhi\u1ec1u ng\u01b0\u1eddi cho r\u1eb1ng h\u1ec7 th\u1ed1ng n\u01b0\u1edbc tinh khi\u1ebft &#8211; Purified Water (PW) kh\u00f4ng c\u1ea7n \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t nghi\u00eam &hellip; <a href=\"https:\/\/sepro.vn\/vi\/nuoc-pw-purified-water-la-gi\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">N\u01b0\u1edbc PW (Purified Water) l\u00e0 g\u00ec? Ti\u00eau Chu\u1ea9n v\u00e0 Quy Tr\u00ecnh Ki\u1ec3m Nghi\u1ec7m<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":9634,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[],"class_list":["post-9557","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\/9557","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=9557"}],"version-history":[{"count":10,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9557\/revisions"}],"predecessor-version":[{"id":9639,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9557\/revisions\/9639"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9634"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9557"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9557"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9557"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}