{"id":9216,"date":"2026-02-24T18:51:28","date_gmt":"2026-02-24T18:51:28","guid":{"rendered":"https:\/\/sepro.vn\/?p=9216"},"modified":"2026-02-25T06:00:34","modified_gmt":"2026-02-25T06:00:34","slug":"nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/","title":{"rendered":"N\u01b0\u1edbc WFI L\u00e0 G\u00ec V\u00e0 D\u00f9ng Th\u1ebf N\u00e0o Trong Nh\u00e0 M\u00e1y D\u01b0\u1ee3c GMP"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">C\u00f3 nh\u1eefng ng\u00e0y m\u1ecdi ch\u1ec9 ti\u00eau \u0111\u1ec1u \u0111\u1ea1t, nh\u01b0ng nh\u00ecn bi\u1ec3u \u0111\u1ed3 v\u1eabn th\u1ea5y kh\u00f4ng y\u00ean. WFI l\u00e0 ki\u1ec3u h\u1ec7 th\u1ed1ng nh\u01b0 v\u1eady, nh\u00ecn t\u01b0\u1edfng \u1ed5n m\u00e0 ch\u1ec9 c\u1ea7n m\u1ed9t nh\u00e1nh ch\u1ebft ho\u1eb7c m\u1ed9t thao t\u00e1c l\u1ea5y m\u1eabu l\u1ec7ch l\u00e0 k\u00e9o theo c\u1ea3 chu\u1ed7i \u0111i\u1ec1u tra. B\u00e0i n\u00e0y gom l\u1ea1i nh\u1eefng th\u1ee9 c\u1ea7n nh\u1edb, nh\u1eefng m\u1eb9o nh\u1ecf nh\u01b0ng \u0111\u1ee7 \u0111\u1ec3 b\u1ea1n ki\u1ec3m so\u00e1t nh\u1eefng r\u1ee7i ro kh\u00f3 tr\u00e1nh.<\/span><\/p>\n<h2><b>N\u01b0\u1edbc WFI l\u00e0 g\u00ec trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c<\/b><\/h2>\n<figure id=\"attachment_9219\" aria-describedby=\"caption-attachment-9219\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-9219\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-5.png\" alt=\"nuoc-wfi-la-gi\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-5.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-5-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-5-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-5-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9219\" class=\"wp-caption-text\"><em>N\u01b0\u1edbc WFI l\u00e0 g\u00ec<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">N\u01b0\u1edbc WFI l\u00e0 m\u1ed9t lo\u1ea1i n\u01b0\u1edbc d\u01b0\u1ee3c d\u1ee5ng cho pha ch\u1ebf thu\u1ed1c ti\u00eam v\u00e0 cho c\u00e1c b\u01b0\u1edbc kh\u1eed khu\u1ea9n b\u1ec1 m\u1eb7t thi\u1ebft b\u1ecb, d\u1ee5ng c\u1ee5 y t\u1ebf. \u0110i\u1ec3m c\u1ed1t l\u00f5i \u1edf \u0111\u00e2y l\u00e0 lo\u1ea1i n\u01b0\u1edbc \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ch\u1eb7t v\u1ec1 vi sinh, n\u1ed9i \u0111\u1ed9c t\u1ed1 v\u00e0 c\u00e1c ch\u1ec9 ti\u00eau h\u00f3a l\u00fd theo quy tr\u00ecnh c\u1ee7a nh\u00e0 m\u00e1y \u0111\u1ec3 h\u1ea1n ch\u1ebf nhi\u1ec5m b\u1ea9n ng\u01b0\u1ee3c trong v\u1eadn h\u00e0nh.<\/span><\/p>\n<h2><b>N\u01b0\u1edbc WFI l\u00e0 g\u00ec v\u00e0 WFI l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a g\u00ec<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">WFI l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a Water for Injection, ngh\u0129a l\u00e0 n\u01b0\u1edbc pha cho ti\u00eam, th\u01b0\u1eddng d\u00f9ng \u0111\u1ec3 l\u00e0m dung m\u00f4i ho\u1eb7c \u0111\u1ec3 pha lo\u00e3ng trong c\u00e1c c\u00f4ng \u0111o\u1ea1n v\u00f4 tr\u00f9ng n\u00ean y\u00eau c\u1ea7u ki\u1ec3m so\u00e1t r\u1ee7i ro cao h\u01a1n c\u00e1c nh\u00f3m n\u01b0\u1edbc d\u00f9ng cho m\u1ee5c \u0111\u00edch kh\u00f4ng v\u00f4 tr\u00f9ng. B\u1ea1n n\u00ean ph\u00e2n bi\u1ec7t r\u00f5 WFI d\u1ea1ng kh\u1ed1i l\u01b0u h\u00e0nh trong h\u1ec7 th\u1ed1ng nh\u00e0 m\u00e1y v\u1edbi n\u01b0\u1edbc d\u00f9ng cho ti\u00eam \u0111\u00e3 ti\u1ec7t khu\u1ea9n v\u00e0 \u0111\u00f3ng g\u00f3i th\u00e0nh ph\u1ea9m, v\u00ec h\u1ed3 s\u01a1 th\u1ea9m \u0111\u1ecbnh v\u00e0 c\u00e1ch qu\u1ea3n tr\u1ecb r\u1ee7i ro c\u1ee7a hai nh\u00f3m n\u00e0y kh\u00f4ng gi\u1ed1ng nhau.<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><em>Tham kh\u1ea3o th\u00eam<\/em>: <strong><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-quality-water-pharmaceutical-use_en.pdf\" target=\"_blank\" rel=\"noopener\">EMA Guideline WFI<\/a><\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u0110\u1ed1i di\u1ec7n v\u1edbi c\u00e1c c\u00e2u h\u1ecfi \u0111\u1ebfn t\u1eeb nh\u00e0 th\u1ea9m \u0111\u1ecbnh, c\u00e1ch tr\u1ea3 l\u1eddi an to\u00e0n nh\u1ea5t l\u00e0 \u0111i t\u1eeb m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t r\u1ee7i ro, sau \u0111\u00f3 m\u1edbi d\u1eabn sang c\u00e1c ti\u00eau chu\u1ea9n nh\u00e0 m\u00e1y \u0111ang \u00e1p d\u1ee5ng nh\u01b0 USP (United States Pharmacopeia, D\u01b0\u1ee3c \u0111i\u1ec3n Hoa K\u1ef3) v\u00e0 Ph. Eur. (European Pharmacopoeia, D\u01b0\u1ee3c \u0111i\u1ec3n ch\u00e2u \u00c2u).<\/span><\/p>\n<p><b>N\u01b0\u1edbc WFI d\u00f9ng \u0111\u1ec3 l\u00e0m g\u00ec trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Trong v\u1eadn h\u00e0nh, WFI th\u01b0\u1eddng g\u1eafn v\u1edbi hai nh\u00f3m nhu c\u1ea7u l\u1edbn, v\u1eeba l\u00e0 nguy\u00ean li\u1ec7u cho pha ch\u1ebf h\u00f3a ch\u1ea5t kh\u1eed khu\u1ea9n v\u00f4 tr\u00f9ng v\u1eeba l\u00e0 n\u01b0\u1edbc d\u00f9ng cho b\u01b0\u1edbc v\u1ec7 sinh b\u1ec1 m\u1eb7t thi\u1ebft b\u1ecb, d\u1ee5ng c\u1ee5 ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp s\u1ea3n ph\u1ea9m, v\u00ec \u0111\u00e2y l\u00e0 n\u01a1i r\u1ee7i ro nhi\u1ec5m ng\u01b0\u1ee3c hay xu\u1ea5t hi\u1ec7n n\u1ebfu ch\u1ea5t l\u01b0\u1ee3ng n\u01b0\u1edbc kh\u00f4ng \u1ed5n \u0111\u1ecbnh. \u1ede g\u00f3c \u0111\u1ed9 c\u1ee7a c\u1ea3 QA (Quality Assurance, \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng) v\u00e0 QC (Quality Control, ki\u1ec3m nghi\u1ec7m ch\u1ea5t l\u01b0\u1ee3ng), m\u1ed7i \u0111i\u1ec3m d\u00f9ng c\u1ea7n c\u00f3 m\u1ee5c \u0111\u00edch r\u00f5 r\u00e0ng \u0111\u1ec3 tr\u00e1nh vi\u1ec7c chi ph\u00ed v\u1eadn h\u00e0nh t\u0103ng nh\u01b0ng hi\u1ec7u qu\u1ea3 v\u1ec7 sinh l\u1ea1i kh\u00f4ng \u0111\u1ea1t y\u00eau c\u1ea7u<\/span><\/p>\n<p><span style=\"font-weight: 400;\">C\u00e1c t\u00ecnh hu\u1ed1ng th\u01b0\u1eddng hay s\u1eed d\u1ee5ng n\u01b0\u1edbc WFI t\u1ea1i c\u00e1c nh\u00e0 m\u00e1y:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Pha dung m\u00f4i, pha lo\u00e3ng ho\u1eb7c v\u1ec7 sinh m\u00f4i tr\u01b0\u1eddng cho thu\u1ed1c ti\u00eam trong khu v\u1ef1c v\u00f4 tr\u00f9ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Tr\u00e1ng l\u1ea1i thi\u1ebft b\u1ecb sau khi v\u1ec7 sinh t\u1ea1i ch\u1ed7 CIP (Clean-In-Place, v\u1ec7 sinh t\u1ea1i ch\u1ed7) tr\u01b0\u1edbc ti\u1ec7t khu\u1ea9n t\u1ea1i ch\u1ed7 SIP (Sterilize-In-Place, ti\u1ec7t khu\u1ea9n t\u1ea1i ch\u1ed7) ho\u1eb7c tr\u01b0\u1edbc khi l\u1eafp r\u00e1p<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">L\u00e0 th\u00e0nh ph\u1ea7n kh\u00f4ng th\u1ec3 thi\u1ebfu, d\u00f9ng c\u00f9ng c\u00e1c dung d\u1ecbch v\u1ec7 sinh, kh\u1eed tr\u00f9ng khi quy tr\u00ecnh l\u00e0m s\u1ea1ch y\u00eau c\u1ea7u n\u01b0\u1edbc \u0111\u1ea1t m\u1ee9c WFI<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">C\u1ea5p n\u01b0\u1edbc cho m\u1ed9t s\u1ed1 thi\u1ebft b\u1ecb c\u00f4ng ngh\u1ec7 c\u00f3 y\u00eau c\u1ea7u ki\u1ec3m so\u00e1t n\u1ed9i \u0111\u1ed9c t\u1ed1, t\u00f9y \u0111\u00e1nh gi\u00e1 r\u1ee7i ro v\u00e0 thi\u1ebft k\u1ebf<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Nhi\u1ec1u nh\u00e0 m\u00e1y hay nh\u1ea7m l\u1eabn \u1edf ch\u1ed7 d\u00f9ng WFI cho m\u1ecdi b\u01b0\u1edbc r\u1eeda t\u1eeb \u0111\u1ea7u v\u1edbi suy ngh\u0129 d\u00f9ng c\u00e0ng nhi\u1ec1u c\u00e0ng s\u1ea1ch, trong khi th\u1ef1c t\u1ebf r\u1ee7i ro th\u1eadt s\u1ef1 n\u1eb1m \u1edf b\u01b0\u1edbc v\u1ec7 sinh cu\u1ed1i v\u1edbi nguy c\u01a1 nhi\u1ec5m ng\u01b0\u1ee3c. V\u00ec v\u1eady, ph\u00e2n t\u1ea7ng \u0111\u00fang PW v\u00e0 WFI theo r\u1ee7i ro th\u01b0\u1eddng cho hi\u1ec7u qu\u1ea3 t\u1ed1t h\u01a1n, v\u1eeba ki\u1ec3m so\u00e1t t\u1ed1t v\u1eeba tr\u00e1nh l\u00e3ng ph\u00ed.<\/span><\/p>\n<h2><b>WFI kh\u00e1c g\u00ec n\u01b0\u1edbc PW<\/b><\/h2>\n<figure id=\"attachment_9221\" aria-describedby=\"caption-attachment-9221\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9221\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-5.png\" alt=\"nghien-cuu-va-kiem-soat-vi-sinh-o-nuoc-wfi\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-5.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-5-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-5-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-5-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9221\" class=\"wp-caption-text\"><em>Nghi\u00ean c\u1ee9u v\u00e0 ki\u1ec3m so\u00e1t vi sinh \u1edf n\u01b0\u1edbc WFI<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">WFI kh\u00e1c PW ch\u1ee7 y\u1ebfu n\u1eb1m \u1edf m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 m\u1ee9c ki\u1ec3m so\u00e1t n\u1ed9i \u0111\u1ed9c t\u1ed1, vi sinh v\u00e0 v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng, ch\u1ee9 kh\u00f4ng ch\u1ec9 l\u00e0 t\u1ef7 l\u1ec7 trong COA (Certificate of Analysis, gi\u1ea5y ch\u1ee9ng nh\u1eadn ph\u00e2n t\u00edch) nh\u00ecn th\u1ea5y tr\u00ean gi\u1ea5y. N\u00f3i theo ng\u00f4n ng\u1eef v\u1eadn h\u00e0nh th\u00ec PW th\u01b0\u1eddng d\u00f9ng cho pha ch\u1ebf kh\u00f4ng v\u00f4 tr\u00f9ng v\u00e0 c\u00e1c b\u01b0\u1edbc v\u1ec7 sinh \u0111\u1ea7u ti\u00ean, c\u00f2n WFI d\u00f9ng cho pha ch\u1ebf ti\u00eam truy\u1ec1n v\u00e0 b\u01b0\u1edbc tr\u00e1ng cu\u1ed1i li\u00ean quan v\u00f4 tr\u00f9ng v\u00ec y\u00eau c\u1ea7u qu\u1ea3n tr\u1ecb r\u1ee7i ro c\u1ee7a hai nh\u00f3m kh\u00e1c nhau.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Gi\u1ea3i th\u00edch vi\u1ebft t\u1eaft trong b\u1ea3ng: RO l\u00e0 th\u1ea9m th\u1ea5u ng\u01b0\u1ee3c. EDI l\u00e0 kh\u1eed ion \u0111i\u1ec7n. UF l\u00e0 si\u00eau l\u1ecdc.<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>M\u1ee5c<\/b><\/td>\n<td><b>PW<\/b><\/td>\n<td><b>WFI<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u00c1p d\u1ee5ng<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Pha kh\u00f4ng v\u00f4 tr\u00f9ng, r\u1eeda \u0111\u1ea7u<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Thu\u1ed1c ti\u00eam, tr\u00e1ng cu\u1ed1i v\u00f4 tr\u00f9ng<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Tr\u1ecdng t\u00e2m<\/span><\/td>\n<td><span style=\"font-weight: 400;\">T\u1ea1p ion, vi sinh m\u1ee9c ph\u00f9 h\u1ee3p<\/span><\/td>\n<td><span style=\"font-weight: 400;\">N\u1ed9i \u0111\u1ed9c t\u1ed1, vi sinh, nhi\u1ec5m ng\u01b0\u1ee3c<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">T\u1ea1o n\u01b0\u1edbc<\/span><\/td>\n<td><span style=\"font-weight: 400;\">RO, EDI, UF<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Ch\u01b0ng c\u1ea5t ho\u1eb7c mang \u0111\u1ee7 ki\u1ec3m so\u00e1t<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Ph\u00e2n ph\u1ed1i<\/span><\/td>\n<td><span style=\"font-weight: 400;\">C\u00f3 th\u1ec3 kh\u00f4ng tu\u1ea7n ho\u00e0n<\/span><\/td>\n<td><span style=\"font-weight: 400;\">V\u00f2ng tu\u1ea7n ho\u00e0n, h\u1ea1n ch\u1ebf nh\u00e1nh ch\u1ebft<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><b>Y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng n\u01b0\u1edbc WFI g\u1ed3m nh\u1eefng ch\u1ec9 ti\u00eau n\u00e0o<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng WFI th\u01b0\u1eddng xoay quanh ba nh\u00f3m, h\u00f3a l\u00fd nh\u01b0 TOC v\u00e0 \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n, n\u1ed9i \u0111\u1ed9c t\u1ed1 nh\u01b0 endotoxin, v\u00e0 vi sinh theo ki\u1ec3m so\u00e1t t\u1ea3i khu\u1ea9n, v\u00ec m\u1ed7i nh\u00f3m ph\u1ea3n \u00e1nh m\u1ed9t ki\u1ec3u r\u1ee7i ro kh\u00e1c nhau trong h\u1ec7 th\u1ed1ng n\u01b0\u1edbc. \u0110i\u1ec3m quan tr\u1ecdng \u1edf \u0111\u00e2y l\u00e0 s\u1ed1 li\u1ec7u \u0111\u1ea1t t\u1eebng l\u1ea7n v\u1eabn c\u00f3 th\u1ec3 b\u1ecb \u0111\u00e1nh l\u1eeba n\u1ebfu b\u1ea1n kh\u00f4ng c\u00f3 theo d\u00f5i xu h\u01b0\u1edbng v\u00e0 gi\u1edbi h\u1ea1n c\u1ea3nh b\u00e1o, h\u00e0nh \u0111\u1ed9ng r\u00f5 r\u00e0ng theo SOP (Standard Operating Procedure, quy tr\u00ecnh thao t\u00e1c chu\u1ea9n).<\/span><\/p>\n<h3><b>Endotoxin trong n\u01b0\u1edbc WFI l\u00e0 g\u00ec<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Endotoxin l\u00e0 n\u1ed9i \u0111\u1ed9c t\u1ed1 t\u1eeb vi khu\u1ea9n Gram \u00e2m, c\u00f3 th\u1ec3 g\u00e2y ph\u1ea3n \u1ee9ng s\u1ed1t v\u00e0 l\u00e0 r\u1ee7i ro \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng v\u1edbi ch\u1ebf ph\u1ea9m ti\u00eam truy\u1ec1n. C\u00e1i d\u1ec5 b\u1ecb b\u1ecf s\u00f3t n\u1eb1m \u1edf l\u1edbp b\u00e1m vi sinh trong \u0111\u01b0\u1eddng \u1ed1ng, v\u00ec endotoxin c\u00f3 th\u1ec3 nh\u00edch l\u00ean theo xu h\u01b0\u1edbng tr\u01b0\u1edbc khi vi sinh t\u0103ng r\u00f5, l\u00e0m OOT (Out of Trend, l\u1ec7ch xu h\u01b0\u1edbng) xu\u1ea5t hi\u1ec7n b\u1ea5t ng\u1edd v\u00e0 h\u1ed3 s\u01a1 \u0111i\u1ec1u tra k\u00e9o d\u00e0i.<\/span><\/p>\n<h3><b>TOC v\u00e0 \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n c\u1ee7a n\u01b0\u1edbc WFI<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">TOC (Total Organic Carbon, t\u1ed5ng carbon h\u1eefu c\u01a1) ph\u1ea3n \u00e1nh t\u1ea1p h\u1eefu c\u01a1, c\u00f2n \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n ph\u1ea3n \u00e1nh t\u1ea1p ion v\u00e0 tr\u1ea1ng th\u00e1i c\u00e2n b\u1eb1ng c\u1ee7a n\u01b0\u1edbc, n\u00ean hai ch\u1ec9 ti\u00eau n\u00e0y th\u01b0\u1eddng ph\u00e1t hi\u1ec7n h\u1ec7 th\u1ed1ng b\u1eaft \u0111\u1ea7u tr\u01b0\u1ee3t s\u1edbm h\u01a1n khi vi sinh t\u0103ng r\u00f5. Tr\u00ean th\u1ef1c t\u1ebf v\u1eadn h\u00e0nh, TOC nh\u00edch l\u00ean sau b\u1ea3o tr\u00ec ch\u01b0a ch\u1eafc do n\u01b0\u1edbc b\u1ea9n, \u0111\u00f4i khi ch\u1ec9 v\u00ec v\u1eadt li\u1ec7u m\u1edbi ho\u1eb7c gio\u0103ng m\u1edbi c\u1ea7n \u0111\u01b0\u1ee3c tr\u00e1ng r\u1eeda \u0111\u1ee7 theo quy tr\u00ecnh tr\u01b0\u1edbc khi h\u1ec7 \u1ed5n \u0111\u1ecbnh tr\u1edf l\u1ea1i.<\/span><\/p>\n<h3><b>Ki\u1ec3m nghi\u1ec7m vi sinh n\u01b0\u1edbc WFI v\u00e0 theo d\u00f5i xu h\u01b0\u1edbng<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Ki\u1ec3m nghi\u1ec7m vi sinh WFI kh\u00f4ng ch\u1ec9 l\u00e0 \u0111\u1ebfm khu\u1ea9n, m\u00e0 l\u00e0 qu\u1ea3n tr\u1ecb xu h\u01b0\u1edbng theo \u0111i\u1ec3m l\u1ea5y m\u1eabu, theo th\u1eddi gian v\u00e0 theo m\u1ed1i li\u00ean h\u1ec7 v\u1edbi l\u1ea7n kh\u1eed tr\u00f9ng h\u1ec7 th\u1ed1ng, nhi\u1ec7t \u0111\u1ed9 v\u1eadn h\u00e0nh v\u00e0 t\u1ed1c \u0111\u1ed9 tu\u1ea7n ho\u00e0n, v\u00ec vi sinh th\u01b0\u1eddng t\u0103ng \u00e2m \u1ec9 r\u1ed3i b\u00f9ng l\u00ean. Khi m\u1ed9t \u0111i\u1ec3m dao \u0111\u1ed9ng nh\u01b0ng to\u00e0n h\u1ec7 v\u1eabn \u1ed5n, k\u1ebft lu\u1eadn t\u1ed1t th\u01b0\u1eddng d\u1ef1a v\u00e0o xu h\u01b0\u1edbng d\u1eef li\u1ec7u v\u00e0 \u0111i\u1ec1u ki\u1ec7n l\u1ea5y m\u1eabu, thay v\u00ec ph\u1ea3n \u1ee9ng theo m\u1ed9t k\u1ebft qu\u1ea3 \u0111\u01a1n l\u1ebb.<\/span><\/p>\n<h2><b>H\u1ec7 th\u1ed1ng t\u1ea1o WFI v\u00e0 h\u1ec7 th\u1ed1ng v\u00f2ng tu\u1ea7n ho\u00e0n l\u01b0u tr\u1eef ph\u00e2n ph\u1ed1i<\/b><\/h2>\n<figure id=\"attachment_9223\" aria-describedby=\"caption-attachment-9223\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9223\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-5.png\" alt=\"he-thong-tao-wfi-va-he-thong-vong-tuan-hoan-luu-tru-phan-phoi\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-5.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-5-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-5-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-5-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9223\" class=\"wp-caption-text\"><em>H\u1ec7 th\u1ed1ng t\u1ea1o WFI v\u00e0 h\u1ec7 th\u1ed1ng v\u00f2ng tu\u1ea7n ho\u00e0n l\u01b0u tr\u1eef ph\u00e2n ph\u1ed1i<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">H\u1ec7 th\u1ed1ng WFI th\u01b0\u1eddng g\u1ed3m kh\u1ed1i t\u1ea1o n\u01b0\u1edbc, b\u1ed3n ch\u1ee9a, b\u01a1m tu\u1ea7n ho\u00e0n, \u0111\u01b0\u1eddng \u1ed1ng v\u00f2ng v\u00e0 c\u00e1c \u0111i\u1ec3m d\u00f9ng, v\u00e0 ph\u1ea7n n\u00e0y c\u1ea7n \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 h\u1ea1n ch\u1ebf nh\u00e1nh ch\u1ebft v\u00ec nh\u00e1nh ch\u1ebft l\u00e0 n\u01a1i l\u1edbp b\u00e1m vi sinh d\u1ec5 h\u00ecnh th\u00e0nh. \u1ede g\u00f3c qu\u1ea3n tr\u1ecb r\u1ee7i ro, th\u1ee9 c\u1ea7n h\u1ecfi kh\u00f4ng ph\u1ea3i ch\u01b0ng c\u1ea5t hay m\u00e0ng t\u1ed1t h\u01a1n, m\u00e0 l\u00e0 chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t c\u00f3 \u0111\u1ee7 m\u1ea1nh \u0111\u1ec3 gi\u1eef h\u1ec7 \u1ed5n \u0111\u1ecbnh theo th\u1eddi gian, nh\u1ea5t l\u00e0 sau c\u00e1c s\u1ef1 ki\u1ec7n nh\u01b0 b\u1ea3o tr\u00ec, thay v\u1eadt li\u1ec7u ho\u1eb7c thay \u0111\u1ed5i t\u1ea3i d\u00f9ng.<\/span><\/p>\n<h3><b>V\u1ec7 sinh kh\u1eed tr\u00f9ng h\u1ec7 th\u1ed1ng WFI<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Kh\u1eed tr\u00f9ng h\u1ec7 th\u1ed1ng c\u00f3 th\u1ec3 theo nhi\u1ec7t ho\u1eb7c theo h\u00f3a ch\u1ea5t, v\u00e0 n\u1ebfu d\u00f9ng h\u00f3a ch\u1ea5t th\u00ec SDS (Safety Data Sheet, b\u1ea3ng d\u1eef li\u1ec7u an to\u00e0n h\u00f3a ch\u1ea5t) v\u00e0 PPE (Personal Protective Equipment, ph\u01b0\u01a1ng ti\u1ec7n b\u1ea3o h\u1ed9 c\u00e1 nh\u00e2n) c\u1ea7n \u0111\u01b0\u1ee3c n\u00eau r\u00f5 trong SOP \u0111\u1ec3 tr\u00e1nh r\u1ee7i ro an to\u00e0n v\u00e0 nguy c\u01a1 t\u1ed3n l\u01b0u. N\u1ebfu ch\u1ec9 ch\u1ea1y kh\u1eed tr\u00f9ng theo l\u1ecbch cho c\u00f3, b\u1ea1n s\u1ebd kh\u00f3 gi\u1ea3i th\u00edch khi xu h\u01b0\u1edbng d\u1eef li\u1ec7u b\u1eaft \u0111\u1ea7u l\u1ec7ch, n\u00ean c\u00e1ch l\u00e0m b\u1ec1n l\u00e0 b\u00e1m xu h\u01b0\u1edbng d\u1eef li\u1ec7u, s\u1ef1 ki\u1ec7n b\u1ea3o tr\u00ec v\u00e0 r\u1ee7i ro theo t\u1eebng \u0111i\u1ec3m d\u00f9ng \u0111\u1ec3 quy\u1ebft \u0111\u1ecbnh th\u1eddi \u0111i\u1ec3m v\u00e0 ph\u01b0\u01a1ng ph\u00e1p ph\u00f9 h\u1ee3p.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Tham kh\u1ea3o th\u00eam: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/revision-manufacture-sterile-medicinal-products-2022-08-25_en\" target=\"_blank\" rel=\"noopener\"><strong>EU GMP Annex 1<\/strong><\/a><\/span><\/p>\n<p><b>Audit note cho QA QC.<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">[\u0110i\u1ec1n danh s\u00e1ch \u0111i\u1ec3m l\u1ea5y m\u1eabu \u0111\u00e3 th\u1ea9m \u0111\u1ecbnh, c\u00f3 l\u00fd do theo r\u1ee7i ro]<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">[\u0110i\u1ec1n gi\u1edbi h\u1ea1n c\u1ea3nh b\u00e1o v\u00e0 h\u00e0nh \u0111\u1ed9ng cho vi sinh, TOC, \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n, endotoxin theo SOP]<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">[\u0110i\u1ec1n l\u1ecbch kh\u1eed tr\u00f9ng v\u00e0 ti\u00eau ch\u00ed k\u00edch ho\u1ea1t kh\u1eed tr\u00f9ng b\u1ea5t th\u01b0\u1eddng]<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">[\u0110i\u1ec1n ti\u00eau ch\u00ed \u0111\u00e1nh gi\u00e1 nh\u00e1nh ch\u1ebft, \u0111\u1ed9 d\u1ed1c, kh\u1ea3 n\u0103ng tho\u00e1t n\u01b0\u1edbc v\u00e0 v\u1eadt li\u1ec7u 316L]<\/span><\/li>\n<\/ul>\n<h2><b>L\u1ea5y m\u1eabu n\u01b0\u1edbc WFI \u0111\u00fang c\u00e1ch v\u00e0 x\u1eed l\u00fd OOS OOT<\/b><\/h2>\n<figure id=\"attachment_9225\" aria-describedby=\"caption-attachment-9225\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9225\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-3.png\" alt=\"kiem-soat-wfi-oos-oot-dung-cach\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-3.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-3-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-3-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-3-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9225\" class=\"wp-caption-text\"><em>Ki\u1ec3m so\u00e1t WFI, OOS, OOT \u0111\u00fang c\u00e1ch<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">L\u1ea5y m\u1eabu l\u00e0 \u0111i\u1ec3m d\u1ec5 t\u1ea1o sai l\u1ec7ch nh\u1ea5t v\u00ec ch\u1ec9 c\u1ea7n thao t\u00e1c ch\u1ea1m sai v\u00e0o van ho\u1eb7c x\u1ea3 tr\u01b0\u1edbc ch\u01b0a \u0111\u1ee7, k\u1ebft qu\u1ea3 vi sinh v\u00e0 endotoxin c\u00f3 th\u1ec3 t\u0103ng gi\u1ea3, r\u1ed3i c\u1ea3 \u0111\u1ed9i m\u1ea5t th\u1eddi gian \u0111i\u1ec1u tra, x\u1eed l\u00fd v\u00e0 \u0111\u00e1nh gi\u00e1 \u1ea3nh h\u01b0\u1edfng. N\u1ebfu ph\u1ea3i ch\u1ecdn m\u1ed9t \u0111i\u1ec1u \u0111\u1ec3 nh\u1edb th\u00ec \u0111\u00f3 l\u00e0 d\u1eef li\u1ec7u t\u1ed1t b\u1eaft \u0111\u1ea7u t\u1eeb thao t\u00e1c l\u1ea5y m\u1eabu chu\u1ea9n, n\u00ean ti\u00eau chu\u1ea9n h\u00f3a thao t\u00e1c v\u00e0 ghi nh\u1eadn \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh ngay l\u00fac l\u1ea5y m\u1eabu s\u1ebd gi\u00fap gi\u1ea3m \u0111i\u1ec1u tra kh\u00f4ng c\u1ea7n thi\u1ebft.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">T\u00ecnh hu\u1ed1ng minh h\u1ecda, nh\u01b0ng r\u1ea5t hay g\u1eb7p.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sai l\u1ea7m kh\u00f3 s\u1eeda: QC l\u1ea5y m\u1eabu ngay sau khi m\u1edf van, kh\u00f4ng x\u1ea3 b\u1ecf ph\u1ea7n n\u01b0\u1edbc n\u1eb1m trong nh\u00e1nh ch\u1ebft n\u00ean vi sinh t\u0103ng v\u00e0 b\u1ecb \u0111\u00e1nh OOT<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">C\u00e1ch kh\u1eafc ph\u1ee5c: x\u1ea3 tr\u01b0\u1edbc theo th\u1eddi gian ho\u1eb7c th\u1ec3 t\u00edch \u0111\u00e3 th\u1ea9m \u0111\u1ecbnh, kh\u1eed tr\u00f9ng \u0111i\u1ec3m l\u1ea5y m\u1eabu \u0111\u00fang c\u00e1ch, ghi nh\u1eadn nhi\u1ec7t \u0111\u1ed9 v\u00e0 th\u1eddi \u0111i\u1ec3m kh\u1eed tr\u00f9ng g\u1ea7n nh\u1ea5t<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">B\u00e0i h\u1ecdc: nhi\u1ec1u OOT th\u1ef1c ra l\u00e0 l\u1ed7i thao t\u00e1c, n\u00ean hu\u1ea5n luy\u1ec7n v\u00e0 quan s\u00e1t hi\u1ec7n tr\u01b0\u1eddng th\u01b0\u1eddng \u0111\u00e1ng gi\u00e1 h\u01a1n m\u1ed9t trang gi\u1ea3i tr\u00ecnh \u0111\u1eb9p<\/span><\/li>\n<\/ul>\n<h3><b>Checklist l\u1ea5y m\u1eabu cho QA QC<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Checklist gi\u00fap \u0111\u1ed3ng b\u1ed9 thao t\u00e1c v\u00e0 gi\u1ea3m kh\u1ea3 n\u0103ng t\u1ea1o OOS gi\u1ea3, nh\u01b0ng c\u1ea7n ch\u1ec9nh theo SOP v\u00e0 thi\u1ebft k\u1ebf \u0111i\u1ec3m l\u1ea5y m\u1eabu c\u1ee7a nh\u00e0 m\u00e1y v\u00ec m\u1ed7i h\u1ec7 th\u1ed1ng c\u00f3 c\u1ea5u h\u00ecnh v\u00e0 r\u1ee7i ro kh\u00e1c nhau. M\u1ee5c ti\u00eau r\u1ea5t r\u00f5 l\u00e0 thao t\u00e1c \u1edf c\u00f9ng m\u1ed9t \u0111i\u1ec3m l\u1ea5y m\u1eabu ph\u1ea3i nh\u1ea5t qu\u00e1n qua nhi\u1ec1u ng\u01b0\u1eddi v\u00e0 nhi\u1ec1u ca, khi \u0111\u00f3 xu h\u01b0\u1edbng d\u1eef li\u1ec7u m\u1edbi \u0111\u1ee7 tin \u0111\u1ec3 ra quy\u1ebft \u0111\u1ecbnh.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">X\u00e1c nh\u1eadn \u0111i\u1ec3m l\u1ea5y m\u1eabu v\u00e0 m\u00e3 \u0111i\u1ec3m. [\u0110i\u1ec1n m\u00e3 \u0111i\u1ec3m, v\u1ecb tr\u00ed, lo\u1ea1i van]<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">L\u00e0m s\u1ea1ch v\u00e0 kh\u1eed tr\u00f9ng \u0111i\u1ec3m l\u1ea5y m\u1eabu theo SOP. [\u0110i\u1ec1n t\u00e1c nh\u00e2n v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac]<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">X\u1ea3 tr\u01b0\u1edbc khi l\u1ea5y m\u1eabu. [\u0110i\u1ec1n th\u1eddi gian ho\u1eb7c th\u1ec3 t\u00edch x\u1ea3 \u0111\u00e3 th\u1ea9m \u0111\u1ecbnh]<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">L\u1ea5y m\u1eabu v\u00f4 tr\u00f9ng, tr\u00e1nh ch\u1ea1m v\u00e0o mi\u1ec7ng chai v\u00e0 \u0111\u1ea7u l\u1ea5y m\u1eabu<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ghi nh\u1eadn \u0111i\u1ec1u ki\u1ec7n. [\u0110i\u1ec1n nhi\u1ec7t \u0111\u1ed9 v\u00f2ng, tr\u1ea1ng th\u00e1i v\u00f2ng n\u00f3ng hay v\u00f2ng l\u1ea1nh, th\u1eddi \u0111i\u1ec3m kh\u1eed tr\u00f9ng g\u1ea7n nh\u1ea5t]<\/span><\/li>\n<\/ul>\n<h3><b>Ma tr\u1eadn x\u1eed l\u00fd OOS OOT n\u01b0\u1edbc WFI<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">OOT (Out of Trend, l\u1ec7ch xu h\u01b0\u1edbng) l\u00e0 l\u1ec7ch xu h\u01b0\u1edbng d\u00f9 ch\u01b0a v\u01b0\u1ee3t chu\u1ea9n, c\u00f2n OOS (Out of Specification, ngo\u00e0i gi\u1edbi h\u1ea1n ti\u00eau chu\u1ea9n) l\u00e0 v\u01b0\u1ee3t gi\u1edbi h\u1ea1n ch\u1ea5t l\u01b0\u1ee3ng, v\u00ec v\u1eady h\u01b0\u1edbng x\u1eed l\u00fd hi\u1ec7u qu\u1ea3 l\u00e0 ph\u00e2n nh\u00e1nh theo r\u1ee7i ro v\u00e0 b\u1eb1ng ch\u1ee9ng hi\u1ec7n tr\u01b0\u1eddng. Khi thi\u1ebfu xu h\u01b0\u1edbng d\u1eef li\u1ec7u v\u00e0 thi\u1ebfu th\u00f4ng tin \u0111i\u1ec1u ki\u1ec7n l\u1ea5y m\u1eabu, k\u1ebft lu\u1eadn r\u1ea5t d\u1ec5 b\u1ecb l\u1ec7ch, \u0111\u1eb7c bi\u1ec7t l\u00e0 trong c\u00e1c ca OOT xu\u1ea5t hi\u1ec7n l\u1ebb t\u1ebb r\u1ed3i bi\u1ebfn m\u1ea5t.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ma tr\u1eadn g\u1ee3i \u00fd, b\u1ea1n ch\u1ec9nh theo SOP.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">OOT \u0111\u01a1n \u0111i\u1ec3m, kh\u00f4ng l\u1eb7p, nghi ng\u1edd thao t\u00e1c l\u1ea5y m\u1eabu. \u0110i\u1ec1u tra thao t\u00e1c, l\u1ea5y m\u1eabu l\u1ea1i c\u00f3 ki\u1ec3m so\u00e1t, r\u00e0 b\u01b0\u1edbc x\u1ea3 v\u00e0 kh\u1eed tr\u00f9ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">OOT l\u1eb7p t\u1ea1i c\u00f9ng \u0111i\u1ec3m. R\u00e0 thi\u1ebft k\u1ebf \u0111i\u1ec3m l\u1ea5y m\u1eabu, nh\u00e1nh ch\u1ebft, t\u1ea7n su\u1ea5t s\u1eed d\u1ee5ng, \u0111\u00e1nh gi\u00e1 nguy c\u01a1 l\u1edbp b\u00e1m c\u1ee5c b\u1ed9, c\u00e2n nh\u1eafc kh\u1eed tr\u00f9ng m\u1ee5c ti\u00eau<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">OOS \u1edf ch\u1ec9 ti\u00eau tr\u1ecdng y\u1ebfu. K\u00edch ho\u1ea1t h\u1ed3 s\u01a1 sai l\u1ec7ch, \u0111\u00e1nh gi\u00e1 \u1ea3nh h\u01b0\u1edfng l\u00f4, khoanh v\u00f9ng \u0111i\u1ec3m d\u00f9ng, t\u0103ng t\u1ea7n su\u1ea5t gi\u00e1m s\u00e1t, ch\u1ea1y CAPA (Corrective and Preventive Action, h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">OOS k\u00e8m t\u00edn hi\u1ec7u to\u00e0n h\u1ec7. T\u1ea1m d\u1eebng d\u00f9ng \u0111i\u1ec3m r\u1ee7i ro, \u0111\u00e1nh gi\u00e1 to\u00e0n v\u00f2ng, r\u00e0 l\u1ecbch kh\u1eed tr\u00f9ng v\u00e0 \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh, x\u1eed l\u00fd t\u1edbi n\u01a1i<\/span><\/li>\n<\/ul>\n<h2><b>FAQ v\u1ec1 n\u01b0\u1edbc WFI<\/b><\/h2>\n<h3><b>WFI l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a g\u00ec<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">WFI l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a Water for Injection, ngh\u0129a l\u00e0 n\u01b0\u1edbc d\u00f9ng cho ti\u00eam, v\u00e0 trong nh\u00e0 m\u00e1y n\u00f3 th\u01b0\u1eddng t\u1ed3n t\u1ea1i d\u1ea1ng n\u01b0\u1edbc kh\u1ed1i l\u01b0u h\u00e0nh trong h\u1ec7 th\u1ed1ng v\u00f2ng tu\u1ea7n ho\u00e0n \u0111\u1ec3 ph\u1ee5c v\u1ee5 pha ch\u1ebf thu\u1ed1c ti\u00eam truy\u1ec1n v\u00e0 b\u01b0\u1edbc tr\u00e1ng cu\u1ed1i li\u00ean quan v\u00f4 tr\u00f9ng. Khi vi\u1ebft h\u1ed3 s\u01a1, b\u1ea1n n\u00ean \u0111\u1ed1i chi\u1ebfu \u0111\u1ecbnh ngh\u0129a theo d\u01b0\u1ee3c \u0111i\u1ec3n v\u00e0 SOP c\u1ee7a nh\u00e0 m\u00e1y \u0111\u1ec3 tr\u00e1nh nh\u1ea7m v\u1edbi n\u01b0\u1edbc d\u00f9ng cho ti\u00eam \u0111\u00e3 ti\u1ec7t khu\u1ea9n v\u00e0 \u0111\u00f3ng g\u00f3i th\u00e0nh ph\u1ea9m.<\/span><\/p>\n<h3><b>Endotoxin trong n\u01b0\u1edbc WFI l\u00e0 g\u00ec v\u00e0 v\u00ec sao hay b\u1ecb \u0111\u00e1nh gi\u00e1 h\u1ecfi s\u00e2u<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Endotoxin l\u00e0 n\u1ed9i \u0111\u1ed9c t\u1ed1 t\u1eeb vi khu\u1ea9n Gram \u00e2m v\u00e0 li\u00ean quan tr\u1ef1c ti\u1ebfp t\u1edbi y\u00eau c\u1ea7u kh\u00f4ng g\u00e2y s\u1ed1t c\u1ee7a ch\u1ebf ph\u1ea9m ti\u00eam truy\u1ec1n, n\u00ean \u0111o\u00e0n \u0111\u00e1nh gi\u00e1 th\u01b0\u1eddng h\u1ecfi s\u00e2u v\u1ec1 c\u00e1ch ki\u1ec3m so\u00e1t v\u00e0 c\u00e1ch ph\u1ea3n \u1ee9ng khi c\u00f3 t\u00edn hi\u1ec7u b\u1ea5t th\u01b0\u1eddng. H\u1ecd th\u01b0\u1eddng mu\u1ed1n th\u1ea5y xu h\u01b0\u1edbng d\u1eef li\u1ec7u, \u0111\u00e1nh gi\u00e1 nguy\u00ean nh\u00e2n g\u1ed1c v\u00e0 chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t l\u1edbp b\u00e1m vi sinh trong \u0111\u01b0\u1eddng \u1ed1ng, ch\u1ee9 kh\u00f4ng ch\u1ec9 m\u1ed9t k\u1ebft qu\u1ea3 \u0111\u1ea1t t\u1ea1i m\u1ed9t th\u1eddi \u0111i\u1ec3m.<\/span><\/p>\n<h3><b>TOC v\u00e0 \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n c\u1ee7a WFI n\u00f3i l\u00ean \u0111i\u1ec1u g\u00ec<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">TOC ph\u1ea3n \u00e1nh t\u1ea1p h\u1eefu c\u01a1, c\u00f2n \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n ph\u1ea3n \u00e1nh t\u1ea1p ion v\u00e0 tr\u1ea1ng th\u00e1i c\u00e2n b\u1eb1ng c\u1ee7a n\u01b0\u1edbc, v\u00ec v\u1eady hai ch\u1ec9 ti\u00eau n\u00e0y th\u01b0\u1eddng gi\u00fap ph\u00e1t hi\u1ec7n h\u1ec7 th\u1ed1ng b\u1eaft \u0111\u1ea7u tr\u01b0\u1ee3t s\u1edbm h\u01a1n khi vi sinh t\u0103ng r\u00f5. Sau b\u1ea3o tr\u00ec, hai ch\u1ec9 ti\u00eau n\u00e0y c\u00f3 th\u1ec3 nh\u00edch nh\u1eb9 do v\u1eadt li\u1ec7u m\u1edbi ho\u1eb7c \u0111i\u1ec1u ki\u1ec7n tr\u00e1ng r\u1eeda ch\u01b0a \u0111\u1ee7, n\u00ean v\u1eabn c\u1ea7n \u0111i\u1ec1u tra theo SOP thay v\u00ec k\u1ebft lu\u1eadn v\u1ed9i.<\/span><\/p>\n<h3><b>V\u00f2ng n\u00f3ng v\u00e0 v\u00f2ng l\u1ea1nh kh\u00e1c nhau ra sao<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">V\u00f2ng n\u00f3ng v\u1eadn h\u00e0nh \u1edf nhi\u1ec7t \u0111\u1ed9 cao \u0111\u1ec3 h\u1ea1n ch\u1ebf vi sinh, c\u00f2n v\u00f2ng l\u1ea1nh v\u1eadn h\u00e0nh th\u1ea5p h\u01a1n v\u00e0 d\u1ef1a nhi\u1ec1u v\u00e0o kh\u1eed tr\u00f9ng \u0111\u1ecbnh k\u1ef3, thi\u1ebft k\u1ebf v\u00e0 gi\u00e1m s\u00e1t \u0111\u1ec3 gi\u1eef t\u1ea3i khu\u1ea9n \u1ed5n \u0111\u1ecbnh. L\u1ef1a ch\u1ecdn ph\u00f9 h\u1ee3p c\u1ea7n d\u1ef1a tr\u00ean \u0111\u00e1nh gi\u00e1 r\u1ee7i ro v\u00e0 d\u1eef li\u1ec7u v\u1eadn h\u00e0nh c\u1ee7a nh\u00e0 m\u00e1y, v\u00ec v\u00f2ng n\u00f3ng kh\u00f4ng m\u1eb7c \u0111\u1ecbnh t\u1ed1i \u01b0u n\u1ebfu x\u00e9t c\u1ea3 n\u0103ng l\u01b0\u1ee3ng, v\u1eadt li\u1ec7u v\u00e0 \u0111\u1ed9 b\u1ec1n v\u1eadn h\u00e0nh.<\/span><\/p>\n<h3><b>OOS v\u00e0 OOT n\u01b0\u1edbc WFI x\u1eed l\u00fd th\u1ebf n\u00e0o cho \u0111\u00fang<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Khi g\u1eb7p OOT, b\u1ea1n n\u00ean \u01b0u ti\u00ean ki\u1ec3m tra thao t\u00e1c l\u1ea5y m\u1eabu, \u0111i\u1ec1u ki\u1ec7n x\u1ea3 tr\u01b0\u1edbc v\u00e0 t\u00ecnh tr\u1ea1ng kh\u1eed tr\u00f9ng \u0111i\u1ec3m l\u1ea5y m\u1eabu, v\u00ec l\u1ec7ch xu h\u01b0\u1edbng r\u1ea5t th\u01b0\u1eddng \u0111\u1ebfn t\u1eeb thao t\u00e1c ho\u1eb7c \u0111i\u1ec1u ki\u1ec7n l\u1ea5y m\u1eabu kh\u00f4ng nh\u1ea5t qu\u00e1n. Khi g\u1eb7p OOS, c\u1ea7n k\u00edch ho\u1ea1t h\u1ed3 s\u01a1 sai l\u1ec7ch v\u00e0 \u0111\u00e1nh gi\u00e1 \u1ea3nh h\u01b0\u1edfng t\u1edbi l\u00f4 theo SOP, \u0111\u1ed3ng th\u1eddi khoanh v\u00f9ng \u0111i\u1ec3m d\u00f9ng \u0111\u1ec3 ki\u1ec3m so\u00e1t r\u1ee7i ro thay v\u00ec ch\u1ec9 l\u1ea5y m\u1eabu l\u1ea1i nhi\u1ec1u l\u1ea7n.<\/span><\/p>\n<h2><b>K\u1ebft lu\u1eadn<\/b><\/h2>\n<p><span style=\"font-weight: 400;\"><strong><a href=\"https:\/\/sepro.vn\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/\">N\u01b0\u1edbc WFI<\/a><\/strong> l\u00e0 g\u00ec kh\u00f4ng ch\u1ec9 l\u00e0 \u0111\u1ecbnh ngh\u0129a trong d\u01b0\u1ee3c \u0111i\u1ec3n m\u00e0 c\u00f2n l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng v\u00e0 m\u1ed9t th\u00f3i quen qu\u1ea3n tr\u1ecb r\u1ee7i ro, b\u1eaft \u0111\u1ea7u t\u1eeb thi\u1ebft k\u1ebf v\u00f2ng tu\u1ea7n ho\u00e0n, kh\u1eed tr\u00f9ng, l\u1ea5y m\u1eabu \u0111\u1ebfn theo d\u00f5i xu h\u01b0\u1edbng v\u00e0 ph\u1ea3n \u1ee9ng OOT, OOS theo SOP c\u1ee7a nh\u00e0 m\u00e1y. N\u1ebfu b\u1ea1n \u0111ang r\u00e0 so\u00e1t h\u1ec7 th\u1ed1ng, c\u00e1ch \u0111i hi\u1ec7u qu\u1ea3 th\u01b0\u1eddng l\u00e0 b\u1eaft \u0111\u1ea7u t\u1eeb xu h\u01b0\u1edbng d\u1eef li\u1ec7u v\u00e0 c\u00e1c \u0111i\u1ec3m l\u1ea5y m\u1eabu hay g\u00e2y tranh c\u00e3i r\u1ed3i m\u1edbi quay l\u1ea1i c\u00e2u chuy\u1ec7n c\u00f4ng ngh\u1ec7 t\u1ea1o n\u01b0\u1edbc, v\u00ec d\u1eef li\u1ec7u v\u1eadn h\u00e0nh m\u1edbi l\u00e0 th\u1ee9 tr\u1ea3 l\u1eddi \u0111\u00fang nh\u1ea5t.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>C\u00f3 nh\u1eefng ng\u00e0y m\u1ecdi ch\u1ec9 ti\u00eau \u0111\u1ec1u \u0111\u1ea1t, nh\u01b0ng nh\u00ecn bi\u1ec3u \u0111\u1ed3 v\u1eabn th\u1ea5y kh\u00f4ng y\u00ean. WFI l\u00e0 ki\u1ec3u h\u1ec7 th\u1ed1ng nh\u01b0 v\u1eady, nh\u00ecn t\u01b0\u1edfng \u1ed5n m\u00e0 ch\u1ec9 c\u1ea7n m\u1ed9t nh\u00e1nh ch\u1ebft ho\u1eb7c m\u1ed9t thao t\u00e1c l\u1ea5y m\u1eabu l\u1ec7ch l\u00e0 k\u00e9o theo c\u1ea3 chu\u1ed7i \u0111i\u1ec1u tra. B\u00e0i n\u00e0y gom l\u1ea1i nh\u1eefng th\u1ee9 c\u1ea7n nh\u1edb, nh\u1eefng &hellip; <a href=\"https:\/\/sepro.vn\/vi\/nuoc-wfi-la-gi-va-dung-the-nao-trong-nha-may-duoc-gmp\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">N\u01b0\u1edbc WFI L\u00e0 G\u00ec V\u00e0 D\u00f9ng Th\u1ebf N\u00e0o Trong Nh\u00e0 M\u00e1y D\u01b0\u1ee3c GMP<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":9227,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[],"class_list":["post-9216","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"_links":{"self":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9216","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=9216"}],"version-history":[{"count":6,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9216\/revisions"}],"predecessor-version":[{"id":9233,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9216\/revisions\/9233"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9227"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9216"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9216"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9216"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}