{"id":2258,"date":"2026-07-12T00:34:09","date_gmt":"2026-07-11T17:34:09","guid":{"rendered":"https:\/\/inoxcuongthinh.com\/ong-phu-kien-inox-vi-sinh-tieu-chuan-va-lap-dat-khong-moi-chet\/"},"modified":"2026-07-12T00:34:09","modified_gmt":"2026-07-11T17:34:09","slug":"ong-phu-kien-inox-vi-sinh-tieu-chuan-va-lap-dat-khong-moi-chet","status":"publish","type":"post","link":"https:\/\/inoxcuongthinh.com\/ong-phu-kien-inox-vi-sinh-tieu-chuan-va-lap-dat-khong-moi-chet\/","title":{"rendered":"\u1ed0ng &#038; ph\u1ee5 ki\u1ec7n Inox vi sinh: ti\u00eau chu\u1ea9n v\u00e0 l\u1eafp \u0111\u1eb7t kh\u00f4ng m\u1ed1i ch\u1ebft"},"content":{"rendered":"\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-left kksr-valign-top\"\n    data-payload='{&quot;align&quot;:&quot;left&quot;,&quot;id&quot;:&quot;2258&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;top&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;0&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;0&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;\u0110\u00e1nh gi\u00e1&quot;,&quot;legend&quot;:&quot;0\\\/5 - (0 b\u00ecnh ch\u1ecdn)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;\u1ed0ng \\u0026amp; ph\u1ee5 ki\u1ec7n Inox vi sinh: ti\u00eau chu\u1ea9n v\u00e0 l\u1eafp \u0111\u1eb7t kh\u00f4ng m\u1ed1i ch\u1ebft&quot;,&quot;width&quot;:&quot;0&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 0px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            <span class=\"kksr-muted\">\u0110\u00e1nh gi\u00e1<\/span>\n    <\/div>\n    <\/div>\n<div class=\"custom-toc\">\n<h3>N\u1ed9i dung ch\u00ednh<\/h3>\n<ul>\n<li><a href=\"#toc-0-ong-va-phu-kien-inox-vi-sinh-la-gi\">\u1ed0ng v\u00e0 ph\u1ee5 ki\u1ec7n Inox vi sinh l\u00e0 g\u00ec?<\/a><\/li>\n<li><a href=\"#toc-1-tieu-chuan-ap-dung-quan-trong\">Ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng quan tr\u1ecdng<\/a><\/li>\n<li><a href=\"#toc-2-thiet-ke-khong-moi-chet-hygienicaseptic-design\">Thi\u1ebft k\u1ebf \u201ckh\u00f4ng m\u1ed1i ch\u1ebft\u201d (hygienic\/aseptic design)<\/a><\/li>\n<li><a href=\"#toc-3-ky-thuat-han-vi-sinh-de-khong-moi-chet\">K\u1ef9 thu\u1eadt h\u00e0n vi sinh \u0111\u1ec3 kh\u00f4ng m\u1ed1i ch\u1ebft<\/a><\/li>\n<li><a href=\"#toc-4-lam-sach-thu-dong-hoa-cipsip-va-xac-nhan\">L\u00e0m s\u1ea1ch, th\u1ee5 \u0111\u1ed9ng h\u00f3a, CIP\/SIP v\u00e0 x\u00e1c nh\u1eadn<\/a><\/li>\n<li><a href=\"#toc-5-nhung-loi-pho-bien-tao-moi-chet-va-cach-khac-phuc\">Nh\u1eefng l\u1ed7i ph\u1ed5 bi\u1ebfn t\u1ea1o \u201cm\u1ed1i ch\u1ebft\u201d v\u00e0 c\u00e1ch kh\u1eafc ph\u1ee5c<\/a><\/li>\n<li><a href=\"#toc-6-yeu-cau-dien-hinh-thuc-pham-vs-duocy-te\">Y\u00eau c\u1ea7u \u0111i\u1ec3n h\u00ecnh: Th\u1ef1c ph\u1ea9m vs. D\u01b0\u1ee3c\/Y t\u1ebf<\/a><\/li>\n<li><a href=\"#toc-7-checklist-thi-cong-va-nghiem-thu-he-thong-inox-vi-\">Checklist thi c\u00f4ng v\u00e0 nghi\u1ec7m thu h\u1ec7 th\u1ed1ng Inox vi sinh<\/a><\/li>\n<li><a href=\"#toc-8-goi-y-lua-chon-ong-phu-kien-pho-bien-tai-viet-nam\">G\u1ee3i \u00fd l\u1ef1a ch\u1ecdn \u1ed1ng &#038; ph\u1ee5 ki\u1ec7n ph\u1ed5 bi\u1ebfn t\u1ea1i Vi\u1ec7t Nam<\/a><\/li>\n<li><a href=\"#toc-9-faq-ngan\">FAQ ng\u1eafn<\/a><\/li>\n<li><a href=\"#toc-10-tai-lieu-tham-khao\">T\u00e0i li\u1ec7u tham kh\u1ea3o<\/a><\/li>\n<\/ul>\n<\/div>\n<p>Trong c\u00e1c ng\u00e0nh C\u00f4ng nghi\u1ec7p S\u1ea1ch nh\u01b0 th\u1ef1c ph\u1ea9m, y t\u1ebf v\u00e0 d\u01b0\u1ee3c ph\u1ea9m, \u1ed1ng v\u00e0 ph\u1ee5 ki\u1ec7n Inox vi sinh ph\u1ea3i \u0111\u1ea1t chu\u1ea9n v\u1ec7 sinh cao v\u00e0 thi\u1ebft k\u1ebf \u201ckh\u00f4ng m\u1ed1i ch\u1ebft\u201d \u0111\u1ec3 l\u00e0m s\u1ea1ch\/s\u00e1t khu\u1ea9n hi\u1ec7u qu\u1ea3. B\u00e0i vi\u1ebft n\u00e0y cung c\u1ea5p ti\u00eau chu\u1ea9n k\u1ef9 thu\u1eadt c\u1ed1t l\u00f5i, c\u00e1ch l\u1ef1a ch\u1ecdn v\u1eadt li\u1ec7u\/b\u1ec1 m\u1eb7t v\u00e0 quy tr\u00ecnh l\u1eafp \u0111\u1eb7t, h\u00e0n vi sinh \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o h\u1ec7 th\u1ed1ng v\u1eadn h\u00e0nh an to\u00e0n, b\u1ec1n v\u00e0 tu\u00e2n th\u1ee7.<\/p>\n<h2 id=\"toc-0-ong-va-phu-kien-inox-vi-sinh-la-gi\">\u1ed0ng v\u00e0 ph\u1ee5 ki\u1ec7n Inox vi sinh l\u00e0 g\u00ec?<\/h2>\n<p>&#8211; \u1ed0ng vi sinh (sanitary\/hygienic tubing): \u1ed0ng Inox h\u00e0n ho\u1eb7c k\u00e9o ngu\u1ed9i c\u00f3 b\u1ec1 m\u1eb7t trong\/ngo\u00e0i nh\u1eb5n, kh\u00f4ng r\u1ed7, k\u00edch th\u01b0\u1edbc ch\u00ednh x\u00e1c, chuy\u00ean cho m\u00f4i tr\u01b0\u1eddng y\u00eau c\u1ea7u v\u1ec7 sinh cao.<br \/>\n&#8211; Ph\u1ee5 ki\u1ec7n vi sinh: c\u00fat, t\u00ea, co, gi\u1ea3m, clamp, ferrule, n\u1eafp, van m\u00e0ng\/van l\u1ea5y m\u1eabu, ph\u1ee5 ki\u1ec7n \u0111o\u2026 thi\u1ebft k\u1ebf h\u1ea1n ch\u1ebf khe k\u1ebd v\u00e0 d\u1ec5 v\u1ec7 sinh.<br \/>\n&#8211; M\u1ee5c ti\u00eau: D\u1eabn truy\u1ec1n s\u1ea3n ph\u1ea9m v\u00e0 m\u00f4i ch\u1ea5t CIP\/SIP m\u00e0 kh\u00f4ng gi\u1eef c\u1eb7n (no product hold-up), kh\u00f4ng t\u1ea1o \u201cm\u1ed1i ch\u1ebft\u201d\/dead leg.<\/p>\n<h2 id=\"toc-1-tieu-chuan-ap-dung-quan-trong\">Ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng quan tr\u1ecdng<\/h2>\n<h3>V\u1eadt li\u1ec7u v\u00e0 k\u00edch th\u01b0\u1edbc<\/h3>\n<p>&#8211; M\u00e1c th\u00e9p: 304\/304L v\u00e0 316L l\u00e0 ph\u1ed5 bi\u1ebfn; 316L \u01b0u ti\u00ean cho d\u01b0\u1ee3c\/y t\u1ebf v\u00e0 m\u00f4i tr\u01b0\u1eddng chloride nh\u1edd ch\u1ed1ng \u0103n m\u00f2n k\u1ebd n\u1ee9t t\u1ed1t h\u01a1n (PREN cao h\u01a1n).<br \/>\n&#8211; Ti\u00eau chu\u1ea9n \u1ed1ng:<br \/>\n  &#8211; ASTM A270 (sanitary tubing), t\u00f9y ch\u1ecdn S2 cho \u0111\u00e1nh b\u00f3ng t\u0103ng c\u01b0\u1eddng.<br \/>\n  &#8211; ASME BPE (Bioprocessing Equipment) \u2013 quy \u0111\u1ecbnh chi ti\u1ebft k\u00edch th\u01b0\u1edbc, dung sai v\u00e0 ho\u00e0n thi\u1ec7n b\u1ec1 m\u1eb7t cho sinh d\u01b0\u1ee3c.<br \/>\n  &#8211; EN 10357 (thay DIN 11850), ISO 2037 cho th\u1ecb tr\u01b0\u1eddng EU; DIN 11866 li\u00ean k\u1ebft BPE\/ISO\/DIN theo series A\/B\/C.<br \/>\n&#8211; Ch\u1ee9ng ch\u1ec9: EN 10204 3.1 (truy xu\u1ea5t nhi\u1ec7t luy\u1ec7n\/m\u1ebb), PMI khi c\u1ea7n.<br \/>\n&#8211; \u0110\u1ed9 d\u00e0y v\u00e0 \u0111\u01b0\u1eddng k\u00ednh: series inch (1\/2&#8243;\u20134&#8243;) v\u00e0 metric (DN10\u2013DN100) v\u1edbi th\u00e0nh m\u1ecfng \u0111\u1ec3 d\u1ec5 l\u00e0m s\u1ea1ch, truy\u1ec1n nhi\u1ec7t t\u1ed1t.<\/p>\n<p>Ngu\u1ed3n: ASTM A270; ASME BPE; EN 10357\/ISO 2037.<\/p>\n<h3>B\u1ec1 m\u1eb7t ho\u00e0n thi\u1ec7n (Ra) v\u00e0 l\u1edbp th\u1ee5 \u0111\u1ed9ng<\/h3>\n<p>&#8211; Th\u1ef1c ph\u1ea9m\/\u0111\u1ed3 u\u1ed1ng: Ra \u2264 0,8 \u00b5m th\u01b0\u1eddng \u0111\u1ee7; nhi\u1ec1u nh\u00e0 m\u00e1y ch\u1ecdn 0,6 \u00b5m \u0111\u1ec3 t\u0103ng bi\u00ean an to\u00e0n.<br \/>\n&#8211; D\u01b0\u1ee3c\/y t\u1ebf: theo ASME BPE, c\u00e1c h\u1ea1ng SF (SF1\u2026SF6). Ph\u1ed5 bi\u1ebfn:<br \/>\n  &#8211; SF1: c\u01a1 kh\u00ed \u0111\u00e1nh b\u00f3ng Ra \u2264 0,51 \u00b5m (20 \u00b5in).<br \/>\n  &#8211; SF4: \u0111i\u1ec7n ho\u00e1 (EP) Ra \u2264 0,38 \u00b5m (15 \u00b5in).<br \/>\n&#8211; B\u1eaft bu\u1ed9c t\u1ea9y g\u1ec9 &#038; th\u1ee5 \u0111\u1ed9ng h\u00f3a theo ASTM A380\/A967 \u0111\u1ec3 t\u00e1i t\u1ea1o l\u1edbp oxit Cr b\u1ea3o v\u1ec7 sau gia c\u00f4ng\/h\u00e0n.<\/p>\n<p>Ngu\u1ed3n: ASME BPE; ASTM A380\/A967.<\/p>\n<h3>K\u1ebft n\u1ed1i v\u00e0 gio\u0103ng<\/h3>\n<p>&#8211; K\u1ebft n\u1ed1i clamp (Tri-Clamp\/Tri-Clover) theo 3-A SSI, ASME BPE; clamp hai m\u1ea3nh\/ba m\u1ea3nh.<br \/>\n&#8211; K\u1ebft n\u1ed1i v\u00f4 tr\u00f9ng DIN 11864-3 (h\u00ecnh n\u00f3n\/flat) cho ti\u1ec7t tr\u00f9ng cao.<br \/>\n&#8211; Gio\u0103ng: EPDM, FKM (Viton), PTFE, silicone platinum-cured. Ch\u1ee9ng nh\u1eadn:<br \/>\n  &#8211; FDA 21 CFR 177.2600 (ti\u1ebfp x\u00fac th\u1ef1c ph\u1ea9m).<br \/>\n  &#8211; USP Class VI (d\u01b0\u1ee3c), EU 1935\/2004.<br \/>\n&#8211; Ch\u1ecdn gio\u0103ng theo h\u00f3a ch\u1ea5t CIP\/SIP, nhi\u1ec7t \u0111\u1ed9, v\u00e0 th\u1ea9m th\u1ea5u h\u01a1i.<\/p>\n<p>Ngu\u1ed3n: 3-A Sanitary Standards; DIN 11864; FDA 21 CFR 177.2600.<\/p>\n<h2 id=\"toc-2-thiet-ke-khong-moi-chet-hygienicaseptic-design\">Thi\u1ebft k\u1ebf \u201ckh\u00f4ng m\u1ed1i ch\u1ebft\u201d (hygienic\/aseptic design)<\/h2>\n<p>\u201cM\u1ed1i ch\u1ebft\u201d\/dead leg l\u00e0 v\u00f9ng l\u01b0u ch\u1ea5t \u00edt\/kh\u00f4ng ch\u1ea3y qua \u2014 n\u01a1i c\u1eb7n v\u00e0 vi sinh t\u00edch t\u1ee5, CIP\/SIP kh\u00f3 ti\u1ebfp c\u1eadn.<\/p>\n<h3>T\u1ef7 l\u1ec7 dead leg (L\/D)<\/h3>\n<p>&#8211; Theo ASME BPE: chi\u1ec1u d\u00e0i nh\u00e1nh im l\u1eb7ng (LB) t\u1eeb th\u00e0nh \u1ed1ng ch\u00ednh \u0111\u1ebfn \u0111i\u1ec3m b\u1ecbt\/gh\u1ebf van kh\u00f4ng v\u01b0\u1ee3t qu\u00e1 2 l\u1ea7n \u0111\u01b0\u1eddng k\u00ednh trong (LB\/ID \u2264 2) v\u1edbi h\u1ec7 th\u1ed1ng y\u00eau c\u1ea7u tho\u00e1t s\u1ea1ch\/CIP\/SIP.<br \/>\n&#8211; EHEDG th\u01b0\u1eddng khuy\u1ebfn ngh\u1ecb nghi\u00eam ng\u1eb7t h\u01a1n (t\u1edbi 1,5D) \u1edf \u1ee9ng d\u1ee5ng th\u1ef1c ph\u1ea9m \u0111\u1ed9 r\u1ee7i ro cao.<br \/>\n&#8211; Th\u1ef1c h\u00e0nh t\u1ea1i Vi\u1ec7t Nam: \u00e1p d\u1ee5ng \u2264 2D cho \u0111a s\u1ed1, \u2264 1,5D cho d\u01b0\u1ee3c\/v\u1ecb tr\u00ed nh\u1ea1y (l\u1ea5y m\u1eabu, \u0111o l\u01b0\u1eddng).<\/p>\n<p>Ngu\u1ed3n: ASME BPE; EHEDG Doc. 8\/13.<\/p>\n<h3>\u0110\u1ed9 d\u1ed1c v\u00e0 kh\u1ea3 n\u0103ng t\u1ef1 tho\u00e1t (drainability)<\/h3>\n<p>&#8211; \u0110\u1ed9 d\u1ed1c t\u1ed1i thi\u1ec3u: 1:100 (1%) theo ASME BPE cho c\u00e1c \u0111\u01b0\u1eddng c\u1ea7n t\u1ef1 tho\u00e1t; c\u00f3 th\u1ec3 2% v\u1edbi s\u1ea3n ph\u1ea9m nh\u1edbt.<br \/>\n&#8211; H\u01b0\u1edbng d\u1ed1c v\u1ec1 \u0111i\u1ec3m x\u1ea3 th\u1ea5p nh\u1ea5t; tr\u00e1nh \u0111o\u1ea1n l\u01b0ng l\u1ea1c \u0111\u00e0. Elbow d\u00e0i (LR) gi\u00fap tho\u00e1t t\u1ed1t.<br \/>\n&#8211; B\u1ed1 tr\u00ed vent\/x\u1ea3 t\u1ea1i \u0111i\u1ec3m cao\/th\u1ea5p, kh\u00f4ng \u0111\u1ec3 t\u00fai n\u01b0\u1edbc \u0111\u1ecdng sau SIP.<\/p>\n<h3>B\u1ed1 tr\u00ed nh\u00e1nh, co gi\u1ea3m, tee<\/h3>\n<p>&#8211; \u01afu ti\u00ean t\u00ea ch\u1ea1c 45\u00b0 (lateral) thay v\u00ec t\u00ea vu\u00f4ng 90\u00b0 \u0111\u1ec3 gi\u1ea3m v\u00f9ng t\u00f9 \u0111\u1ecdng.<br \/>\n&#8211; D\u00f9ng co gi\u1ea3m \u0111\u1ed3ng t\u00e2m tr\u00ean \u0111o\u1ea1n \u0111\u1ee9ng v\u00e0 l\u1ec7ch t\u00e2m (c\u1ea1nh ph\u1eb3ng \u1edf \u0111\u00e1y) tr\u00ean \u0111o\u1ea1n ngang theo h\u01b0\u1edbng d\u00f2ng ch\u1ea3y.<br \/>\n&#8211; Tr\u00e1nh ren trong; n\u1ebfu b\u1eaft bu\u1ed9c, d\u00f9ng ren v\u1ec7 sinh v\u1edbi ch\u1ea5t b\u1ecbt t\u01b0\u01a1ng th\u00edch FDA v\u00e0 kh\u1ea3 n\u0103ng th\u00e1o r\u1eeda.<\/p>\n<h3>Van v\u00e0 thi\u1ebft b\u1ecb \u0111o l\u01b0\u1eddng<\/h3>\n<p>&#8211; Van m\u00e0ng (diaphragm) th\u00e2n r\u00e3nh, gh\u1ebf van s\u00e1t \u0111\u01b0\u1eddng ch\u00ednh, l\u1eafp theo h\u01b0\u1edbng t\u1ef1 tho\u00e1t.<br \/>\n&#8211; C\u1ea3m bi\u1ebfn (nhi\u1ec7t \u0111\u1ed9, \u00e1p, pH, d\u1eabn \u0111i\u1ec7n) d\u00f9ng c\u1ed5ng aseptic, tee ng\u1eafn L\/D \u0111\u1ea1t chu\u1ea9n; m\u1eb7t \u0111o ch\u00eca v\u00e0o d\u00f2ng ch\u00ednh.<br \/>\n&#8211; \u0110i\u1ec3m l\u1ea5y m\u1eabu n\u00ean d\u00f9ng van aseptic, chi\u1ec1u d\u00e0i ng\u1eafn, g\u1ea7n \u0111\u01b0\u1eddng ch\u00ednh.<\/p>\n<h3>Gi\u00e1 \u0111\u1ee1, gi\u00e3n n\u1edf nhi\u1ec7t v\u00e0 v\u1eadt li\u1ec7u ph\u1ee5<\/h3>\n<p>&#8211; K\u1eb9p\/treo v\u1ec7 sinh (h\u1edf, kh\u00f4ng t\u00edch t\u1ee5), kho\u1ea3ng c\u00e1ch 1\u20131,5 m t\u00f9y DN.<br \/>\n&#8211; Ch\u00e8n Teflon\/nh\u1ef1a v\u1ec7 sinh t\u1ea1i g\u1ed1i \u0111\u1ee1 \u0111\u1ec3 gi\u1ea3m k\u1ebd k\u1eb9t v\u00e0 \u0103n m\u00f2n k\u1ebd.<br \/>\n&#8211; B\u1ed1 tr\u00ed kh\u1edbp gi\u00e3n n\u1edf\/khe b\u00f9 tr\u00ean tuy\u1ebfn d\u00e0i, v\u1eabn gi\u1eef \u0111\u1ed9 d\u1ed1c y\u00eau c\u1ea7u.<\/p>\n<h2 id=\"toc-3-ky-thuat-han-vi-sinh-de-khong-moi-chet\">K\u1ef9 thu\u1eadt h\u00e0n vi sinh \u0111\u1ec3 kh\u00f4ng m\u1ed1i ch\u1ebft<\/h2>\n<p>M\u1ed1i h\u00e0n l\u00e0 n\u01a1i r\u1ee7i ro cao v\u1ec1 b\u00e1m c\u1eb7n v\u00e0 \u0103n m\u00f2n. H\u00e0n \u0111\u00fang chu\u1ea9n quy\u1ebft \u0111\u1ecbnh th\u00e0nh c\u00f4ng h\u1ec7 th\u1ed1ng.<\/p>\n<h3>Nguy\u00ean t\u1eafc h\u00e0n<\/h3>\n<p>&#8211; Quy tr\u00ecnh: GTAW\/TIG t\u1ef1 ch\u1ea3y (autogenous) ho\u1eb7c h\u00e0n orbital cho \u1ed1ng m\u1ecfng; h\u00e0n tay ch\u1ec9 d\u00f9ng khi kh\u00f4ng th\u1ec3 orbital.<br \/>\n&#8211; B\u1ea3o v\u1ec7 m\u1eb7t trong b\u1eb1ng kh\u00ed tr\u01a1 (argon) v\u1edbi ki\u1ec3m so\u00e1t O2 d\u01b0 < 50 ppm; nhi\u1ec1u nh\u00e0 m\u00e1y d\u01b0\u1ee3c \u0111\u1eb7t m\u1ee5c ti\u00eau 10\u201320 ppm.\n- Ki\u1ec3m so\u00e1t nhi\u1ec7t v\u00e0o \u0111\u1ec3 h\u1ea1n ch\u1ebf v\u00f9ng \u1ea3nh h\u01b0\u1edfng nhi\u1ec7t (HAZ) v\u00e0 \u0111\u1ed5i m\u00e0u. M\u00e0u r\u01a1m nh\u1ea1t l\u00e0 ch\u1ea5p nh\u1eadn; xanh t\u00edm\/\u0111en l\u00e0 oxy h\u00f3a qu\u00e1 m\u1ee9c c\u1ea7n x\u1eed l\u00fd l\u1ea1i.\n- D\u1ee5ng c\u1ee5: tungsten 2% lanthanated, g\u00f3c m\u00e0i nh\u1ea5t qu\u00e1n; backing\/purge dam chuy\u00ean d\u1ee5ng.\n\nNgu\u1ed3n: ASME BPE (y\u00eau c\u1ea7u m\u1ed1i h\u00e0n v\u00e0 m\u00e0u), nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb h\u00e0n orbital.\n\n\n\n<h3>Quy tr\u00ecnh h\u00e0n m\u1eabu t\u1eebng b\u01b0\u1edbc<\/h3>\n<p>1) Chu\u1ea9n b\u1ecb:<br \/>\n&#8211; Ki\u1ec3m tra ch\u1ee9ng ch\u1ec9 3.1, v\u1ec7 sinh b\u1eb1ng dung d\u1ecbch kh\u00f4ng clo, lau isopropanol.<br \/>\n&#8211; C\u1eaft l\u1ea1nh, v\u00e1t m\u00e9p ch\u00ednh x\u00e1c; sai l\u1ec7ch c\u0103n ch\u1ec9nh \u2264 10% \u0111\u1ed9 d\u00e0y th\u00e0nh.<br \/>\n2) L\u1eafp gh\u00e9p &#038; \u0111\u00ednh:<br \/>\n&#8211; D\u00f9ng clamp\/alignment tool; tr\u00e1nh khe h\u1edf g\u1edd trong.<br \/>\n&#8211; Ni\u00eam k\u00edn hai \u0111\u1ea7u v\u00e0 \u0111\u1eb7t \u0111\u01b0\u1eddng kh\u00ed purge; \u0111o O2 online, \u1ed5n \u0111\u1ecbnh < ng\u01b0\u1ee1ng r\u1ed3i m\u1edbi m\u1ed3i h\u1ed3 quang.\n3) H\u00e0n:\n- Orbital: theo WPS t\u01b0\u01a1ng \u1ee9ng k\u00edch c\u1ee1\/th\u00e0nh \u1ed1ng; ghi log.\n- H\u00e0n tay: d\u00f2ng th\u1ea5p, h\u1ed3 quang ng\u1eafn, d\u00e2y \u0111\u1ea9y t\u1ed1i thi\u1ec3u (\u01b0u ti\u00ean autogenous).\n4) L\u00e0m s\u1ea1ch sau h\u00e0n:\n- T\u1ea9y g\u1ec9 ch\u1ecdn l\u1ecdc m\u1ed1i h\u00e0n (pickle) r\u1ed3i th\u1ee5 \u0111\u1ed9ng ho\u00e1 (ASTM A380\/A967).\n- R\u1eeda si\u00eau s\u1ea1ch, s\u1ea5y kh\u00f4 b\u1eb1ng kh\u00ed s\u1ea1ch (ISO 8573-1 Class 1).\n\n\n\n<h3>Ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng m\u1ed1i h\u00e0n<\/h3>\n<p>&#8211; N\u1ed9i soi (borescope) 100% c\u00e1c m\u1ed1i h\u00e0n s\u1ea3n ph\u1ea9m ch\u00ednh; l\u01b0u \u1ea3nh.<br \/>\n&#8211; \u0110o nh\u00e1m b\u1ec1 m\u1eb7t c\u1ee5c b\u1ed9 khi y\u00eau c\u1ea7u (\u0111\u1eb7c bi\u1ec7t h\u1ec7 d\u01b0\u1ee3c EP).<br \/>\n&#8211; Ki\u1ec3m tra th\u1ea9m th\u1ea5u m\u00e0u ch\u1ec9 d\u00f9ng khi quy \u0111\u1ecbnh v\u00e0 c\u00f3 quy tr\u00ecnh l\u00e0m s\u1ea1ch lo\u1ea1i b\u1ecf d\u01b0 l\u01b0\u1ee3ng.<br \/>\n&#8211; H\u1ed3 s\u01a1: WPS\/PQR, ch\u1ee9ng ch\u1ec9 th\u1ee3 h\u00e0n, log O2, b\u1ea3n \u0111\u1ed3 m\u1ed1i h\u00e0n, bi\u00ean b\u1ea3n QC.<\/p>\n<h2 id=\"toc-4-lam-sach-thu-dong-hoa-cipsip-va-xac-nhan\">L\u00e0m s\u1ea1ch, th\u1ee5 \u0111\u1ed9ng h\u00f3a, CIP\/SIP v\u00e0 x\u00e1c nh\u1eadn<\/h2>\n<p>&#8211; T\u1ea9y d\u1ea7u, t\u1ea9y g\u1ec9 v\u00e0 th\u1ee5 \u0111\u1ed9ng: tu\u00e2n ASTM A380\/A967. Tr\u00e1nh h\u00f3a ch\u1ea5t ch\u1ee9a chloride.<br \/>\n&#8211; CIP tham kh\u1ea3o:<br \/>\n  &#8211; Bazo (NaOH 1\u20132%) 70\u201385\u00b0C, 20\u201345 ph\u00fat t\u00f9y b\u1ea9n h\u1eefu c\u01a1.<br \/>\n  &#8211; Axit (HNO3\/H3PO4 nh\u1eb9) 50\u201370\u00b0C, 10\u201320 ph\u00fat \u0111\u1ec3 lo\u1ea1i v\u00f4 c\u01a1\/\u0111\u00e1 v\u00f4i.<br \/>\n&#8211; SIP: h\u01a1i b\u00e3o h\u00f2a 121\u00b0C \u2265 30 ph\u00fat ho\u1eb7c theo F0 y\u00eau c\u1ea7u. \u0110\u1ea3m b\u1ea3o tho\u00e1t n\u01b0\u1edbc ho\u00e0n to\u00e0n tr\u01b0\u1edbc SIP.<br \/>\n&#8211; X\u00e1c nh\u1eadn: ki\u1ec3m tra \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n \u0111\u1ea7u\/cu\u1ed1i, ATP\/vi sinh b\u1ec1 m\u1eb7t, endotoxin (d\u01b0\u1ee3c), th\u1eed \u00e1p v\u00e0 ki\u1ec3m tra r\u00f2.<\/p>\n<p>Ngu\u1ed3n: 3-A SSI; ISPE Baseline; th\u00f4ng l\u1ec7 CIP\/SIP c\u00f4ng nghi\u1ec7p.<\/p>\n<h2 id=\"toc-5-nhung-loi-pho-bien-tao-moi-chet-va-cach-khac-phuc\">Nh\u1eefng l\u1ed7i ph\u1ed5 bi\u1ebfn t\u1ea1o \u201cm\u1ed1i ch\u1ebft\u201d v\u00e0 c\u00e1ch kh\u1eafc ph\u1ee5c<\/h2>\n<p>&#8211; Tee nh\u00e1nh d\u00e0i LB\/ID > 2: thay b\u1eb1ng lateral 45\u00b0 ho\u1eb7c r\u00fat ng\u1eafn nh\u00e1nh, \u0111\u1ed5i lo\u1ea1i van m\u00e0ng th\u00e2n r\u00e3nh.<br \/>\n&#8211; \u0110\u1ed9 d\u1ed1c kh\u00f4ng \u0111\u1ee7\/\u0111\u1ee9t \u0111o\u1ea1n: ch\u1ec9nh g\u1ed1i \u0111\u1ee1, ch\u00eam b\u1ed5 sung, t\u00e1i c\u0103n tuy\u1ebfn.<br \/>\n&#8211; Co gi\u1ea3m \u0111\u1ed3ng t\u00e2m \u0111\u1eb7t ngang: \u0111\u1ed5i sang l\u1ec7ch t\u00e2m theo h\u01b0\u1edbng ch\u1ea3y.<br \/>\n&#8211; M\u1ed1i h\u00e0n ch\u00e1y x\u00e9m\/\u0111\u1ed5i m\u00e0u: t\u1ea9y\/EP l\u1ea1i ho\u1eb7c c\u1eaft thay \u0111o\u1ea1n; c\u1ea3i thi\u1ec7n purge\/O2.<br \/>\n&#8211; Gio\u0103ng sai v\u1eadt li\u1ec7u: \u0111\u1ed5i gio\u0103ng \u0111\u1ea1t FDA\/USP ph\u00f9 h\u1ee3p CIP\/SIP.<br \/>\n&#8211; \u0110i\u1ec3m \u0111o\/l\u1ea5y m\u1eabu khu\u1ea5t: thay c\u1ed5ng aseptic ng\u1eafn, \u0111\u01b0a g\u1ea7n d\u00f2ng ch\u00ednh.<\/p>\n<h2 id=\"toc-6-yeu-cau-dien-hinh-thuc-pham-vs-duocy-te\">Y\u00eau c\u1ea7u \u0111i\u1ec3n h\u00ecnh: Th\u1ef1c ph\u1ea9m vs. D\u01b0\u1ee3c\/Y t\u1ebf<\/h2>\n<p>&#8211; B\u1ec1 m\u1eb7t:<br \/>\n  &#8211; Th\u1ef1c ph\u1ea9m: Ra \u2264 0,8 \u00b5m; c\u01a1 kh\u00ed \u0111\u00e1nh b\u00f3ng.<br \/>\n  &#8211; D\u01b0\u1ee3c\/y t\u1ebf: Ra \u2264 0,5 \u00b5m (SF1) ho\u1eb7c EP \u2264 0,38 \u00b5m (SF4).<br \/>\n&#8211; Thi\u1ebft k\u1ebf:<br \/>\n  &#8211; C\u1ea3 hai: L\/D \u2264 2; d\u01b0\u1ee3c \u01b0u ti\u00ean \u2264 1,5D \u1edf \u0111i\u1ec3m nh\u1ea1y.<br \/>\n&#8211; T\u00e0i li\u1ec7u:<br \/>\n  &#8211; Th\u1ef1c ph\u1ea9m: ch\u1ee9ng ch\u1ec9 v\u1eadt li\u1ec7u ch\u00ednh, b\u1ea3n v\u1ebd, ki\u1ec3m tra \u00e1p l\u1ef1c.<br \/>\n  &#8211; D\u01b0\u1ee3c\/y t\u1ebf: \u0111\u1ea7y \u0111\u1ee7 truy xu\u1ea5t 3.1, h\u1ed3 s\u01a1 h\u00e0n, n\u1ed9i soi, log O2, IQ\/OQ\/PQ.<br \/>\n&#8211; V\u1ec7 sinh:<br \/>\n  &#8211; Th\u1ef1c ph\u1ea9m: CIP l\u00e0 ch\u1ee7 y\u1ebfu.<br \/>\n  &#8211; D\u01b0\u1ee3c\/y t\u1ebf: CIP + SIP v\u00e0 x\u00e1c nh\u1eadn vi sinh.<\/p>\n<h2 id=\"toc-7-checklist-thi-cong-va-nghiem-thu-he-thong-inox-vi-\">Checklist thi c\u00f4ng v\u00e0 nghi\u1ec7m thu h\u1ec7 th\u1ed1ng Inox vi sinh<\/h2>\n<p>Thi\u1ebft k\u1ebf:<br \/>\n&#8211; X\u00e1c \u0111\u1ecbnh chu\u1ea9n \u00e1p d\u1ee5ng (ASME BPE\/3-A\/EN 10357), v\u1eadt li\u1ec7u 316L cho d\u01b0\u1ee3c.<br \/>\n&#8211; R\u00e0 so\u00e1t m\u1ecdi nh\u00e1nh theo L\/D, b\u1ed1 tr\u00ed \u0111\u1ed9 d\u1ed1c \u2265 1%.<br \/>\n&#8211; Ch\u1ecdn van, c\u1ed5ng \u0111o aseptic, co gi\u1ea3m \u0111\u00fang v\u1ecb tr\u00ed.<\/p>\n<p>V\u1eadt t\u01b0:<br \/>\n&#8211; \u1ed0ng\/ph\u1ee5 ki\u1ec7n c\u00f3 ch\u1ee9ng ch\u1ec9 EN 10204 3.1; b\u1ec1 m\u1eb7t \u0111\u1ea1t Ra m\u1ee5c ti\u00eau.<br \/>\n&#8211; Gio\u0103ng \u0111\u1ea1t FDA\/USP; clamp\/ph\u1ee5 ki\u1ec7n \u0111\u1ed3ng b\u1ed9 chu\u1ea9n.<\/p>\n<p>Thi c\u00f4ng:<br \/>\n&#8211; C\u1eaft, c\u0103n \u0111\u1ed3ng t\u00e2m; purge O2 < 50 ppm; h\u00e0n orbital \u01b0u ti\u00ean.\n- T\u1ea9y g\u1ec9\/th\u1ee5 \u0111\u1ed9ng; l\u00e0m s\u1ea1ch h\u1ea1t m\u00e0i, d\u1ea7u m\u1ee1.\n\nNghi\u1ec7m thu:\n- Borescope 100%; th\u1eed \u00e1p\/l\u1ec7ch ch\u00e2n kh\u00f4ng n\u1ebfu y\u00eau c\u1ea7u.\n- Ki\u1ec3m tra \u0111\u1ed9 d\u1ed1c, \u0111i\u1ec3m x\u1ea3\/vent; t\u00e0i li\u1ec7u ho\u00e0n c\u00f4ng \u0111\u1ea7y \u0111\u1ee7.\n\n\n\n<h2 id=\"toc-8-goi-y-lua-chon-ong-phu-kien-pho-bien-tai-viet-nam\">G\u1ee3i \u00fd l\u1ef1a ch\u1ecdn \u1ed1ng &#038; ph\u1ee5 ki\u1ec7n ph\u1ed5 bi\u1ebfn t\u1ea1i Vi\u1ec7t Nam<\/h2>\n<p>&#8211; \u1ed0ng 316L ASTM A270\/ASME BPE OD 1&#8243;\u20133&#8243;, WT 1,5\u20132,0 mm; ho\u00e0n thi\u1ec7n SF1 ho\u1eb7c EP cho d\u01b0\u1ee3c.<br \/>\n&#8211; Ph\u1ee5 ki\u1ec7n clamp 1,5&#8243;\/2&#8243;\/3&#8243;, ferrule d\u00e0i, c\u00fat LR 90\u00b0\/45\u00b0, tee lateral 45\u00b0, co gi\u1ea3m l\u1ec7ch t\u00e2m.<br \/>\n&#8211; Van m\u00e0ng th\u00e2n r\u00e3nh DN15\u2013DN50, n\u1eafp l\u1ea5y m\u1eabu aseptic.<br \/>\n&#8211; Gio\u0103ng EPDM \u0111en cho CIP ki\u1ec1m; PTFE ho\u1eb7c FKM cho nhi\u1ec7t\/ho\u00e1 ch\u1ea5t m\u1ea1nh; silicone platinum cho y t\u1ebf.<\/p>\n<h2 id=\"toc-9-faq-ngan\">FAQ ng\u1eafn<\/h2>\n<p>&#8211; Khi n\u00e0o b\u1eaft bu\u1ed9c d\u00f9ng 316L? Khi c\u00f3 SIP, ho\u00e1 ch\u1ea5t \u0103n m\u00f2n, ho\u1eb7c y\u00eau c\u1ea7u d\u01b0\u1ee3c\/y t\u1ebf; 316L b\u1ec1n pitting\/cloride h\u01a1n 304L.<br \/>\n&#8211; C\u00f3 c\u1ea7n EP cho m\u1ecdi tuy\u1ebfn? Kh\u00f4ng. EP \u01b0u ti\u00ean cho ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c nh\u1ea1y. Khu v\u1ef1c CIP h\u1ed3i l\u01b0u c\u00f3 th\u1ec3 d\u00f9ng SF1 n\u1ebfu \u0111\u00e1nh gi\u00e1 r\u1ee7i ro cho ph\u00e9p.<br \/>\n&#8211; T\u1ef7 l\u1ec7 d\u1ed1c 1% c\u00f3 \u0111\u1ee7 cho s\u1ea3n ph\u1ea9m nh\u1edbt? V\u1edbi nh\u1edbt cao c\u00f3 th\u1ec3 c\u1ea7n 1,5\u20132% v\u00e0 t\u0103ng v\u1eadn t\u1ed1c d\u00f2ng \u0111\u1ec3 cu\u1ed1n tr\u00f4i.<\/p>\n<h2 id=\"toc-10-tai-lieu-tham-khao\">T\u00e0i li\u1ec7u tham kh\u1ea3o<\/h2>\n<p>&#8211; ASME BPE: Bioprocessing Equipment Standard (2022\/2023). asme.org<br \/>\n&#8211; ASTM A270: Standard Specification for Seamless and Welded Austenitic Stainless Steel Sanitary Tubing. astm.org<br \/>\n&#8211; ASTM A380\/A967: Cleaning, Descaling, and Passivation of Stainless Steel. astm.org<br \/>\n&#8211; EN 10357; ISO 2037; DIN 11866\/11864 (k\u1ebft n\u1ed1i aseptic). din.de, iso.org<br \/>\n&#8211; 3-A Sanitary Standards (Clamp fittings, sanitary design guidance). 3-a.org<br \/>\n&#8211; EHEDG Guidelines (Doc 8, Doc 13): Hygienic Equipment Design. ehedg.org<br \/>\n&#8211; FDA 21 CFR 177.2600 (Elastomers for food contact). ecfr.gov<br \/>\n&#8211; ISPE Baseline Guide Vol. 6: Biopharmaceutical Manufacturing Facilities. ispe.org<\/p>\n<p>K\u1ebft lu\u1eadn<br \/>\n\u0110\u1ec3 \u0111\u1ea1t h\u1ec7 th\u1ed1ng \u1ed1ng vi sinh \u201ckh\u00f4ng m\u1ed1i ch\u1ebft\u201d, c\u1ea7n ph\u1ed1i h\u1ee3p \u0111\u1ed3ng b\u1ed9: ch\u1ecdn 316L\/chu\u1ea9n \u1ed1ng \u0111\u00fang (ASTM A270\/EN 10357\/ASME BPE), b\u1ec1 m\u1eb7t \u0111\u1ea1t Ra m\u1ee5c ti\u00eau (\u01b0u ti\u00ean EP cho d\u01b0\u1ee3c), thi\u1ebft k\u1ebf L\/D \u2264 2 v\u00e0 \u0111\u1ed9 d\u1ed1c \u2265 1%, d\u00f9ng ph\u1ee5 ki\u1ec7n\/van aseptic, v\u00e0 h\u00e0n vi sinh v\u1edbi purge O2 ki\u1ec3m so\u00e1t nghi\u00eam ng\u1eb7t. Ki\u1ec3m tra n\u1ed9i soi 100%, t\u1ea9y g\u1ec9\u2013th\u1ee5 \u0111\u1ed9ng h\u00f3a v\u00e0 quy tr\u00ecnh CIP\/SIP chu\u1ea9n h\u00f3a l\u00e0 nh\u1eefng b\u01b0\u1edbc ch\u1ed1t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o an to\u00e0n vi sinh, tu\u1ed5i th\u1ecd v\u00e0 tu\u00e2n th\u1ee7. C\u1ea7n h\u1ed7 tr\u1ee3 ch\u1ecdn c\u1ea5u h\u00ecnh, ti\u00eau chu\u1ea9n v\u00e0 b\u00e1o gi\u00e1 v\u1eadt t\u01b0 ph\u00f9 h\u1ee3p d\u1ef1 \u00e1n? Li\u00ean h\u1ec7 Inox C\u01b0\u1eddng Th\u1ecbnh \u0111\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n chuy\u00ean s\u00e2u v\u00e0 gi\u00e1 t\u1ed1t.<\/p>\n<p>Li\u00ean h\u1ec7: Inox C\u01b0\u1eddng Th\u1ecbnh \u2013 Hotline 0343.417.281 \u2013 Email: inoxcongnghiep.cuongthinh@gmail.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>H\u01b0\u1edbng d\u1eabn ch\u1ecdn \u1ed1ng, ph\u1ee5 ki\u1ec7n Inox vi sinh theo ASME BPE\/3-A v\u00e0 k\u1ef9 thu\u1eadt h\u00e0n, b\u1ed1 tr\u00ed \u201ckh\u00f4ng m\u1ed1i ch\u1ebft\u201d \u0111\u1ea1t CIP\/SIP cho th\u1ef1c ph\u1ea9m, y t\u1ebf, d\u01b0\u1ee3c ph\u1ea9m.<\/p>\n","protected":false},"author":7,"featured_media":1006,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[23],"tags":[],"class_list":["post-2258","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"_links":{"self":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts\/2258","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/comments?post=2258"}],"version-history":[{"count":0,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts\/2258\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media\/1006"}],"wp:attachment":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media?parent=2258"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/categories?post=2258"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/tags?post=2258"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}