{"id":2262,"date":"2026-07-13T00:33:54","date_gmt":"2026-07-12T17:33:54","guid":{"rendered":"https:\/\/inoxcuongthinh.com\/chung-nhan-vat-lieu-3-1-cho-inox-duoc-yeu-cau-gmp-kiem-tra\/"},"modified":"2026-07-13T00:33:54","modified_gmt":"2026-07-12T17:33:54","slug":"chung-nhan-vat-lieu-3-1-cho-inox-duoc-yeu-cau-gmp-kiem-tra","status":"publish","type":"post","link":"https:\/\/inoxcuongthinh.com\/chung-nhan-vat-lieu-3-1-cho-inox-duoc-yeu-cau-gmp-kiem-tra\/","title":{"rendered":"Ch\u1ee9ng nh\u1eadn v\u1eadt li\u1ec7u 3.1 cho inox d\u01b0\u1ee3c: y\u00eau c\u1ea7u GMP &#038; ki\u1ec3m tra"},"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;2262&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;Ch\u1ee9ng nh\u1eadn v\u1eadt li\u1ec7u 3.1 cho inox d\u01b0\u1ee3c: y\u00eau c\u1ea7u GMP \\u0026amp; ki\u1ec3m tra&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-chung-nhan-31-la-gi-khung-en-10204-va-khac-biet-22\">Ch\u1ee9ng nh\u1eadn 3.1 l\u00e0 g\u00ec? Khung EN 10204 v\u00e0 kh\u00e1c bi\u1ec7t 2.2\/3.2<\/a><\/li>\n<li><a href=\"#toc-1-vi-sao-31-gan-nhu-bat-buoc-trong-duoc\">V\u00ec sao 3.1 g\u1ea7n nh\u01b0 \u201cb\u1eaft bu\u1ed9c\u201d trong d\u01b0\u1ee3c?<\/a><\/li>\n<li><a href=\"#toc-2-31-phai-co-gi-cach-doc-mot-chung-chi-dung-chuan\">3.1 ph\u1ea3i c\u00f3 g\u00ec? C\u00e1ch \u0111\u1ecdc m\u1ed9t ch\u1ee9ng ch\u1ec9 \u0111\u00fang chu\u1ea9n<\/a><\/li>\n<li><a href=\"#toc-3-tieu-chi-ky-thuat-trong-yeu-voi-inox-duoc\">Ti\u00eau ch\u00ed k\u1ef9 thu\u1eadt tr\u1ecdng y\u1ebfu v\u1edbi inox d\u01b0\u1ee3c<\/a><\/li>\n<li><a href=\"#toc-4-cach-xac-minh-chung-nhan-31-quy-trinh-6-buoc\">C\u00e1ch x\u00e1c minh ch\u1ee9ng nh\u1eadn 3.1: quy tr\u00ecnh 6 b\u01b0\u1edbc<\/a><\/li>\n<li><a href=\"#toc-5-khi-nao-can-32-thay-vi-31\">Khi n\u00e0o c\u1ea7n 3.2 thay v\u00ec 3.1?<\/a><\/li>\n<li><a href=\"#toc-6-he-qua-neu-thieu-31-bai-hoc-chi-phi-cao\">H\u1ec7 qu\u1ea3 n\u1ebfu thi\u1ebfu 3.1: b\u00e0i h\u1ecdc chi ph\u00ed cao<\/a><\/li>\n<li><a href=\"#toc-7-thuc-hanh-tot-quan-tri-tai-lieu-vat-lieu-mdrmoc\">Th\u1ef1c h\u00e0nh t\u1ed1t qu\u1ea3n tr\u1ecb t\u00e0i li\u1ec7u v\u1eadt li\u1ec7u (MDR\/MOC)<\/a><\/li>\n<li><a href=\"#toc-8-checklist-mua-inox-cho-duoc-da-chat-loc\">Checklist mua inox cho d\u01b0\u1ee3c (\u0111\u00e3 ch\u1eaft l\u1ecdc)<\/a><\/li>\n<li><a href=\"#toc-9-vi-du-doc-nhanh-mot-31-dat-cho-ong-asme-bpe\">V\u00ed d\u1ee5 \u0111\u1ecdc nhanh m\u1ed9t 3.1 \u201c\u0111\u1ea1t\u201d cho \u1ed1ng ASME BPE<\/a><\/li>\n<li><a href=\"#toc-10-nguon-tham-khao\">Ngu\u1ed3n tham kh\u1ea3o<\/a><\/li>\n<li><a href=\"#toc-11-ket-luan\">K\u1ebft lu\u1eadn<\/a><\/li>\n<\/ul>\n<\/div>\n<p>Trong h\u1ec7 th\u1ed1ng thi\u1ebft b\u1ecb v\u00e0 \u0111\u01b0\u1eddng \u1ed1ng ng\u00e0nh d\u01b0\u1ee3c, ch\u1ee9ng nh\u1eadn v\u1eadt li\u1ec7u 3.1 (EN 10204) l\u00e0 \u201cx\u01b0\u01a1ng s\u1ed1ng\u201d c\u1ee7a truy xu\u1ea5t ngu\u1ed3n g\u1ed1c v\u00e0 tu\u00e2n th\u1ee7 GMP. B\u00e0i vi\u1ebft n\u00e0y gi\u1ea3i th\u00edch 3.1 l\u00e0 g\u00ec, v\u00ec sao g\u1ea7n nh\u01b0 b\u1eaft bu\u1ed9c v\u1edbi inox ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m, c\u00e1ch \u0111\u1ecdc \u2013 ki\u1ec3m tra ch\u1ee9ng ch\u1ec9, kh\u00e1c bi\u1ec7t v\u1edbi 2.2\/3.2, v\u00e0 m\u1ed9t checklist mua h\u00e0ng th\u1ef1c d\u1ee5ng cho k\u1ef9 s\u01b0, nh\u00e0 th\u1ea7u v\u00e0 ch\u1ee7 x\u01b0\u1edfng.<\/p>\n<h2 id=\"toc-0-chung-nhan-31-la-gi-khung-en-10204-va-khac-biet-22\">Ch\u1ee9ng nh\u1eadn 3.1 l\u00e0 g\u00ec? Khung EN 10204 v\u00e0 kh\u00e1c bi\u1ec7t 2.2\/3.2<\/h2>\n<p>&#8211; EN 10204 \u2013 3.1 (Material Test Certificate, MTC): Nh\u00e0 s\u1ea3n xu\u1ea5t c\u1ea5p, x\u00e1c nh\u1eadn k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m theo l\u00f4 nhi\u1ec7t (heat\/charge) c\u1ee7a ch\u00ednh s\u1ea3n ph\u1ea9m giao h\u00e0ng. Ng\u01b0\u1eddi k\u00fd l\u00e0 \u0111\u1ea1i di\u1ec7n ki\u1ec3m \u0111\u1ecbnh ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ed9c l\u1eadp v\u1edbi s\u1ea3n xu\u1ea5t n\u1ed9i b\u1ed9 c\u1ee7a nh\u00e0 m\u00e1y.<br \/>\n&#8211; EN 10204 \u2013 2.2 (Test Report): B\u00e1o c\u00e1o ph\u00f9 h\u1ee3p\/ki\u1ec3m tra th\u00f4ng th\u01b0\u1eddng; kh\u00f4ng b\u1eaft bu\u1ed9c l\u00e0 k\u1ebft qu\u1ea3 th\u1eed tr\u00ean ch\u00ednh l\u00f4 h\u00e0ng, t\u00ednh ph\u00e1p ch\u1ee9ng v\u00e0 truy xu\u1ea5t th\u1ea5p.<br \/>\n&#8211; EN 10204 \u2013 3.2: Nh\u01b0 3.1 nh\u01b0ng c\u00f3 th\u00eam ch\u1ee9ng nh\u1eadn c\u1ee7a b\u00ean th\u1ee9 ba \u0111\u1ed9c l\u1eadp (t\u1ed5 ch\u1ee9c gi\u00e1m \u0111\u1ecbnh) ho\u1eb7c \u0111\u1ea1i di\u1ec7n ng\u01b0\u1eddi mua; \u00e1p d\u1ee5ng cho h\u1ea1ng m\u1ee5c c\u1ef1c k\u1ef3 quan tr\u1ecdng v\u1ec1 an to\u00e0n\/\u00e1p l\u1ef1c.<\/p>\n<p>K\u1ebft lu\u1eadn nhanh: Trong d\u01b0\u1ee3c ph\u1ea9m, m\u1ecdi chi ti\u1ebft inox ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp s\u1ea3n ph\u1ea9m\/qu\u00e1 tr\u00ecnh (tubing, fittings, b\u1ed3n, skid c\u00f4ng ngh\u1ec7) n\u00ean t\u1ed1i thi\u1ec3u c\u00f3 3.1; h\u1ea1ng m\u1ee5c ch\u1ecbu \u00e1p\/quan tr\u1ecdng c\u00f3 th\u1ec3 y\u00eau c\u1ea7u 3.2 theo URS\/DQ.<\/p>\n<h2 id=\"toc-1-vi-sao-31-gan-nhu-bat-buoc-trong-duoc\">V\u00ec sao 3.1 g\u1ea7n nh\u01b0 \u201cb\u1eaft bu\u1ed9c\u201d trong d\u01b0\u1ee3c?<\/h2>\n<h3>1) Tu\u00e2n th\u1ee7 GMP v\u00e0 h\u1ed3 s\u01a1 MOC (Material of Construction)<\/h3>\n<p>&#8211; EU GMP Annex 15 v\u00e0 h\u01b0\u1edbng d\u1eabn ISPE y\u00eau c\u1ea7u t\u00e0i li\u1ec7u truy xu\u1ea5t v\u1eadt li\u1ec7u trong h\u1ed3 s\u01a1 DQ\/IQ\/OQ\/PQ. 3.1 l\u00e0 b\u1eb1ng ch\u1ee9ng g\u1ed1c v\u1ec1 th\u00e0nh ph\u1ea7n v\u00e0 t\u00ednh ch\u1ea5t c\u01a1 l\u00fd c\u1ee7a inox d\u00f9ng cho b\u1ec1 m\u1eb7t ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m.<br \/>\n&#8211; Khi audit (GMP-WHO\/EU-GMP\/cGMP), thi\u1ebfu 3.1 cho v\u1eadt li\u1ec7u ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m th\u01b0\u1eddng b\u1ecb ghi Major\/CR v\u00ec kh\u00f4ng ch\u1ee9ng minh \u0111\u01b0\u1ee3c MOC.<\/p>\n<h3>2) Qu\u1ea3n tr\u1ecb r\u1ee7i ro nhi\u1ec5m b\u1ea9n v\u00e0 \u0103n m\u00f2n<\/h3>\n<p>&#8211; Sai m\u00e1c th\u00e9p ho\u1eb7c th\u00e0nh ph\u1ea7n Mo\/Ni\/S ngo\u00e0i kho\u1ea3ng ki\u1ec3m so\u00e1t c\u00f3 th\u1ec3 g\u00e2y pitting, rouging, th\u00f4i nhi\u1ec5m ion kim lo\u1ea1i, l\u00e0m h\u1ecfng m\u1ebb s\u1ea3n xu\u1ea5t, th\u1eadm ch\u00ed thu h\u1ed3i s\u1ea3n ph\u1ea9m.<br \/>\n&#8211; 3.1 cho ph\u00e9p \u0111\u1ed1i chi\u1ebfu th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc, l\u1ef1a ch\u1ecdn m\u00e1c h\u1ee3p l\u00fd (v\u00ed d\u1ee5 1.4435 Mo cao h\u01a1n 1.4404), ph\u00f9 h\u1ee3p m\u00f4i tr\u01b0\u1eddng CIP\/SIP nhi\u1ec1u chloride.<\/p>\n<h3>3) \u0110\u1ea3m b\u1ea3o kh\u1ea3 n\u0103ng h\u00e0n, b\u1ec1 m\u1eb7t v\u00e0 v\u1ec7 sinh<\/h3>\n<p>&#8211; C\u00e1c y\u00eau c\u1ea7u ASME BPE v\u1ec1 sulfur (S) \u0111\u1ec3 t\u1ed1i \u01b0u h\u00e0n\/\u0111\u1ed9 ch\u1ea3y m\u1ed1i h\u00e0n, gi\u1edbi h\u1ea1n \u0111\u1ed9 nh\u00e1m b\u1ec1 m\u1eb7t Ra (SF1\u2013SF4) v\u00e0 \u0111i\u1ec7n \u0111\u00e1nh b\u00f3ng (EP) c\u1ea7n ch\u1ee9ng c\u1ee9 \u0111i k\u00e8m. 3.1 l\u00e0 \u0111i\u1ec3m xu\u1ea5t ph\u00e1t \u0111\u1ec3 x\u00e1c nh\u1eadn c\u00e1c \u0111\u1eb7c t\u00ednh n\u00e0y b\u1eb1ng th\u1eed nghi\u1ec7m b\u1ed5 sung.<\/p>\n<h2 id=\"toc-2-31-phai-co-gi-cach-doc-mot-chung-chi-dung-chuan\">3.1 ph\u1ea3i c\u00f3 g\u00ec? C\u00e1ch \u0111\u1ecdc m\u1ed9t ch\u1ee9ng ch\u1ec9 \u0111\u00fang chu\u1ea9n<\/h2>\n<p>M\u1ed9t MTC 3.1 \u0111\u1ea1t chu\u1ea9n th\u01b0\u1eddng bao g\u1ed3m:<br \/>\n&#8211; Nh\u1eadn di\u1ec7n s\u1ea3n ph\u1ea9m: t\u00ean nh\u00e0 s\u1ea3n xu\u1ea5t, m\u00e1c th\u00e9p theo EN\/ASTM (v\u00ed d\u1ee5 EN 1.4404 ho\u1eb7c 1.4435 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng 316L), ti\u00eau chu\u1ea9n s\u1ea3n xu\u1ea5t (ASTM A270 S2\/ASME BPE cho \u1ed1ng v\u1ec7 sinh; ASTM A269; EN 10217-7 cho \u1ed1ng h\u00e0n), k\u00edch th\u01b0\u1edbc, s\u1ed1 l\u01b0\u1ee3ng.<br \/>\n&#8211; Truy xu\u1ea5t: s\u1ed1 l\u00f4 nhi\u1ec7t (Heat\/Charge No.), s\u1ed1 cu\u1ed9n\/tube\/heat coil; ng\u00e0y s\u1ea3n xu\u1ea5t; s\u1ed1 ch\u1ee9ng ch\u1ec9.<br \/>\n&#8211; Th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc: %C, Si, Mn, P, S, Cr, Ni, Mo, N,\u2026 v\u1edbi ph\u01b0\u01a1ng ph\u00e1p th\u1eed\/chu\u1ea9n \u0111\u1ed1i chi\u1ebfu (ASTM\/EN). V\u00ed d\u1ee5 ch\u1ea5p nh\u1eadn \u0111i\u1ec3n h\u00ecnh:<br \/>\n  &#8211; 316L\/1.4404: C \u2264 0,03%; Mo \u2248 2,0\u20132,5%; Ni \u2248 10\u201313%; Cr \u2248 16,5\u201318,5%.<br \/>\n  &#8211; 1.4435: C \u2264 0,03%; Mo \u2248 2,5\u20133,0% (cao h\u01a1n 1.4404); Ni th\u01b0\u1eddng cao h\u01a1n \u0111\u1ec3 t\u0103ng ch\u1ed1ng r\u1ed7.<br \/>\n&#8211; T\u00ednh ch\u1ea5t c\u01a1 h\u1ecdc: Rp0.2 (gi\u1edbi h\u1ea1n ch\u1ea3y), Rm (\u0111\u1ed9 b\u1ec1n k\u00e9o), A% (\u0111\u1ed9 gi\u00e3n d\u00e0i), \u0111\u1ed9 c\u1ee9ng; tr\u1ea1ng th\u00e1i nhi\u1ec7t luy\u1ec7n (solution annealed) v\u00e0 k\u1ebft qu\u1ea3 NDT (n\u1ebfu \u00e1p d\u1ee5ng).<br \/>\n&#8211; Tuy\u00ean b\u1ed1 ph\u00f9 h\u1ee3p: V\u1edbi c\u00e1c ti\u00eau chu\u1ea9n li\u00ean quan (ASTM A270 S2\/ASME BPE\/EN 10217-7, v.v.) v\u00e0 ch\u1eef k\u00fd ng\u01b0\u1eddi c\u00f3 th\u1ea9m quy\u1ec1n.<\/p>\n<p>L\u01b0u \u00fd:<br \/>\n&#8211; Ra b\u1ec1 m\u1eb7t (SF1 \u2264 0,51 \u00b5m; SF4 EP \u2264 0,38 \u00b5m theo ASME BPE) kh\u00f4ng nh\u1ea5t thi\u1ebft n\u1eb1m tr\u00ean 3.1; c\u1ea7n ch\u1ee9ng ch\u1ec9 gia c\u00f4ng b\u1ec1 m\u1eb7t\/\u0111i\u1ec7n \u0111\u00e1nh b\u00f3ng, b\u00e1o c\u00e1o \u0111o Ra ri\u00eang.<br \/>\n&#8211; Ph\u00e2n h\u1ea1ng l\u01b0u hu\u1ef3nh theo ASME BPE (S1\u2013S4) ph\u1ee5c v\u1ee5 ki\u1ec3m so\u00e1t h\u00e0n; gi\u00e1 tr\u1ecb S c\u1ee5 th\u1ec3 n\u00ean \u0111\u01b0\u1ee3c \u0111\u1ed1i chi\u1ebfu t\u1eeb 3.1.<\/p>\n<h2 id=\"toc-3-tieu-chi-ky-thuat-trong-yeu-voi-inox-duoc\">Ti\u00eau ch\u00ed k\u1ef9 thu\u1eadt tr\u1ecdng y\u1ebfu v\u1edbi inox d\u01b0\u1ee3c<\/h2>\n<p>&#8211; M\u00e1c th\u00e9p:<br \/>\n  &#8211; 316L\/EN 1.4404: ph\u1ed5 bi\u1ebfn cho \u1ed1ng, fittings, b\u1ed3n ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m.<br \/>\n  &#8211; EN 1.4435 (316L \u201cMo cao\u201d): \u01b0u ti\u00ean cho d\u1ecbch c\u00f3 chloride\/c\u00e1c m\u00f4i tr\u01b0\u1eddng kh\u1eafc nghi\u1ec7t h\u01a1n nh\u1edd PREN cao h\u01a1n.<br \/>\n  &#8211; M\u00f4i tr\u01b0\u1eddng r\u1ea5t x\u00e2m th\u1ef1c: c\u00e2n nh\u1eafc 904L, 254SMO, AL-6XN; song c\u1ea7n c\u00e2n b\u1eb1ng chi ph\u00ed \u2013 kh\u1ea3 thi v\u1ec7 sinh.<br \/>\n&#8211; B\u1ec1 m\u1eb7t v\u00e0 ho\u00e0n thi\u1ec7n: Tu\u00e2n ASME BPE SF1\u2013SF4; ID Ra \u2264 0,51 \u00b5m (SF1) cho \u0111a s\u1ed1 \u1ee9ng d\u1ee5ng; EP (SF4) cho y\u00eau c\u1ea7u cao v\u1ec1 l\u00e0m s\u1ea1ch\/gi\u1ea3m rouging.<br \/>\n&#8211; H\u00e0n v\u00e0 ferrite: Ki\u1ec3m so\u00e1t v\u1eadt li\u1ec7u\/filler \u0111\u1ec3 ferrite \u1edf m\u1ed1i h\u00e0n th\u1ea5p, gi\u1ea3m nguy c\u01a1 rouging v\u00e0 \u0103n m\u00f2n; \u0111o FN khi URS y\u00eau c\u1ea7u.<br \/>\n&#8211; Truy xu\u1ea5t s\u1ed1 heat: B\u1eaft bu\u1ed9c in\/kh\u1eafc\/\u0111\u00f3ng d\u1ea5u tr\u00ean \u1ed1ng\/ph\u1ee5 ki\u1ec7n ho\u1eb7c duy tr\u00ec li\u00ean k\u1ebft tem \u2013 bao g\u00f3i v\u1edbi bi\u00ean b\u1ea3n nh\u1eadn h\u00e0ng.<\/p>\n<h2 id=\"toc-4-cach-xac-minh-chung-nhan-31-quy-trinh-6-buoc\">C\u00e1ch x\u00e1c minh ch\u1ee9ng nh\u1eadn 3.1: quy tr\u00ecnh 6 b\u01b0\u1edbc<\/h2>\n<p>1) \u0110\u1ed1i chi\u1ebfu s\u1ed1 heat: Tr\u00f9ng kh\u1edbp gi\u1eefa 3.1 \u2013 nh\u00e3n s\u1ea3n ph\u1ea9m \u2013 Packing List \u2013 Line List\/BoM d\u1ef1 \u00e1n.<br \/>\n2) Ki\u1ec3m tra ch\u00e9o m\u00e1c \u2013 ti\u00eau chu\u1ea9n: V\u00ed d\u1ee5 \u201cEN 1.4435 (316L), ASTM A270 S2, ASME BPE\u201d ph\u1ea3i nh\u1ea5t qu\u00e1n; c\u1ea3nh gi\u00e1c \u201cdual grade\u201d n\u1ebfu kh\u00f4ng \u0111\u01b0\u1ee3c URS cho ph\u00e9p.<br \/>\n3) So s\u00e1nh th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc v\u1edbi d\u1ea3i ti\u00eau chu\u1ea9n v\u00e0 y\u00eau c\u1ea7u BPE\/S sulfur: V\u00ed d\u1ee5 S trong kho\u1ea3ng ph\u00f9 h\u1ee3p (t\u00f9y ph\u00e2n h\u1ea1ng S c\u1ee7a BPE); Mo c\u1ee7a 1.4435 t\u1ed1i thi\u1ec3u ~2,5%.<br \/>\n4) R\u00e0 c\u01a1 t\u00ednh v\u00e0 tr\u1ea1ng th\u00e1i nhi\u1ec7t luy\u1ec7n: Rp0.2, Rm, A% \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n; c\u00f3 ghi \u201csolution annealed\u201d v\u00e0 \u201cpickled\/passivated\u201d n\u1ebfu y\u00eau c\u1ea7u.<br \/>\n5) Ki\u1ec3m ch\u1ee9ng \u0111\u1ed9c l\u1eadp (n\u1ebfu r\u1ee7i ro cao): PMI (XRF), \u0111o ferrite weld, test \u0111\u1ed9 nh\u00e1m Ra, coupon ki\u1ec3m tra EP\/passivation \u2013 l\u01b0u l\u1ea1i bi\u00ean b\u1ea3n IQ.<br \/>\n6) T\u00ednh nh\u1ea5t qu\u00e1n h\u1ed3 s\u01a1: \u0110\u1ea3m b\u1ea3o 3.1 \u0111i k\u00e8m c\u00e1c ch\u1ee9ng t\u1eeb b\u1ed5 sung (CoC, b\u00e1o c\u00e1o Ra, cert EP\/passivation, WPS\/PQR\/WPQR, cert filler kim lo\u1ea1i h\u00e0n 3.1).<\/p>\n<h2 id=\"toc-5-khi-nao-can-32-thay-vi-31\">Khi n\u00e0o c\u1ea7n 3.2 thay v\u00ec 3.1?<\/h2>\n<p>&#8211; Thi\u1ebft b\u1ecb\/\u0111\u01b0\u1eddng \u1ed1ng \u00e1p l\u1ef1c quan tr\u1ecdng (v\u1ecf b\u1ed3n, \u0111\u01b0\u1eddng h\u01a1i SIP, skid \u00e1p l\u1ef1c) theo RQP v\u00e0 ph\u00e2n t\u00edch r\u1ee7i ro \u2013 y\u00eau c\u1ea7u 3.2 \u0111\u1ec3 c\u00f3 l\u1edbp gi\u00e1m \u0111\u1ecbnh \u0111\u1ed9c l\u1eadp.<br \/>\n&#8211; Khi d\u1ef1 \u00e1n h\u01b0\u1edbng \u0111\u1ebfn c\u00e1c ti\u00eau chu\u1ea9n kh\u1eaft khe (v\u00ed d\u1ee5 EU-GMP cho nh\u00f3m s\u1ea3n ph\u1ea9m v\u00f4 tr\u00f9ng) ho\u1eb7c theo y\u00eau c\u1ea7u c\u1ee7a ch\u1ee7 \u0111\u1ea7u t\u01b0\/\u0111\u01a1n v\u1ecb th\u1ea9m \u0111\u1ecbnh.<\/p>\n<h2 id=\"toc-6-he-qua-neu-thieu-31-bai-hoc-chi-phi-cao\">H\u1ec7 qu\u1ea3 n\u1ebfu thi\u1ebfu 3.1: b\u00e0i h\u1ecdc chi ph\u00ed cao<\/h2>\n<p>&#8211; Kh\u00f4ng v\u01b0\u1ee3t qua audit GMP: y\u00eau c\u1ea7u thay th\u1ebf\/gi\u00e1m \u0111\u1ecbnh l\u1ea1i; tr\u1ec5 d\u1ef1 \u00e1n, ph\u00e1t sinh chi ph\u00ed l\u1edbn.<br \/>\n&#8211; Nguy c\u01a1 \u00f4 nhi\u1ec5m ch\u00e9o v\u00e0 \u0103n m\u00f2n\/rouging: chi ph\u00ed d\u1eebng m\u00e1y, v\u1ec7 sinh, lo\u1ea1i b\u1ecf m\u1ebb.<br \/>\n&#8211; M\u1ea5t truy xu\u1ea5t ngu\u1ed3n g\u1ed1c: kh\u00f4ng th\u1ec3 khoanh v\u00f9ng l\u00f4 v\u1eadt li\u1ec7u l\u1ed7i \u0111\u1ec3 h\u00e0nh \u0111\u1ed9ng CAPA nhanh.<\/p>\n<h2 id=\"toc-7-thuc-hanh-tot-quan-tri-tai-lieu-vat-lieu-mdrmoc\">Th\u1ef1c h\u00e0nh t\u1ed1t qu\u1ea3n tr\u1ecb t\u00e0i li\u1ec7u v\u1eadt li\u1ec7u (MDR\/MOC)<\/h2>\n<p>&#8211; L\u1eadp Matrix MOC: \u00e1nh x\u1ea1 t\u1eebng d\u00f2ng P&#038;ID\/line list \u0111\u1ebfn s\u1ed1 heat, s\u1ed1 3.1, m\u00e3 v\u1eadt t\u01b0.<br \/>\n&#8211; G\u00f3i h\u1ed3 s\u01a1 Nh\u00e0 ch\u1ebf t\u1ea1o (MDR): 3.1 + CoC + b\u00e1o c\u00e1o Ra + cert EP\/passivation + WPS\/PQR\/WPQR + cert filler + bi\u00ean b\u1ea3n PMI\/ferrite (n\u1ebfu c\u00f3) + b\u1ea3n v\u1ebd As-built.<br \/>\n&#8211; Qu\u1ea3n l\u00fd s\u1ed1 h\u00f3a: L\u01b0u tr\u1eef 3.1 \u0111i\u1ec7n t\u1eed, g\u1eafn QR\/heat tr\u00ean th\u1ebb kho; ki\u1ec3m so\u00e1t phi\u00ean b\u1ea3n trong QMS.<\/p>\n<h2 id=\"toc-8-checklist-mua-inox-cho-duoc-da-chat-loc\">Checklist mua inox cho d\u01b0\u1ee3c (\u0111\u00e3 ch\u1eaft l\u1ecdc)<\/h2>\n<p>&#8211; Y\u00eau c\u1ea7u t\u1ed1i thi\u1ec3u EN 10204 \u2013 3.1 cho m\u1ecdi v\u1eadt li\u1ec7u ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m; 3.2 cho h\u1ea1ng m\u1ee5c r\u1ee7i ro cao.<br \/>\n&#8211; X\u00e1c \u0111\u1ecbnh m\u00e1c: 316L\/1.4404 hay 1.4435; m\u00f4i tr\u01b0\u1eddng chloride cao c\u00e2n nh\u1eafc m\u00e1c si\u00eau austenitic.<br \/>\n&#8211; Chu\u1ea9n \u00e1p d\u1ee5ng: ASTM A270 S2\/ASME BPE cho \u1ed1ng v\u1ec7 sinh; fitting \u0111\u1ed3ng b\u1ed9 BPE.<br \/>\n&#8211; B\u1ec1 m\u1eb7t: SF1 ho\u1eb7c SF4 (EP) theo URS; y\u00eau c\u1ea7u ch\u1ee9ng ch\u1ec9 \u0111o Ra v\u00e0 EP\/passivation.<br \/>\n&#8211; Ki\u1ec3m so\u00e1t S theo ph\u00e2n h\u1ea1ng ASME BPE; r\u00e0ng bu\u1ed9c gi\u00e1 tr\u1ecb S trong PO.<br \/>\n&#8211; Y\u00eau c\u1ea7u in\/kh\u1eafc d\u1ea5u: m\u00e1c, ti\u00eau chu\u1ea9n, size, heat number, BPE\/A270.<br \/>\n&#8211; Nh\u1eadn h\u00e0ng: \u0111\u1ed1i chi\u1ebfu 3.1 \u2013 heat \u2013 nh\u00e3n; th\u1ef1c hi\u1ec7n PMI ng\u1eabu nhi\u00ean theo k\u1ebf ho\u1ea1ch IQ.<br \/>\n&#8211; L\u01b0u h\u1ed3 s\u01a1: li\u00ean k\u1ebft 3.1 v\u00e0o DQ\/IQ\/OQ\/PQ; chu\u1ea9n b\u1ecb s\u1eb5n cho audit.<\/p>\n<h2 id=\"toc-9-vi-du-doc-nhanh-mot-31-dat-cho-ong-asme-bpe\">V\u00ed d\u1ee5 \u0111\u1ecdc nhanh m\u1ed9t 3.1 \u201c\u0111\u1ea1t\u201d cho \u1ed1ng ASME BPE<\/h2>\n<p>&#8211; H\u1ea1ng m\u1ee5c: Tube 1.5&#8243; \u00d7 1.65 mm, ASTM A270 S2, ASME BPE SF1.<br \/>\n&#8211; M\u00e1c: EN 1.4435 (AISI 316L). Heat No.: 7H12345.<br \/>\n&#8211; H\u00f3a h\u1ecdc: C=0,016%; S=0,008%; Cr=17,2%; Ni=13,1%; Mo=2,75%; N=0,045% \u2192 ph\u00f9 h\u1ee3p 1.4435, Mo cao.<br \/>\n&#8211; C\u01a1 t\u00ednh: Rp0.2=210 MPa; Rm=540 MPa; A5=55%; T\u00ecnh tr\u1ea1ng: Solution annealed, pickled.<br \/>\n&#8211; Ghi ch\u00fa: \u0110\u00ednh k\u00e8m b\u00e1o c\u00e1o Ra ID=0,44 \u00b5m; ch\u1ee9ng ch\u1ec9 EP cho nh\u00f3m SF4 n\u1ebfu c\u00f3.<\/p>\n<h2 id=\"toc-10-nguon-tham-khao\">Ngu\u1ed3n tham kh\u1ea3o<\/h2>\n<p>&#8211; EN 10204:2004 \u2013 Metallic products \u2014 Types of inspection documents (khung ch\u1ee9ng nh\u1eadn 2.2\/3.1\/3.2).<br \/>\n&#8211; ASME BPE \u2013 Bioprocessing Equipment Standard (y\u00eau c\u1ea7u v\u1eadt li\u1ec7u, b\u1ec1 m\u1eb7t SF1\u2013SF4, ki\u1ec3m so\u00e1t S). asme.org<br \/>\n&#8211; ASTM A270 \u2013 Standard Specification for Seamless and Welded Austenitic Stainless Steel Sanitary Tubing. astm.org<br \/>\n&#8211; EU GMP Annex 15 \u2013 Qualification and Validation. ema.europa.eu<br \/>\n&#8211; ISPE Baseline\/Good Practice Guides \u2013 Commissioning &#038; Qualification, Water &#038; Steam Systems. ispe.org<br \/>\n&#8211; FDA 21 CFR Part 211 \u2013 Current Good Manufacturing Practice for Finished Pharmaceuticals. fda.gov<\/p>\n<h2 id=\"toc-11-ket-luan\">K\u1ebft lu\u1eadn<\/h2>\n<p>Ch\u1ee9ng nh\u1eadn v\u1eadt li\u1ec7u 3.1 theo EN 10204 l\u00e0 n\u1ec1n t\u1ea3ng \u0111\u1ec3 \u0111\u00e1p \u1ee9ng GMP, ki\u1ec3m so\u00e1t r\u1ee7i ro \u0103n m\u00f2n\/nhi\u1ec5m b\u1ea9n v\u00e0 b\u1ea3o \u0111\u1ea3m truy xu\u1ea5t tuy\u1ec7t \u0111\u1ed1i cho inox ng\u00e0nh d\u01b0\u1ee3c. H\u00e3y m\u1eb7c \u0111\u1ecbnh y\u00eau c\u1ea7u 3.1 cho m\u1ecdi chi ti\u1ebft ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m, s\u1eed d\u1ee5ng 1.4435\/316L \u0111\u00fang b\u1ed1i c\u1ea3nh, tu\u00e2n ASME BPE v\u1ec1 b\u1ec1 m\u1eb7t v\u00e0 th\u00e0nh ph\u1ea7n S, \u0111\u1ed3ng th\u1eddi tri\u1ec3n khai quy tr\u00ecnh x\u00e1c minh 6 b\u01b0\u1edbc v\u00e0 checklist mua h\u00e0ng \u1edf tr\u00ean. L\u00e0m \u0111\u00fang t\u1eeb kh\u00e2u v\u1eadt li\u1ec7u s\u1ebd r\u00fat ng\u1eafn DQ\/IQ\/OQ, gi\u1ea3m chi ph\u00ed v\u00f2ng \u0111\u1eddi v\u00e0 \u201cmi\u1ec5n nhi\u1ec5m\u201d tr\u01b0\u1edbc c\u00e1c cu\u1ed9c audit kh\u00f3 t\u00ednh.<\/p>\n<p>C\u1ea7n t\u01b0 v\u1ea5n ch\u1ecdn m\u00e1c inox, chu\u1ea9n ASME BPE v\u00e0 b\u1ed9 ch\u1ee9ng ch\u1ec9 3.1\/3.2 cho d\u1ef1 \u00e1n d\u01b0\u1ee3c c\u1ee7a b\u1ea1n? Li\u00ean h\u1ec7 Inox C\u01b0\u1eddng Th\u1ecbnh \u0111\u1ec3 \u0111\u01b0\u1ee3c h\u1ed7 tr\u1ee3 k\u1ef9 thu\u1eadt v\u00e0 b\u00e1o gi\u00e1 t\u1ed1t nh\u1ea5t. Hotline: 0343.417.281. Email: inoxcongnghiep.cuongthinh@gmail.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gi\u1ea3i th\u00edch ch\u1ee9ng nh\u1eadn 3.1 (EN 10204) cho inox d\u01b0\u1ee3c, v\u00ec sao b\u1eaft bu\u1ed9c theo GMP, kh\u00e1c g\u00ec 2.2\/3.2, c\u00e1ch \u0111\u1ecdc\u2013x\u00e1c minh MTC, ti\u00eau ch\u00ed ASME BPE, checklist mua h\u00e0ng.<\/p>\n","protected":false},"author":7,"featured_media":1062,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[23],"tags":[],"class_list":["post-2262","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\/2262","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=2262"}],"version-history":[{"count":0,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts\/2262\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media\/1062"}],"wp:attachment":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media?parent=2262"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/categories?post=2262"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/tags?post=2262"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}