{"id":1363,"date":"2025-11-27T12:34:03","date_gmt":"2025-11-27T05:34:03","guid":{"rendered":"https:\/\/inoxcuongthinh.com\/tai-sao-chung-chi-vat-lieu-3-1-bat-buoc-voi-inox-nganh-duoc\/"},"modified":"2025-11-27T12:34:03","modified_gmt":"2025-11-27T05:34:03","slug":"tai-sao-chung-chi-vat-lieu-3-1-bat-buoc-voi-inox-nganh-duoc","status":"publish","type":"post","link":"https:\/\/inoxcuongthinh.com\/tai-sao-chung-chi-vat-lieu-3-1-bat-buoc-voi-inox-nganh-duoc\/","title":{"rendered":"T\u1ea1i sao ch\u1ee9ng ch\u1ec9 v\u1eadt li\u1ec7u 3.1 b\u1eaft bu\u1ed9c v\u1edbi inox ng\u00e0nh d\u01b0\u1ee3c?"},"content":{"rendered":"<div class=\"custom-toc\">\n<h3>N\u1ed9i dung ch\u00ednh<\/h3>\n<ul>\n<li><a href=\"#toc-0-31-certificate-la-gi-va-vi-sao-quan-trong-trong-du\">3.1 Certificate l\u00e0 g\u00ec v\u00e0 v\u00ec sao quan tr\u1ecdng trong d\u01b0\u1ee3c?<\/a><\/li>\n<li><a href=\"#toc-1-ban-do-tuan-thu-31-gan-voi-tieu-chuan-nao\">B\u1ea3n \u0111\u1ed3 tu\u00e2n th\u1ee7: 3.1 g\u1eafn v\u1edbi ti\u00eau chu\u1ea9n n\u00e0o?<\/a><\/li>\n<li><a href=\"#toc-2-inox-cho-duoc-pham-cap-mac-be-mat-va-rui-ro\">Inox cho d\u01b0\u1ee3c ph\u1ea9m: c\u1ea5p m\u00e1c, b\u1ec1 m\u1eb7t v\u00e0 r\u1ee7i ro<\/a><\/li>\n<li><a href=\"#toc-3-chung-chi-31-phai-co-nhung-gi\">Ch\u1ee9ng ch\u1ec9 3.1 ph\u1ea3i c\u00f3 nh\u1eefng g\u00ec?<\/a><\/li>\n<li><a href=\"#toc-4-cach-doc-va-tham-tra-chung-chi-31-quy-trinh-6-buoc\">C\u00e1ch \u0111\u1ecdc v\u00e0 th\u1ea9m tra ch\u1ee9ng ch\u1ec9 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-checklist-mua-inox-cho-nha-may-duoc\">Checklist mua inox cho nh\u00e0 m\u00e1y d\u01b0\u1ee3c<\/a><\/li>\n<li><a href=\"#toc-7-rui-ro-neu-thieu-31-hoac-tham-tra-kem\">R\u1ee7i ro n\u1ebfu thi\u1ebfu 3.1 ho\u1eb7c th\u1ea9m tra k\u00e9m<\/a><\/li>\n<li><a href=\"#toc-8-cac-cau-hoi-thuong-gap\">C\u00e1c c\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p<\/a><\/li>\n<li><a href=\"#toc-9-nguon-tham-khao\">Ngu\u1ed3n tham kh\u1ea3o<\/a><\/li>\n<li><a href=\"#toc-10-ket-luan\">K\u1ebft lu\u1eadn<\/a><\/li>\n<\/ul>\n<\/div>\n<p>Trong c\u00e1c \u1ee9ng d\u1ee5ng C\u00f4ng nghi\u1ec7p S\u1ea1ch, \u0111\u1eb7c bi\u1ec7t l\u00e0 d\u01b0\u1ee3c ph\u1ea9m, sai l\u1ec7ch nh\u1ecf \u1edf v\u1eadt li\u1ec7u inox c\u00f3 th\u1ec3 d\u1eabn t\u1edbi \u0103n m\u00f2n \u0111i\u1ec3m, nhi\u1ec5m h\u1ea1t kim lo\u1ea1i, t\u1ea1o biofilm v\u00e0 h\u1ecfng m\u1ebb. Ch\u1ee9ng nh\u1eadn v\u1eadt li\u1ec7u (Material Test Certificate \u2013 MTC) lo\u1ea1i 3.1 theo EN 10204 l\u00e0 n\u1ec1n t\u1ea3ng \u0111\u1ec3 ch\u1ee9ng minh t\u00ednh ph\u00f9 h\u1ee3p c\u1ee7a inox v\u1edbi y\u00eau c\u1ea7u GMP\/EU-GMP\/FDA v\u00e0 ASME BPE. B\u00e0i vi\u1ebft n\u00e0y ph\u00e2n t\u00edch v\u00ec sao 3.1 l\u00e0 \u201cb\u1eb1ng ch\u1ee9ng s\u1ed1ng\u201d cho truy xu\u1ea5t ngu\u1ed3n g\u1ed1c, c\u00e1ch \u0111\u1ecdc \u2013 th\u1ea9m tra, v\u00e0 checklist mua h\u00e0ng gi\u00fap nh\u00e0 m\u00e1y d\u01b0\u1ee3c tr\u00e1nh r\u1ee7i ro.<\/p>\n<h2 id=\"toc-0-31-certificate-la-gi-va-vi-sao-quan-trong-trong-du\">3.1 Certificate l\u00e0 g\u00ec v\u00e0 v\u00ec sao quan tr\u1ecdng trong d\u01b0\u1ee3c?<\/h2>\n<p>&#8211; \u0110\u1ecbnh ngh\u0129a: Ch\u1ee9ng ch\u1ec9 3.1 theo EN 10204 do b\u1ed9 ph\u1eadn ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ed9c l\u1eadp v\u1edbi s\u1ea3n xu\u1ea5t c\u1ee7a nh\u00e0 m\u00e1y luy\u1ec7n\/\u0111\u00fac\/\u1ed1ng ph\u00e1t h\u00e0nh, x\u00e1c nh\u1eadn k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u00ean s\u1ea3n ph\u1ea9m t\u1eeb c\u00f9ng m\u1ebb luy\u1ec7n (heat) v\u1edbi h\u00e0ng giao.<br \/>\n&#8211; Kh\u00e1c bi\u1ec7t v\u1edbi c\u00e1c lo\u1ea1i kh\u00e1c:<br \/>\n  + 2.1: Tuy\u00ean b\u1ed1 ph\u00f9 h\u1ee3p c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t, kh\u00f4ng c\u00f3 k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m c\u1ee5 th\u1ec3.<br \/>\n  + 2.2: C\u00f3 k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m \u0111i\u1ec3n h\u00ecnh, kh\u00f4ng theo m\u1ebb.<br \/>\n  + 3.1: C\u00f3 k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m theo m\u1ebb, do QA c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t k\u00fd.<br \/>\n  + 3.2: Nh\u01b0 3.1 nh\u01b0ng c\u00f3 th\u00eam x\u00e1c nh\u1eadn c\u1ee7a b\u00ean th\u1ee9 ba (inspector\/kh\u00e1ch h\u00e0ng).<br \/>\n&#8211; T\u1ea1i sao d\u01b0\u1ee3c c\u1ea7n t\u1ed1i thi\u1ec3u 3.1:<br \/>\n  + Truy xu\u1ea5t ngu\u1ed3n g\u1ed1c t\u1edbi m\u1ebb luy\u1ec7n (heat number) \u2013 y\u00eau c\u1ea7u c\u1ed1t l\u00f5i c\u1ee7a h\u1ec7 th\u1ed1ng GMP cho thi\u1ebft b\u1ecb ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m\/ti\u1ec7n \u00edch s\u1ea1ch.<br \/>\n  + Ki\u1ec3m so\u00e1t th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc (Cr, Ni, Mo, S, N&#8230;) v\u00e0 c\u01a1 t\u00ednh theo chu\u1ea9n, \u0111\u1ea3m b\u1ea3o ch\u1ed1ng \u0103n m\u00f2n v\u00e0 kh\u1ea3 n\u0103ng h\u00e0n.<br \/>\n  + H\u1ed7 tr\u1ee3 th\u1ea9m \u0111\u1ecbnh thi\u1ebft b\u1ecb (DQ\/IQ\/OQ) v\u00e0 h\u1ed3 s\u01a1 b\u00e0n giao (Turnover Package) theo EU GMP Annex 15.<\/p>\n<h2 id=\"toc-1-ban-do-tuan-thu-31-gan-voi-tieu-chuan-nao\">B\u1ea3n \u0111\u1ed3 tu\u00e2n th\u1ee7: 3.1 g\u1eafn v\u1edbi ti\u00eau chu\u1ea9n n\u00e0o?<\/h2>\n<p>&#8211; EN 10204: Quy \u0111\u1ecbnh lo\u1ea1i ch\u1ee9ng ch\u1ec9 (3.1\/3.2).<br \/>\n&#8211; V\u1eadt li\u1ec7u v\u00e0 s\u1ea3n ph\u1ea9m:<br \/>\n  + T\u1ea5m\/th\u00e9p cu\u1ed9n: ASTM A240 \/ EN 10088.<br \/>\n  + \u1ed0ng v\u1ec7 sinh: ASTM A270-S1, ASME BPE.<br \/>\n  + Ph\u1ee5 ki\u1ec7n\/van: ASTM A351\/A479, EN 10272.<br \/>\n&#8211; Y\u00eau c\u1ea7u ng\u00e0nh:<br \/>\n  + ASME BPE: V\u1eadt li\u1ec7u, th\u00e0nh ph\u1ea7n S, Mo; b\u1ec1 m\u1eb7t SF1\u2013SF4 (Ra), h\u1ed3 s\u01a1 passivation\/electropolishing.<br \/>\n  + FDA 21 CFR Part 211; EU GMP\/EU GMP Annex 15; WHO GMP: nh\u1ea5n m\u1ea1nh thi\u1ebft b\u1ecb ph\u00f9 h\u1ee3p, c\u00f3 h\u1ed3 s\u01a1 v\u00e0 truy xu\u1ea5t.<br \/>\n  + L\u00e0m s\u1ea1ch\/th\u1ee5 \u0111\u1ed9ng h\u00f3a: ASTM A380\/A967 (acid pickling &#038; passivation).<\/p>\n<h2 id=\"toc-2-inox-cho-duoc-pham-cap-mac-be-mat-va-rui-ro\">Inox cho d\u01b0\u1ee3c ph\u1ea9m: c\u1ea5p m\u00e1c, b\u1ec1 m\u1eb7t v\u00e0 r\u1ee7i ro<\/h2>\n<p>&#8211; C\u1ea5p m\u00e1c ph\u1ed5 bi\u1ebfn:<br \/>\n  + 316L (EN 1.4404\/ASTM 316L): ti\u00eau chu\u1ea9n cho b\u1ed3n, \u0111\u01b0\u1eddng \u1ed1ng s\u1ea3n ph\u1ea9m, WFI, PW, Clean Steam.<br \/>\n  + 1.4435 (X2CrNiMo18-14-3): ki\u1ec3m so\u00e1t Mo cao v\u00e0 t\u1ea1p ch\u1eb7t h\u01a1n, \u0111\u01b0\u1ee3c \u01b0a chu\u1ed9ng trong d\u01b0\u1ee3c ch\u00e2u \u00c2u \u0111\u1ec3 t\u0103ng ch\u1ed1ng r\u1ed7.<br \/>\n  + 304L: ch\u1ec9 n\u00ean d\u00f9ng cho ti\u1ec7n \u00edch kh\u00f4ng ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp (kh\u00f4ng khuy\u1ebfn ngh\u1ecb cho d\u01b0\u1ee3c ph\u1ea9m\/ PW\/WFI).<br \/>\n&#8211; C\u00e1c th\u00f4ng s\u1ed1 c\u1ea7n ch\u00fa \u00fd:<br \/>\n  + H\u00e0m l\u01b0\u1ee3ng S (l\u01b0u hu\u1ef3nh) ki\u1ec3m so\u00e1t h\u1eb9p theo ASME BPE \u0111\u1ec3 v\u1eeba h\u00e0n t\u1ed1t v\u1eeba gi\u1ea3m \u0103n m\u00f2n bi\u00ean h\u1ea1t; nhi\u1ec1u nh\u00e0 m\u00e1y y\u00eau c\u1ea7u 0.005\u20130.017% S.<br \/>\n  + T\u00ecnh tr\u1ea1ng nhi\u1ec7t luy\u1ec7n: solution annealed + pickled, lo\u1ea1i b\u1ecf ferit t\u1ef1 do v\u00e0 l\u00e0m \u0111\u1ed3ng nh\u1ea5t austenite.<br \/>\n  + B\u1ec1 m\u1eb7t: theo ASME BPE SF1\u2013SF4; Ra \u2264 0.51 \u00b5m (SF1) cho \u1ed1ng ti\u00eau chu\u1ea9n, ho\u1eb7c th\u1ea5p h\u01a1n v\u1edbi electropolish cho m\u00f4i tr\u01b0\u1eddng ph\u00ea b\u00ecnh (WFI).<br \/>\n&#8211; R\u1ee7i ro khi v\u1eadt li\u1ec7u k\u00e9m:<br \/>\n  + Sai m\u00e1c\/thi\u1ebfu Mo -> r\u1ed7, pitting trong m\u00f4i tr\u01b0\u1eddng Cl\u2212.<br \/>\n  + S qu\u00e1 th\u1ea5p ho\u1eb7c qu\u00e1 cao -> kh\u00f3 h\u00e0n\/hot cracking ho\u1eb7c gi\u1ea3m ch\u1ed1ng \u0103n m\u00f2n.<br \/>\n  + B\u1ec1 m\u1eb7t th\u00f4\/\u00f4 nhi\u1ec5m s\u1eaft t\u1ef1 do -> rouging, t\u1ea1o \u1ed5 vi sinh.<\/p>\n<h2 id=\"toc-3-chung-chi-31-phai-co-nhung-gi\">Ch\u1ee9ng ch\u1ec9 3.1 ph\u1ea3i c\u00f3 nh\u1eefng g\u00ec?<\/h2>\n<p>M\u1ed9t MTC 3.1 \u0111\u1ea1t y\u00eau c\u1ea7u cho inox ng\u00e0nh d\u01b0\u1ee3c t\u1ed1i thi\u1ec3u g\u1ed3m:<br \/>\n&#8211; Th\u00f4ng tin nh\u00e0 s\u1ea3n xu\u1ea5t (mill), s\u1ed1 ch\u1ee9ng ch\u1ec9, ng\u00e0y k\u00fd, ng\u01b0\u1eddi k\u00fd thu\u1ed9c QA.<br \/>\n&#8211; M\u00f4 t\u1ea3 s\u1ea3n ph\u1ea9m: lo\u1ea1i (t\u1ea5m\/\u1ed1ng\/ph\u1ee5 ki\u1ec7n), k\u00edch th\u01b0\u1edbc, ti\u00eau chu\u1ea9n s\u1ea3n xu\u1ea5t \u00e1p d\u1ee5ng (ASTM\/EN\/ASME BPE).<br \/>\n&#8211; M\u00e1c th\u00e9p k\u00e9p (song song): ASTM 316L \u2013 EN 1.4404 ho\u1eb7c 1.4435; k\u00fd hi\u1ec7u X2CrNiMo17-12-2\/18-14-3.<br \/>\n&#8211; Heat number v\u00e0 batch\/lot, match v\u1edbi marking tr\u00ean v\u1eadt li\u1ec7u.<br \/>\n&#8211; Th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc \u0111o \u0111\u01b0\u1ee3c v\u00e0 gi\u1edbi h\u1ea1n chu\u1ea9n \u0111\u1ed1i chi\u1ebfu: C, Si, Mn, P, S, Cr, Ni, Mo, N, Fe, c\u00f3 th\u1ec3 th\u00eam Cu, Nb.<br \/>\n&#8211; C\u01a1 t\u00ednh: Rp0.2, Rm, A%, \u0111\u1ed9 c\u1ee9ng; tr\u1ea1ng th\u00e1i nhi\u1ec7t luy\u1ec7n.<br \/>\n&#8211; K\u1ebft qu\u1ea3 th\u1eed theo ti\u00eau chu\u1ea9n y\u00eau c\u1ea7u: ki\u1ec3m tra k\u00edch th\u01b0\u1edbc, \u0111\u1ed9 d\u1eb9t\/ovality (\u0111\u1ed1i v\u1edbi \u1ed1ng), ki\u1ec3m tra \u0103n m\u00f2n li\u00ean tinh (n\u1ebfu y\u00eau c\u1ea7u).<br \/>\n&#8211; Tuy\u00ean b\u1ed1 ph\u00f9 h\u1ee3p ti\u00eau chu\u1ea9n v\u00e0 d\u1ea5u\/tem c\u1ee7a nh\u00e0 m\u00e1y.<br \/>\nL\u01b0u \u00fd: Ra b\u1ec1 m\u1eb7t, passivation ho\u1eb7c electropolish th\u01b0\u1eddng n\u1eb1m \u1edf bi\u00ean b\u1ea3n th\u00ed nghi\u1ec7m\/b\u00e1o c\u00e1o ph\u1ee5 tr\u1ee3 (kh\u00f4ng ph\u1ea3i ph\u1ea7n m\u1eb7c \u0111\u1ecbnh c\u1ee7a 3.1) nh\u01b0ng ph\u1ea3i \u0111\u00ednh k\u00e8m h\u1ed3 s\u01a1 d\u1ef1 \u00e1n theo ASME BPE.<\/p>\n<h2 id=\"toc-4-cach-doc-va-tham-tra-chung-chi-31-quy-trinh-6-buoc\">C\u00e1ch \u0111\u1ecdc v\u00e0 th\u1ea9m tra ch\u1ee9ng ch\u1ec9 3.1: quy tr\u00ecnh 6 b\u01b0\u1edbc<\/h2>\n<h3>B\u01b0\u1edbc 1 \u2013 \u0110\u1ed1i chi\u1ebfu PO\/spec<\/h3>\n<p>&#8211; Ki\u1ec3m chu\u1ea9n \u00e1p d\u1ee5ng: ASTM\/EN\/ASME BPE trong \u0111\u01a1n h\u00e0ng c\u00f3 kh\u1edbp v\u1edbi ch\u1ee9ng ch\u1ec9.<br \/>\n&#8211; X\u00e1c nh\u1eadn m\u00e1c, k\u00edch th\u01b0\u1edbc, schedule\/OD-ID, l\u1edbp ho\u00e0n thi\u1ec7n b\u1ec1 m\u1eb7t.<\/p>\n<h3>B\u01b0\u1edbc 2 \u2013 Ki\u1ec3m tra truy xu\u1ea5t<\/h3>\n<p>&#8211; Heat number tr\u00ean ch\u1ee9ng ch\u1ec9 ph\u1ea3i tr\u00f9ng nh\u00e3n\/kh\u1eafc laser tr\u00ean t\u1eebng \u1ed1ng\/t\u1ea5m.<br \/>\n&#8211; V\u1edbi ph\u1ee5 ki\u1ec7n\/van nh\u1ecf, y\u00eau c\u1ea7u tag\/nh\u00e3n k\u00e8m lot v\u00e0 phi\u1ebfu packing list li\u00ean k\u1ebft heat.<\/p>\n<h3>B\u01b0\u1edbc 3 \u2013 R\u00e0 so\u00e1t h\u00f3a h\u1ecdc m\u1ebb<\/h3>\n<p>&#8211; So s\u00e1nh Cr, Ni, Mo, N v\u1edbi gi\u1edbi h\u1ea1n m\u00e1c; Mo c\u1ee7a 1.4435 cao v\u00e0 ch\u1eb7t h\u01a1n 1.4404, gi\u00fap ch\u1ed1ng r\u1ed7 t\u1ed1t h\u01a1n.<br \/>\n&#8211; Ki\u1ec3m tra S n\u1eb1m trong d\u1ea3i ch\u1ea5p nh\u1eadn c\u1ee7a d\u1ef1 \u00e1n\/ASME BPE.<br \/>\n&#8211; T\u1eeb ch\u1ed1i n\u1ebfu ph\u00e1t hi\u1ec7n l\u1ec7ch chu\u1ea9n ho\u1eb7c thi\u1ebfu d\u00f2ng d\u1eef li\u1ec7u nguy\u00ean t\u1ed1 ch\u00ednh.<\/p>\n<h3>B\u01b0\u1edbc 4 \u2013 X\u00e1c minh c\u01a1 t\u00ednh v\u00e0 nhi\u1ec7t luy\u1ec7n<\/h3>\n<p>&#8211; Rp0.2, Rm, A% ph\u00f9 h\u1ee3p ti\u00eau chu\u1ea9n; tr\u1ea1ng th\u00e1i solution annealed + pickled.<br \/>\n&#8211; V\u1edbi \u1ed1ng theo ASTM A270-S1\/ASME BPE: ki\u1ec3m tra k\u1ebft qu\u1ea3 flattening, flange, reverse bend n\u1ebfu c\u00f3.<\/p>\n<h3>B\u01b0\u1edbc 5 \u2013 Th\u00ed nghi\u1ec7m x\u00e1c nh\u1eadn t\u1ea1i ch\u1ed7<\/h3>\n<p>&#8211; PMI\/XRF 100% ng\u1eabu nhi\u00ean theo r\u1ee7i ro: x\u00e1c nh\u1eadn m\u00e1c v\u00e0 Mo.<br \/>\n&#8211; \u0110o ferrite t\u1ea1i m\u1ed1i h\u00e0n (n\u1ebfu \u0111\u00e3 h\u00e0n spool): m\u1ee5c ti\u00eau 3\u201310 FN \u0111\u1ec3 tr\u00e1nh n\u1ee9t n\u00f3ng nh\u01b0ng v\u1eabn ch\u1ed1ng \u0103n m\u00f2n.<br \/>\n&#8211; \u0110o Ra n\u1ed9i b\u1ed9 \u1ed1ng\/b\u1ed3n b\u1eb1ng stylus ho\u1eb7c replica; \u0111\u1ed1i chi\u1ebfu SF1\u2013SF4.<br \/>\n&#8211; Ki\u1ec3m tra passivation theo ASTM A967 (test sau th\u1ee5 \u0111\u1ed9ng) khi y\u00eau c\u1ea7u.<\/p>\n<h3>B\u01b0\u1edbc 6 \u2013 Kh\u00f3a truy xu\u1ea5t t\u00e0i li\u1ec7u<\/h3>\n<p>&#8211; Li\u00ean k\u1ebft heat number -> s\u1ed1 \u1ed1ng\/t\u1ea5m -> s\u1ed1 spool -> s\u1ed1 isometric -> P&#038;ID -> h\u1ec7 th\u1ed1ng (PW\/WFI\/Clean Steam).<br \/>\n&#8211; L\u01b0u MTC 3.1, b\u00e1o c\u00e1o Ra, bi\u00ean b\u1ea3n passivation\/electropolish v\u00e0o g\u00f3i DQ\/IQ\/OQ theo EU GMP Annex 15.<\/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; H\u1ec7 th\u1ed1ng\/ph\u1eadn t\u1ed1i quan tr\u1ecdng nh\u01b0 WFI loop, PW, Clean Steam, b\u1ed3n ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp d\u01b0\u1ee3c ch\u1ea5t c\u00f3 th\u1ec3 y\u00eau c\u1ea7u 3.2 \u0111\u1ec3 t\u0103ng m\u1ee9c \u0111\u1ed9c l\u1eadp gi\u00e1m s\u00e1t, \u0111\u1eb7c bi\u1ec7t trong d\u1ef1 \u00e1n EU-GMP ho\u1eb7c khi quy \u0111\u1ecbnh n\u1ed9i b\u1ed9 th\u1ea9m \u0111\u1ecbnh r\u1ee7i ro cao.<br \/>\n&#8211; 3.2 s\u1ebd t\u0103ng chi ph\u00ed\/lead-time do c\u1ea7n b\u00ean th\u1ee9 ba, nh\u01b0ng gi\u1ea3m r\u1ee7i ro kh\u00f4ng ph\u00f9 h\u1ee3p v\u1eadt li\u1ec7u.<\/p>\n<h2 id=\"toc-6-checklist-mua-inox-cho-nha-may-duoc\">Checklist mua inox cho nh\u00e0 m\u00e1y d\u01b0\u1ee3c<\/h2>\n<p>&#8211; Y\u00eau c\u1ea7u ch\u1ee9ng ch\u1ec9 3.1 theo EN 10204, m\u00e1c 316L (1.4404 ho\u1eb7c 1.4435); n\u00eau r\u00f5 gi\u1edbi h\u1ea1n S v\u00e0 Mo.<br \/>\n&#8211; \u1ed0ng v\u1ec7 sinh: ASTM A270-S1 v\u00e0\/ho\u1eb7c ASME BPE; b\u1ec1 m\u1eb7t SF1 tr\u1edf l\u00ean; y\u00eau c\u1ea7u Ra \u0111o th\u1ef1c t\u1ebf v\u00e0 b\u00e1o c\u00e1o \u0111\u00ednh k\u00e8m.<br \/>\n&#8211; T\u00ecnh tr\u1ea1ng: solution annealed + pickled; n\u1ebfu electropolish, y\u00eau c\u1ea7u h\u1ed3 s\u01a1 quy tr\u00ecnh v\u00e0 ch\u1ee9ng nh\u1eadn.<br \/>\n&#8211; \u0110\u1eb7t \u0111i\u1ec1u ki\u1ec7n ki\u1ec3m tra PMI t\u1ea1i nh\u1eadn h\u00e0ng v\u00e0 quy\u1ec1n t\u1eeb ch\u1ed1i n\u1ebfu l\u1ec7ch.<br \/>\n&#8211; Y\u00eau c\u1ea7u b\u1ea3n m\u1ec1m MTC c\u00f3 m\u00e3 QR\/trace v\u00e0 x\u00e1c nh\u1eadn t\u1eeb mill; tr\u00e1nh \u201cMTC t\u1ed5ng\u201d kh\u00f4ng c\u00f3 heat c\u1ee5 th\u1ec3.<br \/>\n&#8211; R\u00e0ng bu\u1ed9c \u0111\u00f3ng g\u00f3i s\u1ea1ch, b\u1ecbt \u0111\u1ea7u \u1ed1ng, n\u1eafp b\u1ea3o v\u1ec7 m\u1eb7t b\u00edch; d\u1ea5u marking kh\u00f4ng x\u00e2m th\u1ef1c b\u1ec1 m\u1eb7t ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m.<\/p>\n<h2 id=\"toc-7-rui-ro-neu-thieu-31-hoac-tham-tra-kem\">R\u1ee7i ro n\u1ebfu thi\u1ebfu 3.1 ho\u1eb7c th\u1ea9m tra k\u00e9m<\/h2>\n<p>&#8211; Kh\u00f4ng \u0111\u1ea1t th\u1ea9m \u0111\u1ecbnh EU-GMP\/FDA v\u1ec1 truy xu\u1ea5t thi\u1ebft b\u1ecb.<br \/>\n&#8211; Nguy c\u01a1 \u0103n m\u00f2n r\u1ed7\/rouging -> t\u0103ng chi ph\u00ed CIP\/SIP, ng\u1eebng m\u00e1y, h\u1ecfng m\u1ebb.<br \/>\n&#8211; Kh\u00f4ng b\u1ea3o v\u1ec7 tr\u01b0\u1edbc tranh ch\u1ea5p: kh\u00f3 ch\u1ee9ng minh nh\u00e0 cung c\u1ea5p d\u00f9ng \u0111\u00fang v\u1eadt li\u1ec7u.<\/p>\n<h2 id=\"toc-8-cac-cau-hoi-thuong-gap\">C\u00e1c c\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p<\/h2>\n<p>&#8211; B\u1ea3n scan MTC c\u00f3 ch\u1ea5p nh\u1eadn? Ch\u1ea5p nh\u1eadn n\u1ebfu x\u00e1c th\u1ef1c \u0111\u01b0\u1ee3c v\u1edbi mill ho\u1eb7c c\u00f3 ch\u1eef k\u00fd s\u1ed1\/m\u00e3 QR; \u01b0u ti\u00ean b\u1ea3n g\u1ed1c\/digital traceable.<br \/>\n&#8211; MTC ph\u1ea3i b\u1eb1ng ti\u1ebfng g\u00ec? Ti\u1ebfng Anh\/ti\u1ebfng c\u1ee7a n\u01b0\u1edbc s\u1ea3n xu\u1ea5t l\u00e0 ph\u1ed5 bi\u1ebfn; quan tr\u1ecdng l\u00e0 chu\u1ea9n\/gi\u00e1 tr\u1ecb r\u00f5 r\u00e0ng. C\u00f3 th\u1ec3 y\u00eau c\u1ea7u b\u1ea3n d\u1ecbch ch\u1ee9ng th\u1ef1c.<br \/>\n&#8211; 304L c\u00f3 d\u00f9ng cho PW\/WFI? Kh\u00f4ng khuy\u1ebfn ngh\u1ecb; 316L\/1.4435 v\u1edbi b\u1ec1 m\u1eb7t chu\u1ea9n BPE m\u1edbi \u0111\u00e1p \u1ee9ng ch\u1ed1ng \u0103n m\u00f2n\/vi sinh.<br \/>\n&#8211; C\u00f3 c\u1ea7n MTC cho t\u1eebng ph\u1ee5 ki\u1ec7n nh\u1ecf? C\u00f3. T\u1ed1i thi\u1ec3u c\u1ea7n li\u00ean k\u1ebft lot\/heat; g\u1ed9p theo batch cho fitting nh\u1ecf nh\u01b0ng v\u1eabn truy xu\u1ea5t.<\/p>\n<h2 id=\"toc-9-nguon-tham-khao\">Ngu\u1ed3n tham kh\u1ea3o<\/h2>\n<p>&#8211; EN 10204:2004 \u2013 Metallic products \u2013 Types of inspection documents (CEN).<br \/>\n&#8211; ASME BPE \u2013 Bioprocessing Equipment Standard (ASME).<br \/>\n&#8211; ASTM A270 \u2013 Standard Specification for Seamless and Welded Austenitic Stainless Steel Sanitary Tubing (ASTM).<br \/>\n&#8211; ASTM A240 \u2013 Plate, Sheet, and Strip for Corrosion-Resisting Steel (ASTM).<br \/>\n&#8211; ASTM A380\/A967 \u2013 Cleaning, Descaling, and Passivation of Stainless Steel (ASTM).<br \/>\n&#8211; EU GMP Guide &#038; Annex 15 \u2013 Qualification and Validation (European Commission).<br \/>\n&#8211; FDA 21 CFR Part 211 \u2013 Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA).<br \/>\n&#8211; EN 10088 \u2013 Stainless steels (chemical composition for grades) (CEN).<\/p>\n<h2 id=\"toc-10-ket-luan\">K\u1ebft lu\u1eadn<\/h2>\n<p>Trong m\u00f4i tr\u01b0\u1eddng d\u01b0\u1ee3c ph\u1ea9m, ch\u1ee9ng ch\u1ec9 v\u1eadt li\u1ec7u 3.1 kh\u00f4ng ch\u1ec9 l\u00e0 \u201cgi\u1ea5y t\u1edd \u0111i k\u00e8m\u201d m\u00e0 l\u00e0 b\u1eb1ng ch\u1ee9ng l\u00f5i \u0111\u1ec3 b\u1ea3o \u0111\u1ea3m \u0111\u00fang m\u00e1c, \u0111\u00fang m\u1ebb, \u0111\u00fang b\u1ec1 m\u1eb7t v\u00e0 truy xu\u1ea5t \u0111\u1ea7y \u0111\u1ee7 theo GMP\/EU-GMP\/FDA. \u00c1p d\u1ee5ng quy tr\u00ecnh th\u1ea9m tra 6 b\u01b0\u1edbc, g\u1eafn 3.1 v\u1edbi y\u00eau c\u1ea7u ASME BPE, ASTM v\u00e0 qu\u1ea3n tr\u1ecb truy xu\u1ea5t t\u1edbi t\u1eebng spool s\u1ebd gi\u1ea3m m\u1ea1nh r\u1ee7i ro \u0103n m\u00f2n, nhi\u1ec5m b\u1ea9n v\u00e0 kh\u00f4ng ph\u00f9 h\u1ee3p khi th\u1ea9m \u0111\u1ecbnh. H\u00e3y xem 3.1 nh\u01b0 ti\u00eau ch\u00ed b\u1eaft bu\u1ed9c trong m\u1ecdi PO inox cho d\u01b0\u1ee3c, v\u00e0 c\u00e2n nh\u1eafc 3.2 cho h\u1ea1ng m\u1ee5c t\u1edbi h\u1ea1n nh\u01b0 PW\/WFI\/Clean Steam.<\/p>\n<p>C\u1ea7n t\u01b0 v\u1ea5n ch\u1ecdn m\u00e1c, b\u1ec1 m\u1eb7t v\u00e0 h\u1ed3 s\u01a1 3.1\/3.2 cho d\u1ef1 \u00e1n d\u01b0\u1ee3c? Li\u00ean h\u1ec7 Inox C\u01b0\u1eddng Th\u1ecbnh \u0111\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n 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 ch\u1ec9 3.1 theo EN 10204 cho inox d\u01b0\u1ee3c: n\u1ed9i dung c\u1ea7n c\u00f3, c\u00e1ch \u0111\u1ecdc v\u00e0 th\u1ea9m tra theo ASME BPE, GMP\/FDA; checklist mua h\u00e0ng v\u00e0 r\u1ee7i ro khi thi\u1ebfu.<\/p>\n","protected":false},"author":7,"featured_media":1070,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[23],"tags":[],"class_list":["post-1363","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\/1363","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=1363"}],"version-history":[{"count":0,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts\/1363\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media\/1070"}],"wp:attachment":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media?parent=1363"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/categories?post=1363"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/tags?post=1363"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}