{"id":1354,"date":"2025-11-25T12:34:25","date_gmt":"2025-11-25T05:34:25","guid":{"rendered":"https:\/\/inoxcuongthinh.com\/vat-lieu-inox-cho-phong-sach-chon-mac-be-mat-do-day-chuan\/"},"modified":"2025-11-25T12:34:25","modified_gmt":"2025-11-25T05:34:25","slug":"vat-lieu-inox-cho-phong-sach-chon-mac-be-mat-do-day-chuan","status":"publish","type":"post","link":"https:\/\/inoxcuongthinh.com\/vat-lieu-inox-cho-phong-sach-chon-mac-be-mat-do-day-chuan\/","title":{"rendered":"V\u1eadt li\u1ec7u inox cho ph\u00f2ng s\u1ea1ch: ch\u1ecdn m\u00e1c, b\u1ec1 m\u1eb7t, \u0111\u1ed9 d\u00e0y chu\u1ea9n"},"content":{"rendered":"<div class=\"custom-toc\">\n<h3>N\u1ed9i dung ch\u00ednh<\/h3>\n<ul>\n<li><a href=\"#toc-0-yeu-cau-ky-thuat-phong-sach-chi-phoi-viec-chon-ino\">Y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt ph\u00f2ng s\u1ea1ch chi ph\u1ed1i vi\u1ec7c ch\u1ecdn inox<\/a><\/li>\n<li><a href=\"#toc-1-chon-mac-inox-theo-ung-dung\">Ch\u1ecdn m\u00e1c inox theo \u1ee9ng d\u1ee5ng<\/a><\/li>\n<li><a href=\"#toc-2-hoan-thien-be-mat-va-do-nham-yeu-to-quyet-dinh-kha\">Ho\u00e0n thi\u1ec7n b\u1ec1 m\u1eb7t v\u00e0 \u0111\u1ed9 nh\u00e1m: y\u1ebfu t\u1ed1 quy\u1ebft \u0111\u1ecbnh kh\u1ea3 n\u0103ng l\u00e0m s\u1ea1ch<\/a><\/li>\n<li><a href=\"#toc-3-do-day-kich-thuoc-tamong-va-khuyen-nghi-cau-tao\">\u0110\u1ed9 d\u00e0y, k\u00edch th\u01b0\u1edbc t\u1ea5m\/\u1ed1ng v\u00e0 khuy\u1ebfn ngh\u1ecb c\u1ea5u t\u1ea1o<\/a><\/li>\n<li><a href=\"#toc-4-ong-va-phu-kien-ve-sinh-theo-asme-bpeen\">\u1ed0ng v\u00e0 ph\u1ee5 ki\u1ec7n v\u1ec7 sinh theo ASME BPE\/EN<\/a><\/li>\n<li><a href=\"#toc-5-phu-kien-bulong-gioang-keo-tram-cho-phong-sach\">Ph\u1ee5 ki\u1ec7n, bulong, gio\u0103ng, keo tr\u00e1m cho ph\u00f2ng s\u1ea1ch<\/a><\/li>\n<li><a href=\"#toc-6-thiet-ke-chi-tiet-de-chong-nhiem-ban\">Thi\u1ebft k\u1ebf chi ti\u1ebft \u0111\u1ec3 ch\u1ed1ng nhi\u1ec5m b\u1ea9n<\/a><\/li>\n<li><a href=\"#toc-7-gia-cong-lap-dat-nghiem-thu\">Gia c\u00f4ng, l\u1eafp \u0111\u1eb7t, nghi\u1ec7m thu<\/a><\/li>\n<li><a href=\"#toc-8-tuong-thich-hoa-chat-ve-sinh-pho-bien\">T\u01b0\u01a1ng th\u00edch h\u00f3a ch\u1ea5t v\u1ec7 sinh ph\u1ed5 bi\u1ebfn<\/a><\/li>\n<li><a href=\"#toc-9-lua-chon-theo-nganh\">L\u1ef1a ch\u1ecdn theo ng\u00e0nh<\/a><\/li>\n<li><a href=\"#toc-10-so-sanh-chi-phi-vong-doi\">So s\u00e1nh chi ph\u00ed \u2013 v\u00f2ng \u0111\u1eddi<\/a><\/li>\n<li><a href=\"#toc-11-danh-muc-vat-tu-goi-y-bom-tham-khao\">Danh m\u1ee5c v\u1eadt t\u01b0 g\u1ee3i \u00fd (BOM tham kh\u1ea3o)<\/a><\/li>\n<li><a href=\"#toc-12-cau-hoi-thuong-gap\">C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p<\/a><\/li>\n<li><a href=\"#toc-13-nguon-tham-khao\">Ngu\u1ed3n tham kh\u1ea3o<\/a><\/li>\n<li><a href=\"#toc-14-ket-luan\">K\u1ebft lu\u1eadn<\/a><\/li>\n<\/ul>\n<\/div>\n<p>Inox l\u00e0 v\u1eadt li\u1ec7u chu\u1ea9n \u0111\u1ec3 x\u00e2y d\u1ef1ng v\u00e0 l\u1eafp \u0111\u1eb7t n\u1ed9i th\u1ea5t ph\u00f2ng s\u1ea1ch nh\u1edd t\u00ednh tr\u01a1, ch\u1ed1ng \u0103n m\u00f2n v\u00e0 d\u1ec5 v\u1ec7 sinh. B\u00e0i vi\u1ebft n\u00e0y t\u1ed5ng h\u1ee3p ti\u00eau ch\u00ed ch\u1ecdn m\u00e1c th\u00e9p, ho\u00e0n thi\u1ec7n b\u1ec1 m\u1eb7t, \u0111\u1ed9 d\u00e0y, ph\u1ee5 ki\u1ec7n v\u00e0 quy tr\u00ecnh l\u1eafp \u0111\u1eb7t ph\u00f9 h\u1ee3p cho ph\u00f2ng s\u1ea1ch trong th\u1ef1c ph\u1ea9m, y t\u1ebf, d\u01b0\u1ee3c ph\u1ea9m\u2014\u0111\u00e1p \u1ee9ng ISO 14644 v\u00e0 GMP. <\/p>\n<h2 id=\"toc-0-yeu-cau-ky-thuat-phong-sach-chi-phoi-viec-chon-ino\">Y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt ph\u00f2ng s\u1ea1ch chi ph\u1ed1i vi\u1ec7c ch\u1ecdn inox<\/h2>\n<p>&#8211; Kh\u00f4ng sinh b\u1ee5i, kh\u00f4ng th\u1ea5m, kh\u00f4ng n\u1ee9t v\u1ee1; b\u1ec1 m\u1eb7t ph\u1eb3ng, k\u00edn kh\u00edt, d\u1ec5 lau r\u1eeda (ISO 14644-1; EU GMP Annex 1).<br \/>\n&#8211; Ch\u1ecbu \u0111\u01b0\u1ee3c h\u00f3a ch\u1ea5t kh\u1eed khu\u1ea9n ph\u1ed5 bi\u1ebfn: IPA, H2O2 (kh\u00ed VHP), peracetic acid, quats; h\u1ea1n ch\u1ebf clo (NaOCl) \u0111\u1ec3 tr\u00e1nh r\u1ed7 do clorua.<br \/>\n&#8211; Kh\u1ea3 n\u0103ng ch\u1ed1ng \u0103n m\u00f2n v\u00e0 l\u00e0m s\u1ea1ch l\u1eb7p l\u1ea1i; kh\u00f4ng ph\u00e1t sinh ion kim lo\u1ea1i g\u00e2y nhi\u1ec5m b\u1ea9n.<br \/>\n&#8211; Thi\u1ebft k\u1ebf h\u1ea1n ch\u1ebf khe k\u1ebd, g\u00f3c ch\u1ebft; m\u1ed1i n\u1ed1i \u00edt nh\u1ea5t c\u00f3 th\u1ec3; \u01b0u ti\u00ean h\u00e0n k\u00edn.<br \/>\n&#8211; T\u00ednh d\u1eabn \u0111i\u1ec7n gi\u00fap ki\u1ec3m so\u00e1t ESD n\u1ebfu \u0111\u01b0\u1ee3c n\u1ed1i \u0111\u1ea5t \u0111\u00fang c\u00e1ch (h\u1eefu \u00edch trong MD\/\u0111i\u1ec7n t\u1eed s\u1ea1ch).<\/p>\n<h2 id=\"toc-1-chon-mac-inox-theo-ung-dung\">Ch\u1ecdn m\u00e1c inox theo \u1ee9ng d\u1ee5ng<\/h2>\n<p>&#8211; 304\/304L (1.4301\/1.4307, AISI 304\/304L): ph\u1ed5 bi\u1ebfn cho t\u01b0\u1eddng tr\u1ea7n, b\u00e0n k\u1ec7 khu s\u1ea1ch c\u1ea5p kh\u00f4ng qu\u00e1 kh\u1eafc nghi\u1ec7t; PREN ~18.<br \/>\n&#8211; 316L (1.4404, AISI 316L): c\u00f3 Mo 2.0\u20132.5% ch\u1ed1ng r\u1ed7 pitting\/chloride t\u1ed1t h\u01a1n; khuy\u1ebfn ngh\u1ecb cho d\u01b0\u1ee3c, y t\u1ebf, th\u1ef1c ph\u1ea9m m\u1eb7n\/axit, khu th\u01b0\u1eddng xuy\u00ean d\u00f9ng VHP\/NaOCl; PREN ~23.<br \/>\n&#8211; 430 (1.4016, ferritic): d\u00f9ng cho chi ti\u1ebft kh\u00f4ng ti\u1ebfp x\u00fac quy tr\u00ecnh, m\u00f4i tr\u01b0\u1eddng kh\u00f4 (\u1ed1p trang tr\u00ed, v\u1ecf t\u1ee7 \u0111i\u1ec7n). Kh\u00f4ng khuy\u1ebfn ngh\u1ecb cho khu \u1ea9m\/ho\u00e1 ch\u1ea5t.<br \/>\n&#8211; 321\/316Ti: ch\u1ecbu nhi\u1ec7t\/chu k\u1ef3 nhi\u1ec7t cao; \u00edt d\u00f9ng cho n\u1ed9i th\u1ea5t ph\u00f2ng s\u1ea1ch, ph\u00f9 h\u1ee3p \u1ed1ng x\u1ea3\/thi\u1ebft b\u1ecb nhi\u1ec7t.<br \/>\n&#8211; 904L, Duplex 2205: m\u00f4i tr\u01b0\u1eddng clorua r\u1ea5t cao ho\u1eb7c ven bi\u1ec3n; c\u00e2n nh\u1eafc cho k\u1ebft c\u1ea5u ngo\u00e0i tr\u1eddi\/kh\u00ed h\u1eadu m\u1eb7n.<\/p>\n<p>Khuy\u1ebfn ngh\u1ecb th\u1ef1c t\u1ebf:<br \/>\n&#8211; \u1ed0p t\u01b0\u1eddng\/tr\u1ea7n ph\u00f2ng s\u1ea1ch: 304L (kh\u00f4\/\u00edt clo) ho\u1eb7c 316L (VHP\/NaOCl\/\u1ea9m).<br \/>\n&#8211; Pass box, air shower, tay v\u1ecbn, b\u1ec7 ng\u1ed3i, tay n\u1eafm c\u1eeda: 316L.<br \/>\n&#8211; B\u00e0n thao t\u00e1c, k\u1ec7, xe \u0111\u1ea9y: 304L (th\u1ef1c ph\u1ea9m kh\u00f4) ho\u1eb7c 316L (\u01b0\u1edbt\/m\u1eb7n\/axit).<br \/>\n&#8211; B\u1ed3n, ch\u1eadu, siphon, s\u00e0n r\u00e3nh thu n\u01b0\u1edbc: 316L.<br \/>\n&#8211; \u1ed0ng c\u00f4ng ngh\u1ec7, vi sinh, CIP\/SIP: 316L theo ASME BPE\/EN 10217-7.<br \/>\n&#8211; Ph\u1ee5 ki\u1ec7n nh\u1ecf kh\u00f4ng ti\u1ebfp x\u00fac: c\u00f3 th\u1ec3 430 \u0111\u1ec3 t\u1ed1i \u01b0u chi ph\u00ed (m\u00f4i tr\u01b0\u1eddng kh\u00f4).<\/p>\n<h2 id=\"toc-2-hoan-thien-be-mat-va-do-nham-yeu-to-quyet-dinh-kha\">Ho\u00e0n thi\u1ec7n b\u1ec1 m\u1eb7t v\u00e0 \u0111\u1ed9 nh\u00e1m: y\u1ebfu t\u1ed1 quy\u1ebft \u0111\u1ecbnh kh\u1ea3 n\u0103ng l\u00e0m s\u1ea1ch<\/h2>\n<p>&#8211; 2B: m\u1edd s\u00e1ng c\u00e1n ngu\u1ed9i, \u0111\u1ed9 nh\u00e1m Ra ~0,3\u20130,6 \u00b5m; d\u1ec5 lau, \u00edt gi\u1eef b\u1ea9n. R\u1ea5t ph\u00f9 h\u1ee3p cho \u1ed1p t\u01b0\u1eddng\/tr\u1ea7n.<br \/>\n&#8211; BA (Bright Annealed): b\u00f3ng g\u01b0\u01a1ng do \u1ee7 s\u00e1ng; b\u1ec1 m\u1eb7t r\u1ea5t m\u1ecbn, s\u1ea1ch d\u1ec5; th\u1ea9m m\u1ef9 cao cho n\u1ed9i th\u1ea5t hi\u1ec3n th\u1ecb.<br \/>\n&#8211; No.4 \/ Hairline: x\u01b0\u1edbc m\u1ecbn trang tr\u00ed; \u0111\u1eb9p nh\u01b0ng c\u00e1c r\u00e3nh c\u00f3 th\u1ec3 gi\u1eef b\u1ee5i h\u01a1n 2B\/BA; c\u1ea7n lau c\u00f9ng h\u01b0\u1edbng x\u01b0\u1edbc; tr\u00e1nh \u1edf khu Grade cao d\u1ec5 t\u00edch b\u1ea9n.<br \/>\n&#8211; Bead-blast: m\u1edd nh\u00e1m \u0111\u1ed3ng \u0111\u1ec1u; ki\u1ec3m so\u00e1t Ra, l\u01b0u \u00fd tr\u00e1nh qu\u00e1 nh\u00e1m.<br \/>\n&#8211; \u0110i\u1ec7n ho\u00e1 b\u00f3ng (Electropolish, EP): gi\u1ea3m \u0111\u1ec9nh nh\u00e1m, kh\u1eed s\u1eaft t\u1ef1 do; m\u1ee5c ti\u00eau Ra \u2264 0,5 \u00b5m cho b\u1ec1 m\u1eb7t ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m theo ASME BPE.<br \/>\n&#8211; Passivation (ASTM A967): x\u1eed l\u00fd axit nh\u1eb9 t\u1ea1o l\u1edbp oxit crom b\u1ec1n; khuy\u1ebfn ngh\u1ecb sau h\u00e0n\/gia c\u00f4ng.<\/p>\n<p>M\u1ee5c ti\u00eau nh\u00e1m b\u1ec1 m\u1eb7t:<br \/>\n&#8211; B\u1ec1 m\u1eb7t kh\u00f4ng ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m: Ra \u2264 0,8\u20131,6 \u00b5m (2B\/BA \u0111\u1ee7).<br \/>\n&#8211; B\u1ec1 m\u1eb7t ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m\/vi sinh: Ra \u2264 0,5 \u00b5m, \u01b0u ti\u00ean EP theo ASME BPE.<\/p>\n<h2 id=\"toc-3-do-day-kich-thuoc-tamong-va-khuyen-nghi-cau-tao\">\u0110\u1ed9 d\u00e0y, k\u00edch th\u01b0\u1edbc t\u1ea5m\/\u1ed1ng v\u00e0 khuy\u1ebfn ngh\u1ecb c\u1ea5u t\u1ea1o<\/h2>\n<p>T\u1ea5m th\u00e9p kh\u00f4ng g\u1ec9 ti\u00eau chu\u1ea9n: 1219\u00d72438 mm (4\u00d78\u2019), 1219\u00d73048 mm (4\u00d710\u2019), 1500\u00d73000 mm. Ti\u00eau chu\u1ea9n v\u1eadt li\u1ec7u: ASTM A240\/A480 ho\u1eb7c EN 10088-2.<\/p>\n<p>G\u1ee3i \u00fd \u0111\u1ed9 d\u00e0y theo h\u1ea1ng m\u1ee5c:<br \/>\n&#8211; \u1ed0p t\u01b0\u1eddng: 0,8\u20131,0 mm (2B\/BA), gia c\u1ed1 x\u01b0\u01a1ng th\u00e9p m\u1ea1 k\u1ebdm\/inox; ke v\u00e1t bo m\u00e9p.<br \/>\n&#8211; Tr\u1ea7n k\u00edn: 0,6\u20130,8 mm; module k\u1eb9p k\u00edn, gio\u0103ng li\u00ean k\u1ebft.<br \/>\n&#8211; Pass box, air shower v\u1ecf: 1,0\u20131,2 mm; c\u1eeda k\u00ednh c\u01b0\u1eddng l\u1ef1c + khung 316L.<br \/>\n&#8211; B\u00e0n thao t\u00e1c\/qu\u1ea7y: m\u1eb7t 1,2\u20131,5 mm; khung 1,5\u20132,0 mm; ch\u1ed1ng v\u00f5ng b\u1eb1ng g\u00e2n d\u1ecdc.<br \/>\n&#8211; Gi\u00e1 k\u1ec7: \u0111\u1ee3t 1,0\u20131,2 mm; khung 1,5\u20132,0 mm.<br \/>\n&#8211; B\u1ed3n ch\u1eadu\/r\u00e3nh thu n\u01b0\u1edbc: 1,5\u20132,0 mm; d\u1ed1c tho\u00e1t \u22651\u20132%.<br \/>\n&#8211; \u1ed0ng c\u00f4ng ngh\u1ec7: 316L OD theo ASME BPE\/ISO; th\u00e0nh 1,5\u20132,0 mm t\u00f9y \u0111\u01b0\u1eddng k\u00ednh\/\u00e1p su\u1ea5t.<\/p>\n<p>L\u01b0u \u00fd c\u01a1 kh\u00ed:<br \/>\n&#8211; D\u00f9ng stiffener \u1ea9n \u0111\u1ec3 gi\u1eef ph\u1eb3ng t\u1ea5m m\u1ecfng, gi\u1ea3m \u201coil-canning\u201d.<br \/>\n&#8211; M\u00e9p g\u1ea5p \u201chem\u201d 10\u201315 mm ch\u1ed1ng c\u1eaft tay, t\u0103ng c\u1ee9ng.<br \/>\n&#8211; T\u1ed1i \u01b0u kh\u1ed5 c\u1eaft \u0111\u1ec3 gi\u1ea3m m\u1ed1i n\u1ed1i, che m\u1ed1i n\u1ed1i b\u1eb1ng n\u1eb9p inox bo b\u00e1n k\u00ednh.<\/p>\n<h2 id=\"toc-4-ong-va-phu-kien-ve-sinh-theo-asme-bpeen\">\u1ed0ng v\u00e0 ph\u1ee5 ki\u1ec7n v\u1ec7 sinh theo ASME BPE\/EN<\/h2>\n<p>&#8211; Ti\u00eau chu\u1ea9n: ASME BPE (\u1ed1ng\/ph\u1ee5 ki\u1ec7n vi sinh), EN 10217-7 (\u1ed1ng h\u00e0n), ISO 1127 (k\u00edch th\u01b0\u1edbc).<br \/>\n&#8211; K\u1ebft n\u1ed1i: Tri-clamp (sanitary clamp), m\u1eb7t b\u00edch hygienic; gio\u0103ng EPDM, silicone platinum-cured, PTFE; ch\u1ee9ng nh\u1eadn FDA\/USP Class VI.<br \/>\n&#8211; B\u1ec1 m\u1eb7t trong \u1ed1ng: ID Ra \u2264 0,8 \u00b5m (ph\u1ed5 bi\u1ebfn), c\u00e1c tuy\u1ebfn v\u00f4 tr\u00f9ng Ra \u2264 0,5 \u00b5m, EP khi c\u1ea7n.<br \/>\n&#8211; H\u00e0n: Orbital TIG, kh\u00ed che Ar, v\u1ec7 sinh MOP; ki\u1ec3m tra boroscope, PMI khi c\u1ea7n.<br \/>\n&#8211; Thi\u1ebft k\u1ebf tho\u00e1t c\u1eb7n: nghi\u00eang t\u1ed1i thi\u1ec3u 1:100, tr\u00e1nh \u201cdead-leg\u201d >1,5\u00d7\u0110K \u1ed1ng theo BPE.<\/p>\n<h2 id=\"toc-5-phu-kien-bulong-gioang-keo-tram-cho-phong-sach\">Ph\u1ee5 ki\u1ec7n, bulong, gio\u0103ng, keo tr\u00e1m cho ph\u00f2ng s\u1ea1ch<\/h2>\n<p>&#8211; Bulong\/\u0111inh t\u00e1n: A2-70 (304) ho\u1eb7c A4-70 (316) theo ISO 3506; che \u0111\u1ea7u b\u1eb1ng n\u1eafp k\u00edn; tr\u00e1nh th\u00e9p carbon \u0111\u1ec3 ng\u0103n nhi\u1ec5m s\u1eaft.<br \/>\n&#8211; Gio\u0103ng\/\u0111\u1ec7m: EPDM, silicone, FKM, PTFE; ch\u1ecdn lo\u1ea1i low outgassing, ph\u00f9 h\u1ee3p VHP\/IPA; ch\u1ee9ng nh\u1eadn th\u1ef1c ph\u1ea9m\/y t\u1ebf khi c\u1ea7n.<br \/>\n&#8211; Keo tr\u00e1m: silicone trung t\u00ednh, \u00edt VOC; silicone\/PU \u0111\u1ea1t FDA 21 CFR 175.300 ho\u1eb7c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng cho v\u00f9ng c\u00f3 th\u1ec3 v\u0103ng b\u1eafn; ch\u1ed1ng n\u1ea5m m\u1ed1c; t\u01b0\u01a1ng th\u00edch H2O2.<br \/>\n&#8211; Mi\u1ebfng \u0111\u1ec7m c\u00e1ch \u0111i\u1ec7n\/ESD: \u0111\u1ea3m b\u1ea3o n\u1ed1i \u0111\u1ea5t cho m\u1eb7t inox nh\u1eb1m x\u1ea3 t\u0129nh \u0111i\u1ec7n.<br \/>\n&#8211; V\u1eadt li\u1ec7u b\u1ed5 tr\u1ee3: tr\u00e1nh nh\u1ef1a gi\u00f2n\/kh\u00f3 v\u1ec7 sinh; \u01b0u ti\u00ean b\u1ec1 m\u1eb7t ph\u1eb3ng, \u00edt m\u1ed1i gh\u00e9p.<\/p>\n<h2 id=\"toc-6-thiet-ke-chi-tiet-de-chong-nhiem-ban\">Thi\u1ebft k\u1ebf chi ti\u1ebft \u0111\u1ec3 ch\u1ed1ng nhi\u1ec5m b\u1ea9n<\/h2>\n<p>&#8211; Bo g\u00f3c s\u00e0n\u2013t\u01b0\u1eddng\u2013tr\u1ea7n b\u00e1n k\u00ednh \u226525 mm; tr\u00e1nh g\u00f3c 90\u00b0.<br \/>\n&#8211; H\u1ea1n ch\u1ebf b\u1ec1 m\u1eb7t n\u1eb1m ngang; m\u00e1i che thi\u1ebft b\u1ecb d\u1ed1c 3\u20135\u00b0.<br \/>\n&#8211; H\u00e0n li\u00ean t\u1ee5c k\u00edn; tr\u00e1nh v\u00edt l\u1ed9\/khe h\u1edf; b\u1ecbt k\u00edn \u0111\u1ea7u \u1ed1ng h\u1ed9p.<br \/>\n&#8211; Kh\u00f4ng d\u00f9ng h\u1ed9p r\u1ed7ng kh\u00f4ng th\u00f4ng kh\u00ed trong m\u00f4i tr\u01b0\u1eddng VHP; n\u1ebfu c\u00f3, ph\u1ea3i b\u1ecbt k\u00edn tuy\u1ec7t \u0111\u1ed1i.<br \/>\n&#8211; Khe h\u1edf m\u1ed1i n\u1ed1i \u22641 mm, tr\u00e1m keo ph\u1eb3ng; tr\u00e1nh silicone d\u01b0 b\u00e1m b\u1ea9n.<br \/>\n&#8211; C\u1eeda inox: b\u1ea3n l\u1ec1 316L, gio\u0103ng t\u1eeb k\u00edn; ng\u01b0\u1ee1ng d\u1ed1c; c\u1eeda s\u1ed5 k\u00ednh ph\u1eb3ng v\u1edbi khung.<\/p>\n<h2 id=\"toc-7-gia-cong-lap-dat-nghiem-thu\">Gia c\u00f4ng, l\u1eafp \u0111\u1eb7t, nghi\u1ec7m thu<\/h2>\n<p>&#8211; Gia c\u00f4ng: t\u00e1ch khu v\u1ef1c v\u1edbi th\u00e9p carbon; d\u1ee5ng c\u1ee5 ri\u00eang cho inox; kh\u00f4ng m\u00e0i chung \u0111\u1ec3 tr\u00e1nh nhi\u1ec5m Fe; gi\u1eef film PVC \u0111\u1ebfn tr\u01b0\u1edbc khi b\u00e0n giao.<br \/>\n&#8211; Sau h\u00e0n: pickling &#038; passivation (ASTM A967\/A380); r\u1eeda s\u1ea1ch; th\u1eed Ferroxyl ph\u00e1t hi\u1ec7n s\u1eaft t\u1ef1 do khi c\u1ea7n.<br \/>\n&#8211; L\u1eafp \u0111\u1eb7t: g\u0103ng tay s\u1ea1ch, \u0111\u1ec7m m\u1ec1m tr\u00e1nh tr\u1ea7y x\u01b0\u1edbc; v\u1ec7 sinh t\u1eebng l\u1edbp; b\u1ea3o v\u1ec7 b\u1ec1 m\u1eb7t trong su\u1ed1t thi c\u00f4ng.<br \/>\n&#8211; Ki\u1ec3m tra: \u0111\u1ed9 ph\u1eb3ng, khe n\u1ed1i, nh\u00e1m b\u1ec1 m\u1eb7t, t\u00e0i li\u1ec7u m\u00e1c v\u1eadt li\u1ec7u (MTC), ch\u1ee9ng ch\u1ec9 keo\/gio\u0103ng; th\u1eed l\u00e0m s\u1ea1ch; n\u1ebfu thu\u1ed9c d\u01b0\u1ee3c, th\u1ef1c hi\u1ec7n IQ\/OQ theo GMP.<\/p>\n<h2 id=\"toc-8-tuong-thich-hoa-chat-ve-sinh-pho-bien\">T\u01b0\u01a1ng th\u00edch h\u00f3a ch\u1ea5t v\u1ec7 sinh ph\u1ed5 bi\u1ebfn<\/h2>\n<p>&#8211; IPA 70%: t\u01b0\u01a1ng th\u00edch t\u1ed1t v\u1edbi 304\/316L.<br \/>\n&#8211; H2O2 bay h\u01a1i (VHP): 316L b\u1ec1n h\u01a1n; \u0111\u1ea3m b\u1ea3o passivation v\u00e0 \u0111\u1ed9 k\u00edn.<br \/>\n&#8211; Peracetic acid: d\u00f9ng \u0111\u01b0\u1ee3c; x\u1ea3\/rinse sau ti\u1ebfp x\u00fac k\u00e9o d\u00e0i.<br \/>\n&#8211; NaOCl (Javen): nguy c\u01a1 r\u1ed7 clorua \u0111\u1eb7c bi\u1ec7t cho 304; n\u1ebfu bu\u1ed9c d\u00f9ng, \u01b0u ti\u00ean 316L, n\u1ed3ng \u0111\u1ed9 th\u1ea5p, th\u1eddi gian ti\u1ebfp x\u00fac ng\u1eafn, r\u1eeda n\u01b0\u1edbc DI sau c\u00f9ng.<br \/>\n&#8211; Quats: an to\u00e0n v\u1edbi inox; tr\u00e1nh t\u00edch t\u1ee5 d\u00ednh b\u1ec1 m\u1eb7t x\u01b0\u1edbc.<\/p>\n<h2 id=\"toc-9-lua-chon-theo-nganh\">L\u1ef1a ch\u1ecdn theo ng\u00e0nh<\/h2>\n<p>&#8211; Th\u1ef1c ph\u1ea9m: 304L cho khu kh\u00f4; 316L cho mu\u1ed1i\/axit\/s\u1eefa chua\/\u0111\u1ed3 bi\u1ec3n; y\u00eau c\u1ea7u b\u1ec1 m\u1eb7t 2B\/BA d\u1ec5 r\u1eeda, m\u1ed1i n\u1ed1i k\u00edn; tu\u00e2n th\u1ee7 HACCP.<br \/>\n&#8211; Y t\u1ebf\/Thi\u1ebft b\u1ecb y t\u1ebf: \u01b0u ti\u00ean 316L do VHP \u0111\u1ecbnh k\u1ef3; b\u1ec1 m\u1eb7t 2B\/BA, tr\u00e1nh No.4 \u1edf khu Grade B\/C.<br \/>\n&#8211; D\u01b0\u1ee3c ph\u1ea9m: 316L l\u00e0 chu\u1ea9n; b\u1ec1 m\u1eb7t Ra ki\u1ec3m so\u00e1t, EP cho ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m; t\u00e0i li\u1ec7u v\u1eadt li\u1ec7u, truy xu\u1ea5t, v\u1ec7 sinh \u2013 \u0111\u00e1p \u1ee9ng EU GMP Annex 1\/PIC\/S.<\/p>\n<h2 id=\"toc-10-so-sanh-chi-phi-vong-doi\">So s\u00e1nh chi ph\u00ed \u2013 v\u00f2ng \u0111\u1eddi<\/h2>\n<p>&#8211; 316L th\u01b0\u1eddng cao h\u01a1n 304L kho\u1ea3ng 20\u201340% theo c\u1ea5u ki\u1ec7n; b\u00f9 l\u1ea1i chi ph\u00ed v\u00f2ng \u0111\u1eddi th\u1ea5p h\u01a1n trong m\u00f4i tr\u01b0\u1eddng c\u00f3 clo\/VHP nh\u1edd gi\u1ea3m \u0103n m\u00f2n v\u00e0 thay th\u1ebf.<br \/>\n&#8211; 430 r\u1ebb nh\u01b0ng ch\u1ec9 d\u00f9ng cho v\u1ecb tr\u00ed kh\u00f4\/kh\u00f4ng h\u00f3a ch\u1ea5t; d\u00f9ng sai s\u1ebd ph\u00e1t sinh g\u1ec9, \u1ea3nh h\u01b0\u1edfng ki\u1ec3m \u0111\u1ecbnh ph\u00f2ng s\u1ea1ch.<br \/>\n&#8211; Ho\u00e0n thi\u1ec7n EP t\u0103ng chi ph\u00ed ban \u0111\u1ea7u nh\u01b0ng gi\u1ea3m r\u1ee7i ro nhi\u1ec5m b\u1ea9n, th\u1eddi gian v\u1ec7 sinh v\u00e0 d\u1eebng m\u00e1y.<\/p>\n<h2 id=\"toc-11-danh-muc-vat-tu-goi-y-bom-tham-khao\">Danh m\u1ee5c v\u1eadt t\u01b0 g\u1ee3i \u00fd (BOM tham kh\u1ea3o)<\/h2>\n<p>&#8211; T\u1ea5m 316L 2B 0,8\u20131,0 mm cho \u1ed1p t\u01b0\u1eddng; tr\u1ea7n 0,6\u20130,8 mm module gio\u0103ng k\u00edn.<br \/>\n&#8211; Pass box\/air shower: v\u1ecf 316L 1,2 mm; k\u00ednh c\u01b0\u1eddng l\u1ef1c; ch\u1ed1t li\u00ean \u0111\u1ed9ng; gio\u0103ng silicone.<br \/>\n&#8211; B\u00e0n, k\u1ec7, xe \u0111\u1ea9y: 304L m\u1eb7t 1,2\u20131,5 mm; khung 1,5\u20132,0 mm; ch\u00e2n c\u00f3 n\u1eafp b\u1ecbt k\u00edn.<br \/>\n&#8211; R\u00e3nh\/s\u00e0n inox 316L d\u1ed1c v\u1ec1 ph\u1ec5u; l\u01b0\u1edbi th\u00e1o l\u1eafp v\u1ec7 sinh.<br \/>\n&#8211; \u1ed0ng 316L ASME BPE; k\u1eb9p Tri-clamp; gio\u0103ng EPDM\/PTFE; h\u00e0n orbital.<br \/>\n&#8211; Bulong A4-70; n\u1eafp che \u0111\u1ea7u v\u00edt; keo silicone trung t\u00ednh low-VOC.<br \/>\n&#8211; Ph\u1ee5 ki\u1ec7n \u0111i\u1ec7n: t\u1ee7\/v\u1ecf 304L\/316L, IP65\u2013IP66; c\u00e1p b\u1ecdc ch\u1ed1ng b\u1ee5i; n\u1ed1i \u0111\u1ea5t ch\u1ed1ng ESD.<\/p>\n<h2 id=\"toc-12-cau-hoi-thuong-gap\">C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p<\/h2>\n<p>&#8211; 304 hay 316L cho ph\u00f2ng s\u1ea1ch? N\u1ebfu c\u00f3 VHP\/NaOCl, \u1ea9m, ho\u1eb7c r\u1ee7i ro clorua: 316L. Khu kh\u00f4, h\u00f3a ch\u1ea5t nh\u1eb9: 304L \u0111\u1ee7.<br \/>\n&#8211; B\u1ec1 m\u1eb7t x\u01b0\u1edbc No.4 c\u00f3 ph\u00f9 h\u1ee3p? Ch\u1ec9 cho khu \u00edt nh\u1ea1y c\u1ea3m, v\u00ec r\u00e3nh x\u01b0\u1edbc gi\u1eef b\u1ea9n h\u01a1n 2B\/BA.<br \/>\n&#8211; Inox c\u00f3 b\u1ecb nhi\u1ec5m t\u1eeb? 304\/316L g\u1ea7n nh\u01b0 kh\u00f4ng t\u1eeb, nh\u01b0ng gia c\u00f4ng ngu\u1ed9i c\u00f3 th\u1ec3 h\u01a1i nhi\u1ec5m t\u1eeb; kh\u00f4ng \u1ea3nh h\u01b0\u1edfng v\u1ec7 sinh.<br \/>\n&#8211; C\u00f3 n\u00ean d\u00f9ng 201? Kh\u00f4ng khuy\u1ebfn ngh\u1ecb cho ph\u00f2ng s\u1ea1ch do Ni th\u1ea5p, k\u00e9m b\u1ec1n \u0103n m\u00f2n; r\u1ee7i ro g\u1ec9 n\u00e2u theo th\u1eddi gian.<\/p>\n<h2 id=\"toc-13-nguon-tham-khao\">Ngu\u1ed3n tham kh\u1ea3o<\/h2>\n<p>&#8211; ISO 14644-1:2015 Cleanrooms and associated controlled environments \u2013 Part 1: Classification of air cleanliness by particle concentration (ISO).<br \/>\n&#8211; EU GMP Annex 1: Manufacture of Sterile Medicinal Products (2022).<br \/>\n&#8211; ASME BPE: Bioprocessing Equipment Standard (ASME, 2022).<br \/>\n&#8211; ASTM A240\/A480: Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip (ASTM).<br \/>\n&#8211; ASTM A967\/A380: Chemical Passivation and Cleaning of Stainless Steel (ASTM).<br \/>\n&#8211; EN 10088-2: Stainless steels \u2013 Technical delivery conditions for sheet\/plate\/strip for general purposes (CEN).<br \/>\n&#8211; ISO 3506: Mechanical properties of corrosion-resistant stainless steel fasteners (ISO).<br \/>\n&#8211; WHO Technical Report Series 961, Annex 6: WHO GMP for sterile pharmaceutical products.<\/p>\n<h2 id=\"toc-14-ket-luan\">K\u1ebft lu\u1eadn<\/h2>\n<p>\u0110\u1ec3 ph\u00f2ng s\u1ea1ch \u0111\u1ea1t chu\u1ea9n v\u00e0 v\u1eadn h\u00e0nh b\u1ec1n b\u1ec9, h\u00e3y \u01b0u ti\u00ean inox 316L cho khu c\u00f3 VHP\/clorua v\u00e0 304L cho khu kh\u00f4; ch\u1ecdn b\u1ec1 m\u1eb7t 2B\/BA (ho\u1eb7c EP v\u1edbi b\u1ec1 m\u1eb7t ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m); d\u00f9ng \u0111\u1ed9 d\u00e0y ph\u00f9 h\u1ee3p t\u1eebng h\u1ea1ng m\u1ee5c; h\u00e0n k\u00edn, bo g\u00f3c l\u1edbn, ph\u1ee5 ki\u1ec7n A4-70, keo\/gio\u0103ng low-VOC; x\u1eed l\u00fd passivation sau l\u1eafp \u0111\u1eb7t. C\u00e1ch ti\u1ebfp c\u1eadn n\u00e0y \u0111\u1ea3m b\u1ea3o s\u1ea1ch, b\u1ec1n, d\u1ec5 v\u1ec7 sinh v\u00e0 t\u1ed1i \u01b0u chi ph\u00ed v\u00f2ng \u0111\u1eddi.<\/p>\n<p>C\u1ea7n b\u1ea3ng ch\u00e0o chi ti\u1ebft, m\u1eabu v\u1eadt li\u1ec7u v\u00e0 t\u01b0 v\u1ea5n theo ti\u00eau chu\u1ea9n GMP\/ISO 14644 cho d\u1ef1 \u00e1n c\u1ee7a b\u1ea1n? Li\u00ean h\u1ec7 Inox Cuong Thinh \u0111\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n v\u00e0 b\u00e1o gi\u00e1 t\u1ed1t nh\u1ea5t.<br \/>\nHotline: 0343.417.281. Email: inoxcongnghiep.cuongthinh@gmail.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>H\u01b0\u1edbng d\u1eabn ch\u1ecdn inox cho ph\u00f2ng s\u1ea1ch: 304\/316L, \u0111\u1ed9 d\u00e0y, ho\u00e0n thi\u1ec7n b\u1ec1 m\u1eb7t, ti\u00eau chu\u1ea9n ISO 14644 &#038; GMP, l\u1eafp \u0111\u1eb7t ch\u1ed1ng nhi\u1ec5m b\u1ea9n, t\u1ed1i \u01b0u chi ph\u00ed.<\/p>\n","protected":false},"author":7,"featured_media":1054,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[23],"tags":[],"class_list":["post-1354","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\/1354","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=1354"}],"version-history":[{"count":0,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts\/1354\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media\/1054"}],"wp:attachment":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media?parent=1354"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/categories?post=1354"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/tags?post=1354"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}