{"id":1358,"date":"2025-11-26T12:34:44","date_gmt":"2025-11-26T05:34:44","guid":{"rendered":"https:\/\/inoxcuongthinh.com\/ong-inox-vi-sinh-tieu-chuan-phu-kien-va-lap-dat-khong-moi-chet\/"},"modified":"2025-11-26T12:34:44","modified_gmt":"2025-11-26T05:34:44","slug":"ong-inox-vi-sinh-tieu-chuan-phu-kien-va-lap-dat-khong-moi-chet","status":"publish","type":"post","link":"https:\/\/inoxcuongthinh.com\/ong-inox-vi-sinh-tieu-chuan-phu-kien-va-lap-dat-khong-moi-chet\/","title":{"rendered":"\u1ed0ng Inox vi sinh: ti\u00eau chu\u1ea9n, ph\u1ee5 ki\u1ec7n v\u00e0 l\u1eafp \u0111\u1eb7t kh\u00f4ng m\u1ed1i ch\u1ebft"},"content":{"rendered":"<div class=\"custom-toc\">\n<h3>N\u1ed9i dung ch\u00ednh<\/h3>\n<ul>\n<li><a href=\"#toc-0-inox-vi-sinh-va-moi-chet-khai-niem-va-rui-ro\">Inox vi sinh v\u00e0 \u201cm\u1ed1i ch\u1ebft\u201d: kh\u00e1i ni\u1ec7m v\u00e0 r\u1ee7i ro<\/a><\/li>\n<li><a href=\"#toc-1-tieu-chuan-cot-loi-cho-ong-va-phu-kien-inox-vi-sin\">Ti\u00eau chu\u1ea9n c\u1ed1t l\u00f5i cho \u1ed1ng v\u00e0 ph\u1ee5 ki\u1ec7n inox vi sinh<\/a><\/li>\n<li><a href=\"#toc-2-nguyen-tac-thiet-ke-khong-moi-chet-hygienic-design\">Nguy\u00ean t\u1eafc thi\u1ebft k\u1ebf \u201ckh\u00f4ng m\u1ed1i ch\u1ebft\u201d (hygienic design)<\/a><\/li>\n<li><a href=\"#toc-3-ky-thuat-lap-dat-va-han-orbital-cho-he-vi-sinh\">K\u1ef9 thu\u1eadt l\u1eafp \u0111\u1eb7t v\u00e0 h\u00e0n orbital cho h\u1ec7 vi sinh<\/a><\/li>\n<li><a href=\"#toc-4-cipsip-va-ve-sinh-he-thong\">CIP\/SIP v\u00e0 v\u1ec7 sinh h\u1ec7 th\u1ed1ng<\/a><\/li>\n<li><a href=\"#toc-5-nhung-loi-lap-dat-thuong-gap-va-cach-tranh\">Nh\u1eefng l\u1ed7i l\u1eafp \u0111\u1eb7t th\u01b0\u1eddng g\u1eb7p v\u00e0 c\u00e1ch tr\u00e1nh<\/a><\/li>\n<li><a href=\"#toc-6-goi-y-cau-hinh-vat-tu-pho-bien-tai-thi-truong-viet\">G\u1ee3i \u00fd c\u1ea5u h\u00ecnh v\u1eadt t\u01b0 ph\u1ed5 bi\u1ebfn t\u1ea1i th\u1ecb tr\u01b0\u1eddng Vi\u1ec7t Nam<\/a><\/li>\n<li><a href=\"#toc-7-vi-du-tinh-nhanh-ld-va-bo-tri-khong-moi-chet\">V\u00ed d\u1ee5 t\u00ednh nhanh L\/D v\u00e0 b\u1ed1 tr\u00ed kh\u00f4ng m\u1ed1i ch\u1ebft<\/a><\/li>\n<li><a href=\"#toc-8-bao-tri-va-van-hanh\">B\u1ea3o tr\u00ec v\u00e0 v\u1eadn h\u00e0nh<\/a><\/li>\n<li><a href=\"#toc-9-khi-nao-bat-buoc-tuan-asme-bpe3-a\">Khi n\u00e0o b\u1eaft bu\u1ed9c tu\u00e2n ASME BPE\/3-A?<\/a><\/li>\n<li><a href=\"#toc-10-tai-lieu-tham-khao-chinh\">T\u00e0i li\u1ec7u tham kh\u1ea3o ch\u00ednh<\/a><\/li>\n<li><a href=\"#toc-11-ket-luan\">K\u1ebft lu\u1eadn<\/a><\/li>\n<\/ul>\n<\/div>\n<p>Trong c\u00f4ng nghi\u1ec7p s\u1ea1ch (th\u1ef1c ph\u1ea9m, y t\u1ebf, d\u01b0\u1ee3c ph\u1ea9m), h\u1ec7 th\u1ed1ng \u1ed1ng inox vi sinh ph\u1ea3i \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n v\u1ec7 sinh nghi\u00eam ng\u1eb7t v\u00e0 thi\u1ebft k\u1ebf \u201ckh\u00f4ng m\u1ed1i ch\u1ebft\u201d \u0111\u1ec3 tr\u00e1nh t\u00edch t\u1ee5 vi sinh v\u00e0 c\u1eb7n b\u1ea9n. B\u00e0i vi\u1ebft n\u00e0y l\u00e0 h\u01b0\u1edbng d\u1eabn \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 ti\u00eau chu\u1ea9n v\u1eadt li\u1ec7u, l\u1ef1a ch\u1ecdn ph\u1ee5 ki\u1ec7n, nguy\u00ean t\u1eafc thi\u1ebft k\u1ebf, k\u1ef9 thu\u1eadt h\u00e0n l\u1eafp \u0111\u1eb7t v\u00e0 ki\u1ec3m \u0111\u1ecbnh \u0111\u1ec3 b\u1ea1n tri\u1ec3n khai m\u1ed9t h\u1ec7 th\u1ed1ng \u0111\u1ea1t chu\u1ea9n ngay t\u1eeb \u0111\u1ea7u.<\/p>\n<h2 id=\"toc-0-inox-vi-sinh-va-moi-chet-khai-niem-va-rui-ro\">Inox vi sinh v\u00e0 \u201cm\u1ed1i ch\u1ebft\u201d: kh\u00e1i ni\u1ec7m v\u00e0 r\u1ee7i ro<\/h2>\n<p>&#8211; Inox vi sinh l\u00e0 \u1ed1ng v\u00e0 ph\u1ee5 ki\u1ec7n inox b\u1ec1 m\u1eb7t nh\u1eb5n b\u00f3ng (Ra th\u1ea5p), v\u1eadt li\u1ec7u \u1ed5n \u0111\u1ecbnh, li\u00ean k\u1ebft k\u00edn, d\u1ec5 l\u00e0m s\u1ea1ch (CIP\/SIP), d\u00f9ng cho m\u00f4i tr\u01b0\u1eddng ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp s\u1ea3n ph\u1ea9m.<br \/>\n&#8211; \u201cM\u1ed1i ch\u1ebft\u201d (dead leg\/ dead space) l\u00e0 v\u00f9ng l\u01b0u ch\u1ea5t \u00edt\/kh\u00f4ng trao \u0111\u1ed5i khi v\u1eadn h\u00e0nh ho\u1eb7c r\u1eeda, th\u01b0\u1eddng xu\u1ea5t hi\u1ec7n \u1edf c\u00e1c nh\u00e1nh c\u1ee5t, kho\u1ea3ng tr\u1ed1ng sau van, l\u1eafp \u0111\u1eb7t gi\u1ea3m l\u1ec7ch, ho\u1eb7c c\u00e1c h\u1ed1c k\u00edn do h\u00e0n. \u0110\u00e2y l\u00e0 n\u01a1i t\u00edch t\u1ee5 c\u1eb7n, biofilm, g\u00e2y \u00f4 nhi\u1ec5m ch\u00e9o, \u0103n m\u00f2n k\u1ebd h\u1edf v\u00e0 r\u1ee7i ro kh\u00f4ng \u0111\u1ea1t th\u1ea9m \u0111\u1ecbnh v\u1ec7 sinh.<\/p>\n<p>H\u1eadu qu\u1ea3:<br \/>\n&#8211; Nhi\u1ec5m b\u1ea9n vi sinh, gi\u1ea3m h\u1ea1n s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m, kh\u00f4ng \u0111\u1ea1t HACCP, GMP.<br \/>\n&#8211; T\u0103ng th\u1eddi gian, chi ph\u00ed CIP\/SIP, ho\u00e1 ch\u1ea5t v\u00e0 n\u01b0\u1edbc.<br \/>\n&#8211; R\u1ee7i ro \u0111i\u1ec3m g\u1ec9, pitting t\u1ea1i v\u00f9ng kh\u00f3 r\u1eeda.<\/p>\n<h2 id=\"toc-1-tieu-chuan-cot-loi-cho-ong-va-phu-kien-inox-vi-sin\">Ti\u00eau chu\u1ea9n c\u1ed1t l\u00f5i cho \u1ed1ng v\u00e0 ph\u1ee5 ki\u1ec7n inox vi sinh<\/h2>\n<h3>Ti\u00eau chu\u1ea9n \u1ed1ng<\/h3>\n<p>C\u00e1c chu\u1ea9n ph\u1ed5 bi\u1ebfn:<br \/>\n&#8211; ASME BPE: ti\u00eau chu\u1ea9n \u0111\u1eb7c th\u00f9 cho d\u01b0\u1ee3c ph\u1ea9m\/biotech, quy \u0111\u1ecbnh k\u00edch th\u01b0\u1edbc, sai s\u1ed1, \u0111\u1ed9 nh\u00e1m b\u1ec1 m\u1eb7t, v\u1eadt li\u1ec7u v\u00e0 ki\u1ec3m \u0111\u1ecbnh.<br \/>\n&#8211; ASTM A270 (\u0111\u1eb7c bi\u1ec7t A270 S2): \u1ed1ng v\u1ec7 sinh cho th\u1ef1c ph\u1ea9m\/d\u01b0\u1ee3c.<br \/>\n&#8211; EN 10357 (thay th\u1ebf ISO 2037, DIN 11850): \u1ed1ng inox cho c\u00f4ng nghi\u1ec7p th\u1ef1c ph\u1ea9m, d\u01b0\u1ee3c v\u00e0 sinh h\u1ecdc.<br \/>\nY\u00eau c\u1ea7u b\u1ec1 m\u1eb7t tham kh\u1ea3o:<br \/>\n&#8211; Th\u1ef1c ph\u1ea9m\/\u0111\u1ed3 u\u1ed1ng: Ra \u2264 0,8 \u03bcm (MP \u2013 m\u00e0i c\u01a1 h\u1ecdc), m\u1ed1i h\u00e0n l\u00e0m s\u1ea1ch nhi\u1ec7t m\u00e0u.<br \/>\n&#8211; D\u01b0\u1ee3c ph\u1ea9m\/biotech: Ra \u2264 0,5 \u03bcm (ASME BPE SF1) \u0111\u1ebfn \u2264 0,38 \u03bcm (SF4, \u0111i\u1ec7n ho\u00e1 EP) cho b\u1ec1 m\u1eb7t ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m quan tr\u1ecdng.<\/p>\n<p>V\u1eadt li\u1ec7u:<br \/>\n&#8211; SS 304\/304L: th\u1ef1c ph\u1ea9m th\u00f4ng d\u1ee5ng, \u00edt chloride.<br \/>\n&#8211; SS 316L (2.2\u20132.5% Mo): \u01b0u ti\u00ean cho d\u01b0\u1ee3c v\u00e0 m\u00f4i tr\u01b0\u1eddng c\u00f3 chloride\/CIP kh\u1eafc nghi\u1ec7t; L gi\u00fap gi\u1ea3m nh\u1ea1y c\u1ea3m \u0103n m\u00f2n li\u00ean h\u1ea1t.<br \/>\n&#8211; Ch\u1ee9ng ch\u1ec9: EN 10204 3.1, ki\u1ec3m so\u00e1t l\u01b0u hu\u1ef3nh h\u00e0n t\u1ed1t, th\u00e0nh ph\u1ea7n \u1ed5n \u0111\u1ecbnh. B\u1ec1 m\u1eb7t ph\u1ea3i \u0111\u01b0\u1ee3c t\u1ea9y s\u1ea1ch v\u00e0 th\u1ee5 \u0111\u1ed9ng ho\u00e1 theo ASTM A380\/A967 sau ch\u1ebf t\u1ea1o.<\/p>\n<h3>Ti\u00eau chu\u1ea9n ph\u1ee5 ki\u1ec7n v\u00e0 k\u1ebft n\u1ed1i<\/h3>\n<p>&#8211; Clamp v\u1ec7 sinh: ISO 2852, BS 4825; ph\u1ed5 bi\u1ebfn \u201cTri-Clamp\u201d v\u1edbi ferrule ng\u1eafn, kh\u00f4ng k\u1ebd h\u1edf, d\u1ec5 th\u00e1o CIP.<br \/>\n&#8211; \u0110\u1ea7u ren\/h\u00e0n theo DIN 11851 (th\u1ef1c ph\u1ea9m) v\u00e0 DIN 11864 (aseptic).<br \/>\n&#8211; Van m\u00e0ng (diaphragm) chu\u1ea9n ASME BPE\/3-A v\u1edbi tu\u1ef3 ch\u1ecdn zero-dead-leg (ZDL).<br \/>\n&#8211; \u0110\u1ea7u \u0111o\/\u0111\u1ed3ng h\u1ed3 \u00e1p, nhi\u1ec7t \u0111\u1ed9, l\u01b0u l\u01b0\u1ee3ng d\u00f9ng k\u1ebft n\u1ed1i clamp aseptic, que th\u0103m ng\u1eafn.<\/p>\n<p>V\u1eadt li\u1ec7u gio\u0103ng:<br \/>\n&#8211; EPDM, FKM, PTFE\/ETFE, FFKM tu\u1ef3 nhi\u1ec7t\/ho\u00e1 ch\u1ea5t; y\u00eau c\u1ea7u ph\u00f9 h\u1ee3p FDA 21 CFR 177.2600, EU 1935\/2004 v\u00e0\/ho\u1eb7c USP Class VI. V\u1edbi SIP (121\u2013135\u00b0C), \u01b0u ti\u00ean EPDM\/FKM ch\u1ea5t l\u01b0\u1ee3ng cao ho\u1eb7c PTFE bao.<\/p>\n<h2 id=\"toc-2-nguyen-tac-thiet-ke-khong-moi-chet-hygienic-design\">Nguy\u00ean t\u1eafc thi\u1ebft k\u1ebf \u201ckh\u00f4ng m\u1ed1i ch\u1ebft\u201d (hygienic design)<\/h2>\n<h3>Quy t\u1eafc L\/D cho nh\u00e1nh v\u00e0 thi\u1ebft b\u1ecb<\/h3>\n<p>&#8211; ASME BPE v\u00e0 3-A khuy\u1ebfn ngh\u1ecb t\u1ec9 l\u1ec7 L\/D \u2264 2: L l\u00e0 kho\u1ea3ng c\u00e1ch t\u1eeb th\u00e0nh \u1ed1ng ch\u00ednh \u0111\u1ebfn m\u1eb7t gh\u1ebf van\/\u0111i\u1ec3m b\u1ecbt; D l\u00e0 \u0111\u01b0\u1eddng k\u00ednh trong (ID) \u1ed1ng nh\u00e1nh.<br \/>\n&#8211; V\u00ed d\u1ee5: \u1ed1ng nh\u00e1nh DN40, ID ~ 38 mm \u2192 L t\u1ed1i \u0111a \u2248 76 mm. Ch\u1ecdn van ZDL, ferrule ng\u1eafn, ho\u1eb7c tee c\u00fat qu\u00e9t (swept tee) \u0111\u1ec3 \u0111\u1ea1t y\u00eau c\u1ea7u.<\/p>\n<h3>Tho\u00e1t c\u1ea1n v\u00e0 tr\u00e1nh \u0111\u1ecdng<\/h3>\n<p>&#8211; \u0110\u1ed9 d\u1ed1c t\u1ed1i thi\u1ec3u 1% (10 mm\/m) cho \u0111\u01b0\u1eddng s\u1ea3n ph\u1ea9m v\u00e0 WFI\/PUW; 2% khuy\u1ebfn ngh\u1ecb v\u1edbi ch\u1ea5t l\u1ecfng nh\u1edbt.<br \/>\n&#8211; D\u00f9ng gi\u1ea3m l\u1ec7ch t\u00e2m (eccentric reducer) h\u01b0\u1edbng \u201cm\u1eb7t ph\u1eb3ng \u1edf tr\u00ean\u201d tr\u00ean \u0111\u01b0\u1eddng ngang \u0111\u1ec3 tr\u00e1nh h\u1ed1c kh\u00ed\/ch\u1ea5t l\u1ecfng.<br \/>\n&#8211; Tr\u00e1nh \u201ct\u00fai\u201d \u1edf \u0111\u00e1y\/\u0111\u1ec9nh, tr\u00e1nh \u1ed1ng c\u1ee5t. Nh\u00e1nh 45\u00b0 t\u1ed1t h\u01a1n 90\u00b0 cho tho\u00e1t c\u1ea1n.<br \/>\n&#8211; \u0110\u1ecbnh h\u01b0\u1edbng van m\u00e0ng v\u00e0 thi\u1ebft b\u1ecb \u1edf v\u1ecb tr\u00ed cho ph\u00e9p t\u1ef1 tho\u00e1t (th\u01b0\u1eddng 45\u00b0 so v\u1edbi ph\u01b0\u01a1ng ngang).<\/p>\n<h3>Van v\u00e0 \u0111i\u1ec3m l\u1ea5y m\u1eabu<\/h3>\n<p>&#8211; Van m\u00e0ng ZDL: gh\u1ebf van tr\u00f9ng v\u1edbi th\u00e0nh \u1ed1ng, h\u1ea7u nh\u01b0 kh\u00f4ng t\u1ea1o dead leg.<br \/>\n&#8211; \u0110i\u1ec3m l\u1ea5y m\u1eabu aseptic c\u00f3 chi\u1ec1u d\u00e0i t\u1ed1i thi\u1ec3u, gh\u1ebf k\u00edn, c\u00f3 th\u1ec3 h\u1ea5p\/SIP t\u1ea1i ch\u1ed7.<br \/>\n&#8211; Tr\u00e1nh van bi, van c\u1ed5ng cho s\u1ea3n ph\u1ea9m tr\u1ef1c ti\u1ebfp (tr\u1eeb khi lo\u1ea1i aseptic \u0111\u1eb7c bi\u1ec7t).<\/p>\n<h3>\u0110\u1ee1 \u1ed1ng v\u00e0 gi\u00e3n n\u1edf<\/h3>\n<p>&#8211; Kho\u1ea3ng c\u00e1ch gi\u00e1 \u0111\u1ee1 tham kh\u1ea3o: DN25\u2013DN40: 0,8\u20131,2 m; DN50\u2013DN80: 1,5\u20132,0 m; DN100: 2,0\u20132,5 m. D\u00f9ng \u0111\u1ee1 b\u1ecdc nh\u1ef1a\/PTFE \u0111\u1ec3 ch\u1ed1ng m\u00e0i m\u00f2n v\u00e0 c\u1ea7u nhi\u1ec7t l\u1ea1nh\/\u1ea5m.<br \/>\n&#8211; B\u00f9 gi\u00e3n n\u1edf nhi\u1ec7t b\u1eb1ng khung tr\u01b0\u1ee3t, g\u1ed1i treo, u\u1ed1n ch\u1eef U m\u1ec1m; tr\u00e1nh \u1ee9ng su\u1ea5t v\u00e0o m\u1ed1i h\u00e0n vi sinh.<\/p>\n<h2 id=\"toc-3-ky-thuat-lap-dat-va-han-orbital-cho-he-vi-sinh\">K\u1ef9 thu\u1eadt l\u1eafp \u0111\u1eb7t v\u00e0 h\u00e0n orbital cho h\u1ec7 vi sinh<\/h2>\n<h3>Chu\u1ea9n b\u1ecb v\u1eadt t\u01b0 v\u00e0 d\u1ee5ng c\u1ee5<\/h3>\n<p>&#8211; \u1ed0ng\/ferrule c\u1eaft b\u1eb1ng c\u01b0a orbital ho\u1eb7c m\u00e1y c\u1eaft l\u01b0\u1ee1i m\u1ecbn; kh\u00f4ng d\u00f9ng \u0111\u00e1 m\u00e0i g\u00e2y x\u01b0\u1edbc\/bavia.<br \/>\n&#8211; D\u00f9ng d\u1ee5ng c\u1ee5 ri\u00eang cho inox (kh\u00f4ng nhi\u1ec5m s\u1eaft); l\u00e0m s\u1ea1ch isopropanol, n\u01b0\u1edbc DI.<br \/>\n&#8211; B\u1ecbt hai \u0111\u1ea7u b\u1eb1ng n\u1eafp s\u1ea1ch khi l\u01b0u kho; ki\u1ec3m so\u00e1t h\u1ea1t b\u1ee5i.<\/p>\n<h3>G\u00e1 l\u1eafp v\u00e0 c\u0103n ch\u1ec9nh<\/h3>\n<p>&#8211; C\u0103n \u0111\u1ed3ng t\u00e2m: l\u1ec7ch m\u00e9p \u2264 10% chi\u1ec1u d\u00e0y th\u00e0nh \u1ed1ng.<br \/>\n&#8211; Khe h\u1edf m\u1ed1i gh\u00e9p t\u1ed1i thi\u1ec3u, m\u1eb7t c\u1eaft vu\u00f4ng 90\u00b0, kh\u00f4ng bavia trong.<br \/>\n&#8211; S\u1eed d\u1ee5ng k\u1eb9p c\u0103n ch\u1ec9nh v\u1ec7 sinh, h\u1ea1n ch\u1ebf v\u1ebft k\u1eb9p.<\/p>\n<h3>H\u00e0n GTAW\/orbital: th\u00f4ng s\u1ed1 then ch\u1ed1t<\/h3>\n<p>&#8211; H\u00e0n th\u1ea5u ho\u00e0n to\u00e0n, kh\u00f4ng d\u00f9ng backing ring b\u00ean trong.<br \/>\n&#8211; Kh\u00ed tr\u01a1: Argon \u2265 99,99% cho c\u1ea3 m\u1eb7t ngo\u00e0i v\u00e0 purge trong \u1ed1ng; ki\u1ec3m so\u00e1t O2 d\u01b0.<br \/>\n&#8211; M\u1ee9c O2 trong purge: \u2264 50 ppm; v\u1edbi d\u01b0\u1ee3c ph\u1ea9m khuy\u1ebfn ngh\u1ecb \u2264 10\u201320 ppm \u0111\u1ec3 lo\u1ea1i b\u1ecf v\u1ec7t nhi\u1ec7t m\u00e0u v\u00e0 oxi ho\u00e1 \u0111\u01b0\u1eddng h\u00e0n.<br \/>\n&#8211; Que h\u00e0n ph\u00f9 h\u1ee3p: ER308L\/ER316L\/ER317L tu\u1ef3 v\u1eadt li\u1ec7u; \u0111\u01b0\u1eddng h\u00e0n ph\u1ea3i ph\u1eb3ng\/nh\u00f4 nh\u1eb9, kh\u00f4ng l\u00f5m, kh\u00f4ng \u201c\u0111\u01b0\u1eddng g\u00e2n\u201d c\u1ea3n d\u00f2ng.<br \/>\n&#8211; Ghi nh\u1eadt k\u00fd h\u00e0n (weld log): d\u00f2ng, t\u1ed1c \u0111\u1ed9, kh\u00ed, O2 ppm; \u00e1p d\u1ee5ng WPS\/PQR, th\u1ee3 h\u00e0n \u0111\u1ea1t chu\u1ea9n (v\u00ed d\u1ee5 ISO 9606-1 ho\u1eb7c ASME IX).<\/p>\n<p>Ti\u00eau ch\u00ed ch\u1ea5p nh\u1eadn (tham kh\u1ea3o ASME BPE\/B31.3):<br \/>\n&#8211; Kh\u00f4ng r\u1ed7 kh\u00ed, n\u1ee9t, b\u1eafn to\u00e9, x\u1ec9 \u0111\u1ecdng.<br \/>\n&#8211; Kh\u00f4ng \u0111\u1ed5i m\u00e0u b\u00ean trong ho\u1eb7c ch\u1ec9 m\u00e0u r\u01a1m r\u1ea5t nh\u1ea1t; t\u1ed1t nh\u1ea5t l\u00e0 s\u00e1ng b\u1ea1c sau purge \u0111\u00fang v\u00e0 x\u1eed l\u00fd b\u1ec1 m\u1eb7t.<br \/>\n&#8211; Kh\u00f4ng \u201c\u0111\u01b0\u1eddng m\u00e9p\u201d s\u1eafc g\u00e2y nhi\u1ec5u d\u00f2ng\/ch\u1ee9a c\u1eb7n.<\/p>\n<h3>X\u1eed l\u00fd sau h\u00e0n<\/h3>\n<p>&#8211; T\u1ea9y s\u1ea1ch v\u00e0 th\u1ee5 \u0111\u1ed9ng ho\u00e1 theo ASTM A380\/A967 (nitric ho\u1eb7c citric), r\u1eeda k\u1ef9 n\u01b0\u1edbc DI.<br \/>\n&#8211; \u0110i\u1ec7n ho\u00e1 (EP) khu v\u1ef1c quan tr\u1ecdng n\u1ebfu y\u00eau c\u1ea7u Ra th\u1ea5p v\u00e0 kh\u1ea3 n\u0103ng ch\u1ed1ng biofilm cao h\u01a1n.<br \/>\n&#8211; Ki\u1ec3m tra n\u1ed9i soi (borescope) 100% cho \u0111\u01b0\u1eddng quan tr\u1ecdng; \u0111o Ra t\u1ea1i ch\u1ed7 n\u1ebfu quy \u0111\u1ecbnh.<\/p>\n<h3>Ki\u1ec3m tra, th\u1eed \u00e1p v\u00e0 th\u1ea9m \u0111\u1ecbnh<\/h3>\n<p>&#8211; Th\u1eed \u00e1p th\u1ee7y l\u1ef1c 1,5\u00d7 \u00e1p su\u1ea5t thi\u1ebft k\u1ebf, th\u1eddi gian gi\u1eef \u0111\u1ee7 (t\u1ed1i thi\u1ec3u 10\u201330 ph\u00fat theo quy tr\u00ecnh).<br \/>\n&#8211; Ki\u1ec3m tra \u0111\u1ed9 k\u00edn clamp\/gio\u0103ng; v\u1edbi kh\u00ed\/\u0111\u01b0\u1eddng WFI c\u00f3 th\u1ec3 th\u1eed r\u00f2 helium n\u1ebfu spec y\u00eau c\u1ea7u.<br \/>\n&#8211; X\u00e2y d\u1ef1ng P&#038;ID, isometric c\u00f3 map m\u1ed1i h\u00e0n, ch\u1ee9ng t\u1eeb v\u1eadt li\u1ec7u (MTC 3.1), k\u1ebft qu\u1ea3 v\u1ec7 sinh\/\u0111\u1ed9 nh\u00e1m, bi\u00ean b\u1ea3n IQ\/OQ (v\u1edbi d\u01b0\u1ee3c ph\u1ea9m).<\/p>\n<h2 id=\"toc-4-cipsip-va-ve-sinh-he-thong\">CIP\/SIP v\u00e0 v\u1ec7 sinh h\u1ec7 th\u1ed1ng<\/h2>\n<p>&#8211; Thi\u1ebft k\u1ebf CIP: v\u1eadn t\u1ed1c r\u1eeda \u2265 1,5 m\/s \u0111\u1ec3 t\u1ea1o d\u00f2ng ch\u1ea3y xo\u00e1y, \u0111\u1ea3m b\u1ea3o c\u1eaft\/ cu\u1ed1n tr\u00f4i c\u1eb7n biofilm.<br \/>\n&#8211; Ho\u00e1 ch\u1ea5t th\u01b0\u1eddng d\u00f9ng: ki\u1ec1m NaOH, acid nitric\/phosphoric theo quy tr\u00ecnh n\u1ed9i b\u1ed9; s\u00fac r\u1eeda n\u01b0\u1edbc DI.<br \/>\n&#8211; SIP: h\u01a1i s\u1ea1ch 121\u2013135\u00b0C, th\u1eddi gian duy tr\u00ec theo quy tr\u00ecnh; ch\u1ecdn gio\u0103ng ch\u1ecbu h\u01a1i.<br \/>\n&#8211; T\u00e0i li\u1ec7u ho\u00e1 quy tr\u00ecnh, \u0111i\u1ec3m l\u1ea5y m\u1eabu vi sinh sau CIP\/SIP \u0111\u1ec3 x\u00e1c nh\u1eadn hi\u1ec7u qu\u1ea3.<\/p>\n<h2 id=\"toc-5-nhung-loi-lap-dat-thuong-gap-va-cach-tranh\">Nh\u1eefng l\u1ed7i l\u1eafp \u0111\u1eb7t th\u01b0\u1eddng g\u1eb7p v\u00e0 c\u00e1ch tr\u00e1nh<\/h2>\n<p>&#8211; Nh\u00e1nh c\u1ee5t qu\u00e1 d\u00e0i: kh\u00f4ng tu\u00e2n L\/D \u2264 2. Kh\u1eafc ph\u1ee5c: d\u00f9ng van ZDL, ferrule ng\u1eafn, thay tee 90\u00b0 b\u1eb1ng tee qu\u00e9t.<br \/>\n&#8211; Kh\u00f4ng c\u00f3 \u0111\u1ed9 d\u1ed1c ho\u1eb7c ng\u01b0\u1ee3c d\u1ed1c: d\u1eabn \u0111\u1ebfn \u0111\u1ecdng. Kh\u1eafc ph\u1ee5c: c\u0103n cote, d\u00f9ng laser level, b\u1ed1 tr\u00ed hanger c\u00f3 ch\u1ec9nh.<br \/>\n&#8211; H\u00e0n kh\u00f4ng c\u00f3 purge\/ki\u1ec3m so\u00e1t O2 k\u00e9m: \u0111\u01b0\u1eddng h\u00e0n s\u1eadm m\u00e0u, r\u1ed7. Kh\u1eafc ph\u1ee5c: d\u00f9ng m\u00e1y \u0111o O2 online, b\u1ecbt k\u00edn, th\u1eddi gian x\u1ea3 purge \u0111\u1ee7.<br \/>\n&#8211; D\u00f9ng reducer \u0111\u1ed3ng t\u00e2m tr\u00ean \u0111\u01b0\u1eddng ngang: t\u1ea1o b\u1eaby. Kh\u1eafc ph\u1ee5c: d\u00f9ng eccentric, \u0111\u1ecbnh h\u01b0\u1edbng \u0111\u00fang.<br \/>\n&#8211; Bavia trong \u1ed1ng sau c\u1eaft: g\u00e2y gi\u1eef c\u1eb7n. Kh\u1eafc ph\u1ee5c: c\u1eaft orbital, g\u1ecdt m\u00e9p, \u0111\u00e1nh s\u1ea1ch.<br \/>\n&#8211; Ch\u1ecdn gio\u0103ng kh\u00f4ng ph\u00f9 h\u1ee3p CIP\/SIP: tr\u01b0\u01a1ng n\u1edf, n\u1ee9t. Kh\u1eafc ph\u1ee5c: r\u00e0 so\u00e1t h\u00f3a ch\u1ea5t\/nhi\u1ec7t, \u0111\u1ed5i v\u1eadt li\u1ec7u gio\u0103ng \u0111\u1ea1t chu\u1ea9n.<\/p>\n<h2 id=\"toc-6-goi-y-cau-hinh-vat-tu-pho-bien-tai-thi-truong-viet\">G\u1ee3i \u00fd c\u1ea5u h\u00ecnh v\u1eadt t\u01b0 ph\u1ed5 bi\u1ebfn t\u1ea1i th\u1ecb tr\u01b0\u1eddng Vi\u1ec7t Nam<\/h2>\n<p>&#8211; \u1ed0ng EN 10357 series A\/B ho\u1eb7c ASTM A270 (S2), 316L, Ra \u2264 0,8 \u03bcm cho th\u1ef1c ph\u1ea9m; khu v\u1ef1c tr\u1ecdng y\u1ebfu d\u01b0\u1ee3c: 316L EP Ra \u2264 0,4 \u03bcm.<br \/>\n&#8211; Ferrule clamp ISO 2852\/BS 4825, c\u00fat\/tee long radius m\u00e0i c\u01a1 h\u1ecdc, \u0111\u00e1nh b\u00f3ng trong\/ngo\u00e0i \u0111\u1ed3ng \u0111\u1ec1u.<br \/>\n&#8211; Van m\u00e0ng th\u00e2n 316L, m\u00e0ng EPDM\/PTFE, tu\u1ef3 ch\u1ecdn ZDL \u1edf \u0111i\u1ec3m t\u1eed.<br \/>\n&#8211; Gio\u0103ng EPDM tr\u1eafng\/\u0111en \u0111\u1ea1t FDA, USP Class VI; v\u1edbi SIP kh\u1eafc nghi\u1ec7t c\u00e2n nh\u1eafc FKM\/PTFE.<br \/>\n&#8211; Que h\u00e0n ER316L, kh\u00ed Argon UHP; m\u00e1y h\u00e0n orbital c\u00f3 ghi d\u1eef li\u1ec7u v\u00e0 \u0111o O2.<\/p>\n<h2 id=\"toc-7-vi-du-tinh-nhanh-ld-va-bo-tri-khong-moi-chet\">V\u00ed d\u1ee5 t\u00ednh nhanh L\/D v\u00e0 b\u1ed1 tr\u00ed kh\u00f4ng m\u1ed1i ch\u1ebft<\/h2>\n<p>&#8211; B\u00e0i to\u00e1n: L\u1eafp van l\u1ea5y m\u1eabu tr\u00ean \u1ed1ng DN50 (ID ~ 47,5 mm).<br \/>\n&#8211; Y\u00eau c\u1ea7u: L\/D \u2264 2 \u2192 Lmax \u2248 95 mm t\u1eeb th\u00e0nh \u1ed1ng \u0111\u1ebfn gh\u1ebf van.<br \/>\n&#8211; Gi\u1ea3i ph\u00e1p: Ch\u1ecdn van ZDL c\u00f3 ferrule ng\u1eafn L = 60\u201380 mm; n\u1ebfu kh\u00f4ng, d\u00f9ng tee qu\u00e9t 45\u00b0 v\u00e0 \u0111\u1eb7t van tr\u00ean \u0111\u01b0\u1eddng d\u1ed1c \u0111\u1ec3 t\u1ef1 tho\u00e1t.<\/p>\n<h2 id=\"toc-8-bao-tri-va-van-hanh\">B\u1ea3o tr\u00ec v\u00e0 v\u1eadn h\u00e0nh<\/h2>\n<p>&#8211; Ki\u1ec3m tra \u0111\u1ecbnh k\u1ef3 clamp, si\u1ebft \u0111\u00fang m\u00f4-men \u0111\u1ec3 kh\u00f4ng g\u00e2y k\u1ebd h\u1edf\/gio\u0103ng \u00e9p qu\u00e1.<br \/>\n&#8211; Thay gio\u0103ng theo chu k\u1ef3, \u0111\u1eb7c bi\u1ec7t sau s\u1ed1 l\u1ea7n SIP \u0111\u1ecbnh tr\u01b0\u1edbc.<br \/>\n&#8211; N\u1ed9i soi \u0111\u1ecbnh k\u1ef3 c\u00e1c m\u1ed1i h\u00e0n \u1edf v\u00f9ng CIP kh\u00f3 \u0111\u1ec3 ph\u00e1t hi\u1ec7n \u0111\u1ed5i m\u00e0u\/\u0103n m\u00f2n s\u1edbm.<br \/>\n&#8211; Ghi ch\u00e9p v\u1ec7 sinh (CIP log), k\u1ebft qu\u1ea3 vi sinh, \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n n\u01b0\u1edbc x\u1ea3 \u0111\u1ec3 ki\u1ec3m so\u00e1t quy tr\u00ecnh.<\/p>\n<h2 id=\"toc-9-khi-nao-bat-buoc-tuan-asme-bpe3-a\">Khi n\u00e0o b\u1eaft bu\u1ed9c tu\u00e2n ASME BPE\/3-A?<\/h2>\n<p>&#8211; D\u01b0\u1ee3c ph\u1ea9m\/biotech v\u00e0 n\u01b0\u1edbc WFI\/PUW: n\u00ean \u00e1p ASME BPE to\u00e0n di\u1ec7n (v\u1eadt li\u1ec7u, Ra, h\u00e0n, ki\u1ec3m \u0111\u1ecbnh).<br \/>\n&#8211; S\u1eefa\/\u0111\u1ed3 u\u1ed1ng: \u00e1p 3-A SSI v\u00e0\/ho\u1eb7c EHEDG; tu\u00e2n \u0111\u1ed9 d\u1ed1c, L\/D, van v\u00e0 v\u1ec7 sinh theo h\u01b0\u1edbng d\u1eabn ng\u00e0nh.<br \/>\n&#8211; Th\u1ef1c ph\u1ea9m th\u00f4ng d\u1ee5ng: \u00e1p EN 10357 + th\u00f4ng l\u1ec7 hygienic design; \u01b0u ti\u00ean 316L \u1edf m\u00f4i tr\u01b0\u1eddng CIP m\u1ea1nh.<\/p>\n<h2 id=\"toc-10-tai-lieu-tham-khao-chinh\">T\u00e0i li\u1ec7u tham kh\u1ea3o ch\u00ednh<\/h2>\n<p>&#8211; ASME BPE \u2013 Bioprocessing Equipment Standard (\u1ea5n b\u1ea3n m\u1edbi nh\u1ea5t): quy \u0111\u1ecbnh v\u1eadt li\u1ec7u, b\u1ec1 m\u1eb7t, h\u00e0n, ki\u1ec3m \u0111\u1ecbnh cho d\u01b0\u1ee3c\/biotech. https:\/\/www.asme.org\/codes-standards\/find-codes-standards\/bpe-bioprocessing-equipment<br \/>\n&#8211; 3-A Sanitary Standards &#038; Accepted Practices: h\u01b0\u1edbng d\u1eabn thi\u1ebft k\u1ebf v\u1ec7 sinh cho ng\u00e0nh s\u1eefa\/\u0111\u1ed3 u\u1ed1ng. https:\/\/www.3-a.org<br \/>\n&#8211; EN 10357: Stainless steel tubes for the food and chemical industry. https:\/\/standards.iteh.ai\/catalog\/standards\/cen\/2d7b3e39-0a4e-44f1-a8ef-6dc5b19e1427\/en-10357-2013<br \/>\n&#8211; ASTM A270: Standard Specification for Seamless and Welded Austenitic Stainless Steel Sanitary Tubing. https:\/\/www.astm.org\/a0270_a0270m-20.html<br \/>\n&#8211; ISO 2852 \/ BS 4825: Clamp type couplings for food\/biotech applications. https:\/\/www.iso.org\/standard\/48497.html<br \/>\n&#8211; ASTM A380 \/ A967: Cleaning, descaling and passivation of stainless steel parts. https:\/\/www.astm.org\/a0380_a0380m-17.html<br \/>\n&#8211; EHEDG Guidelines (v\u00ed d\u1ee5 Doc 8, 13): nguy\u00ean t\u1eafc thi\u1ebft k\u1ebf v\u1ec7 sinh, l\u00e0m s\u1ea1ch. https:\/\/www.ehedg.org<\/p>\n<h2 id=\"toc-11-ket-luan\">K\u1ebft lu\u1eadn<\/h2>\n<p>M\u1ed9t h\u1ec7 th\u1ed1ng \u1ed1ng inox vi sinh \u201ckh\u00f4ng m\u1ed1i ch\u1ebft\u201d c\u1ea7n b\u1eaft \u0111\u1ea7u t\u1eeb v\u1eadt li\u1ec7u v\u00e0 ph\u1ee5 ki\u1ec7n \u0111\u1ea1t chu\u1ea9n (ASME BPE, 3-A, EN 10357\/ASTM A270), thi\u1ebft k\u1ebf \u0111\u00fang nguy\u00ean t\u1eafc hygienic (L\/D \u2264 2, \u0111\u1ed9 d\u1ed1c t\u1ed1i thi\u1ec3u 1%, tr\u00e1nh h\u1ed1c \u0111\u1ecdng) v\u00e0 thi c\u00f4ng theo k\u1ef9 thu\u1eadt h\u00e0n orbital v\u1edbi purge ki\u1ec3m so\u00e1t O2 ppm, sau \u0111\u00f3 l\u00e0 x\u1eed l\u00fd b\u1ec1 m\u1eb7t, ki\u1ec3m tra n\u1ed9i soi, th\u1eed k\u00edn v\u00e0 th\u1ea9m \u0111\u1ecbnh \u0111\u1ea7y \u0111\u1ee7. L\u00e0m \u0111\u00fang ngay t\u1eeb \u0111\u1ea7u gi\u00fap h\u1ec7 th\u1ed1ng v\u1eadn h\u00e0nh s\u1ea1ch, d\u1ec5 CIP\/SIP, k\u00e9o d\u00e0i tu\u1ed5i th\u1ecd, gi\u1ea3m chi ph\u00ed v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c chu\u1ea9n GMP\/HACCP. <\/p>\n<p>C\u1ea7n t\u01b0 v\u1ea5n l\u1ef1a ch\u1ecdn \u1ed1ng, ph\u1ee5 ki\u1ec7n, quy c\u00e1ch b\u1ec1 m\u1eb7t, c\u0169ng nh\u01b0 gi\u1ea3i ph\u00e1p h\u00e0n orbital v\u00e0 nghi\u1ec7m thu theo chu\u1ea9n? Li\u00ean h\u1ec7 Inox C\u01b0\u1eddng Th\u1ecbnh \u0111\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n k\u1ef9 thu\u1eadt v\u00e0 b\u00e1o gi\u00e1 t\u1ed1t nh\u1ea5t.<br \/>\nHotline: 0343.417.281<br \/>\nEmail: 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, EN 10357; k\u1ef9 thu\u1eadt h\u00e0n orbital, slope, tr\u00e1nh m\u1ed1i ch\u1ebft, ki\u1ec3m tra v\u00e0 nghi\u1ec7m thu th\u1ef1c t\u1ebf.<\/p>\n","protected":false},"author":7,"featured_media":1056,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[23],"tags":[],"class_list":["post-1358","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\/1358","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=1358"}],"version-history":[{"count":0,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts\/1358\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media\/1056"}],"wp:attachment":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media?parent=1358"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/categories?post=1358"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/tags?post=1358"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}