{"id":1356,"date":"2025-11-26T00:34:32","date_gmt":"2025-11-25T17:34:32","guid":{"rendered":"https:\/\/inoxcuongthinh.com\/che-tao-noi-hap-tiet-trung-inox-chiu-nhiet-tieu-chuan-thiet-ke\/"},"modified":"2025-11-26T00:34:32","modified_gmt":"2025-11-25T17:34:32","slug":"che-tao-noi-hap-tiet-trung-inox-chiu-nhiet-tieu-chuan-thiet-ke","status":"publish","type":"post","link":"https:\/\/inoxcuongthinh.com\/che-tao-noi-hap-tiet-trung-inox-chiu-nhiet-tieu-chuan-thiet-ke\/","title":{"rendered":"Ch\u1ebf t\u1ea1o n\u1ed3i h\u1ea5p ti\u1ec7t tr\u00f9ng Inox ch\u1ecbu nhi\u1ec7t: ti\u00eau chu\u1ea9n &#038; thi\u1ebft k\u1ebf"},"content":{"rendered":"<div class=\"custom-toc\">\n<h3>N\u1ed9i dung ch\u00ednh<\/h3>\n<ul>\n<li><a href=\"#toc-0-phan-loai-ung-dung-va-yeu-cau-ky-thuat-cot-loi\">Ph\u00e2n lo\u1ea1i \u1ee9ng d\u1ee5ng v\u00e0 y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt c\u1ed1t l\u00f5i<\/a><\/li>\n<li><a href=\"#toc-1-lua-chon-vat-lieu-inox-chiu-nhiet-va-phu-kien-di-k\">L\u1ef1a ch\u1ecdn v\u1eadt li\u1ec7u inox ch\u1ecbu nhi\u1ec7t v\u00e0 ph\u1ee5 ki\u1ec7n \u0111i k\u00e8m<\/a><\/li>\n<li><a href=\"#toc-2-thiet-ke-binh-chiu-ap-luc-va-buong-noi-hap\">Thi\u1ebft k\u1ebf b\u00ecnh ch\u1ecbu \u00e1p l\u1ef1c v\u00e0 bu\u1ed3ng n\u1ed3i h\u1ea5p<\/a><\/li>\n<li><a href=\"#toc-3-kien-truc-he-thong-pid-chuc-nang\">Ki\u1ebfn tr\u00fac h\u1ec7 th\u1ed1ng: P&#038;ID ch\u1ee9c n\u0103ng<\/a><\/li>\n<li><a href=\"#toc-4-che-do-tiet-trung-dien-hinh\">Ch\u1ebf \u0111\u1ed9 ti\u1ec7t tr\u00f9ng \u0111i\u1ec3n h\u00ecnh<\/a><\/li>\n<li><a href=\"#toc-5-quy-trinh-che-tao-tung-buoc-de-dat-chuan\">Quy tr\u00ecnh ch\u1ebf t\u1ea1o: t\u1eebng b\u01b0\u1edbc \u0111\u1ec3 \u0111\u1ea1t chu\u1ea9n<\/a><\/li>\n<li><a href=\"#toc-6-van-hanh-bao-tri-va-kiem-dinh-dinh-ky\">V\u1eadn h\u00e0nh, b\u1ea3o tr\u00ec v\u00e0 ki\u1ec3m \u0111\u1ecbnh \u0111\u1ecbnh k\u1ef3<\/a><\/li>\n<li><a href=\"#toc-7-nhung-loi-thuong-gap-va-cach-phong-tranh\">Nh\u1eefng l\u1ed7i th\u01b0\u1eddng g\u1eb7p v\u00e0 c\u00e1ch ph\u00f2ng tr\u00e1nh<\/a><\/li>\n<li><a href=\"#toc-8-bai-toan-chi-phi-yeu-to-quyet-dinh-gia\">B\u00e0i to\u00e1n chi ph\u00ed: y\u1ebfu t\u1ed1 quy\u1ebft \u0111\u1ecbnh gi\u00e1<\/a><\/li>\n<li><a href=\"#toc-9-vi-du-cau-hinh-ky-thuat-tham-khao\">V\u00ed d\u1ee5 c\u1ea5u h\u00ecnh k\u1ef9 thu\u1eadt tham kh\u1ea3o<\/a><\/li>\n<li><a href=\"#toc-10-checklist-nhanh-truoc-khi-dat-hangdau-tu\">Checklist nhanh tr\u01b0\u1edbc khi \u0111\u1eb7t h\u00e0ng\/\u0111\u1ea7u t\u01b0<\/a><\/li>\n<li><a href=\"#toc-11-tai-lieu-tham-khao\">T\u00e0i li\u1ec7u tham kh\u1ea3o<\/a><\/li>\n<li><a href=\"#toc-12-ket-luan\">K\u1ebft lu\u1eadn<\/a><\/li>\n<\/ul>\n<\/div>\n<p>N\u1ed3i h\u1ea5p ti\u1ec7t tr\u00f9ng v\u00e0 thi\u1ebft b\u1ecb kh\u1eed khu\u1ea9n b\u1eb1ng inox ch\u1ecbu nhi\u1ec7t l\u00e0 \u201ctr\u00e1i tim\u201d c\u1ee7a c\u00f4ng nghi\u1ec7p s\u1ea1ch, b\u1ea3o \u0111\u1ea3m an to\u00e0n vi sinh cho th\u1ef1c ph\u1ea9m, y t\u1ebf v\u00e0 d\u01b0\u1ee3c ph\u1ea9m. B\u00e0i vi\u1ebft n\u00e0y cung c\u1ea5p h\u01b0\u1edbng d\u1eabn \u0111\u1ea7y \u0111\u1ee7 t\u1eeb ch\u1ecdn m\u00e1c inox, thi\u1ebft k\u1ebf \u2013 ch\u1ebf t\u1ea1o theo ti\u00eau chu\u1ea9n \u00e1p l\u1ef1c, \u0111\u1ebfn v\u1eadn h\u00e0nh \u2013 hi\u1ec7u chu\u1ea9n \u0111\u1ec3 b\u1ea1n c\u00f3 th\u1ec3 ra quy\u1ebft \u0111\u1ecbnh k\u1ef9 thu\u1eadt \u0111\u00fang ngay t\u1eeb \u0111\u1ea7u.<\/p>\n<h2 id=\"toc-0-phan-loai-ung-dung-va-yeu-cau-ky-thuat-cot-loi\">Ph\u00e2n lo\u1ea1i \u1ee9ng d\u1ee5ng v\u00e0 y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt c\u1ed1t l\u00f5i<\/h2>\n<p>&#8211; Y t\u1ebf \u2013 CSSD: N\u1ed3i h\u1ea5p h\u01a1i b\u00e3o h\u00f2a ti\u1ec1n ch\u00e2n kh\u00f4ng (pre-vacuum) cho d\u1ee5ng c\u1ee5 ph\u1eabu thu\u1eadt, v\u1ea3i; chu tr\u00ecnh 121\u00b0C\/134\u00b0C; y\u00eau c\u1ea7u ki\u1ec3m ch\u1ee9ng theo ISO 17665 v\u00e0 EN 285, Bowie\u2013Dick, ch\u1ec9 th\u1ecb sinh h\u1ecdc.<br \/>\n&#8211; D\u01b0\u1ee3c ph\u1ea9m: SIP\/CIP thi\u1ebft b\u1ecb, ti\u1ec7t tr\u00f9ng \u01b0\u1edbt bao b\u00ec, m\u00f4i tr\u01b0\u1eddng; b\u1ec1 m\u1eb7t v\u1ec7 sinh cao, truy xu\u1ea5t v\u1eadt li\u1ec7u 3.1; tu\u00e2n th\u1ee7 GMP WHO\/EU, ASME BPE.<br \/>\n&#8211; Th\u1ef1c ph\u1ea9m: Retort\/Autoclave ti\u1ec7t tr\u00f9ng \u0111\u1ed3 h\u1ed9p, pouch, chai; c\u00f3 th\u1ec3 d\u00f9ng n\u01b0\u1edbc phun\/tu\u1ea7n ho\u00e0n v\u00e0 h\u01a1i c\u00f3 kh\u00ed \u0111\u1ec7m \u00e1p l\u1ef1c; ki\u1ec3m so\u00e1t nhi\u1ec7t \u0111\u1ed3ng \u0111\u1ec1u, F0.<\/p>\n<p>Th\u00f4ng s\u1ed1 h\u01a1i b\u00e3o h\u00f2a th\u1ef1c t\u1ebf:<br \/>\n&#8211; 121\u00b0C \u2248 2.0 bar tuy\u1ec7t \u0111\u1ed1i (~1.0 bar gauge)<br \/>\n&#8211; 134\u00b0C \u2248 3.1 bar tuy\u1ec7t \u0111\u1ed1i (~2.1 bar gauge)<br \/>\nThi\u1ebft k\u1ebf n\u00ean c\u00f3 d\u1ef1 ph\u00f2ng \u0111\u1ebfn 150\u00b0C v\u00e0 \u22654 bar(g) t\u00f9y quy m\u00f4 v\u00e0 tri\u1ebft l\u00fd an to\u00e0n.<\/p>\n<h2 id=\"toc-1-lua-chon-vat-lieu-inox-chiu-nhiet-va-phu-kien-di-k\">L\u1ef1a ch\u1ecdn v\u1eadt li\u1ec7u inox ch\u1ecbu nhi\u1ec7t v\u00e0 ph\u1ee5 ki\u1ec7n \u0111i k\u00e8m<\/h2>\n<h3>M\u00e1c inox g\u1ee3i \u00fd theo t\u1ea3i v\u00e0 m\u00f4i tr\u01b0\u1eddng<\/h3>\n<p>&#8211; 316L (EN 1.4404\/ASTM A240): L\u1ef1a ch\u1ecdn ti\u00eau chu\u1ea9n cho bu\u1ed3ng n\u1ed3i h\u1ea5p, \u0111\u01b0\u1eddng \u1ed1ng h\u01a1i s\u1ea1ch v\u00e0 ng\u01b0ng; ch\u1ed1ng \u0103n m\u00f2n clorua t\u1ed1t h\u01a1n 304, h\u00e0n \u00edt nh\u1ea1y c\u1ea3m \u0103n m\u00f2n k\u1ebd.<br \/>\n&#8211; 304\/304L: C\u00f3 th\u1ec3 d\u00f9ng cho \u00e1o nhi\u1ec7t (jacket), v\u1ecf b\u1ecdc, t\u1ee7 \u0111i\u1ec7n, khung, nh\u01b0ng kh\u00f4ng khuy\u1ebfn ngh\u1ecb cho m\u1eb7t trong bu\u1ed3ng \u1edf khu v\u1ef1c c\u00f3 h\u00f3a ch\u1ea5t t\u1ea9y r\u1eeda\/clorua.<br \/>\n&#8211; 321\/310S: Cho t\u1ee7 s\u1ea5y\/kh\u1eed khu\u1ea9n kh\u00f4 \u1edf 250\u2013350\u00b0C+ (n\u1ebfu \u1ee9ng d\u1ee5ng dry-heat). 310S ch\u1ecbu oxy h\u00f3a cao nhi\u1ec7t t\u1ed1t.<br \/>\n&#8211; 904L\/duplex 2205: C\u00e2n nh\u1eafc n\u1ebfu n\u01b0\u1edbc c\u1ea5p\/condensate c\u00f3 clorua cao, nguy c\u01a1 SCC; th\u01b0\u1eddng kh\u00f4ng c\u1ea7n cho ti\u1ec7t tr\u00f9ng \u01b0\u1edbt ti\u00eau chu\u1ea9n.<br \/>\n&#8211; Gio\u0103ng\/\u0111\u1ec7m: EPDM steam-grade, silicone platinum-cured, PTFE (ho\u1eb7c PTFE b\u1ecdc); tu\u00e2n th\u1ee7 FDA 21 CFR 177; tr\u00e1nh NBR \u1edf nhi\u1ec7t\/ h\u01a1i.<\/p>\n<h3>Y\u00eau c\u1ea7u b\u1ec1 m\u1eb7t v\u00e0 ho\u00e0n thi\u1ec7n<\/h3>\n<p>&#8211; \u0110\u1ed9 nh\u00e1m Ra \u2264 0.8 \u03bcm cho d\u01b0\u1ee3c\/y t\u1ebf; c\u00f3 th\u1ec3 \u0111i\u1ec7n \u0111\u00e1nh b\u00f3ng (electropolish) \u0111\u1ebfn Ra 0.4 \u03bcm \u0111\u1ec3 t\u1ed1i \u01b0u v\u1ec7 sinh v\u00e0 gi\u1ea3m biofilm.<br \/>\n&#8211; T\u1ea9y g\u1ec9 &#038; th\u1ee5 \u0111\u1ed9ng h\u00f3a theo ASTM A380\/A967 (axit citric ho\u1eb7c nitric), sau h\u00e0n v\u00e0 tr\u01b0\u1edbc b\u00e0n giao.<br \/>\n&#8211; M\u1ed1i h\u00e0n n\u1ed9i b\u1ed9 m\u00e0i ph\u1eb3ng, kh\u00f4ng b\u1eadc, purge kh\u00ed Ar khi h\u00e0n GTAW\/orbital.<\/p>\n<h3>\u1ed0ng, ph\u1ee5 ki\u1ec7n v\u00e0 ti\u00eau chu\u1ea9n v\u1ec7 sinh<\/h3>\n<p>&#8211; \u1ed0ng v\u00e0 ph\u1ee5 ki\u1ec7n theo ASTM A270 (sanitary) ho\u1eb7c ASME BPE; k\u1ebft n\u1ed1i clamp (tri-clamp) cho th\u00e1o l\u1eafp nhanh.<br \/>\n&#8211; L\u1ecdc kh\u00ed 0.2 \u03bcm cho th\u1edf\/gi\u1ea3i \u00e1p; b\u1eaby h\u01a1i v\u00e0 x\u1ea3 \u0111\u00e1y ch\u1ea5t l\u01b0\u1ee3ng (v\u00ed d\u1ee5 Spirax Sarco) \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o h\u01a1i kh\u00f4.<br \/>\n&#8211; C\u00e1ch nhi\u1ec7t b\u00f4ng kho\u00e1ng 50\u2013100 mm, \u00e1o b\u1ecdc inox 304 \u0111\u1ec3 ti\u1ebft ki\u1ec7m n\u0103ng l\u01b0\u1ee3ng.<\/p>\n<h2 id=\"toc-2-thiet-ke-binh-chiu-ap-luc-va-buong-noi-hap\">Thi\u1ebft k\u1ebf b\u00ecnh ch\u1ecbu \u00e1p l\u1ef1c v\u00e0 bu\u1ed3ng n\u1ed3i h\u1ea5p<\/h2>\n<h3>Ti\u00eau chu\u1ea9n thi\u1ebft k\u1ebf \u2013 ki\u1ec3m \u0111\u1ecbnh<\/h3>\n<p>&#8211; TCVN 8366:2010 \u2013 B\u00ecnh ch\u1ecbu \u00e1p l\u1ef1c: y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt an to\u00e0n (\u00e1p d\u1ee5ng t\u1ea1i Vi\u1ec7t Nam).<br \/>\n&#8211; ASME BPVC Section VIII Div.1 ho\u1eb7c EN 13445 \u2013 Thi\u1ebft k\u1ebf b\u00ecnh \u00e1p l\u1ef1c.<br \/>\n&#8211; EN 285 \u2013 Sterilizers for medical use (h\u01a1i \u01b0\u1edbt).<br \/>\n&#8211; ISO 17665-1 \u2013 Sterilization of health care products \u2013 Moist heat.<br \/>\n&#8211; ASME BPE \u2013 D\u01b0\u1ee3c &#038; sinh h\u1ecdc: h\u00e0n, \u0111\u1ed9 d\u1ed1c, v\u1ec7 sinh.<br \/>\n&#8211; H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng: ISO 13485 (y t\u1ebf), GMP (d\u01b0\u1ee3c).<\/p>\n<h3>T\u00ednh b\u1ec1n, chi\u1ec1u d\u00e0y v\u00e0 an to\u00e0n<\/h3>\n<p>&#8211; Bu\u1ed3ng tr\u1ee5 tr\u00f2n ho\u1eb7c ch\u1eef nh\u1eadt gia c\u01b0\u1eddng g\u00e2n; chi\u1ec1u d\u00e0y \u0111i\u1ec3n h\u00ecnh 4\u20138 mm cho th\u1ec3 t\u00edch 150\u20131000 L, x\u00e1c \u0111\u1ecbnh b\u1eb1ng t\u00ednh to\u00e1n ASME\/EN v\u00e0 h\u1ec7 s\u1ed1 h\u00e0n.<br \/>\n&#8211; H\u1ec7 s\u1ed1 \u0103n m\u00f2n d\u1ef1 ph\u00f2ng 0.5\u20131.0 mm; c\u1eeda b\u1ea3n l\u1ec1 li\u00ean \u0111\u1ed9ng c\u01a1\u2013\u0111i\u1ec7n, kh\u00f3a c\u01a1 kh\u00ed ng\u0103n m\u1edf khi c\u00f2n \u00e1p\/ nhi\u1ec7t.<br \/>\n&#8211; Van an to\u00e0n c\u00e0i \u0111\u1eb7t \u2264 MAWP; th\u1eed th\u1ee7y l\u1ef1c 1.3\u00d7 MAWP; th\u1eed k\u00edn kh\u00ed x\u00e0 ph\u00f2ng\/helium theo y\u00eau c\u1ea7u.<\/p>\n<h3>Ch\u1ea5t l\u01b0\u1ee3ng h\u01a1i v\u00e0 tho\u00e1t n\u01b0\u1edbc<\/h3>\n<p>&#8211; Theo EN 285: t\u1ef7 ph\u1ea7n kh\u00ed kh\u00f4ng ng\u01b0ng \u2264 3.5% v\/v; \u0111\u1ed9 kh\u00f4 \u2265 0.95; si\u00eau nhi\u1ec7t < 25 K.\n- Thi\u1ebft k\u1ebf \u0111\u00e1y bu\u1ed3ng d\u1ed1c 1\u20132% v\u1ec1 ph\u00eda x\u1ea3 \u0111\u1ec3 tho\u00e1t ng\u01b0ng; lo\u1ea1i b\u1ecf \u0111i\u1ec3m \u0111\u1ecdng n\u01b0\u1edbc.\n- N\u1ebfu d\u00f9ng h\u01a1i s\u1ea1ch: generator h\u01a1i s\u1ea1ch 316L, n\u01b0\u1edbc c\u1ea5p RO\/DI; ki\u1ec3m so\u00e1t d\u1eabn \u0111i\u1ec7n, silica, clorua.\n\n\n\n<h2 id=\"toc-3-kien-truc-he-thong-pid-chuc-nang\">Ki\u1ebfn tr\u00fac h\u1ec7 th\u1ed1ng: P&#038;ID ch\u1ee9c n\u0103ng<\/h2>\n<p>&#8211; M\u1ea1ch h\u01a1i: van ch\u1eb7n, l\u1ecdc, \u0111\u1ed3ng h\u1ed3 \u00e1p, b\u1eaby h\u01a1i, van \u0111i\u1ec1u khi\u1ec3n modulating; c\u1ea3m bi\u1ebfn \u00e1p su\u1ea5t 4\u201320 mA; c\u1ea3m bi\u1ebfn nhi\u1ec7t PT100 l\u1edbp A.<br \/>\n&#8211; Bu\u1ed3ng: jacket gia nhi\u1ec7t, bu\u1ed3ng s\u1ea3n ph\u1ea9m, c\u1ed5ng ch\u00e2n kh\u00f4ng (pre-vac), c\u1ed5ng test Bowie\u2013Dick, c\u1ed5ng \u0111\u1ea7u d\u00f2 \u0111\u1ed9c l\u1eadp.<br \/>\n&#8211; X\u1eed l\u00fd kh\u00f4ng kh\u00ed: b\u01a1m ch\u00e2n kh\u00f4ng v\u00f2ng n\u01b0\u1edbc ho\u1eb7c kh\u00f4; l\u1ecdc 0.2 \u03bcm; van ph\u00e1 ch\u00e2n kh\u00f4ng c\u00f3 l\u1ecdc.<br \/>\n&#8211; X\u1ea3 ng\u01b0ng: b\u00ecnh t\u00e1ch, h\u1ed3i ng\u01b0ng; trao \u0111\u1ed5i nhi\u1ec7t \u0111\u1ec3 h\u1ea1 nhi\u1ec7t x\u1ea3 th\u1ea3i theo QCVN m\u00f4i tr\u01b0\u1eddng.<br \/>\n&#8211; \u0110i\u1ec1u khi\u1ec3n: PLC\/HMI, PID nhi\u1ec1u v\u00f9ng, ghi d\u1eef li\u1ec7u s\u1ed1, t\u00ednh F0, ch\u1eef k\u00fd \u0111i\u1ec7n t\u1eed (n\u1ebfu 21 CFR Part 11).<\/p>\n<h2 id=\"toc-4-che-do-tiet-trung-dien-hinh\">Ch\u1ebf \u0111\u1ed9 ti\u1ec7t tr\u00f9ng \u0111i\u1ec3n h\u00ecnh<\/h2>\n<p>&#8211; Tr\u1ecdng l\u1ef1c (gravity): cho ch\u1ea5t l\u1ecfng, d\u1ee5ng c\u1ee5 \u0111\u01a1n gi\u1ea3n; th\u1eddi gian d\u00e0i h\u01a1n.<br \/>\n&#8211; Ti\u1ec1n ch\u00e2n kh\u00f4ng (pre-vacuum): cho v\u1ea3i, d\u1ee5ng c\u1ee5 c\u00f3 l\u1ed7; 3\u20134 xung ch\u00e2n kh\u00f4ng \u0111\u1ec3 \u0111\u1ea9y kh\u00ed kh\u00f4ng ng\u01b0ng.<br \/>\n&#8211; Retort th\u1ef1c ph\u1ea9m: phun n\u01b0\u1edbc\/tu\u1ea7n ho\u00e0n n\u01b0\u1edbc + h\u01a1i; c\u00f3 kh\u00ed n\u00e9n \u0111\u1ec7m \u0111\u1ec3 c\u00e2n \u00e1p cho bao b\u00ec m\u1ecfng; c\u00f3 th\u1ec3 th\u00eam quay l\u1ed3ng \u0111\u1ec3 \u0111\u1ed3ng \u0111\u1ec1u nhi\u1ec7t.<br \/>\n&#8211; Dry heat (n\u1ebfu c\u00f3): 160\u2013180\u00b0C kh\u1eed pyrogen; y\u00eau c\u1ea7u inox ch\u1ecbu nhi\u1ec7t cao v\u00e0 c\u00e1ch nhi\u1ec7t d\u00e0y.<\/p>\n<h2 id=\"toc-5-quy-trinh-che-tao-tung-buoc-de-dat-chuan\">Quy tr\u00ecnh ch\u1ebf t\u1ea1o: t\u1eebng b\u01b0\u1edbc \u0111\u1ec3 \u0111\u1ea1t chu\u1ea9n<\/h2>\n<p>1) Thi\u1ebft k\u1ebf c\u01a1 kh\u00ed v\u00e0 th\u1ea9m \u0111\u1ecbnh<br \/>\n&#8211; X\u00e1c \u0111\u1ecbnh t\u1ea3i (lo\u1ea1i s\u1ea3n ph\u1ea9m, kh\u1ed1i l\u01b0\u1ee3ng, \u0111\u00f3ng g\u00f3i), th\u1ec3 t\u00edch h\u1eefu \u00edch, chu tr\u00ecnh m\u1ee5c ti\u00eau (121\/134\u00b0C).<br \/>\n&#8211; T\u00ednh b\u1ec1n theo ASME\/EN; ph\u00e2n t\u00edch FEM cho c\u1eeda ch\u1eef nh\u1eadt\/khung ch\u1ecbu l\u1ef1c.<br \/>\n&#8211; P&#038;ID v\u00e0 tri\u1ebft l\u00fd an to\u00e0n (SIL n\u1ebfu c\u1ea7n).<\/p>\n<p>2) Mua v\u1eadt t\u01b0 v\u00e0 truy xu\u1ea5t<br \/>\n&#8211; T\u1ea5m\/\u1ed1ng inox theo ASTM A240\/A270; ch\u1ee9ng ch\u1ec9 EN 10204 3.1; PMI 100% cho 316L.<br \/>\n&#8211; Gio\u0103ng, van, c\u1ea3m bi\u1ebfn c\u00f3 ch\u1ee9ng nh\u1eadn FDA\/USP Class VI n\u1ebfu d\u01b0\u1ee3c\/y t\u1ebf.<\/p>\n<p>3) Gia c\u00f4ng \u2013 h\u00e0n<br \/>\n&#8211; C\u00e1n u\u1ed1n v\u1ecf, R dishing heads; h\u00e0n GTAW\/orbital, back purge Ar; ki\u1ec3m so\u00e1t nhi\u1ec7t v\u00e0o \u0111\u1ec3 h\u1ea1n ch\u1ebf sensitization.<br \/>\n&#8211; NDT m\u1ed1i h\u00e0n: PT 100%, RT theo critical joints; ki\u1ec3m tra ferrite weld 3\u201310% v\u1edbi 316L (t\u00f9y y\u00eau c\u1ea7u).<\/p>\n<p>4) Ho\u00e0n thi\u1ec7n b\u1ec1 m\u1eb7t<br \/>\n&#8211; M\u00e0i, \u0111\u00e1nh b\u00f3ng \u0111\u1ea1t Ra; t\u1ea9y g\u1ec9 \u2013 th\u1ee5 \u0111\u1ed9ng h\u00f3a; ki\u1ec3m tra \u0111\u1ed9 s\u1ea1ch b\u1ec1 m\u1eb7t, test tr\u1eafng kh\u0103n g\u1ea1c.<\/p>\n<p>5) L\u1eafp r\u00e1p \u2013 \u0111i\u1ec7n \u2013 \u0111i\u1ec1u khi\u1ec3n<br \/>\n&#8211; L\u1eafp van, b\u1eaby h\u01a1i \u0111\u00fang h\u01b0\u1edbng; \u0111i \u1ed1ng d\u1ed1c v\u1ec1 drain; gi\u1eef b\u00e1n k\u00ednh v\u1ec7 sinh \u22651.5D cho g\u00f3c chuy\u1ec3n h\u01b0\u1edbng.<br \/>\n&#8211; T\u1ee7 \u0111i\u1ec7n, PLC\/HMI; wiring chu\u1ea9n c\u00f4ng nghi\u1ec7p; interlock c\u1eeda.<\/p>\n<p>6) Th\u1eed nghi\u1ec7m nh\u00e0 m\u00e1y (FAT)<br \/>\n&#8211; \u00c1p l\u1ef1c th\u1ee7y l\u1ef1c 1.3\u00d7; th\u1eed k\u00edn; ch\u1ea1y kh\u00f4ng t\u1ea3i c\u00e1c chu tr\u00ecnh; ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng h\u01a1i theo EN 285.<br \/>\n&#8211; Ki\u1ec3m tra an to\u00e0n: van an to\u00e0n, c\u00f4ng t\u1eafc \u00e1p, interlock c\u1eeda.<\/p>\n<p>7) B\u00e0n giao \u2013 L\u1eafp \u0111\u1eb7t \u2013 SAT<br \/>\n&#8211; G\u00e1 \u0111\u1eb7t n\u1ec1n v\u1eefng, c\u0103n \u0111\u1ed3ng tr\u1ee5c c\u1eeda; \u0111\u1ea5u h\u01a1i, \u0111i\u1ec7n, n\u01b0\u1edbc, ng\u01b0ng; c\u00e1ch nhi\u1ec7t ho\u00e0n thi\u1ec7n.<br \/>\n&#8211; SAT l\u1eadp l\u1ea1i c\u00e1c test quan tr\u1ecdng, t\u00edch h\u1ee3p v\u1edbi ti\u1ec7n \u00edch hi\u1ec7n tr\u01b0\u1eddng.<\/p>\n<p>8) X\u00e1c nh\u1eadn\/Th\u1ea9m \u0111\u1ecbnh (n\u1ebfu y t\u1ebf\/d\u01b0\u1ee3c)<br \/>\n&#8211; IQ\/OQ\/PQ theo ISO 17665 v\u00e0 GMP; Bowie\u2013Dick h\u1eb1ng ng\u00e0y, ch\u1ec9 th\u1ecb sinh h\u1ecdc \u0111\u1ecbnh k\u1ef3; mapping nhi\u1ec7t \u0111\u1ed9 bu\u1ed3ng v\u1edbi \u226512 \u0111\u1ea7u d\u00f2.<\/p>\n<h2 id=\"toc-6-van-hanh-bao-tri-va-kiem-dinh-dinh-ky\">V\u1eadn h\u00e0nh, b\u1ea3o tr\u00ec v\u00e0 ki\u1ec3m \u0111\u1ecbnh \u0111\u1ecbnh k\u1ef3<\/h2>\n<p>&#8211; H\u1eb1ng ng\u00e0y: Ki\u1ec3m tra b\u1eaby h\u01a1i, x\u1ea3 \u0111\u00e1y, test Bowie\u2013Dick (pre-vac), v\u1ec7 sinh gio\u0103ng c\u1eeda, ki\u1ec3m tra r\u00f2.<br \/>\n&#8211; H\u1eb1ng tu\u1ea7n\/th\u00e1ng: Hi\u1ec7u chu\u1ea9n c\u1ea3m bi\u1ebfn T\/P; ki\u1ec3m tra b\u01a1m ch\u00e2n kh\u00f4ng, l\u1ecdc 0.2 \u03bcm; v\u1ec7 sinh b\u1ed9 trao \u0111\u1ed5i.<br \/>\n&#8211; H\u1eb1ng n\u0103m: Ki\u1ec3m \u0111\u1ecbnh b\u00ecnh \u00e1p l\u1ef1c theo TCVN\/\u0111\u01a1n v\u1ecb ch\u1ee9c n\u0103ng; th\u1eed van an to\u00e0n; th\u1eed th\u1ee7y l\u1ef1c khi \u0111\u1ebfn h\u1ea1n.<br \/>\n&#8211; Gio\u0103ng c\u1eeda: thay 6\u201312 th\u00e1ng t\u00f9y t\u1ea7n su\u1ea5t v\u00e0 nhi\u1ec7t; ki\u1ec3m tra n\u1ee9t n\u1ebb\/bi\u1ebfn d\u1ea1ng.<br \/>\n&#8211; N\u01b0\u1edbc c\u1ea5p: ki\u1ec3m so\u00e1t clorua, \u0111\u1ed9 d\u1eabn \u0111i\u1ec7n; n\u1ebfu c\u00f3 c\u00e1u c\u1eb7n, l\u00e0m m\u1ec1m\/RO v\u00e0 v\u1ec7 sinh \u0111\u1ecbnh k\u1ef3.<\/p>\n<h2 id=\"toc-7-nhung-loi-thuong-gap-va-cach-phong-tranh\">Nh\u1eefng l\u1ed7i th\u01b0\u1eddng g\u1eb7p v\u00e0 c\u00e1ch ph\u00f2ng tr\u00e1nh<\/h2>\n<p>&#8211; \u0102n m\u00f2n k\u1ebd\/m\u1ed1i h\u00e0n: do v\u1ec7 sinh kh\u00f4ng \u0111\u1ee7 sau h\u00e0n; kh\u1eafc ph\u1ee5c b\u1eb1ng t\u1ea9y g\u1ec9 \u2013 th\u1ee5 \u0111\u1ed9ng h\u00f3a \u0111\u00fang quy tr\u00ecnh, purge t\u1ed1t.<br \/>\n&#8211; H\u01a1i \u1ea9m th\u1ea5p\/si\u00eau nhi\u1ec7t cao: b\u1ed1 tr\u00ed b\u1eaby h\u01a1i sai, thi\u1ebfu h\u1ed3i ng\u01b0ng; c\u1ea7n thi\u1ebft k\u1ebf l\u1ea1i \u0111i\u1ec3m l\u1ea5y h\u01a1i v\u00e0 b\u1eaby.<br \/>\n&#8211; N\u01b0\u1edbc \u0111\u1ecdng trong bu\u1ed3ng: n\u1ec1n bu\u1ed3ng kh\u00f4ng \u0111\u1ee7 d\u1ed1c; ch\u1ec9nh nghi\u00eang, th\u00eam drain.<br \/>\n&#8211; R\u00f2 c\u1eeda: gio\u0103ng kh\u00f4ng ph\u00f9 h\u1ee3p lo\u1ea1i h\u01a1i\/ nhi\u1ec7t; chuy\u1ec3n sang EPDM steam-grade ho\u1eb7c PTFE b\u1ecdc.<br \/>\n&#8211; Chu tr\u00ecnh kh\u00f4ng \u0111\u1ea1t F0: c\u1ea3m bi\u1ebfn l\u1ec7ch, c\u1ea7n hi\u1ec7u chu\u1ea9n v\u00e0 t\u0103ng s\u1ed1 \u0111\u1ea7u d\u00f2 load.<\/p>\n<h2 id=\"toc-8-bai-toan-chi-phi-yeu-to-quyet-dinh-gia\">B\u00e0i to\u00e1n chi ph\u00ed: y\u1ebfu t\u1ed1 quy\u1ebft \u0111\u1ecbnh gi\u00e1<\/h2>\n<p>&#8211; M\u00e1c inox v\u00e0 b\u1ec1 m\u1eb7t (316L \u0111i\u1ec7n \u0111\u00e1nh b\u00f3ng \u0111\u1eaft h\u01a1n 304 \u0111\u00e1nh b\u00f3ng c\u01a1).<br \/>\n&#8211; D\u1ea1ng bu\u1ed3ng (tr\u00f2n r\u1ebb h\u01a1n ch\u1eef nh\u1eadt l\u1edbn ph\u1ea3i gia c\u01b0\u1eddng).<br \/>\n&#8211; T\u00ednh n\u0103ng: ti\u1ec1n ch\u00e2n kh\u00f4ng, ghi d\u1eef li\u1ec7u 21 CFR Part 11, h\u01a1i s\u1ea1ch, rotary retort l\u00e0m t\u0103ng chi ph\u00ed.<br \/>\n&#8211; T\u1ef1 \u0111\u1ed9ng h\u00f3a: PLC\/SCADA, s\u1ed1 l\u01b0\u1ee3ng I\/O, h\u00e3ng van\/c\u1ea3m bi\u1ebfn.<br \/>\n&#8211; Ch\u1ee9ng nh\u1eadn\/Th\u1ea9m \u0111\u1ecbnh: t\u00e0i li\u1ec7u DQ\/IQ\/OQ\/PQ, mapping, bioburden control.<\/p>\n<h2 id=\"toc-9-vi-du-cau-hinh-ky-thuat-tham-khao\">V\u00ed d\u1ee5 c\u1ea5u h\u00ecnh k\u1ef9 thu\u1eadt tham kh\u1ea3o<\/h2>\n<p>&#8211; N\u1ed3i h\u1ea5p pre-vac 300 L cho CSSD b\u1ec7nh vi\u1ec7n:<br \/>\n  &#8211; Bu\u1ed3ng v\u00e0 \u1ed1ng 316L, Ra \u2264 0.8 \u03bcm; jacket 304.<br \/>\n  &#8211; Thi\u1ebft k\u1ebf 150\u00b0C, 4 bar(g); van an to\u00e0n DN25.<br \/>\n  &#8211; B\u01a1m ch\u00e2n kh\u00f4ng 300 m3\/h; l\u1ecdc 0.2 \u03bcm cho ph\u00e1 ch\u00e2n kh\u00f4ng.<br \/>\n  &#8211; PLC + HMI 10&#8243;; 2 k\u00eanh PT100 \u0111\u1ed9c l\u1eadp; ghi d\u1eef li\u1ec7u, t\u00ednh F0.<br \/>\n  &#8211; Test theo EN 285, ISO 17665; Bowie\u2013Dick \u0111\u1ea1t chu\u1ea9n.<br \/>\n&#8211; Retort th\u1ef1c ph\u1ea9m 1200 L, phun n\u01b0\u1edbc \u2013 h\u01a1i:<br \/>\n  &#8211; Th\u00e2n 316L, c\u00e1nh phun ch\u1ecbu \u0103n m\u00f2n; tu\u1ea7n ho\u00e0n b\u01a1m inox.<br \/>\n  &#8211; \u0110i\u1ec1u khi\u1ec3n nhi\u1ec7t\u2013\u00e1p PID; c\u1ea3m bi\u1ebfn T \u0111\u1eb7t g\u1ea7n bao b\u00ec.<br \/>\n  &#8211; H\u1ec7 h\u1ed3i nhi\u1ec7t ng\u01b0ng \u0111\u1ec3 ti\u1ebft ki\u1ec7m n\u0103ng l\u01b0\u1ee3ng.<\/p>\n<h2 id=\"toc-10-checklist-nhanh-truoc-khi-dat-hangdau-tu\">Checklist nhanh tr\u01b0\u1edbc khi \u0111\u1eb7t h\u00e0ng\/\u0111\u1ea7u t\u01b0<\/h2>\n<p>&#8211; X\u00e1c \u0111\u1ecbnh lo\u1ea1i t\u1ea3i, chu tr\u00ecnh (121\/134\u00b0C, F0 y\u00eau c\u1ea7u).<br \/>\n&#8211; Ch\u1ecdn m\u00e1c inox: 316L cho bu\u1ed3ng\/\u0111\u01b0\u1eddng \u1ed1ng; ho\u00e0n thi\u1ec7n b\u1ec1 m\u1eb7t m\u1ee5c ti\u00eau.<br \/>\n&#8211; Ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng: TCVN 8366, ASME VIII\/EN 13445, EN 285, ISO 17665, ASME BPE.<br \/>\n&#8211; H\u01a1i v\u00e0 n\u01b0\u1edbc c\u1ea5p: ch\u1ea5t l\u01b0\u1ee3ng, l\u01b0u l\u01b0\u1ee3ng, \u00e1p l\u1ef1c; c\u1ea7n h\u01a1i s\u1ea1ch kh\u00f4ng?<br \/>\n&#8211; P&#038;ID: b\u1eaby h\u01a1i, drain, l\u1ecdc kh\u00ed 0.2 \u03bcm, b\u01a1m ch\u00e2n kh\u00f4ng, van an to\u00e0n.<br \/>\n&#8211; \u0110i\u1ec1u khi\u1ec3n: PLC\/HMI, ghi d\u1eef li\u1ec7u, Part 11 (n\u1ebfu c\u1ea7n); s\u1ed1 \u0111\u1ea7u d\u00f2 \u0111o.<br \/>\n&#8211; FAT\/SAT v\u00e0 g\u00f3i IQ\/OQ\/PQ; t\u00e0i li\u1ec7u MTR 3.1, PMI, NDT.<br \/>\n&#8211; K\u1ebf ho\u1ea1ch b\u1ea3o tr\u00ec, ph\u1ee5 t\u00f9ng (gio\u0103ng, l\u1ecdc, b\u1eaby h\u01a1i).<\/p>\n<h2 id=\"toc-11-tai-lieu-tham-khao\">T\u00e0i li\u1ec7u tham kh\u1ea3o<\/h2>\n<p>&#8211; EN 285: Sterilization \u2013 Steam sterilizers \u2013 Large sterilizers.<br \/>\n&#8211; ISO 17665-1: Sterilization of health care products \u2013 Moist heat.<br \/>\n&#8211; ASME Boiler and Pressure Vessel Code, Section VIII Div.1.<br \/>\n&#8211; EN 13445: Unfired pressure vessels.<br \/>\n&#8211; ASME BPE: Bioprocessing Equipment.<br \/>\n&#8211; ASTM A240\/A270; ASTM A380\/A967.<br \/>\n&#8211; TCVN 8366:2010 \u2013 B\u00ecnh ch\u1ecbu \u00e1p l\u1ef1c \u2013 Y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt an to\u00e0n.<br \/>\n&#8211; WHO GMP; 21 CFR 211 (\u0111\u1ed1i v\u1edbi d\u01b0\u1ee3c ph\u1ea9m).<\/p>\n<h2 id=\"toc-12-ket-luan\">K\u1ebft lu\u1eadn<\/h2>\n<p>Ch\u00eca kh\u00f3a ch\u1ebf t\u1ea1o n\u1ed3i h\u1ea5p ti\u1ec7t tr\u00f9ng\/thi\u1ebft b\u1ecb kh\u1eed khu\u1ea9n inox ch\u1ecbu nhi\u1ec7t l\u00e0: ch\u1ecdn \u0111\u00fang 316L cho v\u00f9ng \u01b0\u1edbt, thi\u1ebft k\u1ebf b\u00ecnh \u00e1p l\u1ef1c theo ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf, \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng h\u01a1i \u2013 tho\u00e1t ng\u01b0ng \u2013 b\u1ec1 m\u1eb7t v\u1ec7 sinh, h\u00e0n v\u00e0 th\u1ee5 \u0111\u1ed9ng h\u00f3a chu\u1ea9n, c\u00f9ng h\u1ec7 \u0111i\u1ec1u khi\u1ec3n c\u00f3 kh\u1ea3 n\u0103ng ch\u1ee9ng minh F0 v\u00e0 truy xu\u1ea5t. Th\u1ef1c hi\u1ec7n \u0111\u1ea7y \u0111\u1ee7 FAT\/SAT v\u00e0 IQ\/OQ\/PQ s\u1ebd b\u1ea3o \u0111\u1ea3m tu\u00e2n th\u1ee7 v\u00e0 v\u1eadn h\u00e0nh \u1ed5n \u0111\u1ecbnh l\u00e2u d\u00e0i. C\u1ea7n t\u1ed1i \u01b0u theo t\u1ea3i th\u1ef1c t\u1ebf \u0111\u1ec3 \u0111\u1ea1t hi\u1ec7u qu\u1ea3 \u0111\u1ea7u t\u01b0 v\u00e0 n\u0103ng l\u01b0\u1ee3ng t\u1ed1t nh\u1ea5t.<\/p>\n<p>Li\u00ean h\u1ec7 Inox C\u01b0\u1eddng Th\u1ecbnh \u0111\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n v\u1eadt li\u1ec7u, thi\u1ebft k\u1ebf v\u00e0 b\u00e1o gi\u00e1 t\u1ed1t cho d\u1ef1 \u00e1n n\u1ed3i h\u1ea5p\/retort v\u00e0 thi\u1ebft b\u1ecb kh\u1eed khu\u1ea9n inox ch\u1ecbu nhi\u1ec7t. Hotline: 0343.417.281. Email: inoxcongnghiep.cuongthinh@gmail.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>H\u01b0\u1edbng d\u1eabn ch\u1ecdn inox, thi\u1ebft k\u1ebf, ti\u00eau chu\u1ea9n v\u00e0 quy tr\u00ecnh ch\u1ebf t\u1ea1o n\u1ed3i h\u1ea5p ti\u1ec7t tr\u00f9ng\/thi\u1ebft b\u1ecb kh\u1eed khu\u1ea9n ch\u1ecbu nhi\u1ec7t cho th\u1ef1c ph\u1ea9m, y t\u1ebf, d\u01b0\u1ee3c. C\u00f3 checklist.<\/p>\n","protected":false},"author":7,"featured_media":1022,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[23],"tags":[],"class_list":["post-1356","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\/1356","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=1356"}],"version-history":[{"count":0,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts\/1356\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media\/1022"}],"wp:attachment":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media?parent=1356"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/categories?post=1356"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/tags?post=1356"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}