{"id":9481,"date":"2026-03-21T09:37:45","date_gmt":"2026-03-21T09:37:45","guid":{"rendered":"https:\/\/sepro.vn\/?p=9481"},"modified":"2026-03-21T09:37:45","modified_gmt":"2026-03-21T09:37:45","slug":"endotoxin-trong-san-xuat-duoc-pham","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/endotoxin-trong-san-xuat-duoc-pham\/","title":{"rendered":"Endotoxin trong s\u1ea3n xu\u1ea5t D\u01b0\u1ee3c Ph\u1ea9m: V\u00ec sao xu h\u01b0\u1edbng d\u1eef li\u1ec7u quan tr\u1ecdng h\u01a1n m\u1ed9t k\u1ebft qu\u1ea3 \u0111\u1ea1t"},"content":{"rendered":"

Trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m, \u0111\u1eb7c bi\u1ec7t \u0111\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m v\u00f4 tr\u00f9ng, endotoxin l\u00e0 m\u1ed9t trong nh\u1eefng ngu\u1ed3n nguy c\u01a1 nhi\u1ec5m b\u1ea9n kh\u00f3 ph\u00e1t hi\u1ec7n nh\u1ea5t. <\/span>Kh\u00f4ng<\/b> m\u00e0u, <\/span>kh\u00f4ng<\/b> m\u00f9i v\u00e0 <\/span>kh\u00f4ng<\/b> th\u1ec3 ph\u00e1t hi\u1ec7n b\u1eb1ng m\u1eaft th\u01b0\u1eddng v\u00e0 ch\u00fang <\/span>kh\u00f4ng th\u1ec3<\/b> b\u1ecb lo\u1ea1i b\u1ecf b\u1edfi c\u00e1c <\/span>ph\u01b0\u01a1ng ph\u00e1p kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng<\/b>. Ch\u1ec9 m\u1ed9t s\u01a1 xu\u1ea5t nh\u1ecf khi ki\u1ec3m so\u00e1t <\/span>endotoxin \u00a0trong s\u1ea3n xu\u1ea5t D\u01b0\u01a1c Ph\u1ea9m<\/a><\/strong> l\u00e0 \u0111\u1ee7 \u0111\u1ec3\u00a0\u0110\u1ed9c t\u1ed1<\/strong>n\u00e0y<\/span> x\u00e2m nh\u1eadp v\u00e0o s\u1ea3n ph\u1ea9m ti\u00eam truy\u1ec1n g\u00e2y ph\u1ea3n \u1ee9ng sinh s\u1ed1t (pyrogenic reactions<\/b>) v\u00e0 trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p nghi\u00eam tr\u1ecdng c\u00f3 th\u1ec3 \u0111e d\u1ecda t\u00ednh m\u1ea1ng ng\u01b0\u1eddi b\u1ec7nh.<\/span><\/p>\n

B\u00e0i vi\u1ebft n\u00e0y gi\u1ea3i th\u00edch endotoxin l\u00e0 g\u00ec, c\u00e1ch ki\u1ec3m so\u00e1t endotoxin trong s\u1ea3n xu\u1ea5t D\u01b0\u1ee3c Ph\u1ea9m v\u00e0 m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch d\u01b0\u1ee3c ph\u1ea9m, c\u0169ng nh\u01b0 c\u00e1c d\u1eabn ch\u1ee9ng t\u1eeb FDA.<\/span><\/p>\n

Endotoxin l\u00e0 g\u00ec \u2014 \u0110\u1ecbnh ngh\u0129a ch\u00ednh x\u00e1c<\/b><\/h2>\n
\"cau-tao-cua-endotoxin\"
C\u1ea5u t\u1ea1o c\u1ee7a Endotoxin<\/figcaption><\/figure>\n

Source \u1ea3nh C\u1ea5u tr\u00fac c\u1ee7a Endotoxin: <\/span>https:\/\/www.mdpi.com\/2072-6651\/13\/8\/533<\/span><\/a><\/p>\n

Endotoxin, hay n\u1ed9i \u0111\u1ed9c t\u1ed1 c\u1ee7a vi khu\u1ea9n Gram \u00e2m, l\u00e0 th\u00e0nh ph\u1ea7n lipopolysaccharide (LPS) c\u1ea5u t\u1ea1o n\u00ean m\u00e0ng ngo\u00e0i c\u1ee7a vi khu\u1ea9n Gram \u00e2m nh\u01b0 <\/span>Escherichia coli<\/span><\/i>, <\/span>Pseudomonas aeruginosa<\/span><\/i> v\u00e0 <\/span>Salmonella<\/span><\/i> spp. Endotoxin \u0111\u01b0\u1ee3c gi\u1ea3i ph\u00f3ng khi t\u1ebf b\u00e0o vi khu\u1ea9n ch\u1ebft, b\u1ecb ly gi\u1ea3i ho\u1eb7c b\u1ecb ph\u00e2n h\u1ee7y<\/span><\/p>\n

Endotoxin tr\u1edf th\u00e0nh m\u1ed1i nguy \u0111\u1eb7c bi\u1ec7t trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m do b\u1ed1n \u0111\u1eb7c t\u00ednh quan tr\u1ecdng sau:<\/span><\/p>\n

    \n
  1. Endotoxin c\u00f3 \u0111\u1ed9 b\u1ec1n nhi\u1ec7t cao v\u00e0 kh\u00f4ng b\u1ecb ph\u00e1 h\u1ee7y \u1edf nhi\u1ec7t \u0111\u1ed9 kh\u1eed tr\u00f9ng b\u1eb1ng h\u01a1i n\u01b0\u1edbc th\u00f4ng th\u01b0\u1eddng (121\u00b0C trong autoclave).<\/span><\/li>\n
  2. Endotoxin kh\u00f4ng b\u1ecb gi\u1eef l\u1ea1i b\u1edfi m\u00e0ng l\u1ecdc vi khu\u1ea9n 0,22 \u00b5m, v\u00ec k\u00edch th\u01b0\u1edbc ph\u00e2n t\u1eed nh\u1ecf h\u01a1n t\u1ebf b\u00e0o vi khu\u1ea9n.\u00a0<\/span><\/li>\n
  3. Endotoxin c\u00f3 th\u1ec3 t\u00edch l\u0169y trong h\u1ec7 th\u1ed1ng n\u01b0\u1edbc d\u01b0\u1ee3c d\u1ee5ng v\u00e0 tr\u00ean b\u1ec1 m\u1eb7t thi\u1ebft b\u1ecb n\u1ebfu ch\u01b0\u01a1ng tr\u00ecnh ki\u1ec3m so\u00e1t kh\u00f4ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ea7y \u0111\u1ee7.\u00a0<\/span><\/li>\n
  4. Khi x\u00e2m nh\u1eadp v\u00e0o c\u01a1 th\u1ec3 qua \u0111\u01b0\u1eddng ti\u00eam, endotoxin c\u00f3 th\u1ec3 g\u00e2y ph\u1ea3n \u1ee9ng sinh s\u1ed1t (pyrogenic reaction) ngay c\u1ea3 \u1edf n\u1ed3ng \u0111\u1ed9 r\u1ea5t th\u1ea5p.<\/b><\/li>\n<\/ol>\n

    Ph\u00e2n bi\u1ec7t Endotoxin, Bioburden v\u00e0 Pyrogen<\/b><\/h2>\n
    \"phan-biet-endotoxin-bioburden-pyrogen\"
    Ph\u00e2n bi\u1ec7t Endotoxin, Bioburden v\u00e0 Pyrogen<\/em><\/figcaption><\/figure>\n

    B\u1ea3ng b\u00ean d\u01b0\u1edbi s\u1ebd t\u00f3m t\u1eaft 03 kh\u00e1i ni\u1ec7m trong th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m nghi\u1ec7m d\u01b0\u1ee3c ph\u1ea9m – m\u1eb7c d\u00f9 b\u1ea3n ch\u1ea5t, ph\u01b0\u01a1ng ph\u00e1p \u0111\u1ec3 ph\u00e1t hi\u1ec7n v\u00e0 x\u1eed l\u00fd ho\u00e0n to\u00e0n kh\u00e1c nhau:\u00a0<\/span><\/p>\n\n\n\n\n\n\n\n\n
    Ti\u00eau ch\u00ed<\/b><\/td>\nEndotoxin<\/b><\/td>\nBioburden<\/b><\/td>\nPyrogen<\/b><\/td>\n<\/tr>\n
    B\u1ea3n ch\u1ea5t<\/span><\/td>\nLPS t\u1eeb m\u00e0ng vi khu\u1ea9n Gram \u00e2m<\/span><\/td>\nT\u1ed5ng vi sinh v\u1eadt s\u1ed1ng trong m\u1eabu<\/span><\/td>\nB\u1ea5t k\u1ef3 ch\u1ea5t n\u00e0o g\u00e2y s\u1ed1t khi v\u00e0o c\u01a1 th\u1ec3<\/span><\/td>\n<\/tr>\n
    Ph\u01b0\u01a1ng ph\u00e1p \u0111\u1ec3 nh\u1eadn bi\u1ebft<\/span><\/td>\nBET \/ LAL test (USP <85>)<\/span><\/td>\n\u0110\u1ebfm khu\u1ea9n l\u1ea1c, l\u1ecdc m\u00e0ng<\/span><\/td>\nTh\u1eed nghi\u1ec7m, MAT<\/span><\/td>\n<\/tr>\n
    B\u1ecb lo\u1ea1i b\u1ecf b\u1eb1ng ph\u01b0\u01a1ng ph\u00e1p kh\u1eed khu\u1ea9n<\/span><\/td>\nKh\u00f4ng<\/span><\/td>\nC\u00f3<\/span><\/td>\nT\u00f9y lo\u1ea1i<\/span><\/td>\n<\/tr>\n
    L\u1ecdc 0,22 \u00b5m gi\u1eef l\u1ea1i<\/span><\/td>\nKh\u00f4ng<\/span><\/td>\nC\u00f3<\/span><\/td>\nT\u00f9y lo\u1ea1i<\/span><\/td>\n<\/tr>\n
    M\u1ed1i quan h\u1ec7<\/span><\/td>\nL\u00e0 m\u1ed9t lo\u1ea1i pyrogen<\/span><\/td>\nC\u00f3 nguy c\u01a1 h\u00ecnh th\u00e0nh endotoxin khi t\u0103ng cao k\u00e9o d\u00e0i\u00a0<\/span><\/td>\nKh\u00e1i ni\u1ec7m r\u1ed9ng h\u01a1n endotoxin<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    Ngu\u1ed3n tham kh\u1ea3o: <\/span>https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-technical-guides\/bacterial-endotoxinspyrogens<\/span><\/a><\/p>\n

    Ngu\u1ed3n tham kh\u1ea3o: <\/span>https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/guidance-industry-pyrogen-and-endotoxins-testing-questions-and-answers<\/span><\/a><\/p>\n

    \u0110i\u1ec3m th\u1ef1c h\u00e0nh quan tr\u1ecdng:<\/b> K\u1ebft qu\u1ea3 bioburden \u0111\u1ea1t y\u00eau c\u1ea7u kh\u00f4ng \u0111\u1ed3ng ngh\u0129a v\u1edbi vi\u1ec7c endotoxin c\u0169ng \u0111\u1ea1t y\u00eau c\u1ea7u. Endotoxin c\u00f3 th\u1ec3 t\u1ed3n t\u1ea1i trong h\u1ec7 th\u1ed1ng ngay c\u1ea3 khi bioburden \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t, v\u00ec endotoxin kh\u00f4ng b\u1ecb lo\u1ea1i b\u1ecf b\u1edfi c\u00e1c t\u00e1c nh\u00e2n kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng.<\/span><\/p><\/blockquote>\n

    X\u00e9t nghi\u1ec7m endotoxin l\u00e0 g\u00ec \u2014 BET v\u00e0 LAL test<\/b><\/h2>\n
    \"cac-phuong-phap-xet-nghiem-endotoxin\"
    C\u00e1c ph\u01b0\u01a1ng ph\u00e1p x\u00e9t nghi\u1ec7m Endotoxin<\/figcaption><\/figure>\n

    \u0110\u1ec3 ph\u00e1t hi\u1ec7n v\u00e0 \u0111\u1ecbnh l\u01b0\u1ee3ng endotoxin trong s\u1ea3n ph\u1ea9m, <\/span>c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m th\u01b0\u1eddng s\u1eed d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p Th\u1eed n\u1ed9i \u0111\u1ed9c t\u1ed1 vi khu\u1ea9n<\/b> (Bacterial Endotoxins Test \u2014 BET), c\u00f2n \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 <\/span>LAL test (Limulus Amebocyte Lysate test)<\/b>.<\/span><\/p>\n

    Theo t\u00e0i li\u1ec7u thanh tra k\u1ef9 thu\u1eadt c\u1ee7a FDA:<\/span><\/p>\n

    “Bacterial Endotoxins Test, also termed the Limulus Amebocyte Lysate (LAL) Test.”<\/span><\/i><\/p>\n

    Link tham kh\u1ea3o: <\/span>https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-technical-guides\/bacterial-endotoxinspyrogens<\/span><\/a><\/p>\n

    Nguy\u00ean l\u00fd c\u1ee7a LAL test d\u1ef1a tr\u00ean <\/span>ph\u1ea3n \u1ee9ng \u0111\u00f4ng \u0111\u1eb7c c\u1ee7a d\u1ecbch chi\u1ebft t\u1eeb t\u1ebf b\u00e0o amebocyte c\u1ee7a cua m\u00f3ng ng\u1ef1a (<\/b>Limulus polyphemus<\/i><\/b>) khi ti\u1ebfp x\u00fac v\u1edbi endotoxin<\/b>. \u0110\u00e2y l\u00e0 ph\u01b0\u01a1ng ph\u00e1p nh\u1ea1y, \u0111\u1eb7c hi\u1ec7u v\u00e0 \u0111\u01b0\u1ee3c chu\u1ea9n h\u00f3a trong <\/span>USP <85> Bacterial Endotoxins Test<\/b>.<\/span><\/p>\n

    FDA c\u0169ng ban h\u00e0nh <\/span>h\u01b0\u1edbng d\u1eabn ri\u00eang cho ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m, sinh ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf<\/b> li\u00ean quan \u0111\u1ebfn vi\u1ec7c ki\u1ec3m nghi\u1ec7m endotoxin v\u00e0 ti\u00eau ch\u00ed ch\u1ea5p nh\u1eadn theo USP <85>.<\/span><\/p>\n

    Link tham kh\u1ea3o: <\/span>https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/guidance-industry-pyrogen-and-endotoxins-testing-questions-and-answers<\/span><\/a><\/p>\n

    Ba ph\u01b0\u01a1ng ph\u00e1p BET ph\u1ed5 bi\u1ebfn hi\u1ec7n nay:<\/b><\/h3>\n\n\n\n\n\n\n
    Ph\u01b0\u01a1ng ph\u00e1p<\/b><\/td>\nNguy\u00ean l\u00fd<\/b><\/td>\n\u1ee8ng d\u1ee5ng ph\u1ed5 bi\u1ebfn<\/b><\/td>\n<\/tr>\n
    Gel-clot<\/span><\/td>\nQuan s\u00e1t \u0111\u00f4ng \u0111\u1eb7c gel<\/span><\/td>\n\u0110\u1ecbnh t\u00ednh, b\u00e1n \u0111\u1ecbnh l\u01b0\u1ee3ng<\/span><\/td>\n<\/tr>\n
    Turbidimetric<\/span><\/td>\n\u0110o s\u1ef1 thay \u0111\u1ed5i \u0111\u1ed9 \u0111\u1ee5c<\/span><\/td>\n\u0110\u1ecbnh l\u01b0\u1ee3ng<\/span><\/td>\n<\/tr>\n
    Chromogenic<\/span><\/td>\n\u0110o m\u00e0u sinh ra t\u1eeb ph\u1ea3n \u1ee9ng enzyme<\/span><\/td>\n\u0110\u1ecbnh l\u01b0\u1ee3ng \u0111\u1ed9 nh\u1ea1y cao<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    Ngu\u1ed3n tham kh\u1ea3o: <\/span>https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-technical-guides\/bacterial-endotoxinspyrogens<\/span><\/a><\/p>\n

    Ngu\u1ed3n tham kh\u1ea3o: <\/span>https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/guidance-industry-pyrogen-and-endotoxins-testing-questions-and-answers<\/span><\/a><\/p>\n

    Endotoxin trong n\u01b0\u1edbc WFI v\u00e0 PW \u2014 T\u1ea1i sao h\u1ec7 th\u1ed1ng n\u01b0\u1edbc l\u00e0 \u0111i\u1ec3m ki\u1ec3m so\u00e1t tr\u1ecdng y\u1ebfu<\/b><\/h2>\n

    H\u1ec7 th\u1ed1ng n\u01b0\u1edbc l\u00e0 <\/span>m\u1ed9t trong nh\u1eefng ngu\u1ed3n ph\u00e1t sinh endotoxin ph\u1ed5 bi\u1ebfn nh\u1ea5t trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c ph\u1ea9m<\/b>. Hai lo\u1ea1i n\u01b0\u1edbc c\u1ea7n \u0111\u1eb7c bi\u1ec7t l\u01b0u \u00fd g\u1ed3m:<\/span><\/p>\n

    N\u01b0\u1edbc tinh khi\u1ebft (Purified Water \u2014 PW)<\/b><\/h3>\n

    Purified Water kh\u00f4ng c\u00f3 gi\u1edbi h\u1ea1n endotoxin compendial<\/strong> theo USP, v\u00ec lo\u1ea1i n\u01b0\u1edbc n\u00e0y ch\u1ee7 y\u1ebfu \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho c\u00e1c \u1ee9ng d\u1ee5ng kh\u00f4ng v\u00f4 tr\u00f9ng. Tuy nhi\u00ean, nhi\u1ec1u nh\u00e0 m\u00e1y v\u1eabn theo d\u00f5i endotoxin nh\u01b0 m\u1ed9t ch\u1ec9 s\u1ed1 ki\u1ec3m so\u00e1t n\u1ed9i b\u1ed9, \u0111\u1eb7c bi\u1ec7t trong c\u00e1c h\u1ec7 th\u1ed1ng n\u01b0\u1edbc c\u00f3 nguy c\u01a1 ph\u00e1t sinh vi khu\u1ea9n Gram \u00e2m. N\u1ebfu h\u1ec7 th\u1ed1ng PW b\u1ecb \u00f4 nhi\u1ec5m sinh h\u1ecdc, endotoxin c\u00f3 th\u1ec3 t\u00edch l\u0169y trong h\u1ec7 th\u1ed1ng ph\u00e2n ph\u1ed1i n\u01b0\u1edbc, \u0111\u01b0\u1eddng \u1ed1ng v\u00e0 c\u00e1c \u0111i\u1ec3m l\u1ea5y m\u1eabu.<\/span><\/p>\n

    N\u01b0\u1edbc pha ti\u00eam (Water for Injection \u2014 WFI)<\/b><\/h3>\n

    Theo USP v\u00e0 EP, gi\u1edbi h\u1ea1n endotoxin c\u1ee7a WFI l\u00e0 \u2264 0.25 EU\/mL<\/strong>. Trong th\u1ef1c t\u1ebf v\u1eadn h\u00e0nh, nhi\u1ec1u nh\u00e0 m\u00e1y thi\u1ebft l\u1eadp gi\u1edbi h\u1ea1n ki\u1ec3m so\u00e1t n\u1ed9i b\u1ed9 th\u1ea5p h\u01a1n \u0111\u1ec3 duy tr\u00ec tr\u1ea1ng th\u00e1i ki\u1ec3m so\u00e1t c\u1ee7a h\u1ec7 th\u1ed1ng n\u01b0\u1edbc. WFI \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng tr\u1ef1c ti\u1ebfp trong pha ch\u1ebf thu\u1ed1c ti\u00eam v\u00e0 dung d\u1ecbch truy\u1ec1n, v\u00ec v\u1eady b\u1ea5t k\u1ef3 s\u1ef1 hi\u1ec7n di\u1ec7n c\u1ee7a endotoxin trong c\u00f4ng \u0111o\u1ea1n n\u00e0y \u0111\u1ec1u c\u00f3 th\u1ec3 g\u00e2y h\u1eadu qu\u1ea3 nghi\u00eam tr\u1ecdng cho ng\u01b0\u1eddi b\u1ec7nh.<\/span><\/p>\n

    \u0110\u1ec3 hi\u1ec3u r\u00f5 h\u01a1n v\u1ec1 c\u00e1ch WFI \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t to\u00e0n di\u1ec7n trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c GMP, bao g\u1ed3m c\u1ea3 chi\u1ebfn l\u01b0\u1ee3c x\u1eed l\u00fd OOS v\u00e0 OOT, b\u1ea1n c\u00f3 th\u1ec3 tham kh\u1ea3o th\u00eam t\u1ea1i: <\/span>N\u01b0\u1edbc WFI l\u00e0 g\u00ec v\u00e0 d\u00f9ng th\u1ebf n\u00e0o trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c GMP<\/a><\/strong><\/p>\n

    Ngu\u1ed3n g\u00e2y nhi\u1ec5m endotoxin trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m<\/b><\/h3>\n

    Ki\u1ec3m so\u00e1t endotoxin hi\u1ec7u qu\u1ea3 b\u1eaft \u0111\u1ea7u t\u1eeb vi\u1ec7c x\u00e1c \u0111\u1ecbnh \u0111\u00fang c\u00e1c ngu\u1ed3n ph\u00e1t sinh endotoxin trong h\u1ec7 th\u1ed1ng s\u1ea3n xu\u1ea5t. Trong th\u1ef1c t\u1ebf v\u1eadn h\u00e0nh nh\u00e0 m\u00e1y d\u01b0\u1ee3c, n\u0103m ngu\u1ed3n sau th\u01b0\u1eddng \u0111\u01b0\u1ee3c xem l\u00e0 c\u00e1c \u0111i\u1ec3m nguy c\u01a1 ch\u00ednh c\u1ea7n ki\u1ec3m so\u00e1t.<\/span><\/p>\n

      \n
    1. H\u1ec7 th\u1ed1ng n\u01b0\u1edbc d\u01b0\u1ee3c d\u1ee5ng l\u00e0 m\u1ed9t trong nh\u1eefng ngu\u1ed3n ph\u00e1t sinh endotoxin quan tr\u1ecdng v\u00e0 kh\u00f3 ki\u1ec3m so\u00e1t nh\u1ea5t. C\u00e1c \u0111i\u1ec3m n\u01b0\u1edbc \u0111\u1ecdng, \u0111o\u1ea1n \u1ed1ng ch\u1ebft (dead leg)<\/strong> trong \u0111\u01b0\u1eddng \u1ed1ng v\u00e0 v\u00f2ng tu\u1ea7n ho\u00e0n kh\u00f4ng duy tr\u00ec \u0111\u1ee7 v\u1eadn t\u1ed1c d\u00f2ng ch\u1ea3y l\u00e0 n\u01a1i vi khu\u1ea9n Gram \u00e2m d\u1ec5 t\u00edch t\u1ee5 v\u00e0 ph\u00e1t tri\u1ec3n.<\/span><\/li>\n
    2. Nguy\u00ean li\u1ec7u th\u00f4 v\u00e0 t\u00e1 d\u01b0\u1ee3c c\u1ea7n \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 v\u00e0 ki\u1ec3m so\u00e1t<\/strong> endotoxin trong qu\u00e1 tr\u00ecnh ti\u1ebfp nh\u1eadn v\u00e0 th\u1ea9m \u0111\u1ecbnh nguy\u00ean li\u1ec7u, \u0111\u1eb7c bi\u1ec7t l\u00e0 c\u00e1c nguy\u00ean li\u1ec7u c\u00f3 ngu\u1ed3n g\u1ed1c sinh h\u1ecdc ho\u1eb7c t\u1ef1 nhi\u00ean v\u00ec \u0111\u00e2y l\u00e0 ngu\u1ed3n endotoxin n\u1ed9i sinh kh\u00f3 d\u1ef1 \u0111o\u00e1n.<\/span><\/li>\n
    3. Thi\u1ebft b\u1ecb v\u00e0 b\u1ec1 m\u1eb7t ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m l\u00e0 c\u00e1c \u0111i\u1ec3m r\u1ee7i ro c\u1ea7n \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh ri\u00eang. Endotoxin c\u00f3 th\u1ec3 b\u00e1m d\u00ednh tr\u00ean b\u1ec1 m\u1eb7t inox, th\u1ee7y tinh v\u00e0 polymer n\u1ebfu quy tr\u00ecnh l\u00e0m s\u1ea1ch kh\u00f4ng \u0111\u1ee7 hi\u1ec7u l\u1ef1c \u0111\u1ec3 lo\u1ea1i b\u1ecf lipopolysaccharide (LPS)<\/strong><\/span><\/li>\n
    4. Bao b\u00ec s\u01a1 c\u1ea5p bao g\u1ed3m l\u1ecd th\u1ee7y tinh, t\u00fai IV v\u00e0 n\u00fat cao su<\/strong> c\u1ea7n \u0111\u01b0\u1ee3c x\u1eed l\u00fd kh\u1eed n\u1ed9i \u0111\u1ed9c t\u1ed1 (depyrogenation)<\/strong> tr\u01b0\u1edbc khi \u0111\u01b0a v\u00e0o d\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t.<\/span><\/li>\n
    5. M\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch<\/strong> l\u00e0 ngu\u1ed3n ph\u00e1t sinh endotoxin gi\u00e1n ti\u1ebfp th\u01b0\u1eddng b\u1ecb \u0111\u00e1nh gi\u00e1 th\u1ea5p trong ch\u01b0\u01a1ng tr\u00ecnh ki\u1ec3m so\u00e1t vi sinh. Vi khu\u1ea9n Gram \u00e2m trong kh\u00f4ng kh\u00ed ho\u1eb7c do nh\u00e2n s\u1ef1 mang v\u00e0o c\u00f3 th\u1ec3 tr\u1edf th\u00e0nh \u0111i\u1ec3m kh\u1edfi \u0111\u1ea7u c\u1ee7a chu\u1ed7i nhi\u1ec5m n\u1ebfu ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t vi sinh kh\u00f4ng \u0111\u1ee7 nh\u1ea1y \u0111\u1ec3 ph\u00e1t hi\u1ec7n s\u1edbm.<\/span><\/li>\n<\/ol>\n

      C\u00e1ch ki\u1ec3m so\u00e1t endotoxin trong h\u1ec7 th\u1ed1ng n\u01b0\u1edbc v\u00e0 nh\u00e0 m\u00e1y<\/b><\/h2>\n
      \"cach-kiem-soat-endotoxin-trong-he-thong-nuoc-va-nha-may\"
      C\u00e1ch ki\u1ec3m so\u00e1t Endotoxin trong h\u1ec7 th\u1ed1ng n\u01b0\u1edbc v\u00e0 nh\u00e0 m\u00e1y<\/em><\/figcaption><\/figure>\n

      Ki\u1ec3m so\u00e1t endotoxin kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t bi\u1ec7n ph\u00e1p \u0111\u01a1n l\u1ebb m\u00e0 l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng ph\u00f2ng ng\u1eeba nhi\u1ec1u l\u1edbp trong to\u00e0n b\u1ed9 quy tr\u00ecnh s\u1ea3n xu\u1ea5t.<\/span><\/p>\n

      V\u1edbi h\u1ec7 th\u1ed1ng n\u01b0\u1edbc<\/b>, nguy\u00ean t\u1eafc v\u1eadn h\u00e0nh c\u1ed1t l\u00f5i l\u00e0 kh\u00f4ng \u0111\u1ec3 n\u01b0\u1edbc \u0111\u1ee9ng y\u00ean. V\u00f2ng tu\u1ea7n ho\u00e0n li\u00ean t\u1ee5c v\u1edbi t\u1ed1c \u0111\u1ed9 d\u00f2ng ch\u1ea3y \u0111\u1ee7 ti\u00eau chu\u1ea9n l\u00e0 h\u00e0ng r\u00e0o \u0111\u1ea7u ti\u00ean ch\u1ed1ng l\u1ea1i s\u1ef1 h\u00ecnh th\u00e0nh m\u00e0ng vi sinh (biofilm) v\u00e0 t\u00edch l\u0169y endotoxin. Kh\u1eed tr\u00f9ng \u0111\u1ecbnh k\u1ef3 b\u1eb1ng nhi\u1ec7t ho\u1eb7c h\u00f3a ch\u1ea5t theo SOP \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c. D\u1eef li\u1ec7u l\u1ea5y m\u1eabu t\u1ea1i c\u00e1c \u0111i\u1ec3m s\u1eed d\u1ee5ng c\u1ea7n \u0111\u01b0\u1ee3c ph\u00e2n t\u00edch xu h\u01b0\u1edbng li\u00ean t\u1ee5c \u0111\u1ec3 ph\u00e1t hi\u1ec7n s\u1edbm d\u1ea5u hi\u1ec7u b\u1ea5t th\u01b0\u1eddng tr\u01b0\u1edbc khi ch\u1ea1m ng\u01b0\u1ee1ng ti\u00eau chu\u1ea9n OOS.<\/span><\/p>\n

      V\u1edbi thi\u1ebft b\u1ecb v\u00e0 b\u1ec1 m\u1eb7t<\/b>, quy tr\u00ecnh v\u1ec7 sinh ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 ch\u1ee9ng minh hi\u1ec7u l\u1ef1c lo\u1ea1i b\u1ecf endotoxin kh\u00f4ng ch\u1ec9 lo\u1ea1i b\u1ecf vi sinh v\u1eadt. Ti\u00eau ch\u00ed nghi\u1ec7m thu ph\u1ea3i bao g\u1ed3m c\u1ea3 ch\u1ec9 ti\u00eau endotoxin khi \u00e1p d\u1ee5ng cho thi\u1ebft b\u1ecb ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m v\u00f4 tr\u00f9ng. V\u1ec1 c\u00e1ch x\u00e2y d\u1ef1ng SOP v\u1ec7 sinh \u0111\u00fang chu\u1ea9n cGMP, thi\u1ebft l\u1eadp ti\u00eau ch\u00ed nghi\u1ec7m thu v\u00e0 \u0111o l\u01b0\u1eddng KPI v\u1ec7 sinh, b\u1ea1n c\u00f3 th\u1ec3 \u0111\u1ecdc th\u00eam t\u1ea1i: <\/span>Quy Tr\u00ecnh V\u1ec7 Sinh Nh\u00e0 M\u00e1y Theo GMP EU<\/a><\/strong><\/p>\n

      V\u1edbi m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch<\/b>, ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t vi sinh m\u00f4i tr\u01b0\u1eddng c\u1ea7n \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 ph\u00e1t hi\u1ec7n s\u1ef1 gia t\u0103ng c\u1ee7a vi khu\u1ea9n Gram \u00e2m, v\u00ec \u0111\u00e2y l\u00e0 ch\u1ec9 b\u00e1o gi\u00e1n ti\u1ebfp quan tr\u1ecdng v\u1ec1 nguy c\u01a1 nhi\u1ec5m endotoxin. C\u00f3 th\u1ec3 tham kh\u1ea3o th\u00eam c\u00e1ch tri\u1ec3n khai ch\u01b0\u01a1ng tr\u00ecnh ki\u1ec3m so\u00e1t vi sinh to\u00e0n di\u1ec7n t\u1ea1i: <\/span>Ki\u1ec3m so\u00e1t vi sinh t\u1ea1i ph\u00f2ng s\u1ea1ch<\/a><\/strong><\/p>\n

      Endotoxin OOS l\u00e0 g\u00ec v\u00e0 x\u1eed l\u00fd th\u1ebf n\u00e0o<\/b><\/h2>\n

      K\u1ebft qu\u1ea3 <\/span>OOS (Out of Specification)<\/b> v\u1ec1 endotoxin l\u00e0 t\u00ecnh hu\u1ed1ng k\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m v\u01b0\u1ee3t gi\u1edbi h\u1ea1n cho ph\u00e9p \u0111\u00e3 \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp trong h\u1ed3 s\u01a1 s\u1ea3n ph\u1ea9m ho\u1eb7c ti\u00eau chu\u1ea9n d\u01b0\u1ee3c \u0111i\u1ec3n.<\/span><\/p>\n

      \u0110\u00e2y l\u00e0 t\u00ecnh hu\u1ed1ng ph\u1ea3i \u0111\u01b0\u1ee3c \u0111i\u1ec1u tra theo quy tr\u00ecnh OOS ch\u00ednh th\u1ee9c. C\u00e1c d\u1eabn ch\u1ee9ng t\u1eeb FDA cho th\u1ea5y h\u1eadu qu\u1ea3 nghi\u00eam tr\u1ecdng khi k\u1ebft qu\u1ea3 endotoxin OOS kh\u00f4ng \u0111\u01b0\u1ee3c x\u1eed l\u00fd \u0111\u00fang c\u00e1ch:<\/span><\/p>\n

      “Released the above batches with OOS endotoxin failures for U.S. distribution.”<\/span><\/i><\/p>\n

      “They should not be the sole basis for batch release.”<\/span><\/i><\/p>\n

      \u2014 FDA Warning Letter, Liebel-Flarsheim Company LLC (10\/17\/2025)<\/span><\/p>\n

      Tr\u01b0\u1eddng h\u1ee3p n\u00e0y cho th\u1ea5y vi\u1ec7c ph\u00e1t h\u00e0nh l\u00f4 s\u1ea3n ph\u1ea9m khi c\u00f3 k\u1ebft qu\u1ea3 endotoxin OOS l\u00e0 vi ph\u1ea1m nghi\u00eam tr\u1ecdng nguy\u00ean t\u1eafc ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng. \u0110\u1ed1i v\u1edbi s\u1ea3n ph\u1ea9m ti\u00eam truy\u1ec1n, \u0111i\u1ec1u n\u00e0y c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn nguy c\u01a1 ph\u1ea3n \u1ee9ng sinh s\u1ed1t (pyrogenic reaction) \u1edf b\u1ec7nh nh\u00e2n, \u0111\u1ed3ng th\u1eddi khi\u1ebfn doanh nghi\u1ec7p \u0111\u1ed1i m\u1eb7t v\u1edbi c\u00e1c bi\u1ec7n ph\u00e1p qu\u1ea3n l\u00fd nh\u01b0 thu h\u1ed3i s\u1ea3n ph\u1ea9m, c\u1ea3nh b\u00e1o nh\u1eadp kh\u1ea9u ho\u1eb7c \u0111\u00ecnh ch\u1ec9 s\u1ea3n xu\u1ea5t.<\/span><\/p>\n

      Link tham kh\u1ea3o: <\/span>https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/liebel-flarsheim-company-llc-711508-10172025<\/span><\/a><\/p>\n

      Quy tr\u00ecnh x\u1eed l\u00fd endotoxin OOS theo cGMP th\u01b0\u1eddng bao g\u1ed3m 4 b\u01b0\u1edbc ch\u00ednh.<\/b><\/h3>\n
        \n
      1. B\u01b0\u1edbc \u0111\u1ea7u ti\u00ean l\u00e0 d\u1eebng l\u00f4 v\u00e0 kh\u00f4ng xu\u1ea5t x\u01b0\u1edfng trong khi \u0111ang \u0111i\u1ec1u tra.\u00a0<\/span><\/li>\n
      2. B\u01b0\u1edbc th\u1ee9 hai l\u00e0 \u0111i\u1ec1u tra t\u1ea1i ph\u00f2ng ki\u1ec3m nghi\u1ec7m \u0111\u1ec3 x\u00e1c minh l\u1ed7i c\u00f3 ph\u1ea3i do qu\u00e1 tr\u00ecnh ki\u1ec3m nghi\u1ec7m kh\u00f4ng, bao g\u1ed3m m\u1eabu, thu\u1ed1c th\u1eed, thi\u1ebft b\u1ecb v\u00e0 k\u1ef9 thu\u1eadt vi\u00ean.\u00a0<\/span><\/li>\n
      3. B\u01b0\u1edbc th\u1ee9 ba l\u00e0 \u0111i\u1ec1u tra m\u1edf r\u1ed9ng to\u00e0n di\u1ec7n n\u1ebfu \u0111\u00e3 lo\u1ea1i tr\u1eeb l\u1ed7i t\u1ea1i ph\u00f2ng ki\u1ec3m nghi\u1ec7m, m\u1edf r\u1ed9ng ph\u1ea1m vi \u0111i\u1ec1u tra ra quy tr\u00ecnh s\u1ea3n xu\u1ea5t, h\u1ec7 th\u1ed1ng n\u01b0\u1edbc, v\u1ec7 sinh thi\u1ebft b\u1ecb v\u00e0 nguy\u00ean li\u1ec7u.\u00a0<\/span><\/li>\n
      4. B\u01b0\u1edbc cu\u1ed1i c\u00f9ng l\u00e0 CAPA v\u00e0 \u0111\u00e1nh gi\u00e1 hi\u1ec7u l\u1ef1c, x\u00e1c \u0111\u1ecbnh nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 th\u1ef1c s\u1ef1, tri\u1ec3n khai h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 x\u00e1c nh\u1eadn l\u1ed7i kh\u00f4ng t\u00e1i ph\u00e1t.<\/span><\/li>\n<\/ol>\n

        M\u1ed9t sai l\u1ea7m ph\u1ed5 bi\u1ebfn l\u00e0 m\u1edf \u0111i\u1ec1u tra OOS ch\u1ec9 \u0111\u1ec3 ho\u00e0n t\u1ea5t h\u1ed3 s\u01a1 m\u00e0 kh\u00f4ng x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c nguy\u00ean nh\u00e2n ph\u00e1t ngu\u1ed3n. FDA \u0111\u00e1nh gi\u00e1 r\u1ea5t n\u1eb7ng \u0111i\u1ec1u n\u00e0y, nh\u01b0 \u0111\u00e3 ghi nh\u1eadn trong th\u01b0 c\u1ea3nh b\u00e1o g\u1eedi \u0111\u1ebfn <\/span>Advanced Pharmaceutical Technology (03\/2025)<\/b>, khi FDA nh\u1eadn x\u00e9t ph\u1ea3n h\u1ed3i c\u1ee7a doanh nghi\u1ec7p v\u1ec1 k\u1ebf ho\u1ea1ch ki\u1ec3m so\u00e1t t\u1ea1p nhi\u1ec5m vi sinh v\u00e0 endotoxin l\u00e0 ch\u01b0a \u0111\u1ee7 chi ti\u1ebft v\u00e0 ch\u01b0a gi\u1ea3i quy\u1ebft \u0111\u01b0\u1ee3c g\u1ed1c r\u1ec5 v\u1ea5n \u0111\u1ec1:<\/span><\/p>\n

        “Plan to test for bioburden, prior to release, and will reject lots\u2026 for endotoxin.”<\/span><\/i><\/p>\n

        \u2014 FDA Warning Letter, Advanced Pharmaceutical Technology (03\/14\/2025)<\/span><\/p>\n

        Link tham kh\u1ea3o: <\/span>https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/advanced-pharmaceutical-technology-692576-03142025<\/span><\/a><\/p>\n

        C\u00e1ch x\u1eed l\u00fd t\u00edn hi\u1ec7u Endotoxin theo t\u00ecnh hu\u1ed1ng<\/b><\/h2>\n
        \"cach-xu-ly-endotoxin-trong-san-xuat-duoc-pham-theo-tinh-huong\"
        C\u00e1ch x\u1eed l\u00fd t\u00edn hi\u1ec7u Endotoxin trong s\u1ea3n xu\u1ea5t D\u01b0\u1ee3c Ph\u1ea9m theo t\u00ecnh hu\u1ed1ng<\/em><\/figcaption><\/figure>\n

        Thay v\u00ec ch\u1ec9 d\u00f2 theo c\u00e1c checklist c\u1ee9ng nh\u1eafc, \u0111\u1ed9i QA, QC v\u00e0 \u0111\u1ed9i K\u1ef9 thu\u1eadt n\u00ean \u00e1p d\u1ee5ng <\/span>ma tr\u1eadn tri\u1ec7u ch\u1ee9ng – gi\u1ea3 thuy\u1ebft – h\u00e0nh \u0111\u1ed9ng<\/b> \u0111\u1ec3 l\u00e0m vi\u1ec7c tr\u00ean c\u00f9ng m\u1ed9t h\u1ec7 quy chi\u1ebfu. C\u00e1ch ti\u1ebfp c\u1eadn n\u00e0y bu\u1ed9c \u0111\u1ed9i ng\u0169 ph\u1ea3i \u0111\u1eb7t c\u00e2u h\u1ecfi \u0111\u00fang tr\u01b0\u1edbc khi h\u00e0nh \u0111\u1ed9ng, thay v\u00ec ph\u1ea3n \u1ee9ng theo c\u1ea3m t\u00ednh ho\u1eb7c theo th\u00f3i quen.<\/span><\/p>\n

        T\u00ecnh hu\u1ed1ng 1: Endotoxin t\u0103ng nh\u1eb9, ch\u01b0a OOS, c\u00f3 d\u1ea5u hi\u1ec7u l\u1ec7ch xu h\u01b0\u1edbng<\/b><\/h3>\n

        Gi\u1ea3 thuy\u1ebft hay g\u1eb7p nh\u1ea5t l\u00e0 thao t\u00e1c l\u1ea5y m\u1eabu thi\u1ebfu \u1ed5n \u0111\u1ecbnh, \u0111i\u1ec3m l\u1ea5y m\u1eabu kh\u00f4ng mang t\u00ednh \u0111\u1ea1i di\u1ec7n t\u1ed5ng quan, ho\u1eb7c h\u1ec7 th\u1ed1ng \u0111ang xu\u1ed1ng c\u1ea5p sau c\u00e1c \u0111\u1ee3t b\u1ea3o tr\u00ec g\u1ea7n nh\u1ea5t. H\u00e0nh \u0111\u1ed9ng c\u1ea7n th\u1ef1c hi\u1ec7n l\u00e0 kh\u00f3a ch\u1eb7t \u0111i\u1ec1u ki\u1ec7n l\u1ea5y m\u1eabu v\u00e0 x\u00e9t nghi\u1ec7m, ti\u1ebfn h\u00e0nh l\u1ea5y m\u1eabu l\u1ea1i c\u00f3 ki\u1ec3m so\u00e1t, r\u00e0 so\u00e1t xu h\u01b0\u1edbng theo t\u1eebng \u0111i\u1ec3m l\u1ea5y ri\u00eang bi\u1ec7t v\u00e0 \u0111\u1ed1i chi\u1ebfu v\u1edbi c\u00e1c s\u1ef1 ki\u1ec7n v\u1eadn h\u00e0nh nh\u00e0 m\u00e1y trong c\u00f9ng th\u1eddi k\u1ef3.<\/span><\/p>\n

        T\u00ecnh hu\u1ed1ng 2: Endotoxin OOS \u0111\u01a1n l\u1ebb, c\u00e1c ch\u1ec9 ti\u00eau kh\u00e1c ch\u01b0a b\u00e1o \u0111\u1ed9ng<\/b><\/h3>\n

        Gi\u1ea3 thuy\u1ebft hay g\u1eb7p nh\u1ea5t l\u00e0 sai l\u1ec7ch kh\u00f4ng \u1ed5n \u0111\u1ecbnh trong qu\u00e1 tr\u00ecnh x\u00e9t nghi\u1ec7m m\u1eabu th\u1eed, nh\u00e2n vi\u00ean pha lo\u00e3ng ho\u1eb7c x\u1eed l\u00fd m\u1eabu sai nh\u00e1nh SOP, ho\u1eb7c v\u00f4 t\u00ecnh g\u00e2y nhi\u1ec5m ch\u00e9o trong l\u00fac thao t\u00e1c. H\u00e0nh \u0111\u1ed9ng \u0111\u00fang l\u00e0 gi\u1eef nguy\u00ean m\u1eabu th\u1eed sai l\u1ec7ch, r\u00e0 so\u00e1t to\u00e0n b\u1ed9 \u0111i\u1ec1u ki\u1ec7n th\u1ef1c hi\u1ec7n x\u00e9t nghi\u1ec7m v\u00e0 x\u00e1c minh t\u1ea5t c\u1ea3 c\u00e1c kh\u1ea3 n\u0103ng c\u00f3 th\u1ec3 g\u00e2y sai l\u1ec7ch theo y\u00eau c\u1ea7u c\u1ee7a ph\u01b0\u01a1ng ph\u00e1p tr\u01b0\u1edbc khi quy\u1ebft \u0111\u1ecbnh m\u1edf r\u1ed9ng ph\u1ea1m vi \u0111i\u1ec1u tra ra b\u00ean ngo\u00e0i ph\u00f2ng ki\u1ec3m nghi\u1ec7m.<\/span><\/p>\n

        T\u00ecnh hu\u1ed1ng 3: Endotoxin OOS k\u00e8m t\u00edn hi\u1ec7u t\u1ea1p nhi\u1ec5m vi sinh ho\u1eb7c m\u00f4i tr\u01b0\u1eddng x\u1ea5u \u0111i<\/b><\/h3>\n

        \u0110\u00e2y l\u00e0 t\u00ecnh hu\u1ed1ng nghi\u00eam tr\u1ecdng nh\u1ea5t. Gi\u1ea3 thuy\u1ebft hay g\u1eb7p l\u00e0 h\u1ec7 th\u1ed1ng ki\u1ec3m so\u00e1t t\u1ea1p nhi\u1ec5m \u0111ang th\u1ea5t b\u1ea1i, \u0111\u01b0\u1eddng \u1ed1ng n\u01b0\u1edbc ho\u1eb7c thi\u1ebft b\u1ecb c\u00f3 \u0111i\u1ec3m t\u1ea1o \u0111i\u1ec1u ki\u1ec7n cho vi sinh v\u1eadt ph\u00e1t tri\u1ec3n, ho\u1eb7c m\u00e0ng vi sinh (biofilm) \u0111ang b\u00f9ng ph\u00e1t. H\u00e0nh \u0111\u1ed9ng ph\u1ea3i kh\u1edfi \u0111\u1ed9ng ngay quy tr\u00ecnh x\u1eed l\u00fd sai l\u1ec7ch, khoanh v\u00f9ng c\u00e1c \u0111i\u1ec3m \u00e1p d\u1ee5ng quy tr\u00ecnh, t\u0103ng t\u1ea7n su\u1ea5t l\u1ea5y m\u1eabu gi\u00e1m s\u00e1t, \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng l\u00ean c\u00e1c l\u00f4 s\u1ea3n ph\u1ea9m li\u00ean quan v\u00e0 \u0111\u1ed3ng th\u1eddi r\u00e0 so\u00e1t l\u1ea1i to\u00e0n di\u1ec7n chi\u1ebfn l\u01b0\u1ee3c kh\u1eed tr\u00f9ng hi\u1ec7n t\u1ea1i.<\/span><\/p>\n

        T\u00ecnh hu\u1ed1ng 4: Endotoxin t\u0103ng sau b\u1ea3o tr\u00ec, thay v\u1eadt li\u1ec7u ho\u1eb7c thay c\u1ea5u h\u00ecnh \u0111\u01b0\u1eddng \u1ed1ng<\/b><\/h3>\n

        Gi\u1ea3 thuy\u1ebft hay g\u1eb7p l\u00e0 c\u1eb7n b\u1ea9n v\u00e0 l\u1edbp b\u00e1m l\u00e2u ng\u00e0y b\u1ecb bong tr\u00f3c ra, l\u00e0m khu\u1ea5y \u0111\u1ed9ng quy tr\u00ecnh tr\u00e1ng r\u1eeda sau b\u1ea3o tr\u00ec. H\u00e0nh \u0111\u1ed9ng c\u1ea7n \u00e1p d\u1ee5ng quy tr\u00ecnh x\u1eed l\u00fd theo s\u1ef1 ki\u1ec7n, t\u0103ng c\u01b0\u1eddng c\u00e1c b\u01b0\u1edbc tr\u00e1ng r\u1eeda v\u00e0 kh\u1eed tr\u00f9ng chu\u1ea9n SOP, \u0111\u1ed3ng th\u1eddi theo d\u00f5i d\u1eef li\u1ec7u s\u00e1t sao h\u01a1n trong su\u1ed1t giai \u0111o\u1ea1n ph\u1ee5c h\u1ed3i cho \u0111\u1ebfn khi xu h\u01b0\u1edbng \u1ed5n \u0111\u1ecbnh tr\u1edf l\u1ea1i.<\/span><\/p>\n

        Ch\u1ed1t ghi nh\u1edb:<\/b> \u0110i\u1ec1u tra endotoxin OOS l\u00e0 m\u1ed9t quy tr\u00ecnh x\u1eed l\u00fd l\u1edbn \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng v\u00e0o h\u1ec7 th\u1ed1ng ki\u1ec3m so\u00e1t. \u0110\u00e2y kh\u00f4ng ph\u1ea3i l\u00e0 h\u00e0nh tr\u00ecnh \u0111i t\u00ecm m\u1ed9t c\u00e1i c\u1edb \u0111\u1ec3 h\u1ee3p th\u1ee9c h\u00f3a cho m\u1ed9t k\u1ebft qu\u1ea3 \u0111\u1ea1t.<\/span><\/p>\n

        FAQ v\u1ec1 Endotoxin trong s\u1ea3n xu\u1ea5t D\u01b0\u1ee3c Ph\u1ea9m<\/b><\/h2>\n
        \n

        Endotoxin l\u00e0 g\u00ec?<\/b><\/h3>\n

        Endotoxin hay n\u1ed9i \u0111\u1ed9c t\u1ed1 vi khu\u1ea9n Gram \u00e2m l\u00e0 th\u00e0nh ph\u1ea7n lipopolysaccharide (LPS) trong m\u00e0ng ngo\u00e0i c\u1ee7a vi khu\u1ea9n Gram \u00e2m, \u0111\u01b0\u1ee3c gi\u1ea3i ph\u00f3ng khi vi khu\u1ea9n ch\u1ebft. Endotoxin g\u00e2y ph\u1ea3n \u1ee9ng s\u1ed1t nguy hi\u1ec3m khi v\u00e0o c\u01a1 th\u1ec3 qua \u0111\u01b0\u1eddng ti\u00eam.<\/span><\/p>\n

        X\u00e9t nghi\u1ec7m endotoxin l\u00e0 g\u00ec?<\/b><\/h3>\n

        X\u00e9t nghi\u1ec7m endotoxin hay BET (Bacterial Endotoxins Test)<\/strong> l\u00e0 ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m nghi\u1ec7m s\u1eed d\u1ee5ng d\u1ecbch chi\u1ebft LAL \u0111\u1ec3 ph\u00e1t hi\u1ec7n v\u00e0 \u0111\u1ecbnh l\u01b0\u1ee3ng endotoxin trong s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c, n\u01b0\u1edbc v\u00e0 nguy\u00ean li\u1ec7u, theo ti\u00eau chu\u1ea9n USP <85>.<\/span><\/p>\n

        Gi\u1edbi h\u1ea1n endotoxin trong n\u01b0\u1edbc WFI v\u00e0 PW l\u00e0 bao nhi\u00eau?<\/b><\/h3>\n

        Theo USP, n\u01b0\u1edbc PW c\u00f3 gi\u1edbi h\u1ea1n endotoxin <\/span>\u2264 0,25 EU\/mL<\/b>. N\u01b0\u1edbc WFI c\u00f3 gi\u1edbi h\u1ea1n <\/span>< 0,25 EU\/mL<\/b> v\u00e0 trong th\u1ef1c t\u1ebf v\u1eadn h\u00e0nh th\u01b0\u1eddng \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ch\u1eb7t h\u01a1n gi\u1edbi h\u1ea1n ph\u00e1p l\u00fd.<\/span><\/p>\n

        Endotoxin OOS ph\u1ea3i x\u1eed l\u00fd th\u1ebf n\u00e0o?<\/b><\/h3>\n

        C\u1ea7n d\u1eebng l\u00f4, ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tra 2 giai \u0111o\u1ea1n g\u1ed3m \u0111i\u1ec1u tra t\u1ea1i ph\u00f2ng ki\u1ec3m nghi\u1ec7m v\u00e0 \u0111i\u1ec1u tra m\u1edf r\u1ed9ng to\u00e0n di\u1ec7n, x\u00e1c \u0111\u1ecbnh nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 th\u1ef1c s\u1ef1, tri\u1ec3n khai CAPA v\u00e0 \u0111\u00e1nh gi\u00e1 hi\u1ec7u l\u1ef1c sau m\u1ed9t th\u1eddi gian \u00e1p d\u1ee5ng. Tuy\u1ec7t \u0111\u1ed1i kh\u00f4ng xu\u1ea5t x\u01b0\u1edfng l\u00f4 khi ch\u01b0a c\u00f3 k\u1ebft lu\u1eadn \u0111i\u1ec1u tra \u0111\u1ea7y \u0111\u1ee7.<\/span><\/p>\n

        Endotoxin kh\u00e1c g\u00ec Pyrogen v\u00e0 Bioburden?<\/b><\/h3>\n

        Endotoxin l\u00e0 m\u1ed9t lo\u1ea1i pyrogen c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb vi khu\u1ea9n Gram \u00e2m. Pyrogen l\u00e0 kh\u00e1i ni\u1ec7m r\u1ed9ng h\u01a1n, bao g\u1ed3m m\u1ecdi ch\u1ea5t g\u00e2y s\u1ed1t khi v\u00e0o c\u01a1 th\u1ec3. Bioburden l\u00e0 t\u1ed5ng l\u01b0\u1ee3ng vi sinh v\u1eadt s\u1ed1ng trong m\u1eabu v\u00e0 l\u00e0 ch\u1ec9 b\u00e1o gi\u00e1n ti\u1ebfp c\u1ee7a nguy c\u01a1 endotoxin m\u1ee9c \u0111\u1ed9 t\u1ea1p nhi\u1ec5m vi sinh t\u0103ng cao k\u00e9o d\u00e0i m\u00e0 kh\u00f4ng ki\u1ec3m so\u00e1t s\u1ebd d\u1eabn \u0111\u1ebfn t\u00edch l\u0169y endotoxin, nh\u01b0ng t\u1ea1p nhi\u1ec5m vi sinh \u0111\u1ea1t chu\u1ea9n kh\u00f4ng \u0111\u1ea3m b\u1ea3o endotoxin \u0111\u1ea1t chu\u1ea9n.<\/span><\/p>\n

        Ngu\u1ed3n g\u00e2y nhi\u1ec5m endotoxin trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c l\u00e0 g\u00ec?<\/b><\/h3>\n

        N\u0103m ngu\u1ed3n ch\u00ednh g\u1ed3m h\u1ec7 th\u1ed1ng n\u01b0\u1edbc, nguy\u00ean li\u1ec7u th\u00f4 v\u00e0 t\u00e1 d\u01b0\u1ee3c, thi\u1ebft b\u1ecb v\u00e0 b\u1ec1 m\u1eb7t ti\u1ebfp x\u00fac s\u1ea3n ph\u1ea9m, bao b\u00ec s\u01a1 c\u1ea5p v\u00e0 m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch. Trong \u0111\u00f3 h\u1ec7 th\u1ed1ng n\u01b0\u1edbc l\u00e0 ngu\u1ed3n l\u00e2y nhi\u1ec5m ph\u1ed5 bi\u1ebfn v\u00e0 kh\u00f3 ki\u1ec3m so\u00e1t nh\u1ea5t v\u00ec li\u00ean quan tr\u1ef1c ti\u1ebfp \u0111\u1ebfn c\u1ea5u h\u00ecnh \u0111\u01b0\u1eddng \u1ed1ng v\u00e0 ch\u1ebf \u0111\u1ed9 v\u1eadn h\u00e0nh li\u00ean t\u1ee5c.<\/span><\/p><\/blockquote>\n

        K\u1ebft lu\u1eadn<\/b><\/h2>\n

        Endotoxin l\u00e0 m\u1ed1i nguy ti\u1ec1m \u1ea9n \u0111\u1eb7c th\u00f9 c\u1ee7a ng\u00e0nh d\u01b0\u1ee3c kh\u00f4ng nh\u00ecn th\u1ea5y, kh\u00f4ng ng\u1eedi \u0111\u01b0\u1ee3c, nh\u01b0ng h\u1eadu qu\u1ea3 \u0111\u1ec3 l\u1ea1i v\u1edbi ng\u01b0\u1eddi b\u1ec7nh l\u00e0 kh\u00f4ng th\u1ec3 \u0111\u1ea3o ng\u01b0\u1ee3c. Ki\u1ec3m so\u00e1t endotoxin hi\u1ec7u qu\u1ea3 \u0111\u00f2i h\u1ecfi s\u1ef1 ph\u1ed1i h\u1ee3p \u0111\u1ed3ng b\u1ed9 gi\u1eefa h\u1ec7 th\u1ed1ng n\u01b0\u1edbc \u0111\u01b0\u1ee3c v\u1eadn h\u00e0nh \u0111\u00fang chu\u1ea9n, quy tr\u00ecnh v\u1ec7 sinh c\u00f3 hi\u1ec7u l\u1ef1c \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh, ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t vi sinh ch\u1ee7 \u0111\u1ed9ng v\u00e0 c\u01a1 ch\u1ebf x\u1eed l\u00fd OOS \u0111\u1ee7 chi\u1ec1u s\u00e2u \u0111\u1ec3 t\u00ecm ra nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 th\u1ef1c s\u1ef1.<\/span><\/p>\n

        B\u00e0i h\u1ecdc t\u1eeb c\u00e1c d\u1eabn ch\u1ee9ng t\u1eeb FDA r\u1ea5t r\u00f5 r\u00e0ng: xu\u1ea5t x\u01b0\u1edfng l\u00f4 khi c\u00f3 k\u1ebft qu\u1ea3 endotoxin OOS ho\u1eb7c x\u1eed l\u00fd OOS kh\u00f4ng \u0111\u1ee7 c\u0103n c\u1ee9 khoa h\u1ecdc l\u00e0 vi ph\u1ea1m cGMP nghi\u00eam tr\u1ecdng v\u00e0 FDA kh\u00f4ng b\u1ecf qua \u0111i\u1ec1u \u0111\u00f3.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

        Trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m, \u0111\u1eb7c bi\u1ec7t \u0111\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m v\u00f4 tr\u00f9ng, endotoxin l\u00e0 m\u1ed9t trong nh\u1eefng ngu\u1ed3n nguy c\u01a1 nhi\u1ec5m b\u1ea9n kh\u00f3 ph\u00e1t hi\u1ec7n nh\u1ea5t. Kh\u00f4ng m\u00e0u, kh\u00f4ng m\u00f9i v\u00e0 kh\u00f4ng th\u1ec3 ph\u00e1t hi\u1ec7n b\u1eb1ng m\u1eaft th\u01b0\u1eddng v\u00e0 ch\u00fang kh\u00f4ng th\u1ec3 b\u1ecb lo\u1ea1i b\u1ecf b\u1edfi c\u00e1c ph\u01b0\u01a1ng ph\u00e1p kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng. … Continue reading Endotoxin trong s\u1ea3n xu\u1ea5t D\u01b0\u1ee3c Ph\u1ea9m: V\u00ec sao xu h\u01b0\u1edbng d\u1eef li\u1ec7u quan tr\u1ecdng h\u01a1n m\u1ed9t k\u1ebft qu\u1ea3 \u0111\u1ea1t<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":9492,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[42],"tags":[],"class_list":["post-9481","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized-vi"],"acf":[],"_links":{"self":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9481","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=9481"}],"version-history":[{"count":4,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9481\/revisions"}],"predecessor-version":[{"id":9497,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9481\/revisions\/9497"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9492"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9481"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9481"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9481"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}