{"id":1665,"date":"2026-01-16T02:04:47","date_gmt":"2026-01-16T02:04:47","guid":{"rendered":"https:\/\/gdhpmachine.com\/?page_id=1665"},"modified":"2026-09-17T02:57:57","modified_gmt":"2026-09-17T02:57:57","slug":"ivd-industry-solution","status":"publish","type":"page","link":"https:\/\/gdhpmachine.com\/vi\/solution\/ivd-industry-solution\/","title":{"rendered":"Gi\u1ea3i ph\u00e1p \u0110\u00f3ng g\u00f3i L\u1ecd ch\u1ee9a IVD"},"content":{"rendered":"Gi\u1ea3i ph\u00e1p\n\n

C\u00e1c Gi\u1ea3i Ph\u00e1p \u0110\u1ed5 \u0110\u1ea7y cho Ng\u00e0nh Ch\u1ea9n \u0110o\u00e1n In Vitro<\/h2>\n\nGi\u1ea3i quy\u1ebft c\u00e1c y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t \u0111\u1ed1i v\u1edbi c\u00e1c reagent IVD, h\u1ec7 th\u1ed1ng \u0111\u00f3ng n\u1eafp c\u1ed1t l\u00f5i c\u1ee7a ch\u00fang t\u00f4i \u0111\u1ea1t \u0111\u1ed9 ch\u00ednh x\u00e1c c\u1ef1c k\u1ef3 \u1edf m\u1ee9c mililit, gi\u1ea3m thi\u1ec3u l\u00e3ng ph\u00ed reagents \u0111\u1eaft ti\u1ec1n v\u00e0 \u0111\u1ea3m b\u1ea3o t\u00ednh \u0111\u1ed3ng nh\u1ea5t v\u00e0 \u0111\u00e1ng tin c\u1eady c\u1ee7a m\u1ecdi m\u1eabu th\u1eed. \u0110\u1ed3ng th\u1eddi, ch\u00fang t\u00f4i s\u1eed d\u1ee5ng c\u00f4ng ngh\u1ec7 \u0111\u00f3ng g\u00f3i k\u00edn ho\u00e0n to\u00e0n v\u00e0 thi\u1ebft k\u1ebf ch\u1ed1ng nhi\u1ec5m khu\u1ea9n tu\u00e2n th\u1ee7 GMP, ng\u0103n ch\u1eb7n nghi\u00eam ng\u1eb7t c\u00e1c r\u1ee7i ro nhi\u1ec5m ch\u00e9o xuy\u00ean su\u1ed1t qu\u00e1 tr\u00ecnh t\u1eeb r\u1eeda chai v\u00e0 \u0111\u00f3ng n\u1eafp \u0111\u1ebfn d\u00e1n nh\u00e3n, gi\u00fap ph\u00f2ng th\u00ed nghi\u1ec7m v\u00e0 x\u01b0\u1edfng s\u1ea3n xu\u1ea5t c\u1ee7a b\u1ea1n \u0111\u1ea1t \u0111\u01b0\u1ee3c b\u01b0\u1edbc nh\u1ea3y v\u1ecdt t\u1eeb \"s\u1ea3n xu\u1ea5t\" sang \"s\u1ea3n xu\u1ea5t th\u00f4ng minh.\"\n\n
Th\u1ea3o Lu\u1eadn Gi\u1ea3i Ph\u00e1p T\u00f9y Ch\u1ec9nh c\u1ee7a B\u1ea1n<\/a><\/div><\/div>\n\n

T\u1ea1i sao ch\u1ecdn GDHP l\u00e0m \u0111\u1ed1i t\u00e1c gi\u1ea3i ph\u00e1p trong ng\u00e0nh IVD?<\/h3>\n\n
<\/figure>\n\n

\u0110\u1ed9 Ch\u00ednh X\u00e1c Tuy\u1ec7t \u0110\u1ed1i<\/h3>\n\n\u0110\u01b0\u1ee3c trang b\u1ecb h\u1ec7 th\u1ed1ng \u0111i\u1ec1u khi\u1ec3n servo c\u00f3 \u0111\u1ed9 ph\u00e2n gi\u1ea3i cao v\u00e0 b\u01a1m ceramic ch\u00ednh x\u00e1c, m\u00e1y c\u1ee7a ch\u00fang t\u00f4i \u0111\u1ea1t m\u1ee9c \u0111\u00f3ng c\u00f3 \u0111\u1ed9 ch\u00ednh x\u00e1c \u1edf c\u1ea5p milil\u00edt (th\u1eadm ch\u00ed microlit). \u0110\u1ed9 l\u1ec7ch c\u1ef1c k\u1ef3 th\u1ea5p kh\u00f4ng ch\u1ec9 \u0111\u1ea3m b\u1ea3o t\u00ednh nh\u1ea5t qu\u00e1n c\u1ee7a c\u00e1c reagent ch\u1ea9n \u0111o\u00e1n m\u00e0 c\u00f2n t\u1ed1i \u01b0u h\u00f3a chi ph\u00ed s\u1ea3n xu\u1ea5t b\u1eb1ng c\u00e1ch gi\u1ea3m thi\u1ec3u l\u00e3ng ph\u00ed nguy\u00ean v\u1eadt li\u1ec7u.\n\n
<\/figure>\n\n

\u0110\u1ed9 Tinh Khi\u1ebft Tuy\u1ec7t \u0110\u1ed1i<\/h3>\n\nC\u00e1c gi\u1ea3i ph\u00e1p c\u1ee7a ch\u00fang t\u00f4i \u00e1p d\u1ee5ng quy tr\u00ecnh \u0111\u00f3ng k\u00edn ti\u1ebfp x\u00fac v\u00e0 thi\u1ebft k\u1ebf chu\u1ea9n y t\u1ebf li\u1ec1n m\u1ea1ch, v\u1edbi c\u00e1c tr\u1ea1m l\u00e0m vi\u1ec7c ch\u00ednh t\u00edch h\u1ee3p trong m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch Class 100. T\u1eeb vi\u1ec7c ch\u1ecdn v\u1eadt li\u1ec7u \u1ed1ng d\u1eabn \u0111\u1ebfn \u1ee9ng d\u1ee5ng h\u1ec7 th\u1ed1ng v\u1ec7 sinh v\u00e0 \u0111\u00f3ng g\u1ecdn (CIP), s\u1ef1 nhi\u1ec5m ch\u00e9o v\u00e0 \u0111\u01b0a t\u1ea1p ch\u1ea5t \u0111\u01b0\u1ee3c lo\u1ea1i b\u1ecf to\u00e0n di\u1ec7n.\n\n
<\/figure>\n\n

T\u00edch H\u1ee3p Hi\u1ec7u Qu\u1ea3 Cao<\/h3>\n\nD\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t c\u00f3 s\u1ef1 linh ho\u1ea1t c\u1ef1c k\u1ef3 cao trong vi\u1ec7c x\u1eed l\u00fd c\u00e1c y\u00eau c\u1ea7u \u0111\u00f3ng g\u00f3i kh\u00e1c nhau ph\u1ed5 bi\u1ebfn trong ng\u00e0nh IVD, bao g\u1ed3m c\u00e1c l\u1ecd h\u00ecnh irregular, \u1ed1ng micro v\u00e0 nhi\u1ec1u h\u01a1n th\u1ebf. Th\u00f4ng qua h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd k\u1ef9 thu\u1eadt s\u1ed1, b\u1ea1n c\u00f3 th\u1ec3 theo d\u00f5i d\u1eef li\u1ec7u s\u1ea3n xu\u1ea5t v\u00e0 t\u00ecnh tr\u1ea1ng thi\u1ebft b\u1ecb theo th\u1eddi gian th\u1ef1c, c\u1ea3i thi\u1ec7n \u0111\u00e1ng k\u1ec3 s\u1ef1 \u1ed5n \u0111\u1ecbnh s\u1ea3n xu\u1ea5t v\u00e0 r\u00fat ng\u1eafn th\u1eddi gian \u0111\u01b0a s\u1ea3n ph\u1ea9m ra th\u1ecb tr\u01b0\u1eddng th\u00f4ng qua c\u00e1c quy tr\u00ecnh \u0111i\u1ec1u h\u00e0nh th\u00f4ng minh.\n\n

Nh\u1eefng Th\u00e1ch Th\u1ee9c Ch\u00ednh trong Ng\u00e0nh IVD<\/h2>\n\n

Trong s\u1ea3n xu\u1ea5t Ch\u1ea9n \u0111o\u00e1n In Vitro (IVD), \u0111\u00f3ng g\u00f3i ch\u1ea5t l\u1ecfng kh\u00f4ng ch\u1ec9 l\u00e0 m\u1ed9t b\u01b0\u1edbc giao nh\u1eadn ch\u1ee9a \u0111\u1ef1ng\u2014n\u00f3 l\u00e0 m\u1ed9t ph\u1ea7n m\u1edf r\u1ed9ng tr\u1ef1c ti\u1ebfp c\u1ee7a hi\u1ec7u su\u1ea5t th\u1eed nghi\u1ec7m.<\/p>\n\n

R\u1ee7i ro \u0103n m\u00f2n h\u00f3a h\u1ecdc<\/h3>\n\n

C\u00e1c b\u1ed9 dung d\u1ecbch ph\u00e1 t\u1ebf b\u00e0o m\u1ea1nh, dung m\u00f4i v\u00e0 dung d\u1ecbch c\u00f3 h\u00e0m l\u01b0\u1ee3ng mu\u1ed1i cao t\u1ecfa ra h\u01a1i \u0103n m\u00f2n l\u00e0m h\u1ecfng c\u00e1c th\u00e0nh ph\u1ea7n m\u00e1y m\u00f3c ti\u00eau chu\u1ea9n.\u00a0<\/p>\n\n

Ph\u1ea1m vi H\u00ecnh h\u1ecdc Bao b\u00ec<\/h3>\n\n

Thi\u1ebft b\u1ecb ph\u1ea3i \u0111\u00e1ng tin c\u1eady x\u1eed l\u00fd c\u00e1c bi\u1ebfn th\u1ec3 th\u00f9ng ch\u1ee9a r\u1ed9ng l\u1edbn\u2014t\u1eeb\u00a0\u1ed1ng PCR vi ph\u00e2n 0.2 mL<\/strong>\u00a0v\u00e0 c\u00e1c chai nh\u1ecf c\u1ed5 h\u1eb9p cho \u0111\u1ebfn\u00a0c\u00e1c th\u00f9ng \u0111\u1ef1ng ch\u1ea5t \u0111\u1ec7m dung t\u00edch 5 L<\/strong>\u2014m\u00e0 kh\u00f4ng g\u1eb7p hi\u1ec7n t\u01b0\u1ee3ng nghi\u00eang c\u01a1 h\u1ecdc ho\u1eb7c thi\u1ebfu ngu\u1ed3n c\u1ea5p tr\u00ean d\u00e2y chuy\u1ec1n.<\/p>\n\n

Tr\u00f9ng l\u1eb7p nhi\u1ec5m ch\u00e9o<\/h3>\n\n

C\u00e1c b\u1ed9 kit th\u1eed \u0111a dung d\u1ecbch y\u00eau c\u1ea7u phun ph\u00e2n ph\u1ed1i c\u00e1c dung d\u1ecbch ri\u00eang bi\u1ec7t tr\u00ean c\u00e1c m\u00f4-\u0111un d\u00f9ng chung ho\u1eb7c c\u1ea1nh nhau. Ng\u0103n ng\u1eeba s\u1ef1 mang theo, \u00f4 nhi\u1ec5m gi\u1ecdt kh\u00ed v\u00e0 s\u1ef1 ph\u00e1t tri\u1ec3n vi sinh tr\u00ean c\u00e1c d\u00e2y chuy\u1ec1n \u0111a x\u00e9t nghi\u1ec7m \u0111\u00f2i h\u1ecfi s\u1ef1 c\u00f4 l\u1eadp kh\u00f4ng compromise.<\/p>\n\n

Th\u00e1ch Th\u1ee9c \u0110\u1ed9 Ch\u00ednh X\u00e1c<\/h3>\n\n

Trong khi c\u00e1c d\u00e2y chuy\u1ec1n \u0111\u00f3ng g\u00f3i-\u0111\u1ed5 \u0111\u1ea7y chu\u1ea9n pharma nh\u1eafm t\u1edbi m\u1ee9c dung sai t\u1eeb \u00b11.0% \u0111\u1ebfn \u00b12.0%, c\u00e1c x\u00e9t nghi\u1ec7m ph\u00e2n t\u1eed v\u00e0 ch\u1ea9n \u0111o\u00e1n mi\u1ec5n d\u1ecbch c\u00f3 \u0111\u1ed9 nh\u1ea1y cao th\u01b0\u1eddng y\u00eau c\u1ea7u \u0111\u1ed9 ch\u00ednh x\u00e1c nh\u1ecf h\u01a1n microlit xu\u1ed1ng \u0111\u1ebfn\u00a0\u00b10,5% ho\u1eb7c t\u1ed1t h\u01a1n<\/strong>.<\/p>\n\n

H\u1ec7 th\u1ed1ng \u0110\u1ecbnh v\u1ecb D\u1ecbch v\u1ee5 C\u00f3 \u0110\u1ed9ng c\u01a1 Servo v\u00e0 \u0110\u1ecbnh v\u1ecb D\u1ecdc<\/h3>\n\n

C\u01a1 ch\u1ebf:<\/strong>\u00a0C\u1ee5m m\u00f4-\u0111un servo truy\u1ec1n \u0111\u1ed9ng tr\u1ef1c ti\u1ebfp cung c\u1ea5p ki\u1ec3m so\u00e1t th\u1ec3 t\u00edch \u0111\u1ed9ng, c\u00f3 th\u1ec3 l\u1eadp tr\u00ecnh.<\/p>\n\n

Tr\u01b0\u1eddng h\u1ee3p S\u1eed D\u1ee5ng T\u1ed1t Nh\u1ea5t:<\/strong>\u00a0C\u00e1c buffer c\u00f3 \u0111\u1ed9 nh\u1edbt cao, m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y v\u00e0 dung d\u1ecbch h\u00f3a ch\u1ea5t \u0111\u1eb7c qu\u00e1nh.<\/p>\n\n

\u01afu \u0110i\u1ec3m Ch\u00ednh:<\/strong>\u00a0Ng\u0103n ng\u1eeba tr\u01b0\u1ee3t ch\u1ea5t l\u1ecfng v\u00e0 tr\u1ed9n kh\u00ed trong c\u00e1c ch\u1ea5t l\u1ecfng \u0111\u1eb7c \u0111\u1ed3ng th\u1eddi th\u00edch nghi ngay l\u1eadp t\u1ee9c v\u1edbi h\u00ecnh h\u1ecdc b\u00ecnh ch\u1ee9a bi\u1ebfn \u0111\u1ed5i.<\/p>\n\n

H\u1ec7 Th\u1ed1ng Phun B\u01a1m Peristaltic<\/h3>\n\n

C\u01a1 ch\u1ebf:<\/strong>\u00a0\u0110\u01b0\u1eddng d\u1eabn ch\u1ea5t l\u1ecfng d\u00f9ng m\u1ed9t l\u1ea7n c\u00f3 \u1ed1ng silicon \u0111\u1ea1t chu\u1ea9n y t\u1ebf ho\u1eb7c \u1ed1ng Pharmed cho\u00a0c\u00f4ng ngh\u1ec7 chi\u1ebft r\u00f3t kh\u00f4ng ti\u1ebfp x\u00fac tinh khi\u1ebft<\/strong>.<\/p>\n\n

Tr\u01b0\u1eddng h\u1ee3p S\u1eed D\u1ee5ng T\u1ed1t Nh\u1ea5t:<\/strong>\u00a0D\u01b0\u1ee3c ph\u1ea9m sinh h\u1ecdc, enzyme nh\u1ea1y l\u1ef1c c\u1eaft, kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng, v\u00e0 c\u00e1c x\u00e9t nghi\u1ec7m nh\u1ea1y c\u1ea3m v\u1edbi nhi\u1ec5m ch\u00e9o.<\/p>\n\n

\u01afu \u0110i\u1ec3m Ch\u00ednh:<\/strong>\u00a0Kh\u00f4ng ti\u1ebfp x\u00fac gi\u1eefa ch\u1ea5t l\u1ecfng v\u00e0 m\u00e1y, lo\u1ea1i b\u1ecf x\u00e1c nh\u1eadn l\u00e0m s\u1ea1ch ph\u1ee9c t\u1ea1p gi\u1eefa c\u00e1c l\u00f4, chuy\u1ec3n \u0111\u1ed5i nhanh, v\u00e0 quy tr\u00ecnh CIP\/SIP \u0111\u01a1n gi\u1ea3n.<\/p>\n\n

\u01afu \u0110i\u1ec3m Ch\u00ednh:<\/strong>\u00a0Kh\u00e1ng m\u00f2n v\u01b0\u1ee3t tr\u1ed9i, kh\u00f4ng bong m\u1ea3nh v\u1eadt li\u1ec7u, v\u00e0 ph\u00e2n ph\u1ed1i d\u01b0\u1edbi microl\u00edt \u0111\u00e1ng tin c\u1eady trong c\u00e1c chu k\u1ef3 s\u1ea3n xu\u1ea5t li\u00ean t\u1ee5c d\u00e0i.<\/p>\n\n

Tr\u01b0\u1eddng h\u1ee3p S\u1eed D\u1ee5ng T\u1ed1t Nh\u1ea5t:<\/strong>\u00a0C\u00e1c thu\u1ed1c th\u1eed \u0111\u1ed9 nh\u1edbt th\u1ea5p, h\u1ed7n h\u1ee3p ch\u00ednh, v\u00e0 vi li\u1ec1u l\u1eb7p l\u1ea1i cao y\u00eau c\u1ea7u\u00a0\u0111\u1ed9 ch\u00ednh x\u00e1c th\u1ec3 t\u00edch \u00b10.5%<\/strong>.<\/p>\n\n

B\u01a1m P\u00edt-t\u00f4ng G\u1ed1m \u0110\u1ed9 Ch\u00ednh X\u00e1c Cao<\/h3>\n\n

C\u01a1 ch\u1ebf:<\/strong>\u00a0Thi\u1ebft k\u1ebf p\u00edt-t\u00f4ng g\u1ed1m quay kh\u00f4ng van \u0111\u01b0\u1ee3c ch\u1ebf t\u1ea1o cho\u00a0li\u1ec1u l\u01b0\u1ee3ng ch\u00ednh x\u00e1c \u1edf quy m\u00f4 vi m\u00f4<\/strong>\u00a0\u0111\u1ebfn m\u1ee5c ti\u00eau d\u01b0\u1edbi mili l\u00edt.<\/p>\n\n

\"B\u01a1m<\/figure>\n\n

Ch\u00fang t\u00f4i h\u1ed7 tr\u1ee3 t\u1eeb thi\u1ebft k\u1ebf \u0111\u1ebfn x\u00e1c th\u1ef1c<\/h2>\n\n

01<\/span> Ph\u00e2n t\u00edch Nhu c\u1ea7u Ch\u1ea9n \u0111o\u00e1n & T\u00f9y ch\u1ec9nh C\u00f4ng c\u1ee5<\/h3>\n\n

Ch\u00fang t\u00f4i x\u00e2y d\u1ef1ng m\u1ecdi m\u00e1y m\u00f3c quanh \u0111\u1eb7c t\u00ednh ch\u1ea5t l\u1ecfng v\u00e0 \u0111\u1ecbnh d\u1ea1ng \u0111\u00f3ng g\u00f3i c\u1ee7a b\u1ea1n.\u00a0\u0110\u00e1nh gi\u00e1 Rheology c\u1ee7a t\u00e1c nh\u00e2n<\/strong>: Ph\u00e2n t\u00edch \u0111\u1ed9 nh\u1edbt ch\u1ea5t l\u1ecfng, l\u1ef1c c\u0103ng b\u1ec1 m\u1eb7t v\u00e0 nh\u1ea1y c\u1ea3m shear \u0111\u1ec3 ch\u1ecdn c\u01a1 ch\u1ebf b\u01a1m l\u00fd t\u01b0\u1edfng.\u00a0B\u1ea3n \u0111\u1ed3 b\u00ecnh ch\u1ee9a<\/strong>: Thi\u1ebft k\u1ebf d\u1ee5ng c\u1ee5 t\u00f9y ch\u1ec9nh, b\u00e1nh xe sao, v\u00e0 v\u00f2i b\u01a1m cho \u1ed1ng m\u1eabu, d\u1ea3i PCR, ho\u1eb7c b\u00ecnh buffer nhi\u1ec1u l\u00edt.\u00a0\u0110\u1ecbnh ngh\u0129a m\u1ee5c ti\u00eau th\u00f4ng l\u01b0\u1ee3ng<\/strong>: Ph\u00f9 h\u1ee3p t\u1ed1c \u0111\u1ed9 d\u00e2y chuy\u1ec1n v\u00e0 c\u1ea5u h\u00ecnh tr\u1ea1m tr\u1ef1c ti\u1ebfp v\u1edbi c\u00e1c ch\u1ec9 ti\u00eau \u0111\u1ea7u ra b\u1ea1n m\u1ee5c ti\u00eau.<\/p>\n\n

<\/figure>\n\n

02<\/span> S\u1ea3n xu\u1ea5t Ch\u00ednh x\u00e1c & Ki\u1ec3m tra ch\u1ea5p nh\u1eadn nh\u00e0 m\u00e1y (FAT)<\/h3>\n\n

Ch\u00fang t\u00f4i l\u1eafp r\u00e1p v\u00e0 x\u00e1c nh\u1eadn to\u00e0n di\u1ec7n thi\u1ebft b\u1ecb c\u1ee7a b\u1ea1n t\u1ea1i c\u01a1 s\u1edf tr\u01b0\u1edbc khi v\u1eadn chuy\u1ec3n.\u00a0H\u1ec7 th\u1ed1ng ki\u1ec3m tra ngo\u1ea1i tuy\u1ebfn<\/strong>: X\u00e1c minh \u0111\u1ed9 ch\u00ednh x\u00e1c c\u1ee7a c\u00e1c th\u00e0nh ph\u1ea7n, bao g\u1ed3m \u0111\u1ed9 ch\u00ednh x\u00e1c ph\u00e2n b\u1ed5 b\u01a1m ceramic v\u00e0 gi\u1edbi h\u1ea1n moment si\u1ebft n\u1eafp.\u00a0Giao th\u1ee9c FAT tr\u1ef1c tuy\u1ebfn<\/strong>: Th\u1eed nghi\u1ec7m to\u00e0n di\u1ec7n \u1edf t\u1ed1c \u0111\u1ed9 t\u1ed1i \u0111a b\u1eb1ng c\u00e1c th\u00f9ng ch\u1ee9a m\u1eabu v\u00e0 dung d\u1ecbch th\u1eed c\u1ee7a b\u1ea1n.\u00a0Ph\u00ea duy\u1ec7t tu\u00e2n th\u1ee7<\/strong>: Ho\u00e0n t\u1ea5t\u00a0X\u00e1c th\u1ef1c Ki\u1ec3m tra Ch\u1ea5p thu\u1eadn Nh\u00e0 m\u00e1y (FAT)<\/strong>\u00a0\u0111\u1ea3m b\u1ea3o kh\u00f4ng c\u00f3 l\u1ed7i tr\u01b0\u1edbc khi ph\u00e1t h\u00e0nh ra nh\u00e0 m\u00e1y.<\/p>\n\n

<\/figure>\n\n

03<\/span> B\u1ed9 ph\u1eadn v\u1eadn h\u00e0nh Cleanroom & H\u1ed7 tr\u1ee3 X\u00e1c nh\u1eadn<\/h3>\n\n

C\u00e1c k\u1ef9 s\u01b0 th\u1ef1c \u0111\u1ecba c\u1ee7a ch\u00fang t\u00f4i qu\u1ea3n l\u00fd t\u00edch h\u1ee3p t\u1ea1i ch\u1ed7 v\u00e0o kh\u00f4ng gian cleanroom c\u1ee7a b\u1ea1n \u0111\u1ec3 \u0111\u01a1n gi\u1ea3n h\u00f3a tu\u00e2n th\u1ee7.\u00a0Thi\u1ebft l\u1eadp Cleanroom<\/strong>: \u0110\u1ecbnh v\u1ecb ch\u00ednh x\u00e1c v\u00e0 t\u00edch h\u1ee3p b\u00ean trong c\u00e1c m\u00f4i tr\u01b0\u1eddng ISO Class 5 \/ Class 100 ho\u1eb7c c\u00e1c khu v\u1ef1c RABS.\u00a0Khung T\u00e0i li\u1ec7u IQ\/OQ\/PQ<\/strong>: Cung c\u1ea5p c\u00e1c giao th\u1ee9c th\u1eed nghi\u1ec7m \u0111\u00e3 ti\u1ec1n nghi\u1ec7m v\u00e0 h\u1ed3 s\u01a1 th\u1ef1c thi b\u00e0n giao cho ph\u00ea duy\u1ec7t ph\u00e1p l\u00fd nhanh.\u00a0\u0110\u00e0o t\u1ea1o Operator<\/strong>: H\u01b0\u1edbng d\u1eabn tr\u1ef1c ti\u1ebfp, hands-on cho \u0111\u1ed9i v\u1eadn h\u00e0nh c\u1ee7a b\u1ea1n bao g\u1ed3m thi\u1ebft l\u1eadp l\u00f4 h\u00e0ng, l\u00e0m s\u1ea1ch v\u00e0 thay \u0111\u1ed5i nhanh ch\u00f3ng.<\/p>\n\n

<\/figure>\n\n

04<\/span> H\u1ed7 tr\u1ee3 k\u1ef9 thu\u1eadt sau b\u00e1n h\u00e0ng to\u00e0n c\u1ea7u<\/h3>\n\n

Ch\u00fang t\u00f4i duy tr\u00ec s\u1ea3n xu\u1ea5t c\u1ee7a b\u1ea1n ho\u1ea1t \u0111\u1ed9ng su\u00f4n s\u1ebb trong to\u00e0n v\u00f2ng \u0111\u1eddi v\u1eadn h\u00e0nh c\u1ee7a thi\u1ebft b\u1ecb.\u00a0B\u1ea3o tr\u00ec ph\u00f2ng ng\u1eeba<\/strong>: Ki\u1ec3m tra \u0111\u1ecbnh k\u1ef3 \u0111\u1ec3 thay th\u1ebf c\u00e1c chi ti\u1ebft hao m\u00f2n nh\u01b0 gio\u0103ng v\u00e0 \u1ed1ng d\u1eabn tr\u01b0\u1edbc khi x\u1ea3y ra th\u1eddi gian ng\u1eebng ho\u1ea1t \u0111\u1ed9ng.\u00a0H\u1ed7 tr\u1ee3 t\u1eeb xa & t\u1ea1i hi\u1ec7n tr\u01b0\u1eddng<\/strong>: H\u1ed7 tr\u1ee3 ch\u1ea9n \u0111o\u00e1n nhanh \u0111i k\u00e8m v\u1edbi \u0111i\u1ec1u ph\u1ed1i k\u1ef9 thu\u1eadt vi\u00ean hi\u1ec7n tr\u01b0\u1eddng to\u00e0n c\u1ea7u.\u00a0\u0110\u1ed9 s\u1eb5n c\u00f3 c\u1ee7a ph\u1ee5 t\u00f9ng<\/strong>: Quy tr\u00ecnh giao nhanh c\u00e1c ph\u1ee5 t\u00f9ng thay th\u1ebf quan tr\u1ecdng \u0111\u1ec3 b\u1ea3o v\u1ec7 m\u1ee5c ti\u00eau s\u1ea3n xu\u1ea5t c\u1ee7a b\u1ea1n.<\/p>\n\n

<\/figure>\n\nD\u1ea7u tuy\u1ebfn Pharma & IVD \u00b7 Series \u0110\u1ed5 \u0111\u1ea7y\n\n

Gi\u1ea3i ph\u00e1p \u0110i\u1ec1n & \u0110\u00f3ng n\u1eafp IVD <\/h1>\n\nSo s\u00e1nh c\u00e1c h\u1ec7 th\u1ed1ng d\u00e0nh ri\u00eang cho \u1ee9ng d\u1ee5ng v\u1edbi dung d\u1ecbch b\u1ea3o qu\u1ea3n LBC, chai huy\u1ebft thanh nu\u00f4i c\u1ea5y, m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y, ph\u1ea3n \u1ee9ng kh\u00e1ng nguy\u00ean, \u1ed1ng PCR, v\u00e0 c\u00e1c container IVD b\u1ea5t th\u01b0\u1eddng\u2014t\u1eeb ph\u00e2n ph\u1ed1i tr\u00ean m\u1eb7t b\u00e0n \u0111\u1ebfn c\u00e1c d\u00e2y chuy\u1ec1n turnkey t\u00edch h\u1ee3p.\n\nLBC & b\u1ea3o t\u1ed3n t\u1ebf b\u00e0o\n\n10 mL\n\nChai nu\u00f4i c\u1ea5y m\u00e1u\n\n10\u201360 mL\n\nM\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y\n\n500\u20131,000 mL\n\n\u1ed0ng micro & \u1ed1ng PCR\n\nLi\u1ec1u vi m\u00f4\n\nChai IVD b\u1ea5t th\u01b0\u1eddng\n\nX\u1eed l\u00fd puck\n\nC\u00e1c m\u1ee9c \u0111\u00e3 c\u00f4ng b\u1ed1 l\u00e0 d\u00e0nh cho m\u00f4 h\u00ecnh c\u1ee5 th\u1ec3. C\u1ea5u h\u00ecnh cu\u1ed1i c\u00f9ng ph\u1ee5 thu\u1ed9c v\u00e0o ch\u1ea5t ph\u1ea3n \u1ee9ng, chai, n\u1eafp \u0111\u1eady, \u0111\u1ea7u ra m\u1ee5c ti\u00eau v\u00e0 k\u1ebf ho\u1ea1ch x\u00e1c nh\u1eadn.\n\nDanh m\u1ee5c s\u1ea3n ph\u1ea9m\n\n

H\u1ec7 th\u1ed1ng \u0111i\u1ec1n IVD, \u0111\u01b0\u1ee3c t\u1ed5 ch\u1ee9c theo \u1ee9ng d\u1ee5ng<\/h2>\n\nB\u1eaft \u0111\u1ea7u v\u1edbi \u0111\u1ecbnh d\u1ea1ng g\u00f3i v\u00e0 quy tr\u00ecnh\u2014not ch\u1ec9 t\u1ed1c \u0111\u1ed9 \u0111\u1ed5 danh ngh\u0129a. M\u1ed7i h\u1ec7 th\u1ed1ng d\u01b0\u1edbi \u0111\u00e2y li\u00ean k\u1ebft \u0111\u1ebfn trang s\u1ea3n ph\u1ea9m chi ti\u1ebft v\u1edbi quy tr\u00ecnh l\u00e0m vi\u1ec7c theo m\u00f4 h\u00ecnh v\u00e0 b\u1ea3ng k\u1ef9 thu\u1eadt ri\u00eang.\n\n
<\/a><\/figure>\n\nD\u00f2ng turnkey\n\nC\u1ea5p chai t\u00edch h\u1ee3p, \u0111i\u1ec1n b\u1eb1ng b\u1ed9 ph\u1eadn hai \u0111\u1ea7u, ph\u00e2n lo\u1ea1i n\u1eafp, ni\u00eam phong b\u1eb1ng \u0111\u1ed9ng c\u01a1 servo, d\u00e1n nh\u00e3n ngang v\u00e0 m\u00e3 b\u1eb1ng c\u00f4ng ngh\u1ec7 in b\u1eb1ng m\u1ef1c cho LBC v\u00e0 c\u00e1c dung d\u1ecbch ph\u00f2ng th\u00ed nghi\u1ec7m c\u00f3 \u0111\u1ed9 nh\u1edbt th\u1ea5p li\u00ean quan.\n\nTh\u1ec3 t\u00edch \u0111i\u1ec1n\n\n10 mL\n\n\u0110\u1ea7u ra\n\n50 chai\/ph\u00fat\n\n\u0110\u1ed9 ch\u00ednh x\u00e1c\n\n\u00b10,3 mL\n\nM\u1eabu\n\nD\u00f2ng GHALF-2-2\n\n
<\/a><\/figure>\n\nH\u00fat ch\u00e2n kh\u00f4ng & trao \u0111\u1ed5i gas\n\nChu tr\u00ecnh \u0111i\u1ec1n \u0111\u01b0\u1ee3c ch\u1ebf t\u00e1c ri\u00eang, b\u00e1n b\u1ecbt, h\u00fat ch\u00e2n kh\u00f4ng, trao \u0111\u1ed5i kh\u00ed, b\u1ecbt k\u00edn ho\u00e0n to\u00e0n v\u00e0 \u0111\u00f3ng n\u1eafp cho chai nu\u00f4i c\u1ea5y m\u00e1u v\u00e0 l\u1ecd thu\u1ed1c.\n\nPh\u1ea1m vi \u0111i\u1ec1n\n\n10\u201360 mL\n\n\u0110\u1ea7u ra\n\n1,300\u20131,500 BPH\n\n\u0110\u1ed9 ch\u00ednh x\u00e1c\n\n\u00b10,5 mL*\n\nM\u1eabu\n\nGHAFC-1-1-1\n\n
<\/a><\/figure>\n\nM\u00f4i tr\u01b0\u1eddng dung d\u1ecbch th\u1ec3 t\u00edch l\u1edbn\n\n\u0110i\u1ec1n b\u1eb1ng b\u01a1m d\u1eabn \u0111\u1ed9ng b\u1eb1ng t\u1eeb t\u00ednh v\u00e0 \u0111\u1eb7t n\u1eafp\/\u0111\u00f3ng n\u1eafp b\u1eb1ng b\u1ed1n \u0111\u1ea7u cho m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y, dung d\u1ecbch \u0111\u1ec7m, chai ch\u1ea5t th\u1eed nghi\u1ec7m v\u00e0 c\u00e1c dung d\u1ecbch c\u00f3 \u0111\u1ed9 nh\u1edbt th\u1ea5p kh\u00e1c trong c\u1ea5u h\u00ecnh lu\u1ed3ng laminar t\u1ea1i ch\u1ed7.\n\nPh\u1ea1m vi \u0111i\u1ec1n\n\n500\u20131,000 mL\n\n\u0110\u1ea7u ra\n\nL\u00ean t\u1edbi 700 BPH\n\nL\u1ed7i \u0111i\u1ec1n\n\n\u00b12%\n\nPh\u01b0\u01a1ng ph\u00e1p\n\nB\u01a1m d\u1eabn \u0111\u1ed9ng b\u1eb1ng t\u1eeb t\u00ednh\n\n
<\/a><\/figure>\n\nX\u1eed l\u00fd \u1ed1ng\n\nM\u1ed9t n\u1ec1n t\u1ea3ng t\u1ef1 \u0111\u1ed9ng cho \u1ed1ng ly t\u00e2m, \u1ed1ng PCR \u0111\u01a1n, cryovials, \u1ed1ng l\u1ea5y m\u1eabu axit nucleic, v\u00e0 \u0111\u00f3ng g\u00f3i ch\u1ea5t th\u1eed nghi\u1ec7m nhanh, v\u1edbi x\u1eed l\u00fd ph\u1ee5 thu\u1ed9c \u0111\u1ecbnh d\u1ea1ng.\n\n\u0110\u1ecbnh d\u1ea1ng\n\n\u1ed0ng micro & \u1ed1ng PCR\n\n\u0110\u1ea7u ra c\u00f4ng b\u1ed1\n\n4,000\u20138,000 pcs\/h*\n\n\u0110i\u1ec1u khi\u1ec3n\n\nPLC\n\nNgu\u1ed3n\n\nKho\u1ea3ng 2,5 kW\n\n
<\/a><\/figure>\n\nChai b\u1ea5t th\u01b0\u1eddng\n\nPucks t\u00f9y ch\u1ec9nh \u1ed5n \u0111\u1ecbnh chai c\u00f3 h\u00ecnh h\u1ecdc kh\u00f4ng \u0111\u1ec1u khi m\u1ed9t n\u1ec1n t\u1ea3ng quay t\u00edch h\u1ee3p \u0111i\u1ec1n b\u1eb1ng b\u01a1m d\u1eabn \u0111\u1ed9ng b\u1eb1ng t\u1eeb t\u00ednh, \u0111\u1eb7t n\u1eafp, \u0111\u00f3ng n\u1eafp b\u1eb1ng servo v\u00e0 x\u1ea3 t\u1ef1 \u0111\u1ed9ng.\n\nPh\u1ea1m vi \u0111i\u1ec1n\n\n10\u201360 mL\n\n\u0110\u1ea7u ra 15 mL\n\n>3,000 BPH\n\n\u0110\u1ea7u ra 60 mL\n\n1,800\u20132,000 BPH\n\nM\u1eabu\n\nGHAFC-4-2\n\n
<\/a><\/figure>\n\nPh\u00f2ng th\u00ed nghi\u1ec7m & quy m\u00f4 th\u00ed nghi\u1ec7m\n\nM\u1ed9t b\u00e0n l\u00e0m vi\u1ec7c m\u1ed9t \u0111\u1ea7u g\u1ecdn g\u00e0ng cho c\u1ea5p chai t\u1ef1 \u0111\u1ed9ng, micro-filling, guiding, \u0111\u00f3ng n\u1eafp v\u00e0 x\u1ea3 t\u1ea1i ph\u00f2ng th\u00ed nghi\u1ec7m, nh\u00e0 m\u00e1y th\u00ed nghi\u1ec7m v\u00e0 s\u1ea3n xu\u1ea5t quy m\u00f4 nh\u1ecf.\n\nPh\u1ea1m vi k\u1ef9 thu\u1eadt\n\n0.1\u20131 mL\n\n\u0110\u1ea7u ra\n\n2,000 BPH\n\nLi\u1ec1u tham kh\u1ea3o\n\n510 \u03bcL \u00b110 \u03bcL\n\n\u0110i\u1ec7n \u00e1p\n\n220 V\n\nH\u01b0\u1edbng d\u1eabn ch\u1ecdn l\u1ef1a\n\n

Ch\u1ecdn ki\u1ebfn tr\u00fac d\u00e2y chuy\u1ec1n tr\u01b0\u1edbc khi ch\u1ecdn m\u00f4 h\u00ecnh<\/h2>\n\nM\u00e1y \u0111\u1ed5 \u0111\u1ea7y IVD ph\u00f9 h\u1ee3p nh\u1ea5t ph\u1ee5 thu\u1ed9c v\u00e0o giai \u0111o\u1ea1n s\u1ea3n xu\u1ea5t, \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh c\u1ee7a dung d\u1ecbch ch\u1ee9a, ph\u1ea1m vi li\u1ec1u, tr\u00ecnh t\u1ef1 ni\u00eam phong, chi\u1ebfn l\u01b0\u1ee3c v\u1ec7 sinh v\u00e0 ki\u1ec3m tra sau d\u1eef li\u1ec7u\u2014not on one headline capacity.\n\n

H\u1ec7 th\u1ed1ng b\u00e0n l\u00e0m vi\u1ec7c<\/h3>\n\nS\u1eed d\u1ee5ng khi kh\u00f4ng gian s\u00e0n c\u00f3 h\u1ea1n, l\u00f4 ng\u1eafn v\u00e0 ng\u01b0\u1eddi v\u1eadn h\u00e0nh c\u1ea7n thay \u0111\u1ed5i c\u00f4ng th\u1ee9c ho\u1eb7c container th\u01b0\u1eddng xuy\u00ean.\n\nC\u00f4ng vi\u1ec7c vi m\u00f4\n\nX\u1eed l\u00fd th\u1ee7 c\u00f4ng ho\u1eb7c g\u1ecdn\n\n\u0110\u1ed9 ph\u1ee9c t\u1ea1p \u0111\u1ea7u v\u00e0o th\u1ea5p h\u01a1n\n\nS\u1ea3n xu\u1ea5t t\u00edch h\u1ee3p\n\n

N\u1ec1n t\u1ea3ng m\u00f4-\u0111un m\u1ed9t kh\u1ed1i<\/h3>\n\nS\u1eed d\u1ee5ng khi qu\u00e1 tr\u00ecnh \u0111i\u1ec1n, \u0111\u1eb7t n\u1eafp, \u0111\u00f3ng n\u1eafp v\u00e0 x\u1ea3 ph\u1ea3i chia s\u1ebb m\u1ed9t n\u1ec1n t\u1ea3ng \u0111\u00e1nh ch\u1ec9 m\u1ee5c g\u1ecdn.\n\nChuy\u1ec3n chai \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t\n\nD\u1ea5u \u1ea5n quy tr\u00ecnh g\u1ecdn\n\n\u0110i\u1ec1u khi\u1ec3n PLC\/HMI trung t\u00e2m\n\n\u0110\u1ea7u ra t\u1eeb \u0111\u1ea7u \u0111\u1ebfn cu\u1ed1i\n\n

D\u00e2y chuy\u1ec1n \u0111\u1ed5 \u0111\u1ea7y ch\u00eca kh\u00f3a trao tay<\/h3>\n\nS\u1eed d\u1ee5ng khi c\u1ea5p chai, l\u00e0m s\u1ea1ch kh\u00f4ng kh\u00ed, \u0111\u1ed5 \u0111\u1ea7y, \u0111\u00f3ng n\u1eafp, d\u00e1n nh\u00e3n, m\u00e3 h\u00f3a v\u00e0 ki\u1ec3m tra c\u1ea7n giao di\u1ec7n ph\u1ed1i h\u1ee3p.\n\nC\u00e2n b\u1eb1ng takt \u1edf c\u1ea5p \u0111\u1ed9 d\u00e2y chuy\u1ec1n\n\nT\u00edch h\u1ee3p l\u00ean\/xu\u1ed1ng d\u00f2ng\n\nL\u1eadp k\u1ebf ho\u1ea1ch t\u00e0i li\u1ec7u d\u1ef1 \u00e1n\n\nKi\u1ebfn tr\u00fac quy tr\u00ecnh \u0111i\u1ec3n h\u00ecnh\n\n

T\u1eeb th\u00f9ng r\u1ed7ng \u0111\u1ebfn ch\u1ea5t \u0111\u1ed3ng ph\u00e2n IVD \u0111\u01b0\u1ee3c m\u00e3 h\u00f3a<\/h2>\n\nM\u1ed9t d\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t c\u00f3 th\u1ec3 bao g\u1ed3m to\u00e0n b\u1ed9 ho\u1eb7c ch\u1ec9 m\u1ed9t ph\u1ea7n c\u1ee7a chu\u1ed7i n\u00e0y. V\u0103n b\u1ea3n nu\u00f4i c\u1ea5y m\u00e1u v\u00e0 c\u00e1c \u0111\u1ecbnh d\u1ea1ng \u0111\u00f3ng \u0111\u1eb7c bi\u1ec7t c\u00f3 th\u1ec3 b\u1ed5 sung ch\u00e2n kh\u00f4ng, trao \u0111\u1ed5i kh\u00ed, \u1ea5n stopper, h\u00e0n co, ho\u1eb7c ki\u1ec3m tra theo \u0111\u1ecbnh d\u1ea1ng.\n\n01\n\nC\u1ea5p v\u00e0 \u0111\u1ecbnh h\u01b0\u1edbng\n\nB\u1ed9 \u0111\u1ef1ng, ph\u1ec5u, b\u00e1t rung, ho\u1eb7c t\u1ea3i h\u1ed9p\n\n02\n\nL\u00e0m s\u1ea1ch ho\u1eb7c chu\u1ea9n b\u1ecb\n\nL\u00e0m s\u1ea1ch kh\u00f4ng kh\u00ed ho\u1eb7c ti\u1ec1n x\u1eed l\u00fd \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t khi \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh\n\n03\n\n\u0110o v\u00e0 \u0111\u1ed5 \u0111\u1ea7y\n\nH\u1ec7 th\u1ed1ng \u0111\u1ecbnh li\u1ec1u b\u1eb1ng b\u01a1m xuy\u00ean men ho\u1eb7c h\u1ec7 th\u1ed1ng li\u1ec1u \u0111\u01b0\u1ee3c ch\u1ecdn cho \u1ee9ng d\u1ee5ng\n\n04\n\n\u0110\u1eb7t n\u1eafp closure\n\nN\u1eafp, n\u1eafp \u0111\u1eady, stopper, m\u00e0ng, ho\u1eb7c closure gh\u00e9p\n\n05\n\nSealing & ki\u1ec3m tra\n\nKh\u00f3a n\u1eafp b\u1eb1ng m\u00f4-men xo\u1eafn, \u1ea5n, h\u00e0n crimp, v\u00e0 ph\u00e1t hi\u1ec7n\n\n06\n\nNh\u00e3n m\u00e1c & m\u00e3 h\u00f3a\n\nNh\u1eadn di\u1ec7n, truy xu\u1ea5t ngu\u1ed3n g\u1ed1c, v\u00e0 \u0111\u00f3ng g\u00f3i v\u1ec1 sau\n\nH\u01b0\u1edbng d\u1eabn k\u1ef9 thu\u1eadt \u0111\u1ed5 \u0111\u1ea7y IVD\n\nT\u1eeb ng\u01b0\u1eddi m\u1edbi \u0111\u1ebfn s\u1eb5n s\u00e0ng cho d\u1ef1 \u00e1n\n\n

C\u00e1ch ch\u1ec9 \u0111\u1ecbnh m\u1ed9t m\u00e1y n\u1ea1p ch\u1ea5t th\u1eed IVD<\/h2>\n\n

M\u00e1y n\u1ea1p ch\u1ea5t cho IVD l\u00e0 g\u00ec?<\/h3>\n\nFDA m\u00f4 t\u1ea3 ch\u1ea9n \u0111o\u00e1n in vitro l\u00e0 c\u00e1c x\u00e9t nghi\u1ec7m \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u00ean c\u00e1c m\u1eabu nh\u01b0 m\u00e1u ho\u1eb7c m\u00f4 l\u1ea5y t\u1eeb c\u01a1 th\u1ec3 ng\u01b0\u1eddi. Trong s\u1ea3n xu\u1ea5t, m\u00e1y \u0111\u1ed5 \u0111\u1ea7y IVD \u0111o li\u1ec1u m\u1ed9t ch\u1ea5t ho\u1ea1t tr\u1ecb ch\u1ea9n \u0111o\u00e1n, dung d\u1ecbch \u0111\u1ec7m, m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y, ch\u1ea5t b\u1ea3o qu\u1ea3n, ho\u1eb7c dung d\u1ecbch li\u00ean quan v\u00e0o dung d\u1ecbch ch\u1ee9a ch\u00ednh v\u00e0 c\u00f3 th\u1ec3 t\u00edch h\u1ee3p \u0111\u1eb7t n\u1eafp \u0111\u1eady, kh\u00e9p k\u00edn, ni\u00eam phong, ki\u1ec3m tra, nh\u00e3n v\u00e0 m\u00e3 h\u00f3a.\n\nT\u1eeb \u201cIVD\u201d \u0111\u1ecbnh ngh\u0129a ng\u1eef c\u1ea3nh s\u1ea3n ph\u1ea9m; n\u00f3 kh\u00f4ng t\u1ef1 n\u00f3 x\u00e1c \u0111\u1ecbnh m\u00e1y b\u01a1m, ph\u1ea1m vi \u0111\u1ed5 \u0111\u1ea7y, m\u1ee9c \u0111\u1ed9 t\u1ef1 \u0111\u1ed9ng h\u00f3a hay thi\u1ebft k\u1ebf ph\u00f2ng s\u1ea1ch. Nh\u1eefng quy\u1ebft \u0111\u1ecbnh \u0111\u00f3 \u0111\u1ebfn t\u1eeb ch\u1ea5t h\u00f3a, dung d\u1ecbch ch\u1ee9a, n\u1eafp closure, m\u1ee5c ti\u00eau s\u1ea3n xu\u1ea5t, v\u00e0 chi\u1ebfn l\u01b0\u1ee3c x\u00e1c nh\u1eadn.\n\n

B\u1eaft \u0111\u1ea7u v\u1edbi \u0111\u01b0\u1eddng d\u1eabn ch\u1ea5t ph\u1ea3n \u1ee9ng v\u00e0 ti\u1ebfp x\u00fac v\u1edbi s\u1ea3n ph\u1ea9m<\/h3>\n\nGhi nh\u1eadn \u0111\u1ed9 nh\u1edbt c\u1ee7a t\u00e0i li\u1ec7u, khuynh h\u01b0\u1edbng h\u00ecnh th\u00e0nh b\u1ecdt, c\u00e1c h\u1ea1t l\u01a1 l\u1eedng, nh\u1ea1y c\u1ea3m v\u1edbi shear, t\u00ednh \u0103n m\u00f2n, nhi\u1ec7t \u0111\u1ed9, ph\u01b0\u01a1ng ph\u00e1p l\u00e0m s\u1ea1ch, v\u00e0 v\u1eadt li\u1ec7u ti\u1ebfp x\u00fac v\u1edbi s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn. \u0110\u1ed5 \u0111\u1ea7y b\u1eb1ng b\u01a1m xuy\u00ean m\u1ea1ch th\u01b0\u1eddng \u0111\u01b0\u1ee3c ch\u1ecdn cho c\u00e1c dung d\u1ecbch ch\u1ea9n \u0111o\u00e1n c\u00f3 l\u01b0u l\u01b0\u1ee3ng th\u1ea5p v\u00ec \u0111\u01b0\u1eddng \u0111i s\u1ea3n ph\u1ea9m c\u00f3 th\u1ec3 gi\u1edbi h\u1ea1n \u1edf \u1ed1ng d\u1eabn v\u00e0 v\u00f2i \u0111\u1ed5, nh\u01b0ng t\u00ednh ph\u00f9 h\u1ee3p v\u1eabn \u0111\u00f2i h\u1ecfi th\u1eed nghi\u1ec7m m\u1eabu.\n\nV\u1edbi m\u00f4i tr\u01b0\u1eddng sinh h\u1ecdc ho\u1eb7c ch\u1ea5t x\u00fac t\u00e1c gi\u00e1 tr\u1ecb cao, \u0111\u00e1nh gi\u00e1 tu\u1ed5i th\u1ecd \u1ed1ng, th\u1ec3 t\u00edch gi\u1eef l\u1ea1i, m\u1ea5t c\u00f4ng priming, r\u00f2 r\u1ec9, ki\u1ec3m so\u00e1t b\u1ecdt, v\u00e0 l\u00e0m s\u1ea1ch thay \u0111\u1ed5i tr\u01b0\u1edbc khi \u0111\u1ed3ng \u00fd v\u1edbi thi\u1ebft k\u1ebf b\u01a1m v\u00e0 v\u00f2i \u0111\u1ed5 cu\u1ed1i c\u00f9ng.\n\n

\u0110\u1ed9 geometry c\u1ee7a b\u00ecnh ch\u1ee9a ki\u1ec3m so\u00e1t s\u1ef1 \u1ed5n \u0111\u1ecbnh c\u1ee7a \u0111\u01b0\u1eddng d\u1eabn<\/h3>\n\nN\u1eafp v\u00f2ng tr\u00f2n c\u00f3 th\u1ec3 s\u1eed d\u1ee5ng c\u00e1c guide th\u00f4ng th\u01b0\u1eddng, b\u00e1nh sao, ho\u1eb7c b\u1ed9 n\u1ea1p chai. \u1ed0ng PCR, \u1ed1ng cryovial, \u1ed1ng c\u00f3 tay c\u1ea7m, v\u00e0 c\u00e1c chai IVD b\u1ea5t \u0111\u1ed1i x\u1ee9ng c\u00f3 th\u1ec3 \u0111\u00f2i h\u1ecfi c\u00e1c nest d\u00e0nh ri\u00eang ho\u1eb7c puck tu\u1ea7n ho\u00e0n. M\u1ed9t puck chuy\u1ec3n \u0111\u1ed5i h\u00ecnh d\u1ea1ng b\u00ean ngo\u00e0i kh\u00f4ng \u1ed5n \u0111\u1ecbnh th\u00e0nh d\u1eef li\u1ec7u x\u1eed l\u00fd l\u1eb7p l\u1ea1i th\u00f4ng qua c\u00e1c tr\u1ea1m \u0111\u1ed5 \u0111\u1ea7y v\u00e0 \u0111\u00f3ng n\u1eafp.\n\nG\u1eedi s\u1eb5n c\u00e1c chai \u0111\u1ea1i di\u1ec7n, n\u1eafp, stopper v\u00e0 m\u00e0ng s\u1edbm. \u0110\u1ed9 dung sai k\u00edch th\u01b0\u1edbc v\u00e0 s\u1ef1 bi\u1ebfn \u0111\u1ed5i c\u1ee7a closure quan tr\u1ecdng nh\u01b0 drawing danh ngh\u0129a khi thi\u1ebft k\u1ebf s\u00e0ng l\u1ecdc, chi\u1ebfm v\u00e0 \u0111\u1eb7t, v\u00e0 ki\u1ec3m so\u00e1t m\u00f4-men.\n\n

X\u00e1c \u0111\u1ecbnh \u0111\u1ed9 ch\u00ednh x\u00e1c c\u00f9ng v\u1edbi li\u1ec1u l\u01b0\u1ee3ng v\u00e0 t\u1ed1c \u0111\u1ed9<\/h3>\n\nM\u1ed9t t\u1ec9 l\u1ec7 ph\u1ea7n tr\u0103m m\u00e0 kh\u00f4ng c\u00f3 th\u1ec3 t\u00edch \u0111\u1ed5 \u0111\u1ea7y \u0111i k\u00e8m l\u00e0 ti\u00eau ch\u00ed ch\u1ea5p nh\u1eadn ch\u01b0a \u0111\u1ea7y \u0111\u1ee7. X\u00e1c \u0111\u1ecbnh th\u1ec3 t\u00edch ho\u1eb7c tr\u1ecdng l\u01b0\u1ee3ng m\u1ee5c ti\u00eau, sai l\u1ec7ch cho ph\u00e9p, ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra, k\u1ebf ho\u1ea1ch l\u1ea5y m\u1eabu, \u0111i\u1ec1u ki\u1ec7n ch\u1ea5t l\u1ecfng v\u00e0 \u0111\u1ea7u ra y\u00eau c\u1ea7u. X\u00e1c nh\u1eadn xem t\u1ed1c \u0111\u1ed9 c\u00f4ng b\u1ed1 c\u00f3 \u00e1m ch\u1ec9 chai m\u1ed7i ph\u00fat, chai m\u1ed7i gi\u1edd hay t\u1eebng th\u00e0nh ph\u1ea7n ri\u00eang l\u1ebb, v\u00e0 c\u00f3 bao g\u1ed3m c\u00e1c ho\u1ea1t \u0111\u1ed9ng downstream hay kh\u00f4ng.\n\nC\u00e1c th\u1eed nghi\u1ec7m t\u1ea1i nh\u00e0 m\u00e1y n\u00ean s\u1eed d\u1ee5ng c\u00f4ng th\u1ee9c d\u1ef1 \u0111\u1ecbnh ho\u1eb7c ch\u1ea5t l\u1ecfng th\u1eed \u0111\u1ea1i di\u1ec7n c\u00f9ng v\u1edbi container v\u00e0 n\u1eafp \u0111\u1eady d\u1ef1 \u0111\u1ecbnh. Ti\u00eau ch\u00ed ch\u1ea5p nh\u1eadn n\u00ean ph\u00e2n bi\u1ec7t m\u1ee5c ti\u00eau thi\u1ebft k\u1ebf thi\u1ebft b\u1ecb t\u1eeb k\u1ebft qu\u1ea3 quan s\u00e1t \u0111\u01b0\u1ee3c trong FAT ho\u1eb7c \u0111\u00e1nh gi\u00e1 t\u1ea1i c\u01a1 s\u1edf.\n\n

Ph\u00e2n lo\u1ea1i ph\u00f2ng s\u1ea1ch v\u00e0 tu\u00e2n th\u1ee7 s\u1ea3n ph\u1ea9m l\u00e0 c\u00e1c quy\u1ebft \u0111\u1ecbnh ri\u00eang bi\u1ec7t<\/h3>\n\nISO 14644-1 ph\u00e2n lo\u1ea1i \u0111\u1ed9 s\u1ea1ch c\u1ee7a kh\u00f4ng kh\u00ed b\u1eb1ng n\u1ed3ng \u0111\u1ed9 h\u1ea1t ph\u00e2n t\u00e1n trong kh\u00f4ng kh\u00ed. N\u00f3 kh\u00f4ng ch\u1ee9ng nh\u1eadn m\u1ed9t s\u1ea3n ph\u1ea9m IVD hay t\u1ef1 \u0111\u1ed9ng l\u00e0m cho m\u1ed9t d\u00e2y chuy\u1ec1n \u0111\u1ed5 \u0111\u1ea7y ph\u00f9 h\u1ee3p. T\u01b0\u01a1ng t\u1ef1, Quy \u0111\u1ecbnh (EU) 2017\/746 c\u1ee7a EU thi\u1ebft l\u1eadp khu\u00f4n kh\u1ed5 qu\u1ea3n l\u00fd cho thi\u1ebft b\u1ecb y t\u1ebf IVD, nh\u01b0ng nh\u00e0 s\u1ea3n xu\u1ea5t v\u1eabn ch\u1ecbu tr\u00e1ch nhi\u1ec7m cho h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng, qu\u1ea3n l\u00fd r\u1ee7i ro, x\u00e1c nh\u1eadn quy tr\u00ecnh v\u00e0 s\u1ef1 ph\u00f9 h\u1ee3p.\n\nM\u1ed9t m\u00e1y c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t v\u1ec7 sinh ho\u1eb7c trong m\u00f4i tr\u01b0\u1eddng ki\u1ec3m so\u00e1t. S\u1ef1 tu\u00e2n th\u1ee7 GMP cu\u1ed1i c\u00f9ng, IVDR, FDA, ph\u00f2ng s\u1ea1ch v\u00e0 x\u00e1c nh\u1eadn ph\u1ee5 thu\u1ed9c v\u00e0o to\u00e0n b\u1ed9 qu\u00e1 tr\u00ecnh l\u1eafp \u0111\u1eb7t, t\u00e0i li\u1ec7u, ti\u1ec7n \u00edch, quy tr\u00ecnh v\u1eadn h\u00e0nh v\u00e0 tr\u00e1ch nhi\u1ec7m ph\u00e1p l\u00fd c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t.\n\n

Nh\u1eefng g\u00ec n\u00ean c\u00f3 trong URS c\u1ee7a b\u1ea1n<\/h3>\n\nT\u00ean ch\u1ea5t th\u1eed v\u00e0 \u0111\u1eb7c t\u00ednh v\u1eadt l\u00fd\n\nM\u1ee5c ti\u00eau v\u00e0 th\u1ec3 t\u00edch \u0111\u1ed5 \u0111\u1ea7y t\u1ed1i thi\u1ec3u\/t\u1ed1i \u0111a\n\nM\u1eabu chai, \u1ed1ng, n\u1eafp, stopper v\u00e0 m\u00e0ng\n\n\u0110\u1ea7u ra y\u00eau c\u1ea7u v\u00e0 m\u00f4 h\u00ecnh ca\n\n\u0110\u1ecbnh ngh\u0129a \u0111\u1ed9 ch\u00ednh x\u00e1c v\u00e0 giao th\u1ee9c th\u1eed\n\nChu\u1ea9n b\u1ecb, l\u00e0m s\u1ea1ch v\u00e0 chu tr\u00ecnh closure\n\nV\u1eadt li\u1ec7u ti\u1ebfp x\u00fac v\u1edbi s\u1ea3n ph\u1ea9m v\u00e0 khung m\u00e1y\n\nY\u00eau c\u1ea7u ph\u00f2ng s\u1ea1ch v\u00e0 lu\u1ed3ng kh\u00f4ng kh\u00ed c\u1ee5c b\u1ed9\n\nLogic lo\u1ea1i b\u1ecf, c\u1ea3nh b\u00e1o, v\u00e0 truy v\u1ebft\n\nFAT, SAT, IQ\/OQ, v\u00e0 ph\u1ea1m vi t\u00e0i li\u1ec7u\n\n\u0110i\u1ec7n \u00e1p c\u00f3 s\u1eb5n, kh\u00ed n\u00e9n v\u00e0 ti\u1ec7n \u00edch c\u1ee7a nh\u00e0 m\u00e1y\n\nB\u1ed1 tr\u00ed tuy\u1ebfn v\u00e0 giao di\u1ec7n m\u1edf r\u1ed9ng trong t\u01b0\u01a1ng lai\n\nC\u00e1c c\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p\n\n

C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p v\u1ec1 m\u00e1y \u0111\u00f3ng g\u00f3i IVD<\/h2>\n\n

Ph\u01b0\u01a1ng ph\u00e1p \u0111\u00f3ng dung d\u1ecbch n\u00e0o ph\u00f9 h\u1ee3p cho ch\u1ea5t chu\u1ea9n ch\u1ea9n \u0111o\u00e1n?<\/h3>\n\n

Kh\u00f4ng c\u00f3 ph\u01b0\u01a1ng ph\u00e1p ph\u1ed5 qu\u00e1t. C\u00e1c dung d\u1ecbch v\u1edbi l\u01b0\u1ee3ng nh\u1ecf, \u0111\u1ed9 nh\u1edbt th\u1ea5p th\u01b0\u1eddng \u0111\u01b0\u1ee3c \u0111\u00f3ng b\u1eb1ng ph\u01b0\u01a1ng ph\u00e1p b\u01a1m n\u00f4ng ho\u1eb7c b\u01a1m kim th\u1ee7y l\u1ef1c ch\u00ednh x\u00e1c, trong khi c\u00e1c ch\u1ea5t l\u1ecfng kh\u00e1c c\u00f3 th\u1ec3 y\u00eau c\u1ea7u nguy\u00ean t\u1eafc c\u1ea5p \u0111\u1ecbnh l\u01b0\u1ee3ng kh\u00e1c. L\u1ef1a ch\u1ecdn c\u1ea7n tu\u00e2n theo ki\u1ec3m tra ch\u1ea5t l\u1ecfng, ph\u1ea1m vi li\u1ec1u, ti\u00eau chu\u1ea9n \u0111\u1ed9 ch\u00ednh x\u00e1c, chi\u1ebfn l\u01b0\u1ee3c l\u00e0m s\u1ea1ch v\u00e0 y\u00eau c\u1ea7u ti\u1ebfp x\u00fac v\u1edbi s\u1ea3n ph\u1ea9m.<\/p>\n\n

M\u1ed9t d\u00f2ng c\u00f3 th\u1ec3 x\u1eed l\u00fd nhi\u1ec1u \u0111\u1ecbnh d\u1ea1ng chai ho\u1eb7c \u1ed1ng kh\u00f4ng?<\/h3>\n\n

C\u00f3, khi m\u00e1y \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf v\u1edbi c\u00e1c b\u1ed9 thay \u0111\u1ed5i, h\u1ed9p d\u1eabn h\u01b0\u1edbng \u0111i\u1ec1u ch\u1ec9nh, g\u1ed1i gh\u00e9p c\u00f3 th\u1ec3 ho\u00e1n \u0111\u1ed5i ho\u1eb7c c\u00e0i \u0111\u1eb7t \u0111i\u1ec1u khi\u1ec3n b\u1eb1ng c\u00f4ng th\u1ee9c. Th\u1eddi gian chuy\u1ec3n \u0111\u1ed5i th\u1ef1c t\u1ebf v\u00e0 ph\u1ea1m vi t\u01b0\u01a1ng th\u00edch ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn t\u1eeb m\u1eabu container v\u00e0 n\u1eafp \u0111\u1eady th\u1ef1c t\u1ebf.<\/p>\n\n

Khi n\u00e0o monoblock t\u1ed1t h\u01a1n so v\u1edbi d\u00e2y chuy\u1ec1n inline?<\/h3>\n\n

Monoblock h\u1eefu \u00edch khi c\u00e1c ho\u1ea1t \u0111\u1ed9ng \u0111\u00f3ng v\u00e0 ni\u00eam phong c\u1ea7n truy\u1ec1n t\u1ea3i theo ch\u1ec9 s\u1ed1 l\u1eb7p l\u1ea1i v\u00e0 chi\u1ebfm di\u1ec7n t\u00edch nh\u1ecf. D\u00e2y chuy\u1ec1n inline cho ph\u00e9p t\u1ef1 do th\u00eam b\u1ed9 \u0111\u1ec7m, ki\u1ec3m tra, d\u00e1n nh\u00e3n, \u0111\u00f3ng h\u1ed9p v\u00e0 c\u00e1c tr\u1ea1m t\u01b0\u01a1ng lai. L\u1ef1a ch\u1ecdn ph\u1ee5 thu\u1ed9c v\u00e0o c\u00e2n b\u1eb1ng takt, \u1ed5n \u0111\u1ecbnh container, di\u1ec7n t\u00edch m\u1eb7t s\u00e0n v\u00e0 k\u1ebf ho\u1ea1ch m\u1edf r\u1ed9ng.<\/p>\n\n

C\u00e1c chai IVD b\u1ea5t th\u01b0\u1eddng \u0111\u01b0\u1ee3c gi\u1eef \u1ed5n \u0111\u1ecbnh b\u1eb1ng c\u00e1ch n\u00e0o?<\/h3>\n\n

C\u00e1c g\u1ed1i gh\u00e9p ho\u1eb7c t\u1ed5 h\u1ed7 tr\u1ee3 d\u00e0nh ri\u00eang cho container c\u00f3 \u0111\u00e1y kh\u00f4ng \u0111\u1ec1u, c\u1ed5 l\u1ec7ch t\u00e2m ho\u1eb7c \u1ed5n \u0111\u1ecbnh y\u1ebfu. Thi\u1ebft b\u1ecb c\u1ed1 \u0111\u1ecbnh v\u1eadn chuy\u1ec3n t\u1eebng chai qua qu\u00e1 tr\u00ecnh \u0111\u00f3ng v\u00e0 ni\u00eam, trong khi m\u1ed9t b\u0103ng chuy\u1ec1n tr\u1ea3 l\u1ea1i tu\u1ea7n ho\u00e0n c\u00e1c g\u1ed1i r\u1ed7ng t\u1edbi \u0111i\u1ec3m t\u1ea3i.<\/p>\n\n

C\u00e1c m\u1eabu n\u00e0o c\u1ea7n c\u00f3 tr\u01b0\u1edbc khi b\u00e1o gi\u00e1?<\/h3>\n\n

Cung c\u1ea5p ch\u1ea5t l\u1ecfng \u0111\u1ea1i di\u1ec7n, chai ho\u1eb7c \u1ed1ng, n\u1eafp, n\u00fat ch\u1eb7n, ph\u1edbt, b\u1ea3n v\u1ebd, th\u1ec3 t\u00edch m\u1ee5c ti\u00eau, \u0111\u1ed9 l\u1ec7ch ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c, s\u1ea3n l\u01b0\u1ee3ng, ti\u1ec7n \u00edch, b\u1ed1 tr\u00ed d\u00f2ng v\u00e0 y\u00eau c\u1ea7u ph\u00f2ng s\u1ea1ch. C\u00e1c m\u1eabu v\u1eadt l\u00fd gi\u00fap x\u00e1c nh\u1eadn gi\u1ea3 \u0111\u1ecbnh c\u1ea5p feeding, \u0111\u00f3ng, ni\u00eam v\u00e0 \u0111\u1ed5i m\u1eabu.<\/p>\n\n

Thi\u1ebft b\u1ecb c\u00f3 \u0111\u1ea3m b\u1ea3o tu\u00e2n th\u1ee7 GMP, FDA hay IVDR kh\u00f4ng?<\/h3>\n\n

Kh\u00f4ng. Thi\u1ebft k\u1ebf thi\u1ebft b\u1ecb c\u00f3 th\u1ec3 h\u1ed7 tr\u1ee3 s\u1ea3n xu\u1ea5t h\u1ee3p v\u1ec7 sinh v\u00e0 x\u00e1c th\u1ef1c, nh\u01b0ng s\u1ef1 tu\u00e2n th\u1ee7 thu\u1ed9c v\u1ec1 h\u1ec7 th\u1ed1ng s\u1ea3n xu\u1ea5t ho\u00e0n ch\u1ec9nh. N\u00f3 ph\u1ee5 thu\u1ed9c v\u00e0o m\u00f4i tr\u01b0\u1eddng c\u00e0i \u0111\u1eb7t, qu\u1ea3n l\u00fd r\u1ee7i ro, x\u00e1c nh\u1eadn, x\u00e1c th\u1ef1c qu\u00e1 tr\u00ecnh, t\u00e0i li\u1ec7u, quy tr\u00ecnh v\u1eadn h\u00e0nh v\u00e0 h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t h\u1ee3p ph\u00e1p.<\/p>\n\n

S\u1ea3n xu\u1ea5t IVD kh\u00f4ng c\u00f3 ch\u1eeba ch\u1ed7 cho sai s\u00f3t.<\/h2>\n\n

H\u00ecnh h\u1ecdc h\u1ed9p d\u1ee5ng c\u1ee5, h\u00e0nh vi c\u1ee7a ch\u1ea5t th\u1eed v\u00e0 ki\u1ec3m so\u00e1t nhi\u1ec5m b\u1ea9n \u1ea3nh h\u01b0\u1edfng tr\u1ef1c ti\u1ebfp \u0111\u1ebfn hi\u1ec7u su\u1ea5t x\u00e9t nghi\u1ec7m. Thi\u1ebft b\u1ecb c\u1ee7a b\u1ea1n ph\u1ea3i t\u00ednh \u0111\u1ebfn c\u1ea3 ba y\u1ebfu t\u1ed1 n\u00e0y.<\/p>\n\n04<\/strong>\n\n

H\u00f3a h\u1ecdc \u0103n m\u00f2n<\/h3>\n\n

C\u00e1c dung d\u1ecbch phong \u1ee7 t\u1ebf b\u00e0o, dung m\u00f4i v\u00e0 c\u00e1c ch\u1ea5t ph\u1ea3n \u1ee9ng c\u00f3 n\u1ed3ng \u0111\u1ed9 mu\u1ed1i cao \u0111\u00f2i h\u1ecfi v\u1eadt li\u1ec7u ti\u1ebfp x\u00fac \u0111\u01b0\u1ee3c ch\u1ecdn l\u1ecdc c\u1ea9n th\u1eadn.<\/p>\n\n03<\/strong>\n\n

Bi\u1ebfn \u0111\u1ed5i \u0111\u1ecbnh d\u1ea1ng<\/h3>\n\n

T\u1eeb \u1ed1ng PCR 0,2 mL v\u00e0 chai gi\u1ecdt \u0111\u1ebfn c\u00e1c th\u00f9ng \u0111\u1ef1ng buffer 5 L, s\u1ef1 \u1ed5n \u0111\u1ecbnh l\u00e0m thay \u0111\u1ed5i m\u1ecdi th\u1ee9.<\/p>\n\n02<\/strong>\n\n

Nhi\u1ec5m ch\u00e9o<\/h3>\n\n

C\u00e1c x\u00e9t nghi\u1ec7m nh\u1ea1y cao c\u00f3 th\u1ec3 \u0111\u00f2i h\u1ecfi li\u1ec1u t\u1ed1i thi\u1ec3u \u1edf m\u1ee9c sub-microlit v\u00e0 \u0111\u1ed9 ch\u00ednh x\u00e1c \u00b10,5% ho\u1eb7c t\u1ed1t h\u01a1n.<\/p>\n\n01<\/strong>\n\n

Th\u1eed th\u00e1ch \u0111\u1ed9 ch\u00ednh x\u00e1c<\/h3>\n\n

C\u00e1c x\u00e9t nghi\u1ec7m nh\u1ea1y cao c\u00f3 th\u1ec3 \u0111\u00f2i h\u1ecfi li\u1ec1u t\u1ed1i thi\u1ec3u \u1edf m\u1ee9c sub-microlit v\u00e0 \u0111\u1ed9 ch\u00ednh x\u00e1c \u00b10,5% ho\u1eb7c t\u1ed1t h\u01a1n.<\/p>","protected":false},"excerpt":{"rendered":"

Solution Filling Solutions for the In Vitro Diagnostic Industry Addressing the stringent requirements of IVD reagents, our core filling system achieves extreme precision down to the milliliter level, effectively reducing the waste of expensive reagents and ensuring the uniformity and reliability of every sample test. Simultaneously, we employ fully enclosed filling technology and a GMP-compliant […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1438,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1665","page","type-page","status-publish","hentry"],"_hostinger_reach_plugin_has_subscription_block":false,"_hostinger_reach_plugin_is_elementor":false,"_links":{"self":[{"href":"https:\/\/gdhpmachine.com\/vi\/wp-json\/wp\/v2\/pages\/1665","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gdhpmachine.com\/vi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/gdhpmachine.com\/vi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/gdhpmachine.com\/vi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gdhpmachine.com\/vi\/wp-json\/wp\/v2\/comments?post=1665"}],"version-history":[{"count":14,"href":"https:\/\/gdhpmachine.com\/vi\/wp-json\/wp\/v2\/pages\/1665\/revisions"}],"predecessor-version":[{"id":15671,"href":"https:\/\/gdhpmachine.com\/vi\/wp-json\/wp\/v2\/pages\/1665\/revisions\/15671"}],"up":[{"embeddable":true,"href":"https:\/\/gdhpmachine.com\/vi\/wp-json\/wp\/v2\/pages\/1438"}],"wp:attachment":[{"href":"https:\/\/gdhpmachine.com\/vi\/wp-json\/wp\/v2\/media?parent=1665"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}