RTU cov koob txhaj tshuaj ntxiv puv tshuab
Cov kev daws teeb meem rau kev txuag, tshuaj aseptic tshuaj
Prefilled Doaving TshuabNrog kev loj hlob sai ntawm biopharmaceutical, tshuaj tiv thaiv, thiab high-igh-aws injababab custome,RTU (Npaj-rau-Siv) Cov koob txhaj tshuajtau dhau los ua kev lag luam thoob ntiaj teb nyiam kev xaiv vim lawv txoj kev yooj yim, thiab txo cov kev pheej hmoo. Ntawm lub plawv ntawm cov khoom siv no saw dag cov lus dagRTU cov koob txhaj tshuaj-a Cov ntsiab lus tseem ceeb ntawm kev ua haujlwm siab, ua raws li kev siv tshuaj tiv thaiv.
Cov ntawv no tshawb nrhiav cov txuj ci tseem ceeb, cov ntawv thov kev lag luam, thiab yav tom ntej cov qauv ntawm RTU cov koob txhaj tshuaj nrog kev txiav txim siab rau cov chaw txiav txim.
1. Kev ua lag luam tsav tsheb rau RTU cov koob txhaj tshuaj
Biopharmaceutical innovation
Cov tshuaj tua tsiaj siab xws li monoclonal antibodies thiab cov gene kws kho mob thov ntim ntim tsis huv. RTU cov koob txhaj tshuaj ntxiv, uas tshem tawm cov kev ua haujlwm theem siab, yog qhov zoo rau kev sib cuag tshuaj ncaj.
Post-Pandemic Cov Tshuaj Tiv Thaiv Ntau Lawm
Cov tshuaj tiv thaiv thoob ntiaj teb, tsav los ntawm MRNA-based Covid {{}}}} acceler acceler acceler adop aws. Cov koob txhaj tshuaj uas ua kom tau los ntawm kev npaj lub sijhawm thiab txhim kho kev ua kom raug.
Tus neeg mob-centric kev xa tshuaj
Kev tswj hwm tus kheej (piv txwv li, insulin, anticocuulants) yuav tsum siv cov neeg siv cov qauv zoo uas txo qis kev siv phom sij.
2. Core Technical nta ntawm RTU cov khoom siv ua kom tiav cov tshuab
1. Aseptic Filling Technology
Rho tawm lossis txwv txoj kev nkag mus rau cov tshuab hluav taws xob (Rabs) tswj hwm ISO chav kawm 5 (qib A) ib puag ncig.
Compatibility nrog hydrogen peroxide (h₂o₂) vapor lossis e-nqaj kom tsis muaj ncua rau kev rhiab photical.
2. Precision Filling Tswj
Servo motor-driven pumps with mass flow meters achieve ±1% accuracy across 0.1mL–5mL volumes.
Anti-nqus tsim cov qauv luam tawm tsawg heev siv cov tshuaj poob.
3. Yooj Yim & Kev Lag Luam 4. 0}}} sib xyaw
Modular configations Pab tau ceev kev hloov pauv ntawm iav (piv txwv li hom i) thiab polymer (cop / coc) koob txhaj tshuaj.
Scada cov khoom siv tiag tiag tiag tiag tiag (tag nrho cov cuab yeej ua tau zoo) thiab ua raws li FDA 21 CFR Ntu 11 Cov ntaub ntawv kev cai lij choj 11.
4. Kev Tswj Fwm
Raws li CGMP, EU GMP Annex 1, thiab USP<797>yuav tsum tau.
Kev them nyiaj yug tag nrho (IQ / OQ / PQ / PQ) nrog kev txheeb xyuas txoj kev thiab lub peev xwm hluav taws xob.
3. Cov ntawv thov kev lag luam tseem ceeb
Biopharraceuticals: Monoclonal Antibodies, kho mob ntawm tes, recombott cov proteins.
Cov tshuaj tiv thaiv kab mob: MRA platforms, tus mob khaub thuas, Zoster.
Ntev thiab kev saib xyuas kev zoo nkauj: Insulin, enoxaparin, hyaluronic acid, botulinum toxin.
4. Kev xaiv tseem ceeb rau RTU FILLING MACHINE
Lub peev xwm dlej: Xaiv cov qes qis (tsawg dua los yog sib npaug rau 5, {2}} units / hr) lossis siab dua los yog sib npaug / hr) qauv.
Cov khoom siv tau sib xws: Siv tau nrog iav, siliconized / tsis-siliconized cop koob txhaj tshuaj.
Neeg Muag Khoom Tshaj Tawm: Ua ntej muab cov neeg muab khoom nrog cov pov thawj biologics puv.
Kev them nyiaj thoob ntiaj teb: Ua kom ntseeg tau tias muaj cov khoom lag luam muaj thiab kev teb sai sai.
5. Yav Tom Ntej Tiam: Ntse & Kev Tsim Khoom Siv
Ai-powered twv ua ntej txij nkawm: Siv lub tshuab kev kawm tshuaj xyuas cov khoom siv rau cov khoom tsis txaus.
Eco-tus phooj ywg daws teeb meem: Lub zog-ua tau zoo thiab siv cov koob txhaj tshuaj polymer.
Me-batch yooj yim: Agile ntau lawm rau kev kuaj mob sim thiab tshuaj kho tus kheej.
RtuPrefilled DoTagre Puv MachineTsis yog cov kauj ruam "kawg nkaus" hauv cov tshuaj tsim khoom - lawv yog cov cuab yeej siv tswv yim kom muaj kev nyab xeeb khoom thiab kev sib tw kev sib tw. Raws li cov kev kho tshiab tawm txawv thiab thoob ntiaj teb kev tswj hwm ua kom ruaj khov, kev nqis peev hauv cov khoom siv tau zoo, txhim khu kev qha
Tus neeg yus paubPeb cov kws tshaj lij hnub no rau kev hloov pauv RTU sau ua cov qauv siv lossis lub tshuab ua kom zoo nkauj!