Dab tsi yog cov khoom ntawm peb cov syringe filling khoom
1. Cov khoom siv sib xyaw
Filling System: Cov khoom tseem ceeb, suav nrog siab - cov twj tso kua mis muaj tseeb (xws li peristaltic lossis piston twj), nozzles, lossis rab koob kom paub meej tias muaj kua ntau npaum li cas.
Conveyance System: Thauj cov koob txhaj tshuaj, feem ntau yog nruab nrog cov cuab yeej tso tawm kom paub meej qhov chaw sau.
Tswj System: PLC lossis lub khoos phis tawj muaj rau kev teeb tsa tsis tau (sau ntim, ceev) thiab saib xyuas cov txheej txheem. Qee lub tshuab txhawb nqa cov ntaub ntawv nkag (ua raws li GMP cov cai).
Kev soj ntsuam System: Kev txheeb xyuas qhov hnyav lossis cov khoom siv hluav taws xob kom ntseeg tau tias tsis muaj cov koob txhaj tshuaj khoob, tsis tuaj yeem sau, lossis tsis muaj paug.
Aseptic Barrier: Laminar flow hood (ISO Class 5 cleanliness) rau kev tswj hwm qhov chaw tsim khoom aseptic.
Cov khoom siv ntxiv: Kev xaiv cov khoom siv rau kev tso tseg / koob txhaj tshuaj, daim ntawv lo, ntim, thiab lwm yam.
2. Kev ua haujlwm
Chaw thau khoom: Cov koob txhaj tshuaj tau teem rau ntawm txoj siv conveyor ntawm lub tais vibratory lossis centrifugal feeder.
Qhov chaw: Sensors paub meej tias qhov chaw txhaj tshuaj thiab ruaj ntseg ntawm qhov chaw ntim khoom.
Sau: Lub twj tso kua mis txhaj cov kua raws li qhov ntim preset, feem ntau nrog cov yam ntxwv tiv thaiv -drip.
Kev tshuaj xyuas: Tiag -lub sij hawm kuaj xyuas cov ntim ntim nrog kev tsis lees paub ntawm cov tsis yog-cov chav nyob.
Post{0}}Kev ua haujlwm: Stoppering, capping, sterilization (yog tias xav tau), thiab ntim.
3. Cov ntsiab lus tseem ceeb
Sau Volume Range: 0.1 mL txog 50 mL (cov qauv sib txawv haum rau ntau qhov ntau thiab tsawg).
Ceev: 700 mus rau 11,000 units ib feeb (nyob ntawm seb lub koob txhaj tshuaj loj thiab qib automation).
Qhov tseeb± 1% los yog zoo dua.
Siv tau koob txhaj tshuaj: iav / yas, txheem qhov ntau thiab tsawg xws li 1 mL, 3 mL, 5 mL, thiab lwm yam.
4. Cov cheeb tsam thov
Pharmaceuticals: Tshuaj tiv thaiv, insulin, biologics.
Cov cuab yeej kho mob: Ua ntej- cov koob txhaj tshuaj, tshuaj pleev xim rau.
Laboratories: Me me -batch reagent filling.
5. Kev xaiv xaiv
Aseptic Requirements: Xaiv cov khoom siv nrog cov khoom sib cais lossis muaj peev xwm ua haujlwm hauv Qib C lossis siab dua chav huv.
Yooj yim: Kev hloov pauv sai ntawm cov pwm kom hloov mus rau qhov sib txawv syringe specifications.
6. Kev tu thiab siv tau
Kev tu txhua hnub: Ntxuav twj tso kua mis sib dhos, hloov cov ntsaws ruaj ruaj, calibrating sensors.
Periodic Validation: Sau cov kev xeem raug, kev soj ntsuam ib puag ncig aseptic (piv txwv li, kho cov phaj).
Kev daws teeb meem: Cov teeb meem tshwm sim muaj xws li sau ntim sib txawv (kho cov twj tso kua mis) lossis cov khoom siv sib xyaw ua ke (xyuas phau ntawv qhia kev sib txawv).
7. Kev nyab xeeb & kev ua haujlwm
Kev nyab xeeb nta: Cov nyees khawm nres thaum muaj xwm ceev, tiv thaiv npog, kev ruaj ntseg interlocks.
Kev cob qhia neeg ua haujlwm: Cov neeg ua haujlwm yuav tsum raug cob qhia ntawm HMI interface, hloov cov khoom siv, thiab cov txheej txheem xwm txheej ceev.
Peb lub tuam txhab tau sib sau ua ke ib pab neeg ntawm cov kws tshaj lij thiab cov neeg ua haujlwm tsim nyog, tsom mus rau kev tshawb fawb thiab kev tsim kho tshiab ntawm cov khoom ua ntej -cov syringe filling kab ntau lawm. Ua raws li "tus neeg siv khoom ua ntej" lub tswv yim, peb tsis tu ncua pib los ntawm cov neeg siv khoom xav tau, tsis tu ncua los ntawm kev tsis sib haum xeeb. Ntau ntawm peb cov kev ua tau zoo R & D tau txais daim ntawv pov thawj patent hauv lub tebchaws thiab muaj qhov sib txawv ntawm kev lag luam. Peb lub tuam txhab kuj tau dhau ISO9001 kev tswj hwm qhov system ntawv pov thawj, tsis tu ncua kev txhim kho peb txoj haujlwm thiab kev tswj hwm qib.
Tam sim no, peb cov khoom tseem ceeb muaj xws li: tag nrho tsis siv neegsyringe filling khoom, ua ntej- puv koob tubing flushing ntaus ntawv sau cov kab ntau lawm, aseptic tshuajvial filling ntau lawm kab, zoo lisyringe pas nrig labeling tshuab, lub teeb tshuaj xyuas tshuab, loaders, thiab lub tshuab nqus tsev sib xyaw homogenizers, thiab lwm yam. Tag nrho cov khoom ua tau raws li GMP cov cai thiab tau dhau EU CE daim ntawv pov thawj kev nyab xeeb, ua kom muaj kev nyab xeeb, txhim khu kev qha, thiab ua raws li cov khoom siv syringe filling rau peb cov neeg siv khoom.
Nrog kev ua tau zoo ntawm cov khoom lag luam thiab kev pabcuam dav dav,ALWELL covCov khoom lag luam tsis tsuas yog muag zoo thoob plaws hauv Suav teb tab sis kuj tseem xa tawm mus rau ntau lub tebchaws thiab cheeb tsam hauv Tebchaws Europe, Amelikas, Middle East, thiab Southeast Asia, tau txais txiaj ntsig zoo thiab qhuas los ntawm cov neeg siv khoom hauv tebchaws thiab thoob ntiaj teb.
Saib tom ntej, Shanghai ALWELL yuav ruaj khov ua tiav nws lub hom phiaj ntawm "ua cov chaw tsim khoom ntse dua thiab ua haujlwm zoo dua," txuas ntxiv cog cov khoom lag luam biopharmaceutical, thiab muab cov neeg siv tshuaj thoob ntiaj teb nrog cov khoom sib tw, nyab xeeb, thiab txhim khu kev qha, kev daws teeb meem, thiab cov kev pabcuam dav dav.