Dab tsi yog Sterile Syringe Filling Machine?
Lub Tshuab Sterile Syringe Filling Tshuab yog cov cuab yeej siv tshuaj tshwj xeeb uas tsim los kom ua tiav cov tshuaj ua kua rau hauv cov koob txhaj tshuaj hauv qhov chaw tswj hwm nruj, aseptic ib puag ncig. Siv cov tshuab thev naus laus zis thev naus laus zis, cov cuab yeej no ua kom tag nrho cov txheej txheem sau ua tiav raws li GMP (Good Manufacturing Practice) cov qauv, tiv thaiv cov kab mob microbial, cov kab mob sib kis, thiab hla - paug kom lav cov khoom kawg kev nyab xeeb thiab kev ua tau zoo.
Peb tsis muaj menyuamsyringe filling tshuabntiav cov thev naus laus zis cais lossis Cov Txheej Txheem Txwv Kev Nkag Mus Nkag (RABS) thiab tau nruab nrog HEPA pom cov tshuab kom ua tiav thiab tswj hwm ISO Class 5 (Qib A) chav huv huv hauv thaj chaw tseem ceeb. Cov tshuab muaj peev xwm tuav tau ntau qhov ntau thiab tsawg ntawm pre{2}} cov koob txhaj tshuaj, xws li 0.5mL txog 50mL, ua tau raws li kev ntim tshuaj sib txawv.
Daim ntawv thov teb ntawm Sterile Syringe Filling Machine
1.Kev lag luam Biopharmaceutical
Kev tsim tshuaj tiv thaiv (nrog rau cov tshuaj tiv thaiv COVID-19, thiab lwm yam)
Monoclonal antibody tshuaj
Gene therapy khoom
Kev npaj kho mob ntawm tes
2. Kev lag luam tshuaj niaj hnub
Me me molecule txhaj tshuaj
Tshuaj tua kab mob
Tshuaj loog
Cov tshuaj thaum muaj xwm ceev
3. Cov khoom siv kho mob tshwj xeeb
Contrast agents
Kev txhaj tshuaj noj zaub mov
Cov khoom siv kho mob zoo nkauj (xws li, hyaluronic acid injectables)
Reagents rau cov khoom siv kho mob
4. R&D thiab kev cog lus tsim khoom
CMO/CDMO Enterprises
Pilot- teev ntau lawm hauv cov tsev tshawb fawb
Clinical trial drug manufacturing
Cov Cheebtsam tseem ceeb ntawm Sterile Syringe Filling Machine
1. Aseptic Barrier System
Isolator lossis RABS system
HEPA filtration unit
Aseptic hloov pauv interfaces
Hnab looj tes ports rau kev ua haujlwm
2. Filling thiab Weighing System
High -precision peristaltic twj tso kua mis los yog piston twj tso kua mis filling units
Hauv - kab checkweighing system
Tsis muaj syringe detection system
Kev kuaj pom qhov system rau qib kua
3. Syringe Handling System
Syringe unwrapping thiab conveying module
Alignment thiab positioning ntaus ntawv
Siliconization unit (yog tias xav tau)
Stopper placement thiab insertion system
4. Txheej txheem tswj thiab saib xyuas qhov system
PLC{0}}raws li kev tswj tsis siv neeg
Tib neeg -Machine Interface (HMI) ua haujlwm vaj huam sib luag
Kev saib xyuas ib puag ncig (kub, av noo, siab sib txawv, particle suav)
Cov ntaub ntawv kaw thiab traceability system
5. Cov Txheej Txheem Pabcuam
Txheej txheem cua npaj system
CIP/SIP (Tshuaj-hauv-Qhov Chaw / Sterilize-hauv-Qhov Chaw)
Kev tuav pov tseg
Kev ruaj ntseg interlock devices
Cov ntsiab lus tseem ceeb cuam tshuam tus nqi ntawm Sterile Syringe Filling Machine
1. Cov Khoom Siv Teeb Meem & Cov Txheej Txheem
Hom aseptic barrier: Isolators feem ntau kim dua RABS.
Degree ntawm automation: Tag nrho cov tshuab automation hais kom tus nqi siab dua semi-automated ones.
Filling raug: Cov txheej txheem nrog cov precision nce nqi.
Cov zis ceev: siab- qauv ceev (piv txwv li, 6000+ units / teev) yog kim dua.
2. Kev ua raws cai & ntawv pov thawj yuav tsum tau
Ua raws li ntau yam kev cai hauv cheeb tsam (FDA, EMA, NMPA, thiab lwm yam)
Ua tiav ntawm cov ntaub ntawv pov thawj (IQ / OQ / PQ)
Cov ntaub ntawv kev ncaj ncees (21 CFR Part 11 ua raws)
3. Khoom siv & Kev tsim khoom zoo
Qib ntawm cov khoom sib cuag (316L stainless hlau vs . 304 stainless hlau)
Nto tiav txheej txheem (electropolishing, passivation)
Kev siv cov khoom muaj npe (xws li Siemens, Schneider)
4. Customization Requirements
Adaptations rau tshwj xeeb syringe specifications
Kev koom ua ke ntawm cov txheej txheem tshwj xeeb (piv txwv li, lyo-syringe filling)
Cov kev xav tau rau kev koom ua ke nrog cov kab ntau lawm
5. Tom qab-Kev Pabcuam Muag & Kev Pabcuam
Scope thiab qhov tob ntawm kev cob qhia tau muab
Warranty lub sij hawm thiab cov nqe lus
Muaj kev txhawb nqa hauv zos
Spare xeem muab guarantee
Vim Li Cas Xaiv PebSterile Syringe Filling Tshuab?
Peb muab ntau yam kev daws teeb meem aseptic, sib txuas nrog ntau tshaj 20 xyoo kev lag luam los muab peb cov neeg siv khoom nrog:
Modular tsim rau kev nthuav dav yooj yim raws li kev xav tau
Kev tsim cov txheej txheem ua raws li cov qauv zoo tshaj plaws thoob ntiaj teb
Cov kev pabcuam kev lees paub zoo
Localized technical service teams
Cov nqi sib tw thiab tus nqi tshwj xeeb rau cov nyiaj
Tiv tauj pebrau Personalized Quotation & Solution
Peb pawg kws tshaj lij yuav muab cov lus pom zoo tshaj plaws rau kev teeb tsa cov cuab yeej thiab cov ncauj lus kom ntxaws raws li koj cov kev xav tau tshwj xeeb (muaj peev xwm, hom khoom, peev nyiaj, thiab kev xav tau ua raws). Txawm hais tias koj yog tus pib- nce lossis lub tuam txhab tshuaj loj, peb tuaj yeem muab cov kev daws teeb meem sib tw.
Cim npe nrov: sterile syringe filling tshuab, Tuam Tshoj sterile syringe filling tshuab manufacturers, lwm tus neeg, Hoobkas
