Fully Automatic Prefilled Syringe Filling Machine yog tsim los rau siab -tus nqi biologics, cov ntaub ntawv zoo nkauj, thiab kev kho mob. Ua raws li GMP thiab ISO 13485 cov qauv kev tswj xyuas zoo. Featuring modular design, nws txhawb nqa 0.5mL-20mL koob txhaj tshuaj (iav / COP cov ntaub ntawv) thiab ua kom muaj kev ua haujlwm siab thiab lub tshuab nqus tsev vacuum rau hyaluronic acid, tshuaj tiv thaiv, tshuaj ntsev, thiab lwm yam kev siv tsis muaj menyuam.
1. Ntau-Cov ntaub ntawv siv ntau yam & txheej txheem Engineering
Engineered rau High-Value Parenterals, Biologics & Dermal Gels
Lub ALWELL Aseptic Prefilled Syringe (PFS) Filling Tshuab yog cGMP - ua raws li kev ntim khoom tsim los rau nested RTU (Npaj-To-Siv) syringes (0.5ml txog 20ml). Ua los tswj cov dej sib txawv, lub platform teeb tsa cov kev siv tshuaj tshwj xeeb raws li koj cov tshuaj tsim tawm:
High-Viscosity Aesthetic Gels (Hyaluronic Acid / Collagen)
- Siv High-Nqus Liquid Dosing thiab Nqus Plunger Placement los tiv thaiv huab cua micro- npuas.
- Nruab nrog siab -purity Ceramic Rotary Piston Pumps thiab lub tsho cua sov hoppers kom tswj tau cov dej ntws zoo yam tsis muaj thermal degradation.
Cov tshuaj Biopharmaceuticals Sensitive & Vaccines (mAbs / mRNA / Insulin):
- Ua haujlwm Gentle Peristaltic Pumping los yog siv ib zaug xwb - siv cov kua dej los siv xoom shear force, khaws cia cov protein molecular kev ncaj ncees.
- Kev xaiv Nitrogen Purging (Pre- thiab Post-Dosing) los tiv thaiv oxygen-sensitive APIs.
Parenteral Solutions & Flush Syringes (IV Fluids / Saline / Heparin)
- Optimized rau siab -throughput, nruam volumetric dosing nrog nruam drip-dawb diving nozzles.
2. Advanced Cleanroom & Aseptic Barrier Integration
Ua raws li EU -GMP Annex 1 & US FDA cGMP Regulations
Niaj hnub nimno biopharmaceutical ntau lawm xav tau kev tswj hwm huab cua nruj thiab tsis suav nrog microbial.
- Aseptic Barrier Compatibility: Lub modular chassis nta aerodynamic, sloped 316L stainless hlau nto uas seamlessly integrates nrog Qhib RABS, Kaw RABS (cRABS), los yog VHP Aseptic Isolator Units.
- Unidirectional Laminar Airflow Alignment: Tag nrho cov tshuab tsav thiab servo motors raug kaw hauv qab lub phaj phaj kom tshem tawm cov cua turbulence thiab particle shedding nyob rau hauv chav kawm A / ISO 5 qhov chaw tseem ceeb.
- CIP/SIP Muaj Peev Xwm: Cov kua dej sib txuas txhawb nqa automated Clean-hauv-Place (CIP) thiab Sterilize-hauv-Place (SIP) niaj hnub, lossis tag nrho kev sib raug zoo nrog gamma-sterilized single- siv tubing manifold.
- 100% IPC Dynamic Checkweighing: Optional tare-thiab-tag nrho cov hluav taws xob ntsuas hluav taws xob txheeb xyuas qhov tseeb ntawm lub sijhawm, tuaj yeem kho lub twj tso kua mis stroke ntim ntawm cov lus tawm tswv yim tsis txwv kev tsim khoom.
Technical Specifications
Ua ntej -Syringe Filling Tshuab
| Parameter | Paub meej |
|---|---|
| Daim ntawv thov | Hyaluronic acid, monoclonal antibodies / tshuaj tiv thaiv, IV kev daws teeb meem (xws li, saline), collagen (siab / qisviscosity kua) |
| Ntim ntim | 0.1mL-30mL (kho tau) |
| Qhov tseeb | Tsawg dua lossis sib npaug rau ± 1% (kho raws li viscosity) |
| Ntau lawm ceev | 2,000-6,000 syringes/teev (ntau-channel parallel ua haujlwm) |
| Txoj Kev Sealing | Nqus nres + capping (tiv thaiv -oxidation) |
| Tswj System | Siemens PLC + 10" creen (ntau- txhawb nqa lus) |
| Khoom siv | 316L stainless hlau qhov chaw tiv tauj, cov twj tso kua mis ceramic (corrosion{1}}resistant) |
| Cov ntawv pov thawj | CE, TÜV, ISO 9001, GMP (nrog rau thib peb-cov ntaub ntawv pov thawj lees paub) |
Ntsiab nta
Prefilled Syringe Filling Tshuab
1. Precision filling tshuab
Servo-tsav ceramic twj tso kua mis: Txhawb nqa 0.1mL micro- koob tshuaj (piv txwv li, tshuaj tiv thaiv) mus rau 30mL loj- cov kua ntim (piv txwv li, IV cov tshuaj), viscosity ntau 0.5-50,000cP
Vacuum anti-drip system: Dual sealing rau koob qhia kom tiv thaiv oxidation thiab hla - paug
2. Tag nrho - txheej txheem Aseptic Control
C-RABS isolation system(optional): ISO Class 5 cleanroom integration, particle count<=3,520/m³.
3. Smart Production Management
Cov ntaub ntawv traceability: Tiag -lub sij hawm sau cov ntim ntim, batch tooj, thiab cov khoom siv raws li txoj cai (FDA 21 CFR Part 11 ua raws).
Tus kheej- kuaj mob: 32 cov txheej txheem kev nyab xeeb suav nrog tsis muaj - lub thawv nres thiab cov lus ceeb toom thaiv
Daim ntawv thov
Ua ntej -Syringe Filling TshuabDaim ntawv thov
① Aesthetic Medicine Industry
Hyaluronic Acid / Dermal Fillers: Tau tshaj tus ntoo khaub lig-txuas siab- cov qauv viscosity (piv txwv li, microsphere-raws li muab tub lim), raug ± 0.5mL
Collagen: Bubble- pub dawb puv hom rau tsis yog -Newtonian kua.
② Biopharmaceuticals
Cov tshuaj tiv thaiv mRNA: Tsawg- qhov kub thiab txias filling module (-20℃txog 5 degree) los khaws cov tshuaj ua haujlwm.
Monoclonal Antibodies/Cell Therapies: Nitrogen{0}}purged ib puag ncig (O₂<0.1%).
③ Cov cuab yeej kho mob
Prefilled Catheter Flushers: Siab - ceev saline / heparin filling (4,000 syringes / teev)
Ntawv pov thawj & Warranty
Ntiaj teb no ua raws: EU CE-MDD, FDA cGMP kev tshuaj xyuas (EDMF cov ntaub ntawv muaj).
Warranty: 1-xyoo puv tshuab kev pab them nqi, 3-xyoo txuas ntxiv warranty rau cov khoom tseem ceeb (servo motors, PLC), 48-teev thoob ntiaj teb kev txhawb nqa.
FAQ
Cov Lus Nug Nquag (FAQ) rau cGMP PFS Line Procurement
Q1: Lub tshuab no ua li cas ua npuas - pub dawb rau siab - viscosity Hyaluronic Acid (HA) gels?
A:Kev tshem tawm npuas yog ua tiav los ntawm ob lub- txheej txheem nqus tsev. Lub syringe chim tau raug tshem tawm ntawm lub tshuab nqus tsev ua ntej txhaj tshuaj kom tshem tawm micro-pockets ntawm huab cua. Tom qab ntawd, cov roj hmab plunger tau muab tso rau hauv lub kaw tsis zoo - lub siab chamber (-0.098 MPa). Qhov no yuam lub stopper ncaj qha mus rau cov kua nto nrog xoom trapped cua headspace.
Q2: Cov kab puas tuaj yeem muaj kev nyab xeeb ua cov tshuaj tiv thaiv kab mob los yog cov protein uas nkag siab rau lub zog shear thiab hlau ion leaching?
A:Yog lawm. Rau bio-sensitive formulations, peb teeb tsa lub tshuab nrog qis-shear peristaltic twj system ua ke nrog ua ntej-sterilized, ib zaug- siv silicone lossis C-Flex tubing manifolds. Qhov no tshem tawm kev sib cuag hlau, tiv thaiv kev sib kis -, thiab ua kom tsis muaj protein ntau.
Q3: Puas yog lub tshuab ua raws li Revised EU-GMP Annex 1 cov cai rau kev ua aseptic?
A:Ua raws nraim. Lub tshuab tsim ua raws li Annex 1 Quality Risk Management (QRM) cov qauv. Nws nta qhov chaw huv si, unidirectional laminar airflow optimization, hnab looj tes-chaw nres nkoj kev koom ua ke rau cRABS / Isolators, thiab automated particle / siv tau ib puag ncig saib xyuas chaw nres nkoj interfaces.
Q4: Yuav ua li cas 100% Hauv -Kev Tswj Xyuas Txheej Txheem (IPC) ua haujlwm yam tsis txo cov kab nrawm?
A:Cov kab sib koom ua ke siab -ceev tare- thiab -tag nrho cov hluav taws xob hluav taws xob sib npaug (EMFR) hnyav cov hlwb raws lub hnub qub thauj. Cov koob txhaj tshuaj khoob raug ntsuas ua ntej sau thiab rov- hnyav tam sim tom qab noj. Yog tias qhov kev sib txawv ntau dhau qhov kev ua siab ntev, lub kaw lus cia li ua rau lub tswv yim tawm tswv yim los kho lub servo lub twj tso kua mis stroke thaum ejecting qhov tsis yog - raws li syringe down the auto-rejection chute.
Q5: Yuav ua li cas nyuaj rau kev hloov pauv ntawm qhov sib txawv prefilled syringe ntau thiab tsawg (piv txwv li, 1ml ntev txog 5ml)?
A:Lub tshuab siv cov cuab yeej- tsawg dua, nrawm- xauv hom hloov pauv cov khoom (cov neeg nqa zes, lub hnub qub, thiab cov nres). Daim ntawv qhia tsis ua kom nrawm nrawm, twj tso kua mis stroke, dhia qhov siab, thiab lub tshuab nqus tsev tau txais kev cawmdim hauv Siemens HMI kov npo. Kev hloov pauv tiav yuav siv sijhawm li 30 feeb rau cov neeg ua haujlwm tau txais kev cob qhia.
Q6: Cov pob ntawv txhawb nqa kev lees paub dab tsi koj muab rau kev xa tawm thoob ntiaj teb kev tswj hwm (FDA / EMA)?
A:Peb muab tag nrho cGMP Validation Package, suav nrog Kev Ntsuam Xyuas Risk (RA), Tsim Tsim Nyog (DQ), Kev Tsim Nyog Tsim Nyog (IQ), Kev Tsim Nyog Ua Haujlwm (OQ), thiab Kev Ua Haujlwm Tsim Nyog (PQ) raws tu qauv. Tag nrho cov software suav nrog 21 CFR Part 11 kev tshuaj xyuas txoj hauv kev, kos npe hluav taws xob, thiab kev tswj hwm tus password.
Cim npe nrov: cGMP Aseptic Prefilled Syringe (PFS) Filling & Stoppering Kab|ALWELL, Tuam Tshoj cGMP Aseptic Prefilled Syringe (PFS) Filling & Stoppering Kab|ALWELL manufacturers, lwm tus neeg, Hoobkas
