Automated Cartridge Filling thiab Stoppering Tshuab rau Biopharmaceuticals
Khoom Description
ALWELL Automated Cartridge Filling thiab Stoppering Tshuab yog ib qho kev ua haujlwm siab, siab -kev daws teeb meem uas tau tsim tshwj xeeb rau biopharmaceutical thiab life sciences industries. Tsim los ntawm kev ua raws li FDA, EU GMP, thiab cGMP cov qauv, lub tshuab ua haujlwm siab no yog qhov zoo tagnrho rau kev ua haujlwm siab -tus nqi biologics, insulin, kev loj hlob hormones, monoclonal antibodies (mAbs), thiab kho hniav tshuaj loog.Equipped nrog saj zawg zog dosing technologies -premiums thiab ceramics -5} thiab ntau yam qis-shear peristaltic twj tso kua mis- lub tshuab lav qhov tshwj xeeb sau qhov tseeb ntawm Tsawg dua lossis sib npaug li ± 1%, tiv thaiv shear- cov qauv tsim muaj protein ntau los ntawm kev degradation. Nws lub xeev- ntawm-- lub tshuab nqus tsev nqus- pab nres lub kaw lus tshem tawm cov huab cua seem ua ntej tso tawm, xa 100% npuas- pub dawb sealing kom ntev{17}}lub sij hawm tshuaj stability.Featuring a sleek {1}2, {0} hneev taw, chav tsev seamlessly integrates nrog LAF, oRABS, thiab Aseptic Isolator barrier systems kom tswj tau Class A (ISO 5) ib puag ncig kev ncaj ncees. Nrog cov cuab yeej- tsawg dua, hloov pauv hloov pauv sai rau ntau qhov ntau thiab tsawg (1.5ml, 3ml, thiab qhov ntau thiab tsawg) thiab xaiv tau 100% IPC checkweighing, ALWELL xa qhov kawg- rau- kawg, ultra- huv, thiab txhim khu kev qha turnkey tov rau niaj hnub sterile ntim kab.
Ntsiab nta
Precision & Qhov tseeb
Kev siv siab -kawg servo- tswj cov tshuab kom paub meej qhov ua tiav ntawm ± 1%, txo qis cov khoom pov tseg ntawm siab -tus nqi biologics thiab GLP-1 tshuaj.
Lub tshuab nqus tsev nres tshuab
Tshwj xeeb tsim los rau siab -viscosity gels (zoo li Hyaluronic Acid), peb lub tshuab nqus tsev vacuum ua kom muajnpuas -dawbfilling txheej txheem thiab zoo meej stopper tso.
RTU Flexibility
Siab tshaj nrogNpaj-rau-Siv (RTU)cov thawv zes, tso cai rau kev hloov pauv ntawm cov cartridges, koob txhaj tshuaj, thiab vials ntawm ib kab.
Tus neeg siv -PLC tswj tus phooj ywg
Teem thiab saib xyuas tag nrho cov kev txwv tsis pub dhau - ntim ntim, ceev, thiab qhov kub thiab txias- nrog yooj yim ntawm lub vijtsam xim. Lub intuitive interface ua kom yooj yim rau kev khiav lag luam thiab txo lub sijhawm kawm.
Robust & Compliant Construction
Ua los ntawm cov khoom siv ruaj khov, corrosion-tiv taus stainless hlau hauv txhua yam khoom-cov chaw sib cuag, lub tshuab ua tau raws li cov qauv cGMP. Nws cov qauv tsim kom huv si ua kom yooj yim tu thiab tu.
Modular & Adaptable Tsim
Tus naj npawb ntawm lub taub hau filling tuaj yeem kho kom haum rau koj lub peev xwm ntau lawm. Lub kaw lus txhawb ntau hom filling (xws li, piston, peristaltic) kom haum rau koj cov khoom tshwj xeeb.
Technical Specifications
| Parameter | Paub meej |
|---|---|
| Qauv | YS-PFS Series / Automated Cartridge filling tshuab |
| Filling Volume Range | 1.5ml, 1.8ml, 3ml, 5ml Cartridges (iav) / Custom Size |
| Filling Qhov tseeb | ±1% |
| Muaj Peev Xwm Ntau Lawm | 1, 000 - 6,000 pcs / teev (kev cai) |
| Fais fab mov | 380V 50Hz |
| Kev siv fais fab | 2 KW - 3KW |
| Qib Automation | Tsis siv neeg puv |
| Tswj System | PLC nrog HMI Touchscreen |
| Cov ntsiab lus tseem ceeb | Servo Tsav, Precision Twj, PLC Tswjhwm |
| Txoj kev nres | Advanced Nqus Tsev- pab nres (100% npuas-dawb) |
| Tshwj xeeb nta | Adjustable Filling Ceev |
Kev Lag Luam Ua Haujlwm
hom ntawmCartridge Filling Tshuab
Qhov no ntau yam filling tshuab yog zoo tagnrho rau ntau yam kev siv:
Peb cov tshuab tsis siv neeg lub tshuab ua kua filling tshuab xa ultra- maj mam, siab- kev ua tiav rau ob qho RTU (Npaj-rau-Siv) zes hom thiab cov cartridges loj, haum rau qhov ntau thiab tsawg ntawm 1.5ml txog 3ml (nrog rau qhov ntau thiab tsawg txog 10ml muaj).
Biopharmaceuticals
Aseptic Filling rau Biologics, GLP-1, Insulin, Hormones, thiab Tshuaj Tiv Thaiv.
Kev kho mob zoo nkauj
Hyaluronic Acid (HA), Collagen, thiab Skin Boosters.
Kev lag luam tshuaj
Reliably sau cov nplaum, sealants, thiab lwm yam khoom siv tshuaj viscous.
Cov cuab yeej kho mob
Kev Kho Hniav, Saline Flush, thiab Cartridge- raws li kev xa khoom.
Flexible Combo Options: Tool-tso tawm hom hloov pauv tsim uas tso cai rau ntau- lub hom phiaj ua hla Cartridges, Pre-Syringes, thiab Vials ntawm ib kab.
Aseptic Isolation & Regulatory Ua raws
cGMP Compliant & Aseptic Barrier Npaj
Tsim los ntawm hauv av kom ua tau raws li nruj cGMP, FDA, thiab EU-GMP Annex 1 cov qauv kev tswj hwm, ua kom muaj kev tiv thaiv cov khoom pov thawj thaum lub sij hawm aseptic kua filling:
- Cleanroom Integration: Streamlined, aerodynamic 316L stainless hlau contours optimized rau Class A / ISO 5 laminar airflow.
- Barrier Systems Compatibility: Seamlessly integrates nyob rau hauv cRABS (Closed Restricted Access Barrier Systems), los yog tag nrho kaw Aseptic Isolators.
Kev khiav hauj lwm txheej txheem & Automation
1.Automatic Tub Denesting: Robotic grippers maj mam tshem cov nested cartridges yam tsis muaj kev sib cuag los yog iav khawb.
2.Pre-Filling Nitrogen Flushing: Tshem tawm cov pa oxygen los ntawm cov cartridges khoob los tiv thaiv oxidation- cov tshuaj rhiab heev.
3.Servo Ceramic Dosing: Hauv qab - nce dynamic kua filling minimizes foaming thiab nto nro teeb meem.
4.Vacuum Plunger Insertion: Mechanical vacuum module seats rubber stoppers at precise, pre-set depths.
Quality Assurance & Support
Peb muab kev qhia dav1-xyoo warrantytxhawb nqa los ntawm teb video technical support.
Cov khoom tseem ceeb raug kuaj nruj, thiab peb tuaj yeem muab cov yeeb yaj kiab lees paub hauv lub Hoobkas ua ntej xa khoom xa tuaj.
Peb mob siab rau tom qab- pab pawg muag khoom tau cog lus tias yuav xa cov kev pabcuam raws sijhawm thiab kws tshaj lij kom koj cov haujlwm ua haujlwm tau zoo.
Ua kom koj qhov kev ua haujlwm puv puv
Tsis txhob cia cov khoom siv niaj hnub txwv koj cov khoom tsim tau. Peb cov kws tshaj lij filling yuav muab kev daws teeb meem rau koj raws li koj xav tau thiab ntim.
Mus cuag tau tam sim nolos tham txog koj cov kev xav tau thiab saib seb peb tuaj yeem pab tau li cas.
fAQ
Q1: Lub tshuab puas tuaj yeem ua haujlwm siab -viscosity gels yam tsis muaj npuas?
A1: Yog lawm, peb lub tshuab nqus tsev filling thiab stoppering tshuab tshwj xeeb yog tsim los rau siab -cov ntaub ntawv viscosity xws li Hyaluronic Acid, ua kom muaj npuas - pub dawb.
Q2: Puas yog ALWELL muab cov ntaub ntawv pov thawj rau kev tshuaj xyuas tshuaj?
A2:kiag li. Peb muab tag nrho DQ / IQ / OQ / PQ cov ntaub ntawv los pab koj qhov chaw hla GMP thiab FDA kev tshuaj xyuas zoo.
Q3: Lub tshuab ua haujlwm li cas shear-sensitive proteins thiab ilv biologics thaum sau?
A3: Peb muab cov kev cai qis -shear peristaltic twj tso kua mis nrog ib zaug - siv kev kho mob- qib silicone tubing. Txoj kev ua kua dej tsis muaj cov khoom siv kho tshuab lossis cov ntsaws ruaj ruaj, tiv thaiv kom tsis txhob muaj zog shear degradation thiab hla - paug.
Q4: Dab tsi mechanism ua kom 100% npuas -dawb sealing thaum lub sij hawm cartridge nres?
A4: Lub kaw lus siv lub tshuab nqus tsev- pab nres tshuab. Ua ntej tso cov roj hmab plunger, lub chamber evacuates cua los ntawm lub caj dab cartridge. Lub tshuab nqus tsev rub lub plunger mus rau hauv qhov chaw thaum rub tawm cov cua hauv nruab nrog, ua kom nruj, huab cua - npuas -dawb foob los tiv thaiv cov tshuaj los ntawm oxidation.
Q5: Kev hloov pauv sai npaum li cas tuaj yeem ua tiav ntawm qhov sib txawv ntawm qhov ntau thiab tsawg (piv txwv li, 1.5ml txog 3ml)?
A5: Ua tsaug rau peb cov cuab yeej- nrawm dua-clamp tsim thiab ua ntej- khaws cia HMI daim ntawv qhia tsis, kev hloov pauv tag nrho (xws li zes, twj, thiab cov cuab yeej nres) tuaj yeem ua tau los ntawm ib tus neeg teb xov tooj hauv qis dua 30 feeb.
Q6: Kev txhawb nqa thiab cov ntaub ntawv pov thawj dab tsi (IQ / OQ / PQ) koj muab rau cGMP ua raws?
Q7: Peb muab tag nrho, tshawb xyuas-cov ntaub ntawv pov thawj npaj tau raws li GAMP 5 thiab FDA 21 CFR Tshooj 11 tus qauv. Qhov no suav nrog FAT/SAT raws tu qauv, IQ (Installation Qualification), OQ (Operational Qualification), 316L cov ntaub ntawv pov thawj traceability, thiab software validation ntaub ntawv.
Cim npe nrov: Tuam Tshoj Automated Cartridge Filling Tshuab Chaw tsim tshuaj paus, lwm tus neeg, Hoobkas
