Aseptic Prefilled Syringe (PFS) Filling Equipment Line
ALWELL Fully Automated Prefilled Syringe (PFS) Ntim Kab yog ib qho kev sib xyaw ua ke, kawg - mus rau -kawg aseptic filling thiab ntim cov kua tshuaj engineered rau nested RTU (Npaj-To-Siv) syringes. Tsim los kom tau raws li nruj cGMP, FDA 21 CFR Part 11, thiab EU-GMP Annex 1 tus qauv, cov kab no seamlessly unifies tub de-zes, siab{10}}precision kua dosing, npuas{11}}dawb lub tshuab nqus tsev stoppering, servo plunger insertion, siab {0% 10} thiab siab {{0} 0. kev tshuaj xyuas zoo rau hauv ib qho kev ua haujlwm tas mus li.
1. Multi-Format Versatility & Process Engineering
Kev tsim cov parenteral niaj hnub xav tau cov kab hloov pauv uas muaj peev xwm tuav cov kua dej sib txawv viscosity yam tsis muaj kev ceev ceev lossis tsis muaj menyuam. ALWELL integrated kab txhawb iav, COP, thiab COC nested RTU syringes xws li 0.5 ml txog 20 ml:
Biopharmaceuticals & Sensitive Vaccines: Gentle peristaltic pumps los yog pov tseg ib leeg - siv cov kua dej siv lub zog me me, khaws cov protein molecular qauv thiab tshem tawm cov kab mob sib kis -.
High-Viscosity Aesthetic Gels (Hyaluronic Acid): High-Torque ceramic rotary piston twj ua ke nrog lub tsho kub hnyiab tau-tswj hoppers kom du volumetric dosing yam tsis muaj dej tailing los yog xov kab mob.
IV Solutions & Saline Flush Syringes: Nruam siab -speed volumetric filling optimized rau siab -throughput coj mus muag batch execution.
2. Xaus-rau-End Integrated Line Workflow
Robotic Tub De-Nesting:Tsis siv neeg lub hau / liner tshem tawm thiab maj mam hloov zes nyob rau hauv Chav Kawm A unidirectional airflow.
Nitrogen Purging (Yeem):Ua ntej- filling inert gas flush kom tshem tawm cov pa oxygen rau oxidation -sensitive formulations.
Servo Aseptic Dosing:Multi- taub hau ceramic/peristaltic filling nrog hauv qab- nce diving nozzles kom tshem tawm cov cua nkag.
Nqus Plunger Stoppering:Plungers zaum hauv qhov tsis zoo -siab chamber (txog -0.098 MPa) kom ntseeg tau tias tsis muaj huab cua headspace.
Plunger Rod Insertion & Screwing:Servo-tsav pas nrig pub nrog kev tswj lub zog meej kom tiv thaiv kom tsis txhob txav chaw.
High-Precision Wrap-Nyob ib ncig ntawm kev sau npe:Bubble- daim ntawv thov pub dawb nrog kev sib koom ua ke tiag -lub sijhawm thermal/laser code luam ntawv.
100% Vision Inspection & Auto-Kev tsis lees paub:AI-tsim kho qhov muag siv tau rau cov khoom, lub rooj zaum nres, thiab daim ntawv lo kom raug nrog kev hloov pauv tsis siv neeg tsis zoo.
3. Technical Specifications Table
| Specification Parameter | ALWELL Integrated PFS Ntim Kab Standard |
|---|---|
| Txhawb Cov Hom Tshuaj Txhaum Cai | 0.5 ml, 1 ml ntev, 2.25 ml, 3 ml, 5 ml, 10 ml, 20 ml (iav / COP / COC RTU) |
| Ntau lawm ceev | 2-Nozzle: 1,200–2,400 PPH|4-Nozzle: 3,000–4,800 PPH|10-Nozzle: Mus txog 12,000 PPH |
| Filling Qhov tseeb | Tsawg dua lossis sib npaug ± 0.5% (Aqueous Solutions)|Tsawg dua lossis sib npaug li ± 1.0% (Viscous Hyaluronic Acid Gels) |
| Vacuum Stoppering Rate | Pass Rate Ntau dua los yog sib npaug rau 99.8% (Nqus Qib mus txog -0.098 MPa, Tsis muaj npuas) |
| Cleanroom Barrier Compatibility | Chav Kawm A / ISO 5 Cleanroom |
| Hauv -Kev Tswj Xyuas Txheej Txheem (IPC) | Kev xaiv 100% Hauv -Line Dynamic Weighing nrog Auto-Tom ntej Stroke Kho |
| Tswj System & Ua raws cai | Siemens S7-1500 PLC, Ethernet / IP, FDA 21 CFR Part 11 Kev Tshawb Fawb Txoj Kev Tau Txais |
Cov lus nug nquag nug (FAQ) rau Turnkey Line Procurement
Q1: Dab tsi yog cov cuab yeej muaj nyob rau hauv ib qho kev ua tiav automated prefilled syringe (PFS) ntim kab?
A:Ib qho kev hloov pauv ALWELL PFS ntim kab feem ntau sib txuas ua ke tub de- zes, aseptic kua filling thiab nqus nres, plunger pas nrig ntxig thiab ntsia hlau, qhwv- nyob ib puag ncig daim ntawv lo, tshuaj xyuas hauv online kho qhov muag, thiab lub tshuab ntim khoom siv lub tshuab ntim khoom.
Q2: Yuav ua li cas cov kab tiv thaiv huab cua npuas thaum lub sij hawm siab - viscosity gel filling?
A:Kev tshem tawm npuas yog ua tiav los ntawm ob -theem lub tshuab nqus tsev. Ua ntej, hauv qab- nce diving nozzles sau cov kua hauv qab lub tshuab nqus tsev los tiv thaiv micro- npuas. Qhov thib ob, cov roj hmab stopper tau muab tso rau hauv qhov tsis zoo - lub tshuab nqus tsev siab (-0.098 MPa), rub tag nrho lub taub hau cua tawm ua ntej tso qhov kawg nres.
Q3: PFS puas tuaj yeem ua ke nrog VHP Aseptic Isolators rau cov tshuaj muaj zog?
A:Yog lawm. Peb cov qauv kab qauv tsim tau tsim los rau kev koom ua ke ncaj qha nrog VHP (Vaporized Hydrogen Peroxide) Aseptic Isolator systems lossis cRABS enclosures, muab Chav Kawm A rau kev tuav cov tshuaj cytotoxic biopharmaceuticals, tshuaj tiv thaiv nyob, thiab cov khoom xyaw tshuaj muaj zog heev (HPAPIs).
Q4: Yuav ua li cas lub kaw lus tswj kev siv lub tshuab ua haujlwm tsis raug lees paub yam tsis muaj kev txwv ntau lawm?
A:Kev sib xyaw ua ke 100% IPC ntsuas lub hlwb thiab lub koob yees duab kho qhov muag txuas ntxiv saib xyuas qhov tseeb ntim, nres txoj haujlwm, thiab kev nyeem ntawv barcode. Cov koob txhaj tshuaj tsis raug tau txais kev taug qab thiab hloov mus rau qhov kev lees paub kev ruaj ntseg chute yam tsis ua kom qeeb lossis cuam tshuam cov khoom loj.
Q5: Cov ntaub ntawv pov thawj dab tsi thiab FAT / SAT kev txhawb nqa koj muab rau kev ua raws li thoob ntiaj teb?
A:Peb muab tag nrho lub neej- lub voj voog siv tau cov pob khoom, suav nrog DQ, IQ, OQ, thiab PQ kev ua tiav raws tu qauv, 21 CFR Tshooj 11 kev soj ntsuam kev ua raws li txoj kev, FAT/SAT cov ntaub ntawv ua tiav, cov ntaub ntawv 3.1 traceabilities, thiab tag nrho schematics los txhawb koj FDA, EMA, los yog NMPA kab.
Shanghai ALWELL Machinery Equipment Co., Ltd
syringe filling tshuab chaw tsim tshuaj paus
Founded hauv 2013, Shanghai ALWELL Machinery Equipment Co.Ltd.Lub tuam txhab muaj siab - cov neeg ua haujlwm zoo thiab cov neeg ua haujlwm, tsom mus rau kev tshawb fawb thiab kev tsim kho ua ntej -fiing syninge fling ntau lawm kab pib los ntawm cov neeg siv khoom xav tau, ua raws li cov neeg siv khoom thawj zaug nruam innovaion, ib tug xov tooj ntawm cov kev ua tau zoo hauv lub teb chaws tau txais txiaj ntsig zoo thiab kev ua tiav ntawm lub teb chaws. kev lag luam. Cov khoom tseem ceeb yog tsis siv neeg ua ntej -filing nqus cov ntaub ntawv ntau lawm kab, ua ntej- ling catheter irigator fling productionine, thiab.. nyob rau hauv wth GMP cov kev cai, los ntawm EU CE daim ntawv pov thawj kev nyab xeeb. cov khoom throuchout lub couniv thiab exported rau cov teb chaws Europe, lub tebchaws United States lub Middle East, Southeast Asia thiab lwm lub teb chaws thiab cheeb tsam, nyiam los ntawm cov neeg siv thiab qhuas. Shanohai ALWelL wladhere rau lub hom phiaj ntawm "ua factones smanter thiab ntau eifcent", depen lub biopharmaceutical kev lag luam, thiab muab cov neeg muas zaub nrog kev sib tw, kev nyab xeeb thiab txhim khu kev qha khoom,
15+
Xyoo Kev Paub
30+
Cov kws tshaj lij
50+
Cov cuab yeej cuab tam
5000+
Thaj tsam
Shanghai ALWELL Machinery Equipment Co., Ltd
| Peb Yuav Ua Li Cas Rau Koj? |
| 1. Lub tshuab tuaj yeem hloov kho raws li qhov xav tau ntawm cov neeg siv khoom. |
| 2. Koj cov qauv pob tuaj yeem kuaj dawb ntawm peb lub tshuab. |
| 3. Muab kev sab laj kev lag luam thiab kev txhawb nqa kev lag luam, ntxiv rau kev ua haujlwm pub dawb. |
| 4. Ua ib lub tshuab layout rau cov neeg siv khoom raws li cov neeg siv khoom cov chaw tsim khoom. |
| 5. Tag nrho cov tshuab rau 1 xyoo zoo warranty. Hauv ib xyoos, yog tias muaj kev puas tsuaj, cov khoom seem yuav raug xa tuaj rau koj dawb. |
| 6. Cov yeeb yaj kiab ntawm kev teeb tsa; Kev them nyiaj yug online; engineer txawv teb chaws cov kev pab cuam. |
Thov qhia rau kuv paub koj cov kev xav tau tshwj xeeb thiab peb yuav muab cov kev daws teeb meem zoo tshaj plaws rau koj.
Hu rau tam sim no
Cim npe nrov: Prefilled Syringe (PFS) Filling Equipment Line, Tuam Tshoj Prefilled Syringe (PFS) Filling Equipment Line manufacturers, lwm tus neeg, Hoobkas
