filling and closing machine for pharma
Engineered for sterile drug production, ALWELL's integrated filling-closing system delivers ±0.5% filling accuracy and >99.98% closure integrity in vials, cartridges, and pre-filled syringes. Our patented anti-crystallization nozzle technology prevents API waste while robotic stopper placement ensures zero human intervention in aseptic cores.
Key Advantages:
✅ Dual-Process Integration
Filling + stoppering/capping in single HMI-controlled operation
✅ Contamination Control
ISO Class 5 laminar airflow with real-time particle monitoring ports
✅ Data Integrity
Audit trail & electronic records compliant with ALCOA+ principles
✅ Rapid Changeover
Adjustable format parts for containers 1ml-30ml (30min tool-free switch)
Technical Specifications
Model: filling and closing machine for pharma
| Parameter | Specification |
|---|---|
| Filling Accuracy | ±0.5% of set volume (0.1ml-30ml range) |
| Closure Type | Rubber stoppers, Flip-off caps, Crimp seals |
| Aseptic Class | ISO 14644-1 Class 5 environment |
| Power Supply | 380V/50Hz (3-phase) or customizable |
| Material Contact | 316L SS, USP Class VI polymers, EPDM seals |
| Control System | Siemens PLC + 15" GMP touchscreen |
| Data Compliance | 21 CFR Part 11, Annex 11, GAMP 5 |
Applications
Product Material
Injectables: Vaccines, mAbs, Cytotoxics
Biologics: Cell therapies, Lyophilized products
Ophthalmic: Unit-dose eye drops
High-Viscosity: Hyaluronic acid, Suspensions
Production packing
FAQ
Q: What's the lead time for machine delivery?
A: Standard configuration: 16-20 weeks FOB Shanghai. Express slots available for urgent projects.
Q: What's the lead time for machine delivery?
A: Standard configuration: 16-20 weeks FOB Shanghai. Express slots available for urgent projects.
Q:Can we validate the machine with our specific drug formulation?
A: Yes – our factroy supports 3-day process development trials. Bring your containers & APIs.
Q: How do you ensure sterility during stopper placement?
A: Features include:
UV tunnel decontamination of stopper bowls
Positive pressure RABS with glove ports
VHP-compatible chamber (optional)
Q: What after-sales support is provided?
A: Global coverage:
24/7 remote diagnostics
Q: Is the machine scalable for future expansion?
A: Modular design allows:
Adding in-line leak tester
Integration with freeze-dryer loading
Upgrade to isolator technology
Our Certificate
CE
ISO 9001:2015
CE
Trust Indicators
Certifications Badges: CE, ISO 9001, FDA GMP compliance statement
Request a customized solution? Please contact us.
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