Aseptic Ophthalmic Filling System
Introducing OphthaFill – a complete aseptic ophthalmic filling solution, designed for efficiency and adaptability. This system handles unscrambling, filling, weighing, plugging, and capping at speeds of up to 200 units per minute, integrating Industry 4.0 features for enhanced connectivity.
Ideal for both 3-piece and 2-piece preservative-free containers, it operates within aseptic Grade A environments, including LAF, RABS, or Isolators.
The system provides real-time OEE visualisation and 100% in-process control (IPC) weight monitoring at full speed. Fully servo-driven for precise control, it accommodates various packaging materials, enabling quick changeovers. Additionally, the machine can be configured to run nasal spray applications, maximising its versatility.
Features
- Performance – Walking beam Nozzle for one time filling to achieve more filling time for gentle filling, Individual Servo Filling pump
for highest accuracy. - Product Safety – Multiple detection and inspection available, 100% tare in tare out, under torque etc.
- Conversion – Full Servo Driven with rapid changeover via recipe and minimum change part
- Cmlin – 15” IPC HMI coml to FDA 21 CFR Part 11 and Euroean safet CE Marked.
- Digitalization – Ready with OPCUA communication port for MES and ERP , Cloud base real-time OEE Monitoring.
- Barrier System – LAF , Open RABs or Isolator design to GMP Annex 1.
- Documentation – Full Validation document DQ(RA, FSDS, HDS, SDS, CSV) , IQ, OQ.
- Barrier System – Grade A or ISO Class 5 environment, Suitable for Laminar Flow, Open RABs or Isolator, VHP compatible
Software & Digitalization
- 15” IPC intuitive design HMI
- Comply to FDA 21 CFR Part 11
- Electronic Batch Record
- Non-editable Audit Trial
- 3 level user management
- Recipes
- OEE dashboard visualization
- OPCUA communication ready
- Remote Access troubleshooting (optional)
- Cloud base Real-time OEE monitoring (optional)OEE Dashboard Visualization
Machine Specification
| HFS60 | HFS120 | HFS180 | HFS250 | |
|---|---|---|---|---|
| Speed | 50upm | 100upm | 150upm | 200upm |
| Dosing Range | 5ml – 30ml | |||
| Container | LDPE, PET round or ellipse | |||
| Plug | Protrude inner plug | |||
| Closure | Screw On Cap or Aptar Snap On Cap | |||
| Plug | 380V – 415V, 50Hz | |||
| Air | 6 bar | |||
Plugging Sorting Via 316l Full Welding Mirror Finishing Vibratory Bowl With Autoclave
Pre And Post N2 Flush For Oxigen Sensitive Product
Gentle Bottle Handling Via Synchronize Speed Of Pitcher To Main Bottle Indexer
Ceramic Valveless Rotary Piston Pump With Stainless Steel Housing Enhance Robustness
Fan Wheel For More Stable And Gently Bottle Handling
Barrier System Suitable For Laminar Flow, Open RABs Or Isolator
Vacuum Starwheel For Vial Unload
Auto Quick Summary Batch Record
OPCUA Communication Port For MES & ERP
cGMP Design
Accurate Filling Accuracy Up To + / - 0.5%
Electronic Torque Control For Highest Capping Repeatability
Pre-capping Spindle via 3 Axis Robot Improve Capping Yield
Machine Layout
