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
| HFS 60 |
HFS 120 |
HFS 180 |
HFS 250 |
|
|---|---|---|---|---|
| Speed (upm) |
50 | 100 | 150 | 200 |
| 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
Frequently Asked Questions (FAQs)
What is the throughput of the system, and can it accommodate high-speed production?
OphthalFill supports speeds up to 200 units per minute. It therefore helps manufacturers meet higher output demands while maintaining consistent performance.
How does the machine ensure filling accuracy and control for small volumes (e.g., 5-30 ml) in aseptic conditions?
OphthalFill features an individual servo-driven filling pump plus a walking beam nozzle for one-time filling, enabling accurate, gentle filling. It also offers 100% in-process control (IPC) weight monitoring at full speed for real-time assurance.
Can the system manage changeovers and conversions between different container types or formats?
OphthalFill is “fully servo driven with rapid changeover via recipe and minimum change part”. It supports various packaging materials and both 2-piece and 3-piece preservative-free containers.
What level of integration and digitalization does the system offer (for Industry 4.0, MES/ERP connectivity)?
OphthalFill offers a 15″ IPC HMI compliant with FDA 21 CFR Part 11, electronic batch records, audit trails, recipe management, plus OPC UA communications for MES/ERP integration and optional cloud-based real-time OEE monitoring.
How does the equipment meet aseptic/sterility and regulatory requirements (barrier systems, environment class, documentation)?
OphthalFill supports use in aseptic Grade A/ISO Class 5 environments, is compatible with laminar flow, open RABS, or isolator designs, and is VHP-compatible. Documentation compliant with FDA 21 CFR Part 11.
