Automatic Ampoule Filling Line: (Ampoule Compact Line)
Description
An Ampoule Compact Line is a fully integrated production line for washing, sterilizing, filling, and sealing ampoules in a continuous operation. It is designed for pharmaceutical and biotech industries to handle high-speed, aseptic ampoule production in compliance with cGMP and FDA standards.
Features of Automatic Ampoule Filling Line: (Ampoule Compact Line)
- Compact footprint – integrated washer, sterilizer, filler, and sealer.
- Designed for aseptic filling under laminar airflow.
- High-speed, low-maintenance operation.
- Optional automatic infeed/outfeed to packaging lines.
- HEPA-filtered air handling for Class 100 (ISO 5) environment.
Automatic Ampoule Filling Line: (Ampoule Compact Line) Technical Specification
Ampoule Washing Machine
| Output Speed: | Up to 300 ampoules/minute |
|---|---|
| Ampoule Sizes: | 1 ml to 20 ml (ISO standard) |
| Washing Stations: | 8 – 10 (internal & external washing) |
| Water Usage: | WFI (Water for Injection) and compressed air washing |
| Construction: | SS316L contact parts, SS304 frame |
Ampoule Sterilizing Tunnel (Depyrogenation Tunnel)
| Capacity: | Matches washer output (300 APM) |
|---|---|
| Heating Zone Temperature: | Up to 320°C (validated) |
| Cooling Zone: | Laminar airflow with HEPA filters (H14) |
| Control: | PLC with temperature profile recording |
| Construction: | SS316L in product contact areas, fully insulated |
Ampoule Filling & Sealing Machine
| Output Speed: | Up to 300 APM |
|---|---|
| Filling Range: | 1 ml to 20 ml |
| Filling Accuracy: | ±0.5% |
| No. of Filling Heads: | 6 – 12 heads (rotary or linear) |
| Sealing Type: | Flame sealing with LPG/oxygen mixture |
| Gas Usage: | Optional inert gas flushing (before & after filling) |
| Servo-driven indexing system | |
Control & Compliance:
| Automation: | Fully PLC controlled with HMI interface |
|---|---|
| Data Recording: | 21 CFR Part 11 compliance (optional) |
| Validation: | DQ, IQ, OQ, PQ documentation support |
| Construction: | cGMP compliant, easy-to-clean design |
Utilities Required:
| Electrical Supply: | 415V, 3 Phase, 50Hz |
|---|---|
| Compressed Air: | 6 bar dry, oil-free |
| WFI Supply: | 2 – 3 bar pressure |
| Oxygen & LPG: | For sealing burners |
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