Sterifill RS Series Aseptic Processing
Machine overview
Simplifying fill-finish design
Syringe, vial and cartridge-based injectables have nowadays evolved into a manageable dosing strategy for a variety of medical conditions. The STERIFILL RS fill-finish series for RTU components allows for flexible production methods for injectable pharmaceuticals.
A flexible, reliable small-batch solution for the filling and stoppering of a wide range of Ready-To-Use disposable components, STERIFILL RS is specifically designed according to cGMP and FDA regulations and is fit for conventional cleanrooms, closed RABS or isolation technology.
Production plant
IMA Pharmasiena
Machine highlights
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Filling groups
Set for 2,5 or 10 filling groups.
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Accurate dosing
Peristaltic or volumetric pumps for dosing accuracy.
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100% IPC
Fully automated 100% or statistical in-line process control.
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Vacuum filling system
Avoids air bubbling in the case of viscous products.
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Handles nested components
Flexibility to fill and close nested components with fast changeover times.
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Small-scale suitability
Simple and agile solution for small-scale manufacturing.
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Integration with D-NEST
Downstream connections with D-NEST, syringe and vial denesting machine.
Varied portfolio
STERIFILL RS meets the current need to process a wide range of Ready-To-Use components such as syringes, vials and cartridges. Its simple and efficient production of a varied portfolio, ensures easy handling of nested glass components, preserving sterility requirements.
Machine details
Technical information
| STERIFILL RS TECHNICAL DATA | |||
|---|---|---|---|
| Features | STERIFILL RS P2 | STERIFILL RS P5 | STERIFILL RS P10 |
| Automation | Fully automated | Fully automated | Fully automated |
| Footprint (mm) | 2,100 x 1,540 x 2,080 [L x W x H] | 2,100 x 1,600 x 2,080 [L x W x H] | 2,560 x 1,940 x 2,080 [L x W x H] |
| In-process Control | Statistical | Statistical | Statistical |
| RTU vial dimensions | Ø 16 – 42.4 mm | Ø 16 – 42.4 mm | Ø 16 – 42.4 mm |
| Vial output | up to 4,400 pcs/h | up to 10.800 pcs/h | up to 14,500 pcs/h |
| RTU syringe dimensions | 0.5 – 20 ml | 0.5 – 20 ml | 0.5 – 20 ml |
| Syringe output | up to 4,800 pcs/h | up to 12,000 pcs/h | up to 18,000 pcs/h |
| RTU cartridge dimensions | 1 -20 ml | 1 -20 ml | 1 -20 ml |
| Cartridge output | up to 3,100 pcs/h | up to 7,800 pcs/h | up to 12,000 pcs/h |
| Suitable for high-potent | Yes | Yes | Yes |
| Loading from depyrogenration tunnel | No | No | No |
