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STERIFILL RS
Fill-finish machine for Ready-To-Use components
Syringe, vial and cartridge-based injectables have nowadays evolved into a manageable dosing strategy for a variety of medical conditions. The STERIFILL RS series allows for flexible production methods for injectable pharmaceuticals.
Syringe, vial and cartridge-based injectables have nowadays evolved into a manageable dosing strategy for a variety of medical conditions. The STERIFILL RS series allows for flexible production methods for injectable pharmaceuticals.
Simplifying fill-finish design
As patient safety and dosing accuracy are the main issues concerning injectable administration, IMA Life offers a flexible, reliable small-batch machine for the filling and stoppering of a wide range of Ready-To-Use disposable components. The STERIFILL RS series is specifically designed according to cGMP and FDA regulations and is fit for conventional clean rooms, closed RABS or isolation technology.
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Production Plant
IMA Life Pharmasiena
STERIFILL RS Highlights
1.
Set for 2, 5 or 10 filling groups.
2.
Peristaltic or volumetric pumps for dosing accuracy.
3.
Fully automated 100% or statistical in-line process control .
4.
Vacuum filling system to avoid air bubbling, in case of viscous products.
5.
Flexibility to fill and close nested components with fast changeover times.
6.
Simple and agile solution for small-scale manufacturing.
7.
Downstream connections with D-NEST, de-nesting machine.
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.
- Technical Data
- Machine Layout
| Features |
STERIFILL RS TECHNICAL DATA |
||
| 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 |
STERIFILL RS Gallery
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Tub opening station under isolator - external view
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Syringe nest pick up
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Vial filling and stoppering
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Vial filling and lyo stoppering
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Cartridge 100% check-weighing
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Cartridge filling and plugging
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Syringe 100% check-weighing
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Cartridge 100% check weighing
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Plunger infeed
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Lyo stoppering
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Syringe nest positioning into the tub and outfeed