Model SA25 - Aseptic Filling Workcell
Gloveless system that reduces risk for flexible vial, syringe, and cartridge filling. The SA25 Aseptic Filling Workcell is able to fill vials, syringes, and cartridges with an aseptic process that reduces risk and improves quality. The SA25 robotic process reduces the risk of product contamination and can handle multiple formats.
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Flexibility
The SA25 can fill any nested vial, syringe, or cartridge format from 0.2 – 50 mL, with the ability to change between formats in just 45 minutes.
That’s not all, the capability of the SA25 can be expanded to include dual chamber syringes and cartridges. So, when your forecast or pipeline changes, you can be ready for it.
Reduced Risk
Choose sterility assurance. The SA25 is an integrated gloveless robotic isolator that removes the need for operator intervention. Advanced automation seamlessly combines every aspect of the aseptic process.
Speed to Market
Typically, isolated systems can take 15 months or longer just to finish a factory acceptance test (FAT), meaning it can be years before GMP operations can begin.
The SA25 is a standardized system that can be delivered and qualified quickly. Customers have reached GMP production within 15 months of placing their purchase order.
Customer Story: WuXi Biologics
CDMO WuXi Biologics installed the SA25 Aseptic Filling Workcell at its DP4 drug product operations, reaching its first GMP batch release 15 months after purchasing the machine.
Customer story: Emergent BioSolutions
Emergent BioSolutions selected the SA25 Aseptic Filling Workcell while revamping aseptic filling operations at their Winnepeg site. The team wanted a machine that could provide superior product quality, sterility assurance, and flexibility.
Technical Specifications
- Parameter: SA25 Hardware Unit
- Throughput: Up to 20 000 units per batch
- Pump type: Dynamic peristaltic pump
- Fill volume range: 0.2 – 50 mL
- In-process control: Programmable up to 100% of units
- Product contact materials: Single-use flow path assembly
- Interior classification: ISO 5 / Grade A
- Cleanroom classification: ISO 8 / Grade D
- Dimensions: 1.8 × 4.1 × 2.4 m (57 × 164 × 93 in.)
- Required cleanroom space: 40 m² (430 sq. ft.)
- Electrical: 208–240 VAC, single phase, 50–60 Hz, FLA 67
- Air supply (from room): 300 m³/h
- Compressed air: 90 L/min, >0.55 MPa (5.5 bar (g))
- Control system: 21 CFR Part 11 compliant
- Pack size: 1
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