MODULINE™
Collaboration of Getinge & Dara Pharma.
A fully automated filling station is placed inside a standard isolator of a single design, for processing either vials, bottles, syringes or cartridges, for automatic filling of any liquid or powder in sterile conditions.
Main features
- For aseptic and aseptic-toxic products, i.e. operation under positive or negative pressure.
- Compact and modular design.
- Good ergonomics and easy access through one-piece glass window with "automatic" opening and closing.
- Same isolator design to process vials, bottles, syringes and cartridges.
- Suitable for “Ready to Use (RTU)" containers supplied in nest & tub, or containers supplied in bulk.
- Easy and safe HEPA filters replacement from the front side. Standard filters.
- One single isolator construction shell which surrounds filling machine frame with a continuous jointless base.
- DPTE® solutions for product, closures, and tools transfer in & out of the isolator.
- Ideal for small scale clinical trials as well as for mass production.
- Cost-effective and optimized delivery time thanks to standard design and manufacturing.
Control system
- Single HMI for both filling line and isolator with integrated SCADA system.
- Integrated viable and non-viable particles monitoring system, and glove integrity tester.
- GAMP® 5 compliant software.
- 21 CFR part 11 compliant data acquisition system.
- Allen-Bradley or Siemens PLC.
