Compact and modular design / Easy access through a single front window / Output up to 100 upm. / Conforms with cGMP - US FDA.
GETINGE Group + DARA Pharma:
Two specialists. One solution.
GETINGE Group and DARA Pharma, leaders in equipment manufacturing for the bio-pharmaceutical industry, have reached an agreement on the manufacturing and distribution of a compact and modular solution for aseptic and aseptic-toxic filling.
GETINGE Group is a global isolator technology leader, inventor of DPTE® systems, and the largest supplier of isolator components. DARA Pharma manufactures individual machines as well as complete lines for washing, sterilizing, filling and closing vials, bottles, syringes, cartridges and IV bags, for liquids and powders in sterile conditions.
The isolator technology is the future of the pharmaceutical industry as the concept of sterile area is reduced to the smallest possible area, allowing the equipment to operate in a clean room class D, ensuring the safety of the product and people during the filling process.
From this agreement between the companies, a new concept of aseptic filling line inside isolator, named Moduline™, was born. It is a compact, modular and standard isolator of a single design to process either vials, bottles, syringes or cartridges, for automatic filling of any liquid or powder in sterile conditions.
It was designed according to cGMP and US FDA regulations and in special compliance with the requirements of the pharmaceutical and biotech industries.
The main characteristics of Moduline™ are:
- Compact and modular design.
- Good ergonomics and easy access through a single front window with automatic opening and closing.
- Same isolator design to process vials, bottles, syringes and cartridges.
- Suitable for “Ready to Use” (RTU) materials supplied in nest & tub, or materials supplied in bulk.
- For aseptic and aseptic-toxic products. Operation under positive or negative pressure.
- 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.
- Integrated DPTE® solutions for materials 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.
Supervision & Control:
- Single HMI with integrated SCADA system.
- Monitoring: Air velocity, differential pressure, relative humidity, temperature, non-viable particle and microbiological monitoring.
- Software complying with GAMP.
- Process data acquisition software in accordance with FDA 21CFR Part 11.
- Allen Bradley or Siemens PLC.