Disposable Single Use Filling Lines
mdi disposable single-use filling lines offer customized solutions for final fill of drug products, overcoming flexibility and productivity constraints associated with traditional fill and finish systems.
These ready to use, gamma sterilized filling assemblies are designed to not only ensure regulatory compliance but also enhance product and operator safety.
mdi disposable single-use final fill assemblies ensure:
- Quick turnaround time
- Product and operator safety
- Reduced risk of cross contamination
- No cleaning validation
- Increased flexibility and productivity
mdi works closely with the process owners to understand their functional as well as regulatory requirements. A technical feasibility of the required design isestablished based on available components and an initial drawing is proposed. Product prototyping and final approval leads to user specific filling line realization.
Customization may include but is not limited to:
- Bag size and ports
- Filter MOC, size and pore size
- Tubing length, lumen and thickness
- Different filling needle lumen for different fill volumes
- Filling needle hub connections with hose barb or female luer lock