The current therapeutic healthcare is becoming more and more focused on highly potent, high-value drugs from both the biopharmaceutical as well as the pharmaceutical industry. This has resulted in a continuous stream of new drug products with smaller lot sizes, requiring quick turnaround times and thereby challenging the existing reusable Fill Finish systems with time and manpower-consuming cleaning and sterilization processes.
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 single-use filling lines are customized to suit new as well as existing fill and finish systems. These are designed to comply with regulatory requirements such as “Final sterile filtration should be carried out as close as possible to the filling point” and “The integrity of the sterilized filter should be verified before use and should be confirmed immediately after use by an appropriate method such as a bubble point, diffusive flow or pressure hold test” (European Union Current Good Manufacturing Practices).
However, combining both these within an Isolator/RABS** system becomes quite challenging.
Disposable Filling Lines for Isolator/RABS
These ready-to-use gamma sterilized filling lines are also available housed within a specially designed bag with a Beta Port for transfer into and out of an Isolator or RABS.
These assemblies are pre-validated, pre-assembled, pre-sterilized systems with bags, tubings, connectors, filters, and filling needles, placed inside a beta port bag for easy and secure insertion and removal around the aseptic filling system.
MDI works closely with the process owners to understand their functional as well as regulatory requirements.
The technical feasibility of the required design is established based on available components and an initial drawing is proposed. Product prototyping and final approval lead 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