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).