The Filtration and Separation Blog

Process owners in biopharma manufacturing are concerned about leakages and contamination in single use systems. Annex1 also highlights that manual handling activities associated with single-use systems, such as assembly and connection of components require appropriate controls and must be verified during Aseptic Process Simulation (APS). Where there is a potential risk to product sterility, suitable system integrity testing should be implemented to demonstrate robustness.

Furthermore, Annex 1 emphasizes that closed systems should be intentionally designed to minimize manual interventions and the risks they introduce. Thus, SUS assemblies should be engineered with the minimum number of connections necessary, using robust, well-qualified connection technologies to reduce contamination risk and ensure consistent aseptic performance.

Continue reading “Advancing critical SUS design with Overmolding Technology”

The advent of ready to use single use filling line has revolutionized the fill-finish process for sterile injectables, enabling faster product changeovers and reducing risks related to cleaning validation and cross-contamination. However, concerns remain around E&L, particulate contamination, variable fills, adsorption, and product loss, especially with high-value drugs.

These challenges can be addressed by careful material selection, Efficient design, and monitoring and Control of Particulate Matter during manufacture of these complex single use systems.

Careful Selection of Materials

Careful selection of single-use components with low extractables is crucial to minimize leachable risks, avoiding costly redesigns and delays. At MDI, our advanced analytical labs offer extractables profiling and toxicological assessments to identify target leachables. To address product loss from adsorption, especially in low-volume or high-value drug; we provide validation services to evaluate component compatibility and recommend surface modifications or material change, or flush volumes to ensure label claim compliance.

Continue reading “Designing Disposable Single Use Filling Lines for Minimizing Losses and Maximizing Yield”