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Final Sterile Filtration

    Single-use system for final sterile filtration and filling

    Sterile filtration of drug products is a critical step in ensuring product sterility and drug safety for patients. Manufacturers must focus on ensuring sterility and maximizing product recovery, while meeting regulatory requirements. The design of an effective filtration system considers multiple filter options and process requirements, including the number of sterilizing filters, sampling needs, and whether pre-use post-sterilization integrity testing (PUPSIT) will be performed.

    Single-use Assemblies for Final Aseptic Filtration and Fill-Finish Operations

    Single-use systems are increasingly being adopted into fill-finish processes to meet today's complex drug production demands. Single-use assemblies deliver improved process flexibility and productivity, increase operator and product safety, and reduce validation requirements and process turnaround time. These systems integrate multiple single-use components, including SU beta bags, sterile connectors, sterile filters, header bags, pump tubing, and filling needles, to create an optimized final filtration and filling system that is tailored to meet specific process needs.

    Benefits of implementing a single-use assembly into the final sterile filtration and filling process include:

    • Improved safety, efficiency, and productivity
    • Reduced cleaning, set-up and validation
    • Decreased risk of cross-contamination
    • Minimization of bottlenecks on the filling line

    For optimal results, manufacturers can collaborate with single-use experts on the design of custom assemblies. An experienced partner can seamlessly integrate the right single-use solution into the final filtration and filling process, while leveraging the benefits of existing infrastructure.

    Related Product Resources

    mAb Expression, Purification, and Formulation

    mAbsizer™ Calculator

    Webinars

    Webinar: Improved Design Reduces Contamination Risks in Final Filtration and Filling Processes
    Webinar: Potential Impact of Draft Annex 1 on Sterilizing Filtration
    Webinar: The Role of BPOG Extractables Data in the Effective Adoption of Single-use Systems

    Technical Resources

    Brochure: Mobius® Single-Use Final Fill Solutions
    Tech Note: Redesigned Filter Capsule Improves Final Filtration Assembly Design & Operation
    Tech Note: Millipak® Final Fill Filters Reduce Contamination Risks and Simplify Filtration System Design and Operation
    Tech Note: Improved Product Recovery Using Blow-down and Millipak® Final Fill Filters
    Specification Sheet: Single-use Filling Needles Integrated into Mobius® Final Fill Assemblies

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