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 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:
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.
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
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