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Final Sterile Filtration & Filling

Mobius formulation fill

Final sterile filtration and filling are the last steps in the production process and are critical operations to assure product sterility and drug safety for patients. Our Mobius® single-use systems can be designed to include either single or redundant sterilizing filters and offer manufacturers speed, flexibility, and improved efficiency.   

Filters for Aseptic Filtration

Gas filters are critical to maintaining a boundary between the environment and the aseptic fluid path. Filters containing our sterilizing-grade Millipore Express® SPG (Sterile, Phobic Gamma) hydrophobic membrane are the preferred choice for gas filtration and venting in single-use applications.

Millipak® barrier filters contain both hydrophilic and hydrophobic sterilizing-grade Durapore® membranes, allowing the flow of both liquid and gas. These filters simplify PUPSIT by maintaining the sterility of the system while removing the constrains of a flush bag or a can.

For sterile filtration of aqueous liquids, filters containing our proven Durapore® polyvinylidene fluoride (PVDF) membrane offer low protein binding and superior robustness. For some processes, our trusted polyethersulfone (PES) Millipore Express® membrane filters may be a better option.

Our membrane filters are available in multiple filter formats and are fully scalable from small-scale tools to pilot and production scale manufacturing. Capsule filters are compatible with autoclave or gamma irradiation and are also available pre-sterilized for maximum flexibility.

Single-use Filling Assemblies for Fill Finish Processes

Our single-use filling assemblies are custom designed to integrate with various brands of isolator or RABS filling machines. Our Mobius® experts collaborate with you and your machine vendor to ensure the system is designed to your needs and meets regulatory expectations. Our diverse portfolio of single-use components can be easily integrated into your filling system, and includes:

  • Sterile connectors
  • 2D header bags up to 50 L
  • Dosing pump tubing
  • Molded TC manifolds
  • Beta bags
  • Single-use filling needles

The result is a single-use final fill system that’s ready to use out of the box, featuring modular, fully optimized assemblies. These systems are replicable, scalable, and simplify technology transfer across multiple sites.

Please contact your local representative for help with designing a custom final filtration and filling assembly. 

Regulatory Compliance

Complementing our product portfolio, the Emprove® Program consolidates comprehensive product-specific testing data, quality statements, and regulatory information in a readily available format to simplify your compliance needs.

Related Product Resources

mAb Expression, Purification, and Formulation

mAbsizer™ Calculator

Product Operations

Application Note: Integrity Test Troubleshooting – Beyond Rewet and Retest
Technical Note: Improved Product Recovery Using Blow-down with Millipak® Final Fill Filters
Application Note: Establishing Product Specific Bubble Point Values for Sterilizing-Grade Filters
Webinar: Filter Integrity Testing Best Practices
Webinar: Potential Impact of Draft Annex 1 on Sterilizing Filtration
Webinar: Does PUPSIT Reduce Risk for Sterile Filtration?

Product Selection

Technical Note: Millipak® Final Fill Filters Reduce Contamination Risks and Simplify Filtration System Design and Operation
White Paper: Adoption Of Single-Use For Final Filtration
Webinar: Improved Design Reduces Contamination Risks in Final Filtration and Filling Processes
Webinar: Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes for Investigational Medicinal Compounds
Webinar: Final Filling Process Design Considerations Part 2 – Sterile Filtration

Product Specifications

Data Sheet: Durapore® Family Guide
Specification Sheet: Single-Use Filling Needles Integrated into Mobius® Final Fill Assemblies

 

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Highlights

Minimizing Risk in SU FF


This presentation focuses on final filtration and filling in single use assemblies and provides a short overview of our webinar "Improved Design Reduces Contamination Risks in Final Filtration & Filling Processes."

Improved Design Reduces Contamination Risks in Final Filtration & Filling Processes

Improved Design Reduces Contamination Risks in Final Filtration & Filling Processes

This webinar focuses on final filtration and filling in single use assemblies. We discuss new product and system designs that help customers meet regulatory expectations and reduce contamination risk while maximizing product recovery.

Single-Use Redundant Filtration Process

Learn how single-use systems can help minimize contamination risk in final filtration and filling.

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