Optimization of Final Filtration Operations Using Single-Use Systems

Optimization of Final Filtration Operations Using Single-Use Systems

07/17/2020, 10:15 AM - 11:00 AM

Stage 3, Booth 1877, Exhibit Hall
Language:
English
Final sterilizing filtration is the last operation in downstream processing to assure sterility of medicinal products for human use. There is extensive regulatory guidance for final filtration encompassing both microbial retention, as well as pre-use, post-sterilization integrity testing (PUPSIT). As single use systems are increasingly being adopted in all areas of bioprocessing, there is a focus on implementing a more holistic approach to assuring sterility of the system that encompasses the filters and components. This presentation will highlight new developments in filter technology that demonstrate significant improvements for maintaining an aseptic flow path while maximizing product recovery and simplifying final filtration system design. The proposed design leverages filter capsule improvements in contamination prevention and existing best practices to recover more product. These changes offer opportunities for process risk mitigation and product yield improvements.

Contributors

  • Chuck Raye

    Speaker

    Final Fill Product Manager

    MilliporeSigma

    Chuck Raye holds a BS in Mechanical Engineering and has 9 years of experience in the bioprocessing industry working with single-use systems at...

Objective

  1. Objective 1. New filter design reduces the risk of contaminating the aseptic flow path during venting, sampling and operation. 2. Modifications to filtration operations and designs can result in yield improvements. 3. Simplifying single-use filtration designs leveraging new design features on filters to enable PUPSIT.

Type of Session

  1. Type of Session
    Session

Categories

  1. Track
    Processing/Manufacturing