Filtration stérile

Ressources connexes

• Brochure: Mission Control: Strategies for Effective Bioburden and Aseptic Control

  In this series of articles, we provide information to highlight the differing objectives for bioburden control by unit operation and discuss the parameters that guide filter selection and optimization.

• Tech Note: Holistic Buffer Preparation

  Buffer preparation is critical in biologics production, requiring significant volume and precise timing. The document will discuss optimizing in-house preparation and potential outsourcing, considering various options based on process needs.

• Application Note: Cell Culture Media Mixing and Microfiltration: Reducing Risk with Single-use Technology

  This application note provides an overview of considerations for mixing reconstituted powdered cell culture media and filtration of the reconstituted media using sterilizing or mycoplasma removal filters.

• Tech Note: How Membrane Prefilters Enhance BioProcessing Efficiency

  Milligard^® PES filters with two layers of asymmetric polyethersulfone (PES) membranes are widely used in biopharmaceutical production to remove particulates from process fluids. When used as prefilters they can increase the capacity of sterilizing filters and improve process economics.

• Application Note: Cell Culture Media Filtration – Filter Selection and Sizing

  This document discusses the trend in bioprocessing to enhance productivity upstream through improved cell culture media processing, highlighting the challenges posed by concentrated and complex media that can lead to premature fouling of membrane filters. It emphasizes the importance of selecting the right membrane filter, particularly addressing microbial retention, and explores the trade-offs between different filter options such as traditional sterilizing-grade filters and mycoplasma-retentive filters in minimizing bioreactor contamination risk.

• Technical Note: Demonstrating Millipore Express^® SHR Mycoplasma Clearance Capability at Pilot and Production Scale over an Extended Filtration

  Two studies were conducted to assess the mycoplasma retentive properties of Millipore Express^® SHR with Prefilter filters using Acholeplasma laidlawii ATCC^® 23206™, simulating typical processing parameters and operating pressures. The studies demonstrated that the filters, in both production scale and pilot scale configurations, were fully retentive when challenged with A. laidlawii at low organism challenge levels over extended filtration times.

• Technical Note: Mycoplasma Clearance by Millipore Express^® SHR Filters at Pilot and Production Scales

  The Millipore Express^® SHR filters, equipped with a 0.1 µm polyethersulfone (PES) sterilizing membrane, offer enhanced microbial risk reduction, particularly targeting mycoplasma contaminants in cell culture media. Retention studies demonstrated that both pilot and production-scale filters consistently provided the expected level of mycoplasma retention over extended filtration times, affirming their performance under continuous flow processing conditions.

• Tech Note: Integrity Test Troubleshooting - Beyond Rewet and Retest

  Integrity testing is crucial for sterilizing grade filters in biopharmaceutical processing. This application note aims to ensure accurate integrity testing and address specific challenges.

• Application Note: Cell Culture Media Filtration - Evaluating Cell Culture Performance

  This document addresses the challenge of efficiently processing highly concentrated and complex cell culture media, emphasizing the benefits of membrane filtration in reducing the risk of bioreactor contamination. It discusses key considerations in selecting membrane filters based on microbial retention, compatibility, and capacity for specific media.