Media Filtration
Upstream bioburden control focuses on preventing microorganisms from entering cell culture processes. Sterile filtration is routinely implemented to protect the bioreactor and upstream processes from contamination.
Selecting the Right Filter for Cell Culture Media Filtration
There are multiple media filtration options that deliver sterility assurance and high performance at every step. Filter selection is guided by risk analysis to identify the level of bioburden control required, the efficiency (throughput) of cell culture media processing, and the filter formats available. Before filter selection is finalized, acceptable performance of your cell culture process should be confirmed.
Millipore Express® SHR (Sterile, High Retention) filters contain one layer of 0.1 µm polyethersulfone (PES) membrane and are available with an optional integrated 0.5 µm PES membrane prefilter that protects the high flux membrane, preventing premature plugging. These filters typically offer ≥ 7.0 log removal of mycoplasma and sterilizing-grade performance.
Millipore Express® SHC (Sterile, High Capacity) filters contain two layers (0.5/0.2 µm) of PES membrane and provide superior throughput and capacity for plugging streams. These filters offer sterilizing-grade performance.
Durapore® 0.1 µm and 0.22 µm filters contain one layer of polyvinylidene fluoride (PVDF) membrane and provide high flow rates and throughputs. These filters offer sterilizing-grade performance.
Related Resources
- Aseptic Filter Formats: Selection Guide
This technical article provides a high level overview of different formats available to help guide product selection.
- 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.
- 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.
- 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.
- Application Note: Integrity Test Troubleshooting – Beyond Rewet and Retest
Integrity testing is crucial for sterilizing grade filters in biopharmaceutical processing, offering a fast, definitive, non-destructive way to ensure filter retention performance. However, while non-integral filters are unlikely to pass the integrity test, there are numerous ways an integral filter can fail, leading to retests and potential productivity and product loss.
- Technical Brief: Extended Bacterial Retention Testing of Millipore Express® 0.2 μm Filters in a Continuous Flow System
The technical brief describes the microbial retention performance of sterilizing-grade Millipore Express® SHF filters under continuous flow operations for up to 16 hours, addressing the limitations of traditional testing methods and providing a more comprehensive understanding of filter performance in real-world biomanufacturing processes.
- 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.
- PDF: Millpore Express® Family Guide
Millipore Express® filters, featuring hydrophilic polyethersulfone (PES) membranes, are trusted for their sterilizing-grade filtration, high flux, and capacity, with broad chemical compatibility and ease of use for wetting and integrity testing. These filters are versatile, suitable for various biomanufacturing operations, including filtration of cell culture media, monoclonal antibodies (mAbs), vaccines, plasma, viral vector, and parenteral production at different scales.
- Durapore® Family Guide
Durapore® polyvinylidene fluoride (PVDF) membranes are a trusted choice for various bioprocessing operations, including liquid sterile filtration, sterile tank and gas venting, and final sterilizing filtration, offering low protein binding, broad chemical compatibility, and low extractables. These membranes are versatile, suitable for applications such as filtration of cell culture media, monoclonal antibodies (mAbs), vaccines, plasma, viral vector intermediates, and ophthalmics, with the additional assurance of 100% integrity testing for all Durapore® sterilizing filters during manufacturing.
Selecting the Right Filter Format for Cell Culture Media Processing
Our filters are fully scalable, from small-scale tools to pilot and production scale manufacturing. Most are offered as disposable capsule filters, as well as cartridge filters for use in stainless steel housings. Some filters are offered in high-area formats which double the membrane area compared to standard area filters, without increasing filter footprint. Each filter is available with several connection options, providing flexibility for your specific process needs.
QUALITY STANDARDS AND DOCUMENTATION
Our filters are supported by the Emprove® Program which provides three types of dossiers to support different stages of development and manufacturing operations such as qualification, risk assessment, and process optimization. The dossiers consolidate comprehensive product-specific testing data, quality statements, and regulatory information in a readily available format.
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