Choosing the Right Buffer Filter
Biopharma production requires large volumes of multiple buffers for different processing steps. Choosing a buffer filter can be complex: the filtration membrane and format you select will depend on your process step, level of bioburden control you need, buffer volume, and buffer characteristics. Whether you need a buffer filter for process development or for a critical formulation buffer, we have it covered. Our Millipore Express® and Milligard® PES, non-PFAS, buffer filters all deliver high flow and capacity at a reasonable cost and are offered with bacterial retention specifications that deliver the right level of bioburden control for your specific process needs.
Sterilizing Buffer Filters
For sterile filtration of non-plugging buffers we recommend Millipore Express® SHF (Sterile, High Flux) filters or Millipore Express® PHF (Process protection, high flux) filters. All Millipore Express® capsule and cartridge filters contain a 0.2 µm PES sterilizing membrane, that provides high permeability, easy wetting and integrity testing and broad chemical compatibility.
For more plugging buffers, Millipore Express® SHC (Sterile, High Capacity) filters are a better option. These filters contain an integrated 0.5 µm polyethersulfone (PES) membrane prefilter that protects the 0.2 µm PES sterilizing membrane, maximizing filter capacity.
- Millipore Express® SHF and Millipore Express® SHC filters should be used for critical process buffers steps that require sterility assurance.
- Millipore Express® PHF filters are a cost-effective, sterile buffer filtration option for buffers used in less critical steps, that may not need sterility assurance.
Bioburden Reduction Buffer Filters
Milligard® PES filters can be used as bioburden reduction buffer filters. These filters offer fast flow, high throughput, easy wetting and integrity testing and broad chemical compatibility and are a cost-effective buffer filtration option.
Two pore sizes are available, each with different bioburden reduction specifications:
- Milligard® PES 1.2/0.2 µm nominal: typically ≥ 6 log Brevundimonas diminuta removal based on ASTM F838 methodology
- Milligard® PES 1.2/0.45 µm: typically ≥ 6 log Serratia marcescens removal based on ASTM D3863 and F838 methodology
Approximate filtration areas of capsule and cartridge filters. Refer to product specifications for complete information.
Quality Standards and Documentation
All Millipore Express® and Milligard® PES filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO 9001 Quality Systems Standard, and are supported by a certificate of quality.
Millipore Express® SHF, Millipore Express® SHC and Milligard® PES 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 so you can move forward with confidence.
Related Webinars
Selecting an aseptic filter for biomanufacturing depends on specific processing needs. Learn how to choose the best filter for your process.
Change management is often perceived as complex. Learn how to use a risk-based approach to expedite post-approval product changes.
Learn about the importance of sterilizing filters in small-volume parenterals processes and how to validate performance to assure sterility.
Related Articles
- Aseptic filters are offered in disposable capsules and cartridge formats. This guide will help you find the right format for your bioburden control.
- Some prefilters reduce bioburden and can be used as a cost-effective alternative to sterilizing filters for bioburden control in bioprocessing.
Related Documents
- Brochure: Mission Control: Strategies for Effective Bioburden and Aseptic Control
Read this brochure to learn more about bioburden control, filter selection, and optimization of your filtration process.
- Millipore Express® Family Guide
Filters containing Millipore Express® membranes provide broad chemical compatibility across a wide pH range, are easy to wet and integrity test, and are available in a range of formats to meet the specific needs of different biomanufacturing operations.
- Technical Note: Extended Bacterial Retention Testing of Millipore Express® SHF 0.2 μm Filters in a Continuous Flow System.
This technical note summarizes retention performance of Millipore Express SHF sterilizing filter over long duration, constant flow processing conditions.
- Technical Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
Filter integrity testing doesn’t always go smoothly. Learn how to avoid costly mistakes and troubleshoot integrity test challenges.
- Technical Note: Bioburden Reduction and Particulate Retention Using Milligard® PES Filters
Explore Milligard® PES filters’ high flux, high throughput, efficient bioburden reduction performance for efficient filtration of bioprocessing fluid streams.
- Application Note: Optimizing Buffer Mixing and Preparation
This study develops optimal process conditions for mixing and filtration of 1x PBS buffer using the single-use Mobius® MIX solution and Millipore Express® filters.
- Application Note: Improved Accuracy of Scaling with OptiScale® 25 Devices
In this application note, the scalability of OptiScale® 25 devices to 10 inch cartridges was evaluated.
Related Video
This video describes how to perform a small-scale normal flow filtration study with Vmax™ filter sizing method, to assess the performance of any feed solution on a membrane filter.
