Buffer Filtration
Biomanufacturing requires large volumes of buffers for different steps in downstream processing, with filter selection highly dependent on the needs of the specific process step. For non-critical steps we offer bioburden reduction filters for superior process economics, while our sterilizing-grade buffer filters deliver fast flow and extended throughput for superior process efficiency.
All our filters are fully scalable from lab-scale process development tools to pilot and production scale manufacturing, with most offered in both single-use, gamma ready capsule and cartridge formats. In addition, each filter is available with several connection options to provide flexibility for your specific process needs.
- Milligard® PES filters contain two layers of polyethersulfone (PES) membrane and reduce bioburden while providing broad chemical compatibility. Milligard® PES 1.2/0.2 µm nominal filters typically provide ≥ 6.0 log removal of Brevundimonas diminuta
- Millipore Express® PHF (Process, High Flux) filterscontain a single layer of 0.2 µm sterilizing-grade PES membrane and provide a cost-effective option for high flux buffer filtration.
- Millipore Express® SHF (Sterile, High Flux) filters contain a single layer of 0.2 µm sterilizing-grade PES membrane and provide with high flux with broad chemical compatibility. Each filter is integrity tested during manufacturing.
- Millipore Express® SHC (Sterile, High Capacity) filters contain two layers (0.5/0.2 µm) of PES membrane and provide sterilizing-grade performance, broad chemical compatibility and superior capacity for plugging streams. Each filter is integrity tested during manufacturing.
- 0.22 µm Durapore® filters contain a single layer of 0.22 µm polyvinylidene fluoride (PVDF) membrane and are low-binding, non fiber releasing with low extractables. Each filter is integrity tested during manufacturing.
Products
Related Resources
- Tech Note: Bioburden Reduction and Particulate Retention Using Milligard® PES Filters
Milligard® PES filters with two layers of asymmetric polyethersulfone (PES) membranes are widely used in biopharmaceutical production to safeguard process fluids from contaminants. They can be used as prefilters to increase the capacity of sterilizing filters or independently to reduce bioburden and turbidity in process streams, providing an alternative to sterilizing-grade filters for bioburden risk reduction in non-critical process steps.
- 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.
- Tech Note: Recommendations for Steam-in-place Sterilization of Filtration Trains Containing Milligard® PES Prefilters
Milligard® PES filters reduce bioburden and protect downstream filters in biotechnology manufacturing. They can be sterilized by SIP, autoclave, and gamma irradiation, but require wetting before use. Studies are ongoing to establish best practices for SIP sterilization when using these filters in a filtration train.
- 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.
- Guide: Durapore® Family Guide
Durapore® polyvinylidene fluoride (PVDF) membranes, known for their reliability, are offered in multiple pore sizes and formats to meet diverse bioprocessing needs such as liquid sterile filtration, in-line integrity testing, and final sterilizing filtration. These low protein binding and non-fiber releasing filters are widely applicable, including in cell culture media filtration, monoclonal antibodies, vaccines, and ophthalmic and parenteral production, with all Durapore® sterilizing filters undergoing 100% integrity testing during manufacturing.
- Guide: Millipore Express® Family Guide
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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