Buffer Filtration

Proven capsule filters for preparing high quality buffers used in biotechnology and pharmaceutical processing.

Critical Process Filtration capsule filters are used in single and multi-use use applications. Mini capsules are perfect for product development or smaller batches and CPF standard capsules (ranging from 2 to 30 inches in length) handle larger volumes. The PES membrane products below deliver fast flow and high retention. Our hydrophobic PTR Filter is designed for sterile tank vent and process gas applications.

Capsules 225x300
  • Sterilizing

  • Bioburden Control 

  • Clarification

  • Prefiltration

  • Endotoxin Removal

CPF buffer filtration solutions retain biological and particulate contaminants in buffers that are used in both upstream and downstream processing.

BPS Filters for bioburden control in buffer filtrationBCWPS Filters for particle removal in buffersSPS Filters for sterile filtration of buffersPPC Filters for endotoxin removal in buffersPTR 175 x 342-1

The core, cage and end fittings of all CPF capsule and mini-capsule devices are constructed from the same materials to ensure consistent performance from development through production.
Bacteria Retention Validation

CPF bacteria retention filters are validated using test procedures that comply with ASTM F 838-15(ae1) protocols for the determination of bacterial retention in filters used for liquid filtration. The challenge level is a minimum of 107 organisms per cm2 of filter media. CPF filters have > 7-log removal when challenged with the organisms listed below (0.03μm, 0.10μm and 0.22μm meet the FDA definition of sterilizing grade filters). 

  • 0.03μm: Acholeplasma laidlawii
  • 0.10μm: Brevundimonas diminuta
  • 0.22μm: Brevundimonas diminuta
  • 0.45μm: Serratia marcescens
  • 0.65μm: Saccharomyces cerevisiae

For mycoplasma, choose any of the sterilizing filters above in a 0.03 micron configuration.

Quality Assurance and Standards

Critical Process Filtration filters are designed for use in cGMP compliant processes. Our state-of-the-art manufacturing facility and quality-management system both meet ISO 9001:2015 standards. Each operation from assembly and test to cleaning, drying, and packaging is done in appropriately rated clean rooms, and each filter is assigned a lot code to ensure the traceability of manufacturing data and materials. A sophisticated MRP system collects and processes real-time data from manufacturing centers and inspection points. 

USP Biosafety and FDA Compliance

The materials used to construct pharmaceutical-grade filters are non-toxic and meet the requirements for the MEM Elution Cytotoxicity Test and the requirements for Biological Reactivity Tests in the current version of the United States Pharmacopeia (USP) for Class VI - 121 °C Plastics. Critical Process Filtration filters comply with Title 21 CFR sections 210.3 (b)(6) and 211.72, for non-fiber-releasing filters. The levels of bacterial endotoxins in aqueous extracts from pharmaceutical-grade filters are below current USP limits as specified for water for injection.