Buffer Preparation

Sterile filtration of buffers begins with the right strategy and proven filters that deliver results.

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Buffer sterile filtrationProducing the highest quality buffers for use in bio/pharmaceutical applications begins with validated bacteria removal filters that offer high flow rates and low pressure drops.

Filtration is critical in preparing buffers so that biological and particulate contaminants do not affect cell growth in a bioreactor or negatively impact the efficiency of chromatography columns.

Made from CPF's proprietary high capacity PES membrane, BCWPS Filters excel in protecting downstream filters. With its low binding characteristics, BCWPS filters are used for the clarification and prefiltration of products with high proteins and preservatives. Membrane based prefilters, such as the BCWPS offer greater retention than a depth filter.

Critical Process Filtration’s sterilizing SPS Filters consists of 0.2 micron filters constructed with a single layer Polyethersulfone (PES) membrane. SPS filters' low binding, broad pH and chemical compatibility perform well with many types of buffers. They deliver faster processing times with high flow rates and low pressure drops. To achieve greater flow rates, the SPS/HA model with an increased filtration area delivers your best performance. 

For bioburden control, our BPS Filters, consisting of a single or double layer PES membrane, have low-binding characteristics making them a good fit for clarifying and prefiltering products. 

When endotoxin removal is needed, CPF's PPC Sterilizing Filter and GPC Prefilter are both positively charged to remove gram-negative bacteria debris.

CPF's PTR Filters can prevent environmental and process gas sources of bacteria and contaminants. These hydrophobic sterilizing filters are made with Polytetrafluoroethylene (PTFE) membrane to capture microbials as air/gas enters a tank. Likewise, as air/gas is released from the tank, the PTR filter protects operators in the surrounding work space.

Product sizes scale for lab use, process development and production arena, and are available in cartridges and single-use capsules.

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.