Cell Culture Media Filters

Assure product purity with quality filters that remove bacteria, mycoplasma and other harmful contaminants

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Develop superior cell culture media with sterilizing and clarification filters that scale from lab to production.

 

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Application Summaries

Filtration in the Preparation of Cell Culture Media and Buffers Used in Biopharmaceutical Operations

Tank Vent & Process Gas Filtration


 

Sterilizing & Bioburden Reduction

One of the most efficient ways to achieve sterile Cell Culture Media (CCM) is through highly efficient Polyethersulfone (PES) membrane filters. Critical Process Filtration's PPS Filters consist of a double layer of PES for the most critical applications and have low binding characteristics for filtering products with preservatives and protein solutions that can adsorb to media.

For increased capacity when filtering liquids with high particle loads, HPPS Filters provide a dual layer PES membrane configuration - an integrated prefilter layer with an asymmetric PES final filter. This 2-in-1, prefilter and sterilizing model is a good solution for combining multiple filtrations into a single step.

The life of the final filters is an important consideration as it pertains to premature clogging and cost. To protect these more expensive filters, reducing the bioburden load prior to reaching the final filter will improve its performance and assure sterile product and avoid extra changeouts. CPF's BPS Filters are available in PES single and dual layer configurations. They are designed to reduce bioburden contamination and are utilized in clarifying and prefiltering products with high proteins and preservatives. 

Where mycoplasma is an issue, CPF recommends 0.03 micron filters for capturing small deformable particles that might penetrate through a traditional 0.2 micron filter. Use of 0.03 micron filters in a validated process ensures sterile, mycoplasma-free serum and plasma.  

Clarification & Prefiltration

Particulates originating in natural and synthetic CCM ingredients are most efficiently removed with pleated depth media filters. These economical yet highly effective prefilters work to protect your more critical and expensive final filters. 

Characterized by its high flow rates and particle removal capability, our PGD Prefilters are made with pleated fiberglass depth media and have a high contaminant holding capacity. 

PPD Prefilters, constructed with pleated polypropylene depth media, are a great choice for retention of fine particles and have broad chemical compatibility for use in a variety of applications.  When dealing with fluids that have high solids content or contamination, CPF's HLP Prefilters,  which contain high-loft pleated polypropylene depth media, combine superior filtration capacity with exacting retention of fine particles.

Protecting tank contents and the process environment

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.

 

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.