Solutions that aid in the stability of serum and plasma products.
Our proven filters are used in the retention of bacteria, mycoplasma, endotoxins, and other unwanted contaminants in serum and plasma.
Designed with configuration flexibility, your filters will have the right combination of media, layers, and pore sizes based on the fluid's makeup and contamination levels.
CPF application engineers will assist you in choosing the right filter, and testing your fluids with our products when necessary.
- No need to search through a myriad of products with preconfigured filters
- Configuring the best-fit filter improves filtration efficiency
- Avoid expensive product loss with targeted filter performance
Sterilizing
Sterilizing insurance. Our PPS Filters are recommended for the most stringent and critical applications to insure 100% bacteria retention. This filter’s media consists of two identical, hydrophilic membranes. Pore sizes range from 0.03 to 1.2 µm.
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Targeted bacteria retention. DPPS filters deliver custom bacteria retention based on your fluid load. You choose the pore sizes of both the prefilter and final layer to achieve targeted results. The prefilter acts as both a bioburden reduction and particle-removing filter.
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Sterilizing fluids with high particle loads. CPF’s HPPS Filters handle increased capacity and high particle loads with an integrated prefilter for particle removal and a sterilizing final filter. This dual-layer model reduces two filtration steps into one..png?width=350&name=HPPS%20side%20by%20side%20layers%20(350%20x%20117%20px).png)
Sterilizing & endotoxin removal. The PPC Filter consists of a double-layer sterilizing membrane for stringent bacteria retention and it has been positively charged to remove any gram-negative bacteria debris. If sterilizing is not needed, the GPC Filter is a single-layer, positively charged filter that will retain fine particles and endotoxins.
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Bioburden Reduction
Bioburden reduction, non-sterilizing. BPS Filters reduce microbial in aqueous liquids when sterilizing is not required. These hydrophilic filters are available in single and dual-layer configurations with a choice of pore sizes for each layer to provide the right level of retention.
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Mycoplasma
Mycoplasma control. When your goal is mycoplasma reduction, all CPF sterilizing filters rated at 0.10 microns will reliably reduce mycoplasma in your fluids. When validation of >log 7 removal is required, choose any CPF sterilizing filter rated at 0.03 microns.
Tank Vent & Process Gas Filtration
Protecting tank contents and the environment. CPF's PTR Filters are hydrophobic sterilizing filters made with Polytetrafluoroethylene (PTFE) membrane to capture microbial as air/gas enters a tank. Likewise, as air/gas is released from the tank, the PTR filter protects operators and the environment in the surrounding workspace.
Prefiltration is the key to lowering costs while adding filters to offload and protect the final filters.
CPF prefilters can be standalone (from one to many filters), or integrated into the main filter.
Clarification & Prefiltration
Clarifying and prefiltering microbial and particulates found in serum and plasma will reduce the contamination load on the final filter. In processing applications where the sterile product is critical and final filters carry the greatest cost, CPF prefilters do the bulk of filtration, resulting in:
- fewer changeouts
- extending the life of your sterilizing filters
- lower overall filtration costs
High particle loads. BCWPS Filters, made from CPF's proprietary high-capacity PES membrane, 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 prefilters, such as the BCWPS offer greater retention than a depth filter.
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High flow and particle removal. Our PGD Prefilters are made with pleated fiberglass depth media and have a high contaminant holding capacity while still delivering high flow rates.
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The heavy solids content and contamination. CPF's HLP Prefilters, constructed with high-loft pleated polypropylene depth media, combine superior filtration capacity with exacting retention of fine particles.
Products
Brochure: Life Science Products
Application Summary
Prefiltration and Sterilizing Filtration of Plasma-Based Products
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 of 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.