Filtration of Serum and Plasma used in bioprocessing

Solutions that aid in the stability of serum and plasma products.

Introducing the newest member of the CPF Sterilizing product family, the DPPS Filter!

Critical Process Filtration Cartridge & Capsule FiltersOur 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.

PPS side by side layers (350 x 117 px)

Targeted bacteria retention.  DPPS filters deliver custom bacteria retention based on your fluids 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.

DPPS side by side layers (350 x 117 px)

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.HPPS side by side layers (350 x 117 px)

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.

PPC side by side layers (350 x 117 px)

Bioburden Reduction


Bioburden reduction, non-sterilizing. BPS Filters reduce microbials 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.

BPS side by side layers (350 x 117 px)

Mycoplasma


Mycoplasma control.  When your goal is mycoplasma reduction, all CPF sterilizing filters rated at 0.10 micron will reliably reduce mycoplasma in your fluids. When a validation of  >log 7  removal is required, choose any CPF sterilizing filter rated at 0.03 micron.

 

Tank Vent & Process Gas Filtration


Critical Process Filtration Tank Vent FilterProtecting tank contents and the environment. CPF's PTR Filters are hydrophobic sterilizing filters 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 and the environment in the surrounding work space.

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.

 

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Clarification & Prefiltration

Clarifying and prefiltering microbials and particulates found in serum and plasma will reduce the contamination load on the final filter. In processing applications where 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.

BCWPS side by side layers (350 x 117 px)

 

PGD side by side layers (2)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.  

 

HLP side by side layers (1)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.

 


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.