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Life Sciences

Sterile Filtration for Bioprocessing

POREX BIOSOLUTIONS

Porex Sterilizing & Bioburden Reduction Filters

Since 1961, Porex has been a global leader in porous plastic solutions. Our materials are used by many of the big names in filtration.  Now Porex BioSolutions is taking that same expertise, combined with a team of industry veterans, to offer sterilizing grade and bioburden reduction filters for bioprocessing.

Our promise:

Validated performance
Our filters undergo rigorous testing and validation to ensure performance and reliability.

Precision manufacturing
Manufactured in a clean room facility, our filters adhere to ISO9001 and GMP standards. Each filter is integrity tested and comes with a Certificate of Quality.

Exceptional service
We are committed to providing superior service. Through continuous diligence, we maintain short lead times and responsive support to meet your needs efficiently.

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Filter Formats

Porex BioSolutions filters are available in a variety of formats and sizes, facilitating the seamless scalability from small volume filtrations to full-scale processes. Available in 0.2/0.2μm and 0.45/0.2μm dual-layer sterilizing grades, as well as 0.2μm, 0.45μm and 0.8μm single-layer bioburden reduction grades as standard configurations. Other sizes/configurations are available upon request.

Cartridges

Available non-sterile in two sizes with effective filtration area (EFA) of 0.28 and 0.56 m2. Connection formats are available in flat, fin, 222 and 226 end caps.

Capsules

Available sterile and non-sterile, offered with EFA ranging from 0.097 to 0.56 m2. Connection formats are available in multiple sanitary flange fittings (1” and 1.5” for capsules; ¾” and 1” for mini capsules) and multiple hose barb sizes (1/4” and 1/2” for capsules; ¼”, 3/8” and ½” for mini capsules).

Key Features & Applications

  • High-capacity, high-flux hydrophilic PES membranes. 
  • 100% integrity tested, with guaranteed reliability, consistency, and repeatable filtration performance 
  • Validated for bacteria retention greater than 7 LRV for sterilizing grade filters. 
  • Expanded surface area and capacity, enhancing process efficiency and economy, resulting in a longer service life, reduced change-outs, and decreased operating costs. 
  • Superior throughput in challenging, high fouling streams, including those containing media and proteins. 
  • 100% thermally bonded materials, incorporating ultrapure polypropylene supporting materials to minimize leachables, eliminate fiber migration and shedding. 
  • Broad chemical compatibility across a wide pH range (1-14), making it compatible with caustic solutions. 
  • Materials comply with safety and biocompatibility requirements including CFR Title 21 (include BSE/TSE and fiber shedding), ROHS, REACH, in vitro cytotoxicity (ISO® 10993-5), USP Class VI and low extractables standards.
  • Sterilization options are available. Capsules can be provided pre-sterilized by Gamma irradiation. Non-sterile capsules and cartridges can be sterilized by steam or autoclave.
  • Validation Guide is available upon request, providing comprehensive information on the product’s performance and capabilities.
  • Buffers 
  • Cell culture media, supplements, additives and feeds 
  • CIP and WFI water 
  • Harvest clarification and intermediate process steps of Biotherapeutics including mAbs, recombinant proteins, vaccines, viral vectors, etc 
  • Plasma and serum 
  • Chromatography protection – packed resin & membrane 
  • Small volume parenteral (SVP) 
  • Large volume parenteral (LVP)

 

  • 100% integrity tested
  • Identified by lot for traceability
  • Meets USP<88> Biological Reactivity test in vivo, for class VI plastics
  • Meets the criteria for extractables per USP Physiochemical Tests for Plastics, and USP Oxidizable Substances.
  • Non-cytotoxic per MEM elution ISO® 10993-5
  • Meets the criteria for a non-fiber releasing filter per 21 CFR 210.3 (b)(6)
  • Pass USP <85> Bacteria Endotoxins(< 0.25 EU/mL)

Download the specification table here

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porous filter image for background

Looking for custom porous media options for
bioprocessing applications?

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Technical Resources

Brochure

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Performance Guide

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Instructions for Use

Capsule
Cartridge

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Reach out to our Porex BioSolutions team with any questions.

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