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Biopharm High-Capacity PVDF Capsules

Biopharm High-Capacity PVDF Capsules

Biopharm High-Capacity PVDF Capsules

Product catalog summary
Construction Materials
BPVWL Capsule Filters are constructed using polypropylene for the housing, media support, end caps, center core, and outer support cage. The filtration media is a high capacity polyvinylidene fluoride (PVDF) membrane, and the sealing method is thermal bonding.
Applications
These filters are suitable for use with buffers, feedstocks, SVPs, WFI water, LVPs, serum, vaccines, and plasma products.
Maximum Operating Parameters
Liquid operational pressure is 80 psi at 20°C, and gases operational pressure is 60 psi at 20°C. The operating temperature is 43°C at 30 psi in water. Forward differential pressure is 50 psid, and reverse differential pressure is 40 psid. The recommended changeout pressure is 35 psid.
Pore Size and Flow Rate
Pore sizes range from 0.22 μm to 1.0 μm, with corresponding flow rates in GPM and LPM provided for each size.
Filtration Area
The filtration area varies with capsule length, from 1.0 ft² for a 2” capsule to 18.0 ft² for a 30” capsule.
Performance and Features
BPVWL capsules offer bioburden reduction, excellent flow rates, minimal leachables and extractables, and low adsorption of proteins and preservatives. They are designed for critical applications in biopharmaceutical production.
Sanitization/Sterilization
Capsules can be autoclaved at 250°F for 30 minutes and sanitized with industry-standard chemicals. They are available in pre-sterilized and non-sterilized forms.
Compliance and Quality Assurance
Materials meet USP and FDA requirements for non-toxicity and are suitable for repeated food contact. The manufacturing process adheres to ISO 9001:2008 standards, ensuring high quality and traceability.
Ordering Information
Capsules can be ordered with specific micron ratings, sterilization status, lengths, and inlet/outlet configurations. Example order number format is provided.
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Catalog excerpts

Biopharm High-Capacity PVDF Capsules-1

BPVWL Capsule Filters High Capacity PVDF Membrane Applications Buffers and Feedstocks Plasma Products Applications for BPVWL capsule filters are bioburden reduction in buffers and media, water for injection (WFI), solvents, alcohols and other liquids. Our capsules provide high efficiency, validatable performance to protect downstream processes and sterilizing filters. Bioburden reduction in multiple biologicals applications Excellent flow rates with high throughput D esigned for minimal leachables and extractables PVDF is particularly suited for the filtration of products containing elements that can adsorb to the media, such as preservatives and proteins. The very low binding nature of PVDF makes it a good choice for filtration of valuable protein solutions as well as products that contain low amounts of preservatives. Low adsorption of proteins and preservatives BPVWL Capsule Filters - Filtration Area Capsule Length High Capacity PVDF Membrane Flow Rate / Filtration Area The following table represents typical water flow at a one psi (69 mbar) pressure differential across a single 2 inch capsule with 1.0 ft² (930 cm²) of media with 1/2” FNPT ports. The test fluid is water at ambient temperature. Higher pressure drops are acceptable, but as flows increase the pressure drop of the housing becomes more apparent. 0.22 μm Pore Size * For approximate flow rates for 5” through 30” capsules, refer to the appropriate cartridge data sheet Construction Materials Maximum Operating Parameters Liquid Operational Pressure Filtration Media High Capacity Polyvinylidene fluoride (PVDF) Membrane Gases Operational Pressure Operating Temperature Media Support Forward Differential Pressure 50 psid (3.4 bard) at 20 °C (68 °F) Center Core Reverse Differential Pressure Outer Support Cage Sealing Method Thermal Bonding Recommended Changeout Pressure Biopharmaceutical Grade BPVWL capsules are made using high capacity hydrophilic polyvinylidene fluoride (PVDF) membrane. The proprietary membrane casting process creates a thick membrane with a high capacity to hold contaminants, excellent retention characteristics, high flow rates and low protein binding. BPVWL capsules are used for critical applications in the processing of a wide range of liquids in biopharmaceutical production.

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Biopharm High-Capacity PVDF Capsules-2

Biopharmaceutical grade filters typically exhibit low levels of non-volatile residues. The materials used to construct BPVWL capsule 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. In addition, the materials meet the requirements listed by the FDA as appropriate for use in articles intended for repeated food contact as specified in Title 21 CFR sections 174.5, 177.1500, 177.1520, 177.1630, 177.2440, and 177.2600...

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