KleanCap PES membrane Capsule Filters Sterilizing Grade

Request pricing for KleanCap PES membrane Capsule Filters Sterilizing Grade from MS factory when your process demands a validated sterile filtration step with high throughput and verifiable integrity. The filters are constructed of double layer hydrophilic polyethersulfone membrane in an all polypropylene capsule, offering broad chemical compatibility, high flow rate at low pressure drop, and low extractables. The double layer configuration provides staged interception in which the upstream layer captures larger contaminants while the downstream layer delivers final sterile retention, improving loading tolerance and reducing premature blockage in variable feed conditions.

The polyethersulfone membrane is particularly suitable for filtration of products containing substances that adsorb to membrane surfaces, and its low protein binding characteristics make it an excellent choice for filtration of valuable protein solutions such as vaccines, biologicals, and parenteral drugs. Each sterilizing grade capsule is 100 percent integrity tested before shipment, and the Staubli vent connection supports on line bubble point verification for routine production quality control.

Comparing PES to Other Sterile Filtration Membranes

When selecting a sterile grade membrane, buyers often evaluate PES against PVDF, PTFE, and Nylon. Each material has distinct strengths, and the right choice depends on your process fluid and priorities.

PVDF offers hydrophilic behavior with low protein adsorption and low extractables focus, making it a strong alternative for aqueous processing. PES typically provides higher flow rates at equivalent pressure drop and is widely established in biopharmaceutical sterile filtration.

PTFE is naturally hydrophobic and is typically evaluated first for hydrophobic gas venting or harsh solvent resistance. For aqueous sterile filtration, PTFE requires pre wetting and may not match the flow characteristics of naturally hydrophilic PES.

Nylon provides naturally hydrophilic start up and strong flow in many aqueous services, but can exhibit higher protein binding than PES. For protein containing solutions where yield recovery is critical, PES is frequently the preferred choice.

Technical Specifications

Materials of Construction

•Filter Media: Double Layer PES

•Media Support: Polypropylene

•End Caps: Polypropylene

•Inner Core: Polypropylene

•Outer Cage: Polypropylene

Food Safety Compliance

Construction materials meet FDA food contact requirements under 21 CFR and conform to EU Directive 10/2011 for materials intended to come into contact with foodstuffs during beverage and food processing.

Integrity Specifications (Wetted Membrane)

Validation Documentation Package

For sterile grade filtration, documentation is as important as the filter itself. MS factory provides a comprehensive package for KleanCap PES membrane Capsule Filters Sterilizing Grade:

•100% integrity test records per production batch

•Certificate of Analysis (COA) per batch

•USP Class VI (121°C) biocompatibility certificate

•FDA 21 CFR and EU 10/2011 compliance declaration

•Recommended wetting and integrity test protocols

For GMP procurement programs, additional documentation such as sterilization validation guidance can be discussed with our technical team.

Primary Applications

Sterilizing grade PES capsules are deployed across cell culture media sterile filtration, large volume parenteral final filtration, pharmaceutical bulk chemical sterile processing, diagnostics reagent sterilization, blood and serum fraction filtration, purified water and WFI point of use sterile control, cold sterile filtration of beer wine and spirits, aseptic juice and soft drink filling, and premium bottled water sterile production.

Frequently Asked Questions

Q: What does double layer mean for sterile filtration?

A: The double layer configuration combines an upstream pre filter layer with a downstream sterile retention layer. The upstream layer handles larger contaminants and reduces the load on the final sterile layer, which extends service life and helps maintain stable throughput during longer filtration cycles.

Q: How often should I perform an integrity test?

A: Industry best practice recommends pre use integrity testing to confirm the membrane is intact after installation, and post use testing to verify that the membrane remained intact during the filtration cycle. The Staubli vent connection on this capsule supports both tests without removal.

Q: Can this capsule be used for organic solvent filtration?

A: PES membrane offers broad chemical compatibility, but compatibility should be confirmed for each specific solvent and concentration. Contact MS factory technical support with your fluid details for a compatibility assessment.

Typical Flow Rate per 10 inch, 1.5 inch TC

Ordering Information