KleanCap PES membrane Capsule Filters BioBurden-Reduction Grade

1) KleanCap PES membrane Capsule Filters BioBurden-Reduction Grade

Summary

Source KleanCap PES membrane Capsule Filters BioBurden-Reduction Grade from MS factory for high throughput bio burden control in aqueous process liquids where verifiable retention and routine integrity testing are operational priorities. This full size capsule combines single layer hydrophilic PES membrane, 0.6 m² filtration area per 10 inch, and a Staubli vent connection that enables on line integrity testing without capsule removal, supporting documented quality routines in pharmaceutical and food beverage production.

Introduction

Order KleanCap PES membrane Capsule Filters BioBurden-Reduction Grade from MS factory when your process needs a full size, high area PES capsule that emphasizes bacterial load reduction and practical validation routines. The capsule is constructed with a single layer hydrophilic polyethersulfone membrane in an all polypropylene hardware design, offering broad chemical compatibility, high flow rate at low pressure drop, and low extractables. The polyethersulfone membrane is particularly suitable for filtration of products containing substances that tend to adsorb to membrane surfaces, and its low protein binding characteristics make it a dependable choice for valuable protein solutions such as vaccines and biologicals.

The defining engineering feature of this capsule is the Staubli connection at the vent port, which transforms integrity testing from a laboratory procedure into a routine production step. Operators can perform bubble point tests while the capsule remains installed in the housing, eliminating disassembly, reducing handling contamination risk, and shortening the time between test initiation and result documentation. For production facilities that run multiple shifts and require integrity records per batch, this capability directly reduces downtime and supports consistent audit readiness.

Performance Specifications

222

Materials of Construction

•Filter Media: Polyethersulfone (PES)

•Media Support: Polypropylene

•End Caps: Polypropylene

•Inner Core: Polypropylene

•Outer Cage: Polypropylene

Food Safety Compliance

All materials in contact with food are manufactured in accordance with FDA 21 CFR and EU 10/2011 regulations, ensuring safe use in food and beverage processing environments.

Integrity Test Data (Wetted Membrane)

PES Capsule Filter

Application Scenarios by Industry

Cell Culture Media. In biopharmaceutical media preparation, bio burden reduction capsules are installed upstream of sterilizing grade filters to lower incoming microbial load and extend the service life of final sterile membranes. The high 0.6 m² area per 10 inch supports long production batches without premature pressure rise.

Large Volume Parenterals. For intravenous solution manufacturing, upstream bio burden control is a critical component of the sterility assurance strategy. This capsule reduces microbial count before final sterile filtration, lowering the challenge to the sterilizing grade membrane.

Beer, Wine and Spirits. In beverage production, the low protein binding PES membrane reduces microbial load without adsorbing flavor active compounds, helping maintain product taste and aroma while extending shelf stability after filling.

Bottled Water. High throughput bottled water lines benefit from the large filtration area and stable flux of this capsule, which provides consistent bio burden reduction at production flow rates with manageable changeout frequency.

Additional applications include pharmaceutical bulk chemical solutions, diagnostics reagent preparation, blood and serum fractions, purified water distribution, and juice and soft drink pre filling filtration.

Certificates and Test Reports

MS factory provides the following documentation for KleanCap PES membrane Capsule Filters BioBurden-Reduction Grade:

•ISO 9001 quality management system certificate

•USP Class VI (121°C) biological safety test report

•Integrity test (bubble point) report per production batch

•Certificate of Analysis (COA) with batch traceability

•FDA 21 CFR and EU 10/2011 food contact compliance declaration

Batch Traceability

Every production batch of KleanCap PES membrane Capsule Filters BioBurden-Reduction Grade is assigned a unique identifier that links raw material lot numbers, production date, integrity test results, and shipment records. For buyers who require serialized unit tracking, we can discuss custom labeling and documentation programs.

Typical Flow Rate per 10 inch, 1.5 inch TC

Ordering Information