KleapCap T-line PES membrane Capsule Filter Sterilizing Grade

Request a quote for KleapCap T-line PES membrane Capsule Filter Sterilizing Grade from MS factory when you need sterile oriented PES filtration in a compact inline form factor. 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 contaminant capture in which the upstream pre filter layer handles larger particles while the downstream layer delivers final sterile retention, improving loading tolerance and helping maintain stable throughput during longer filtration cycles.

The T-line geometry is purpose built for inline integration, with aligned inlet and outlet connections that reduce piping complexity and save valuable skid space. This format is particularly valuable for filling machines, modular process skids, and compact production systems where conventional capsule housings cannot fit. The Staubli vent connection supports on line integrity testing to validate sterile performance without disassembly, which is essential for aseptic processing environments.

Process Risk Control Scenarios

Sterile filtration is a critical control point in many production processes, and the choice of filter format directly impacts risk management. In compact filling and transfer systems, the T-line sterile capsule helps reduce particulate related defects and supports consistent downstream operations by providing validated bacterial retention in a format that fits within existing equipment footprints.

Pharmaceutical aseptic filling. In aseptic filling lines, cabinet space is tightly controlled and every component must support sterility assurance. The T-line format integrates directly into filling machine piping without requiring additional housing space, and the on line integrity test capability supports pre use and post use validation routines that are essential for sterility assurance.

Biologics production. The staged double layer membrane structure helps keep throughput stable during longer filtration runs of biological fluids, where variable particulate loading can cause premature blockage in single layer alternatives. Low protein binding PES protects product yield throughout the filtration cycle.

Beverage aseptic processing. For sensitive beverages where heat pasteurization is undesirable, cold sterile filtration with the compact T-line capsule provides a space efficient solution that fits within existing aseptic filling equipment.

Technical Specifications

Construction Materials

•Filter Media: Polyethersulfone Double Layer

•Media Support: Polypropylene

•End Caps: Polypropylene

•Inner Core: Polypropylene

•Outer Cage: Polypropylene

Food Safety Compliance

Food contact safety is assured through compliance with FDA 21 CFR regulations and EU 10/2011 material standards for all wetted components of this sterile grade capsule.

Integrity Specifications (Wetted Membrane)

Validation Documentation Package

For sterile grade filtration, documentation is as important as the filter itself. MS factory provides a comprehensive validation documentation package for KleapCap T-line PES membrane Capsule Filter Sterilizing Grade that includes:

•100 percent integrity test records per production batch

•Certificate of Analysis (COA) per batch

•Material compliance declarations for USP Class VI 121 degree C

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

•Batch traceability certificates linking raw material lots to finished units

•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

T-line sterile grade PES capsules serve cell culture media sterile filtration in compact bioreactor feed systems, large volume parenteral filling in restricted cabinet space, pharmaceutical bulk chemical sterile processing in transfer modules, diagnostics reagent sterile filtration in automated filling equipment, blood and serum fraction sterile filtration, purified water and WFI point of use sterile control in compact distribution modules, cold sterile filtration of craft and premium beverages, and aseptic juice and soft drink filling.

Typical Flow Rate per 10 inch, 1.5 inch TC

Ordering Information