Bio-Burden Reduction Junior Capsule Filters / PES membrane

Order Bio-Burden Reduction Junior Capsule Filters / PES membrane from MS factory when you need a compact, sanitizable PES capsule for pilot scale production, small batch processing, or research and development applications. The SPBRJC series is 100 percent integrity tested and ensures bio burden and small particle removal in a wide range of food and beverage, biological liquids, and intermediate bulk pharmaceutical fluids. Constructed of a single layer hydrophilic asymmetric polyethersulfone membrane, it offers broad chemical compatibility, high flow rates at low pressure drops, and low extractables.

The asymmetric PES membrane structure features a more open upstream side that captures larger contaminants and a tighter downstream side that provides fine retention, combining high dirt holding capacity with reliable bio burden reduction. Thermal bonding sealing eliminates adhesives and supports low extractables performance, while the compact junior format is ideal for applications where full size capsules would result in excessive hold up volume and product waste. For high value biologicals and pharmaceutical intermediates produced in small batches, every milliliter of hold up volume directly impacts yield, making the junior format an economically rational choice.

Thermal Bonding Construction and Why It Matters

Unlike capsule filters that use adhesives or solvents to seal the membrane pack, this junior PES capsule uses thermal bonding to fuse the membrane, support layers, and end caps into a single integrated structure. This construction method eliminates adhesive channels that could create bypass paths, reduces the potential for extractables from adhesive materials, and provides a more consistent seal that maintains integrity through repeated sanitization cycles. For buyers who perform extractables testing or who operate under strict cleanliness requirements, thermal bonding is a preferred construction technology.

Sanitization Validation for Repeated Use

The junior PES capsule is designed to support repeated sanitization cycles, which is important for pilot and small batch operations where single use filters may be cost prohibitive. Two sanitization methods are supported:

Filtered hot water. 90 degree C (194 degree F) for 30 minutes, multiple cycles, with maximum 3 psid forward flow. This method is suitable for facilities with hot water sanitization systems and is commonly used for food and beverage and pharmaceutical water applications.

Autoclave. 121 degree C (250 degree F) for 30 minutes, multiple cycles. Autoclaving provides a higher level of microbial kill and is preferred for biopharmaceutical and clinical applications where thermal resistance of organisms is a concern.

When planning repeated sanitization, buyers should consider the cumulative effect of cycles on membrane integrity and housing materials. MS factory can provide guidance on expected cycle life based on your specific sanitization parameters and fluid conditions.

Technical Specifications

Construction Materials

•Filter Membrane: PES

•Media Support: Polypropylene

•End Caps: Polypropylene

•Inner Core: Polypropylene

•Outer Cage: Polypropylene

•Capsule: Polypropylene

•Sealing Method: Thermal Bonding

Food Safety Compliance

The capsule is built with materials that conform to FDA 21 CFR food contact regulations and EU 10/2011 directives for food processing use, supporting safe deployment in food and beverage pilot operations.

Integrity Data (Water Wetted Membrane)

Scale Up from Pilot to Production

The junior PES capsule serves as an effective tool for process development and scale up studies. Because it uses the same asymmetric PES membrane technology and thermal bonding construction as the full size KleanCap production capsules, data generated at junior scale can be used to predict performance at production volume with reasonable confidence. This reduces the risk of unexpected performance changes during technology transfer from pilot to manufacturing. MS factory technical team can assist with linear scale up calculations based on filtration area ratios, helping you determine the number and size of production capsules required to match your pilot scale performance parameters.

Quality and Certification

MS factory provides the following for Bio-Burden Reduction Junior Capsule Filters / PES membrane:

•100 percent integrity test per unit

•USP Class VI (121°C) biocompatibility report

•FDA 21 CFR and EU 10/2011 compliance declaration

•Thermal bonding process validation summary

•Batch traceability certificate

Typical Applications

Junior bio burden reduction PES capsules are used for pilot scale cell culture media preparation, small batch parenteral product development, clinical trial API filtration, diagnostic reagent small batch production, serum derived product filtration, pilot plant purified water point of use control, craft beverage small batch filtration, juice and soft drink pilot filling, and specialty bottled water small production runs.

Typical Flow Rate, 1 inch TC, 2.5 inch

Ordering Information