Sterilizing Junior Capsule Filters / PES membrane

Request pricing for Sterilizing Junior Capsule Filters / PES membrane from MS factory when your pilot scale or small batch process requires a validated sterile filtration step in a compact capsule format. The SPSTJC series is 100 percent integrity tested and constructed of double layer hydrophilic asymmetric polyethersulfone membrane, offering broad chemical compatibility, high flow rates at low pressure drops, and low extractables. Polyethersulfone is particularly suited for the filtration of products that contain substances that adsorb to the media, and the lower binding characteristics of PES make it a good choice for filtration of valuable protein solutions such as vaccines and biologicals.

The double layer asymmetric PES configuration combines an upstream pre filter layer with a downstream sterile retention layer, providing staged interception that improves loading tolerance and helps maintain stable throughput during longer filtration cycles. The compact junior format is ideal for clinical trial batches, pilot plant operations, and small volume production where full size capsules would create excessive hold up volume and product loss. Thermal bonding construction ensures adhesive free, low extractables performance that supports regulatory compliance.

Sterile Filtration Best Practices at Pilot Scale

Successful sterile filtration at pilot scale requires attention to several key practices that are often overlooked in small volume operations.

Pre wetting. PES membrane is naturally hydrophilic, but proper pre wetting with the process fluid or water for injection is essential to ensure complete membrane wetting and accurate integrity test results. Inadequate wetting is a common cause of false integrity test failures.

Upstream prefiltration. Even at pilot scale, installing a pre filter upstream of the sterile grade capsule reduces particulate load and extends the service life of the sterile filter. This is especially important for biological fluids that may contain cell debris or protein aggregates.

Pre use and post use integrity testing. Both tests are recommended for sterile filtration applications. The pre use test confirms the membrane is intact after installation and wetting. The post use test verifies that the membrane remained intact during the filtration cycle, which is critical for batch release documentation.

Pressure and flow control. Operating within recommended pressure and flow limits prevents membrane damage and ensures consistent retention performance. The junior capsule format is sensitive to pressure spikes during start up, so gradual pressurization is recommended.

Technical Specifications

Construction Materials

•Filter Membrane: PES

•Media Support: Polypropylene

•End Caps: Polypropylene

•Inner Core: Polypropylene

•Outer Cage: Polypropylene

•Sealing Method: Thermal Bonding

Food Safety Compliance

Material selection follows FDA 21 CFR food contact guidelines and EU 10/2011 standards, ensuring safe contact with food and beverage products during pilot scale sterile filtration.

Sanitization and Sterilization

•Filtered Hot Water: 90 degree C (194 degree F), 30 minutes, multiple cycles, max 3 psid forward flow

•Autoclave: 121 degree C (250 degree F), 30 min, multiple cycles

Integrity Data (Water Wetted Membrane)

Technology Transfer Path to Production Scale

One of the key advantages of the junior sterile PES capsule is its role as a bridge between laboratory filtration and full scale production. The same double layer asymmetric PES membrane and thermal bonding construction are used in the full size KleanCap Sterilizing Grade capsules, which means filtration performance characteristics such as flux, pressure drop, and loading capacity can be scaled with reasonable accuracy using filtration area ratios. This consistency reduces technology transfer risk and supports smoother regulatory filings when moving from clinical trial batches to commercial production.

MS factory technical team can provide scale up support including area ratio calculations, expected throughput at production scale, and recommendations for capsule configuration based on pilot scale data. This support helps process engineers design production scale filtration systems with confidence.

Documentation for GMP Compliance

For clinical and GMP pilot operations, MS factory provides a documentation package for Sterilizing Junior Capsule Filters / PES membrane that includes:

•100 percent integrity test records per batch

•Certificate of Analysis (COA) per batch

•Material compliance declarations for USP Class VI, FDA 21 CFR, and EU 10/2011

•Batch traceability certificates

•Recommended wetting and integrity test protocols

•Sanitization validation guidance

Additional documentation support can be discussed for regulatory submissions.

Typical Applications

Junior sterile grade PES capsules serve pilot scale cell culture media sterile filtration, clinical trial parenteral product sterile filtration, API clinical manufacturing sterile filtration, diagnostic reagent small batch sterile filtration, serum derived therapeutic sterile filtration, WFI and purified water pilot plant point of use sterile control, craft beverage cold sterile filtration, aseptic pilot filling for sensitive beverages, and specialty bottled water small scale sterile production.

Typical Flow Rate, 1 inch TC, 2.5 inch

Ordering Information