Bio-burden Reduction Capsule Filters Hydrophobic ePTFE Membrane

China quality Bio-burden Reduction Capsule filters Hydrophobic ePTFE membrane from MS are professionally engineered for routine vent filtration and process gas protection in pharmaceutical, biotech and fermentation production lines. Constructed with premium single-layer expanded PTFE membrane, the filter features broad chemical compatibility and excellent airflow throughput while maintaining a low pressure drop throughout continuous operation.

Each finished capsule undergoes strict 100% integrity testing before shipment to ensure consistent and repeatable filtration performance. Adopting full thermal bonding sealing technology without adhesive additives, this bio-burden reduction filter effectively avoids medium contamination, serving as a stable and cost-effective pre-protection and gas purification solution for various sterile process air systems.

Product Features & Functional Advantages

- High-Performance ePTFE Membrane: Single-layer expanded PTFE structure ensures uniform pore distribution, realizing efficient bio-burden reduction and stable fine particle interception.

- High Flow & Low Pressure Drop: Optimized membrane structure delivers excellent gas throughput, reducing system operating pressure and improving overall process efficiency.

- Ultra-Low Extractables & Non-Fiber Releasing: High-purity raw materials prevent fiber shedding and substance migration, effectively protecting process gas purity.

- Full Thermal Bonding Structure: Adhesive-free thermal bonding sealing eliminates secondary contamination risks, ensuring safe and sanitary filtration.

- 100% Integrity Tested: Full-batch factory integrity inspection guarantees stable out-of-box performance and consistent batch quality.

- Reusable Sanitary Performance: Supports multiple cycles of hot water sanitization and autoclave sterilization, adapting to long-term cyclic production use.

- Food-Grade Compliance: Fully meets FDA and EU food-contact standards, applicable for food and beverage related bioprocess gas filtration.

Typical Application

Fementer

Formulation Tank air feed

RO and WFI storage tank

Fermentation air feed

Container purge air

Aspetic packaging air

Food Safety Compliance

Food Contact Compliance: Materials comply with FDA 21 CFR for food-contact applications and are consistent with EU 10/2011 requirements for materials used in media and hardware.

Construction Materials

Filter Membrane: PTFE

Media Support: Polypropylene

End Caps: Polypropylene

Inner Core: Polypropylene

Outer Cage: Polypropylene

Sealing Method: Thermal Bonding

Benefits

100% integrity tested

FDA food contact compliant

Thermal bonding

Non-fiber releasing

Filter Area

H: 550cm^2    S: 1150cm^2    L: 2450cm^2

Toxicity

Components comply with USP Class VI (121℃) plastics biocompatibility requirements.

Sanitization/Sterilization

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

Autoclave 121°(250 °F), 30 min, multiple cycles.

Integrity （Water wetted membrane）

Typical Flow Rate, 1"TC, 2.5"

Quality and Compliance

USFDA 21 CFR 210.3(b)(6) fiber release compliance

USFDA 21 CFR 177.1520 fractional dissolution compliance

Passes USP <88> in vivo biological reactivity tests and reaches Class VI plastic grade

Passes USP <87> in vitro biological reactivity and cytotoxicity tests

Compliant with EU Regulation (EC) No 10/2011

KOSHER and HALAL certificates are available upon request for regulated projects.

Factory Support for SPBRJC Programs

MS provides reliable full-process supporting services for Bio-burden Reduction Hydrophobic ePTFE Capsule Filters, fully meeting SPBRJC program and industrial batch procurement demands:

- Genuine factory-direct supply with flexible OEM production and private labeling options

- Diversified connection options covering mainstream vent and gas-line interface specifications

- Strict full-process quality control system, covering incoming material inspection, in-process monitoring and final pre-dispatch inspection

For ordering Bio-burden Reduction Capsule filters Hydrophobic ePTFE membrane, please select pore size option and connection.

Ordering Information