Sterilizing Capsule Filters Hydrophobic PTFE Membrane

MS Sterilizing Capsule filters Hydrophobic PTFE membrane is specially engineered for absolute sterile gas and air filtration requirements in GMP-compliant pharmaceutical, biotech, and fermentation production lines. Different from conventional bio-burden reduction filters for daily pollution control, this sterilzing model adopts a unique double-layer PTFE membrane design with a coarse-to-fine gradient filtration structure, achieving 100% reliable interception of bacteria, spores, and ultrafine microbial contaminants to meet industrial sterile production standards.

All sterilizing capsule filters undergo strict 100% individual integrity testing before shipment to ensure consistent sterile filtration performance in high-standard production environments. Equipped with a standard Staubli vent port, the filter supports convenient on-line integrity testing without disassembly, simplifying factory validation procedures and daily operational maintenance. With excellent chemical inertness and stable pressure resistance, this double-layer PTFE filter adapts to long-term continuous sterile venting and gas purification in complex bioprocess working conditions.

Product Features

- Double-Layer PTFE Gradient Filtration: 

Adopts independent double-layer hydrophobic PTFE membrane structure with coarse pre-filtration and fine precision filtration design, effectively improving dirt holding capacity, reducing filter clogging, and extending service life compared with single-layer filters.

- Absolute Sterile Retention Performance: 

Professional sterilizing-grade membrane ensures complete interception of airborne microorganisms, spores, and fine particulates, fully meeting the strict sterile requirements of pharmaceutical and biologic production processes.

- High Flow & Low Pressure Drop: 

Optimized pleated membrane structure provides large filtration area and stable gas throughput, maintaining low pressure drop during long-term operation to improve production efficiency.

- Excellent Chemical Inertness: 

Pure hydrophobic PTFE material resists various corrosive gases, organic vapors and process media, avoiding chemical reaction or medium contamination to ensure production safety.

- Support On-Line Integrity Verification: 

Integrated Staubli vent connection realizes in-situ integrity testing, convenient for GMP workshop daily validation, batch monitoring and quality traceability.

- Full Batch Quality Assurance: 

100% factory integrity tested for each product, with stable batch consistency and zero unqualified products, suitable for high-standard sterile continuous production.

Typical Application

Fermentation Tanks – Aseptic vent filtration

Bio Bags – Sterile gas protection

Pharmaceuticals – Process gas purification

Gas filtration – High purity sterile air treatment

Biologics – Production air sterilization

Antibiotics Venting – Microbial contamination control

Serums – Aseptic process gas handling

Food Safety Compliance

Food and Beverage Contact: For food-contact use, materials comply with FDA 21 CFR and are aligned with EU 10/2011 requirements.

Materials of Construction

Filter Media: Double layer PTFE

Media Support:  Polypropylene

End Caps:    Polypropylene

Inner Core:   Polypropylene

Outer Cage:   Polypropylene

Filtration Area： 6500cm^2/10"

Capsule Integrity

Minimum burst pressure:123.5psi(8.5barg）

Toxicity

All wetted structural materials pass strict USP Class VI (121℃) plastic biocompatibility evaluation, with non-toxic properties and no biological irritation, fully compliant with biological and pharmaceutical sterile production safety standards.

Integrity

Typical Flow Rate in gas/air, 10"

Quality and Compliance

1.USFDA 21 CFR 210.3(b)(6):

All wetted components satisfy non-fiber releasing requirements. No fiber shedding occurs during operation to prevent secondary contamination of process fluid and guarantee production purity.

2.USFDA 21 CFR 177.1520:

Polypropylene construction materials comply with olefin polymer specifications, limiting substance migration and meeting standards for indirect food-contact applications.

3.USP <88> Biological Reactivity Tests, In vivo, Class VI Plastics:

Raw materials pass in-vivo biological assessment under 121°C conditions, demonstrating low toxicity and safe deployment in biopharmaceutical workflows.

4.USP <87> Biological Reactivity Tests, In vitro, cytotoxicity tested:

Materials complete standardized in-vitro cytotoxicity evaluation, presenting no adverse cellular reactions for biological media contact.

5.EU Regulation (EC) No 10/2011 compliant:

Plastic components fulfill EU requirements for plastics contacting food, supporting safe use within food processing and edible bioprocess production.

KOSHER and HALAL certificates can be provided as part of your document package.

Product Selection Guidance

This double-layer PTFE sterilzing capsule filter is dedicated to absolute sterile process gas filtration scenarios, which is the core difference from conventional bio-burden reduction filters. It is the preferred choice for pharmaceutical sterile production, fermentation aseptic venting, and high-standard biologic manufacturing that require zero microbial contamination. The unique double-layer gradient structure effectively enhances dirt holding capacity and avoids frequent filter replacement, perfectly matching long-cycle sterile industrial production needs.

Supply and Support

As a professional manufacturer of sterile-grade capsule filters, MS provides one-stop customized services for this double-layer PTFE sterilizing filter:

- Factory direct sales with imported high-purity PTFE membrane raw materials to ensure stable sterile filtration performance

- Various interface configurations and customized structural solutions for different sterile production skids

- Complete GMP validation documents and professional integrity test technical support

- OEM private label and batch customized production services to support customer brand building

- Standby equipment to accommodate increased order volumes

To order Sterilizing Capsule filters Hydrophobic PTFE membrane, specify pore size, connection, and configuration.

Ordering Information