KleanAssure Sterilizing Capsule Filters Hydrophobic PTFE Membrane

China KleanAssure Sterilizing Capsule filters Hydrophobic PTFE membrane from MS are engineered for sterile gas and air vent filtration in bioprocess applications with SIP and hot gas exposure. This integrated capsule filter comes fitted with standard Staubli vent connection to facilitate convenient on-line integrity testing. Featuring high-flow hydrophobic PTFE membrane with broad chemical tolerance, every finished unit completes 100% integrity inspection to guarantee stable and reliable out-of-box filtration performance.

Core Product Features

1. SIP & hot gas resistant performance：Stable filtration performance for bioprocess conditions involving SIP cycles and hot gas exposure.

2. Broad chemical compatibility & moisture resistance：Highly adaptive hydrophobic PTFE membrane fits diverse process gas environments.

3. Verified sterile filtration efficiency：0.2μm pore size delivers reliable sterile gas and vent filtration for biomanufacturing.

4. On-line integrity testable：Standard Staubli vent port supports convenient in-situ integrity verification without disassembly.

5. 100% factory integrity tested：Every unit is fully inspected to ensure stable and consistent out-of-box performance.

6. High structural safety：Robust PP structure provides high burst pressure resistance for steady gas filtration operation.

7. Full biocompatibility & food safety compliant：Meets USP Class VI, FDA and EU food-contact standards for pharmaceutical and bioprocess use.

Product Application

Fermentation Tanks

Bio Bags

Pharmaceuticals

Gas filtration

Biologics

Antibiotics Venting

Serums

Food Safety Compliance

Food-Contact Regulations: Materials of construction comply with FDA 21 CFR requirements for food contact, and EU 10/2011 alignment is supported for materials used in filter media and hardware.

Construction Materials

Filter Media: PTFE

Media Support: Polypropylene

End Caps: Polypropylene

Inner Core: Polypropylene

Outer Cage: Polypropylene

Toxicity

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

Capsule Integrity

Minimum burst pressure: 123.5psi (8.5barg)

Integrity

Typical Flow Rate in gas/air, 2.5"

Quality Assurance

1. Compliant with USFDA 21 CFR 210.3(b)(6) for fiber release control

2. Meets USFDA 21 CFR 177.1520 requirements on fractional dissolution performance

3. Passed USP <88> in-vivo biological reactivity test, conforming to Class VI plastic standards

4. Completed USP <87> in-vitro biological reactivity assessment with qualified cytotoxicity performance

5. Fully compliant with EU (EC) No 10/2011 regulatory standards

KOSHER and HALAL certificates are available upon request where required.

Why Buyers Choose MS

When sourcing KleanAssure Sterilizing Capsule filters Hydrophobic PTFE membrane from MS, buyers gain access to complete support services:

Factory-direct manufacturing under standardized cleanroom production environments

Professional technical assistance and integrity testing supporting documentation

Multiple connection selections to match mainstream bioprocess gas interfaces

For ordering KleanAssure Sterilizing Capsule filters Hydrophobic PTFE membrane, specify pore size and connection

Ordering Information