KleanAssure Capsule Filters Bio-burden Reduction PTFE Membrane

The quality KleanAssure Capsule filters Bio-burden Reduction PTFE membrane from MS are engineered for daily gas filtration and bioburden control in pilot bioprocess, pharmaceutical and fermentation workflows. Constructed with premium single-layer hydrophobic PTFE membrane, this disposable filter achieves steady removal of airborne fine particles, bacteria and spores without obstructing normal gas circulation.

Distinct from sterilzing capsule filters for absolute sterile retention, KleanAssure series focuses on economical routine protection, pre-filtration and non-critical gas vent scenarios. Each unit is fully inspected before delivery to maintain consistent filtering effects in daily production. Equipped with standard Staubli vent port, the capsule supports in-situ integrity testing, simplifying validation work and lowering maintenance workload for manufacturers.

Key Features & Functional Advantages

1. Stable Hydrophobic PTFE Membrane Performance: Inherent water repellent structure prevents blockage caused by vapor condensation, sustaining steady high gas flow and low pressure drop during continuous operation.

2. Effective Bio-burden Control Capacity: Capable of intercepting airborne spores, bacteria and micro particles, offering dependable contamination prevention for bioreactors, disposable bio bag systems and pilot production lines.

3. Broad Chemical Compatibility & Low Extractables: Resists organic vapors and corrosive process gases. Ultra-low extractable substances avoid medium pollution and protect final product quality.

4. In-situ Integrity Test Available: Integrated Staubli vent connector enables integrity testing without filter disassembly, facilitating regular validation in GMP-compliant workshops.

5. 100% Factory Integrity Inspection: Strict individual testing before shipment ensures uniform performance across batches and reduces risks of defective products.

6. Reinforced All-PP Construction: Integrally molded polypropylene framework provides high burst resistance and adapts to environments with fluctuating gas pressure.

Typical Applications

Fermentation Tanks – Routine vent protection

Bio Bags – Process gas bioburden control

Pharmaceuticals – Pilot scale gas purification

Gas filtration – Low-to-medium purity air treatment

Biologics – Lab & pilot production air shielding

Antibiotics Venting – Pre-filtration protection

Serums – Small batch process gas handling

Food Safety Compliance：

Regulatory Food Contact: Materials comply with FDA 21 CFR for food-contact applications, and conformity with EU 10/2011 is supported for materials used to produce the filter media and hardware.

Toxicity：

The manufacturing materials we use meet the USP Class VI plastics standard at 121°C regarding biocompatibility.

Construction Materials

Filter Media: PTFE

Media Support: Polypropylene

End Caps: Polypropylene

Inner Core: Polypropylene

Outer Cage: Polypropylene

Capsule Integrity

Minimum burst pressure:

123.5psi (8.5barg)

Typical Flow Rate in gas/air, 2.5"

Integrity

Quality and Compliance

1. Complies with USFDA 21 CFR 210.3(b)(6) requirements regarding fiber shedding

2. Complies with USFDA 21 CFR 177.1520 requirements regarding fractional dissolution

3. Complies with USP <88> Biological Reactivity Tests (In Vivo)—Class VI Plastics standards

4. Complies with USP <87> Biological Reactivity Tests (In Vitro)—Cytotoxicity test requirements

5. Complies with EU Regulation (EC) No 10/2011

Compliance statements and certificates are available for audit and validation needs.

OEM and Engineering Notes

For KleanAssure Capsule filters Bio-burden Reduction PTFE membrane, we support:

1.OEM and ODM manufacturing with engineering review

2.Connection and format customization to match vent assemblies

3.Raw material inspection and final release checks

For ordering KleanAssure Capsule filters Bio-burden Reduction PTFE membrane, confirm pore rating and vent connection requirements.

Ordering Information