KleanCap T-line PTFE membrane Capsule Filter Bio-burden Reduction

MS is a professional KleanCap T-line PTFE membrane Capsule Filter Bio-burden Reduction factory. It can streamline in-line vent filtration while maintaining high gas flow. Built on a full-size capsule platform, it combines a hydrophobic PTFE membrane with a Staubli vent connection that enables on-line integrity testing. Each cartridge is 100% integrity tested and suited for critical gas applications requiring efficient particle/microorganism reduction.

Core Features & Functional Advantages

- Space-Saving T-line In-line Structure: Compact inline design fits limited-installation spaces, enabling flexible layout on various bioprocess skids and pipeline systems.

- Stable Bio-Burden Reduction Performance: High-performance 0.2μm PTFE membrane effectively reduces fine particles and microbial contaminants for daily process gas protection.

- Integrated On-Line Test Port: Built-in Staubli vent connection supports in-situ integrity testing, improving GMP validation efficiency without filter disassembly.

- High Gas Flow Capacity: Optimized internal structure maintains steady high airflow, suitable for continuous in-line gas vent filtration.

- 100% Factory Integrity Tested: Full batch inspection ensures consistent out-of-box performance and reliable long-term operation stability.

- Full Biocompatible & Food-Grade Construction: All wetted materials meet USP Class VI, FDA and EU food-contact standards for safe biopharma and biological process use.

Typical Application

Fermentation Tanks

Bio Bags

Pharmaceuticals

Gas filtration

Biologics

Antibiotics Venting

Serums

Food Safety Compliance

Food Contact Statement: Materials comply with FDA 21 CFR for food and beverage contact and are consistent with EU 10/2011 expectations 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

Capsule Integrity

Minimum burst pressure: 123.5psi (8.5barg)

Toxicity

Biological safety conforms to USP Class VI plastics criteria at 121℃ for the materials of construction.

Integrity

Typical Flow Rate in gas/air, 10"

Quality and Compliance

1. Complies with USFDA 21 CFR 210.3(b)(6) fiber release specifications

2. Aligns with USFDA 21 CFR 177.1520 fractional dissolution criteria

3. Satisfies USP <88> in vivo biological reactivity requirements for Class VI plastics

4. Fulfills USP <87> in vitro biological reactivity and cytotoxicity testing standards

5. Conforms to EU Regulation (EC) No 10/2011 compliance guidelines

6. Relevant technical documents and certification files are available to support customer qualification validation.

Factory Service Highlights

MS provides professional customized and compatible services for KleanCap T-line PTFE capsule filters:

- Direct factory replacement solutions for mainstream international brand filter setups

- Diversified connection options to match different pipeline layouts and production skids

- Flexible OEM private-label and customized production support

To order KleanCap T-line PTFE membrane Capsule Filter Bio-burden Reduction, please confirm vent connection and length.

Ordering Information