Introduction of Cobetter PFAS-Free Sterilizing-grade Vent Filter

Introduction

In recent years, the European Union has gradually issued restrictions on per- and polyfluoroalkyl substances (PFAS) to reduce their impact on the environment and human health.

• In 2020, EU member states and the European Chemicals Agency (ECHA) proposed a comprehensive restriction on all PFAS substances to reduce the use of these chemicals and seek more environmentally friendly alternatives.
• In February 2023, ECHA officially released a proposal to restrict PFAS substances, covering various PFAS materials, including PTFE, and introducing a series of specific restrictions on production, import, and use.
• It is expected that new PFAS restrictions will be formally implemented between 2025 and 2026, impacting many industries and encouraging the adoption of alternative materials to meet new environmental requirements.

PFAS are widely used in many industrial and consumer products due to their excellent properties, such as heat resistance and chemical corrosion resistance. However, these chemicals are difficult to degrade, have persistent pollution, and exhibit bioaccumulation, which has drawn increasing regulatory attention. PTFE (Polytetrafluoroethylene) and PVDF (Polyvinylidene Fluoride), commonly used in filtration, are also types of PFAS. To comply with regulations and reduce environmental risks, the adoption of PFAS-free materials as alternative solutions has become a significant trend.

Notably, PES (Polyethersulfone) offers good chemical compatibility and excellent mechanical performance while being free of PFAS, making it an ideal choice for compliance and sustainable development.

Cobetter has introduced a completely PFAS-free, sterilizing-grade hydrophobic PES filter cartridge. This filter uses Cobetter's independently developed hydrophobic PES membrane and can be widely applied in gas sterilization filtration in the pharmaceutical, bioproducts, and fermentation industries.

Application Areas of Gas/Vent Filter Cartridges

1. Sterilizing filtration applications for compressed air and oxygen
2. Sterile gas inlets and outlets for fermentation tanks, liquid storage tanks, and mixing tanks
3. Sterilizing filtration applications in single-use systems:
   • Respirators
   • Sterile gas inlets
4. Sterilizing filtration applications for sterile filling gases

Cartridge Structure

Performance Comparison of Cobetter Purcise™ Hydrophobic PES Filter Cartridge with Cobetter Hydrophobic PTFE and PVDF Membrane Filter Cartridges

Cobetter's hydrophobic PES filter cartridge offers excellent hydrophobic properties and provides comparable airflow performance to hydrophobic PTFE and PVDF filter cartridges. In addition to its good steam resistance, the hydrophobic PES product also demonstrates gamma resistance equivalent to that of hydrophobic PVDF, making it a viable option for single-use system applications.

Regulatory Compliance of Cobetter Purcise™ Series Hydrophobic PES Membrane Filter Cartridges

• Meets the "non-fiber releasing" filter standard defined in 21 CFR 210.3 (b) (6).
• Insoluble particulate matter in filtrate complies with USP <788>.
• Bacterial endotoxins comply with USP <85>.
• Bacterial retention validation conforms to ASTM F838 standards.
• Retention efficiency for Bacteriophage Phi-X174 (ATCC® 13706-B1) is >99.99999%.
• All component materials comply with FDA indirect food additive requirements defined in 21 CFR Part 177–182.
• Biocompatibility meets USP <87> and USP <88>.
• All components of this product are made from non-animal derived materials.