Purcise™ AERB 0.2 μm Hydrophobic PES Sterilizing-Grade V50D Vent Filter Pack of 10

Physical Properties Filter Format Bricap™ Vent Filter Scale Process Development, for Filterability Test Filter Size V50D (20 cm²) Pore Size 0.2 μm Pre-filter / Bubble Point ≥0.11 MPa at 20°C, 60% IPA 40% water wetted, air Max. Differential Pressure (Forward) 0.42 Mpa at 25°C Max. Operating Temp 50°C Materials Membrane Material Hydrophobic Polyethersulfone (PES) Housing Material Polypropylene (PP) Regulatory Compliance Compliance USP <788> Particulate Matter USP <87> Cytotoxicity USP <88> Biological Reactivity FDA Indirect Food Additives, 21 CFR 177-182 ADCF Materials Bacterial Retention 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) according to ASTM F838 Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85> Non-Fiber Releasing The products meet the criteria as defined in 21 CFR 210.3(b)(6) Sterility Sterilization Method Non-sterile - Autoclavable Pre-sterilized - Gamma irradiation at 25 kGy Package Pack Size Pack of 10 Packaging Individually packaged in double PE Bags