APSEA Asymmetric PES Filter Cartridge φ69mm, Bioburden Reduction

Physical Properties Filter Format Cartridge Filter Scale Production Scale Filtration Area 0.66 m² per 10" Pore Size 0.22/0.45/0.65/0.8/1.0/1.2/3.0/5.0 μm Bubble Point 0.22 μm: ≥0.11 MPa at 20 °C, water wetted, air 0.45 μm: ≥0.07 MPa at 20 °C, water wetted, air 0.65 μm: ≥0.04 MPa at 20 °C, water wetted, air Materials Membrane Material Polyethersulfone (PES) Support Fleece Polypropylene (PP) Housing Polypropylene (PP) O-ring / Seal Silicone Operating Conditions Max. Differential Pressure (Forward) 0.69 MPa at 25 °C 0.4 MPa at 60 °C 0.24 MPa at 80 °C Max. Differential Pressure (Reverse) 0.3 MPa at 25 °C 0.1 MPa at 80 °C 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 Delivery Condition Non-sterile Sterilization Method Can be SIP for 30 min at 135 °C 100 cycles (<30kPa) Can be autoclaved 200 cycles for 30 min at 130 °C Package Pack Size Pack of 1 Packaging Individually packed in a double PE bag