Bacterial Retention: Quantitative Retention of 1 × E7 CFU/cm² BrevundimonasDiminuta ATCC 19146 per ASTM methodology
Bacterial Endotoxins: < 0.25 EU/mL as determined by the LAL test
Biological Reactivity: All materials of this filter element meet the requirements of the current USP Biological Reactivity tests <88> for plastics Class VI (Systemic Injection, Intracutaneous and Implantation tests).
Extractables: The total amount of extractables is well below the limits established by the current USP under “Sterile Water for Injection”.
GMP Compliance: This product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
Filter Size: 30″(2.4 m² / 25.8 ft²)
Outer Diameter: 137 mm (110 mm without Connection / Valves)
Capsule/Cartridge Format: Maxicaps
Maximum Allowable Back Pressure: 2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
Minimum Required Bubble Point: 3.2 bar | 46 psi
Vent Valve: Standard
Housing Material: Polypropylene (PP)
Material O-ring | seal: Silicone (SI)
Support Fleece: Polyester (PET)
Maximum Operating Pressure: 5 bar (72.5 psi)
Pore Size Final-filter: 0.2 µm
Pore Size Pre-filter: 0.8 µm
Sterilization Procedures: Gamma Irradiation: with 50 kGy, 1 Cycle
