Description
Sartorius Stedim Sartopore 2 XLG MaxiCaps – 54473076G3–SS
- Bacterial Retention: Quantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta 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
rbb/bcl – 004491 R1 B3 P165
