| Application | Blood and Plasma Vaccine Production |
| 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 unter "Sterile Water for Injection". |
| Connector Inlet | 1.5" Tri-Clamp 50 mm |
| Connector Outlet | 1.5" Tri-Clamp 50 mm |
| Filter Size | 30"(1.8 m² / 19.4 ft²) |
| Filtration Area | 1.8 m² / 19.4 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 |
| Maximum Diffusion | 45 mL/min at 2.5 bar | 36 psi |
| Minimum Required Bubble Point | 3.2 bar | 46 psi |
| Vent Valve | Standard |
| Filter Material | Cellulose Acetate (CA) |
| Housing Material | Polypropylene (PP) |
| Material O-ring | Seal | Silicone (SI) |
| Support Fleece | Polypropylene (PP) |
| Maximum Differential Pressure | 20 °C: 5 bar; 50 °C: 3 bar |
| Maximum Operating Pressure | 5 bar (72.5 psi) |
| Non-fiber Releasing | This filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72. |
| Pore Size Final-filter | 0.2 µm |
| Pore Size Pre-filter | 0.45 µm |
| Brand | Sartobran® P |
| Sterilization Method | Autoclavable |
| Sterilization Procedures | Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles |
