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Sartorius Sartopore™ 2 Capsule
Sartopore™ 2 is the industry standard of high-performance polyethersulfone (PES) liquid filters. A broad variety of different pore size combinations ensures highly economic and safe filtration performance. From single-layer high flow solutions, to specific Mycoplasma retentive filters. Sartopore™ 2 perfectly adapts to your specific process needs.
Brand: Sartorius 5441307H4-00-B
This item is not returnable.
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Description
Sartopore™ 2 Capsule is the identical, final 0.2 μm membrane layer which ensures sterility of your product. Depending on specific product properties a finer or coarser pre-filter layer can significantly improve the capacity of the filter. Quasi particle-free liquids like buffer solutions can be filtered without any pre-filter layer for increasing the flow performance. If a new process is designed or existing processes are optimized, Sartopore™ 2 allows cost reduction of up to 90%. The best-performer of your specific application can be easily identified by Increase™ filterability trials. Make use of this service to understand the benefit for your filtration process.
- Biological Information
- Bacterial Retention: Quantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC™ 19146 per ASTM methodology
- Compliance Information
- Biosafety: 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'.
- GMP Compliance: This product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
- Operating Conditions
- Maximum Differential Pressure: 20°C: 4 bar or 50°C: 2 bar
- Physicochemical Information
- Bacterial Endotoxins: < 0.25 EU/mL as determined by the LAL test
- 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.
- Specifications
- Capsule/Cartridge Format: Capsules Size 4 and 5
- Maximum Allowable Back Pressure: 2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
- Maximum Diffusion: 1 mL/min at 2.5 bar (36 psi) at 20 °C
- Minimum Required Bubble Point: 3.2 bar (46 psi)
- Sterilization Procedures
- Autoclave at 134°C for 30 min, 2 bar, Minimum 5 Cycles
Specifications
| Autoclavable | |
| Size 4 | |
| PES, Asymmetric | |
| Sterile | |
| High Capacity Platform for Conventional Sterile Filtration | |
| 1/4 in. Multiple Stepped Hose Barb | |
| 5/Pk. | |
| Capsule | |
| 63 mm (46 mm without Connection / Valves) |
| USP Biological Reactivity tests <88> for plastics Class VI, USP under 'Sterile Water for Injection', Title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72, Manufactured in conformance with established Current Good Manufacturing Practice (cGMP) Standards | |
| Silicone (O-ring), Polypropylene (Support Fleece) | |
| 0.45 μm (Pre-filter), 0.2 μm (Final Filter) | |
| 0.015 m2 | |
| Polypropylene (PP) | |
| 4 bar (58 psi) | |
| 1/4 in. Multiple Stepped Hose Barb | |
| 102 mm |