Sartopore® XLI 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.
Item no.: 5441307I4--OO--B
Sterilizing-Grade, 0.2 µm Rated Filters
Sartopore®2 HF Pore size: 0.2 µm (single layer)
Sartopore®2 Pore size: 0.45 | 0.2 µm (heterogeneous PES double layer)
Sartopore®2 XLG Pore size: 0.8 | 0.2 µm (heterogeneous PES double layer)
Sartopore®2 XLIPore size: 0.35 | 0.2 µm (heterogeneous PES double layer)
It is the identical final 0.2 µm membrane layer which ensures sterility of your product. But it is the pre-filter porosity which makes the difference. 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.
- Lowest filtration costs (highest filter capacity)
- Various filter solutions within one platform (identical materials used for your process)
Mycoplasma-Retentive, 0.1 µm Rated Filters
Sartopore®2 XLM Pore size: 0.2 | 0.1 µm (heterogeneous PES double layer)
It is well known that Mycoplasma can be present in commercially available cell culture media. Because Mycoplasma are able to penetrate 0.2 µm rated sterile filters, the industry specifically developed finer filter membranes (0.1 µm) for the successful retention of Mycoplasma.
It is the highly asymmetric structure and the perfect fit between the 0.2 µm prefilter layer and the 0.1 µm final membrane which ensures an unmet combination of highest safety and highest filtration capacity. Sartopore® 2 XLM is the most powerful filter in the market and is fully validated as sterilizing grade filter (according to ASTM…) and Mycoplasma removal.
- Lowest filter consumption by high filtration capacity
- Lowest risk of Mycoplasma contamination for you fermentation process
- Perfect fit to Sartopore® 2 used in other process steps
Bioburden Reduction, 0.45 µm Rated Filters
Sartopore®2 Pore size: 0.8 | 0.45 µm (heterogeneous PES double layer)
Sartopore®2 0.45 µm rated filter cartridges are designed for bioburden reduction and particle removal from a broad range of pharmaceutical products. They offer extremely high flow rates and total throughputs and are therefore ideally suited for membrane prefiltration of aqueous solutions and highly viscous, difficult to filter pharmaceutical products.
For highest process flexibility all Sartopore®2 filters are available for conventional or single use applications. All filter elements are available in various sizes and adapter combinations. Please review the selection guide in the supporting resources literature.
Bacterial RetentionQuantitative 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
BiosafetyAll 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).
ExtractablesThe total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
GMP ComplianceThis product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
Filter Sizesize 4 (0.021 m² / 0.22 ft²)
Filtration Area0.021 m²
Outer Diameter63 mm (46 mm without Connection / Valves)
Capsule/Cartridge FormatCapsules Size 4&5
Maximum Allowable Back Pressure2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
Maximum Diffusion1.1 mL/min at 2.5 bar | 36 psi at 20 °C
Minimum Required Bubble Point3.2 bar | 46 psi
Materials of Construction
Housing MaterialPolypropylene (PP)
Material PrefiltersPolyethersulfone (PES), asymmetric
Material o-ring | sealSilicone (SI)
Support FleecePolypropylene (PP)
Maximum Operating Pressure4 bar (58 psi)
Non-Fiber ReleasingThis 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-filter0.2 µm
Pore Size Pre-filter0.35 µm
Sterilization ProceduresAutoclaving: at 134°C, 30 min, 2 bar, min. 5 Cycles
The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester with automated Quality Risk Management (QRM) designed to cover the complete range of integrity testing from small syringe filters up to large multi-round housings and tangential flow cassettes.
All members of the Sartoguard family utilize a highly asymmetric polyether sulfone (PES) membrane double layer for unmatched protection of final filters and bioburden reduction with an LRV of 6 per cm². In addition, combinations with different depth filter materials and gamma sterilizable versions are available.