Sartopore® Platinum Gamma Midicaps®
Sartopore® Platinum is the latest polyethersulfone (PES) filter platform from Sartorius Stedim Biotech. The result of an innovative surface modification technology is a filter which is highly suitable for modern single-use applications, making the processes highly economic, user friendly and safe. Using Sartopore® Platinum you will benefit from cutting-edge membrane technology.
Item no.: 5495307H7G-HH--A
Choose your Sartopore® Platinum
Pore size: 0.45 | 0.2 µm (heterogeneous PES double layer)
Sartopore® Platinum, the best-wetting filter in the market, abolishes any potential wetting induced issues with integrity testing. And the perfect wettability of the new PES membrane leads to drastic reduction of the required flushing volume (up to 95% less water needed) which is highly beneficial for single-use processes. On top of it the new technology created a new membrane with the lowest protein adsorption of any PES membrane in the market by which your product yield can be maximized.
Moreover, the new pleating technology (TwinPleat) results in large-area capsules (1 m² filtration area per 10”) by which larger batch sizes can be filtered by a single device. This highly simplifies the handling of single-use assemblies.
Your Benefits:
- Smaller filters, less filters - highest effective filter area (1 m²/10”)
- Smaller dimensioning of assemblies – smaller bags, less tubing, hardware
- No risk of wetting issues and re-testing
- High filtration capacity by proven asymmetric PES membrane and perfect fit between pre- and final filter layer
For highest process flexibility all Sartopore® Platinum 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.
Biological Information
-
Bacterial RetentionQuantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology
Compliance Information
-
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.
Dimensions
-
Filter Sizesize 7 (0.065 m² / 0.7 ft²)
-
Filtration Area0.065 m²
-
Outer Diameter108.5 mm (77 mm without Connection / Valves)
General Specifications
-
Capsule/Cartridge FormatMidicaps®
-
Maximum Allowable Back Pressure2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
-
Maximum Diffusion4 mL/min at 2.5 bar | 36 psi
-
Minimum Required Bubble Point3.5 bar | 51 psi
-
Vent ValveStandard
Materials of Construction
-
Housing MaterialPolypropylene (PP)
-
Material o-ring | sealSilicone (SI)
-
Support FleecePolyester (PET)
Operating Conditions
-
Maximum Operating Pressure5 bar (72.5 psi)
Physicochemical Information
-
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-filter0.45 µm
Product Information
-
Filter TypeLiquid Filters
Usage Protocols
-
Sterilization ProceduresGamma Irradiation: with 50 kGy, 1 Cycle
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.