Product Description
Effective Filtration Area: 0.1 m² | 1.1 ft²
Pore Size: 0.8 µm prefilter | 0.45 µm final filter
Connectors: Inlet: Sanitary 1 ½“| Outlet: Sanitary 1 ½“
Sterilization: Gamma sterializable
Membrane Material: Polyethersulfone
Pack Size: 4 pieces
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Extremely high flow rates and total throughputs
Number one choice for bioburden reduction & particle removal
Broad compatibility and easy scalability
Outstanding filtration performance of aqueoussolutions that are highly viscous & difficult to filter
Main Applications
Typical applications include bioburden and particle removal of:
Therapeutica
Injection solutions
Buffer
Biological Fluids
Tissue culture media
Acidic and alkaline solutions
Membrane
Sartopore® 2 uses a heterogeneous double membrane made of polyethersulfone
Compatibility
Sartopore®2 filters have been developed for sterilization using autoclaving at 134°C | 2bar. The polyethersulfone membrane is compatible within a pH range of 1-14. This makes the Sartopore® 2 filters ideal for filtering solutions with a high/low pH.
Cost savings:
By using single-use filter elements, there is no need to invest in stainless steel filter housings. Additional costs for cleaning the housing and cleaning validation are eliminated.
Flexibility
Sartopore® 2 filters are available in different sizes and formats with corresponding filter areas from 4.5 cm² up to 1.8 m². Different connections allow easy integration into existing systems.
Scale Up:
Consistent and predictable scale-up and scale-down procedures can be performed safely because all Sartopore® filter elements are manufactured with the same membrane type and construction materials.
Quality:
Every single element is tested for integrity to meet the highest quality requirements.
Microbial Retention
Sartopore® 2 filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.
Documentation:
Sartopore® 2 filters have been designed, developed and produced in accordance with the ISO 9001 certified quality management system. A validation manual is available in accordance with regulatory requirements.
Specifications
Applications:
Application: High capacity platform for conventional sterile filtration
Industry: Pharma / Biotech
Modality: Downstream Intermediates; Harvest | Cell Removal
Scale: Production | Small Scale
Compliance Information:
Extractables: The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Connections (Physical):
Connector Inlet: 1.5" Sanitary
Connector Outlet: 1.5" Sanitary
Connector(s): Inlet: 1 ½" Sanitary | Outlet: 1 ½" Sanitary
Dimensions:
Filter Size: size 8 (0.1 m² / 1.1 ft²)
General Specifications:
Capsule/Cartridge Format: Midicaps®
Maximum Allowable Back Pressure: 2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
Maximum Diffusion: at 20 °C and 2.5 bar | 36 psi: 0.065 m² | 0.7 ft²: 5 mL/min; 0.13m² | 1.4 ft²: 6 mL/min; 0.26 m² | 2.8 ft²: 9 mL/min; 0.52 m² | 5.6 ft²: 18 mL/min
Minimum Required Bubble Point: 3.2 bar | 46 psi
Vent Valve: Standard
Materials of Construction:
Housing Material: Polypropylene (PP)
Material o-ring | seal: Silicone (SI)
Membrane Material: Polyethersulfone (PES)
Support Fleece: Polyester (PET)
Physicochemical Information:
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: 0.45 µm
Pore Size Pre-filter: 0.8 µm
Product Information:
Brand: Sartopore® 2
Pack Size: 4
Sterility/Purity:
Delivery Condition: Non sterile - Gamma irradiatable
Sterilization Method: Gamma Irradiatable
Order Guidelines
1. Price & Stock Available on Request. Click to send email to: service@iright.com
2. Please DO NOT make payment before confirmtaion.
3. Minimum order value of $1,000 USD required.
4. 100% prepayment required.
Collaboration
Tony Tang
Email: Tony.Tang@iright.com
Mobile/WhatsApp/Wechat: +86-17717886924