Sartorius, 5447306G3G-SS, Sartopore® 2 | Gamma Maxicaps® | 0.45µm | 30"

Effective Filtration Area: 1.8 m² | 19.4 ft²
Pore Size: 0.8 µm prefilter | 0.45 µm final filter
Membrane Material: Polyethersulfone
Connectors: Inlet: Sanitary 1 ½“| Outlet: Sanitary 1 ½“
Sterilization: Gamma-irradiatable
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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 | Large Scale

Compliance Information:
Bacterial Endotoxins: < 0.25 EU/mL as determined by the LAL test
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: 30"(1.8 m² / 19.4 ft²)

General Specifications:
Capsule/Cartridge Format: Maxicaps®
Maximum Diffusion: 12 mL/min at 1.7 bar | 25 psi at 20 °C per 10 inch element
Vent Valve: Standard

Materials of Construction:
Housing Material: Polypropylene (PP)
Material o-ring | seal: Silicone (SI)
Membrane Material: Polyethersulfone (PES)
Support Fleece: Polypropylene (PP)

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: 1
Type: Inline (γ-irradiatable)

Sterility/Purity:
Delivery Condition: Non sterile - Gamma irradiatable
Sterilization Method: Autoclavable

Usage Protocols:
Sterilization Procedures: Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles