Sartorius, 5445307GS--FF--M, Sartopore® 2 XLG | Sartoscale 47 | 0.2µm | 3pc.

Effective Filtration Area: 17.3 cm²
Pore Size: 0.8 µm prefilter | 0.2 µm final filter
Connectors: Inlet: Sanitary ¾“| Outlet: Sanitary ¾“
Membrane Material: Polyethersulfone
Pack Size: 3 pieces

Sartopore® 2 XLG is a high-performance membrane filter, offering more than just reliable sterilizing-grade filtration in biopharmaceutical processes. Its highly asymmetric membrane structure and composition of 0.8µm prefilter in front of the sterilizing-grade filter (0.2 µm pore size), boosts the filtration efficiency in downstream processing of protein-based therapies or innovative drug delivery systems like lipid nanoparticles (LNPs). Thanks to the outstanding total throughput, Sartopore® 2 XLG is also a choice for filtration after the cell harvest.
Main Applications
Focus applications include:
Cell culture media preparation
Post cell harvest filtration
Protein-based therapies (Downstream intermediates, form & fill)
Lipid nanoparticles (Downstream intermediates, form & fill)
Your Benefits
Increased total throughput leads to less filter consumption, less process interruptions and reduced costs
Increased effective filtration enables the use of smaller filters to reduce footprint and waste
Proven and robust membrane chemistry known from the widely established Sartopore® 2 family lowers validation effort in case of process optimization
Broad range of formats and sizes assures scalability and enables use of Sartopore® 2 XLG along the whole drug product lifecycle: from development to commercial processes
Offers secure bacterial retention according to ASTM guidelines
Sartoscale
SartoScale units are ideally suited for all types of filterability studies with the aim of selecting the optimal prefilter for an optimal application. Moreover, they can determine the ideal combination of pre- and final filters with the aid of a minimum product volume.
Developed for the execution of reliable filterability samples
Made from the same non-woven fabric material as the original filter cartridges
Ready-to-use single-use test filter unit
Membrane
Sartopore® 2 XLG uses a heterogeneous double membrane made of polyethersulfone
Original filter material
SartoScale units contain the original filter active material of the corresponding filter cartridges to ensure the repeatability of test results.
Flexibility
Sartopore® 2 XLG filters are available in a wide range of filtration areas from 4.5 cm² up to 2.4 m² and with a variety of commonly used connections to ensure easy integration into your process regardless of batch size.
Ready to Use
Using SartoScale during filtration studies saves time which would otherwise be used for the installation preparations for the punch piece in the stainless steel filter brackets and prevents possible installation errors.
Scalability
After the material selection or the definition of a pre/final filter combination with the SartoScale units, a scale-up method should be carried out for the flow rate and total flow using pleated capsule units of small scales (e.g. capsule size 4).
Optimized design
SartoScale units have an extremely low residual volume for performing filterability samples with minimized product volumes.
Process Reliability
SartoScale test filter units are equipped with suitable filter membranes for integrity testing so that their integrity can be determined using the bubble point test in order to ensure absolute reliability of the test results.
Zero-T test system
We recommend using the SartoScale units together with the Zero-T Filter Test System to make the filtration studies as effective as possible. The Zero-T system consists of hardware and software modules which make it easy to handle and install Sartoscale test filter units. Automatic data collection is achieved by connecting a frame to a laptop. The software automatically analyzes the incoming data for the scale-up calculations.

Specifications
Applications:
Application: High capacity platform for conventional sterile filtration
Industry: Pharma / Biotech
Modality: Media Filtration; Buffer & Auxiliaries Filtration; Downstream Intermediates; Filtration after Virus Inactivation; Form & Fill
Scale: Product Development | Material Screening Filters

Compliance Information:
Bacterial Endotoxins: < 0.25 EU/mL as determined by the LAL test
Biological Reactivity: 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".

Connections (Physical):
Connector Inlet: 3/4" Sanitary
Connector Outlet: 3/4" Sanitary
Connector(s): Inlet: ¾" Sanitary | Outlet: ¾" Sanitary

Dimensions:
Filter Size: 17.3 cm²
Filtration Area: 17.3 cm²

General Specifications:
Capsule/Cartridge Format: Sartoscale 47
Minimum Required Bubble Point: 3.2 bar | 46 psi

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

Operating Conditions:
Maximum Differential Pressure: 20 °C: 5 bar, 80 °C: 2 bar
Maximum Operating Pressure: 5 bar (72.5 psi)

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: 0.2 µm
Pore Size Pre-filter: 0.8 µm

Product Information:
Brand: Sartopore® 2 XLG
Pack Size: 3

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

Usage Protocols:
Sterilization Procedures: Autoclaving: 1 cycle at max. 134 °C, 2 bar | 29 psi, 30 min.