Sartorius, 5445307HV--LX--C, Sartopore® 2 | Sartoscale 25 | 0.2µm | 6pc.

Ready-to-use single-use flat filter for impressive filtration tests of biopharmaceutical liquids to the smallest scale.
Effective Filtration Area: 4.5 cm²
Pore Size:0.45 µm prefilter | 0.2 µm final filter

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
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 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 filters are available in a wide range of filtration areas from 4.5 cm² up to 1.8 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
Modality: Buffer & Auxiliaries Filtration
Scale: Product Development | Material Screening Filters

Compliance Information:
Bacterial Endotoxins: < 0.18 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: Female Luer Lock
Connector Outlet: Male Luer Slip
Connector(s): Inlet: Female Luer | Outlet: Male Luer

Dimensions:
Filter Size: 4.5 cm²

General Specifications:
Capsule/Cartridge Format: Sartoscale 25

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

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: 0.45 µm

Product Information:
Brand: Sartopore® 2
Pack Size: 6

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.