Sartorius, 5475358GV--LX--C, Sartoguard PES | Sartoscale 25 | 0.1µm | 6pc.

Effective Filtration Area: 4.5 cm² - 17.3 cm²
Pore Size: 0.8 µm prefilter | 0.1 µm final filter
Membrane Material: Polyethersulfone
Connectors: Hose Barb ¼“ | Sanitary ¾“ | Luer

The asymmetric polyether sulfone (PES) membranes used in Sartoguard PES filters achieve an LRV of 6 per cm². This significantly reduces the bioburden in the downstream process and protects subsequent purification steps. When used upstream of sterilization grade filters, Sartoguard PES increases overall throughput and reduces the number of filters required and process costs.
Main Applications
Bioburden reduction in protein- and virus-based therapies as well as in processes producing pDNA/mRNA based therapies
Protection of purification equipment and sterilizing-grade filters
Benefits
More economical process flow
Downsizing of filtration systems
Significantly higher total throughput performance
LRV of 6 per cm2 filtration area for Brevundimonas Diminuta (0.1 µm version) and for Serratia Marcescens (0.2 µm version)
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
Sartoguard PES 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
Sartoguard PES 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: mAB Production; Protection of Final Filters
Modality: Media Filtration; Buffer & Auxiliaries Filtration; Downstream Intermediates; Form & Fill
Scale: Product Development | Material Screening Filters

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: 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: 0.1 µm
Pore Size Pre-filter: 0.8 µm

Product Information:
Brand: Sartoguard PES
Pack Size: 6

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