Sartorius, 5482558M1, Sartoguard GF | Cartridge | 0.1µm | 10"

Effective Filtration Area: 0.45 m² | 4.8 ft²
Pore Size: 0.2 µm prefilter | 0.1 µm final filter
Membrane Material: Polyethersulfone
Fleece Material: Glass Fiber
Sterilization: Delivered non-sterile: In-line steamable | Autoclavable
Adapter: 2-Flange Bayonet | 226 Double O-ring
O-ring material: Silicone

Sartoguard GF filter elements are polyethersulfone membrane based prefilters. The membrane double layer is protected by a layer of glass fiber fleece material. They combine the defined retention performance of membrane filters with the high total throughput capacity of depth filter material. Therefore, Sartoguard GF prefilters offering optimal protection of sterile filters and validated bioburden reduction.
The asymmetric polyethersulfone (PES) membranes used in Sartoguard GF filters achieve an LRV of 6 per cm². This significantly reduces the bioburden in the downstream process and protects subsequent purification steps.
Additionally Sartoguard GF filters are ideally suited for the effective retention of colloids and lipids, which quickly block more expensive mycoplasma filters or membrane filters
Main Applications
Sartoguard GF filter elements are typically used for prefiltration of:
Cell Culture Media
Buffers
Serum
Ophthalmics
Large Volume Parenterals
Colloid and lipid containing liquids
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)
Membrane
The heterogeneous double layer PES membranes provide secure and reliableretention needed for critical applications.
The glassfiber fleece provides high particle loadingcapacity and effective retention of large and small particlesas well as excellent turbidity reduction.
Flexibility
Sartoguard GF 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.
Scale Up:
Consistent and predictable scale-up and scale-down procedures can be safely performed because all Sartoguard GF filter elements are manufactured with the same membrane type, support fleeces and construction materials.
Sterilization
Sartoguard GF filter cartridges have been developed for sterilization using either autoclaving at max. 134°C | 2 bar or in-line-steaming at 134°C | 0.5 bar.
Quality:
Every single element is tested for integrity to meet the highest quality requirements.
Documentation:
Sartoguard GF 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
Accessories Information:
Adapter: Bottom: 2-Flange Bayonet w. 226 double o-ring | Top: S-Adapter

Applications:
Application: mAB Production; Protection of Final Filters
Industry: Pharma / Biotech
Modality: Media Filtration; Harvest | Cell Removal; Filtration after Virus Inactivation
Scale: Production | Large Scale

Compliance Information:
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".

Dimensions:
Filter Size: 10"(0.45 m² / 4.8 ft²)
Filtration Area: 0.45 m²
Outer Diameter: 70 mm

General Specifications:
Capsule/Cartridge Format: Cartridges
Filter Format: Cartridges
Maximum Diffusion: 17 mL/min at 2.5 bar | 36 psi
Minimum Required Bubble Point: 2.3 bar | 33 psi
Test Pressure: 2.5 bar

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

Operating Conditions:
Maximum Differential Pressure: 5 bar

Physicochemical Information:
Pore Size Final-filter: 0.1 µm
Pore Size Pre-filter: 0.2 µm

Product Information:
Brand: Sartoguard GF
Pack Size: 1

Sterility/Purity:
Delivery Condition: Non sterile - Autoclavable | Steamable
Sterilization Method: Autoclavable & In-Line Steam Sterilizable

Usage Protocols:
Sterilization Procedures: In-Line Steam Sterilization: at 134 °C, 20 min., 0.5 bar; Autoclaving: at 134°C, 30 min, 2 bar