Sartorius, 5475307F0G-SO--V, Sartoguard PES | Gamma Midicaps® | 0.2µm | Size 0 | 2pc

Effective Filtration Area: 0.52 m² | 5.6 ft²
Pore Size: 1.2 µm prefilter | 0.2 µm final filter
Connectors: Inlet: Sanitary 1 ½“| Outlet: Hose Barb ½“ single stepped
Sterilization: Gamma-irradiatable
Membrane Material: Polyethersulfone
Pack Size: 2 pieces

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)
Membrane
Sartoguard PES uses a heterogeneous double membrane made of polyethersulfone
Compatibility
Sartoguard PES 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 Sartoguard PES filters ideal for filtering solutions with a high/low pH.
Cost savings:
The use of disposable filter elements eliminates the need to invest in stainless steel filter housings. Additional costs for housing cleaning and cleaning validation are eliminated.
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.
Scale Up:
Consistent and predictable scale-up and scale-down procedures can be safely performed because all Sartoguard PES filter elements are manufactured with the same membrane type, support fleeces and construction materials.
Quality:
Every single element is tested for integrity to meet the highest quality requirements.
Documentation:
Sartoguard PES 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: mAB Production; Protection of Final Filters
Industry: Pharma / Biotech
Modality: Media Filtration; Harvest | Cell Removal; Filtration after Virus Inactivation
Scale: Production | Small Scale

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: 1.5" Tri-clamp 50 mm
Connector Outlet: 1/2" Single Stepped Hose Barb
Connector(s): Inlet: 1 ½" Sanitary | Outlet: ½" Hose Barb

Dimensions:
Filter Size: size 0 (0.52 m² / 5.6 ft²)
Outer Diameter: 108.5 mm (77 mm without Connection / Valves)

General Specifications:
Capsule/Cartridge Format: Midicaps®
Filter Format: Capsules
Maximum Diffusion: 12 mL/min at 1.2 bar | 17.5 psi
Minimum Required Bubble Point: 1.8 bar | 26 psi

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

Operating Conditions:
Maximum Differential Pressure: 5 bar

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: 1.2 µm

Product Information:
Brand: Sartoguard PES
Pack Size: 2

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

Usage Protocols:
Sterilization Procedures: Gamma Irradiation: with 50 kGy