Sartorius, 5625305G8--OO--A, Sartoclean® CA | Midicaps® | 0.65µm | Size 8 | 4pc.

Effective Filtration Area: 0.1 m² | 1.1 ft²
Pore Size: 0.8 µm prefilter | 0.65 µm final filter
Membrane Material: Cellulose Acetate
Connectors: Hose Barb ½“ single stepped | Hose Barb ½“ single stepped
Sterilization: Delivered sterile (Autoclaved)
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The Sartoclean® family is a cellulose acetate (CA) membrane based prefilter. These filters are optimized for the protection of downstream equipment and Sartobran® cellulose acetate final filters.
Main Applications
Since the Sartoclean® CA filters have an excessively low binding cellulose acetate membrane, they are commonly used for membrane prefiltration of:
Plasma
Vaccines
mAb
Diagnostics
Purified protein solutions
Biological fluids
Preservative solvents
Benefits
Highest product yields
Ultra-low unspecific binding membrane
More economical process flow
Increased total throughput performance
Membrane
Sartoclean® CA uses a heterogeneous double-layer membrane made of cellulose acetat. The "built-in pre-filtration" results in the highest possible total flow, so that a filter change during filtration is avoided.
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
Sartoclean® CA 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 Sartoclean® CA filter elements are manufactured with the same membrane type, support fleeces and construction materials.
Sterilization
Sartoclean® CA filters have been developed for sterilization using autoclaving at 134°C | 2bar or in-line-steaming (Only filter cartridges).
Quality:
Every single element is tested for integrity to meet the highest quality requirements.
Documentation:
Sartoclean® CA 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: Vaccine Production; Blood and Plasma
Industry: Pharma / Biotech
Modality: Harvest | Cell Removal; Form & Fill; Downstream Intermediates
Scale: Production | Small Scale

Compliance Information:
Bacterial Endotoxins: < 0.18 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: 1/2" Single Stepped Hose Barb
Connector Outlet: 1/2" Single Stepped Hose Barb
Connector(s): Inlet: ½" Hose Barb | Outlet: ½" Hose Barb

Dimensions:
Filter Size: size 8 (0.1 m² / 1.1 ft²)
Filtration Area: 0.1 m² / 1.1 ft²
Outer Diameter: 108.5 mm (77 mm without Connection / Valves)

General Specifications:
Capsule/Cartridge Format: Midicaps®
Filter Format: Capsules
Maximum Allowable Back Pressure: 2 bar (29 psi) at 20°C

Materials of Construction:
Filter Material: Cellulose Acetate (CA)
Housing Material: Polypropylene (PP)
Material o-ring | seal: Silicone (SI)
Membrane Material: Cellulose Acetate (CA)
Support Fleece: Polypropylene (PP)

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: 0.65 µm
Pore Size Pre-filter: 0.8 µm

Product Information:
Brand: Sartoclean® CA
Pack Size: 4

Sterility/Purity:
Delivery Condition: Sterile - Autoclaved
Sterilization Method: Autoclavable

Usage Protocols:
Sterilization Procedures: Autoclaving: at 134°C, 30 min, 2 bar