Sartoclean® CA MidiCaps

Sartoclean® CA MidiCaps 5625304E0--OO--V

Filtration Area: 0,08 – 0,6 m²

Ready-to-use disposable capsules for bioburden & particle reduction in pilot- or small scale production of biopharmaceutical industry.
  • Ready to use, self-contained capsules
  • Presterilized
  • Ideally Suited For High Performance Prefiltration

Description

Sartoclean® CA MidiCaps® are self contained, ready to use filter units. They are the ideal choice for a broad range of prefiltration applications in the biopharmaceutical industry from particle removal to bioburden reduction. Sartoclean® CA MidiCaps® offer a defined retention performance by size exclusion. The use of Sartoclean® CA prefilters avoids early blockage of downstream sterilizing grade membrane filters and contributes significantly to an economical design of your filtration system. Featuring ultra low binding cellulose acetate membranes, Sartoclean® CA filters are typically used for membrane prefiltration of several solutions like Plasma Fractions, Vaccines, Purified Protein Solutions or Solutions containing Preservatives. The cellulose acetate membranes of the Sartolclean® CA filters have proven to be the membrane material with lowest unspecific binding capabilities, assuring highest protein yields and rapid preservative recovery enhancing your process efficiency. Sartoclean® CA filters with heterogeneous double layer construction (3.0/0.8 µm & 0.8/0.65 µm) offer highest total throughput performance due to the “built-in prefiltration” to avoid filter change during filtration and assure economical system design. Single layer Sartoclean® CA filters (0.45 µm & 0.2 µm) offer highest flow rates for microbial retentive filtration. Sartoclean® CA capsules are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements. Sartoclean® CA MidiCaps® are delivered as individually packed units and available with 4 different filtration areas and 3 different inlet/outlet connectors to meet your application and installation requirements. For linear scale-up and broadest process flexibility Sartoclean® CA filters are as well available as cartridges, Maxicaps®, and mini cartridges.

Applications:

Featuring ultra low binding cellulose acetate membranes, Sartoclean CA filters are typically used for membrane prefiltration of:

  • Plasma Fractions
  • Vaccines
  • MAB
  • Diagnostics
  • Purified Protein Solutions
  • Biological Fluids
  • Solutions containing Preservatives

Highest Product Yield:

Throughout the years the cellulose acetate membranes of the Sartoclean CA filters have proven to be the membrane material with lowest unspecific binding capabilities, assuring highest protein yields and rapid preservative recovery enhancing your process efficiency.

Performance:

Sartoclean CA filters with heterogeneous double layer construction (3.0 |0.8 μm & 0.8|0.65 μm) offer highest total throughput performance due to the “build-in prefiltration” to avoid filter change during filtration and assure economical system design. Single layer Sartoclean CA filters (0.45 μm & 0.2 μm) offer highest flow rates for microbe retentive filtration.

Mechanical Strength:

The reinforcement of the membrane results in increased mechanical and thermal resistance, especially of interest in applications with high differential pressure and with repeated steam sterilization of the filters.

Scalability:

Sartoclean® CA filters are available as standard mini cartridges, MidiCaps®, standard cartridges and MaxiCaps® offering broadest choice for scale-up and easiest adoption to varying process volumes.

Quality Control:

Each individual element is integrity tested by diffusion and bubble point test prior to release, assuring absolute reliability.

Documentation:

Sartoclean CA capsules are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.

Product properties

Branch
Pharma / Biotech
Filter type
Filter Capsules
Type
Prefilter
Filtration area
0,45 m²
Material prefilters
Cellulose Acetate

Technical attributes

Support Layers
Polypropylene (PP)
Structural Compounds
Polypropylene (PP)
Outer diameter
74 mm
Overall length
Connector Combination SS: 0.08 m² | 0.8 ft²: 124.5 mm; 0.16 m² | 1.6 ft²: 162.5 mm; 0.3 m² | 3 ft²: 210.5 mm; 0.6 m² | 6 ft²: 349 mm
Max. Differential Pressure
20 °C: 4 bar; 80 °C: 2 bar
Bacterial Endotoxins
<0.18 EU/mL as determined by the LAL test
Extractables
Product meets or exceeds the Quality standards set for "Sterile Water for Injection" by the current USP.
Biosafety
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).
Sterilisation
Autoclaving: Min. 25 cycles at max. 134 °C, 2 bar | 29 psi, 30 min.
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.
GMP Compliance
The product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
Membrane material
Cellulose Acetate (CA)
Connectors Inlet
1/2'' Hose Barb
Connectors Outlet
1/2'' Hose Barb
Order number:

5625304E0--OO--V

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