Sartoclean® CA Membrane Filter Capsule 5625306A7--FH--A
- 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 |
Capsule
|
| Type |
Prefilter
|
| Pore size |
0,45 µm
|
| Connector Inlet/Outlet |
FH (3/4'' sanitary Tri-Clamp®/ multiple-stepped hose barb)
|
| Filtration area |
0,05 m²
|
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)
|


