Sartobran® P MidiCaps®

Sartobran® P MidiCaps® 5235307H0--OO--V

Filtration Area: 0,05 - 0,45 m²

Ready-to-use disposable filter capsules for sterilizing grade filtration of complex biological fluids, cell culture media and DSP intermediates for pilot & small scale production.
  • Ready to Use Sterile Filter Units
  • Highest Product Yields
  • Extremely Low Unspecific Adsorption
  • Excellent Flow Rate/Throughput Performance

Description

Sartobran® P membrane filter MidiCaps® are self contained, ready to use, sterile filter units for sterilizing grade filtration in the pharma| biotech industry. The extremely low unspecific adsorption of their cellulose acetate membranes assures highest protein yields and rapid preservative recovery. Applications: Sartobran® P filter elements have proven throughout the years to be the first choice for all applications in the biopharmaceutical industry requiring low adsorption capabilities. They are typically used for sterilizing grade filtration of: – Coagulation Factors, Albumin, IgG – Bacterial & Viral Vaccines – MAB – Bio-processed Pharmaceuticals – Diagnostics – Purified Protein Solutions – Biological Fluids – Fluids containing preservatives. Easy to use: Sartobran® P MidiCaps® are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated. Flexibility: Sartobran® P 0.2 µm MidiCaps® are available with various filtration areas from 500cm² | 0.5 ft² up to 0.5m² | 5 ft² for easy adoption to any filtration process independent from the batch size. Scalability: Consistent and predictable scale-up and down trials can reliably be performed as all Sartobran® P MidiCaps® are produced with the same type of membrane and identical materials of construction. Cost Saving: The use of the disposable capsule design concept avoids investments into stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation. Microbiological Retention: Sartobran® P MidiCaps® 0.2 µm rated are fully validated as sterilizing grade filters according to HIMA and ASTM F-838-05 guidelines. Quality Control: Each individual element is tested for integrity by B.-P. and Diffusion-Test prior to be released assuring absolute reliability. Documentation: Sartobran® P MidiCaps® 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.

Applications:

Sartobran P filters are ideally suited for all applications that require highest product recovery rates like: Coagulation Factors, Albumine, IgG, Bacterial and Viral Vaccines, MAB's, Bio-processed Pharmaceuticals, Diagnostics, Purified Protein Solutions, Biological Fluids, Solutions containing Preservatives.

Easy to Use:

Sartobran® P MidiCaps® are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated.

Flexibility:

Sartobran P 0.2 µm filters are available in traditional cartridge formats and disposable capsules from 150 cm² to 1.8 m² for simple linear scale up and process flexibility.

Scalability:

Consistent and predictable scale-up and down trials can reliably be performed as all Sartobran® P MidiCaps® are produced with the same type of membrane and identical materials of construction.

Cost Saving:

The use of the disposable capsule design concept avoids investments into stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation.

Microbiological Retention:

Sartobran® P 0.2 µm rated MidiCaps® are fully validated as sterilizing grade filter elements according to HIMA and ASTM F-838-05 guidelines.

Quality Control:

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

Documentation:

Sartobran® P MidiCaps® are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System. A Validation Guide and Extractables Guide are available for compliance with regulatory requirements.

Product properties

Branch
Pharma / Biotech
Filter Type
Filter Capsules
Type
Sterile filter
Filtration area
0,45 m²
Membrane filter material
Cellulose Acetate

Technical attributes

Support Layers
Polypropylene (PP)
Structural Compounds
Polypropylene (PP)
Outer diameter
77 mm
Overall length
Connector Combinations SS & FF: 0.05 m² | 0.5 ft²: 115 mm; 0.1m² | 1 ft²: 148 mm; 0.2 m² | 2 ft²: 197 mm; 0.45 m² | 5 ft²: 330 mm
Min. required Bubble Point
3.2 bar | 46 psi
Max. allowed air diffusion
at 20 °C and 2.5 bar | 36 psi: 0.05 m² | 0.5 ft²: 3 ml/min; 0.1 m² | 1 ft²: 4 ml/min; 0.2 m²| 2 ft²: 5 ml/min; 0.45 m²| 4.5 ft²: 10 ml/min
Bacterial Retention
Quantitative Retention of 1 x E7 CFU/cm² Brevundimonas Diminuta ATCC 19146 per ASTM methodology
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, 30 min
Non-Fiber Releasing
This product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72
GMP Compliance
This product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
Membrane material
Cellulose Acetate (CA)
Max. Differential Pressure
20 °C: 5 bar; 80 °C: 2 bar
Connectors Inlet
1/2'' Hose Barb
Connectors Outlet
1/2'' Hose Barb
Order number:

5235307H0--OO--V

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