Water Filters from Sartorius Group

Sartopore® 2 MidiCaps® 0.1 µm Liquid Filters -- 5445358K9G-**--A


 
 

Sartopore® 2 0.1 μm rated MidiCaps are self-contained, ready-to-use membrane filter units for validated sterile filtration and reliable Mycoplasma removal in the pharma| biotech industry. Applications: Typical applications include sterilizing grade filtration and Mycoplasma removal from: – Animal Sera – Cell Culture Media – Media Components – Bioprocessed Pharmaceuticals – Biological Fluids. Any other application requiring sub 0.2 μm filtration for enhanced sterility assurance. Compatibility: The polyethersulfone membrane is compatible with a pH range from pH 1 to pH 14 making Sartopore® 2 MidiCaps ideal for filtration of solutions with high |low pH. Easy to use: Sartopore® 2 capsules are delivered as individually packed sterile units. On site,pre-use sterilization can be eliminated. Flexibility: Sartopore® 2 0.1 μm MidiCaps are available with various filtration areas from 500 cm² | 0.5 ft² up to 4.5 m² |5 ft² for easy use in any filtration process independent from the batch size. Scalability: Consistent and predictable scale-up and scale-down trials can reliably be performed as all Sartopore® 2 MidiCaps are produced with the same type of membrane, materials and identical construction. Cost Saving: The use of the capsule design concept avoidsinvestment in stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation. Microbiological Retention: Sartopore® 2 0.1 μm MidiCaps are validated as sterilizing grade filters according to ASTM F 838-05 standard and for Mycoplasma removal with a Log Reduction Value (LRV) of 7 for Acholeplasma laidlawii. Quality Control: Each individual element is tested for integrity by diffusion test prior to release assuring absolute reliability. Documentation: Sartopore® 2 MidiCaps are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide and Extractables Guide are available for compliance with regulatory requirements.

Sartopore 2 Gamma MidiCaps are designed for connection to flexible-bag-container-systems prior to sterilization by gamma-irradiation. They are available with 0.2 µm & 0.1 µm final membranes for sterilizing grade filtration and Mycoplasma removal. Applications:Typical applications include sterilizing grade filtration and Mycoplasma removal of: – Biologicals – Pharmaceuticals – Cell Culture Media (serum free or serum containing) – Culture Media Components – Serum – Buffers. Compatibility: Sartopore 2 Gamma MidiCaps are designed for sterilization by gamma irradiation < 50 kGy irradiation dosage. The Polyethersulfone membrane of the Sartopore 2 Gamma MidiCaps offers a broad chemical compatibility from pH 1 to pH 14 making them ideally suited forfiltration of high and low pH-buffers in the Pharma| Biotech field. Performance: Due to the superior construction including a “built-in” prefiltration by a heterogeneous double layer membrane Sartopore 2 Gamma Midi-Caps achieve outstanding total throughputs and excellent flow rates. Flexibility: Sartopore 2 Gamma MidiCaps are ideally suited to be used in large scale filtration applications in combination with flexible bag containers due to their superior effective filtration area of up to 1.8 m²/18 ft² per 30” element. Microbiological Retention: Sartopore 2 Gamma MidiCaps 0.2 µm & 0.1 µm rated are fully validated as sterilizing grade filters according to HIMA and ASTM F-838-05 guidelines. In addition Sartopore 2 Gmma MidiCaps are validated for Mycoplasma removal with a LRV of 7 for Acholeplasma Laidlawii. Quality Control: Each individual element is tested for integrityby B.-P. (0.2 µm only) and Diffusion-Test prior to be released assuring absolute reliability. Documentation: Sartopore 2 Gamma 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:

Typical applications include sterilizing grade filtration and Mycoplasma removal from: – Animal Sera – Cell Culture Media – Media Components – Bioprocessed Pharmaceuticals – Biological Fluids. Any other application requiring sub 0.2 μm filtration for enhanced sterility assurance.

Typical applications include sterilizing grade filtration and Mycoplasma removal from:

  • Animal Sera
  • Cell Culture Media
  • Media Components
  • Bioprocessed Pharmaceuticals
  • Biological Fluids
  • Any other application requiring sub 0.2 μm filtration for enhanced sterility assurance

Compatibility:

The polyethersulfone membrane is compatible with a pH range from pH 1 to pH 14 making Sartopore® 2 MidiCaps ideal for filtration of solutions with high | low pH.

Easy to Use:

Sartopore® 2 capsules are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated.

Flexibility:

Sartopore® 2 0.1 μm MidiCaps are available with various filtration areas from 500 cm² | 0.5 ft² up to 4.5 m² | 5 ft² for easy use in any filtration process independent from the batch size.

Scalability:

Consistent and predictable scale-up and scale-down trials can reliably be performed as all Sartopore® 2 MidiCaps are produced with the same type of membrane, materials and identical construction.

Cost Saving:

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

Microbiological Retention:

Sartopore® 2 0.1 μm MidiCaps are validated as sterilizing grade filters according to ASTM F 838-05 standard and for Mycoplasma removal with a Log Reduction Value (LRV) of 7 for Acholeplasma laidlawii.

Quality Control:

Each individual element is tested for integrity by diffusion test prior to be released assuring absolute reliability.

Documentation:

Sartopore® 2 MidiCaps are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide and Extractables Guide are available for compliance with regulatory requirements.


Specifications

Product Category
Water Filters
Configuration
Housing Included
Maximum Pressure
29 to 72 psi (20.41 to 51.02 m H2O)
Filtration Grade
0.10 to 0.20 µm (0.0039 to 0.0079 mils)
Filter Medium Material
 
Housing Material
 
Application / Industry