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.
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:
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.
Sartorius Lab Instruments GmbH & Co. KG | |
---|---|
Product Category | Filter Elements |
Product Number | 5445358K9--**--A |
Product Name | Sartopore® 2 MidiCaps® 0.1 µm Liquid Filters |
Configuration | In-line |
Application / Industry | Biopharmaceutical |
Filtration Product | Water; Liquids |
Filter Medium Material | Polyethersulfone |