Sartopore
® 2 0.45 μm MidiCaps
® are self-contained, ready-to-use filter elements for bioburden and particle removal for a wide range of pharmaceutical products. Membrane prefiltration of aqueous solutions and high-value pharmaceutical products that are difficult to filter can be performed effectively, due to the excellent overall flow and flow rate performance of the Sartopore
® 2 0.45 μm MidiCaps
®.
- Single-Use MidiCaps® for Process Scale
- Reduction of Cleaning & Cleaning Validation
- Familiar performance characteristics of the Sartopore® 2
Applications:
Typical applications include bioburden and particle removal of:
- Therapeutica
- Injection solutions
- Buffer
- Biological Fluids
- Tissue culture media
- Acidic and alkaline solutions
Compatibility:
The polyethersulfone membrane is compatible within a pH range of 1-14. This makes the Sartopore® 2 MidiCaps® ideal for filtering solutions with a high/low pH.
Easy to use:
Sartopore® 2 MidiCaps® are supplied as single and sterile packaged, ready-to-use units, eliminating the need for sterilization prior to use.
Flexibility:
Sartopore® 2 0.45 μm MidiCaps® are supplied with a wide range of filtration areas from 500 cm² | 0.5 ft² up to 0.45 m² | 4.5 ft² and with various connections to ensure easy adaptation to your application filtration needs regardless of batch size.
Scale Up:
Consistent and predictable scale-up and scale-down procedures can be performed safely because all Sartopore® filter elements are manufactured with the same membrane type and construction materials.
Cost savings:
By using single-use filter elements, there is no need to invest in stainless steel filter housings. Additional costs for cleaning the housing and cleaning validation are eliminated.
Microbiological retention:
Sartopore® 2 MidiCaps® 0.45 μm were validated with a Log Reduction Value (LRV) of 7 for "Serratiam marcessens" according to HIMA and ASTM F-838-05 specifications.
Quality:
Every single element is tested for integrity to meet the highest quality requirements.
Documentation:
Sartopore® 2 MidiCaps® have been designed, developed and produced in accordance with the ISO 9001 certified quality management system. A validation manual is available in accordance with regulatory requirements."
