Sartopore® 2 0.45 μm Gamma 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 Gamma MidiCaps®.
- Single-Use Gamma MidiCaps® for Process Scale
- Reduction of Cleaning & Cleaning Validation
- Familiar performance characteristics of the Sartopore® 2
- Gamma Irradiatable
Applications:
Typical applications include bioburden and particle removal of:
- Therapeutica
- Injection solutions
- Buffer
- Biological Fluids
- Tissue culture media
- Acidic and alkaline solutions
Compatibility
Sartopore®2 Gamma Midicaps® have been developed for sterilization using gamma irradiation < in 50 kGy irradiation doses. The Sartopore® 2 polyethersulfone membrane has a high chemical compatibility between pH 1 to 14, making Sartopore® 2 Gamma Midicaps® ideally suited for the filtration of high and low pH buffers in pharmaceutical | Biotech Industry
Easy to use:
Sartopore® 2 Gamma MidiCaps® are supplied ready-to-use, non-sterile and double-packaged to facilitate transfer to cleanroom areas."
Flexibility:
Sartopore® 2 0.45 μm Gamma 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 Gamma 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 Gamma 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."
