Sartopore® 2 Gamma Midicaps® 0.45µm size 0 | 2pc

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

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."