Sartopore® 2 XLG | Gamma Maxicaps® | 0.2µm | 30"

Sartopore® 2 XLG is a high-performance membrane filter, offering more than just reliable sterilizing-grade filtration in biopharmaceutical processes. Its highly asymmetric membrane structure and composition of 0.8µm prefilter in front of the sterilizing-grade filter (0.2 µm pore size), boosts the filtration efficiency in downstream processing of protein-based therapies or innovative drug delivery systems like lipid nanoparticles (LNPs). Thanks to the outstanding total throughput, Sartopore® 2 XLG is also a choice for filtration after the cell harvest.

Main Applications

Focus applications include:

• Cell culture media preparation
• Post cell harvest filtration
• Protein-based therapies (Downstream intermediates, form & fill)
• Lipid nanoparticles (Downstream intermediates, form & fill)

Your Benefits

• Increased total throughput leads to less filter consumption, less process interruptions and reduced costs
• Increased effective filtration enables the use of smaller filters to reduce footprint and waste
• Proven and robust membrane chemistry known from the widely established Sartopore® 2 family lowers validation effort in case of process optimization
• Broad range of formats and sizes assures scalability and enables use of Sartopore® 2 XLG along the whole drug product lifecycle: from development to commercial processes
• Offers secure bacterial retention according to ASTM guidelines

The XL family

The XL in its name indicates an increased effective filtration area (EFA). By using a different pleating technology, the EFAs of Sartopore ® 2 XLG filters are - depending on filter format - 30-40% higher than for the conventional Sartopore® 2 filters. This leads to higher total throughput per filter element and less filter consumption or enables the use of a smaller filter element for a process to reduce the footprint and waste.

Membrane

Sartopore^® 2 XLG uses a heterogeneous double membrane made of polyethersulfone

Compatibility

Sartopore^®2 XLG Gamma filters 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 XLG Gamma filters ideally suited for the filtration of high and low pH solutions in pharmaceutical | Biotech Industry

Cost savings:

The use of disposable filter elements eliminates the need to invest in stainless steel filter housings. Additional costs for housing cleaning and cleaning validation are eliminated.

Flexibility

Sartopore^® 2 XLG filters are available in a wide range of filtration areas from 4.5 cm² up to 2.4 m² and with a variety of commonly used connections to ensure easy integration into your process 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.

Quality:

Every single element is tested for integrity to meet the highest quality requirements.

Microbial Retention

Sartopore^® 2 XLG filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.

Documentation:

Sartopore^® 2 XLG filters 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.