Sartopore® 2 XLI | Gamma Midicaps® | 0.2µm | Size 0 | 2pc.

• Specially designed for sterile filtration of pharmaceutical solutions with a homogeneous particle spectrum
• Unique heterogeneous double-layer PES membrane combination
• Specifically designed to ensure exceptionally high total flow and flow rates for the entire chemical process fluids and other process fluids of the small particle spectrum biotech manufacturing processes

Main Applications

Focus applications include:

• Ophthalmic solutions
• Chemically defined cell culture media
• Large volumes of highly viscous parenterals
• Any completely chemically defined medium

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 XLI 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 XLI 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 XLI uses a heterogeneous double membrane made of polyethersulfone

Compatibility

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

Economical Filtration

The combination of the built-in 0.35 μm pre-filter in front of a 0.2 μm final filter together with an exceptionally high effective filtration area enables outstanding overall flow and flow rate performance in the target applications. This ensures maximum process efficiency, minimized filtration costs and short filtration times.

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 XLI 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 XLI filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.

Documentation:

Sartopore^® 2 XLI 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.