Sartopore® 2 XLM | Gamma Maxicaps® | 0.1µm | 10"

Sartopore^® 2 XLM is specifically designed for sterile filtration and safe mycoplasma retention in cell culture media. A long filter life is guaranteed by the extremely asymmetrical and heterogeneous PES Membrane and allows a >50% better performance compared to existing 0.1 μm filter cartridges.

• Lowest filter consumption by high filtration capacity
• Lowest risk of Mycoplasma contamination for your fermentation process
• High performance 0.1 μm Mycoplasma retentive filter
• Fully validated as sterilizing-grade filter (according to current ASTM F-838 guideline)

Main Applications

Focus applications include:

• Cell culture media containing vegetable peptone, soy or yeast
• Serum containing cell culture media
• Cell Culture Media Components
• All other cell culture media used in biotechnical production

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 XLM 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 XLM 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 XLM uses a heterogeneous double membrane made of polyethersulfone

Compatibility

Sartopore^®2 XLM filters have been developed for sterilization using autoclaving at 134°C | 2bar. The polyethersulfone membrane is compatible within a pH range of 1-14. This makes the Sartopore^® 2 XLM filters ideal for filtering solutions with a high/low pH.

Economical Filtration

The built-in pre-filter membrane is specially designed to protect the 0.1 μm membrane in cell culture media filtration. The optimized membrane combination together with the exceptionally high filter area of 0.8m²/10'' filter element allow a >50% better performance compared to existing 0.1 μm filter elements, which ensures low filtration costs per litre, minimized filtration times and smallest footprint of the filtration system.

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

Documentation:

Sartopore^® 2 XLM 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.