Sartopore® 2 XLI | Sartoscale 47 | 0.2 µm | 3pc.

• 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

SartoScale units are ideally suited for all types of filterability studies with the aim of selecting the optimal prefilter for an optimal application. Moreover, they can determine the ideal combination of pre- and final filters with the aid of a minimum product volume.

• Developed for the execution of reliable filterability samples
• Made from the same non-woven fabric material as the original filter cartridges
• Ready-to-use single-use test filter unit

Membrane

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

SartoScale units contain the original filter active material of the corresponding filter cartridges to ensure the repeatability of test results.

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.

Using SartoScale during filtration studies saves time which would otherwise be used for the installation preparations for the punch piece in the stainless steel filter brackets and prevents possible installation errors.

After the material selection or the definition of a pre/final filter combination with the SartoScale units, a scale-up method should be carried out for the flow rate and total flow using pleated capsule units of small scales (e.g. capsule size 4).

SartoScale units have an extremely low residual volume for performing filterability samples with minimized product volumes.

SartoScale test filter units are equipped with suitable filter membranes for integrity testing so that their integrity can be determined using the bubble point test in order to ensure absolute reliability of the test results.

We recommend using the SartoScale units together with the Zero-T Filter Test System to make the filtration studies as effective as possible. The Zero-T system consists of hardware and software modules which make it easy to handle and install Sartoscale test filter units. Automatic data collection is achieved by connecting a frame to a laptop. The software automatically analyzes the incoming data for the scale-up calculations.