Sartopore Evo® | 0.2 µm | Sartoscale 47 | 3pc.

Sartopore Evo® marks the next generation of high-performance, sterilizing-grade filters for pharmaceutical and biopharmaceutical fluids. An innovative modification of polyethersulfone (PES) membranes minimizes the adsorption of proteins and excipients, such as polysorbates, to ensure stable drug formulations and reduce the number of vials that must be discarded during form and fill operations.

Unlike the polyvinylidene fluoride (PVDF) membrane filters, Sartopore Evo® does not intentionally use PFAS compounds in its construction material.

In addition, Sartopore Evo® filters achieve much higher flow rates and throughputs than PVDF membrane filters, allowing the use of a smaller filter element, further reducing adsorption and disposable waste.

Main Applications and Process Steps

Sterilizing-grade filtration of bulk drug substance and final filtration of drug product in applications like:

• Monoclonal antibodies (mAbs)
• Adeno-associated virus (AAV)-based therapies
• Lipid nanoparticles (LNPs)

Features and Benefits

• Minimized adsorption of proteins and excipients, like polysorbate 20 and 80, to increase yield and ensure stable drug formulation, supporting compliance with specifications
• High filter capacity and flow rates for efficient process operations
• No intentional use of PFAS compounds, protecting the long-term supply security of critical components

Sartoscale

SartoScale units are ideally suited for all types of filterability studies with the aim of selecting the optimal filter 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 membrane material as the original filter
• Ready-to-use single-use test filter unit
• Extremely low residual volume for performing filterability samples with minimized product volumes.

Membrane

Sartopore Evo® uses a double double layer membrane made of polyethersulfone.

The combination of the built-in 0.8 μm pre-filter in front of a 0.2 μm final filter enables outstanding overall flow and flow rate performance in the target applications.

Unique Surface Modification

The Sartopore Evo® filter's unique surface modification is fundamental to its robust performance. This feature minimizes the adsorption of proteins and excipients, such as polysorbates, which are commonly used in drug formulations. The adsorption of these components can lead to significant challenges, including reduced drug efficacy and stability. By effectively reducing adsorption, the Sartopore Evo® filter ensures that the integrity and potency of the drug product are maintained throughout the filtration process and significantly reduces lost batches due to deviations from formulation specifications. This increases the process yield and reduces costs.

Flexibility

Sartopore Evo® 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.

Scalability

Consistent and predictable scale-up and scale-down procedures are ensured with Sartopore Evo® filter elements, as they are all crafted using the same membrane type, support fleeces, and construction materials, providing reliability across applications.

Environmental Impact

Unlike PVDF filters, the Sartopore Evo® is made without the intentional introduction of PFAS compounds. As regulatory pressures mount against PFAS due to their potential health and environmental risks, the Sartopore Evo® filter provides a future-proof solution that aligns with global sustainability goals.

This ensures that manufacturers can confidently meet regulatory requirements and maintain a reliable supply chain while maintaining the highest standards of product safety and efficacy.