Sartoscale
Reliable Filter Testing With Minimal Product Volume
Sartoscale single-use filters are ideal for screening filter materials in biopharmaceutical and pharmaceutical development. Designed for minimal product volumes, they are especially useful in early-stage work with limited or costly materials.
Sartoscale also supports process scale-up by using the same materials as full-scale filters for reliable transfer. Its single-use format saves time, eliminates the need to install filter discs in stainless steel holders, prevents installation errors, and removes the risk of cross-contamination and the need for cleaning.
Sartoscales are available in two sizes:
Sartoscale 25 has a 4.5 cm² effective filtration area (EFA), and Sartoscale 47 offers an EFA of 17.3 cm².
These compact device constructions offer extremely low hold-up volumes (Sartoscale 25: ≤ 1 mL) and enable filtration trials with minimal product volume and high product recovery.
Each Sartoscale unit is laser-labeled with the product name, pore size or retention rate, lot number, and piece number, assuring reliable filter identification and complete traceability. In addition, the Sartoscale 25 carries a 2D barcode for automatic data transfer.
Sartoscale single-use filters utilize identical product-contacting filter materials as their process-scale counterparts to ensure consistency during scale-up. Additionally, the use of these identical filter materials facilitates small-scale adsorption studies of formulation components or high-value product streams.
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Performance Deep Dive
Confidence® Validation Services: A SartoScale 25 Approach
Sartorius’ Confidence® Validation Services offer an optimized testing approach with the Sartoscale 25, ensuring high standards. The Sartoscale 25 testing approach enables the execution of bacterial challenge tests, chemical compatibility, and product testing in a single run. Automated testing with Sartoscale 25 reduces the required product volume for testing by up to tenfold, requiring only 0.5 L.
The approach captures thousands of data points in a single run, including pressure, flow rate, pH, and conductivity. Complex process management is facilitated by the simple simulation of complex start-stop filtration processes thanks to automated and highly customizable test protocols. Compliance with regulations is based on existing test procedures and conforms to ASTM F838, PDA TR26, and ISO 13408.
