Sartopure® GF Plus Sartoscale 25 0.65 µm

Sartopure^® GF Plus Sartoscale

Sartopure^® GF Plus Sartoscale is a small-scale format for evaluating Sartopure^® GF Plus adsorptive depth filtration in pharmaceutical and biopharmaceutical process development. It uses the Sartopure^® GF Plus two-layer glass-fiber fleece concept to support clarification and prefiltration studies before transfer to larger capsule or cartridge formats. The filter matrix combines adsorptive and mechanical retention to reduce colloids, lipids, protein aggregates and particles in challenging process streams.

Main Formats:

• Retention Ratings: Available with 0.65 µm and 1.2 µm retention ratings to support selection according to feed stream composition, particulate load and downstream filtration requirements.
• Sartoscale Format: Small-scale format for process development, filter screening and scale-up studies using Sartopure^® GF Plus filter.
• Development-Scale Use: Suitable for evaluating filtration behavior with limited sample volumes before moving to Midicaps^®, Maxicaps^® or cartridge formats.
• Scalable Filter Concept: Supports process transfer by using the same Sartopure^® GF Plus depth filtration principle as larger formats.

Applications:

• Filter Selection Studies: Used to assess the suitable retention rating and filtration setup for a defined process stream.
• Process Development: Supports early-stage clarification and prefiltration trials with limited feed volumes.
• Scale-Up Preparation: Helps generate process understanding before transfer to larger Sartopure^® GF Plus formats.
• Cell Culture Harvest Clarification: Supports reduction of particles, colloids, lipids and protein aggregates in harvested cell culture fluids.
• Fermentation Broth Prefiltration: Applicable for small-scale clarification trials before downstream membrane filtration, chromatography or ultrafiltration.
• Media and Serum Filtration: Suitable for evaluating filtration of serum-free or serum-containing media and fluids containing lipid or colloidal contaminants.
• Viscous Solution Trials: Can be used for development work with viscous pharmaceutical process fluids, such as ophthalmic or large-volume parenteral solutions, at appropriate scale.

Materials Used:

• Filter Medium: Two-layer glass-fiber fleece for combined adsorptive and mechanical retention.
• Support Material: Polypropylene support fleece.
• Structural Components: Polypropylene components, depending on selected Sartoscale configuration.
• Sealing Materials: Silicone as standard in Sartopure^® GF Plus configurations, with EPDM or fluoroelastomer options available for selected formats depending on article and process requirements.
• Retention Options: 0.65 µm and 1.2 µm.

Advantages:

• Small-Scale Evaluation: Supports filtration studies when sample volume is limited.
• Adsorptive Depth Filtration: Glass-fiber fleece helps reduce colloids, lipids, protein aggregates and particles.
• Process Development Support: Enables assessment of clarification performance before larger-scale implementation.
• Scale-Up Orientation: Helps support transfer to Sartopure^® GF Plus Midicaps^®, Maxicaps^® or cartridge formats.
• Defined Retention Choices: Two retention ratings allow adaptation to different process fluids and clarification needs.
• Downstream Process Protection: Helps evaluate reduction of particulate and colloidal burden before membrane filters, chromatography columns and ultrafiltration systems.
• Application Flexibility: Suitable for small-scale trials involving cell culture harvests, fermentation broths, media, serum-containing fluids and viscous pharmaceutical solutions.

Together, these features make Sartopure^® GF Plus Sartoscale a practical small-scale format for filtration screening, process development and scale-up preparation in biopharmaceutical and pharmaceutical workflows.