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High-Performance Sterilizing-Grade Filtration for Solvents and Oily Formulations

Sartorius Stedim Biotech GmbH

Broad chemical compatibility with unique hydrophilic nylon membrane design

Superior total throughput with heterogeneous double-layer construction

Scalable filtration areas from 0.2 to 2.4 m² for R&D to production scale

Enhanced Chemical Compatibility and Superior Throughput for Pharmaceutical Applications

Sartolon® sterilizing-grade filter elements deliver exceptional performance for sterile filtration of solvents and oily formulations in pharmaceutical and chemical manufacturing. The innovative hydrophilic nylon (polyamide) membrane provides outstanding mechanical strength and broad chemical compatibility, making these filters the preferred choice where chemical stability is critical.

The heterogeneous double-layer design features both 0.45 μm prefilter and 0.2 μm endfilter membranes, delivering superior total throughput and flow rates compared to conventional single-layer nylon filters. This advanced architecture significantly reduces filtration costs and cycle times while maintaining sterilizing-grade performance validated according to ASTM F-838 guidelines.

Applications span large volume parenterals, bulk pharmaceutical chemicals, antibiotics production, and antibody-drug conjugate (ADC) processes. The filters excel with solvents, oily formulations, and challenging chemical environments where traditional filtration solutions may fail.

Available in multiple formats including cartridges (10" to 40"), Maxicaps® capsules, and Midicaps® for flexible scale-up. Filtration areas range from 0.2 m² for laboratory screening to 2.4 m² for production-scale operations. All elements withstand multiple sterilization cycles (minimum 25 cycles at 134°C) and meet USP requirements for water for injection quality standards.

The polypropylene construction with silicone O-rings ensures compatibility with aggressive solvents while maintaining integrity under differential pressures up to 5 bar at 20°C. Each element undergoes individual bubble point and diffusion testing to guarantee sterilizing-grade performance and regulatory compliance including USP Plastic Class VI certification and non-pyrogenic validation.

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Filters: Sartolon

High-Performance Sterilizing-Grade Filtration for Solvents and Oily Formulations

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