Sartopore® 2: Sterilizing-Grade Filters
Sartopore® 2 Polyethersulfone (PES) filters in 0.2 µm and 0.45 µm support sterilizing-grade filtration and bioburden reduction across liquid processing. The hydrophilic double-layer design delivers high throughput, broad chemical compatibility, and reliable scale-up.
Key Features
- Hydrophilic Double Layer: 0.45 µm prefilter with 0.2 µm final membrane for sterile filtration; 0.8 µm prefilter with 0.45 µm final membrane for bioburden reduction and particle removal. This setup helps maintain flow and limits early blockage.
- PES Membrane: Broad chemical compatibility across pH 1–14 with thermal resistance. This supports consistent performance with buffers, media, and diverse process fluids.
- Integrity Tested: Every element is tested by diffusion and bubble point methods. This provides process assurance and supports dependable release criteria.
- Scalable Formats: Available from 4.5 cm² up to 1.8 m² per element. This enables linear scale-up from PD to production.
- PFAS Considerations: Manufactured without intentionally using PFAS compounds. This helps prepare processes for potential future restrictions.
Applications
- Therapeutics, biological fluids, injectables, and ophthalmic solutions.
- SVPs and LVPs, bulk pharmaceutical products, antibiotics.
- Buffers, media, Water for Injection (WFI), chemicals.
- Cleaning and sanitizing agents, acetic and basic solutions.
- Tissue culture media and related processing steps.
Benefits
- High Throughput: Membrane architecture supports high flow at low pressure drops, helping shorten cycle times and improve line utilization.
- Broad Compatibility: Hydrophilic PES with pH 1–14 tolerance enables use across buffers, media, and challenging liquids, increasing application flexibility.
- Reliability and Compliance: Integrity testing to ASTM F‑838 principles and defined bubble point and diffusion criteria support robust qualification.
- Cost Efficiency: Total throughput and flow performance help reduce filter consumption and processing costs while supporting efficient changeovers.
- Seamless Scale-Up: Common materials and construction across formats simplify transition from R&D to full-scale production and help standardize validation.
Sartopore® 2 filters are designed to meet the demanding needs of the pharmaceutical and biotechnology industries, offering unparalleled performance and reliability.
