Sartorius Sartolab® P20/P20 Plus and RF/BT Large-Volume Sterile Filtration Systems

Overview

The Sartorius Sartolab® P20/P20 Plus and RF/BT filtration systems are engineered for high-efficiency, sterile processing of large-volume biological samples in research, bioprocessing, and quality control laboratories. These devices operate on the principle of pressure-driven (positive-pressure) or vacuum-assisted (negative-pressure) membrane filtration, enabling rapid, reproducible removal of microorganisms and particulates from aqueous and low-viscosity solutions. The core architecture integrates a polyethersulfone (PES) membrane—selected for its high flow rate, low protein binding, and broad chemical compatibility—with an optimized support structure that minimizes hold-up volume and bubble formation. Designed for scalability and regulatory alignment, the Sartolab® platform supports both single-use sterile filtration workflows and multi-sample parallel processing via the Sartolab® Multistation manifold—making it suitable for applications ranging from cell culture media preparation to buffer sterilization and sample clarification prior to downstream analytics.

Key Features

• High-flow PES membranes with pore sizes of 0.1 µm, 0.22 µm, and 0.45 µm—validated for bacterial retention (Brevundimonas diminuta challenge per ASTM F838-22)
• Sartolab® P20/P20 Plus: Positive-pressure filtration units rated for volumes from 500 mL to 10 L; P20 Plus includes integrated glass fiber (GF) prefilter for turbid or particle-rich samples
• Sartolab® RF: Complete, ready-to-use vacuum filtration assemblies with sterile, pre-attached collection bottles (150 mL–1000 mL); bottle caps supplied separately to maintain sterility until use
• Sartolab® BT: Bottle-top vacuum filters compatible with user-supplied receptacles; enables flexible volume scaling and multi-bottle sequential filtration
• Low-retention design: Optimized membrane support geometry reduces residual volume to ≤0.5 mL (for 500 mL RF units), minimizing sample loss and improving recovery of precious biomolecules
• Ergonomic construction: Molded graduations on funnel and bottle, tactile grip surfaces, and stackable configuration for cold storage and shelf space efficiency
• Vacuum interface compatibility: Standard 45 mm neck thread ensures leak-tight sealing with common laboratory bottles; yellow adapter enables secure mounting on Sartolab® Multistation for up to six parallel filtrations

Sample Compatibility & Compliance

The Sartolab® systems are validated for use with cell culture media (including serum-containing formulations), buffers, saline solutions, and purified protein preparations. All fluid-contact materials—including PES membrane, housing, gaskets, and tubing interfaces—meet USP Class VI biological reactivity requirements and are certified non-cytotoxic per ISO 10993-5. Manufacturing occurs in an ISO 13485-certified facility under ISO 8 (Class 100,000) cleanroom conditions. Each unit is gamma-irradiated and tested for endotoxin levels <0.25 EU/mL. Batch-specific certificates of analysis (CoA), sterility test reports, and bioburden data are available upon request. For GxP environments, full traceability, lot-level documentation, and audit-ready records align with GLP and GMP expectations—including support for electronic record integrity per FDA 21 CFR Part 11 when integrated with compliant LIMS or ELN platforms.

Software & Data Management

While the Sartolab® filtration devices are hardware-only, their operational consistency and validation data integrate seamlessly into regulated digital workflows. Sartorius provides downloadable technical dossiers—including filter validation summaries, extractables/leachables profiles, and compatibility matrices—for inclusion in SOPs and validation protocols. When used with Sartorius’s Biostat® or Ambr® platforms, or third-party process monitoring systems, filtration events can be logged via barcode-scanned lot numbers and time-stamped in electronic batch records. All documentation packages comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), supporting inspection readiness for EMA, FDA, and PMDA audits.

Applications

• Sterile filtration of cell culture media, supplements, and buffers prior to bioreactor inoculation
• Clarification and sterilization of monoclonal antibody (mAb) and recombinant protein formulations during early-stage development
• Pre-filtration of lysates and clarified harvest streams ahead of chromatography or ultrafiltration steps
• Routine QC testing of water-for-injection (WFI) and purified water systems using 0.1 µm RF units
• Preparation of sterile reagents for stem cell expansion, CRISPR editing workflows, and organoid culture systems
• High-throughput sample cleanup in proteomics and metabolomics pipelines where low protein adsorption is critical

FAQ

What is the maximum recommended operating pressure for Sartolab® P20/P20 Plus units?

The P20 series is rated for continuous positive-pressure operation up to 0.7 bar (10 psi); transient peaks up to 1.0 bar are permissible for short durations during system priming.
Can Sartolab® RF units be used with non-Sartorius collection bottles?

Yes—units with 45 mm neck threads are compatible with any ANSI/ISO-standard 45–400 threaded bottle; however, sterility and vacuum integrity must be verified independently when substituting receptacles.
Are Sartolab® filters suitable for filtering viscous or high-protein-concentration solutions?

For solutions >5 cP or >10 mg/mL total protein, prefiltration with GF or 0.45 µm PES is recommended; the P20 Plus variant is specifically designed for such challenging matrices.
Do Sartolab® BT filters include a built-in vacuum regulator?

No—they require external vacuum control; users should maintain ≤0.6 bar vacuum to prevent membrane collapse or premature clogging.
How is sterility assurance maintained across batch production?

Each lot undergoes 100% visual inspection, microbial challenge testing, and endotoxin quantification; gamma irradiation dose is validated per ISO 11137-2 and documented in the Certificate of Conformance.