Waters Prep SFC 150 AP System

Overview

The Waters Prep SFC 150 AP System is a fully integrated, open-bed preparative supercritical fluid chromatography (SFC) platform engineered for automated, UV- and/or mass spectrometry (MS)-guided purification of small-molecule compounds. Unlike conventional liquid chromatography systems, this instrument leverages carbon dioxide (CO₂) as the primary mobile phase—operating above its critical point (31.1 °C, 73.8 bar)—to deliver rapid equilibration, low backpressure, reduced organic solvent consumption, and enhanced separation efficiency for chiral and achiral molecules. Its architecture is purpose-built for pharmaceutical process development, where reproducible, scalable, and environmentally sustainable purification workflows are essential. The system operates under precisely controlled temperature and pressure conditions to maintain CO₂ in its supercritical state, enabling high-resolution separations with superior mass transfer kinetics compared to HPLC. Designed for routine use in regulated environments, it supports method transfer from analytical to preparative scale while maintaining retention time fidelity and peak shape integrity.

Key Features

• Integrated QGM Low-Pressure Quaternary Gradient Pump: Delivers co-solvent (modifier) at flow rates up to 150 mL/min with high precision and pulse-free operation; compatible with methanol, ethanol, isopropanol, acetonitrile, and other common modifiers.
• P200X High-Pressure CO₂ Pump: Dual-head stainless-steel pump featuring sapphire-plunger cam-driven actuators, self-priming check valves, integrated pressure transducers, analog pressure gauges, brushless DC motor drive, and certified burst disc safety assembly; dynamically regulated via real-time feedback from both pressure sensors and mass flow meters.
• Modifier Stream Injector: Enables discrete injection of modifier-only streams using a 2 mL standard loop and 5 mL syringe; incorporates programmable air gaps before and after sample to minimize band broadening and dilution during injection.
• 2767 Sample Manager (Open-Bed Configuration): Supports automated sample introduction and fraction collection; includes dedicated fume hood integration kit for safe CO₂ handling; compatible with user-selectable rack formats for vials, tubes, or microtiter plates.
• Overlapping Injection Capability: Allows sequential injections without waiting for column re-equilibration, significantly increasing throughput for high-volume purification campaigns.

Sample Compatibility & Compliance

The Prep SFC 150 AP System accommodates a broad range of thermally stable, non-polar to moderately polar small molecules—including chiral pharmaceutical intermediates, natural products, agrochemicals, and synthetic polymers. It complies with fundamental design principles aligned with ISO/IEC 17025 for testing laboratories and supports documentation practices consistent with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). While the system itself does not include on-board detectors, its architecture is fully compatible with external UV-Vis absorbance monitors and mass spectrometers equipped with SFC-compatible interfaces (e.g., ESI, APCI), enabling real-time fraction triggering per spectral signature. All fluidic pathways are constructed from electropolished 316 stainless steel and Hastelloy components rated for sustained operation at pressures exceeding 400 bar.

Software & Data Management

Operation is coordinated through FractionLynx Application Software—a validated, Windows-based platform supporting method development, sequence definition, fraction tracking, and post-run data review. When paired with Waters Open Access software, users can implement fully automated workflows that link analytical pre-screening, preparative purification, and secondary analysis of collected fractions—all within a single audit-trail-enabled environment. FractionLynx provides comprehensive electronic records including injection history, pressure/temperature logs, fraction map overlays, and integration with LIMS via ASTM E1578-compliant export protocols. The system supports 21 CFR Part 11 compliance when deployed with appropriate server infrastructure, electronic signatures, and role-based access control configurations.

Applications

• Chiral resolution of racemic drug candidates during lead optimization and API purification
• Removal of synthetic impurities and residual catalysts in fine chemical synthesis
• Isolation of bioactive constituents from botanical extracts and fermentation broths
• Preparative-scale purification of oligonucleotides and peptide conjugates
• Method scouting and scalability assessment for continuous SFC processes

FAQ

Does the Prep SFC 150 AP System include an integrated detector?
No. It is a detector-agnostic platform designed for external UV or MS coupling.
What is the maximum operating pressure of the CO₂ delivery system?
The P200X pump is rated for continuous operation up to 400 bar, with safety-certified pressure relief mechanisms.
Can the system perform gradient elution with multiple modifiers?
Yes—the QGM pump supports quaternary gradient mixing of up to four modifiers, though typical SFC applications use one or two.
Is method transfer from analytical SFC to preparative scale supported?
Yes, FractionLynx includes scaling algorithms based on linear velocity and column geometry normalization to preserve selectivity and resolution.
What regulatory documentation is available for GMP validation?
Waters provides IQ/OQ documentation templates, DQ support packages, and vendor-supplied calibration certificates traceable to NIST standards.