Agilent ProStar/PrepStar/SepTech Skid Liquid Chromatography System
| Brand | Agilent Technologies |
|---|---|
| Origin | Germany |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Imported Instrument |
| Model | ProStar/PrepStar/SepTech Skid |
| Instrument Type | Conventional High-Performance Liquid Chromatograph (HPLC) |
| Flow Rate Range | 0.001–3200 mL/min |
| Maximum Pressure | 8700 psi (600 bar) |
| UV-Vis Detector Wavelength Range | 190–700 nm |
| UV-Vis Detector Noise | ±5 × 10⁻⁶ AU |
| Compliance | GLP, ISO 9001, cGMP (design-qualified), FDA 21 CFR Part 11-ready software architecture |
Overview
The Agilent ProStar/PrepStar/SepTech Skid Liquid Chromatography System is a modular, scalable platform engineered for end-to-end chromatographic workflow execution—from analytical method development and validation through preparative purification to pilot-scale and continuous manufacturing operations. Built upon Agilent Technologies’ legacy of precision fluid handling and robust system integration, this tri-tier architecture leverages shared core components—including high-fidelity dual-piston reciprocating pumps, thermally stabilized column compartments, and optically calibrated UV-Vis detection modules—to ensure method transferability and linear scalability across all operational scales. The system operates on the principle of high-pressure liquid mobile-phase delivery through packed stationary phases, enabling separation based on differential partitioning kinetics, polarity, size exclusion, or affinity interactions. Its design adheres to fundamental chromatographic theory while accommodating real-world constraints in pharmaceutical process development, biologics purification, natural product isolation, and synthetic chemistry support.
Key Features
- Three-tiered platform architecture: ProStar (analytical & semi-preparative), PrepStar (gram-to-kilogram scale preparative), and SepTech Skid (pilot- to production-scale, >1 L/min flow)
- Ultra-broad flow range: 0.001–3200 mL/min, achieved via interchangeable pump heads (isocratic, binary, quaternary, and high-flow configurations)
- Chemically inert fluidic path options: Stainless steel, titanium, and PEEK-wetted materials—selected per application requirements for metal-sensitive biomolecules or aggressive solvents
- Multi-detector compatibility: UV-Vis (190–700 nm), diode array (DAD), refractive index (RI), fluorescence (FLD), and electrochemical (ECD) detectors—each with traceable calibration and noise performance ≤±5 × 10⁻⁶ AU
- Automated sample handling: 96- and 384-position autosamplers with programmable injection volume, needle wash, and vial agitation—validated for both analytical quantitation and preparative fraction triggering
- Integrated fraction collection: Time-, peak-, or threshold-triggered collection with position mapping, solvent-resistant trays, and optional refrigerated storage
- STAR workstation software: Windows-based, multi-instrument control (up to four systems simultaneously), audit-trail enabled, and compliant with FDA 21 CFR Part 11 data integrity requirements
Sample Compatibility & Compliance
The system supports a wide spectrum of sample matrices—including small-molecule APIs, peptides, monoclonal antibodies, oligonucleotides, natural extracts, and polymer additives—without compromising resolution or recovery. All wetted materials are selected per USP <661>, ISO 10993, and ASTM F2028 guidelines for extractables and leachables profiling. The PrepStar and SepTech Skid configurations are designed to meet current Good Manufacturing Practice (cGMP) infrastructure requirements, including Class A/B cleanroom integration readiness, pressure-relief valve certification (PED 2014/68/EU), explosion-proof enclosures (ATEX Zone 1/21 certified variants available), and redundant safety interlocks with real-time pressure/temperature monitoring. System qualification documentation follows IQ/OQ/PQ protocols aligned with ICH Q5, Q7, and Q9 frameworks.
Software & Data Management
Control and data acquisition are managed via Agilent STAR Chromatography Data System (CDS), a validated, 21 CFR Part 11-compliant platform supporting electronic signatures, role-based access control, automated backup, and immutable audit trails. The software provides method translation tools for seamless scale-up from ProStar to PrepStar to SepTech Skid—including gradient dwell volume compensation, dwell time normalization, and column dimension recalibration. Raw data files (.ch) are stored in vendor-neutral formats compatible with third-party processing tools (e.g., Chromeleon, Empower, OpenLab CDS). All instrument logs—including pump pressure traces, detector baselines, valve actuation timestamps, and temperature profiles—are archived with SHA-256 hash verification for regulatory submission readiness.
Applications
- Pharmaceutical R&D: Forced degradation studies, impurity profiling, chiral separation method development, and stability-indicating assay validation
- Bioprocess purification: Capture and polishing steps for mAbs, ADCs, and viral vectors using protein A, ion exchange, and size-exclusion columns
- Generic drug development: Bioequivalence support, dissolution testing, and reference standard qualification
- Academic & contract research: Natural product dereplication, metabolomics sample fractionation, and synthetic intermediate purification
- Industrial manufacturing: Continuous chromatographic purification skids for peptide synthesis, vaccine adjuvant refinement, and oligonucleotide desalting
FAQ
What distinguishes the ProStar, PrepStar, and SepTech Skid configurations?
ProStar is optimized for analytical and low-volume semi-preparative work (≤50 mL/min); PrepStar extends to gram- to kilogram-scale purification (up to 3200 mL/min, 8700 psi); SepTech Skid is a fully engineered, skid-mounted system for continuous operation at pilot or commercial scale (>1 L/min), with integrated utilities, safety systems, and cGMP documentation support.
Is method transfer between tiers supported?
Yes—STAR CDS includes built-in scaling calculators that adjust gradient times, flow rates, and column dimensions while preserving retention time ratios and resolution metrics, ensuring reproducible method translation across all three platforms.
Can the system be qualified for GMP environments?
All PrepStar and SepTech Skid systems ship with full IQ/OQ documentation packages; PQ support is provided onsite. Optional 21 CFR Part 11 compliance packages include electronic signature workflows, audit trail configuration, and periodic review reports.
What column hardware options are available?
Standard offerings include stainless steel, titanium, and PEEK-lined columns ranging from 2.1 mm to 100 mm ID, with lengths from 10 mm to 1000 mm. Custom-packed columns, guard cartridges, and column re-packaging services are available through Agilent’s Global Column Center.
How is maintenance and service support structured internationally?
Agilent provides global field service engineers certified to ISO/IEC 17025 standards, with SLA-backed response times, remote diagnostics, and preventive maintenance contracts covering calibration, leak testing, and pump seal replacement.
