Waters ACQUITY UPLC H-Class Bio Used Ultra-Performance Liquid Chromatograph
| Brand | Waters |
|---|---|
| Origin | USA |
| Model | ACQUITY UPLC H-Class Bio |
| Instrument Age | 5–7 years |
| Warranty | 6 months |
| Configuration | Bio-QSM Quaternary Solvent Manager, Bio-SM FTN Sample Manager, Column Manager, TUV Tunable UV/Vis Detector |
| Compliance | Designed for biopharmaceutical analysis under GLP/GMP-aligned workflows |
| Software Platform | Empower 3 (or later) compatible |
| Detection Principle | UV/Vis absorbance (190–700 nm, tunable) |
| Flow Path Material | Titanium, PEEK, and bio-inert stainless steel alloys |
| Maximum Pressure | 15,000 psi (103 MPa) |
| Injection Volume Range | 0.1–100 µL (with precision of ±0.3% RSD) |
| Column Temperature Range | 4–100 °C (±0.1 °C stability) |
| Gradient Delay Volume | < 100 µL (system-dependent) |
Overview
The Waters ACQUITY UPLC H-Class Bio is a pre-owned, fully refurbished ultra-performance liquid chromatography system engineered specifically for the robust, reproducible, and high-resolution separation of sensitive biomolecules. Built upon the foundational architecture of the ACQUITY UPLC H-Class platform, this bio-optimized configuration integrates inert fluidic pathways—constructed from titanium, PEEK, and electropolished stainless steel—to minimize surface adsorption, metal-catalyzed degradation, and carryover during analysis of proteins, monoclonal antibodies (mAbs), peptides, oligonucleotides, glycans, and other labile macromolecules. Its operational principle relies on high-pressure, low-dispersion liquid chromatography coupled with precise gradient formation, sub-2-µm particle-packed columns, and thermally stabilized column environments to deliver superior peak capacity, resolution, and retention time reproducibility. Unlike conventional HPLC systems, the H-Class Bio enables method transfer across laboratories without re-optimization—supporting harmonized workflows in global biopharma development, QC release testing, and comparability studies.
Key Features
- Bio-inert fluidic path: Titanium solvent manifolds, PEEK-lined capillaries, and low-binding injection needle design reduce protein adsorption and improve recovery for intact mAb and fragment analysis.
- Quaternary solvent delivery with AutoBlend Plus™ technology: Enables on-the-fly pH and organic modifier adjustment—critical for shallow gradients in ion-exchange (IEX) and hydrophilic interaction (HILIC) separations.
- FTN (Flow-Through Needle) sample manager: Delivers <0.05% carryover across diverse sample matrices, supports 96- and 384-well plate compatibility, and maintains quantitative precision (RSD < 0.5% at 5 µL injection).
- Column Manager with dual-zone temperature control: Independently regulates column oven and detector flow cell temperatures (4–100 °C, ±0.1 °C stability) to preserve secondary structure integrity and ensure retention time transferability.
- Tunable UV/Vis (TUV) Detector: Provides real-time spectral acquisition (190–700 nm, 1 nm resolution), enabling peak purity assessment, wavelength optimization for low-abundance analytes, and compliance with ICH Q5E guidelines for higher-order structure monitoring.
Sample Compatibility & Compliance
The ACQUITY UPLC H-Class Bio accommodates a broad range of biomolecular samples—including denatured and native proteins, antibody-drug conjugates (ADCs), viral vectors, plasmid DNA, and complex glycoprotein mixtures—across reversed-phase (RP), size-exclusion (SEC), ion-exchange (IEX), and hydrophilic interaction (HILIC) modes. Its hardware and firmware support audit-trail-enabled operation per FDA 21 CFR Part 11 when paired with Waters Empower 3 CDS (Chromatography Data System). All refurbished units undergo full functional validation per ASTM E2500-13 and ISO/IEC 17025 traceable protocols, including pressure testing, gradient accuracy verification, injection precision assessment, and baseline noise evaluation. Each system ships with a Certificate of Reconditioning and full service history documentation.
Software & Data Management
This instrument is validated for use with Waters Empower 3 Feature Release 6 or later, supporting electronic signatures, user role-based access control, and automated report generation compliant with ALCOA+ principles. Method templates for common biopharma assays—including SEC-MALS integration, peptide mapping, and charge variant profiling—are included. Raw data files (.raw) are natively compatible with third-party processing tools such as UNIFI, MassLynx, and BioConfirm. All refurbished systems include licensed software media, activation keys, and optional remote diagnostics setup via Waters Connect™.
Applications
- Monoclonal antibody purity and aggregation profiling via SEC-UPLC
- Peptide mapping and post-translational modification (PTM) characterization under denaturing RP conditions
- Charge variant analysis using cation-exchange UPLC (CEX-UPLC)
- Glycan release and HILIC-based profiling of N-linked oligosaccharides
- Plasmid DNA supercoiled vs. open-circular isoform quantification
- Stability-indicating assays for biosimilars and novel biologics
FAQ
Is this system eligible for Waters factory service contracts?
Yes—refurbished ACQUITY UPLC H-Class Bio systems retain full eligibility for Waters Extended Service Agreements (ESAs), including Preventive Maintenance (PM), priority response, and parts coverage.
What documentation accompanies the instrument?
Each unit includes a Certificate of Reconditioning, full calibration report, IQ/OQ test records, service history log, and original OEM manuals (digital and printed).
Can it be integrated into an existing Empower 3 network?
Absolutely—the system ships with network-ready Ethernet interface, configured for seamless domain authentication and centralized data archiving within enterprise Empower deployments.
Are column heaters and autosampler cooling options available?
Yes—optional column heater modules (up to 120 °C) and refrigerated sample manager (4 °C) kits can be added prior to shipment.
Does SpectraLab Scientific provide application support post-purchase?
Yes—our team offers complimentary method transfer assistance, system qualification guidance, and biopharma-specific troubleshooting for six months following installation.
