Hanbon Cs-Prep Industrial Preparative Liquid Chromatography System
| Brand | Hanbon |
|---|---|
| Origin | Jiangsu, China |
| Manufacturer Type | OEM Manufacturer |
| Region of Origin | Domestic (China) |
| Models | 200, 300, 450, 500, 600, 800, 1000 |
| Application Level | Industrial-Scale Preparative |
| Instrument Type | High-Pressure Preparative Liquid Chromatograph |
| Flow Rate Range | 0–300 L/h |
| Flow Accuracy | ±1.5% |
| Flow Precision (RSD) | ≤0.1% |
| Maximum Operating Pressure | 10 MPa |
| Wavelength Range | ±1 nm |
| Wavelength Repeatability | ±0.2 nm |
| Baseline Noise | ±0.5 × 10⁻⁵ AU (at 254 nm) |
| Data Acquisition Frequency | 20 Hz |
Overview
The Hanbon Cs-Prep Industrial Preparative Liquid Chromatography System is a fully integrated, high-pressure preparative HPLC platform engineered for scalable, GMP-compliant purification of active pharmaceutical ingredients (APIs), fine chemicals, natural product isolates, and high-value intermediates. Built upon the principles of reversed-phase, normal-phase, and ion-exchange chromatography, the system delivers precise gradient elution control, real-time UV/Vis detection, and automated fraction collection under programmable process conditions. Its modular architecture supports column diameters from 50 mm to 1,000 mm ID and accommodates both stainless steel and inert flow paths—critical for handling corrosive solvents or metal-sensitive compounds. Designed explicitly for continuous operation in pilot and production environments, the Cs-Prep system operates within validated pressure, flow, and spectral performance envelopes, ensuring batch-to-batch reproducibility across multi-kilogram purification campaigns.
Key Features
- Industrial-grade high-pressure pumping system with dual-plunger design, delivering stable flow across the full 0–300 L/h range at up to 10 MPa (1450 psi) maximum pressure.
- UV/Vis detector with ±1 nm wavelength accuracy and ±0.2 nm repeatability, calibrated per ISO 17025 traceable standards; baseline noise ≤0.5 × 10⁻⁵ AU at 254 nm enables reliable low-concentration peak detection.
- GMP-aligned hardware configuration: explosion-proof cabinet option (ATEX/IECEx compliant), solvent-resistant wetted materials (Hastelloy C-276, PEEK, sapphire windows), and redundant pressure relief mechanisms.
- Integrated fraction collector with position-synchronized triggering, variable tube rack support (13–50 mm vials), and optional cold-tray integration for thermolabile compound recovery.
- Self-contained wash-in-place (WIP) and clean-in-place (CIP) sequences, programmable via method editor to minimize cross-contamination and downtime between batches.
Sample Compatibility & Compliance
The Cs-Prep system accommodates a broad spectrum of sample matrices—including crude fermentation broths, synthetic reaction mixtures, botanical extracts, and polymer solutions—without requiring pre-filtration beyond standard 0.45 µm membrane filtration. Its fluidic design minimizes dead volume and shear-induced degradation, supporting biomolecules up to 2 MDa. Regulatory alignment includes full adherence to FDA 21 CFR Part 11 (electronic records/signatures), EU Annex 11, and ICH Q5A/Q5D guidelines for biopharmaceutical purity assessment. All factory-installed software modules follow GAMP 5 lifecycle documentation standards, and the system ships with IQ/OQ/PQ protocol templates, risk assessments (FMEA), and raw data integrity validation reports.
Software & Data Management
Control and data acquisition are managed through a hardened iFix-based SCADA platform, extended with Hanbon’s proprietary Cs-Prep Process Suite. The interface supports role-based access control (RBAC) with five hierarchical permission levels—from operator to QA reviewer—preventing unauthorized parameter modification. Audit trails record all user actions, method changes, calibration events, and alarm acknowledgments with immutable timestamps. Data is stored in native .csv and .tdms formats, with optional integration into LIMS or MES via OPC UA or RESTful API. Electronic signatures comply with ALCOA+ principles, and all raw detector signals, pump profiles, and fraction triggers are archived with SHA-256 hash verification for forensic traceability.
Applications
- Pharmaceutical manufacturing: Isolation of chiral APIs, removal of genotoxic impurities, and polishing of monoclonal antibody fragments.
- Fine chemical synthesis: Purification of catalysts, ligands, and asymmetric intermediates where stoichiometric purity >99.5% is required.
- Natural product research: Scalable isolation of alkaloids, flavonoids, and terpenoids from plant extracts with minimal structural alteration.
- Food & nutraceuticals: Decaffeination, anthocyanin enrichment, and removal of mycotoxins from grain-derived streams.
- Polymer science: Fractionation of polydispersed synthetic polymers by molecular weight for structure–property correlation studies.
FAQ
What regulatory documentation is provided with the Cs-Prep system?
Standard delivery includes complete GMP validation packages: URS, FDS, DQ/IQ/OQ/PQ protocols, traceability matrices, calibration certificates (NIST-traceable), and 21 CFR Part 11 compliance evidence.
Can the system be integrated into an existing plant automation network?
Yes—it supports Modbus TCP, Profibus DP, and OPC UA connectivity for seamless integration with DCS or PLC-based infrastructure.
Is remote monitoring and troubleshooting supported?
The system includes secure TLS-encrypted remote desktop access (with customer-defined firewall rules) and predictive maintenance alerts based on pump cycle count and pressure deviation trends.
What column hardware options are available?
Hanbon offers standardized flanged connections (DIN 28178) compatible with major column vendors (e.g., Waters, YMC, Agilent); custom jacketed or heated columns can be integrated upon request.
How is data integrity ensured during long-duration runs (e.g., >72 hours)?
Continuous write-caching with battery-backed RAM, automatic checksum validation on file close, and dual-storage redundancy (SSD + NAS backup) prevent data loss or corruption.
