Hanbon Cs-Prep Industrial-Scale Preparative Liquid Chromatography System
| Brand | Hanbon |
|---|---|
| Origin | Jiangsu, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Domestic |
| Model | CS-Prep 1600 |
| Application Level | Industrial 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 | 7 MPa |
| Wavelength Range | 190–800 nm |
| Wavelength Accuracy | ±1 nm |
| Wavelength Repeatability | ±0.2 nm |
| Baseline Noise | ±0.5 × 10⁻⁵ AU @ 254 nm |
| Data Acquisition Frequency | 20 Hz |
| Regulatory Compliance | Designed and validated per GAMP5 |
Overview
The Hanbon Cs-Prep Industrial-Scale Preparative Liquid Chromatography System is a fully integrated, high-pressure preparative HPLC platform engineered for continuous, large-volume purification of active pharmaceutical ingredients (APIs), fine chemicals, natural product isolates, and high-value intermediates. Based on classical liquid chromatographic separation principles—employing high-resolution column packing materials and precisely controlled solvent gradients—the system delivers scalable, reproducible fractionation under programmable pressure, flow, and detection conditions. Unlike analytical or semi-preparative systems, the Cs-Prep 1600 is architecturally optimized for industrial environments: its modular fluidic design supports uninterrupted operation at up to 300 L/h, with pressure stability maintained up to 7 MPa (1015 psi), enabling efficient use of both silica-based and polymeric stationary phases across diverse mobile phase chemistries (including aqueous/organic, acidic/basic, and corrosive solvent systems). All mechanical, electrical, and software subsystems are developed in accordance with ISO 13485-aligned quality management practices and engineered for long-term reliability in 24/7 production settings.
Key Features
- Industrial-grade high-pressure pumping architecture with dual-plunger reciprocating pumps, delivering stable flow from 0–300 L/h with ≤0.1% RSD and ±1.5% absolute accuracy across full range
- UV-Vis detector with 190–800 nm spectral coverage, ±1 nm wavelength accuracy, and ultra-low baseline noise (±0.5 × 10⁻⁵ AU @ 254 nm) for high-sensitivity peak tracking during macro-scale elution
- Automated, programmable fraction collector capable of synchronized valve switching and vial positioning, supporting multi-column parallel processing and sequential collection based on time, volume, or UV threshold triggers
- Instrument-integrated cleaning-in-place (CIP) and validation-in-place (VIP) routines compliant with ASME BPE and ISPE guidelines, minimizing cross-contamination risk between batches
- Explosion-proof enclosure options (ATEX Zone 1 / Class I Div 1 certified variants available upon request) for safe operation with flammable organic solvents
- Redundant pressure monitoring with real-time diaphragm rupture detection, emergency shutdown logic, and hardware interlocks meeting IEC 61511 SIL-2 functional safety requirements
Sample Compatibility & Compliance
The Cs-Prep 1600 accommodates a broad spectrum of sample matrices—including crude fermentation broths, plant extracts, synthetic reaction mixtures, and polymer solutions—without requiring extensive pre-filtration beyond standard 5 µm inline filtration. Column compatibility spans inner diameters from 50 mm to 600 mm and lengths up to 1 m, supporting both stainless steel and Hastelloy® wetted-path configurations for aggressive media. The system meets regulatory expectations for pharmaceutical manufacturing: it is designed following GAMP5 lifecycle principles, with documented user requirement specifications (URS), functional specifications (FS), and design specifications (DS); factory-acceptance testing (FAT) and site-acceptance testing (SAT) protocols are provided. All control software modules undergo rigorous verification against FDA 21 CFR Part 11 criteria—including role-based access control, electronic signature enforcement, immutable audit trails, and secure electronic record storage—and support full GMP validation packages (IQ/OQ/PQ documentation included).
Software & Data Management
Control and data acquisition are managed through a customized iFix SCADA platform, extended with Hanbon-developed chromatography-specific logic engines and method editors. The interface provides real-time visualization of all critical parameters—pressure profiles, flow deviations, UV absorbance trends, and fraction collection status—with configurable alarm thresholds and event logging. Multi-threaded data handling ensures deterministic response times even during concurrent acquisition (20 Hz sampling), method switching, and archive compression. All user actions—including method creation, parameter modification, run initiation, and report export—are captured in a tamper-evident audit trail with timestamp, operator ID, and contextual metadata. Raw chromatograms, processed peak tables, and system logs are stored in vendor-neutral HDF5 format, compatible with third-party CDS platforms and enterprise LIMS integration via OPC UA or RESTful API.
Applications
The Cs-Prep 1600 serves as a core purification workhorse in regulated and non-regulated industrial settings. Typical applications include: isolation of monoclonal antibody fragments from mammalian cell culture harvests; chiral resolution of racemic APIs under supercritical or normal-phase conditions; recovery of thermolabile alkaloids from botanical extracts using low-temperature gradient elution; purification of oligonucleotide synthesis by-products via ion-pair reverse-phase chromatography; and continuous polishing of peptide intermediates prior to lyophilization. Its scalability enables direct process transfer from lab-scale (e.g., 10 g injections) to pilot (kg-scale) and commercial (100+ kg/batch) operations without re-optimization of retention or selectivity.
FAQ
Does the Cs-Prep 1600 support method transfer from analytical or semi-preparative HPLC systems?
Yes—retention time, selectivity, and resolution are preserved across scales when column geometry and mobile phase composition are proportionally scaled using established dimensionless number correlations (e.g., reduced plate height, h = H/dp). Hanbon provides scale-up consulting and column selection guidance.
Is remote monitoring and troubleshooting supported?
The system includes embedded Ethernet connectivity with TLS-encrypted web-based HMI access, enabling secure remote diagnostics, firmware updates, and live parameter viewing without compromising network segmentation requirements.
Can the system be integrated into an existing MES or automation infrastructure?
Yes—OPC UA server functionality is standard, allowing bidirectional communication with Siemens PCS7, Emerson DeltaV, and Rockwell FactoryTalk environments for batch record synchronization and automated recipe dispatch.
What validation documentation is supplied with the system?
A complete GMP validation package is delivered, including URS, FS, DS, FAT/SAT reports, IQ/OQ/PQ protocols and executed records, software validation summary, and 21 CFR Part 11 compliance statement—all traceable to ISO/IEC 17025-accredited test laboratories.
Are spare parts and service support available globally?
Hanbon maintains regional technical service centers in Europe, North America, and APAC, with 48-hour critical spares dispatch and certified field engineers trained to ISO 9001 maintenance standards.
