Hanbon Cs-Prep Industrial Preparative Liquid Chromatography System

Overview

The Hanbon Cs-Prep Industrial Preparative Liquid Chromatography System is a high-pressure, large-scale preparative HPLC platform engineered for robust, continuous separation and purification of active pharmaceutical ingredients (APIs), fine chemicals, natural product isolates, and high-value intermediates. Built upon classical liquid chromatographic principles—namely, differential partitioning of analytes between a stationary phase (e.g., silica, C18, or specialized chiral media) and a mobile phase under controlled pressure gradients—the Cs-Prep system delivers reproducible, scalable, and regulatory-compliant purification workflows. Its architecture supports both gradient and isocratic elution modes, with precise solvent delivery across flow rates up to 300 L/h and sustained operation at pressures up to 7 MPa—enabling efficient resolution of complex mixtures in batch or semi-continuous mode. Designed from inception for industrial deployment, the system integrates seamlessly into existing manufacturing infrastructure and meets fundamental engineering requirements for Class I Div 1 hazardous area compatibility (ATEX/IECEx optional configurations available).

Key Features

• Modular, GMP-ready mechanical design featuring stainless-steel fluidic pathways, explosion-proof motor drives, and redundant pressure monitoring circuits
• Certified high-accuracy dual-piston metering pumps with real-time flow compensation and pressure ripple suppression
• UV-Vis detection module with thermally stabilized optics, wavelength calibration traceable to NIST standards, and baseline stability verified per USP <621>
• Fraction collector with programmable vial/tank positioning, integrated level sensing, and inert gas purging capability for oxygen-sensitive compounds
• Full-system interlock logic including overpressure shutdown, leak detection via differential pressure monitoring, and membrane rupture alarm with automatic solvent isolation
• Hardware-level data integrity safeguards: write-once storage for raw chromatograms, hardware timestamping, and non-volatile parameter logging

Sample Compatibility & Compliance

The Cs-Prep system accommodates diverse sample matrices—including viscous crude extracts, suspension-loaded feeds, and high-salinity process streams—via configurable injection manifolds (loop or direct-injection), column oven integration (ambient to 80 °C), and backflush-compatible valve assemblies. All wetted materials comply with USP Class VI and FDA 21 CFR 177.2600 specifications. The platform is validated per ASTM E2500-13 and aligned with ICH Q5A(R2), Q7, and Q9 frameworks. Full qualification documentation—including DQ/IQ/OQ/PQ protocols, risk assessments (FMEA), and change control records—is provided as part of the GAMP 5-based validation package. System architecture conforms to FDA 21 CFR Part 11 requirements for electronic records and signatures, with audit trail generation enabled by default and immutable log retention for ≥36 months.

Software & Data Management

• iFix-based control software customized for chromatographic process orchestration, supporting method templates, sequence scheduling, and real-time deviation alerts
• Multi-tier user access control (5 defined roles) with role-based parameter lockout, enforced password policies, and session timeout enforcement
• FDA 21 CFR Part 11-compliant electronic signature workflow with biometric or PKI token options, dual-authorization for critical actions (e.g., method override, fraction discard)
• Comprehensive audit trail capturing operator ID, timestamp, action type, pre-change value, and post-change value for all configuration and acquisition events
• Raw data export in vendor-neutral formats (e.g., .cdf, .mzML-compatible metadata wrappers) and native support for LIMS/SCADA integration via OPC UA 1.04
• Real-time trending dashboards for pressure, UV absorbance, flow rate, and fraction volume—with configurable alarm thresholds and automated PDF report generation

Applications

The Cs-Prep system is deployed across regulated and non-regulated industrial environments for: purification of monoclonal antibody fragments (mAb-Fc, scFv) following capture chromatography; isolation of cytotoxic payloads in ADC manufacturing; recovery of enantiomerically pure chiral synthons for asymmetric synthesis; desalting and buffer exchange of oligonucleotide therapeutics; and large-scale isolation of polyphenols, alkaloids, and terpenoids from botanical extracts. Its scalability—from lab-scale method transfer (using identical chemistry and gradient profiles) to multi-hundred-liter production runs—ensures consistent purity profiles (≥99.5% by HPLC-area normalization) and batch-to-batch yield reproducibility (RSD ≤2.3% across 50 consecutive runs). Process analytical technology (PAT) readiness enables integration with inline NIR or Raman probes for real-time concentration monitoring during collection.

FAQ

Does the Cs-Prep system support method transfer from analytical or semi-preparative HPLC systems?

Yes—retention time scaling, gradient dwell volume compensation, and column dimension normalization algorithms are embedded in the method conversion utility to ensure seamless translation of UHPLC or analytical methods to industrial scale.
Is remote monitoring and troubleshooting supported?

The system includes secure TLS 1.2-enabled remote desktop access (with configurable firewall rules) and diagnostic telemetry upload capability for predictive maintenance analytics.
Can the system be integrated into an existing MES or ERP environment?

Native OPC UA server implementation allows bidirectional data exchange with SAP MES, Siemens Opcenter, or Rockwell FactoryTalk, including batch ID propagation, material consumption tracking, and equipment utilization KPIs.
What validation documentation is included with delivery?

A complete GAMP 5-aligned validation suite is supplied: User Requirements Specification (URS), Functional Specification (FS), Design Specification (DS), Traceability Matrix, IQ/OQ/PQ protocols with executed reports, and Change Control & Deviation Logs.
Are spare parts and service contracts available globally?

Hanbon maintains certified service centers in the EU, US, and APAC regions; all critical consumables (pump seals, UV lamp housings, fraction tubing) are stocked with ≤72-hour lead time under standard warranty terms.