KEZHE ScalePuri-100 Bench-Scale High-Pressure Preparative Liquid Chromatography System
| Brand | KEZHE SHANGHAI |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | ScalePuri-100 |
| Application Level | Laboratory & Pilot-Scale |
| Instrument Type | Medium-to-High Pressure Preparative LC |
| Flow Rate Range | 0–100 mL/min (pump), up to 800 mL/min (gradient mixing) |
| Flow Accuracy | RSD = 0.5% |
| Flow Precision | RSD = 1% |
| Max Operating Pressure | 150 bar |
| Wavelength Range | 190–850 nm |
| Wavelength Accuracy | ±1 nm |
| Wavelength Repeatability | ±0.2 nm |
| Baseline Noise | 3 × 10⁻⁵ AU |
| Data Acquisition Rate | 5 Hz |
| Detection Mode | UV-VIS with Quad-Wavelength Real-Time Monitoring |
| Column Compatibility | Axial Compression Columns, 50–100 mm ID |
| Prep Capacity | Gram-scale (up to 100 g per run) |
| System Control | Fully Software-Driven with Audit Trail, User Management, and Electronic Signature Support |
Overview
The KEZHE ScalePuri-100 is a bench-scale high-pressure preparative liquid chromatography system engineered for reproducible, scalable purification of complex natural product mixtures—particularly those derived from traditional Chinese medicine (TCM) extracts, synthetic intermediates, and bioactive pharmaceutical compounds. Built on a dual-pump high-pressure binary gradient architecture, the system operates within a validated pressure envelope of up to 150 bar, enabling robust separation on axial compression columns (50–100 mm internal diameter) while maintaining flow stability and gradient fidelity across wide flow ranges (0–100 mL/min standard; up to 800 mL/min with integrated mixing). Its core analytical engine integrates a dual-lamp UV-VIS detector (deuterium + tungsten) covering 190–850 nm with quad-wavelength real-time monitoring, baseline noise < 3 × 10⁻⁵ AU, and wavelength repeatability of ±0.2 nm—ensuring consistent detection sensitivity for both early-eluting impurities and late-eluting target fractions. Designed for transition from analytical method development to pilot-scale isolation, the ScalePuri-100 bridges the gap between research-grade HPLC and industrial production systems.
Key Features
- Fully integrated medium-to-high pressure preparative platform with dual high-capacity reciprocating pumps and active gradient mixing for precise solvent composition control
- UV-VIS detector with selectable quad-wavelength acquisition, automatic lamp intensity calibration, and lamp lifetime tracking—supporting simultaneous monitoring of multiple chromophores
- Modular axial compression column interface compatible with DAC100 and other 50–100 mm ID columns; optimized for uniform flow distribution and minimized band broadening
- Intelligent fraction collector with programmable collection modes: time-based, volume-triggered, peak-threshold, or voltage-synchronized—configurable for 30 mm tubes (60-position rack standard)
- Real-time pressure monitoring with overpressure alarm, automatic shutdown, and dynamic pressure compensation to maintain flow integrity during viscosity shifts
- Comprehensive software suite featuring peak deconvolution, quantitative integration, method validation templates, and full 21 CFR Part 11 compliance—including electronic signatures, audit trail logging, and role-based user access control
- Modular workstation architecture supporting optional detectors (e.g., ELSD), auxiliary modules (in-line filter, stirrer, sample loop pump), and customizable tube rack configurations
Sample Compatibility & Compliance
The ScalePuri-100 accommodates a broad spectrum of sample matrices—including crude TCM extracts, fermentation broths, combinatorial synthesis libraries, and polymerized small molecules—without requiring pre-filtration beyond standard 0.45 µm membrane filtration. Its 150-bar pressure rating supports C18, phenyl-hexyl, cyano, and silica-based stationary phases in both reversed-phase and normal-phase modes. The system meets essential regulatory requirements for non-GMP pilot manufacturing environments: it supports IQ/OQ/PQ documentation packages, complies with GLP principles for nonclinical laboratory studies (OECD Series 1998), and implements data integrity safeguards aligned with FDA 21 CFR Part 11 and EU Annex 11 expectations—including immutable audit trails, operator authentication, and tamper-evident electronic records. All firmware and software revisions are version-controlled and traceable per ISO/IEC 17025:2017 clause 7.7.1.
Software & Data Management
The ScalePuri-100 runs on KEZHE’s modular LC workstation software—a Windows-based application built on .NET Framework with SQL Server Express backend. It provides full method lifecycle management: from gradient editor and column equilibration scheduler to real-time chromatogram overlay, retention time alignment, and automated fraction assignment. Raw data files (.raw) are stored in vendor-neutral format with embedded metadata (instrument ID, operator, timestamp, method hash). The system enforces ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. Audit trail entries record all parameter modifications, method saves, fraction triggers, and user logins—with timestamps synchronized to NTP servers. Export options include CSV, PDF reports with digital signature embedding, and XML-compatible results for LIMS integration.
Applications
- Purification of bioactive alkaloids, flavonoids, and saponins from plant extracts under ICH Q5A-compliant conditions
- Isolation of chiral intermediates for asymmetric synthesis workflows requiring >99% ee verification
- Desalting and buffer exchange of peptide fragments prior to lyophilization or MS analysis
- Removal of residual catalysts (e.g., Pd, Ru) from API synthesis streams using immobilized scavenger columns
- Scale-up of analytical HPLC methods developed on Agilent 1260 or Waters Alliance systems via retention time and selectivity mapping
- Preparative separation of oligonucleotide impurities (n−1, n−2) using ion-pairing RP-LC protocols
FAQ
What column diameters does the ScalePuri-100 support?
The system is optimized for axial compression columns with internal diameters ranging from 50 mm to 100 mm, including standard DAC100 configurations.
Can the system operate under GMP conditions?
While not certified as a GMP manufacturing system, it fully supports 3Q qualification (IQ/OQ/PQ), 21 CFR Part 11 compliance, and audit-ready documentation—making it suitable for GLP-compliant pilot batches and clinical trial material purification.
Is gradient delay volume compensated in method transfer?
Yes—the software includes dead-volume estimation tools and allows manual or auto-compensation for dwell volume differences when transferring methods from analytical to preparative scale.
Does the UV detector support post-run spectral library matching?
Spectral acquisition is limited to four fixed wavelengths per run; full-spectrum scanning (e.g., 190–400 nm at 1 nm intervals) requires optional diode-array upgrade—not included in base ScalePuri-100 configuration.
How is data integrity ensured during long-duration runs (>48 h)?
The system performs periodic checksum validation of raw data buffers, writes to redundant storage paths (local SSD + network share), and logs all hardware interrupts with millisecond-resolution timestamps in the audit trail.
