Vemex YMC K-Prep FC750 Medium- to Low-Pressure Preparative Liquid Chromatography System

Overview

The Vemex YMC K-Prep FC750 is a robust, medium- to low-pressure preparative liquid chromatography system engineered for reproducible isolation and purification of target compounds at pilot-scale and early industrial process development stages. Designed around classical high-performance liquid chromatography (HPLC) principles—specifically gradient elution, isocratic separation, and fraction collection under programmable pressure and flow control—the system supports column diameters from 50 mm to 150 mm (ID), enabling throughput scaling from gram- to multi-hundred-gram quantities per run. Its architecture integrates a high-capacity dual-piston pump, UV/Vis detection with 1 nm wavelength resolution, and a fraction collector synchronized with real-time chromatographic data. The system operates within a maximum pressure limit of 10 MPa (100 bar), positioning it between analytical HPLC and high-pressure preparative systems—offering enhanced solvent compatibility, reduced backpressure constraints, and extended column lifetime for silica- and polymer-based stationary phases.

Key Features

• Wide-flow-range binary gradient pump delivering stable, pulse-free flow from 1 to 750 mL/min, calibrated and verified per ISO 11607 and ASTM D7849 standards for volumetric accuracy.
• UV/Vis detector with fixed-wavelength or scanning capability (1 nm resolution), optimized for sensitivity and linearity across 190–800 nm range; baseline noise and drift specifications conform to ICH Q2(R2) guidelines for quantitative method validation support.
• GMP-aligned hardware design: stainless-steel fluidic pathways, leak-detection sensors, pressure interlocks, and configurable alarm thresholds meeting JIS B 7981 and ISO 13485 requirements for medical device and pharmaceutical manufacturing environments.
• Modular fraction collector with programmable tube rack indexing, timed or peak-triggered collection, and optional chilled compartment (4 °C) for thermolabile compound stability.
• Front-panel touchscreen interface supplemented by full remote operation via Ethernet-connected PC, supporting role-based user access control and audit trail logging.

Sample Compatibility & Compliance

The K-Prep FC750 accommodates a broad spectrum of sample matrices—including natural product extracts, synthetic intermediates, peptides, oligonucleotides, and small-molecule APIs—without requiring derivatization or extensive pre-filtration. Column compatibility spans reversed-phase (C18, C8), normal-phase (silica, amino), ion-exchange, and size-exclusion chemistries, with recommended particle sizes from 10 to 40 µm for optimal loading capacity and resolution trade-off. The system meets essential regulatory expectations for pharmaceutical process development: it is IQ/OQ-validated out-of-the-box, supports documented installation and operational qualification protocols, and its software architecture complies with Japan’s Ministry of Health, Labour and Welfare (MHLW) “Guideline on Computerized Systems in Pharmaceutical Manufacturing” (CSV standard). Full 21 CFR Part 11 compliance—including electronic signatures, audit trails with immutable timestamps, and user permission hierarchies—is enabled through optional software licensing and configuration.

Software & Data Management

The proprietary K-Prep Control Suite is a Windows-based application developed in alignment with MHLW CSV principles and validated per GAMP 5 Category 3 criteria. It provides real-time monitoring of pressure, flow, UV absorbance, and fraction events; automated method sequencing; and integrated data archiving in vendor-neutral .csv and .cdf formats. All instrument parameters, acquisition logs, and user actions are recorded with time-stamped, tamper-evident audit trails. Raw chromatograms and processed peak tables can be exported directly to LIMS or ELN platforms via OPC UA or RESTful API interfaces. Data integrity safeguards include automatic backup to network drives, encrypted local storage, and configurable retention policies aligned with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Applications

• Purification of active pharmaceutical ingredients (APIs) during clinical trial material (CTM) synthesis and Phase II–III process optimization.
• Isolation of bioactive constituents from botanical extracts for nutraceutical and cosmeceutical development.
• Scale-up of chiral separations using polysaccharide-based columns (e.g., Chiralpak®, Chiralcel®) under isocratic or step-gradient conditions.
• Desalting and buffer exchange of peptides and proteins prior to lyophilization or formulation studies.
• Recycling and reprocessing of reaction mixtures in fine chemical manufacturing to improve atom economy and reduce waste generation.

FAQ

What column dimensions are supported by the K-Prep FC750?

The system is optimized for preparative columns with internal diameters ranging from 50 mm to 150 mm and lengths up to 500 mm.
Does the system support method transfer from analytical to preparative scale?

Yes—scaling rules based on constant linear velocity and mass load are embedded in the software; method translation tools assist in preserving selectivity and resolution during scale-up.
Is the software compliant with FDA 21 CFR Part 11?

Full Part 11 compliance—including electronic signatures, audit trail review functionality, and system validation documentation—is available with licensed software modules and proper site-specific configuration.
Can the K-Prep FC750 operate unattended overnight?

Yes—scheduled runs, automatic shutdown sequences, and email/SMS alerts (via optional gateway integration) enable extended unattended operation under monitored laboratory conditions.
What maintenance intervals are recommended for pump seals and UV lamp?

Pump seal replacement is advised every 6 months under continuous operation; UV lamp lifetime is rated at ≥2,000 hours, with real-time usage tracking and predictive maintenance alerts in the control software.