puriFlash®5.015‐XL Process-Kilo-Lab Preparative Chromatography System
| Brand | Advion Interchim Scientific |
|---|---|
| Origin | France |
| Model | puriFlash®5.015‐XL |
| Max Flow Rate | 825 mL/min |
| Max Operating Pressure | 15 bar |
| Scale | Process to Kilo-Lab (up to 1–5 kg purified material per run) |
| Compliance | CE, ISO 9001-certified manufacturing |
Overview
The puriFlash®5.015‐XL Process-Kilo-Lab Preparative Chromatography System is an engineered solution for scalable, reproducible purification of organic compounds, natural products, peptides, and small-molecule pharmaceuticals—from late-stage discovery through early clinical supply. Designed and manufactured by Advion Interchim Scientific in France, this system implements medium-pressure liquid chromatography (MPLC) with gradient elution capability, operating within a validated pressure range up to 15 bar and delivering flow rates from 10 to 825 mL/min. Its architecture bridges the gap between analytical-scale flash systems and industrial preparative HPLC, supporting column diameters from 40 mm to 300 mm (ID) and accommodating both silica- and reversed-phase media. The system integrates dual high-precision piston pumps, UV/Vis detection with variable wavelength (200–400 nm), fraction collection synchronized to retention time or UV threshold, and a modular solvent management unit—enabling robust, walk-away operation under GMP-aligned workflows.
Key Features
- Scalable platform supporting purification from gram- to kilogram-scale batches (typical output: 1–5 kg purified compound per run)
- Dual-piston, pulseless pumping system with integrated backpressure regulation for consistent flow delivery across viscous mobile phases
- Real-time UV/Vis spectral monitoring with peak tracking, baseline correction, and multi-wavelength ratio analysis for co-elution assessment
- Automated fraction collector with programmable tube rack indexing, solvent-resistant vial trays, and optional mass-directed triggering (when interfaced with Advion expression® CMS)
- Touchscreen HMI with embedded method editor, audit trail logging, and user-level access control (compliant with ALCOA+ principles)
- Modular design permitting on-site expansion: optional add-ons include automated sample injector, column oven (ambient to 60 °C), and solvent degassing module
Sample Compatibility & Compliance
The puriFlash®5.015‐XL accommodates a broad range of sample matrices—including crude reaction mixtures, fermentation broths, plant extracts, and synthetic intermediates—without requiring extensive pre-filtration beyond standard 0.45 µm membrane filtration. It supports normal-phase (hexane/EtOAc), reversed-phase (water/acetonitrile), and ion-pairing mobile phases, with compatibility for corrosive solvents (e.g., TFA, HCl in methanol) via optional chemically resistant fluidic paths. The system is CE-marked and built under ISO 9001-certified production protocols. While not inherently 21 CFR Part 11-compliant out-of-the-box, its software architecture supports electronic signature implementation and full audit trail export when deployed with validated IT infrastructure—facilitating alignment with GLP, GMP, and ICH Q5/Q7 quality frameworks.
Software & Data Management
Control and data acquisition are managed via Interchim’s puriFlash® Software Suite (v5.x), a Windows-based application offering method development wizards, real-time chromatogram overlay, peak integration with customizable baselines, and automatic purity calculation based on area normalization. All acquisition parameters, instrument states, and user actions are timestamped and logged with immutable records. Raw data (.pfw files) are stored in vendor-neutral formats (CSV, PDF report export) and support third-party integration via OPC UA or ASCII-based API. For regulated environments, optional IQ/OQ documentation packages and CSV/Excel-based raw data archiving modules are available to meet FDA and EMA data integrity expectations.
Applications
- Purification of synthetic APIs and chiral intermediates prior to crystallization or formulation studies
- Isolation of bioactive natural product fractions for structure–activity relationship (SAR) profiling
- Desalting and buffer exchange of oligonucleotides and short peptides post-solid-phase synthesis
- Removal of catalyst residues (e.g., Pd, Ru) from cross-coupling reaction outputs
- Parallel purification of compound libraries in medicinal chemistry lead optimization campaigns
- Process validation support for Phase I/II clinical material manufacturing under quality-by-design (QbD) paradigms
FAQ
What column sizes are supported on the puriFlash®5.015‐XL?
Standard configurations support columns with internal diameters from 40 mm to 300 mm and bed heights up to 500 mm; custom manifolds are available for non-standard geometries.
Can the system operate with hazardous solvents such as chlorinated hydrocarbons or strong acids?
Yes—when equipped with optional chemically resistant pump seals, tubing, and detector flow cells (e.g., Hastelloy C-276, PEEK, or sapphire windows).
Is remote monitoring or unattended overnight operation possible?
Yes—the system supports Ethernet-connected supervision via VNC or TeamViewer-compatible interfaces, and includes hardware-based emergency shutdown triggers (pressure, temperature, leak detection).
Does the puriFlash®5.015‐XL comply with 21 CFR Part 11 requirements?
Out-of-the-box, it provides audit trail and user authentication features; full Part 11 compliance requires site-specific validation, electronic signature configuration, and secure network deployment per organizational SOPs.
What maintenance intervals are recommended for routine operation?
Pump seal replacement every 6 months (or 1,500 hours), UV lamp replacement annually, and system performance qualification (SPQ) every 6 months using certified reference standards (e.g., caffeine, naphthalene).
