puriFlash®535-XL Process-Scale Flash Purification System
| Brand | Advion Interchim Scientific |
|---|---|
| Origin | France |
| Model | puriFlash®535-XL |
| Max Flow Rate | 400 mL/min |
| Max Pressure | 35 bar |
| Import Status | Imported Instrument |
| Distributor Type | Authorized General Distributor |
| Pricing | Upon Request |
Overview
The puriFlash®535-XL is a high-capacity, modular flash chromatography system engineered for seamless transition from analytical and preparative purification to process-scale fractionation in pharmaceutical development, natural product isolation, and synthetic chemistry laboratories. Built upon Interchim’s proven puriFlash platform architecture, the 535-XL implements low-pressure liquid chromatography (LPLC) principles with precise gradient delivery, real-time UV/Vis detection, and automated fraction collection—enabling reproducible, scalable separations under controlled, GMP-aligned operating conditions. Its design emphasizes robustness, operational safety, and compliance-ready documentation pathways, making it suitable for early-phase API purification, kilogram-scale intermediate refinement, and QC-supporting batch release workflows.
Key Features
- High-throughput pumping system delivering up to 400 mL/min at a maximum pressure of 35 bar—optimized for rapid elution through large-diameter silica or reversed-phase columns (up to 100 mm ID).
- Modular, field-upgradable architecture supporting dual-pump gradient mixing, optional mass-directed fraction collection (when integrated with Advion expression® CMS), and auxiliary solvent modules for ternary or quaternary gradients.
- Integrated UV/Vis detector with dual-wavelength monitoring (200–400 nm), adjustable pathlength flow cells, and baseline stability < ±0.5 mAU/h—ensuring reliable peak tracking across extended runs.
- Automated fraction collector with programmable tube rack recognition, position-based triggering, and solvent-resistant tray options (including deep-well plates and glass vials) for direct compatibility with downstream lyophilization or analytical sampling.
- Touchscreen HMI with preloaded method templates compliant with ICH Q5A and Q5B guidelines for biopolymer purity assessment, plus audit-trail-enabled user access control aligned with FDA 21 CFR Part 11 requirements.
Sample Compatibility & Compliance
The puriFlash®535-XL accommodates a broad range of sample matrices—including crude reaction mixtures, fermentation broths, plant extracts, and peptide libraries—without requiring extensive pre-filtration when used with appropriate guard cartridges and column frits. It supports standard flash media (silica gel, diol, amino, C18, and specialized phases such as NH2 or cyano) in both cartridge and packed-column formats. The system meets ISO 9001-certified manufacturing standards and conforms to CE marking requirements for laboratory instrumentation. When operated with validated methods and calibrated detectors, it satisfies GLP documentation expectations for non-clinical laboratory studies per OECD Principles of Good Laboratory Practice.
Software & Data Management
Controlled via Interchim’s proprietary puriSoft™ v5.2 software, the 535-XL provides full method development, run supervision, and post-run analysis capabilities—including retention time alignment, peak purity evaluation (using spectral deconvolution algorithms), and customizable report generation (PDF/CSV). All method parameters, detector signals, and fraction metadata are timestamped and stored with immutable audit trails. Data export complies with ASTM E2500-17 for instrument qualification records and supports integration into LIMS environments via OPC UA or CSV batch export protocols. Electronic signatures and role-based permissions ensure traceability across multi-user environments.
Applications
- Process development of small-molecule APIs: linear scale-up from 10 g to >500 g purified material per run using standardized column packing and gradient profiles.
- Purification of thermally labile compounds (e.g., macrocycles, glycopeptides) under ambient or chilled conditions without degradation.
- Parallel purification of combinatorial libraries using column-switching modules and multi-channel fraction collection.
- Supporting regulatory submissions: generation of impurity profiles consistent with ICH Q3B(R3) thresholds and structural confirmation readiness for NMR/MS follow-up.
- Academic core facility deployment: shared-resource operation with scheduled maintenance alerts, consumables tracking, and usage-based cost allocation reporting.
FAQ
What column dimensions are supported on the puriFlash®535-XL?
Standard configurations accommodate columns from 15 mm to 100 mm internal diameter; custom hardware kits enable up to 150 mm ID with external pressure regulation.
Is the system compatible with hazardous solvents such as chlorinated or highly flammable mobile phases?
Yes—the fluidic path is constructed from chemically resistant PEEK, stainless steel (316L), and ETFE-lined components; optional explosion-proof enclosures and solvent vapor management modules are available for Class I, Division 1 environments.
Can puriSoft™ software be validated for use in regulated pharmaceutical environments?
Yes—Advion provides IQ/OQ documentation packages, software validation protocols (per GAMP5), and 21 CFR Part 11 configuration guides for qualified sites.
Does the 535-XL support mass-directed purification out-of-the-box?
Not natively—but seamless integration with Advion expression® CMS or other third-party mass spectrometers is enabled via analog/digital I/O and Ethernet-based trigger synchronization.
What service and calibration options are offered for international users?
Global field service network with certified engineers; annual performance verification (APV) packages include pump accuracy testing, UV lamp intensity calibration, and fraction collector positional accuracy certification.
