SOTAX AT Xtend Dissolution Tester (Refurbished)

Overview

The SOTAX AT Xtend Dissolution Tester is a fully modular, regulatory-compliant dissolution testing platform engineered for pharmaceutical quality control laboratories requiring high reproducibility, operational flexibility, and long-term scalability. Built upon the proven mechanical architecture of the SOTAX AT 7smart series, the AT Xtend implements Couette-type hydrodynamic principles to ensure precise, consistent fluid dynamics across all USP-specified apparatus configurations—namely USP Apparatus 1 (basket), USP Apparatus 2 (paddle), USP Apparatus 5 (flow-through cell), and USP Apparatus 6 (reciprocating cylinder). Its core design emphasizes mechanical robustness, thermal stability, and positional accuracy—critical parameters defined in USP , Ph. Eur. 2.9.3, and JP 17 dissolution monographs. The system operates under validated WinSOTAXplus software, which provides full 21 CFR Part 11 compliance—including electronic signatures, role-based access control, and immutable audit trails—making it suitable for GLP and GMP environments subject to FDA, EMA, or PMDA inspection.

Key Features

• Automated centering mechanism ensures repeatable alignment of paddles/baskets relative to dissolution vessels—eliminating manual calibration drift and reducing operator-induced variability.
• Self-aligning shaft and vessel positioning system enables tool-free, rapid transition between USP 1 and USP 2 configurations without recalibration.
• Vertical water bath closure with quick-lock interface allows intuitive, ergonomic engagement—available in both manually actuated and motor-driven variants for enhanced process consistency.
• Modular Xtend architecture supports field-upgradable expansion: users may add temperature monitoring probes, automated sampling modules (e.g., ASR 400), or UV/Vis integration without replacing the base system.
• Thermally stabilized 6–8 vessel water bath tank maintains ±0.2 °C uniformity across all positions per USP requirements, with integrated heater-cooler units and PID-controlled circulation.
• Pre-validated WinSOTAXplus software (v5.3 or higher) includes method templates aligned with ICH Q5C stability guidance and supports raw data export in .csv and .pdf formats for regulatory submission.

Sample Compatibility & Compliance

The AT Xtend accommodates standard USP-compliant dissolution vessels (1000 mL, 900 mL, and 250 mL), including sinker-equipped baskets for low-solubility APIs. It supports extended runtime protocols required for modified-release formulations and biopharmaceuticals per USP . All hardware and firmware components meet CE marking requirements under Directive 2014/30/EU (EMC) and 2014/35/EU (LVD). The system has been verified against ASTM E2503–22 (Standard Practice for Performance Verification of Dissolution Apparatus) and conforms to ISO/IEC 17025:2017 documentation standards when operated within a qualified laboratory environment. Refurbishment includes full mechanical recalibration, temperature mapping (per IQ/OQ protocol), and software revalidation documentation per client request.

Software & Data Management

WinSOTAXplus serves as the central control and data governance layer. It enforces ALCOA+ data integrity principles through time-stamped audit logs, user activity tracking, and electronic signature workflows compliant with FDA 21 CFR Part 11 Subpart C. The software supports multi-level user roles (Administrator, Analyst, Reviewer), customizable report generation (including dissolution profiles, similarity factor f2 calculations), and secure network deployment via Windows Server environments. Raw sensor data—including temperature, rotation speed, and vessel immersion depth—is captured at ≥1 Hz resolution and stored in encrypted local databases. Export functions support FDA eCTD Module 3 formatting and are compatible with LIMS integration via ODBC or REST API extensions.

Applications

This instrument is routinely deployed in QC release testing of immediate- and extended-release solid oral dosage forms, including tablets, capsules, and orally disintegrating films. Its USP 5/6 capability supports advanced formulation development for transdermal patches, implants, and nanoparticle suspensions. In R&D settings, the transparent bath design facilitates real-time visual assessment of tablet erosion, particle aggregation, or sinker performance—critical during OOS investigations and root cause analysis. The system also supports dissolution–permeation coupling studies when interfaced with Franz diffusion cells or parallel artificial membrane permeability assays (PAMPA).

FAQ

Is this unit supplied with full validation documentation?
Yes—each refurbished AT Xtend includes an IQ/OQ summary report, temperature mapping certificate, mechanical performance verification record, and WinSOTAXplus software revalidation summary. Full documentation packages are available upon request.
Can the system be upgraded to support automated sampling?
Yes—the AT Xtend’s modular bus architecture natively supports integration with SOTAX ASR 400 or ASR 600 autosamplers, as well as third-party HPLC/GC interfaces via analog/digital I/O or RS-232.
What is the expected service life after refurbishment?
With proper preventive maintenance (biannual calibration, annual thermal verification), the mechanical platform sustains operational integrity beyond 10 years; the WinSOTAXplus software receives vendor-supported updates until at least 2027.
Does SpectraLab provide on-site installation and qualification support?
Yes—global commissioning services include site preparation review, mechanical installation, operational qualification, and staff training delivered by SOTAX-certified field engineers.
Are spare parts and consumables available post-purchase?
All critical wear components—including drive shafts, vessel holders, temperature sensors, and paddle/basket assemblies—are stocked and shipped globally within 5 business days.