SOTAX AT 7smart Dissolution Tester (Refurbished)

Overview

The SOTAX AT 7smart Dissolution Tester (Refurbished) is a precision-engineered, modular dissolution testing system designed for pharmaceutical quality control laboratories requiring regulatory-compliant, high-reproducibility performance in oral solid dosage form evaluation. Based on the paddle and basket dissolution principles defined in USP , Ph. Eur. 2.9.3, and JP 17, the AT 7smart employs a dual-sensor temperature control architecture with real-time feedback to maintain bath stability within ±0.1 °C across its 17.5 L water reservoir. Its compact 7-vessel configuration features staggered positioning—optimized for ergonomic access, visual monitoring, and spatial efficiency—while maintaining strict geometric conformity to pharmacopeial vessel geometry and immersion depth requirements. The system implements SOTAX’s proprietary Auto-Compliance design, which mechanically enforces precise centering of both dissolution vessels and rotating shafts via integrated alignment guides and self-registering mechanical interfaces—eliminating manual calibration drift and reducing daily operational qualification burden.

Key Features

• Seven-position staggered vessel layout—reduces footprint by up to 30% versus linear 6- or 8-vessel systems while preserving full USP/Ph. Eur. geometric compliance.
• Auto-centering mechanical architecture: Integrated vessel cradles and paddle shaft couplings ensure repeatable axial alignment without user intervention—critical for minimizing hydrodynamic variability between runs.
• Integrated anti-evaporation lid assembly—mechanically coupled to the frame for synchronized centering and thermal sealing; eliminates vapor loss during extended dissolution profiles (e.g., 24-h sustained-release assays).
• Modular pump interface: Supports either CP Xtend peristaltic pump (for high-precision, low-pulse sampling) or CP 7-35 (for robust, high-flow applications); both validated for ≤1% volumetric accuracy per USP sampling tolerance.
• Tool-free paddle height adjustment: Cam-lock spindle coupling enables rapid, repeatable immersion depth setting at 25 mm ±0.5 mm—fully compliant with USP paddle position specifications.
• Programmable timed start and audible sampling alerts: Ensures operator adherence to scheduled timepoints, reducing human error in multi-hour dissolution protocols.

Sample Compatibility & Compliance

The AT 7smart accommodates standard USP Apparatus 1 (basket) and Apparatus 2 (paddle) configurations using interchangeable shafts and vessels (1000 mL capacity). It supports all common dissolution media—including aqueous buffers, surfactant solutions, and organic-aqueous mixtures—within its specified temperature range (20–60 °C). All refurbished units undergo full functional validation per ASTM E2503-22 (Standard Guide for Validation of Dissolution Apparatus) and include documented evidence of vessel temperature uniformity, rotational speed accuracy (±0.5 rpm), and mechanical centering repeatability. Units are supplied with traceable calibration certificates aligned to ISO/IEC 17025-accredited reference standards. The system meets baseline requirements for GLP environments and supports audit-ready documentation when paired with WINSotax software (optional upgrade path).

Software & Data Management

While the base AT 7smart operates via front-panel controls, it is fully compatible with SOTAX WINSotax v5.x dissolution management software—enabling automated method execution, real-time data logging, statistical trend analysis (e.g., f2 similarity factor calculation), and electronic signature support compliant with FDA 21 CFR Part 11 Annex 11 requirements. Refurbished systems include firmware version 4.2 or higher, ensuring backward compatibility with legacy WINSotax installations and secure export of raw dissolution curves in CSV and XML formats. Audit trail functionality—recording all parameter changes, sample events, and user logins—is enabled by default in software-integrated configurations.

Applications

• QC release testing of immediate-release and modified-release tablets, capsules, and pellets per ICH Q5C and Q6A guidelines.
• Comparative dissolution profiling for generic product development and bioequivalence studies.
• Stability-indicating dissolution method development under forced degradation conditions (e.g., pH-shifted media, elevated temperature).
• In-process control of coating thickness and polymer erosion kinetics in film-coated formulations.
• Supporting regulatory submissions requiring full apparatus qualification data packages (e.g., ANDA, MAA, NDA modules 3.2.P.5.3).

FAQ

Is this unit certified for GMP use?
Yes—each refurbished AT 7smart undergoes IQ/OQ protocol execution per ASTM E2503-22 and includes a Certificate of Conformance detailing temperature uniformity, rotational accuracy, and mechanical alignment verification.
What documentation is provided with the system?
You receive a full refurbishment report, calibration certificates traceable to NIST/PTB standards, electrical safety test records, and a 6-month parts-and-labor warranty document.
Can I integrate this with my existing HPLC or UV-Vis quantification workflow?
Absolutely—the C 613/C 615 autosamplers provide standardized 12-mm or 16-mm vial output compatible with most autosampler trays; tubing connections follow ISO 8536-4 specifications for seamless integration.
Are original SOTAX service manuals and schematics included?
Yes—digital copies of the AT 7smart Operator Manual, Maintenance Guide, and WINSotax Software User Guide are delivered upon purchase.
Do you offer installation and on-site qualification support?
Yes—SpectraLab Scientific provides optional IQ/OQ execution services performed by ISO 13485-certified field engineers, including URS review, protocol generation, and final sign-off documentation.