Hanson Research 72RL USP Dissolution Tester

Overview

The Hanson Research 72RL is a benchtop USP-compliant dissolution testing system engineered for precision, repeatability, and regulatory adherence in pharmaceutical quality control and formulation development laboratories. Based on the hydrodynamic principles of USP Apparatus 1 (basket) and Apparatus 2 (paddle), the 72RL employs calibrated mechanical drive systems, thermally stabilized water baths, and synchronized vessel positioning to ensure consistent fluid dynamics across all 12 test positions. Its robust architecture supports both immediate-release and modified-release dosage form evaluation under controlled temperature, rotation speed, and sampling timing—critical parameters defined in ICH Q5A, USP , and FDA’s Guidance for Industry on Dissolution Testing of Immediate-Release Solid Oral Dosage Forms. The system is not a chromatographic instrument; it serves as a pre-analytical sample preparation platform, generating time-point solutions that are subsequently quantified via HPLC, UV-Vis, or other analytical methods.

Key Features

• 12-position dissolution station with independent digital speed control per vessel (25–250 rpm, ±1 rpm accuracy)
• Integrated water bath with PID temperature regulation (30–45 °C range, ±0.2 °C thermal stability over 6 h)
• USP-certified basket (Apparatus 1) and paddle (Apparatus 2) assemblies included; optional sinker and conical vessel kits available
• RS-232 and USB ports for external data logging and integration with LIMS or custom acquisition software
• Stainless steel construction with corrosion-resistant coating; compliant with ISO 9001-certified manufacturing practices
• Pre-installed calibration verification tools: thermometer probe, tachometer, and vessel centering gauge

Sample Compatibility & Compliance

The 72RL accommodates standard 1000 mL dissolution vessels and supports solid oral dosage forms including tablets, capsules, granules, and orally disintegrating tablets (ODTs). It meets mechanical calibration requirements outlined in USP for apparatus verification and is routinely validated per ASTM E2503–21 (Standard Practice for Verification of Performance of Dissolution Apparatus). All refurbished units undergo full functional verification—including temperature uniformity mapping, rotational speed linearity, wobble measurement, and vessel vertical alignment—per PQ (Performance Qualification) protocols aligned with FDA 21 CFR Part 11 expectations for audit-ready documentation. Units are supplied with a Certificate of Operational Verification and traceable calibration records.

Software & Data Management

While the 72RL operates as a standalone hardware platform without proprietary embedded software, its serial and USB interfaces enable seamless integration with third-party data acquisition systems such as Agilent MassHunter Dissolution Module, Waters Empower Dissolution Extension, or custom Python- or LabVIEW-based scripts. Timestamped analog outputs (0–5 V) for temperature and rotation status support real-time monitoring in GLP/GMP environments. All refurbished instruments include documented firmware version logs and interface compatibility reports. For regulated labs, the system supports electronic record retention when paired with 21 CFR Part 11-compliant software—ensuring audit trails, user authentication, and data integrity for dissolution profiles submitted to health authorities.

Applications

• Comparative dissolution profiling of generic vs. reference listed drug (RLD) products
• Excipient screening and formulation optimization during preformulation studies
• Stability-indicating method development for release kinetics assessment
• Biowaiver justification per WHO and EMA biopharmaceutics classification system (BCS) criteria
• Quality-by-Design (QbD) workflows requiring Design Space mapping of dissolution variables
• Regulatory submission support for ANDAs, NDAs, and MAAs requiring USP-apparatus-compliant data

FAQ

Is this unit fully refurbished and tested prior to shipment?
Yes. Each 72RL undergoes comprehensive mechanical, thermal, and metrological verification at SpectraLab Scientific’s ISO/IEC 17025-accredited facility, including temperature mapping, rotational accuracy validation, and vessel alignment checks.
Does the system include USP-compliant baskets and paddles?
Yes. The standard configuration includes twelve USP-certified stainless steel baskets (Apparatus 1) and twelve USP-compliant paddles (Apparatus 2), all individually serialized and verified.
Can the 72RL be integrated into an existing LIMS or ELN environment?
Yes—via RS-232 or USB interface using Modbus RTU or ASCII command protocols; integration support documentation and sample drivers are provided.
What documentation accompanies the instrument?
Certificate of Operational Verification, calibration records traceable to NIST standards, mechanical verification report, and full electrical safety test summary.
Is extended warranty or service contract available?
Yes. Optional 12- or 24-month extended service agreements—including priority remote diagnostics, on-site preventive maintenance, and spare parts provisioning—are available upon request.