Hanson Research SR8-Plus Used Drug Dissolution Tester

Overview

The Hanson Research SR8-Plus is a laboratory-grade, fully programmable dissolution testing system engineered for regulatory compliance and method reproducibility in pharmaceutical quality control and formulation development. Based on the principles of hydrodynamic-controlled drug release measurement—where solid dosage forms are immersed in a standardized dissolution medium under precisely regulated temperature (37.0 ± 0.2 °C), agitation (rotational speed: 25–250 rpm), and sampling geometry—the SR8-Plus delivers traceable, auditable performance aligned with global pharmacopoeial standards. Its architecture reflects over five decades of dissolution instrumentation expertise developed in close consultation with the U.S. Food and Drug Administration (FDA), United States Pharmacopeia (USP), and international regulatory bodies. As a pre-owned unit refurbished and functionally validated by SpectraLab Scientific, this SR8-Plus unit retains full operational integrity—including all mechanical, thermal, and software subsystems—and meets baseline qualification requirements for GLP-compliant laboratories.

Key Features

• Precision-engineered 8-vessel configuration supporting simultaneous parallel testing under identical environmental conditions
• Soft-Flo low-turbulence water circulation system minimizing vortex formation and ensuring uniform thermal distribution across all vessels (±0.1 °C spatial uniformity)
• Self-aligning cup-shaft assembly compliant with USP mechanical calibration specifications
• Dual-mode drive system enabling stable operation at both low-speed (e.g., 25 rpm for extended-release formulations) and high-speed (e.g., 200 rpm for immediate-release tablets) regimes
• Integrated PETG acrylic water bath offering optical clarity, chemical resistance to common dissolution media (e.g., 0.1 N HCl, pH 4.5 acetate buffer), and reduced thermal inertia
• Onboard microprocessor with embedded 21 CFR Part 11 functionality—including electronic signatures, audit trail logging, and role-based access control
• Easy-Icon graphical user interface featuring touch-optimized navigation, real-time dissolution curve plotting, and intuitive method programming via dropdown menus and context-sensitive help screens
• Pre-loaded validation support tools: automated timing prompts for calibration checks, shaft wobble detection routines, and temperature ramp verification sequences

Sample Compatibility & Compliance

The SR8-Plus accommodates all major USP-specified dissolution apparatus types without hardware modification: Apparatus 1 (basket), Apparatus 2 (paddle), Apparatus 5 (paddle-over-disk), and Apparatus 6 (rotating cylinder). Optional accessories enable non-standard configurations including mini-vessel (150 mL), large-volume (2 L), and transdermal patch testing cells. All vessel geometries maintain strict adherence to USP dimensional tolerances and hydrodynamic equivalence criteria. The system has been verified for conformance with ISO/IEC 17025:2017 documentation practices and supports full GMP/GLP audit readiness through its built-in electronic record retention, method versioning, and operator activity logging.

Software & Data Management

The SR8-Plus runs proprietary firmware with native 21 CFR Part 11 compliance architecture. It stores up to 25 user-defined test methods—including agitation profiles, temperature setpoints, sampling intervals, and alarm thresholds—with timestamped revision history. Raw dissolution data (time-stamped absorbance or concentration values per vessel) export directly to CSV or ASTM E1382-compliant ASCII format for integration with LIMS or statistical analysis platforms (e.g., JMP, Minitab). Audit trails capture operator login/logout events, method edits, calibration actions, and system error logs—all encrypted and immutable post-generation. No external PC dependency is required for routine operation, though optional USB data dump and remote diagnostics are supported.

Applications

This instrument serves critical roles across pharmaceutical R&D and QC environments: comparative dissolution profiling of generic vs. reference listed drugs (RLD); stability-indicating release kinetics for modified-release products; excipient interaction studies under varying pH and surfactant conditions; biorelevant dissolution testing (e.g., FaSSIF/FeSSIF media); and regulatory submission support for ANDA, NDA, and DMF dossiers. Its robust mechanical design and validated thermal control make it suitable for long-duration (24+ hour) dissolution runs required for enteric-coated or osmotic pump systems.

FAQ

Is this unit fully calibrated and qualified prior to shipment?
Yes—each SR8-Plus undergoes full operational qualification (OQ) per Hanson Research’s IQ/OQ protocol, including temperature uniformity mapping, rotational speed verification, and mechanical alignment checks.
Does the 6-month warranty cover software updates and firmware patches?
Yes—the warranty includes remote technical support, firmware upgrades, and access to the latest validation documentation packages.
Can the system be integrated into an existing laboratory network for centralized data archiving?
Yes—via USB mass storage mode or optional RS-232/USB-to-serial adapter, enabling scheduled exports to network drives or LIMS ingestion pipelines.
Are original USP-compliant accessories included (e.g., certified baskets, paddles, sinkers)?
Standard USP Apparatus 1 and 2 components are included; specialty fixtures (Apparatus 5/6, mini-vessels) are available separately upon request.
What documentation accompanies the instrument?
A complete refurbishment dossier is provided, including as-found/as-left calibration reports, OQ summary, 21 CFR Part 11 configuration report, and signed certificate of functional verification.