LOGAN SYSTEM ADIS 1200 Automated Dissolution Testing System with Integrated HPLC Online Analysis

Overview

The LOGAN SYSTEM ADIS 1200 is a fully automated, modular dissolution testing platform engineered for precision, reproducibility, and regulatory compliance in pharmaceutical development and quality control laboratories. It integrates real-time dissolution sampling with seamless online coupling to high-performance liquid chromatography (HPLC) systems—enabling continuous, unattended quantification of drug release profiles without manual intervention. The system operates on the principle of standardized USP Apparatus 1 (basket), Apparatus 2 (paddle), and extended configurations including flow-through cell (Apparatus 4), mini-vessel (small-volume), and rotating cylinder methods. Its architecture supports both kinetic dissolution profiling and endpoint analysis under controlled hydrodynamic and thermal conditions, making it suitable for biorelevant dissolution studies, IVIVC modeling, and QbD-driven formulation development.

Key Features

• 12-position fully automated dissolution station with independent temperature control per vessel via integrated Pt100 sensors (±0.2 °C accuracy)
• Dual-stage filtration (0.45 µm + 0.22 µm) prior to HPLC injection, minimizing column fouling and ensuring analytical integrity
• Intelligent sample handling: post-collection recirculation of excess medium to maintain sink conditions—eliminating need for volume replenishment during multi-point sampling
• Programmable dilution capability (1× to 100×) using precision syringe pumps, supporting low-concentration analytes and extended assay linearity
• Modular pump manifold (SYP-1200) and autosampler interface compatible with major HPLC vendors (Agilent, Waters, Shimadzu, Thermo Fisher) via standard 1/16″ PEEK tubing and TTL/RS-232 triggers
• Integrated LED illumination system for real-time visual monitoring of tablet disintegration, capsule erosion, or gel matrix dissolution behavior
• Onboard storage compartment for USP-compliant dissolution accessories—including baskets, paddles, sinkers, and flow-through cells—to optimize lab footprint and workflow continuity

Sample Compatibility & Compliance

The SYSTEM ADIS 1200 accommodates solid oral dosage forms (immediate- and modified-release tablets, capsules), semisolids (transdermal patches, hydrogels), suspensions, and orally disintegrating films. It meets mechanical calibration requirements per USP and , and supports method validation per ICH Q2(R2). Temperature uniformity across all 12 vessels complies with USP acceptance criteria (±0.5 °C). The system’s hardware and firmware architecture support 21 CFR Part 11–compliant electronic records when paired with validated LOGAN Control Suite software—including audit trails, user access levels, and electronic signatures. Optional GLP/GMP configuration packages include IQ/OQ documentation templates and traceable calibration certificates.

Software & Data Management

Control and data acquisition are managed through LOGAN Control Suite v5.x—a Windows-based application supporting method programming, real-time graphing, event logging, and CSV/PDF export. The software enables full parameter scripting: sampling timepoints, rotation speed ramping, temperature setpoints, dilution factors, and HPLC trigger synchronization. Remote monitoring is supported via secure HTTPS-enabled web interface or dedicated iOS/Android app (requires optional cloud gateway module). All raw data—including timestamps, temperature logs, pump actuation events, and HPLC injection markers—are stored in structured SQLite databases with SHA-256 hash verification for data integrity. Audit trail records capture operator ID, timestamp, action type, and pre-/post-change values—fully compliant with ALCOA+ principles.

Applications

• Comparative dissolution profiling for generic product development and bioequivalence assessment
• Formulation screening under physiologically relevant pH and surfactant conditions (e.g., FaSSIF/FeSSIF)
• Stability-indicating dissolution assays for accelerated and long-term stability programs
• Real-time release testing (RTRT) integration within PAT frameworks
• IVIVC establishment using deconvolution-based modeling tools (e.g., WinNonlin, GastroPlus interfaces)
• Regulatory submission support for ANDA, NDA, and MAA dossiers requiring dissolution data per FDA, EMA, PMDA, and Health Canada guidelines

FAQ

Does the SYSTEM ADIS 1200 support USP Apparatus 4 (flow-through cell)?

Yes—when equipped with the optional FC-1200 flow-through cell module and corresponding pump calibration, the system complies with USP specifications for Apparatus 4.
Can temperature be monitored independently for each of the 12 vessels?

Yes—12 embedded Pt100 RTD probes provide continuous, real-time temperature feedback with individual PID control loops.
Is the system compatible with third-party chromatography data systems (CDS)?

Yes—via ASCII-based command protocol or direct HPLC instrument driver integration; validated with Empower, Chromeleon, and OpenLab CDS.
What level of 21 CFR Part 11 compliance does the system offer out-of-the-box?

Core functionality supports electronic signatures and audit trails; full Part 11 compliance requires installation of validated software version and documented SOPs per site-specific risk assessment.
How is carryover minimized during sequential sampling?

The system performs automated triple-rinse cycles with dissolution medium between samples, followed by air purge and internal path drying—validated to ≤0.1% carryover for typical API concentrations.