LOGAN UDT-818A-12 12-Station Automated Dissolution Tester
| Brand | LOGAN |
|---|---|
| Origin | USA |
| Model | UDT-818A-12 |
| Instrument Type | Online Dissolution Tester |
| Number of Vessels | 12 |
| Temperature Range | 20–60°C |
| Temperature Accuracy | ±0.1°C |
| Rotation Speed Range | 25–250 rpm (±1 rpm) |
| Paddle Wobble Amplitude | ≤0.5 mm |
| Basket Wobble Amplitude | ≤1.0 mm |
| Water Bath Temperature Range | Ambient to 45°C |
| Water Bath Temperature Resolution | 0.1°C |
| Water Bath Volume | 18 L |
Overview
The LOGAN UDT-818A-12 is a high-precision, 12-station online dissolution tester engineered for compliance with USP , , and , as well as ICH Q4B and FDA guidance for dissolution method development and bioequivalence (BE) studies. It operates on the core principles of paddle and basket dissolution methodologies—measuring the rate and extent of drug substance release from solid oral dosage forms (e.g., tablets, capsules, suspensions, transdermal patches, and hydrogels) into a defined dissolution medium under controlled hydrodynamic, thermal, and mechanical conditions. Designed for pharmaceutical R&D labs, QC/QA facilities, and contract research organizations (CROs), the UDT-818A-12 delivers robust reproducibility across extended run durations, supporting both regulatory submissions and comparative dissolution profiling per FDA’s “Dissolution Methods Database” requirements.
Key Features
- Simultaneous operation of 12 independent dissolution vessels with individual temperature monitoring via 12 embedded Pt100 sensors—ensuring vessel-to-vessel thermal uniformity within ±0.1°C.
- Motor-driven shaft assembly with precision-machined bearings and dynamic balancing, achieving paddle wobble ≤0.5 mm and basket wobble ≤1.0 mm at all speeds (25–250 rpm, ±1 rpm accuracy).
- Dual-lid vessel configuration minimizes solvent evaporation (<0.5% mass loss over 6 h at 37°C), critical for low-volume or volatile media (e.g., ethanol/water mixtures).
- Integrated LED illumination system enables real-time visual assessment of tablet disintegration, capsule floating, or gel erosion without opening vessel lids.
- Modular chassis accommodates optional accessories—including automated sampling modules, multi-speed zone controllers, and UV/HPLC/fluorescence interface ports—without hardware retrofitting.
- Water bath system (18 L capacity) features PID-controlled heating/cooling, 0.1°C resolution, and ambient-to-45°C operational range, optimized for stability during long-duration USP Apparatus 2 runs.
Sample Compatibility & Compliance
The UDT-818A-12 supports all USP-specified apparatus types through interchangeable hardware kits: Apparatus 1 (basket), Apparatus 2 (paddle), Apparatus 3 (reciprocating cylinder), Apparatus 4 (flow-through cell), mini-paddle (small-volume), and rotating disc configurations. It is validated for use with coated tablets, extended-release matrices, orally disintegrating tablets (ODTs), buccal films, and semi-solid formulations. The system meets GLP/GMP documentation requirements, including full audit trail support when integrated with compliant software platforms. All mechanical tolerances comply with USP dimensional specifications for vessel geometry, shaft alignment, and rotational centering.
Software & Data Management
When paired with LOGAN’s WinDiss v5.x or third-party 21 CFR Part 11-compliant LIMS interfaces, the UDT-818A-12 enables electronic batch records, user-access controls, electronic signatures, and time-stamped event logs. Raw temperature, speed, and position data are timestamped at 1 Hz resolution and exported in CSV/Excel-compatible formats. Optional camera integration provides synchronized video capture (up to 12 channels) with metadata overlay (time, vessel ID, temperature), facilitating root-cause analysis of anomalous dissolution profiles. Data integrity is preserved via write-once storage protocols and encrypted local backups.
Applications
- Comparative dissolution testing for ANDA submissions and quality-by-design (QbD) initiatives.
- Solubility-limited formulation screening under physiologically relevant pH gradients (e.g., gastric-to-intestinal transition simulations).
- Dissolution-permeation correlation studies using integrated side-by-side diffusion cells or PAMPA membranes.
- Method validation per ICH Q2(R2), including specificity, linearity, accuracy, precision, and robustness assessments.
- Stability-indicating dissolution for detecting degradation-related changes in release kinetics.
- Support for biorelevant media (FaSSIF/FeSSIF) testing with temperature-compensated viscosity calibration.
FAQ
Does the UDT-818A-12 support USP Apparatus 4 (flow-through cell)?
Yes—when equipped with the optional flow-through cell module and peristaltic pump manifold, it complies with USP specifications for open- and closed-loop configurations.
Can vessel temperature be logged independently per station?
Yes—each of the 12 vessels is monitored by a dedicated Pt100 probe; temperature readings are recorded at 1-second intervals and stored with vessel-specific metadata.
Is the system compatible with HPLC autosamplers?
Yes—standardized 1/8″ OD tubing connections and TTL-triggered relay outputs enable direct synchronization with Agilent, Waters, and Shimadzu HPLC systems for timed fraction collection.
What maintenance is required for long-term calibration stability?
Annual verification of shaft concentricity, temperature sensor drift (against NIST-traceable reference), and rotational speed accuracy using certified tachometers is recommended per ISO/IEC 17025 guidelines.
Does LOGAN provide IQ/OQ/PQ documentation support?
Yes—comprehensive qualification templates, test protocols, and raw data worksheets are included with purchase, aligned with ASTM E2500-13 and EU Annex 15 standards.
