LOGAN SYSTEM 860DL Automated 12-Position Dissolution Sampling System
| Brand | LOGAN |
|---|---|
| Origin | USA |
| Model | SYSTEM 860DL |
| 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 | ≤0.5 mm |
| Basket Wobble | ≤1.0 mm |
| Water Bath Temperature Range | Ambient to 45°C |
| Water Bath Temperature Resolution | 0.1°C |
| Water Bath Volume | 30 L |
Overview
The LOGAN SYSTEM 860DL is a fully automated, modular online dissolution testing system engineered for regulatory-compliant, high-throughput solubility and release profiling of solid oral dosage forms. Based on the USP Apparatus 1 (basket) and Apparatus 2 (paddle) principles, it implements precise hydrodynamic control within standardized dissolution vessels to replicate in vivo gastrointestinal fluid dynamics. Designed for pharmaceutical development laboratories and QC/QA units operating under cGMP, the SYSTEM 860DL integrates mechanical precision, thermal stability, and digital traceability into a single platform—enabling rigorous evaluation of drug product performance across formulation optimization, generic equivalence studies (Q1/Q2/Q3), and bioequivalence (BE) support workflows.
Key Features
- Simultaneous operation of 12 dissolution vessels with independent temperature monitoring via integrated 12-channel RTD probes—ensuring vessel-to-vessel thermal uniformity within ±0.1°C.
- High-stability drive mechanism delivering rotation accuracy of ±1 rpm across the full 25–250 rpm range, with paddle wobble ≤0.5 mm and basket wobble ≤1.0 mm per USP mechanical calibration requirements.
- Integrated dual-stage filtration (pre-filter + secondary membrane filter) during automated sampling, minimizing particulate carryover and protecting downstream analytical instrumentation (e.g., UV-Vis, HPLC).
- Programmable sample collection with volume-accurate aspiration using SYP-12L 10 mL syringe pumps (±1% volumetric repeatability), coupled with auto-refill, temperature-matched media replenishment, and closed-loop solvent compensation.
- Hermetic dual-lid vessel sealing architecture reducing solvent evaporation to <0.5 mL/h per vessel—critical for extended dissolution runs (up to 24 h) and low-solubility compound testing.
- FDA 21 CFR Part 11–compliant software architecture featuring electronic signatures, audit trail with immutable timestamped records, and three-tier user permission management (Administrator, Supervisor, Operator).
Sample Compatibility & Compliance
The SYSTEM 860DL supports standard USP-compliant dosage forms including immediate- and extended-release tablets, hard/soft gelatin capsules, suspensions, transdermal patches, and hydrogels. Its modular design permits rapid reconfiguration for alternative methods: miniaturized small-volume vessels (Apparatus 7), rotating cylinder (Apparatus 3), paddle-over-disc (Apparatus 5), and flow-through cell (Apparatus 4). All mechanical components meet ISO 9001-certified manufacturing standards; temperature and rotational performance are validated per USP , , and ASTM E2503. The system is routinely deployed in laboratories undergoing FDA pre-approval inspections and EMA GMP audits.
Software & Data Management
Controlled by DSC-800 system software, the platform provides real-time visualization of vessel temperature, rotation speed, sampling timeline, and pump status. Data export adheres to ASTM E2500-22 for raw data integrity, supporting CSV, PDF, and XML formats. Audit trails record all parameter changes, user logins, sample events, and calibration actions—including operator ID, timestamp, and reason-for-change fields. Optional cloud synchronization enables secure remote access via authenticated web portal or mobile application (iOS/Android), with TLS 1.2 encryption and session timeout enforcement. Software updates maintain backward compatibility with legacy method files and comply with ICH M10 guidance on bioanalytical method validation documentation.
Applications
- Comparative dissolution profiling for ANDA submissions and quality-by-design (QbD) initiatives.
- Discriminatory method development targeting critical process parameters (CPPs) affecting release kinetics.
- Biorelevant dissolution testing using FaSSIF/FeSSIF media under controlled pH and surfactant conditions.
- Integration with UV spectrophotometers (via fiber-optic probes) or HPLC autosamplers for real-time quantification without manual intervention.
- Coupling with permeation systems (e.g., Franz cells or PAMPA) to generate dissolution-permeation correlation models supporting IVIVC Level A development.
- Stability-indicating release testing across accelerated and long-term storage conditions per ICH Q1/Q5.
FAQ
Does the SYSTEM 860DL support USP Apparatus 4 (flow-through cell)?
Yes—by installing the optional FT-860 flow-through cell module and corresponding pump manifold, the system complies with USP specifications for both open- and closed-loop configurations.
Can temperature be monitored independently in each vessel during a run?
Yes—12 calibrated PT100 sensors are embedded in each vessel lid assembly, feeding real-time data to the DSC-800 controller with 0.1°C resolution and automatic deviation alerts.
Is the system compatible with third-party HPLC data systems?
Yes—via configurable ASCII-based trigger signals and time-stamped sample ID tagging, enabling direct synchronization with Agilent OpenLab, Waters Empower, and Thermo Chromeleon platforms.
What validation documentation is provided with the system?
Each shipment includes IQ/OQ protocols compliant with ASTM E2503, as well as a Certificate of Conformance, mechanical calibration report, and factory-installed software verification summary.
How is data integrity maintained during power interruption?
The DSC-800 controller features non-volatile memory with battery-backed real-time clock and auto-resume functionality—preserving method state, elapsed time, and last sampled point without data loss.
