Distek Eclipse 5300 Automated Sampling System for Dissolution Testing

Overview

The Distek Eclipse 5300 Automated Sampling System is an online, high-integrity sampling platform engineered for integration with USP Apparatus I (basket) and II (paddle) dissolution testers. It operates on a syringe-pump-driven fluidic architecture—eliminating traditional rotary valves and peristaltic pumps—to deliver precise, low-volume, time-synchronized sample acquisition directly from dissolution vessels. Designed in accordance with FDA guidance for dissolution method validation and aligned with USP <711>, <724>, and <1092>, the Eclipse 5300 supports quantitative drug release profiling under regulated pharmaceutical development and QC environments. Its core function is to automate the collection, filtration, and volume compensation steps required for accurate dissolution testing while maintaining sample integrity, minimizing carryover, and enabling robust method transfer across laboratories.

Key Features

• Syringe-pump-based sampling architecture ensures repeatable volumetric accuracy without valve-induced dead volume or pump-induced pulsation.
• Optimized internal fluid path with total system wetted volume of only 4.5 mL—reducing sample residence time and cross-contamination risk between sequential runs.
• Valve-free design eliminates maintenance-intensive components and improves long-term operational reliability across 24/7 testing cycles.
• Dual-system capability: A secondary “satellite” sampler (Eclipse 5300-S) can be added to enable concurrent sampling from two independent dissolution apparatuses—each running distinct protocols, vessel counts, or timing schedules.
• Integrated solvent recirculation and media replenishment functions maintain constant dissolution volume throughout testing, satisfying USP requirements for volume correction in sink condition calculations.
• Full-color, capacitive touchscreen interface with intuitive graphical workflow navigation—designed for rapid operator qualification and reduced training burden in GMP-regulated settings.
• Optional integrated filter changer accommodates standard 25 mm syringe filters (e.g., nylon, PVDF, PTFE), eliminating need for custom filter discs or external filtration stations.

Sample Compatibility & Compliance

The Eclipse 5300 is compatible with all major dissolution tester platforms operating under USP Apparatus I and II configurations. It supports sampling from 6- or 8-vessel systems with programmable per-vessel timing and volume control. All wetted materials—including tubing, syringe barrels, and filter housings—are compliant with USP Class VI biocompatibility standards and resistant to common dissolution media (e.g., HCl buffers, surfactant solutions, organic-aqueous mixtures). The system meets critical regulatory expectations for auditability: full electronic records with time-stamped event logs, user access controls, and configurable audit trail functionality—supporting compliance with FDA 21 CFR Part 11, EU Annex 11, and ICH GCP/GLP principles. Temperature and rotational stability data are traceable to NIST-calibrated references.

Software & Data Management

Control and monitoring are managed via Distek’s Eclipse Software Suite—a Windows-based application supporting method creation, real-time status visualization, and automated report generation in PDF or CSV formats. The software enforces method locking, version-controlled protocol storage, and electronic signature workflows. Raw sampling timestamps, temperature profiles, pump actuation events, and filter change logs are retained with immutable metadata. Data export conforms to CDISC SDTM standards for regulatory submissions. Optional LIMS integration is supported through ASTM E1578-compliant API endpoints, enabling bidirectional synchronization with enterprise quality management systems.

Applications

• Immediate- and extended-release solid oral dosage form development and QC release testing.
• Comparative dissolution studies (e.g., generic vs. reference listed drug).
• Stability-indicating dissolution method validation per ICH Q5C and Q2(R2).
• IVIVC (In Vitro–In Vivo Correlation) model input generation requiring high-temporal-resolution sampling.
• Forced degradation studies where minimal sample handling and oxidation-sensitive analytes demand inert, low-dead-volume fluidics.
• Automated multi-point sampling for pharmacopeial compliance (e.g., USP <711> time points at 5, 10, 15, 30, 45, and 60 min).

FAQ

Does the Eclipse 5300 support USP Apparatus III (reciprocating cylinder) or IV (flow-through cell)?

No—the Eclipse 5300 is validated exclusively for Apparatus I and II configurations. Integration with Apparatus III/IV requires third-party fluidic adaptation not covered under Distek’s regulatory support scope.
Can sampling intervals be programmed below 3 minutes?

Yes—minimum programmable interval is 1 minute; however, practical feasibility depends on dissolution medium viscosity, filter loading rate, and system priming stability.
Is the satellite sampler (5300-S) fully autonomous or dependent on the master unit?

The 5300-S operates under centralized control via the primary Eclipse 5300 controller; it shares method libraries, audit trails, and calibration records but executes independent timing and volume commands.
What calibration documentation is provided with the system?

Each unit ships with a NIST-traceable calibration certificate covering temperature sensors, syringe displacement accuracy, and rotational speed verification—all performed at factory prior to shipment.
How is carryover quantified and mitigated during back-to-back runs?

Carryover is assessed per USP <1092> using placebo-to-active transition tests; typical residual levels are <0.1% when using recommended rinse protocols (e.g., 2× 2 mL air flush + 1× 3 mL dissolution medium).