Agilent 8000 Automated Dissolution Sampling Station

Overview

The Agilent 8000 Automated Dissolution Sampling Station is a purpose-built, GMP-compliant platform engineered to automate sample withdrawal, filtration, dilution, and delivery from USP Apparatus I (basket) and II (paddle) dissolution vessels. Operating on precise programmable timing and volumetric control, the system integrates seamlessly with third-party dissolution baths—including those compliant with USP , Ph. Eur. 2.9.3, and JP 17—enabling fully unattended operation across multi-vessel, multi-time-point dissolution studies. Its core architecture employs gravimetric and volumetric verification protocols to ensure sampling accuracy within ±1% RSD for volumes ≥5 mL, supporting robust method transfer and regulatory submission requirements under FDA 21 CFR Part 11 and ICH Q5C.

Key Features

• Automated sequential sampling from up to 12 dissolution vessels per cycle, with configurable time points (e.g., 5, 10, 15, 30, 45, 60, 90, 120 min) and repeat intervals
• Integrated Agilent 810 peristaltic pump module delivering precise flow control (0.1–20 mL/min), compatible with PTFE, silicone, or fluoropolymer tubing for solvent resistance
• On-board filtration using 0.45 µm or 0.22 µm syringe filters (user-supplied) with automatic filter ejection and waste routing
• Programmable post-sampling dilution (1:2 to 1:100) using calibrated precision syringes and solvent reservoirs
• Sample vial handling via XYZ robotic arm with barcode recognition support for traceability (optional configuration)
• Embedded diagnostics, real-time status monitoring, and event logging aligned with ALCOA+ data integrity principles

Sample Compatibility & Compliance

The Agilent 8000 accommodates standard USP-compliant dissolution vessels (100–1000 mL capacity), including glass, stainless-steel, and disposable configurations. It supports aqueous, organic, and mixed-solvent media—including 0.1 N HCl, pH 4.5 acetate buffer, pH 6.8 phosphate buffer, and 1% SDS—with full compatibility for sinker-assisted tablet testing and extended-release formulations. All firmware and operational logic conform to ASTM E2503-22 (Standard Practice for Validation of Dissolution Apparatus) and ISO/IEC 17025:2017 requirements for testing laboratories. The system’s audit trail functionality satisfies FDA 21 CFR Part 11 electronic record and signature criteria when deployed with validated software configuration.

Software & Data Management

Controlled via Agilent’s proprietary Dissolution Workstation Software (v3.x or later), the platform provides intuitive method creation, run scheduling, and real-time graphical monitoring of sampling progress, pump pressure, and temperature synchronization with external baths. Raw data—including timestamps, volume dispensed, filter ID, and vial position—is exported in .csv and .xlsx formats with embedded metadata (operator ID, method name, batch number). Audit trails are immutable, time-stamped, and user-access-controlled; all changes are logged with reason-for-change fields. Optional integration with LIMS (e.g., LabVantage, Thermo Fisher SampleManager) enables automated result ingestion and QC flagging based on pre-defined acceptance criteria.

Applications

• Generic drug bioequivalence studies requiring strict adherence to FDA Guidance for Industry: Dissolution Testing of Immediate-Release Solid Oral Dosage Forms
• Stability-indicating dissolution profiling during accelerated and long-term stability programs (ICH Q1A–Q1E)
• Formulation development for modified-release products, including matrix tablets, osmotic pumps, and multiparticulates
• Quality control release testing in contract manufacturing organizations (CMOs) operating under cGMP environments
• Method validation per USP and ICH Q2(R2), including specificity, accuracy, precision, and robustness assessments

FAQ

Is this unit fully refurbished and performance-verified?
Yes. This Agilent 8000 unit underwent functional validation at SpectraLab Scientific’s ISO/IEC 17025-accredited test facility, including pump calibration, timing accuracy verification, and cross-vessel sampling repeatability assessment (n=6, RSD ≤0.8%).
Does it include original Agilent documentation and software licenses?
The system ships with original hardware documentation, calibration certificates, and a valid license for Dissolution Workstation Software v3.2 (with optional upgrade path to v4.0 upon request).
Can it interface with non-Agilent dissolution baths?
Yes—via dry-contact relay outputs and RS-232/USB TTL serial communication, enabling synchronization with leading third-party baths (e.g., Hanson, Distek, Sotax) using custom protocol mapping.
What maintenance history is available?
Full service log is provided, including pump tube replacement dates, filter housing inspections, and firmware update records dating back to initial commissioning.
Is IQ/OQ documentation support available?
SpectraLab offers optional vendor-supported Installation Qualification (IQ) and Operational Qualification (OQ) packages, including protocol templates, executed reports, and witness sign-off documentation compliant with Annex 11 and EU GMP Annex 15.