Hanson G2 Autoplus/Autofill Automated Sampling and Collection System for Dissolution Testing

Overview

The Hanson G2 Autoplus/Autofill Automated Sampling and Collection System is a fully integrated, online dissolution testing platform engineered for regulatory compliance and operational reproducibility in pharmaceutical quality control (QC), formulation development, and bioequivalence laboratories. Built upon over six decades of dissolution instrumentation expertise, the system implements precise volumetric sampling via positive-displacement syringe pumps and coordinated robotic sample collection—operating in strict accordance with USP and , FDA Guidance for Industry on Dissolution Testing of Immediate- and Extended-Release Solid Oral Dosage Forms, and ICH Q5C stability requirements. The G2 Autoplus performs timed, sequential sampling from up to eight dissolution vessels simultaneously, while the G2 Autofill executes spatially accurate deposition into analytically compatible containers—including UV spectrophotometer-compatible tubes and HPLC/UPLC vials—without manual intervention. Its architecture supports both single-bath (DissoScan) and multi-bath (Maximizer) dissolution configurations, enabling seamless scalability across 6–24-vessel systems through modular electromagnetic valve manifolds and synchronized solvent replenishment logic.

Key Features

• Precision syringe-based sampling with ±1% volumetric accuracy using inert PEEK and fluoropolymer fluid paths compliant with ISO 10993 biocompatibility standards
• Configurable 6- or 8-channel sampling modules with programmable intervals as short as 2 minutes (1 minute achievable under validated thermal and mechanical stabilization)
• Full-color capacitive touchscreen interface providing real-time visualization of all operational parameters—including temperature, rpm, sampling status, and maintenance alerts
• Embedded 32-bit control firmware supporting deterministic timing, automatic calibration prompting, and hardware self-diagnostic routines
• Integrated solvent replenishment and post-sampling rinse cycles managed via dedicated cleaning channel in G2 Autofill unit
• Modular electromagnetic valve manifold (4-port standard, expandable to 16- or 24-position) enabling direct integration with Hanson Classic 6, Elite B, and other USP-compliant dissolution apparatuses
• Onboard storage for up to 100 user-defined dissolution methods, each supporting variable timepoints, volume adjustments, and filtration activation
• Regulatory-ready architecture featuring full 21 CFR Part 11 compliance: role-based access control, electronic signatures, immutable audit trails, and secure data export via USB or network interface

Sample Compatibility & Compliance

The G2 Autoplus/Autofill accommodates standard dissolution media—including aqueous buffers, surfactant solutions, and organic-aqueous mixtures—while maintaining chemical inertness across pH 1–13 and temperatures up to 45°C. All wetted components are constructed from USP Class VI-certified materials: PTFE, FEP, PEEK, and sapphire-reinforced ceramic valves. The system meets ISO 9001:2015 manufacturing standards and carries CE, CSA, and RoHS certifications. It is pre-validated for conformance with USP (Apparatus 1–4), EP 2.9.3, JP XVIII, and ASTM D7896-15. Rack configurations support analytical downstream workflows: 16×100 mm quartz or borosilicate tubes for UV-Vis quantification; 12×32 mm screw-thread HPLC vials meeting ASTM D5198 specifications; and 12×32 mm UPLC vials rated for pressures up to 15,000 psi. Optional in-line 0.45 µm sterile filtration ensures particulate-free samples for chromatographic injection.

Software & Data Management

Control and method management are handled by Hanson’s proprietary Vision G2 software suite, deployed on an embedded Linux-based controller. The system records timestamped metadata for every sampling event—including vessel ID, elapsed time, temperature deviation, pump actuation count, and rinse cycle completion—stored in encrypted binary logs with SHA-256 integrity verification. Data export formats include CSV (for LIMS ingestion), PDF (for GLP report generation), and XML (for SDTM-compliant clinical trial submissions). Remote monitoring is enabled via Ethernet or RS-232, supporting integration with laboratory information management systems (LIMS) and enterprise resource planning (ERP) platforms. All software updates are delivered via signed firmware packages verified at boot time, ensuring traceability and version control in GMP environments.

Applications

• Immediate- and extended-release tablet/capsule dissolution profiling per ICH Q5C and FDA guidance
• Comparative dissolution testing for generic drug development and bioequivalence studies
• Stability-indicating method development supporting forced degradation studies
• Automated QC release testing in cGMP manufacturing facilities
• Formulation optimization trials requiring high-temporal-resolution sampling (e.g., pulsatile release kinetics)
• Multi-vessel sink condition modeling for poorly soluble compounds using Maximizer bath configuration
• Integration with UV-Vis spectrophotometers or HPLC/UPLC autosamplers for real-time or offline analysis

FAQ

Does the G2 Autoplus support solvent replenishment during dissolution runs?

Yes—the system implements dynamic media volume compensation using gravimetric or volumetric feedback loops, maintaining sink conditions per USP Section 7.
Can the G2 Autofill accommodate custom rack geometries?

Rack recognition is based on mechanical keying and optical pattern detection; non-standard trays require factory calibration but are supported under IQ/OQ protocol.
Is audit trail functionality enabled by default?

Yes—full 21 CFR Part 11-compliant audit logging is active at system power-on and cannot be disabled without administrative privileges.
What validation documentation is provided with the system?

Each unit ships with Factory Acceptance Test (FAT) reports, Installation Qualification (IQ) templates, and Operational Qualification (OQ) test scripts aligned with ASTM E2500-13.
How often does the syringe pump require recalibration?

Calibration is recommended annually or after 10,000 actuation cycles, with automated prompts triggered by the embedded maintenance scheduler.