JHT AT MD Automated Dissolution Testing System
| Brand | JHT |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Domestic (China) |
| Model | AT MD |
| Price Range | USD 70,000 – 98,000 |
| Measurement Mode | AC (Alternating Current) |
Overview
The JHT AT MD Automated Dissolution Testing System is a fully integrated, GMP-compliant platform engineered for precision-controlled, high-reproducibility dissolution testing in pharmaceutical development, quality control, and regulatory submission environments. Based on the USP , , and standards—and aligned with ICH Q5A, Q5C, and FDA guidance—the system employs a robust AC-driven mechanical actuation architecture to ensure consistent paddle or basket motion, temperature stability (±0.2 °C), and hydrodynamic uniformity across all vessels. Its modular design supports both single- and multi-vessel configurations (up to 12 stations), with real-time monitoring of dissolution medium temperature, rotation speed, and sampling timing synchronized to pharmacopeial protocols. The system’s core function is to automate the complete dissolution workflow: medium conditioning, tablet/capsule immersion, timed sampling, inline filtration, fraction collection, and data traceability—eliminating manual intervention that introduces variability in critical release kinetics assessment.
Key Features
- AC-synchronized motor drive ensures stable rotational speed control (25–250 rpm) with <±0.5 rpm deviation across all vessels, meeting USP mechanical calibration requirements.
- HollowShaft™ sampling technology enables low-dead-volume, laminar-flow sampling directly from vessel center—minimizing disturbance to dissolution hydrodynamics.
- Dual-filter compatibility: 25 mm membrane filters (for syringe-style or cartridge-based filtration) and 25 mm syringe filters—both validated per ASTM E2861 for extractables and adsorption profiling.
- FS Filtration Workstation with 424-position filter head carousel: enables automated, sequential filter switching without operator input; prevents membrane over-flushing and salt crystallization during extended runs.
- SAM Sample Manager: configurable as either a microfraction collector (standard 12 × 75 mm or 16 × 100 mm test tubes) or an advanced fluid-handling module supporting dilution, buffer exchange, solvent replacement, and LC/UV-Vis interface priming.
- Touch-enabled Easy Touch HMI and WinsOTAxius software provide dual-control redundancy; support audit-trail-enforced user roles, electronic signatures, and 21 CFR Part 11 compliance via optional validation package.
Sample Compatibility & Compliance
The AT MD accommodates solid oral dosage forms including immediate-release tablets, extended-release capsules, orally disintegrating tablets (ODTs), and transdermal patches. It supports all USP Apparatus I (basket), II (paddle), and IV (flow-through cell) configurations with optional accessories. All wetted materials—including tubing, filters, and sample lines—are USP Class VI-certified and compliant with ISO 10993-5 cytotoxicity testing. System validation documentation aligns with ASTM E2503, ISO/IEC 17025, and EU Annex 11 requirements for computerized system validation (CSV). Full IQ/OQ/PQ protocols are available upon request.
Software & Data Management
WinsOTAxius is a validated, standalone dissolution data acquisition and reporting platform built on Microsoft .NET Framework and SQL Server. It supports method-driven scheduling, real-time curve plotting (cumulative % dissolved vs. time), statistical outlier detection (Dixon’s Q-test), and automated report generation in PDF/A-1b and Excel formats. Integrated with LIMS via ASTM E1482-compliant HL7 messaging, it provides full traceability: instrument logs, environmental parameters (bath temp, ambient humidity), operator actions, and electronic signatures—all retained with immutable timestamps. Optional 21 CFR Part 11 add-on delivers role-based access control, biometric login support, and full audit trail export for FDA inspection readiness.
Applications
- Pharmaceutical formulation development: comparative dissolution profiling under discriminatory conditions (e.g., pH-shift, surfactant-modified media).
- QC batch release testing per USP monographs and internal specifications.
- Stability-indicating method development for forced degradation studies.
- Bioequivalence support: generating dissolution similarity metrics (f1/f2) per FDA guidance.
- Regulatory filing: generating eCTD-compliant datasets for NDA/ANDA submissions.
- Process validation: monitoring dissolution consistency across manufacturing scale-up batches.
FAQ
Does the AT MD support USP Apparatus IV (flow-through cell)?
Yes—via optional flow-through cell module with peristaltic pump calibration, reservoir temperature control, and programmable flow rate (1–16 mL/min) traceable to NIST standards.
Can WinsOTAxius integrate with third-party HPLC systems beyond Specord Plus?
Yes—it supports vendor-agnostic LC interfacing via RS-232, Ethernet, or OPC UA; compatible with Agilent, Waters, Shimadzu, and Thermo Fisher systems using standard ASCII command sets.
Is the FS Filtration Workstation compatible with non-JHT filter brands?
It accepts any 25 mm diameter filter housing meeting ISO 8536-4 dimensional tolerances; however, JHT-validated filters are recommended for full compliance documentation.
What validation services are included with purchase?
Standard delivery includes Factory Acceptance Test (FAT) report and electronic copies of IQ/OQ templates; PQ execution and CSV documentation require separate service engagement.
How is temperature uniformity verified across all vessels?
Each vessel is equipped with a calibrated Pt100 sensor; system-level uniformity is verified annually per ASTM E2503 using a NIST-traceable thermal mapping probe array.
