Dissolution Tester - ToronDT™ Veritas 8 (Bathless)
Dissolution Tester - ToronDT™ Veritas 8 (Bathless) is a bathless, high-precision dissolution testing equipment designed to perform reliable dissolution tests for solid oral dosage forms in pharmaceutical Quality control and manufacturing environments. By eliminating traditional water baths, this advanced dissolution test apparatus delivers faster media heating, improved temperature stability, easier cleaning, and reduced operating costs while maintaining strict regulatory compliance.
Dissolution Tester - ToronDT™ Veritas 8 (Bathless) Applications
- Routine Pharmaceutical Quality Control
- Performs standardized dissolution tests on tablets and capsules to verify batch consistency and product performance in regulated Quality control laboratories.
- Pharmaceutical Manufacturing Support
- Used during manufacturing to monitor dissolution behavior and support in-process checks that help maintain uniform product Quality.
- Formulation Development and Optimization
- Assists research and development teams in evaluating how formulation changes affect dissolution profiles during product design.
- Batch Release and Stability Testing
- Supports batch release decisions and long-term stability studies by delivering reproducible dissolution test results over time.
- Method Development and Validation
- Enables development, verification, and validation of dissolution test methods in compliance with USP and international pharmacopeial requirements.
- Regulated Laboratory Environments
- Suitable for use in GMP and FDA-regulated laboratories requiring secure data handling, traceability, and compliant dissolution testing equipment.
Dissolution Tester - ToronDT™ Veritas 8 (Bathless) Key Features
- 21 CFR Part 11 Compliance
- Fully compliant with FDA 21 CFR Part 11, supporting electronic records, electronic signatures, audit trails, and secure user access control for regulated pharmaceutical environments.
- Fingerprint Authentication & User Management
- Integrated fingerprint authentication ensures secure login, user traceability, and controlled system access, strengthening data integrity and regulatory compliance.
- Advanced Data Management & Reporting
- Stores raw and processed dissolution data, generates PDF reports via FTP, and supports machine-to-machine data transfer for production and QC environments.
- Biometric Log-In & Audit Trail
- Combines biometric login with detailed audit trails to track method changes, user actions, and data modifications throughout the testing lifecycle.
- Motorized Lift Mechanism
- Hands-free height adjustment with automatic basket and paddle positioning to meet USP Apparatus 1 and 2 requirements while improving operator ergonomics.
- V-Stir™ Technology (Patented)
- Ensures uniform and continuous wireless temperature monitoring inside vessels without disrupting hydrodynamics, improving test consistency and accuracy.
- Split-Rinse™ & Loop-Rinse™ Cleaning Systems
- Optimized rinse cycles reduce rinse volume by up to 57% while ensuring effective internal cleaning and minimizing carryover contamination.
- Snap-Fit Shaft Design
- One-piece, crevice-free shaft construction allows quick method changeover, precise shaft alignment, and reduced maintenance time.
- Dilution with Stirring (Optional)
- Enables simultaneous purging, mixing, and dilution of aliquots, streamlining sample preparation and improving workflow efficiency.
- D-Light™ Visual & Audible Status Indicators
- Clear visual lights and sound alerts display instrument status in real time, enhancing operational awareness and error prevention.
- Programmable Temperature & Timer Control
- Fully programmable temperature profiles and timers with electronic verification for repeatable and validated dissolution testing.
- Ethernet & Network Connectivity
- Supports static IP and DHCP modules for seamless integration with laboratory networks and LIMS systems.
- Continuous Vibration Monitoring
- Real-time vibration detection ensures mechanical stability during dissolution testing, improving result reliability.
- Ergonomic & Durable Construction
- Wetted and contact parts are made from inert, corrosion-resistant materials, ensuring long-term durability and chemical compatibility.
Tablets positioned in dissolution vessels for controlled dissolution testing.
Dissolution Tester - ToronDT™ Veritas 8 (Bathless) Technical Specification
| Model | ToronDT™ - Veritas 8 |
|---|---|
| Number of Stations | 8 |
| Dissolution Methods | USP Apparatus 1 (Basket) & 2 (Paddle) |
| Speed Range | 20–300 RPM |
| Speed Accuracy | ±0.5 RPM |
| Temperature Range | 20–40 °C |
| Temperature Accuracy | ±0.1 °C |
| Display | 7" intuitive LCD touchscreen |
| Protocol Storage | Up to 1,000 methods |
| Test Report Storage | Up to 50,000 reports |
| Sample Interval | 1 minute to 999 hours, 59 minutes |
| Number of Syringes | Standard: 6 (08-station) / 12 (14-station); Optional: 8 |
| Vessel Capacity | 1 L |
| Stirrer Drive | High-performance BLDC drive, maintenance-free |
| Interfaces | Ethernet, USB, RS-232, RS-485, embedded thermal printer |
| Compliance | USP, Ph. Eur., JP; 21 CFR Part 11 |
| Design Type | Bathless dissolution test apparatus |