Dissolution Tester - ToronDT™ Veritas 14 (Bathless)
Dissolution Tester-ToronDT™ Veritas 14 is an advanced, high-precision piece of dissolution testing equipment for pharmaceutical quality control and manufacturing. This dissolution test apparatus is engineered to perform reliable dissolution tests on solid oral dosage forms. By removing the traditional water bath, the ToronDT™ Veritas 14 offers significant operational advantages: it provides faster media heating, superior temperature stability, simpler cleaning, and lower operating costs, all while upholding rigorous regulatory standards.
Dissolution Tester - ToronDT™ Veritas 14 (Bathless) Applications
- Standardized Quality Control: Executes routine dissolution tests on tablets and capsules for verifying batch consistency and product performance in regulated QC labs.
- Manufacturing Support: Assists in-process checks during pharmaceutical production by monitoring dissolution behavior, helping to maintain uniform product Quality.
- Research & Development: Supports formulation development and optimization by enabling R&D teams to evaluate how changes in formulation affect dissolution profiles during product design.
- Regulatory Compliance & Testing: Facilitates batch release decisions and long-term stability studies with reliable, reproducible dissolution test results. It is also instrumental in the development, verification, and validation of dissolution test methods in compliance with USP and international pharmacopeial standards.
- Regulated Environments: Ideal for use in GMP and FDA-regulated laboratories that require compliant dissolution testing equipment, secure data handling, and full traceability.
Dissolution Tester - ToronDT™ Veritas 14 (Bathless) Key Features
Compliance and Security
- 21 CFR Part 11 Compliance: Fully supports FDA 21 CFR Part 11 regulations, including electronic records, signatures, secure user access, and comprehensive audit trails for regulated pharmaceutical environments.
- Biometric Security (Fingerprint Authentication & Biometric Log-In): Integrated fingerprint authentication ensures secure access and user traceability. This feature, combined with detailed audit trails, tracks all user actions, method changes, and data modifications throughout the testing lifecycle, strengthening data integrity.
Automation and Efficiency
- Motorized Lift Mechanism: Offers hands-free height adjustment and automatic positioning of baskets and paddles, ensuring compliance with USP Apparatus 1 and 2 while improving operator ergonomics.
- Split-Rinse™ & Loop-Rinse™ Cleaning Systems: These optimized rinse cycles significantly reduce rinse volume (by up to 57%) while ensuring effective internal cleaning and minimizing cross-contamination.
- Snap-Fit Shaft Design: The one-piece, crevice-free shaft construction allows for rapid method changeover, precise alignment, and reduced maintenance time.
- Dilution with Stirring (Optional): Streamlines sample preparation and workflow efficiency by enabling simultaneous purging, mixing, and dilution of aliquots.
Data and Connectivity
- Advanced Data Management & Reporting: Stores all raw and processed dissolution data, supports machine-to-machine data transfer for production and QC, and generates regulatory-ready PDF reports via FTP.
- Ethernet & Network Connectivity: Features static IP and DHCP modules for seamless integration with existing laboratory networks and LIMS (Laboratory Information Management Systems).
Performance and Control
- V-Stir™ Technology (Patented): Provides uniform, continuous, and wireless temperature monitoring inside the vessels without disrupting the crucial hydrodynamic environment, thus improving test accuracy and consistency.
- D-Light™ Visual & Audible Status Indicators: Enhances operational awareness and error prevention with clear visual lights and sound alerts that display the instrument's status in real time.
- Programmable Temperature & Timer Control: Offers fully programmable temperature profiles and timers with electronic verification to ensure repeatable and validated dissolution testing.
- Continuous Vibration Monitoring: Provides real-time detection of vibration to ensure mechanical stability during testing, leading to more reliable results.
Durability
- Ergonomic & Durable Construction: Wetted and contact parts are constructed from inert, corrosion-resistant materials, guaranteeing long-term durability and chemical compatibility
Tablets positioned in dissolution vessels for controlled dissolution testing.
Dissolution Tester - ToronDT™ Veritas 14 (Bathless) Technical Specification
| Model | ToronDT™-Veritas 14 |
|---|---|
| Number of Stations | 14 |
| 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 |