Introduction
The TrustE-14 with Syringe Pump and Sample Collector (DC) is an automated 14-station dissolution testing system. It is designed for methods compliant with USP 1, 2, 5, and 6. This system integrates a syringe pump and a sample collector for precise offline sampling. The TrustE-14 with Syringe Pump and Sample Collector (DC) streamlines high-volume testing in quality control labs.
Product Overview
This 14-station dissolution tester is built for efficiency and compliance. It features a robust design with a motorized lift and individual vessel centering. The system operates on IntegrOS software, which provides full 21 CFR Part 11 compliance, including fingerprint authentication, audit trails, and e-signatures. Its unique TimeAction™ function allows for programmed media changeovers, making it ideal for testing sustained-release products. This apparatus automates the entire dissolution process, from tablet dropping to sample collection.
Key Features
- 14-Station Capacity: Allows for high-throughput testing.
- USP Compliance: Supports USP Apparatus 1, 2, 5, and 6 methods.
- Automated Sampling System: Integrated syringe pump and sample collector (DC) for offline sampling.
- Touch Screen: A 7-inch TFT touch screen for intuitive operation.
- 21 CFR Part 11 Compliant: Features include fingerprint login, audit trail, and e-signature.
- TimeAction™ Function: Allows for automated media changeover and infinity tests.
- Motorized Lift: Smooth, vibration-free movement and easy Snap-FitTM shaft engagement.
Technical Specifications
Model | TrustE-14 with DC Sample Collector |
No. of stations | 14 |
Speed range | 20 RPM to 300 RPM |
Temperature range | 20°C to 40°C |
Display | 7″ TFT touch screen |
Vessel capacity | 150ml, 250ml, 1L |
Water bath | One-piece molded, 28 L |
Applications
- Routine quality control of solid oral dosage forms (tablets, capsules).
- Testing of sustained and controlled-release products.
- Dissolution methods requiring USP 1 (Basket), USP 2 (Paddle), USP 5 (Paddle over Disk), and USP 6 (Rotating Cylinder).
- High-throughput pharmaceutical laboratories.
Pricing
Please contact us for consultation and detailed quotation.
Frequently Asked Questions (FAQ)
1. What is the TrustE-14 with Syringe Pump and Sample Collector (DC) used for?
It is used to automate dissolution testing for up to 14 samples at once, making it suitable for high-volume quality control laboratories.
2. What USP methods does the TrustE-14 support?
It supports USP Apparatus 1 (Basket), USP Apparatus 2 (Paddle), USP Apparatus 5 (Paddle over Disk), and USP Apparatus 6 (Rotating Cylinder).
3. How does the automated sampling system function?
The syringe pump withdraws samples at programmed intervals and deposits them into the sample collector for later offline analysis.
4. Is the TrustE-14 system fully 21 CFR Part 11 compliant?
Yes, with the IntegrOS software, it offers full 21 CFR Part 11 compliance features, including fingerprint login, audit trails, and e-signatures.
5. What is the TimeAction™ function used for?
This function allows for programmed, automatic media changes, which is useful for mimicking the changing pH conditions of the GI tract for extended-release drugs.
Conclusion
The TrustE-14 with Syringe Pump and Sample Collector (DC) is a high-capacity, automated dissolution tester. It provides a compliant and efficient solution for modern pharmaceutical QC labs that require high throughput. Its advanced features ensure data integrity and reliable results.
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