Introduction
The TrustE-08 Basic is an 8-station instrument designed for USP-compliant dissolution testing. This tester combines advanced regulatory compliance features with a user-friendly, standalone design. It is equipped with a 7-inch touch screen, a motorized lift, and IntegrOS software to ensure data integrity. It is an ideal choice for labs that require reliability and compliance.
Product Overview
This 8-station dissolution tester is engineered for the modern pharmaceutical lab. It runs on IntegrOS software, providing full 21 CFR Part 11 compliance with features like fingerprint authentication, audit trails, and e-signatures. The unique TimeAction™ function allows for programmed media changeovers, which is useful for extended-release products. The TrustE-08 Basic is a robust, standalone system that delivers accurate and traceable results for quality control and research and development activities.
Key Features
- 8-Station Capacity: Allows for testing of up to 8 samples simultaneously.
- 21 CFR Part 11 Compliant: Features IntegrOS software with fingerprint login, audit trails, and e-signatures.
- 7-inch Touch Screen: An intuitive interface for easy programming and monitoring.
- USP Compliance: Supports methods for USP Apparatus 1, 2, 5, and 6.
- Motorized Lift Mechanism: Ensures smooth, vibration-free movement of the stirrer head.
- TimeAction™ Function: Enables programmed media changeovers for complex dissolution profiles.
Technical Specifications
| Model | TrustE-08 Basic |
| No. of stations | 8 |
| Speed range | 20 RPM to 300 RPM |
| Temperature range | 20°C to 40°C |
| Display | 7″ TFT touch screen |
| Vessel capacity | 150ml, 250ml, 1L, 2L |
| Dimensions (W x L x H) | 517 mm x 712 mm x 690 mm |
Applications
- Quality control testing of solid dosage forms.
- Dissolution profiling of immediate and extended-release drugs.
- Methods requiring USP 1 (Basket), 2 (Paddle), 5 (Paddle over Disk), and 6 (Rotating Cylinder).
- Laboratories requiring 21 CFR Part 11 data integrity.
Pricing
Please contact us for consultation and detailed quotation.
Frequently Asked Questions (FAQ)
1. What is the TrustE-08 Basic used for?
It is used to perform USP-compliant dissolution tests for up to 8 samples, providing a reliable and compliant platform for QC and R&D labs.
2. Is the TrustE-08 Basic compliant with 21 CFR Part 11?
Yes, through its integrated IntegrOS software, it offers full 21 CFR Part 11 compliance features, including fingerprint login, audit trails, and e-signatures.
3. What USP methods are supported by this tester?
It supports USP Apparatus 1 (Basket), 2 (Paddle), 5 (Paddle over Disk), and 6 (Rotating Cylinder).
4. What is the TimeAction™ function on the TrustE-08 Basic?
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.
5. Is this model suitable for automated sampling?
No, the TrustE-08 Basic is a standalone tester designed for manual sampling. For automated sampling, other models are available.
Conclusion
The TrustE-08 Basic is a robust solution for the modern pharmaceutical laboratory. It combines an 8-station capacity with full 21 CFR Part 11 compliance features, ensuring reliable and traceable results. Contact us for more information.
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