TrustE-14 with Sample Collector (Dx)

Introduction

The TrustE-14 with Sample Collector (Dx) is a fully automated 14-station dissolution testing system. It is designed to streamline the testing process from start to finish. This system integrates a syringe pump and a sample collector (Dx) for precise offline sampling. It is ideal for high-throughput quality control labs that require efficiency and high regulatory compliance.

Product Overview

This system is engineered for modern, high-volume pharmaceutical labs. It runs on IntegrOS software, providing full 21 CFR Part 11 compliance with features like fingerprint authentication and audit trails. The unique TimeAction™ function allows for programmed media changeovers, which is useful for extended-release products. The TrustE-14 with Sample Collector (Dx) automates the entire process, from tablet dropping to sample collection, minimizing operator intervention and increasing reproducibility.

Key Features

• 14-Station Capacity: Allows for high-throughput testing of up to 14 samples.
• Automated Sampling System: Integrated syringe pump and sample collector (Dx) for offline sampling.
• 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.
• TimeAction™ Function: Enables programmed media changeovers for complex dissolution profiles.

Technical Specifications

Applications

• Automated, high-throughput quality control testing of tablets and capsules.
• 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 and automation.

Pricing

Please contact us for consultation and detailed quotation.

Frequently Asked Questions (FAQ)

1. What is the TrustE-14 with Sample Collector (Dx) used for?

It is used to fully automate dissolution tests for up to 14 samples, including the collection of samples into tubes or vials for later analysis.

2. How does the automated sampling system work?

The syringe pump withdraws samples at programmed intervals and deposits them into the Dx sample collector, organizing them for easy offline analysis.

3. Is the TrustE-14 with Sample Collector (Dx) compliant with 21 CFR Part 11?

Yes, through its IntegrOS software, it offers full 21 CFR Part 11 compliance features, including fingerprint login, audit trails, and e-signatures.

4. What is the main advantage of this system?

The main advantages are full automation and high capacity, which reduce human error, increase throughput, and ensure end-to-end data integrity.

5. What is the TimeAction™ function on the tester?

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 Sample Collector (Dx) is a comprehensive automated solution for high-capacity dissolution testing. Its 14-station capacity and full 21 CFR Part 11 compliance features make it a reliable choice for busy pharmaceutical laboratories.