ERWEKA Launches New TBH II Tablet Hardness Tester and 21 CFR Part 11 Compliant Software for DT 950 Dissolution Series

Langen, Germany - ERWEKA GmbH, a global leader in high-quality test equipment for the pharmaceutical and life science industries, has introduced two major product innovations: the TBH II manual tablet hardness tester and a new software release for the DT 950 series dissolution tester platform, now including a 21 CFR Part 11-compliant audit trail.

“With the TBH II, we deliver a modern, highly efficient manual hardness tester, while our DT 950 software upgrade strengthens compliance for dissolution testing,” said Martin Kühn, Managing Director at ERWEKA GmbH. “Both launches underline our focus on innovation, usability, and regulatory security - giving our customers exactly what they need in today’s pharmaceutical environment.”

TBH II: Next Generation of Manual Tablet Hardness Testing
The new TBH II offers precise measurement of five physical tablet parameters - hardness, diameter/length, thickness, width, and weight (with external balance) - in a compact, user-friendly design.
  • Small footprint and compact design with modern 7" touchscreen interface for intuitive operation and fast navigation.
  • Te stAssist for testing of predefined methods to ensure reliable results.
  • Comprehensive reporting with data export to USB, network, or LIMS integration (using ERWEKA Export Manager).
  • Built to meet current pharmacopeia requirements (USP/EP/JP).

The TBH II provides laboratories with reliable manual testing functionality, flexible configuration, and full compliance - making it a cost-effective solution for both R&D and QC environments.

DT 950/9510 Software v. 3.0: Full Data Integrity with 21 CFR Part 11 Compliance
The latest software release for ERWEKA’s DT 950/9510 dissolution tester platform introduces a validated, 21 CFR Part 11 conform audit trail. Every action is now logged securely and tamper-proof, enabling GMP laboratories to meet the highest regulatory standards on device, without external software.

  • Audit trail logging who, what, where, when, and why of changes.
  • User and role management for controlled access.
  • Method management for fast and easy testing of repeating methods.
  • Advanced filtering for easy regulatory inspections.

This release ensures that DT 950/9510 customers can operate with complete confidence in data integrity and compliance while maintaining the platform’s established precision, ease-of-use and flexibility.

The DT 950/9510 software release with audit trail functionality is available for free as an upgrade for existing DT 950/9510 customers and comes standard with all new units.

For more details, visit www.erweka.com