Dissolution Workstation Software - Data Sheet

Significance of the topic

Effective dissolution testing is fundamental in pharmaceutical development and quality control. It ensures consistent drug release profiles, supports regulatory compliance, and underpins product performance evaluations.

Objectives and study overview

This document presents an integrated software solution designed to centralize control and data management of multiple dissolution systems. Key goals include networked operation of up to four independent dissolution units per workstation, streamlined data consolidation, and adherence to 21 CFR Part 11 requirements.

Methodology

The software employs a centralized database to store system configurations, method parameters, and run data. Authorized users can configure or modify methods without deleting historical data. Real-time monitoring captures temperature, sampling times, and system status. Audit trails record each action with time stamps to ensure traceability. Remote start capabilities enable off-site initiation of dissolution tests. Vibration monitoring via baseline X-, Y-, and Z-axis measurements supports environmental impact assessment and failure investigations.

Instrumentation used

• Agilent 708-DS Dissolution System and USP Apparatus 3 (Bio-Dis) or 7 configurations
• Automated sampling stations linked via serial or USB interfaces
• 280-DS Mechanical Qualification System Instrument Module for vibration tracking
• Windows-based PC hardware (Intel Pentium or Core processors, minimum 4 GB RAM, USB/RS232 ports)

Key results and discussion

Implementation allows simultaneous operation of multiple dissolution units from a single interface. The central database preserves full configuration histories while enabling rapid retrieval and secure data archiving. Audit logs capture all method changes and equipment actions. Vibration data trends support early QC initiatives and routine mechanical qualification. Remote start and real-time status updates enhance workflow flexibility.

Benefits and practical applications

• Consolidation of all dissolution data into a single paperless database
• Audit-ready environment meeting 21 CFR Part 11 for electronic records
• Secure user access control and version management
• Time savings through remote test initiation and integrated reporting
• Improved maintenance and troubleshooting via vibration monitoring

Future trends and applications

Ongoing developments may include deeper integration with LIMS and business intelligence platforms, expansion to cloud-based data storage, enhanced automation of sampling processes, and application of AI algorithms for predictive instrument maintenance and advanced data analytics.

Conclusion

Agilent Dissolution Workstation Software delivers a robust, compliant, and flexible solution for centralized dissolution testing. It enhances reproducibility, accelerates data handling, and provides comprehensive audit and monitoring capabilities.

References

Agilent Technologies, Inc. Agilent Dissolution Workstation Software Data Sheet, Part number 5990-7403EN, 2018.