Digitalizing Freeze-Drying Operations with FDA-Compliant Monitoring
Digitalizing Freeze-Drying Operations with FDA-Compliant Monitoring
Digitalizing Freeze-Drying Operations with FDA-Compliant Monitoring
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Digitalizing Freeze-Drying Operations with FDA-Compliant Monitoring
Share:
Digitalizing Freeze-Drying Operations with FDA-Compliant Monitoring
Share:
Digitalizing Freeze-Drying Operations with FDA-Compliant Monitoring
Share:
Digitalizing Freeze-Drying Operations with FDA-Compliant Monitoring
Share:
Digitalizing Freeze-Drying Operations with FDA-Compliant Monitoring
Share:
Digitalizing Freeze-Drying Operations with FDA-Compliant Monitoring
Converting regulatory requirements into a competitive edge
AG Solution x Dara-Lyo
Challenge
Dara-Lyo (formerly Coolvacuum), a leading manufacturer of industrial and laboratory freeze-dryers, faced a critical transformation need. Their freeze-drying equipment required sophisticated control systems that could meet stringent FDA compliance requirements.
The company needed to remove paper-based documentation while ensuring all electronic records and signatures met 21 CFR Part 11 requirements.
Managing validation documentation across multiple freeze-dryer units was becoming increasingly complex, and the need for more standardization was impacting operational efficiency.
Solution
AG Solution’s team architected a comprehensive digital transformation that balanced regulatory compliance with operational efficiency. Starting with a thorough analysis of FDA requirements and Dara-Lyo's specific needs, we developed:
A tailored SCADA system based on Wonderware technology was built on a template-based architecture. This approach wasn't just about monitoring—it established a standardized framework that could be efficiently deployed across different freeze-dryer models while maintaining individual unit specifications.
Our experts created a complete validation package, including detailed Functional Design Specifications and protocols for Installation, Operational, and Performance Qualification (IQ/OQ/PQ). The virtual development environment enabled thorough testing of all functionalities before deployment, ensuring compliance from the ground up.
The system's architecture incorporated automated audit trail capabilities and electronic signatures, transforming compliance from a documentation burden into an integrated part of daily operations.
Results
The implementation delivered regulatory compliance while driving operational improvements across Dara-Lyo's manufacturing operations:
The template-based SCADA application became a cornerstone for standardization, significantly reducing development time for new freeze-dryer installations. Each new implementation now follows a validated pattern, ensuring consistency while allowing for equipment-specific customization.
The new application enables batch-based manufacturing, enhancing production efficiency, traceability, continuous improvement and analytical capabilities.
The shift to digital reporting through Dreamreports eliminated paper-based processes, providing immediate access to critical batch records and automated report generation. This improved data integrity and enhanced the efficiency of quality reviews and audits.
This transformation positioned Dara-Lyo to efficiently scale its digital infrastructure across its freeze-dryer portfolio, ensuring consistent quality and compliance standards across all installations.