Pharmaceutical Manufacturing Process Control
AI-enhanced process monitoring and control system for sterile drug manufacturing, achieving 99.99% batch quality and full 21 CFR Part 11 compliance.
The Challenge
A pharmaceutical manufacturer needed to modernize their critical process control systems for sterile drug production. The FDA-regulated environment demanded 100% traceability, validation, and 21 CFR Part 11 compliance. Cleanroom classification (ISO Class 5) prohibited fan-based cooling systems. Real-time process monitoring required integration with 150+ sensors and actuators while maintaining deterministic response times. Any system failure could result in batch loss worth $500K+ and potential regulatory action.
The Solution
We deployed 8 NIA-5000 industrial computing platforms as the foundation of the new process control architecture. The fanless design met cleanroom particle requirements while supporting real-time control workloads. Extensive I/O expansion accommodated all process sensors and control loops. Redundant configurations with automatic failover ensured continuous operation. All software was validated per FDA guidelines with full audit trails. Edge AI models monitor process parameters in real-time, detecting anomalies that could affect batch quality before traditional control systems would respond.
The Results
99.99% batch quality rate, exceeding previous 98.7% average
67% reduction in out-of-specification batches through predictive anomaly detection
Zero unplanned downtime due to control system failures over 3 years
Full 21 CFR Part 11 compliance with comprehensive audit trails
Successful FDA audit with zero findings related to automation systems
$8M annual savings from reduced batch losses and improved yield
Technologies Used
Advanced Thermal Management
Patented cooling solutions for high-performance computing in harsh environments
Learn MoreRugged System Design
MIL-STD-810G certified systems for extreme operating conditions
Learn MoreProducts Deployed
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