Controware, a Certified 21 CFR Part 11 Service Provider, successfully upgraded the Bohle Machine Control System at Sanofi (2019-2020). Leveraging PLC M241 with EcoStruxure Machine Expert V1.1, the project enhanced operational efficiency by integrating an Enclose IPC with EcoStruxure Machine SCADA Expert and an Altivar ATV320 Drive, ensuring seamless monitoring and performance improvements. Comprehensive validation documents were provided to meet stringent FDA – 21 CFR Part 11 compliance for pharmaceutical manufacturing.
- Upgrading the existing Bohle Machine control system to the latest PLC and SCADA technology.
- Ensuring compliance with FDA – 21 CFR Part 11 regulatory requirements for pharmaceutical production.
- Integrating advanced control and drive systems to improve performance and reliability.
Upgraded Control System with PLC M241 and EcoStruxure Machine Expert
Installation of Enclose IPC with SCADA for Enhanced Monitoring
Integration of Altivar ATV320 Drive for Optimized Performance
Preparation of Validation Documents for Regulatory Compliance
Seamless System Integration for Improved Operational Efficiency
Final Commissioning and Testing to Ensure Reliable Production
