The Objective
Total electrical, programming, and commissioning of a fully automated BAI assembly line
The Challenge
Meeting the demanding quality, data integrity, and traceability standards mandated by global regulatory authorities in the pharmaceutical industry
Earthnetic’s Role
Delivering a complete automation lifecycle—from electrical system design and panel wiring to secure, audit-ready software development and full system validation
The Technical Architecture
- Control System: Powered by Mitsubishi Electric’s high-end PLC and HMI for robust processing
- Motion & Vision Integration of high-precision Servos and advanced Vision Systems for component inspection and assembly
- Compliance Framework: Implementation of 21 CFR Part 11 features, including secure user authentication, role-based access, and protected electronic records
Key Performance Results
- Regulatory Readiness: Fully compliant with 21 CFR Part 11, featuring time-stamped data logging and comprehensive audit trails
- Data Integrity: System controls specifically designed to support data integrity, accountability, and protection against unauthorized modification
- High Precision: Reliable assembly of complex breath-actuated inhalers through synchronized motion and sensor integration
- Security: Multi-level user access control (Operator, Supervisor, Engineer) ensuring secure operational environments
- Validation Support: Provided full system testing and validation support to meet pharmaceutical manufacturing rigor





