Summary
Overview
A U.S.-based OEM specializing in automated machinery was contracted to build a high-precision production line for a pharmaceutical manufacturer producing sterile and regulated medical products. The system was designed to perform filling, packaging, inspection, and verification operations under strict pharmaceutical regulatory standards. To meet the project’s documentation requirements and non-negotiable validation milestones, the OEM required experienced technical support for electromechanical assembly and commissioning.
Boltronic was engaged to augment the OEM’s internal engineering team with skilled technicians and a senior controls engineer. Boltronic supported the project with three months of on-site assembly and integration work in Lebanon, Missouri, followed by one month of installation and startup assistance, helping maintain a continuous build and testing schedule.
Key Success Factors
- High-precision assembly capabilities aligned with pharmaceutical standards
- Continuous controls engineering support from offline preparation to commissioning
- Disciplined documentation and revision control practices
- Close coordination with OEM engineering teams during build and testing
The Challenge
Pharmaceutical-Grade Precision Requirements
Mechanical components required strict torque control, alignment verification, and compliance with pharmaceutical manufacturing standards.
Strict Documentation and Revision Control
Engineering documentation required controlled handling, including single hard-copy drawings and sensitive revision management.
Validation and Audit Milestones
The system needed to meet strict SAT/FAT preparation requirements and regulatory validation deadlines without interruption to the build schedule.
Integrated Multidisciplinary Execution
Mechanical assembly, electrical wiring, and controls integration had to be executed simultaneously within tight project timelines.
Boltronic’s Solution
Key contributions included:
- Assembly of mechanical structures, frames, and motion components
- Installation and controlled torquing of high-precision pharmaceutical equipment
- Wiring of sensors, motors, IO modules, and operator interfaces
- Verification of alignment and mechanical tolerances according to engineering specifications
Controls engineering support included:
- Offline programming preparation, simulation, and integration testing including I/O validation and functional verification.
- Online commissioning, system optimization, and collaboration with the OEM engineering team to maintain software and documentation integrity.
BOLTRONIC’S
Results and Impact
Client Value