The Challenge
PSM GmbH, a leading CDMO in the pharma and MedTech sector, required a solution for assembling autoinjectors at clinical scale and for small batches. The previous process was entirely manual, leading to significant challenges:
- Variability: Manual assembly made it difficult to maintain validated process limits
- Traceability: Lack of automated data capture per batch or serial number in manual operations
- Ergonomics: Physical strain on operators due to repetitive manipulation tasks
- Economics: Long throughput times for small, highly valuable batches
The requirements were demanding: A solution for clinical batches had to be flexible enough to handle different autoinjector formats, while being GMP-compliant and fully validatable.
Our Solution
Pharmabotix delivered a compact, flexible assembly system specifically designed for R&D, clinical samples, and market launches:
Robot-Based Automation:
- Yaskawa 6-axis robot handles all critical handling and assembly steps with highest precision
- Automated sequence autonomously assembles rear housing, cartridge, and front housing
- Sterile robot design for GMP-compliant processes
- Complete enclosure with safety glass and interlock mechanisms
Intelligent Joining Station:
- Integrated servo press with real-time force-displacement monitoring
- Guarantees that every injector is assembled within validated limits
- Precise force control eliminates rejects and human variability
- Throughput of 3 units per minute
Flexibility & Data Continuity:
- Recipe Management: Format changes are purely software-based via HMI recipes without mechanical changeovers
- Complete traceability of all process data per batch
- GMP Compliance: Zone-separated safety logic according to CE directives
- Modular design allows reuse for future injector formats
Project Gallery
When production stops due to new regulations like Annex 1, every second counts. An existing customer called us with the highest urgency: A filling line from Crailsheim, Germany, was shut down – a compliant, demountable needle bar was missing. The result: In just 14 days, we delivered the finished, electropolished solution including 3.1 material certificates…
Pharmabotix focuses on innovation: In the highly automated autoinjector assembly line, Pharmabotix integrated the HD series in combination with PSM (Pharma Standard Module). This project received the prestigious ISPE Robotics of the Year Award – proof of innovation power and the future viability of hygienic robotics in the pharmaceutical industry. Highest Standards for Hygiene-Critical Environments…
Pharmabotix, a Swiss company led by Co-Founder and CEO Fabian Stutz, has established itself as an agile specialist for customized automation solutions in the pharmaceutical industry. While large providers deliver standardized production lines, Pharmabotix closes the gap for complex, customer-specific requirements – from robot-supported packaging lines to innovative solutions like segmented needle holders for Annex…
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