The Challenge
Quality assurance after the freeze-drying process (lyophilization) required automated inspection of stopper position. The biggest hurdle was the technological context: it involved an existing system without available digital CAD data.
Identified Pain Points & Risks:
- Minimal Invasiveness: The system had to be integrated so that intervention in the existing system and the existing safety architecture remained minimal
- Precise Singulation: Vials had to be safely removed from the link conveyor, singulated, and positioned for inspection
- Documentation Gaps: Missing technical documentation of the legacy system complicated the design of precisely fitting interfaces
- Background Compliance: The solution had to guarantee full GMP compliance and validatability despite integration into a legacy system
Our Solution
Pharmabotix assumed the complete engineering package to implement a turnkey solution into the existing line.
System Architecture & Components:
- Reverse Engineering & Measurement: Since no data was available, the interfaces of the existing system were precisely measured on-site to guarantee a precisely fitting integration
- Handling Mechanism: Development of a specialized feed system that gently pulls vials from the link conveyor and singulates them for inspection
- High-End Vision System: Integration of an Octum camera system specialized in detecting smallest deviations in stopper position
- Safety Concept: The design was chosen so that the existing safety circuits of the system remained untouched or were seamlessly supplemented
Technology Highlights:
- Retrofit Competence: Successful modernization of a “black box” system without loss of system integrity
- Data Continuity: Connection of inspection data to the HMI for real-time monitoring and error reporting
- GMP Quality: Creation of the complete documentation matrix (IQ/OQ) for the regulated environment
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