Just-in-time clinical trials manufacturing system accelerates drug introduction
Project snapshot
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Challenge
Minimizing time to introduce new medicines
Scotland’s Medicines Manufacturing Innovation Centre (MMIC) required a manufacturing system capable of rapidly introducing new medicines into clinical trials while maintaining pharmaceutical hygiene standards, eliminating cross-contamination risk, and ensuring full product traceability. The system needed to support tablets and capsules, multiple bottle sizes, frequent changeovers between drug types, and strict environmental control—without placing the entire line in an ISO-class clean room.
Innovation
A modular, fully automated, traceable manufacturing platform
AIR delivered a turnkey clinical trials manufacturing system composed of integrated modules that support flexible, small-batch pharmaceutical production while maintaining strict cleanliness and traceability.
Key innovations included:
- Modular system architecture supporting handling, filling, sealing, weighing, marking, labeling, storage, and packing
- Individual filling modules with humidity and temperature monitoring, eliminating the need for a full clean room environment
- Laser marking of each bottle with a unique 2D matrix code for end-to-end traceability
- Independent drug filling modules designed for rapid changeover between drug types and strengths
- Integrated weighing and verification steps linked to bottle ID to confirm correct desiccant and drug loading
- Extensive automated bottle and tray storage, retrieval, and routing capability supporting over 17,000 bottles
- Dedicated labeling system with machine-vision verification prior to label application
- Unique digital dashboard allowing for drugs to be signed off remotely, eliminating hours of paperwork
Result
Flexible, scalable clinical trials manufacturing with full traceability
The completed multi-million-pound system enables MMIC to rapidly manufacture clinical trial medications with full bottle-level traceability, reduced contamination risk, high operational flexibility, while reducing stock inventory requirements and overall cost of clinical trials. By localizing environmental control within individual process modules, the system meets pharmaceutical hygiene requirements while avoiding the complexity of a full clean-room installation. The scalable architecture supports future capacity growth and new packaging formats, helping accelerate the path from development to clinical trials.
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