Clinical trials manufacturing system is designed to reduce the time for medicines to be marketed

Scotland’s new Medical Manufacturing Innovation Centre (MMIC) will take delivery of CME’s clinical trials manufacturing system to help speed development.

Once delivered, this system will provide the MMIC with the flexibility to fill pill bottles with different types of drugs, in tablet or capsule form, without the risk of cross-contamination, while maintaining complete traceability throughout the system.

The multi-million-pound turnkey system, designed and manufactured by CME, comprises a number of individual stations each of which is used to perform discreet operations including: handling, filling, sealing, weighing, marking, labelling and packing. A special feature of this system is its ability to meet the stringent pharmaceutical hygiene and cleanliness standards without the complete system being located in an ISO class clean room environment.

CME’s contribution to this prestigious project began when the company secured an initial contract for the design element of a complete bespoke system capable of receiving on-demand orders, filling pill bottles with the appropriate number of tablets or capsules of the requisite drug, labelling bottles and consolidating those orders all whilst ensuring full product tracking and traceability.

CME’s design solution for the JIT system, while vastly reducing the risk of cross contamination of the bottles and the surrounding equipment and environment, was instrumental in securing both the initial design contract, and the subsequent contract for the manufacture of the automated clinical trials line.

The system handles and processes two different sizes of pill containers – 60cc and 150cc – which are supplied in bulk form and which are fed to the system from bulk hoppers. Each hopper has a capacity for 1,000 or 2,000 bottles depending upon the bottle size and the bottles pass through bowl feeding, orientation and singulation systems ready for loading to the line individually.

Product traceability is an essential element in any medical or pharmaceutical environment, and so this begins with each bottle being laser marked with a unique 2D matrix code which is used for tracking and verification purposes throughout the automated processes.

The first of the ‘filling’ operations involves the loading of a desiccant capsule into each bottle. This is achieved in a humidity and temperature controlled fill station environment. To verify that the correct amount of desiccant has been added, precise tare and fill weights are taken and validated against the product matrix code identifier to ensure it is as expected for the particular bottle and size.

A series of subsequent humidity and temperature controlled drug filling stations, each configured as a fully functioning independent unit, and designed to allow quick changeover of pharma product types, are used to dispense tablets or capsules of differing drug types and strengths. Tablets or capsules pass through the feeding system in a controlled manner with accurate counts populated into a holding chamber.

Prior to the drugs being fed into the pill bottle, the bottle ID marker is again checked to verify the correct correlation between container and product. The processes performed within these stations relating to locating the bottles, feeding the drugs, controlling the environment and preventing cross contamination, eliminates the need for the complete system to be housed in an ISO classed controlled clean room.

This element of the system is subject to patent applications.

This comprehensive and flexible system controls and maintains traceability throughout manufacture, and secure reject areas are incorporated at each manufacturing stage, ensuring that only good and verified product passes to the next operation. The system has also been designed to allow scale up to meet future capacity requirements, and for the future introduction of alternative pack formats and component variants.

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