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In the initial phase, the production area will be 420m2 in size, with plans to expand this to 1,400m2 in 2016. It will include a 400m2 ISO Class 8 cleanroom to the DIN EN ISO 14644 standard, while integrated laminar flow hoods create an ISO Class 7 cleanroom environment in the injection moulding area. A gantry crane inside the cleanroom allows for fast and easy mould changes, the company says.

Gerresheimer Medical Plastic Systems has installed a small-scale pilot production unit at its Technical Competence Centre in Wackersdorf, Germany.

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The control of the entire production process, including order management, production planning and scheduling, mould service, injection moulding/assembly, quality management and freight management, complies with the standards of large-scale production processes.

The pilot plant delivers laboratory prototypes, clinical test samples and small-scale production batches at any project stage. Potential weak points can be spotted at an early stage, optimised during the active project, and the acquired insights applied to large-scale production. Similarly, all intelligence gathered during the mould engineering and automation processes can be applied directly to the construction of moulds and technical equipment for large-scale production. The development and project teams supervise the entire product creation process right through to series production.

The pilot plant has been equipped 11 injection moulding machines with clamping forces of between 65t and 420t, two of which are equipped for two-component injection moulding with clamping forces of 120t and 200t, respectively. It also features project-specific assembly units such as joining machines, bonding units or ultrasound welding systems.

Even at this early pre-production stage, the pilot production unit complies with large-scale quality standards so that the acquired production intelligence can be applied directly to large-scale production processes at any Gerresheimer facility, the company says.

A Management Execution System (MES) guarantees efficient, fast and cost-efficient production processes. Automated quality checks are integrated into the process, while an end-to-end tracking system for individual subassemblies or batches ensures that all products comply with the required quality standards for pharmaceutical and medical technology products.