Prior to large-scale production, pharmaceutical and medical technology applications must undergo complex approval processes, which often require the production of parts such as clinical test samples or stability batches in small volumes. Because of this, Gerresheimer Medical Plastic Systems has now installed its own small-scale pilot production at its Technical Competence Centre in Wackersdorf. At this early pre-production stage however, the pilot production already complies with large-scale quality standards; the acquired production intelligence can be applied directly to large-scale production processes at any Gerresheimer facility. Pilot lines allow fast and straightforward part production at any project stage – from laboratory prototype and clinical test samples right through to small-scale production.
Gerresheimer Medical Plastic Systems’ (GMS) new small-scale pilot production has a total of eleven injection molding machines with clamping forces of between 65 t and 420 t, two of which are equipped for two-component injection moulding with clamping forces of 120 t and 200 t respectively. Moreover, there are project-specific assembly units such as joining machines, bonding units or ultrasound welding systems. GMS says it deliberately selected a generous number of machines and equipment, so as to be able to offer a variety of solutions and near-series mould sampling. In the initial phase, the production area will encompass 420 sqm. It is planned to be expand this to a total of 1,400 sqm in 2016. The production area will include an 400 sqm ISO class 8 cleanroom to the DIN EN ISO 14644 standard. 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 control of the entire production process including order management, production planning and scheduling, mould service, injection molding/assembly, quality management and freight management complies with the standards of large-scale production processes. A Management Execution System (MES) guarantees efficient, fast and cost-efficient production processes. Automated quality checks are integrated into the production 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.
The pilot production delivers laboratory prototypes, clinical test samples and small-scale production batches at any project stage - straight from the Technical Competence Centre. Potential weak points can be spotted at an early project stage, optimised during the active project, and the acquired insights can be 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.