Pilot production with large-scale production standards

Pilotproduktion in Serienqualität / Pilot production in a class 8 cleanroom to DIN EN ISO 14644 standard at the Technical Competence Center in Wackersdorf.

Integrierte Laminarflow-Hauben erzeugen im Spritzgießbereich eine Reinraumumgebung der Klasse 7 / Integrated laminar flow hoods create an ISO class 7 cleanroom environment in the injection molding area.

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 Center 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’ 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 molding 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 deliberately selected a generous number of machines and equipment, so as to be able to offer a wide variety of solutions and near-series mold 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 molding area. A gantry crane inside the cleanroom allows for fast and easy mold changes.

The control of the entire production process including order management, production planning and scheduling, mold 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.