WP1 - Pilot line: Micro-fabrication
Work package leader: Mieke Botermans (Philips)
 
A Pilot Line embedded in industry
Faced with the lack of a suitable production infrastructure for advanced medical micro-fabricated devices, Philips Innovation Services (PInS) took the initiative for a major investment to reorganize the cleanroom Infrastructure from a pure research facility towards a pilot production line with a focus on medical devices. The reorganization is a major activity and investment by Philips Innovation Services. The objective is to create a production facility for medical devices, not only for Philips proprietary products, but also for third parties, such as SMEs and start-ups in need for a production facility. Needless to say that, although the focus will be on medical devices in its broadest sense, the total scope of products is wider.
In order to make the infrastructure suitable for pilot production, a reorganisation is planned comprising a number of steps.  First of all the cleanroom has to be structured to acquire the required capabilities for production. This means a shift of focus from research towards development, vertical integration capability, yield improvement and process stability, traceability and quality control. The production of medical products requires the installation of an extensive manufacturing, quality and documentation system. Amongst others a “Manufacturing Excellence System” system for lot tracking and Statistical Process Control (SPC) data logging will be installed. Staff will need to be trained in the use of this system and the need for rigorous documentation. The cleanroom will be ISO13485 qualified for the design and production of medical devices.
Also with respect to equipment, multi- million euro investments for the coming years have been planned aimed at acquiring the required polymer production capability as required for these medical devices. Since production level processes for these materials are often not available, these also need to be developed. A complete description of all the activities is given in Work Package 1
 
The tasks in this project address the following three topics:
  • The way of working (quality control, logistics, ISO certification, lot tracking, training etc.);
  • Equipment control (preventive maintenance structure, statistical process control implementation of out of control actions plans etc.);
  • Process development (development of certain critical process modules to a production level e.g. polymer processing).

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