High Quality Technologies for Joint Implants
The Felsomat automation technology utlized by the automotive industry over decades, was further developed by Felsomat to suit the needs for manufacturing medical devices.
The engineering of the standard Felsomat components were optimized to suit clean room applications, and thus satisfy the high requirements of the medical industry.
For the control system, the extreme high demands in terms of part tracking, process documentation and operator interface were successfully implemented with a software development process according to GAMP5.
The Felsomat standard and proven software technology was further enhanced and connected to an ORACLE data base, to collect and protocol all required data from the manufacturing process during part handling. Accordingly, the very strict demands of the medical industry, defined in the FDA 21 CFR, were fulfilled in a safe way.
The high standard for such a manufacturing system, can be shown by the example of delivered system for a leading manufacturer of joint implants for knees. The automation system links a total of 30 machines together with a flexible Felsomat logistics module and linear gantries, to handle and control the various work pieces through the 16 individual manufacturing steps. The process sequence of each part type is controlled by the database and can be defined individually for each work type by the operator and changed if required.
The part tracking system keeps a protocol of each work piece handling and all process data with which the work piece was machined. For each implant a unique and complete part history is generated, which will be archived in a redundant server system as a device history record or DHR.
Manual interaction through the operator is only possible with a biometric authentication. The possibility for changes of each operator is based on the training and qualification profile. The status of this profile is checked online prior of each interaction. By handling sensible personal data, Felsomat followed all laws, rules and regulation in this process.
The key feature of the system is the remarkable high uptime. With remote diagnosis, Felsomat can support the operator online for each service request.