In the design of this assembly tools is opted for partially manual tools and partially an semi-automatic tool. The non-critical processes for the realization of the final product have been achieved in handtooling, the critical tooling and processes are automated. This choice is based on the growth of the number of products to be assembled and the corresponding ROI.
The hand tooling can be used for the die-cutting, punching, assembling and placing of the components. We have developed five hand tools for this particular medical device.
The critical processes associated with validation are merged into one semi-automatic machine. First of all, a liquid is dosed within an accuracy of 0.01 ml (10 ul). Subsequently, a component is added by hand after which it is pressed with a certain force up to a certain height. Final step in the assembly process is the die-cutting of aluminum foil and the precize positioning and sealing of the die-cut shape on the product. The challenge was the accurate positioning of the die-cut shape on the product. The validation parameters are embedded through the process. Parameters such as sealing temperature, sealing pressure and seal time can be set.