ZipFix only looks like an ordinary cable tie at first glance. The connectors are used to close the sternum after open heart surgery. Since the first surgery in February 2011, well over 100,000 surgeries have been successfully performed worldwide.
In order to be able to manufacture the Zip-Fix, the needles for the ZipFix must be fed in the clean room via an ultrapure water cleaning system and then overmoulded using the injection moulding process. After injection moulding, the ZipFix fasteners are tested for quality (e.g. tensile strength), laser marked and packaged according to customer specifications. The final step is sterilisation by gamma rays according to EN ISO 11137.
The fact that all processes must be validated is state of the art and is not included in any specifications. This is what customers require.
The success of the project is due on the one hand to the many years of toolmaking know-how in the medical field and in the processing of PEEK, and on the other hand to the possibility of carrying out all the production steps in one place under controlled and validated conditions. This lowers the interface risk to practically zero and reduces errors!
