The WILD Group has in place the bacteria-controlled environment required for production and a well-integrated network of experts for the development of its sterile products.

Sterility is a valuable asset in hospitals. This applies in particular to devices that come into direct contact with patients. Especially in the case of active medical devices with complex electronics, one factor stands out as crucial: These must be designed and produced in a manner that renders them sterile and capable of withstanding several sterilisation cycles. “WILD possesses the expertise and, in addition, a reliable network of partners to develop precisely such sterile products and manufacture them in a bacteria-controlled environment”, stresses Stephan Payer, Head of Business Unit WILD Electronics.

DEVELOPMENT WITH STERILISATION IN MIND
The sterilisability of complex medical products featuring connections and control interfaces depends especially on two factors: “Already during development, you must design the product to ultimately allow for its operation to withstand multiple sterilisation cycles. In addition, it is necessary to timely select the correct cleaning procedure for the corresponding application”, Payer explains.

To guarantee the reproducibility of function and quality, the company uses a proprietary process for bacteria-controlled manufacturing. “Our strength lies in the fact that we cover the entire process chain from product development and assembly to the final tests and packaging. This is why our expertise is so much in demand, in particular for high-end products with a very low bacterial load”, stresses Alfred Michalek, Head of Quality Management at WILD Electronics.

HAND-PICKED SUPPLY CHAIN
To guarantee such a low load, you must apply extremely strict requirements already in the selection of the basic materials and their  suppliers. Over the years, WILD has built up a distinguished network of qualified partners who meet GMP-compliant hygiene standards. For instance, materials are introduced into the bacteria-controlled space already upon delivery. Assembly takes place under operating theatre conditions with the corresponding protective clothing, a competent laboratory provides the necessary approvals and the WILD staff regularly attend hygiene training courses. “Moreover, the environment conditions must be re-qualified and re-validated with each manufacturing batch. Overall, the manufacture of sterile products is therefore a very complex process that we have mastered over several years and which allows us to guarantee a quick time to market for our customers”, says Michalek.