InnoRein

This joint project is investigating the applicability, performance, and suitability of innovative cleaning processes. The focus is on medical technology products and, in particular, areas that are difficult to clean, such as blind holes, undercuts, or cannula holes with a large length-to-diameter ratio. Cleaning is also being considered in connection with the targeted functionalization of material surfaces prior to further processing.

Final cleaning after manufacturing is becoming increasingly important for medical devices. In the context of growing awareness of hygiene issues, notified bodies require proof of the cleanliness and low particle content of product surfaces.

An implant surface that has not been cleaned optimally can lead to significant complications such as inflammation of the surrounding tissue shortly after implantation. Long-term effects can also be responsible for a significantly reduced service life of the implant and result in poor ratings for the product in question, even though the product itself meets all other requirements perfectly.

Traditional wet chemical cleaning processes quickly reach their limits when it comes to difficult product geometries such as blind holes, undercuts, or cannula holes with a large length-to-diameter ratio. The reason for this is usually insufficient rinsing of the material surfaces in these areas, which on the one hand results in insufficient cleaning of the surfaces and on the other hand makes it difficult to remove the loosened contamination.

In many cases, however, cleaning after production is not necessarily the final process step. The cleaned material surface could be subjected to further treatment steps such as surface functionalization by means of suitable coatings or chemical modifications of the material surface itself.

Against this backdrop, there has been an increase in demand for new cleaning methods. Innovative cleaning methods such as plasma cleaning and CO2 snow jet cleaning could lead to significant improvements in this area.

The objectives of the planned joint project are to investigate the applicability, performance, and suitability of new innovative cleaning processes such as plasma cleaning and CO2 snow jet cleaning, primarily in the field of medical technology. The focus is particularly on product geometries that are difficult to clean, such as blind holes, undercuts, or cannula holes with a large length-to-diameter ratio, as well as the targeted functionalization of material surfaces prior to further processing in connection with cleaning.

However, raising cleanliness standards in line with the current state of cleaning technology is expressly not the aim of this joint project.

In addition to the innovative cleaning processes, a wet-chemical validatable cleaning process for medical technology is also to be presented against the background of a possible integration of plasma cleaning and CO2 snow jet cleaning.

The biocompatibility of surfaces treated with the innovative cleaning processes is to be tested on selected surfaces.