InnoRein

Project Image:
Title of the project:

InnoRein

Teasertext:
Innovative cleaning processes in the manufacture of medical technology products
Summary:
applicability, performance and suitability of new innovative cleaning methods such as plasma cleaning and CO2 snow jet cleaning
Start:
01.11.2009
End:
30.11.2011
Project leader:
Allgemeine Adresse Info
Funding reference number:
-
Text:

In this joint project, novel cleaning methods are examined for their applicability, performance and suitability. The focus is on products of medical technology and in particular parts that are difficult to clean, such as blind bores, undercuts or cannula bores with a large length/diameter ratio. Cleaning is also considered in connection with targeted functionalisation of material surfaces before further processing.

Description:

Final cleaning after production  is becoming increasingly important for medical devices. In an environment of increasing sensitization in the hygienic area, notified bodies are required to provide proof of the cleanliness and low particle content of the product surfaces.
A not optimally cleaned implant surface can soon after implantation lead to considerable complications such as inflammation of the surrounding tissue. However, long-term effects can also be responsible for a significantly reduced service life of the implant and mean poor marks for the corresponding product, even though the product itself meets all other requirements perfectly.
Traditional wet-chemical cleaning methods quickly reach their limits with difficult product geometries such as blind holes, undercuts or cannula holes with a large length/diameter ratio. The reason for this is usually insufficient flushing of the material surfaces in these areas, which on the one hand causes insufficient cleaning of the surfaces and on the other hand complicates the removal of the detached contamination.
In many cases, however, cleaning after production is not necessarily the last step in the process. For example, the cleaned material surface could be subjected to further treatment steps such as surface functionalization through suitable coatings or chemical modifications of the material surface itself.
Against this background, there has been an increasing demand for new cleaning processes. Innovative cleaning processes such as plasma cleaning and CO2 snow jet cleaning could lead to significant improvements here.
The objectives of the planned joint project are to investigate the applicability, performance and suitability of new innovative cleaning methods such as plasma cleaning and CO2 snow jet cleaning, primarily in the field of medical technology. In particular, the focus is on product geometries that are difficult to clean, such as blind holes, undercuts or cannula holes with a large length/diameter ratio, as well as the targeted functionalisation of material surfaces prior to further processing in conjunction with cleaning.
An increase of the cleanliness standards according to the current state of the cleaning technology, however, is expressly not the aim of this joint project.
In addition to the innovative cleaning methods, a wet-chemical, validatable cleaning method for medical technology will also be presented against the background of a possible integration of plasma cleaning and CO2 snow jet cleaning.
The biocompatibility of the surfaces treated with the innovative cleaning methods will be tested on selected surfaces.

Project partners:
  • 31 Firmen, vorwiegend aus der Medizintechnik