Medical

Residue-free implant production

January 2009

The ability to completely remove grease, oil and lubricant residues is an increasingly important requirement for mechanically produced metal parts. This type of requirement has generally increased in most industries over recent years. Trends In the automotive industry on one hand parts are becoming increasingly complex and more difficult to clean, and on the other hand the accepted level of residues per part is becoming lower and lower. The lowest possible quantity of residue for automotive parts is very important for the guarantee of the 100 000 km warranty. Any risk of part failure must be reduced or eliminated. In the electronics industry storage density is constantly increasing and part cleanness requirements are becoming increasingly important. For certain parts, following various optimisation steps, we have now reached residue quantities of just a few ng per cm² for organic residues. The last, and perhaps the most easily understandable, industrial sector concerned is the medical industry which is enforcing a “zero residue” requirement. In this sector it is firstly a question of the complete removal of any residual film and secondly also the removal of all particles, including particles down to a micrometer. Residues can interfere with subsequent surface coating, thus causing both technical and toxicological problems. [...] A complete study The company Blaser and Robert Mathys Stiftung in Bettlach (Switzerland) have worked together on a joint project to examine parts for microbiological residues, and for the very first time it was clearly proved that no microbiological material could be detected on the surface of implants. The irregularly-formed parts were previously soaked in cooling lubricants containing bacteria.

"Following the cleaning process the parts were specifically examined for traces of endotoxin, and endotoxin could be detected on none of the parts examined." - A. Flury

Details of the study are available on request.

Regula Kämpfer Blaser Swisslube AG Winterseistrasse 3415 Hasle-Rüegsau Tel +41 344 600 210 Fax +41 344 600 100

www.blaser.com

Source/Quelle Luginbuehl R, Fluri A, „Analysis of Endotoxin Residues on Cleaned Implant Materials” 2008, JAI 5 (2); (JAI101452)

A lot of know how is available for those who need to produce and clean their parts, either with oil producers or with cleaning companies (see also the entry written on Amsonic in this blog [chose "The Categories" and then "Cleaning"]). It is good news. Do not hesitate to contact them.

I will come back on what is called cleanliness later. Cheers py

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