Volume 3, Issue 8 (September 2006)
Industrial Cleaning of Implants: Performance Validation of Cleaning Scheme
The quality of medical devices depends strongly on the proper cleaning of the devices in the line of processing. Residue-free implants are not only a benefit for the patient in the long term, but they also help to reduce the number of rejections due to insufficient surface quality. The performance of the new, fully automated aqueous immersion cleaning system revealed a very high cleaning efficiency for metallic implants. An organically based model process adjuvant was used as contaminant. Custom designed metallic bodies made of implant quality material and exhibiting different surface textures served as test coupons. The analysis of the residues was carried out using gas chromatography separation and mass spectrometry analysis. The amount of organic residues found on the test coupons was below the set quantification limit of 0.1 mg—most of the time even below the detection limit of 0.01 mg total organic compounds.