Volume 3, Issue 3 (March 2006)
Analytical Methods and Acceptance Criteria for Cleaning Validation Protocols for Medical Devices
This paper presents alternative methods to utilize in measuring the effectiveness of cleaning processes and to measure effects of changes in a cleaning process for the manufacture of medical device implants. Recommended methods for setting cleaning validation acceptance criteria for various residues are presented, along with analytical methodologies to measure those residues. The advantages of the proposed analytical methods include their applicability to devices other than metallic implants and the fact that they are established analytical technologies.