ISSN: 1546-962X
Published Online: 21 December 2005
Page Count: 5

Analytical Methods and Acceptance Criteria for Cleaning Validation Protocols for Medical Devices
LeBlanc, DA
Cleaning Validation Technologies, TX

(Received 23 May 2005; accepted 28 September 2005)

Abstract

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.

Keywords:
cleaning, validation, limits, residues, implant

Paper ID: JAI13393
DOI: 10.1520/JAI13393
ASTM International is a member of CrossRef.