Analytical Methods and Acceptance Criteria for Cleaning Validation Protocols for Medical Devices

    Volume 3, Issue 3 (March 2006)

    ISSN: 1546-962X

    CODEN: JAIOAD

    Published Online: 21 December 2005

    Page Count: 5


    LeBlanc, DA
    Cleaning Validation Technologies, San Antonio, 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.


    Paper ID: JAI13393

    DOI: 10.1520/JAI13393

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    Author
    Title Analytical Methods and Acceptance Criteria for Cleaning Validation Protocols for Medical Devices
    Symposium Cleanliness of Implants, 2005-05-18
    Committee F04