Volume 3, Issue 3 (March 2006)

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

    (Received 23 May 2005; accepted 28 September 2005)

    Published Online: 2005

    CODEN: JAIOAD

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    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.


    Author Information:

    LeBlanc, DA
    Cleaning Validation Technologies, San Antonio, TX


    Stock #: JAI13393

    ISSN: 1546-962X

    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