Cell and Tissue Banking

, Volume 6, Issue 4, pp 271–275

Validating a Low Dose Gamma Irradiation Process for Sterilizing Allografts Using ISO 11137 Method 2B

  • Thomas F. Baker
  • Chad J. Ronholdt
  • Simon Bogdansky
Article

DOI: 10.1007/s10561-005-7364-6

Cite this article as:
Baker, T.F., Ronholdt, C. & Bogdansky, S. Cell Tissue Banking (2005) 6: 271. doi:10.1007/s10561-005-7364-6

Abstract

This paper describes the validation of an allograft sterilization method specifically designed for the processing methods used at AlloSource in Centennial, CO. The methods used for this validation followed ISO Standard 11137, Method 2B. Three hundred allografts, collected from three defined production batches were dosed using a series of five incremental doses, beginning at 1 kGy and increasing by 1 kGy until 5 kGy was achieved. Following sterilization dosing, each allograft test article was analyzed using a sterility test to identify any viable microorganisms. The number of positive sterility samples was used to calculate the verification dose (1.27 kGy), which was then verified by an additional batch of 100 allografts. The results from this validation indicate that sterility (10−6 SAL) on human allograft tissue using gamma 60Co radiation can be achieved when a dose of at least 9.2 kGy is employed.

Keywords

Allograft tissueBioburdenGamma 60Co radiationSterility assurance levelSterilization doseValidation

Copyright information

© Springer 2005

Authors and Affiliations

  • Thomas F. Baker
    • 1
  • Chad J. Ronholdt
    • 1
  • Simon Bogdansky
    • 1
  1. 1.AlloSourceCentennialUSA