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BITThis scientific publication is an important case study. The challenges associated with demonstrating to a very high level of assurance of sterility are discussed in the context of case design, instruments, density, F0, maximum load configuration, minimum load configuration. In addition, the biological testing using qualitative and quantitative methodologies are illustrated.

The web address is, http://www.aami.org/publications/BIT/index.html

and in print

Challenges to Validation Of a Complex Nonsterile Medical Device Tray
Daniel Prince, Jozef Mastej, Isabel Hoverman, Raja Chatterjee, Diana Easton, and Daniela Behzad
Biomedical Instrumentation & Technology, Vol. 48, No. 4, July/August 2014: 306-311.