The following information was received from Homewood Products Corporation via fax:
Steris Isomedix Services measuring and test equipment used by NTS (Formerly Wyle Laboratories, Inc.) to determine the applied radiation dose did not account for all of the uncertainties involved, and therefore the actual radiation dose applied to components and reported to Homewood Products Corporation by Wyle Laboratories, could be less than the requested service condition dose.
The following information was received from Homewood Products Corporation as provided to them by National Technical Services, Inc. (formerly Wyle Laboratories, Inc.):
The defect is an error in reporting the variability in the dose delivered or lack thereof on the lsomedix Certificate of Processing for the Whippany, NJ facility. The U.S. Nuclear Regulatory Commission (NRC) under 10 CFR Part 50, Appendix B issued a Notice of Nonconformance 99901145/2014-201-01 to Steris stating that the measuring and testing equipment used to determine the applied radiation dose reported on the lsomedix Certificate of Processing provided with each gamma irradiation run did not account for all the uncertainties involved (i.e. density of unrelated products in carriers, off-carrier locations within the irradiator, and Cobalt-60 source decay) and therefore the actual radiation dose applied to components could be less than requested as reported on the Certificate of Processing.
Steris lsomedix Services completed an evaluation of the dose rate variability of items processed in off-carrier locations in the irradiator. Steris Isomedix Services Position Paper dated 4/27/15 states the overall variability (uncertainty) associated with gamma radiation exposures at their Whippany, NJ facility.
The affected facilities have been notified of the non-conformance. They are:
Homewood Products Corporation, Pittsburgh, PA
Homewood Energy Services, Pittsburgh,
PA