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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 531149 December 2017 08:28:00Agreement StateAgreement State Report - Irradiator Disabled Source Rack

The following information was received from the State of South Carolina by email: On Monday, December 11, 2017 at (1100 CST), the Department (South Carolina Department of Health and Environmental Control) was notified by (the) Corporate RSO (Radiation Safety Officer) of STERIS Isomedix Services that one of the source racks had been stuck in the 'up' position. The incident happened at (0328 CST) on Saturday, December 8, 2017. The worker saw that there was an unload fault on the system indicating that the rack was stuck so he called maintenance to try to correct the problem. At (0340 CST) the Radiation Safety Officer (and then the corporate RSO were notified) about the event. (The RSO) called and left a message on an employee voicemail rather than calling the 24 hour emergency phone number.

The workers were able to go into the penthouse to correct the problem and lower the source rack back into the pool. The workers found that a carrier had a cracked hinge. They checked all of their other carriers and replaced a total of two carrier doors. The RSO informed the CRSO (Corporate Radiation Safety Officer) that the situation was resolved at (0724 CST). The licensee stated that a written report will be sent within 30 days of the event.

ENS 5068115 December 2014 05:00:0010 CFR 21.21(a)(2), Interim Report for Comply or Defect in ComponentInterim Report - Potential Part 21 Notification

The following report was received via fax: ASCO reviewed a Part 21 notification, received from Steris Isomedix Services, to see if the reported non conformance would impact qualification levels. Based on this review, ASCO determined that even if the radiation levels, applied to components, were lower than reported on the original certifications, the additional radiation dose added to meet the 10% margin suggested by IEEE 323 would envelope this variation. Therefore, the qualification levels listed in ASCO qualification reports would not be impacted. Based on this review, ASCO determined that it was not necessary to implement 10 CFR part 21 notifications since the reported qualification levels remain unchanged. If you have any questions, you can contact Michael Adase at Michael.adase@emerson.com or 803-641-9345. Note: The NRC has received reports from four (4) other Steris Isomedix customers concerning this issue; EN #50253, #50285, #50359, and #50434.

  • * * UPDATE AT 1507 EDT ON 8/19/2015 * * *

The following, in part, was received from Asco Valve, Inc. via fax: On December 15, 2014, ASCO Valve Inc. (ASCO) issued an interim report to the USNRC. The interim report was issued because ASCO was awaiting additional information from Steris and was not able to complete their evaluation of Ref B within the 60 day time limit. A December 19, 2014 update from Steris contained no additional substantive information. Although further information from Steris was not received, ASCO has since received the 'Industry Guidance Position Paper Responding to the 2014 Steris 10 CFPR Part 21', from the NUGEQ (Nuclear Utility Group on Equipment Qualification). ASCO has completed the review and calculated the minimum radiation exposure applied during qualification of ASCO nuclear qualified products at Steris. Based on this review, ASCO has determined that the minimum dose is less than what was originally reported in the ASCO qualification reports. ASCO is in the process of updating our reports and revising our certifications. Since ASCO is not able to determine what, if any impact these reduced radiation dose levels will have on the qualification testing of safety related equipment, we are forwarding this information to allow for a review of applicable qualification documentation and reports. Notified R1DO (DeFrancisco), R2DO (Heisserer), R3DO (Riemer), R4DO (Hay), and Part 21 Group (email).

ENS 5028518 July 2014 04:00:0010 CFR 21.21(d)(3)(i), Failure to Comply or DefectPart 21 Report - Improper Irradiation of Samples for Ball Valve Seats and DiaphragmsThe following information was received from ITT Engineered Valves, LLC by facsimile: ITT is submitting this report based on an NRC Inspection finding at Steris Isometric Services in Whippany, NJ, where samples may have received 3-9% less than the minimum target dosage specified during testing. ITT is in the process of determining how best to approach our customers with this information, and how to work with them to determine whether a defect as defined by 10 CFR Part 21 does exist. To that end, we are reviewing the impact of the variability on all projects that required radiated samples, particularly ball valve seats and diaphragms including the entire Ml diaphragm product line, and what effect if any this will have on our results and conclusions. We are also reviewing any ongoing projects with radiated samples from Steris, and making the necessary adjustments. Name and address of the individuals informing the Commission: S. T. Donohue ITT Engineered Valves, LLC 33 Centerville Road Lancaster, PA 17603 stephen.donohue@itt.com Senior Principal Engineer (717) 509-2200
ENS 482816 September 2012 10:02:00Agreement StateAgreement State Report - Source Rack Stuck in Unshielded PositionThe State of South Carolina submitted the following information via email: The SC Department of Health and Environmental Control (SCDHEC) was notified on Thursday, September 6, 2012, at 1500 EDT, that rack #2 failed to return to a shielded position at 0605 EDT due to a cleaning rag that was inadvertently wrapped around the source rack hoist cable. The RSO/Maintenance Manager for the facility stated that authorized personnel were able to clear the obstruction and return the rack to a shielded position at 0700 EDT. There were no personnel exposures and no equipment damage. This event is open and pending the licensee's investigation and report to the SCDHEC. Updates will be made through the national NMED system.