Abstract

With Lutetium (Lu-177) demand forecasted to increase following the conclusion of clinical trials and product registration in key jurisdictions, manufacturers are seeking to improve their production outputs. Naturally, the question falls to operation and maintenance of these production centers to ensure reliable supply to market. Maintenance in the radiopharmaceutical industry is a complex environment with many competing interactions between radiation safety and Good Manufacturing Practice (GMP) requirements. Since its development by the aviation industry in 1960s, the Reliability Centered Maintenance (RCM) concept has seen adoption by many industries. The International Atomic Energy Agency (IAEA) developed a technical document on RCM applications in nuclear industry in May 2007 while the International Society of Pharmaceutical Engineers (ISPE) refers to the concept in their own baseline guides. Too often, blame for reliability issues falls at the feet of the designers. Careful review of existing strategies against these baseline guidelines often tells a different story. With the view of doubling Lutetium production by the end of 2020 and continued increases over the coming years, there was a push to review the existing maintenance strategies in practice at ANSTO's facilities. This document details the results of that investigation, providing information on the gaps found and the systems implemented to bring maintenance strategies back in alignment with current best practice. It also offers commentary on situations requiring compromises between those best practices defined by IAEA and ISPE.

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