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. With the view of doubling lutetium production by the end of 2020 and plans for continued increases over the coming years, a key question was whether the plant reliability could accommodate this increase sustainably. As plant use increases the potential frequency of failure as well as the impact of outages increases, it results in a general increase in risk. 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 as well as other risk-based methods in line with international standards. Blame for reliability issues often falls at the feet of the equipment design with suggestions that wholesale redesign of equipment will solve reliability issues. Careful review of existing strategies against these baseline guidelines tells a different story with clear gaps between existing maintenance strategies and current best practice. 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. The article also offers commentary on situations requiring compromises between those best practices defined by IAEA and ISPE.
