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Global process safety incidents in the pharmaceutical industry
Affiliation:1. Istituto di Ricerche sulla Combustione - Consiglio Nazionale delle Ricerche (IRC-CNR), Piazzale V. Tecchio 80, 80125, Napoli, Italy;2. Dipartimento di Ingegneria Chimica, dei Materiali e della Produzione Industriale, Università degli Studi di Napoli Federico II, Piazzale V. Tecchio 80, 80125, Napoli, Italy
Abstract:The objective of this research is to analyse global process safety incidents within the pharmaceutical industry in terms of their consequences and factors contributing to the incidents. There were 73 process safety incidents leading to 108 fatalities found between 1985 and 2019. Trends between the number of incidents, number of fatalities, location, and contributing factors were identified and summarized. The most reported fatalities occurred in 2018 & 2019. 83% of fatalities occurred in China and India. Explosions were associated with 71% of incidents, which resulted in 89% of fatalities. For most of the international incidents, incident investigations were not available and thus insufficient details were available to determine the causes. Contributing factors were available or estimated from available data for about half of the incidents, with the following most common: hazard awareness & identification; operating procedures; design; safeguards, controls & layers of protection; safety culture; and preventive maintenance. These findings can be used as a basis to improve process safety performance in the pharmaceutical industry.
Keywords:Process safety  Incidents  Hazard analysis  Root causes  Pharmaceutical fires & explosions
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