Process Safety in the Pharmaceutical Industry─Part III: Dust Hazard Evaluation

Safety during process development and production is paramount in the wider chemical industry, including the pharmaceutical industry. To address this challenge, members in the thermal hazards and process safety working group within the International Consortium for Innovation and Quality in Pharmaceutical Development teamed up to share, in a precompetitive collaboration, industry best practices. Initial contributions from the group have focused on thermal hazards. In this third article, we concentrate on dust explosion hazards, which are highly pertinent to the pharmaceutical industry due to the handling of dry powders, including but not limited to isolated intermediates, final active pharmaceutical ingredients, and excipients. Various unit operations such as charging, blending, and milling are capable of generating dust clouds that can potentially ignite, resulting in a flash fire or explosion. Therefore, in this effort, we asked each participating company to provide their best practices and methods used to characterize and assess this hazard. Furthermore, the authors investigated various engineering and mitigation strategies deployed when handling materials known to cause dust explosion hazards.