To meet regulatory and company requirements, a U.S. manufacturer of pharmaceuticals needed to conduct a process hazard analysis (PHA) of their alcohol process for a new bulk pharmaceutical process. This new process was a batch operation and utilized a variety of highly hazardous materials including hydrogenation, potent compounds, flammable liquids, toxic, and water-reactive chemicals.
Our team used the HAZOP methodology for the bulk of the review and supplemented this with What-If and Checklist methodologies. ioMosaic had developed dedicated What-if and Checklists templates to ensure a comprehensive identification of all possible hazards which are included in our software Process Safety Office® PHAGlobal®. In addition, we supplemented the PHA by performing dispersion analysis using Process Safety Office® SuperChems™ to quantify the consequences associated with a possible release through the emergency relief device during the steps where toxic materials were being utilized. A PHA is a risk assessment that evaluates the significance of hazardous situations associated with a process, operation, or activity. It employs qualitative techniques to identify flaws in the design and operation of facilities that may lead to accidents and to assess the risk. PHAs typically concentrate on equipment, instrumentation, utilities, human factors, and external events that might impact the process.
PHA Leader and scribe were provided by ioMosaic, and the PHA was completed in one day using PHAGlobal®. The PHA worksheets from PHAGlobal® were included with the PHA report, as well as the dispersion modeling results and a summary of the recommendations in a format that allowed the tracking of action items to their completion.