Influence of liquid and vapourized solvents on explosibility of pharmaceutical excipient dusts



Hybrid mixtures of a combustible dust and flammable gas are found in many industrial processes. Such fuel systems are often encountered in the pharmaceutical industry when excipient (nonpharmaceutically active ingredient) powders undergo transfer in either a dry or solvent prewetted state into an environment possibly containing a flammable gas.

The research described in this article simulated the conditions of the above scenarios with microcrystalline cellulose and lactose as excipients, and methanol, ethanol, and isopropanol as solvents. Standardized dust explosibility test equipment (Siwek 20-L explosion chamber, MIKE 3 apparatus, and BAM oven) and ASTM test protocols were used to determine the following explosibility parameters: maximum explosion pressure (Pmax), volume-normalized maximum rate of pressure rise (KSt), minimum explosible concentration (MEC), minimum ignition energy (MIE), and minimum ignition temperature (MIT).

The experimental results demonstrate the significant enhancements in explosion likelihood and explosion severity brought about by solvent admixture in either mode. The extent of solvent influence was found to be specific to the given excipient and method of solvent addition. Solvent burning velocity considerations help to account for some of the experimental observations but for others, a more rigorous evaluation of solvent and excipient physical property data is needed. © 2014 American Institute of Chemical Engineers Process Saf Prog 33: 374–379, 2014