Generation of Particulate Matter in Large-Volume Parenteral Containers

Polyvinyl chloride and glass large-volume parenteral containers were examined to determine the effects of agitation, storage, and additive handling on the generation of subvisual particulate matter. It was found that particles in flexible plastic containers can be generated by continuous shaking, with the maximum number of particles recorded after 30hr of shaking. The particles were in the range of 2.33–5.02 μm in diameter, with very few particles recorded above 5 μm. It was also established that the generation and subsequent disappearance of particles during storage after an interval of continuous shaking are not only functions of time but also of temperature.