Particulate Contamination Monitoring

Many pharmaceutical and industrial manufacturing processes require monitoring of liquid product particularly with respect to the limit of larger particulate matter in the fluid. Particulate Contamination in liquids can be in demand for industries including pharmaceutical injectables, speciality hydraulic oils and fluids, ultra pure water, printing inks, emulsions and specific slurries While conventional Particle Size Distribution (PSD) techniques may be able to monitor mean, D90 etc. for evidence of PSD shifts, they have difficulty detecting the very small number of particles that can cause embolisms or block up injectors, spray nozzles and other hydraulic orifices.

The Accusizer using Single Particle optical Sizing (SPOS) is able to detect particle concentrations as low as parts per million. Typically the sensor can count 500,000 particles per minute so that the necessary PSD statistics can be built in several minutes. USP-788 and USP-729, drafted by the US FDA to monitor pharmaceutical intravenous fluid preparations, requires product quality to be tested for oversize particulate material using SPOS equipment. Particle Sizing Systems offer two particulate monitoring instruments, the 7030 and 780-SIS that conform to the requirements of the two FDA standards.

The 7030 is a new release that can draw up to 1 litre of fluid through the sensor by a peristaltic pump. The system can be optioned with extra pumps to add diluents or reagents. The SIS-780 model is ideal for small volume sampling and accurate flow rates through the sensor where it can be drawn through the sensor at slow speed and be reclaimed and reloaded through the sensor many times when coupled with the collection loop. Sample retrieval is also possible.