Particulate contamination in plastic ampoules

Plastic ampoules of Water for Injections, JP, and Injection Sodium Chloride, JP, were investigated to determine their particle load. Four batches were studied. The ampoules were twist-opened as they would be in the clinical setting and the total particle load, both inherent and that created in opening, was determined by reading the contents with a HIAC 420 particle counter with a CMB 60 sensor. The total particle content was found to be minimal, easily complying with world L.V.P. standards and the S.V.P. standard of the USP XXI. The number of particles found in these opened plastic ampoules was significantly lower than that found in clinically snap-opened glass ampoules and also slightly lower than that found in laboratory heat-opened glass ampoules. Whilst the plastic ampoule has a restricted application because it is not suitable for all drugs, it is concluded that when they are used as the immediate container for Water for Injections and Injection Sodium Chloride they are highly effective in reducing the particulate contamination generated in opening.