PARTICULATE CONTAMINATION FROM SILICONIZED RUBBER STOPPERS - A STATISTICAL EVALUATION

Siliconized stoppers, when used with parenteral drug products, have be en shown to be a source of particulate contamination. In this study, f ive different variables: Ph of the solution, buffer concentration, Tef lon coating on the stopper, autoclaving cycle (F0), and lot-to-lot var iation of the siliconization process were evaluated using an eight-run Plackett-Burman design with respect to their impact on the level of p articulate contamination from siliconized stoppers. Results show that pH of the solution can significantly affect the particulate level of s amples using siliconized stoppers (p < 0.05). An alkaline solution (pH = 8) was shown to produce a higher particulate load than an acid solu tion (pH = 4). The main effect of the remaining four variables was det ermined to be statistically insignificant (p > 0. 15).