TSB 1999/009: Industry Survey-Stopper Particle Loads & Surface Silicone Levels

Evaluates several samples of elastomeric closures from the pharmaceutical industry for surface silicone, sub-visible and visible particle levels.

The washing and siliconization of rubber stoppers historically has taken place at the pharmaceutical manufacturer’s location. In addition to removing endotoxin, this step is intended to reduce the amount of visible and subvisible particulate matter, and to apply silicone oil evenly over the surface of the closures so that efficient line speeds and toppering into vials can occur...

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