Testing Your Metal: Best Practices from PTI
With plenty of viable, affordable metal detection technologies on the market (see below), you’d think that metals contamination would be one problem drug manufacturers would have mastered. Not so, according to recent FDA warnings that show many manufacturers of powder, solid, or liquid products continue to be mystified by metal, as well as other particulates. Here are three snippets from recent letters:
“The investigation into the source of the particles in the drug product has found the following types of particles: metal particulates, colored and transparent fibers (cotton and polyester), rubber like particles, and glass particles. The firm has not completely identified the source of all foreign matter contaminants or implemented corrective measures to reduce the foreign matter in final drug product.”
“There were consumer complaints reporting the presence of a screw and two washers found inside a bottle of [Product A] capsules were received at your site. Other complaints reporting the presence of a foreign metal object (ejector pins from the filling/packaging line) found inside a bottle of [Product B] tablets and a bottle of [Product C] tablets were also received.”
“Oil spots were seen on the tablets and metal shavings were found on the tablet press upon further investigation. Only the sacks of products filling at the time and two previous sacks of tablets were quarantined for metal detection. Three lots had been compressed since the last Type 1 cleaning but the firm failed to evaluate these lots."