Glass delamination is the culprit behind the recalls of five injectables since mid-2010, and drug quality and authenticity consortium Rx-360 is tackling the problem through alerts and information. But the question remains of why the glass-flake contamination cases were clustered over seven months.
The problem of glass particle contamination in vials of injectables.is not widely understood despite being well documented, says the consortium. Glassmaking processes are a big factor, with the likelihood of delamination rising from molded vials at the low end, through silica-coated and regular tubing vials, to ammonium-sulfate treated tubing vials. Citrate buffers and sodium chloride accelerate glass delamination while lower-temperature glass melt deters it, though cooler processing slows vial production.
Drug formulation characteristics also can affect delamination.
- here's the alert