John Erdner, product manager, aseptic fill-finish systems, SP Scientific PennTech, discusses the advances being made in vial processing to help reduce the risk of vial damage and particle contamination.
Pharmavials
There has been at least one recall for parenteral products packaged in vials with chipped rim surfaces and a number of US Food & Drug Administration (FDA) 483 notices issued to pharmaceutical manufacturers for glass particles found in vials. When this occurs, it is obviously a critical event for the manufacturer of parenteral products. Sometimes these instances can go undetected – the vial progresses to filling, is stoppered and capped before inspection. If the vial is capped, this defect will be difficult to identify.