Glass Delamination in Parenterals: A Brief Overview

Abstract

Packaging of parenteral formulations is a critical step in the product development process and most commonly achieved by using a glass container due to its relative inertness. Historically, the pharmaceutical market has utilized glass vials made from borosilicate and soda lime glass as preferred storage of pharmaceutical preparations. A potential issue with glass containers is glass delamination. Glass delamination results from surface degradation and subsequent glass chipping which is observed visually as glass flakes or lamella within the drug product solution. Though clinical relevance of visual particulate, including glass lamella, is difficult to ascertain, glass delamination should be taken seriously as any foreign particulate injected may be hazardous. The issue of glass delamination has caused several pharmaceutical manufacturers to voluntarily recall their drug products. As glass delamination might take multiple years to develop, pharmaceutical companies struggle to identify potential risky drug products in the early stages of development process and may be severely impacted due to occurrence while marketing. Financial burdens, both direct and indirect, may accrue if the drug product is actively marketed and subsequently recalled. Hence, the Food and Drug Administration recommends conducting stability studies of the pharmaceutical drug product with the intended packaging components. Glass manufacturers are also conducting new techniques and statistical control testing to determine the delamination propensity of the glass vials [1].