Within pharmaceutical supply chains, most attention has been focused on “last mile”. This distribution segment is thought to contain the highest levels of variability with respect to transport hazards. This presentation examines a special case found in the “first mile” within the lifecycle of a parenteral combination product.

Glass has been and will continue to be used as a primary container for parenteral solutions. Therefore, glass quality is a critical quality attribute. Defect-free glass ensures the sterility and safety of the overall combination product spanning the time from initial processing to patient use.

Findings from the study shared emphasizes that this “first mile” defect analysis has been neglected by most companies producing parental products and combination products. Glass defect rates have been tolerated to date. A recent commercial offering has focused on making a “stronger” glass at a considerable premium, without examining the root cause of defects.

Important tool used in identifying the root cause is a specialty known as “Glass Fractography.”