Reducing crack occurrence from frictive damage with externally coated pharmaceutical glass vials

Handling of parenteral glass packaging introduces strength-limiting defects that can increase the likelihood of cracking and breakage. Cracking is particularly problematic because it is a critical defect that can compromise the sterility of a drug product and present a serious safety risk to patients. Low coefficient of friction coatings can be externally applied to glass containers to increase resistance against damage caused by blunt frictive contact (e.g., glass-on-glass contact). A ball-on-heel test was used to evaluate the response of uncoated and coated Type I borosilicate glass vials to applied loads between 50 N to 350 N. Observed vial responses included survival (with or without checks), cracking, and breakage. The external coating was found to provide a ∼3× reduction in the probability of cracking relative to uncoated vials with 95% confidence. The external coating was also found to shift the onset of cracking to higher applied loads (200 N for uncoated vials to 250 N for coated vials).