Industry Must Move Away From Dye Ingress

This Article is written by Oliver Stauffer published in PDA Letter in June 2020.

Few events have contributed more to society’s understanding of pharmaceutical container closure integrity than the 1970 outbreak of bacterial infections from IV fluid container failure. Eight hospitals across seven states received compromised IV fluids, leading to nine deaths. The outbreak was eventually attributed to closure failure of IV fluid bottles during the sterilization process. The closure system failure was not something that would be detected with CCI protocols of that time.