By Oliver Stauffer
Pharmaceutical parenteral delivery systems are the highest risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a significant threat of bacterial ingress as shown in research by Kirsch et al. in 1997. To manage this risk, the industry has continued to pursue leak detection methods that are more sensitive and reliable for vials, ampoules, cartridges and syringes.
Dye ingress was long thought to be a simple method, but since then studies have shown a lack of reliability for this leak test method (Wolf et al. 2009). In the past, the microbial ingress method was viewed as the gold standard, but the outdated method remains probabilistic and is challenged by uncontrollable circumstances. For both dye and microbial ingress methods, there are no harmonized standards that are globally recognized, despite their decades of use. The pharmaceutical industry has shifted direction towards newer measurement technologies. Using deterministic test methods that have defined controllable inputs is the primary focus of the United States Pharmacopeia (USP) Chapter 1207 on container closure integrity (CCI).