A crack in a glass ampoule or glass vial is in fact a breach of sterility. Why are some CCIT vendors claiming it is not necessary to detect a crack?
Container Closure Integrity Testing will forever be necessary in the world of Parental Drugs. There are many options out there for your CCIT, but is one really better than another?
Pressure decay vendors are claiming that a crack in a glass vial or ampoule is not a breach of sterility, when within 2 years companies like J & J 2011, Hospira 2010, Amgen 2009 2010, Merck 2010, and Novo Nordisk 2010 had recalled millions of units due to the potential of cracks in their injectable products. (RxPax, LLC, PDA Metro Chapter, May 2011)
Pressure decay vendors do not want to disclose that they can not detect a crack. Any company with these systems knows this as they validate with laser drilled holes. The problem with simply validating with laser drilled holes is visited by Dana Morton Guazzo, PhD, in Sterile Product Package Integrity Testing: Current Practice, Common Mistakes, New Developments.
In the text, Guazzo writes “Real leak paths are not holes, tubes, pipettes. Natural defects are long, complex, irregular channels.”
Natural defects, such as a crack, need to be mimicked in order to prove that the CCIT system can find them.
High Voltage Leak Detection will not only detect a crack, it will consistently detect a crack to prevent a major recall.