Sterile Product Package Integrity Testing- HVLD vs. Vacuum decay

Dana Morton Guazzo, PhD, gives an in depth look at Sterile Product Package Integrity Testing: Current Practice, Common Mistakes, and New Developments.  The author goes into detail about the Best Practices Leak Test Methods, with studies that show the difference between HVLD and Vacuum Decay.

Leak Detection vs. Defect Size & Type

SUMMARY
  • HVLD and Vacuum decay are effective leak detection methods
    • Channel defects
      • land seal surface
      • land + valve seal surfaces
    • Hole defects in vial wall
    • Split or cracked finish defects
  • HOWEVER
    • HVLD detected a larger % of potential leaking packages
RxPax, LLC, PDA Metro Chapter, May 2011

Leak Detection vs. Product Formulation &

Storage time

SUMMARY

  • Vacuum decay FAILED to find package defects
    • Protein blockage of defect leak path suspected
  • HVLD DETECTED all leaks
    • HVLD not influenced by protein presence
  • Protein blockage risk increases over time
RxPax, LLC, PDA Metro Chapter, May 2011

For the entire article, click Sterile Product Package Integrity Testing