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Quantitative CCIT Inspection Solutions to Navigate USP <1207>


PTI’s non-destructive inspection technologies verify container closure system integrity. Deterministic quantitative test methods for vials, ampoules, syringes, cartridges and auto-injectors.

MicroCurrent HVLD Leak Detection Technology

  • Applications include liquid based products ranging from extremely low conductivity sterile water for injection (WFI) to proteinaceous products with suspensions.
  • Non-conductive container materials can be glass, plastic or poly laminates
  • Detects small pinholes, micro cracks and seal Defect detection down to single digit microns

VeriPac Vacuum Decay
Technology

  • ASTM Test Method F2338 and FDA Consensus Standard
  • Defect detection down to 0.05 ccm
  • Measures seal integrity of entire container or package
  • Tests for gas leaks for dry products (lyophilized vials, powder filled)
  • Tests for liquid leaks (liquid filled vials, ampoules, cartridges and pre-filled syringes)