/ Container Closure Integrity Testing
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.
- 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
- 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)