Container Closure Integrity (CCI)

Container closure integrity testing (CCIT) ensures adequate pharmaceutical packaging for your product. As an independent partner, OFI offers the optimal method of analysis for your packaging system.

Non-destructive testing of glass vials is performed by laser headspace analysis for oxygen ingress. Thus, the same samples can be monitored during stability studies under various conditions. Vials and bottles of all sizes are also subjected to the dye ingress method using methylene blue. For flexible plastic packaging systems, the bubble test allows to determine the smallest leaks. All tests are performed according to the USP <1207.2> under GMP.

In addition, we determine the moisture vapor transmission rate (MVTR) of plastic materials and their permeability by water vapor and oxygen.