Cap Closing Integrity (CCI) tests are performed on hard containers such as vials, screw-cap bottles, syringes, and automatic injector-type devices to check for leaks.
Paint dipping uses a tracer dye in vacuum to pull the paint from any defects. Bacterial immersion uses a bacterial solution, pressure, and vacuum.
PDA Technical Report 27 recommends performing both a physical and a microbial test when evaluating container closure integrity for pharmaceutical packaging. USP <1207> recommends deterministic CCI tests (see Mass Extraction). Both dye dipping and bacterial immersion are possible test methods.
Dye Immersion: Samples are immersed in a dye solution and a vacuum is applied. The vacuum is released, and the containers are washed to remove the dye from the outer surfaces. The containers are then analyzed for dye presence after exposure using an ultraviolet-visible (UV/Vis) or visual technique. The UV/Vis method has a higher sensitivity level for dye detection compared to the visual method.
UV / Vis analysis samples cannot have viscous or opaque liquids.
Bacterial Immersion: Samples are tested by immersing containers filled with medium in a microbial challenge for a specified period of time using pressure and vacuum. The containers are then removed from the test, rinsed, incubated, and examined for growth. A bacteriostasis test is performed concurrently with the test or at the end of seven days of incubation. Checks are performed with each challenge.
The selection of B. diminuta as the challenging organism is based on its very small size when grown under carefully controlled conditions. Due to its size, B. diminuta represents the most serious bacterial challenge. Other organisms can be selected. The high concentration in microbiological challenge contributes to the worst case conditions for the test.
Samples must arrive sterile if filled by the sponsor. B. diminuta is an aerobic organism, therefore it is recommended to allow an airspace of ≥ 50% of the total volume of the container when filling the test samples, if possible.
EUROLAB, with its highly expert team and internationally accredited laboratories, Cup Closure Integrity Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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