Methods for Testing Container Closure Integrity: Cleanroom Products – Part 1

There are a number of alternative methods to test container closer integrity for drug products. Start comparing these methods here.

Container closure integrity (CCI) of a drug product must be preserved throughout its entire shelf life. There are a number of ways to conduct a CCI test, each with its pros and cons.  Here is a rundown of the most familiar methods.

  1. Dye Ingress Testing. This is probably one of the most popular tests used. Some of the benefits are that being a visual test, the drug can be in its final configuration (syringe or vial.) It also only requires an observation of the dye to see whether the container has been compromised. This is a basic and efficient means of testing; however, it should only be used as a gross analysis of cracks and misalignment. There are much more sensitive tests available for a full analysis.
  1. Vacuum Decay. This test uses a rise in chamber pressure to expose leaks. While the previous test destroys the product, this test is non-destructive and can be used on solid products. Additionally, it can be performed in vials of any color, whereas the dye ingress test requires a clear container. On the other hand, the method is labor-intensive, requires specific instrumentation, and only offers a pass/fail result as opposed to isolating the source of the problem.
  1. Headspace Analysis. This is a highly-sensitive, non-destructive test. It uses frequency modulation spectroscopy to determine the pressure inside the vial. It’s a rapid test that can be conducted on varying container sized. It’s more accurate than the previous two tests. However, the containers do need to be transparent, the test can’t be done on syringes, and you cannot pinpoint the source of a leak

In part two, we will evaluate a couple of methods that are more sophisticated in their sensitivity. If you need assistance with compliance for your cleanroom, Gerbig Engineering Company can help. We offer cleanroom validation and certification. Our experts also build hardwall and softwall Airecell cleanrooms. For more information, call 888-628-0056 or email