Container closure integrity is a must for drug manufacturers. Here are the last 2 of 5 common methods to test this integrity
As mentioned in part 1, container closure integrity (CCI) is paramount for the entirety of the shelf life of any drug product. There are numerous ways to test CCI. In part 1, we discussed dye ingress testing, vacuum decay, and headspace analysis. Here we will wrap up with the final two most popular methods: helium leak and high voltage leak detection.
Helium Leak. While the previous methods discussed are not extremely sensitive, this test is the most accurate, giving the most reproducible results. Helium is one of the safest gases to use for such a test, and the vials or syringes can be filled manually or arrive with helium in them. A mass spectrometer that only detects helium ions picks up the rate of helium leaking from a container. Vials can contain liquids or lyophilized product; syringes must be empty. The helium does destroy the product, but this test can pinpoint a leak, and it can be conducted in cold temperatures.
High Voltage Leak Detection (HVLD). This method is very practical for stability studies, biologics, and containment systems holding liquid with no headspace. A high-voltage current is applied to the liquid in the container, and a voltage differential identifies an integrity breech. It’s a non-destructive method that produces rapid results and requires little operator skill.
The right CCI test will depend on your specific application and needs. For cleanroom validation or certification, contact Gerbig Engineering Company. We have thirty years of experience in the cleanroom industry: 888-628-0056; email@example.com.