Headspace Gas Analysis (HGA) is a non-destructive method used to inspect the integrity of pharmaceutical product packaging, accurately examining 100% of products ready to be placed on the market. Headspace Gas Analysis identifies various types of defects and provides useful information on the production process as a whole, making it a particularly effective Container Closure Integrity Test (CCIT) method.
Headspace Gas Analysis is an inspection method that determines the concentration of certain molecules inside a sealed container.
HGA uses laser absorption spectroscopy (TDLAS) to analyse the headspace (i.e., the space inside a sealed container that is not occupied by the product itself) inside the sample. The sample to be inspected is crossed by a laser beam tuned to the frequency of the specific molecule whose concentration is to be determined. Then, the amount of laser light absorbed by the gas in the headspace is detected. If absorption is greater than anticipated, this means that the concentration of the molecule is higher than that expected for the process and therefore higher than the limit set for acceptance. So, the product could be damaged, improperly sealed, punctured or contaminated.
HGA can be used to measure the presence of different types of molecules, such as:
As stated, Headspace Gas Analysis is one of the inspection methods that can be used for Container Closure Integrity Testing (CCIT). It offers many advantages, and can be used:
Headspace Gas Analysis can be effective in monitoring the production process and for CCIT. While this type of inspection can be very beneficial, many factors need to be carefully evaluated when designing an HGA system. Here are some of the things to consider during the design phase:
Headspace Gas Analysis is a safe and effective CCIT method used to inspect a wide range of products and packaging types. However, in order to ensure that this type of test meets expectations, the characteristics of the production line and of the products to be inspected must first be thoroughly analyzed to ensure that the HGA system is designed appropriately. This is where an experienced and competent partner like Bonfiglioli Engineering can provide critical support.