Headspace Systems

Headspace  Analyzer
The FMS Headspace Analyzer is a non-destructive gas analyzer for monitoring headspace gas concentrations in sealed parenteral containers. This compact benchtop instrument utilizes a patented laser absorption technique developed with funding from the Food and Drug Administration. Headspace oxygen, moisture/pressure, carbon dioxide and water activity levels can be analyzed using this technology. 

Light from a near-infrared diode laser is tuned to match an internal absorption frequency of the gas molecule of interest and passed through the empty container headspace above the product. The amount of laser light absorbed is proportional to the gas concentration in the headspace. The measurement method is rapid and non-destructive. These characteristics allow for multiple measurements on the same sample enabling the accurate monitoring of headspace gas concentrations of a single sample over time. Because the sample is not destroyed there are no waste disposal issues and potentially valuable product can be saved for other tests.

The analyzer is a robust solid state device and is straightforward to use.  Operators do not require special expertise to run the system meaning the accuracy of the measurements does not depend on operator skill. Systems can be permanently situated in laboratories for product development, release testing, and QC investigations or mounted on carts and wheeled from line to line for in-process monitoring and troubleshooting activities.

Applications

Applications include:

• (Vacuum) Leak detection
• Container closure integrity studies
• IPC monitoring of oxygen levels during the filling of oxygen-sensitive product
• IPC monitoring of carbon dioxide levels during the filling of product purged with carbon dioxide in the headspace
• Microbial growth detection in media vials
• Optimization and validation of purging systems on filling lines
• Oxygen/Moisture degradation studies
• Stability trends, end-of-shelf life studies
• Moisture determination of lyo product
• Lyo chamber moisture mapping
• Water vapor permeation studies