Headspace Gas Analysis for Parenteral Manufacturing

Headspace content verification is a solution to ensure parenteral product stability and sterility maintenance. Integrity defects as well as failures in the aseptic manufacturing process, including unexpected variability in the nitrogen flushing or vacuum application, pose a risk to the product quality and patient safety.

 

Monitoring the maintenance of container headspace conditions is needed for sterile drugs such as oxygen sensitive liquid products and lyophilized or powdered products. Any modification to the headspace pressure, moisture or oxygen level may result in product degradation, reduce of potency, shelf life and safety.

The cGMP even regulates specific aspects of production of sterile drugs that also requires that Containers sealed under vacuum should be tested for maintenance of that vacuum after a predetermined time period.

To satisfy this segment of the market, Bonfiglioli Engineering has developed multiple products that can continuously perform such content integrity verification processes. The Laser Cube is a non-destructive, non-invasive laser-based inspection technology for measuring the headspace level of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

The inspection method is created to meet specific customer requirements offering extreme stability and accuracy in inspection even where the headspace is limited. Bonfig Laser Cube is a compact and lightweight system that is easy to use and set up via integrated PC and any wireless touchscreen tablet. HGA inspection process is based on the Tunable Diode Laser Absorption Spectroscopy (TDLAS) method which uses a laser beam to detect the target molecules within container headspace. HGA is therefore ideal for the accurate investigation of:
•    Headspace conditions for products packaged under modified atmosphere
•    Closure integrity in pharmaceutical finished containers

 

For more information or to schedule a Demo please give us a call 800-829-5741

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