Headspace Gas Analysis (HGA)
Inline CCIT and nitrogen purge quality control for lyophilized containers.
HGA｜Optimum Technology for Quality Assurance of Lyophilized Vials
For lyophilized drug products, the HGA system serves a dual purpose: it provides oxygen monitoring during the nitrogen purging process and serves as a CCIT method, verifying seal integrity.
HGA as a CCIT Method
After the container is sealed under vacuum, and following a defined stabilization period, a gas analyzer sensor is used to measure the oxygen concentration within the headspace of the container.
In the case of a leak, external air enters the container, causing an increase in the internal oxygen concentration. By monitoring this change, products can be reliably classified and sorted as either good or defective.
In-process Oxygen Monitoring and Control
During aseptic filling of oxygen-sensitive products such as biologics, Headspace Gas Analysis (HGA) can be used to efficiently monitor oxygen levels in real time, ensuring the effectiveness of nitrogen purging or the quality of vacuum stoppering.
Laser HGA systems employ infrared/near-IR lasers tuned to oxygen (or other gas) absorption lines, passing the beam through the container’s headspace to quantify gas concentration and pressure. HGA is uniquely valuable for in-process oxygen monitoring and control. For example, a rise in headspace O₂ above the set point signals ingress or purge failure or stopper seating issues.
- Up to 600 pcs/min, enabling high-speed inline performance.
- Supports a wide range of ISO and non-ISO container sizes.
- Can be used for ampoules, vials and LVPs.
- The compact HGA laser sensor has a small footprint and can be combined easily with existing lines.
- Sensor options are flexible and can measure oxygen (O₂), carbon dioxide (CO₂), or total H₂O pressure, depending on the product.