Oxygen Monitoring

Monitoring headspace oxygen levels is essential for oxygen sensitive products to ensure their stability and potency. LIGHTHOUSE offers solutions for oxygen monitoring based on non-destructive laser-based headspace analysis. These solutions can be applied in manufacturing, development and quality control.

Monitoring oxygen levels with headspace analysis is...

  • Rapid and non-destructive
  • Capable of testing up to 100% of products
  • Ideal for purge optimization of filling lines
  • Capable of selecting the right package for your product
Oxygen monitoring

Sterile filling lines increasingly incorporate purge capabilities to protect large molecule biopharmaceuticals from oxidation, to extend shelf life and maintain product stability. Ensuring that headspace oxygen levels are consistently low becomes crucial for product stability.

Using a fast and robust oxygen monitoring method significantly streamlines the characterization, optimization, and validation of filling lines. With non-destructive headspace oxygen determination, destructive methods can be replaced and more data can be generated, faster.

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Headspace Oxygen Determination

Headspace Oxygen Determination

Nitrogen purge characterization, optimization and validation

To protect oxygen sensitive products from degradation, it is important that these products are closed at consistently low headspace oxygen levels. With non-destructive headspace analysis, it is straightforward to determine the performance of a filling line and to monitor that performance during filling.

With LIGHTHOUSE analyzers this can be done at-line or as a 100% inspection in-line, analyzing samples immediately after sealing. This streamlines filling line optimization and qualification during set-up and enables in-process control measurements during routine production.

 

 

Optimization and qualification of nitrogen purge in manufacturing

Primary package selection, permeation and stability studies

For oxygen sensitive products, choosing the right primary package becomes even more critical to ensure product stability and efficacy over shelf life. Besides a loss of potency and reduction in shelf life, exposure of such products to oxygen can result in product discoloration, changes in dissolution rate and profile, and even toxicity or other negative side effects. 

Packaging and permeation studies are therefore critical for these types of products, as final containers that are not sealed by fusion are inherently not gas-tight, which leads to an increase in headspace oxygen levels over time.

Headspace oxygen analysis can help identify suitable packaging components and ensure the integrity of the package over shelf life. In addition, LIGHTHOUSE offers headspace oxygen monitoring for products on stability. This helps assessing at which moment any added antioxidants are used up, and the product is at risk of oxidation.

 

 

stability study oxygen
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