Oxygen Monitoring throughout the Product Life Cycle
Monitoring headspace oxygen levels in sterile parenteral containers is essential to ensure the stability and potency of oxygen-sensitive product. Besides a loss of efficacy 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 pharmacological properties associated with negative side effects.
LIGHTHOUSE offers solutions for oxygen monitoring based on non-destructive laser-based headspace analysis. These solutions can be applied throughout the product life cycle, in Manufacturing, Development and Quality Control.
Oxygen Consumption (Stability) Studies
Pharmaceutical formulations, especially delicate large molecule biopharmaceuticals, may have some level of oxygen-sensitivity leading to degradation of the active pharmaceutical ingredient. Laser-based headspace oxygen analysis enables accurate, efficient determination of oxygen consumption curves. Accurate measurement of the oxidation rate supports the determination of headspace oxygen specifications and end-of-shelf life stability
Packaging & Permeation Studies
Choosing the right package for sterile drug product is critical to ensure stability and an optimal shelf life. Packaging and permeation studies using headspace oxygen analysis can be used to identify appropriate packaging components and to ensure good package integrity.
Nitrogen Purge Characterization, Optimization and Validation
Sterile filling lines are increasingly being implemented with nitrogen purge capabilities. Large molecule biopharmaceuticals can be prone to oxidation and to prevent this from occurring, the headspace is often purged with an inert gas during filling to ensure a longer shelf life. Consistently producing containers with specified headspace oxygen conditions is therefore essential of product stability. The use of a fast and robust oxygen monitoring method can significantly streamline the characterization, optimization and validation of a filling line.
In-Process Control during Filling
The need to monitor headspace oxygen levels in parenteral containers arises from the requirement to ensure the stability and potency of oxygen-sensitive product. During the entire product life cycle studies are performed to investigate oxygen sensitivity and to maintain stability. In addition, headspace oxygen levels are often monitored during the filling process as an in-process control (IPC) of the purging system used to bring headspace oxygen levels below the required specification.
100% Oxygen Inspection of Finished Product
The analysis of statistical sets of finished pharmaceutical product is increasingly being used to determine if the process is capable of reproducible commercial manufacturing. Process study results can enable an assessment of whether appropriate process controls have been implemented as well as giving direction to continuous improvement programs. Lighthouse can support clients with automated 100% oxygen inspection of sealed parenteral containers.
Troubleshooting and Investigations of Oxygen Sensitive Product
A complaint from the market about defective pharmaceutical samples will trigger a root cause investigation. Lighthouse can support with root cause investigations of oxygen sensitive product by performing headspace oxygen analysis to check package integrity.