Product/Service

Oxygen Monitoring Of Sensitive Formulations

vials

The need to monitor headspace oxygen levels in parenteral containers arises from the requirement to ensure the stability and potency of oxygen-sensitive product. LIGHTHOUSE offers complete solutions for (in-process control) oxygen monitoring of oxygen-senstive formulations, from Development to Manufacturing and Quality Control. 

The need to monitor headspace oxygen levels in parenteral containers arises from the requirement 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 Oxygen Monitoring solutions for:

  • Stability testing
  • Packaging studies
  • Permeation studies
  • Characterizing Nitrogen Purging systems (In-Process Control)
  • Nitrogen Purge Optimization and Validation
  • 100% Oxygen Analysis of Finished Product
  • Release Testing of Oxygen Sensitive Product
  • Recalls and Investigations of Oxygen Senstive Product

Our Oxygen Monitoring solutions include:

  • Feasibility studies
  • Process and Package studies
  • Method Development
  • Method Validation Protocols
  • Automated Oxygen Lease Platforms
  • Onsite trouble shooting and support

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