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The Development of a Novel Headspace O₂ Concentration Measurement Sensor for Vials.

Xiao Chen¹, Hao Sun¹, Wei Huang¹

¹School of Energy and Power Engineering, University of Shanghai for Science and Technology, Shanghai 200093, China.

Sensors (Basel, Switzerland)

|March 11, 2023

Summary

A new sensor accurately measures oxygen in vials, crucial for pharmaceutical quality. This tunable diode laser absorption spectroscopy (TDLAS) method ensures medicine safety by detecting air leaks.

Keywords:

O2 concentration measurement sensor vial

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Area of Science:

Analytical Chemistry
Spectroscopy
Pharmaceutical Science

Background:

Vial integrity is critical during manufacture and transport to prevent oxygen ingress.
Oxygen contamination degrades medicines and reduces pesticide efficacy, posing patient risks.
Accurate headspace oxygen measurement is vital for pharmaceutical quality control.

Purpose of the Study:

To develop a novel headspace oxygen concentration measurement (HOCM) sensor for vials.
To enhance measurement accuracy and reliability for pharmaceutical packaging.
To provide a tool for online quality supervision in production lines.

Main Methods:

Development of a novel HOCM sensor utilizing tunable diode laser absorption spectroscopy (TDLAS).
Optimization of a long-optical-path multi-pass cell for enhanced sensitivity.
Calibration and validation using vials with controlled oxygen concentrations (0–25%) and varying leak sizes.

Main Results:

The optimized TDLAS system achieved a root mean square error of 0.13 in fitting.
The novel HOCM sensor demonstrated high accuracy with an average percentage error of 1.9%.
The sensor showed non-invasive operation, fast response, and high accuracy in detecting oxygen variations over time.

Conclusions:

The developed HOCM sensor effectively measures headspace oxygen concentration in vials.
The TDLAS-based sensor offers a reliable solution for ensuring pharmaceutical product integrity.
The technology shows significant potential for real-time quality control in pharmaceutical manufacturing.