The Development of a Novel Headspace O 2 Concentration Measurement Sensor for Vials.

In the process of manufacture and transportation, vials are prone to breakage and cracks. Oxygen (O₂) in the air entering vials can lead to the deterioration of medicine and a reduction in pesticide effects, threatening the life of patients. Therefore, accurate measurement of the headspace O₂ concentration for vials is crucial to ensure pharmaceutical quality. In this invited paper, a novel headspace oxygen concentration measurement (HOCM) sensor for vials was developed based on tunable diode laser absorption spectroscopy (TDLAS). First, a long–optical–path multi–pass cell was designed by optimizing the original system. Moreover, vials with different O₂ concentrations (0%, 5%, 10%, 15%, 20%, and 25%) were measured with this optimized system in order to study the relationship between the leakage coefficient and O₂ concentration; the root mean square error of the fitting was 0.13. Moreover, the measurement accuracy indicates that the novel HOCM sensor achieved an average percentage error of 1.9%. Sealed vials with different leakage holes (4, 6, 8, and 10 mm) were prepared to investigate the variation in the headspace O₂ concentration with time. The results show that the novel HOCM sensor is non-invasive and has a fast response and high accuracy, with prospects in applications for online quality supervision and management of production lines. [ABSTRACT FROM AUTHOR]