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

ABSTRACT

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.