Russell Publishing Ltd.

Raman spectroscopy

Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.

Researchers have demonstrated the potential of a fast and non-invasive approach to detect pharmaceutical products contaminated with low levels of bacteria within their vials. The technique uses dispersive Raman spectroscopy (RS) in association with partial least squared discriminant analysis (PLS-DA).

Sterility testing is a crucial step in quality control of pharmaceutical drug products before their commercial release. However, the current procedures for bioburden testing, which are primarily growth based, are highly time-consuming, costly and have limited sensitivity and specificity.

RS is under investigation as a lower cost, more rapid alternative; however, researchers have struggled to balance robustness, sensitivity, cost and a low limit of detection (LOD).