title: Near-infrared spectroscopy for the detection and quantification of bacterial contaminations in pharmaceutical products.
abstract: Accurate detection and quantification of microbiological contaminations remains an issue mainly due the lack of rapid and precise analytical techniques. Standard methods are expensive and time-consuming being associated to high economic losses and public health threats. In the context of pharmaceutical industry, the development of fast analytical techniques able to overcome these limitations is crucial and spectroscopic techniques might constitute a reliable alternative. In this work we proved the ability of Fourier transform near infrared spectroscopy (FT-NIRS) to detect and quantify bacteria (Bacillus subtilis, Escherichia coli, Pseudomonas fluorescens, Salmonella enterica, Staphylococcus epidermidis) from 10 to 10(8) CFUs/mL in sterile saline solutions (NaCl 0.9%). Partial least squares discriminant analysis (PLSDA) models showed that FT-NIRS was able to discriminate between sterile and contaminated solutions for all bacteria as well as to identify the contaminant bacteria. Partial least squares (PLS) models allowed bacterial quantification with limits of detection ranging from 5.1 to 9 CFU/mL for E. coli and B. subtilis, respectively. This methodology was successfully validated in three pharmaceutical preparations (contact lens solution, cough syrup and topic anti-inflammatory solution) proving that this technique possess a high potential to be routinely used for the detection and quantification of bacterial contaminations.
authors.affiliation: CEB-Centro de Engenharia Biológica, Universidade do Minho, Braga, Portugal.
authors.forename: Cristina
authors.initials: C
authors.lastname: Quintelas
authors.affiliation: CEB-Centro de Engenharia Biológica, Universidade do Minho, Braga, Portugal.
authors.forename: Daniela P
authors.initials: DP
authors.lastname: Mesquita
authors.affiliation: iMed, Departamento de Farmácia Galénica e Tecnologia Farmacêutica, Faculdade de Farmácia, Universidade de Lisboa, Lisboa, Portugal.
authors.forename: João A
authors.initials: JA
authors.lastname: Lopes
authors.affiliation: CEB-Centro de Engenharia Biológica, Universidade do Minho, Braga, Portugal.
authors.forename: Eugénio C
authors.initials: EC
authors.lastname: Ferreira
authors.affiliation: CEB-Centro de Engenharia Biológica, Universidade do Minho, Braga, Portugal. Electronic address: clara.sousa@ceb.uminho.pt.
authors.forename: Clara
authors.initials: C
authors.lastname: Sousa
mesh_terms: D000893:Anti-Inflammatory Agents / Q000032:analysis; D000996:Antitussive Agents / Q000032:analysis; D001419:Bacteria / Q000302:isolation & purification*; D058491:Bacterial Load; D018639:Contact Lens Solutions / Q000032:analysis; D004340:Drug Contamination; D016018:Least-Squares Analysis; D019999:Pharmaceutical Solutions / Q000032:analysis*; D019265:Spectroscopy, Near-Infrared
chemical_list: D000893:Anti-Inflammatory Agents; D000996:Antitussive Agents; D018639:Contact Lens Solutions; D019999:Pharmaceutical Solutions
keywords: Bacterial contaminations; Chemometrics; FT-NIRS; Pharmaceutical products; Process analytical technology