title: Rapid at-line pharmaceutical cleaning verification using a novel light induced fluorescence (LIF) sensor.
abstract: A novel light emitting diode (LED) array-based light induced fluorescence (LIF) sensor is presented as an analytical methodology for at-line cleaning verification within the pharmaceutical industry. This sensor differs from conventional LIF sensors through the ability to dynamically control both the LED excitation array and detection parameters, enabling the exploitation of the optical power and detection sensitivity to rapidly detect trace concentrations of residual drug. This feature makes this sensor an ideal alternative to conventional cleaning verification analytical methodologies. In this study, the LIF sensor was validated as an analytical technique through the analysis of specificity, precision, linearity, limit of quantitation, and accuracy, with respect to solutions and swab extracts of a single pharmaceutical compound (Compound A). The validated system was then utilized for cleaning process optimization and subsequent routine cleaning process verification following three manufacturing campaigns. The LIF sensor enabled a significant improvement in the analysis time for quantitative detection of Compound A; individual swab and rinsate extracts were analyzed in less than 1 min. The results presented herein effectively demonstrate the ability of the novel LIF sensor to efficiently function as a valid at-line analytical methodology for cleaning verification.
authors.affiliation: GlaxoSmithKline, 5 Moore Drive, Durham, NC 27709, United States. dana.x.peles@gsk.com
authors.forename: Dana N
authors.initials: DN
authors.lastname: Peles
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Ely
authors.forename: Timothy M
authors.initials: TM
authors.lastname: Crowder
authors.forename: Mike
authors.initials: M
authors.lastname: Ponstingl
mesh_terms: D004345:Drug Industry / Q000379:methods*; D005453:Fluorescence; D008027:Light; D012680:Sensitivity and Specificity; D013678:Technology, Pharmaceutical / Q000379:methods*