New protocol for αAstree electronic tongue enabling full performance qualification according to ICH Q2

•PQ procedure was successfully applied to the αAstree taste sensing system.•αAstree can now be used as qualified instrument in the pharmaceutical industry.•A valuable tool is introduced to assess the performance of applied sensors.•Log-linearity was proven for quinine hydrochloride.•Besides sensor s...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2013-09, Vol.83, p.157-163
Main Authors: Pein, Miriam, Eckert, Carolin, Preis, Maren, Breitkreutz, Jörg
Format: Article
Language:English
Subjects:
Biosensing Techniques - instrumentation
Biosensing Techniques - methods
caffeine
Caffeine - chemistry
citrates
Citrates - chemistry
Drug Industry - instrumentation
Drug Industry - methods
Electronic tongue
Electronics - instrumentation
Electronics - methods
ICH guideline Q2
ingredients
Performance qualification
pharmaceutical industry
quality control
quinine
Quinine - chemistry
Sensor performance control
taste
Taste - physiology
Taste sensing system αAstree
Technology, Pharmaceutical - instrumentation
Technology, Pharmaceutical - methods
Tongue - physiology
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Summary:•PQ procedure was successfully applied to the αAstree taste sensing system.•αAstree can now be used as qualified instrument in the pharmaceutical industry.•A valuable tool is introduced to assess the performance of applied sensors.•Log-linearity was proven for quinine hydrochloride.•Besides sensor set #2 also set #5 might be used for pharmaceutical applications. Performance qualification (PQ) of taste sensing systems is mandatory for their use in pharmaceutical industry. According to ICH Q2 (R1) and a recent adaptation for taste sensing systems, non-specificity, log-linear relationships between the concentration of analytes and the sensor signal as well as a repeatability with relative standard deviation (RSD) values
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2013.05.005