Tunable diode laser absorption spectroscopy as method of choice for non-invasive and automated detection of microbial growth in media fills.
Tunable diode laser absorption spectroscopy (TDLAS) was evaluated on its potential to detect bacterial growth of contaminated media fill vials. The target was a replacement/ automation of the traditional visual media fill inspection. TDLAS was used to determine non-invasively O2and/or CO2changes in headspaces of such vials being induced by metabolically active microorganisms. Four different vial formats, 34 microorganisms (inoculation volume<10 cells) and two different media (TSB/FTM) were tested. Applying parallel CO2and O2headspace measurements all format-organism combinations were detected within <11 days reliably with reproducible results. False negatives were exclusively observed for samples that were intentionally breached with syringes of 0.3mm in diameter. Overall it was shown that TDLAS functionality for a replacement of the visual media fill inspection is given and that investing in further validation and implementation studies is valuable. Nevertheless, some small but vincible challenges remain to have this technology in practical use.
Center of Biomechanics & Biocalorimetry, University Basel, Gewerbestr. 14, CH-4123 Allschwil, Switzerland; F. Hoffmann - La Roche, Ltd., Sterile Drug Product Manufacturing, Wurmisweg, CH-4303 Kaiseraugst, Switzerland.
David
D
Brueckner
Novartis Pharma Stein AG, CH-4332 Stein, Switzerland.
David
D
Roesti
F. Hoffmann - La Roche, Ltd., Sterile Drug Product Manufacturing, Wurmisweg, CH-4303 Kaiseraugst, Switzerland.
Ulrich
U
Zuber
F. Hoffmann - La Roche, Ltd., Sterile Drug Product Manufacturing, Wurmisweg, CH-4303 Kaiseraugst, Switzerland.
Meik
M
Sacher
Lighthouse Instruments B.V., Science Park 408, 1098XH Amsterdam, The Netherlands.
Derek
D
Duncan
Clinical Pharmacology & Toxicology, Universitätsspital Basel, Markgräflerhof, Hebelstrasse 2, CH-4031 Basel, Switzerland.
Stephan
S
Krähenbühl
Center of Biomechanics & Biocalorimetry, University Basel, Gewerbestr. 14, CH-4123 Allschwil, Switzerland. Electronic address: olivier.braissant@unibas.ch.
Olivier
O
Braissant
D001331:Automation; D001419:Bacteria / Q000254:growth & development*; D003470:Culture Media; D005658:Fungi / Q000254:growth & development*; D054023:Lasers, Semiconductor; D013057:Spectrum Analysis
D003470:Culture Media
Microbe; Pharmaceutical; Sterility testing; Tunable diode laser absorption spectroscopy (TDLAS)