The Application of Noninvasive Headspace Analysis to Media Fill Inspection

DEREK DUNCAN; TONY CUNDELL; LAUREN LEVACJAMES VEALESUZANNE KUIPERRAVI RAO

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The Application of Noninvasive Headspace Analysis to Media Fill Inspection

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The results of a proof-of-principle study demonstrating a new analytical technique for detecting microbial growth directly in pharmaceutical containers are described. This analytical technique, laser-based head-space analysis, uses tunable diode laser absorption spectroscopy to nondestructively determine gas concentrations in the headspace of a media-filled pharmaceutical container. For detecting microbial growth, the levels of headspace oxygen and carbon dioxide are measured. Once aerobic microorganisms begin to divide after the lag phase and enter the exponential growth phase, there will be significant consumption of oxygen and concomitant production of carbon dioxide in the sealed container. Laser-based headspace analysis can accurately measure these changes in the headspace gas composition. The carbon dioxide and oxygen measurement data for the representative microorganisms Staphylococcus aureus, Bacillus subtilis, Candida albicans, and Aspergillus brasiliensis were modeled using the Baranyi-Roberts equation. The mathematical modeling allowed quantitative comparisons to be made between the data from the different microorganisms as well as to the known growth curves based on microbial count. Because laser-based headspace analysis is noninvasive and can be automated to analyze the headspace of pharmaceutical containers at inspection speeds of several hundred containers per minute on-line, some potential new applications are enabled. These include replacing the current manual human visual inspection with an automated analytical inspection machine to determine microbial contamination of media fill and pharmaceutical drug product vials.

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《PDA journal of pharmaceutical science and technology》 |2016年第3期|230-247|共18页
作者
DEREK DUNCAN; TONY CUNDELL; LAUREN LEVACJAMES VEALESUZANNE KUIPERRAVI RAO;
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作者单位

Lighthouse Instruments BV, Amsterdam, The Netherlands;

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正文语种英语
中图分类药学;
关键词
Microbial detection; Microbiological test method; Media fill inspection; Headspace analysis; Headspace oxygen; Headspace carbon dioxide; Microbial growth; Frequency modulation spectroscopy.;

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The Application of Noninvasive Headspace Analysis to Media Fill Inspection

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