Application Note

Non-Invasive Headspace Analysis For Automated Media Fill Microbial Inspection

Detection of Microbial Contamination In Sterile Containers Using Headspace Analysis

Sterility testing in the pharmaceutical industry has long been based on growth media culture methods. The general approach is to incubate for 14 days and then determine potential contamination with a visual inspection of the media sample. Over the last decade a number of Rapid Microbial Methods based on various analytical techniques have been implemented. These provide quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods. Recently, it has been demonstrated that laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product. Applications for this method include automated media fill inspection and rapid non-destructive contamination testing directly in finished product containers.

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