Media Fill Inspection in the pharmaceutical industry has long been based on growth media culture methods. The general approach to media fill inspection is to incubate media filled vials 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
- Contamination inspection directly in finished product containers.
Opportunities for improving and streamlining the media fill process are interesting for aseptic filling operations. In particular, the manual visual inspection process used to inspect media vials for signs of contamination after incubation is considered to be tedious and time consuming. Because the visual inspection is performed by operators, there is also risk for human error due to subjectivity and fatigue. In addition, difficult-to-inspect containers such as molded or colored glass, or certain plastic containers, pose inspection challenges for operators. An inspection method that is analytical and automated should improve the media fill inspection and fit with the industry trend of removing human subjectivity from the process. Studies have demonstrated that laserbased headspace inspection platforms can detect microbial growth in media-filled pharmaceutical containers. For detecting microbial growth, the levels of headspace oxygen and carbon dioxide are measured in the media vials. The implementation of a 100% headspace inspection machine enables an automated analytical media fill inspection process that has advantages over current manual processes.