Research on the application of nanopore sequencing technology in investigating microbial data deviation

Area of Science:

• Microbiology
• Genomics
• Pharmaceutical Quality Control

Background:

• Microbial contamination incidents pose significant risks in pharmaceutical manufacturing.
• Achromobacter xylosoxidans is an opportunistic pathogen known for its resilience in various environments.

Purpose of the Study:

• To investigate and identify the source of Achromobacter xylosoxidans contamination in sterile pharmaceutical products.
• To demonstrate the utility of nanopore sequencing and environmental source tracing in microbial data deviation investigations.

Main Methods:

• Strain isolation and biochemical identification of Achromobacter xylosoxidans.
• Disinfection efficacy testing of laboratory disinfectants against A. xylosoxidans.
• Whole-genome sequencing using nanopore technology for phylogenetic analysis (MLST, SNPs).

Main Results:

• Achromobacter xylosoxidans was confirmed in contaminated sterile products.
• The bacterium showed significant resistance to a waterless surgical hand sanitizer gel.
• Nanopore sequencing successfully identified the hand sanitizer gel as the contamination source.

Conclusions:

• The waterless surgical hand sanitizer gel was identified as the source of Achromobacter xylosoxidans contamination.
• Nanopore sequencing provides a rapid and scientifically validated method for microbial source tracking.
• This approach enhances the reliability of investigations into microbial contamination events.