A manufacturing company tests all incoming raw ingredients and all finished product lots based on the presence/absence of E. coli, S. aureus and Salmonella. While Salmonella and S. aureus are rarely recovered, an E. coli positive ingredient is typically obtained about 2 times a year, which is then rejected and returned to the supplier. A finished product has never tested positive for E. coli from this manufacturer…until now.
This case study examines how the company used Accugenix strain typing to:
- Decern how routine compendial testing didn’t recover contaminants
- Reveal blind spots and determine the appropriate dilution for each of the raw materials and final product
- Identify suspicious colonies, and confirm raw materials contaminated with multiple strains of E. coli
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