The Question posed on LinkedIn:
“Dear experts, During microbial contamination testing for specific organisms – salmonella growing was observed. identification shows that is not Salmonella, but Bacillus subtilis. How i shoud interprated the results, pass specification or not?“
There were plenty of replies and I replied to an answer with some additional guidance. My reply was this:
“I would add that if B. subtilis has been found, what is the risk to the end user, (and also product efficacy). If you are testing for Salmonella sp. then I assume the product is meant for ingestion. Spores can survive cooking and germinate under warm conditions. If the product is meant to be stored in a fridge, assume the end user will keep it on a bench. That could lead to illness, especially in an already ill patient. I recommend quarantining the batch and conducting a full investigation and risk assessment. G M Butcher’s site contamination concerns are also valid.“