I wrote the first version of this article in 2014 based on training I developed in 2006. I have updated and reviewed the content to ensure it remains relevant in 2020.
When testing non sterile products, as well as allowed numbers of microbes, there are certain types of microbes that are specified in the regulations as not allowed and still others that can de deemed to be objectionable.
If you work as a microbiologist where you test total microbial aerobic counts (TMAC), total yeast and mould counts (TMYC) and for specific microbes or conduct investigations into the nature of microbes and what impact they may have on the product and the end user, this presentation will benefit you. I will teach you the the following:
- What makes a specified organism
- What makes an objectionable organism
- How to determine if a microbe is objectionable
- Risk assessment considerations
- The benefits of knowing the differences between specified & objectionable organisms
I reply to a post on LinkedIn.
“The Patties Foods frozen berries scandal is a warning for directors about managing risks – what lessons could you learn? ”
There’s lots of testing for bacterial contamination in such products as it’s regulated at Government level. Testing for viruses is not a routine requirement (it is not regulated). There’s been discussions on changing this as reportedly, about 20% of food contamination is caused by viruses and it might be a good idea to start testing.
The TMC is broken into two parts: a basic look for contamination and a look for more specific forms of contamination. The basic test is described in the USP in section <61> or in the EP in section 2.6.12. The more specific or specified microbe testing is described in USP section <62> or in the EP in section 2.6.13. Continue reading
What is a specified organism?
A specified organism is one that according to the pharmacopeia, cannot be present in a sample (usually 10g). These microbes are specified either as they may be an indicator organism (a microbe where its presence may indicate a pathogenic microbe could be present) or they may actually pose product safety concerns (whether by reducing the efficacy or posing a risk to the end user). Continue reading