Friday 20 May 2016

Objectionable Microorganisms

An objectionable organism is one which can either cause illness or degrade the product thus making it less effective. But how to define what is an objectionable organism?

Microbiologics have an interesting discussion paper on the subject. Here is an extract:

A manufacturer can detect objectionable organisms in its product by:

1.Performing tests for specified microorganisms as described in USP <62>.
2.Identifying all suspicious colonies growing on agar plates used in microbial enumeration tests. To find out more about microbial enumeration tests, see USP <61>.
3.Performing a risk analysis to determine which organisms would be objectionable and then devising a plan for detecting the organisms.

To access the paper, see Microbiologics

Posted by Dr. Tim Sandle

No comments:

Post a Comment

Pharmaceutical Microbiology Resources

Special offers