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).
What is an objectionable organism?
An objectionable organism is one that we do not want to see in product based upon what the microbe is, how many microbes were recovered, how the product is used, and who the end user is. It can be argued that a specified microbe is not necessarily objectionable. All microbes recovered from any total aerobic microbial count (TAMC) test should be identified and examined to determine if they are objectionable.
The primary difference is between specified and objectionable microbes is that a specified microbe MUST NOT be present in any product. An objectionable microbe must also be absent, but it is up to the manufacture to determine is a recovered microbe is objectionable.
How does one determine is a recovered microbe is objectionable?
At food and pharmaceutical manufacturing sites we are concerned if microbes that are not specified are recovered during the specified test. We evaluate whether the microbe is objectionable by reviewing:
- Microbe pathogenicity
- Microbe source
- Potential product spoilage
- Results of the TAMC test
- The product’s target user and mode of application
Ideally we should be identifying all microbes recovered from both the TAMC and specified microbes test and determine if they are objectionable. Enumerating microbes and identifying non typical colonies may not capture all the microbes present within a sample.
How will knowing the differences between specified and objectionable help you?
- Being aware that any microbe recovered during TAMC is potentially objectionable is important as people tend to assume specified = objectionable and all other microbes are acceptable.
- By examining microbes recovered during TAMC testing one may determine if they are detrimental to the product or patient. This ensures quality products are released to the market that do not have unexpected (or negative) impacts to the manufacturer or the customer
- PMF Newsletter Volume 12, Number 6 June, 2006 – Microbial Limits Test: The difference between Absence of Objectionable Microorganisms and Absence of Specified Microorganisms
- PMF Newsletter Volume 12, Number 7 July, 2006 – How to determine if an Organism is ˜Objectionable“ section II: Microbiological Testing of Non Sterile Products
- http://vm.cfsan.fda.gov/~mow/intro.html US FDA – The Bad Bug Book
- Water System Validation – Demystifying the microbiology, Contract Pharma October 2004
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