What is Absence of Objectionable Organism Testing?

Absence of objectionable organism testing is microbiological analysis which confirms the absence of specific organisms in a water system. Typically, demonstrated absence of Pseudomonas and Enterobacteriaceae in pharmaceutical water systems is an indicator of water system quality control. Pseudomonads are a group of waterborne gram-negative bacteria. Enterobacteriaceae are a large family of gram-negative bacteria that are composed on commensal and pathogenic bacteria found commonly in the enteric system of humans and animals

Why do we do it?

Pseudomonas and Enterobacteriaceae build a picture of the type of contamination in a water system and its source. Pseudomonas can produce biofilm which poses a serious challenge to water system sanitization in the industry. Pseudomonas contamination usually indicates indicate issues with the engineering or design of a water system. Contamination with Enterobacteriaceae often indicates human contamination which may be due to a failure in training or procedures. Performing this analysis is essential for identifying the root cause of potential out of specifications.

How can we help assure compliance?

We are specialists in determining the absence of objectionable/specific organisms. Although we have largely focused on Pseudomonas and Enterobacteriaceae which is common for the industry, we are also capable of performing a wide range of cGMP bacterial absence testing some of which include:

  • Absence of Pseudomonas spp.
  • Absence of Enterobacteriaceae
  • Absence of Staphylococcus spp.
  • Absence of Salmonella spp.

Absence testing uses selective agar which only supports the growth of the desired organism to determine the presence of an objectionable organism family. Further biochemical tests are then performed to determine species. 

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