Microbial identification

 

By utilising state-of-the-art analytical equipment, RSSL can provide rapid and accurate identification of microorganisms.

 

Although EU GMP Annex 1 regulations only require the speciation of microbes detected in Grade A and Grade B cleanrooms, it is recommended that all organisms found in clean areas should be considered for identification. This can be beneficial as it allows trending of environmental monitoring data and enables facilities to review and improve their processes. 

 

Utilising both traditional staining and biochemical methods of identification and state-of-the-art analytical equipment, RSSL can quickly and accurately identify any microorganisms.  

Our capabilities

 

Our capabilities for microbial identification include Matrix-Assisted Laser Desorption Ionisation – Time of Flight (MALDI-ToF) mass spectrometry (MS). By determining the unique proteomic fingerprint of organisms, MALDI-ToF MS can be used for a number of purposes, including:  

 

  • Screening pharmaceutical products for specified and/or objectionable organisms. 
  • Investigating out of specification or out of trend results to identify probable sources of contamination. 
  • Characterisation of the microbial flora of production and testing environments. 
  • Verifying the identity of reference cultures. 

 

 

Additionally, if the isolate being identified is not found in our database, we can work with an external partner to conduct genomic analysis.  

 

 

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