MALDI-ToF in Practice; Validated Application of a Rapid Microbiological Method

Synopsis

Throughout the manufacturing process of a pharmaceutical product or medical device, there are any number of opportunities for microbial contamination to occur due to environmental factors, operator error, or sterility failures among others. Manufacturers therefore must rely on robust process validation and environmental monitoring to reduce the risk of contamination and identify when it does occur.

Traditional identification techniques have utilised time consuming and labour intensive methods such as selective medium subculturing, Gram staining, biochemical testing or morphological identification. Recently, however, rapid methods have been developed which have the ability to reduce turnaround time and provide greater testing accuracy.

Despite the issues inherent in adoption of new methods, rapid methods are an expanding area of microbiology and are now considered viable alternatives to more traditional methods. This seminar will focus on the validation of one rapid method in particular, MALDI-ToF (Matrix Assisted Laser Desorption Ionization-Time of Flight), which utilises mass spectrometry to identify microorganisms by measuring their unique protein fingerprints.