Inhalation drug product testing
NEW eLearning course
Introduction to pharmaceutical microbiology
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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 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:
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