New Standardized Methodology to Evaluate Environmental Monitoring Plates Inspection Using an Automated System

To efficiently control the quality of pharmaceutical products, manufacturers must monitor for potential microbial contaminants. This is typically performed using irradiated culture media in Petri plates throughout the production process, especially within clean rooms, isolators and controlled production environments.

To efficiently control the quality of pharmaceutical products, manufacturers must monitor for potential microbial contaminants. This is typically performed using irradiated culture media in Petri plates throughout the production process, especially within clean rooms, isolators and controlled production environments.

The widely accepted practice for Petri plate examination is extremely manual, variable, and error prone, but it remains the standard procedure used for hundreds of millions of samples per year. When so many plates are evaluated manually, pharmaceutical QC becomes vulnerable to data integrity failures, incorrect enumerations and missed samples. The net result is a negative impact on patient safety due to time consuming, and expensive investigations.

Therefore, the importance of accurate and precise enumeration and counting of microorganisms has been stressed by global regulatory agencies.

In this white paper, we assessed the performance of visual Petri plate inspection in a pharmaceutical setting and introduced a novel standardized methodology to automate the incubation and enumeration of Petri plates using the 3P® STATION, shown on the right. Results were compared to the ones generated according to the routine EM Standard Operating Procedure in four global pharmaceutical companies [....]

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