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Application note

Application note: Single temperature analysis for environmental monitoring samples

This application note explores how to determine the feasibility and the impact of the single temperature for environmental monitoring microorganisms.

Environmental monitoring (EM) is one of the main microbiological controls that pharmaceutical industries perform to ensure the safety and efficacy of pharmaceutical products. To efficiently control the quality of these products, the presence of potential microbial contaminants must be monitored. Although the traditional method is extremely manual, variable and error-prone, it remains the standard procedure used in industry for hundreds of millions of samples per year.

While the level of requirements in data integrity and data traceability is increasing from regulations and inspections, pharma manufacturers are simultaneously willing to improve process efficiency and productivity thanks to time saving and deviation reduction. This enables traditional methods and practices to be questioned, such as the incubation period for EM samples.

Download this application note to discover more about:

  • Using dual or single temperature
  • Studies on single temperature incubation
  • Times to results and to detect

About the author

Marion Louis, biomerieuxMarion Louis is Global Market Manager in the Pharma Quality Control business of bioMérieux. She holds an engineer degree in Biotechnology from Polytech’ Clermont Ferrand and a Master’s degree in Management, France. For the last 15 years, she worked in microbiology for pharmaceutical applications and she is now supporting the key pharmaceutical industries worldwide in implementing digital and automated solutions dedicated for Environmental Monitoring.