What is the point of environmental monitoring?

BY DR TIM SANDLE | PHARMACEUTICAL MICROBIOLOGY AND CONTAMINATION CONTROL EXPERT

30th September

Environmental monitoring is an important component in the manufacturing of pharmaceutical and healthcare products. The activity embraces the assessment of viable microorganisms, airborne particles and physical controls (such as pressure, airflow, temperature etc.) Data assessment requires a holistic approach, assessing all data types and points across all cleanroom grades (especially interfacing areas).

There are some essentials relating to environmental monitoring that are periodically worth re-emphasising, not least the importance of risk assessment. This article benchmarks the basics to allow the reader to reassess their approach.