Pharmaceutical Requirements for Portable Monitoring in Cleanrooms

All pharmaceutical and biotech products must be manufactured in accordance with the current Good Manufacturing Practice (cGMP) regulations. Environmental monitoring of these pharmaceutical manufacturing areas meets the requirement for contamination control of an environment, which is essential in defining clean manufacturing and demonstrating the necessary controls are working. A pharmaceutical company must have a quality department that is responsible for the routine quality assurances that:

Establishes documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. [1]

To satisfy these requirements, the products are manufactured in controlled environments/cleanrooms. Cleanrooms are employed to reduce the variability of production environments, and as controlled environments they can be tested and proven to meet specific standards. GMP require that these environments be rigorously tested and monitored to ensure that there is full and constant awareness of current environmental conditions for both viable and nonviable contamination.