What are the goals for facilities and engineering controls to minimize microbial contamination?

The goal of minimizing microbial contamination in facilities and engineering controls is to ensure high air quality standards that prevent airborne contaminants. Maintaining strict air quality helps to reduce the risk of contamination during the compounding process, which is critical in sterile environments. By controlling airflow, filtration, and pressure differentials, facilities can create a controlled environment that minimizes the introduction of microbial pathogens into the workspace.

This focus on air quality is essential because airborne contaminants can easily settle on surfaces or into compounded preparations, potentially leading to infections or product contamination. Standards for air quality are established based on the class of the environment; for instance, a Class 100 cleanroom requires that the air contains no more than 100 particles per cubic meter of air.

Other options, while they may have some relevance to facility design and operation, do not directly focus on the critical goal of controlling air quality to minimize microbial contamination. For example, preventing personnel movements and limiting accessibility can help to some extent but do not address the airborne contamination aspect as effectively as maintaining stringent air quality controls. Similarly, reducing cleaning protocols would likely increase the risk of contamination, contradicting the goal of maintaining a sterile environment.