What is one factor that could lead to the need for recertification of a facility?

Recertification of a facility can be necessitated by significant movement of the Primary Engineering Control (PEC). The PEC, which includes equipment like laminar flow hoods or compounding isolators, plays a crucial role in maintaining the sterile environment necessary for compounding. When a PEC is moved, it may affect the airflow patterns and the overall sterility of the compounding area, potentially leading to contamination risks.

After any substantial relocation, the facility must be re-evaluated to ensure that air quality and environmental controls are still compliant with regulatory standards. This involves comprehensive testing to confirm that the PEC is still functioning correctly in its new position, ensuring that it can adequately protect sterile preparations.

While factors like changes in drug formulation, increases in staff numbers, or alterations in operating procedures can influence practice quality or staff training needs, they do not inherently compromise the sterile environment as directly as the movement of the PEC does, hence they are not primary triggers for immediate recertification.