How often should certification for facilities and engineering controls be performed after the initial certification?

Certification for facilities and engineering controls must be conducted regularly to ensure compliance with established standards and to maintain a safe environment for sterile compounding. Six months is the recommended interval between certifications after the initial one because this frequency allows for consistent monitoring of air quality, particle counts, and airflow patterns—critical elements that can change over time due to a variety of factors, including use, environmental conditions, and changes in equipment. By adhering to this six-month schedule, facilities can promptly identify and address any issues that may affect the integrity of the sterile compounding process, ensuring patient safety and the efficacy of compounded preparations.

Other intervals, such as three months, one year, or two years, are not typically standard in this context as they could lead to insufficient monitoring. A three-month interval might be excessive and could lead to unnecessary costs, while a one-year or two-year interval could result in prolonged instances of non-compliance or safety hazards going unnoticed. Thus, the six-month recommendation strikes a balance between thorough oversight and practical administration of sterile compounding standards.