How often should the HEPA filters of a PEC be certified?

The certification of HEPA filters in a primary engineering control (PEC) is critical for ensuring the safety and sterility of compounded sterile preparations. The correct frequency for certification is at least every 6 months and whenever maintenance is performed.

This schedule is driven by the importance of maintaining the integrity of the airflow and filtration systems that protect sterile products from contamination. Regular certification ensures that the HEPA filters are functioning properly and effectively removing particulate matter, which is essential for minimizing the risk of infection in patients. Additionally, any maintenance performed on the PEC can potentially disrupt the airflow or the filters themselves, warranting an immediate re-certification to ensure that the specialized environment remains sterile.

While some might think that certification every 3 months or once a year could suffice, these intervals do not align with the stringent requirements of sterile compounding practices, which prioritize patient safety above all. Moreover, certifying weekly would not be practical or feasible given the nature of the work environment. Thus, performing certification at least biannually, along with maintenance checks, aligns with industry standards set forth in guidelines such as USP 797. This ensures that any potential issues are addressed promptly, helping to uphold the highest levels of sterility.