What is the required frequency for air particle testing if a device is relocated or serviced?

Air particle testing is a critical component in ensuring the sterility and safety of compounded sterile preparations. The requirement for testing after a device has been relocated or serviced is driven by the need to verify that the air quality and particle levels remain within acceptable limits.

When a device is moved or serviced, there can be changes to the airflow patterns, contamination levels, or the integrity of the cleanroom environment. Therefore, conducting air particle testing at this point helps check for any potential deficiencies or alterations that could compromise sterility.

Testing every six months is a standard practice that aligns with guidelines from various regulatory bodies, including the USP. This frequency ensures that any changes resulting from service or relocation are promptly assessed, allowing for the maintenance of safe compounding environments. Regular assessments every six months help in identifying trends or risks associated with air quality, thus supporting compliance with best practices in sterile compounding.