How often should clean rooms be certified following relocation or major service?

Clean rooms, which are critical environments in pharmaceutical manufacturing and compounding, require strict adherence to certification protocols to ensure they maintain the necessary levels of cleanliness and control over environmental factors. Following any relocation or major service of clean rooms, it is essential to assess and certify that they meet the required cleanliness standards.

The correct interval for certification after such significant changes is every 6 months. This frequency reflects the need for diligent monitoring due to potential alterations in airflow patterns, surface cleanliness, and other environmental controls that may occur as a result of moving or extensively servicing the clean room. Regular certification ensures that the clean room continues to meet the stringent standards required for its intended use, which is particularly important in areas involving sterile drug preparation and compounding.

In contrast, the annual or yearly assessment frequency, while valuable for general upkeep and regulatory compliance, does not provide the necessary immediacy for certification following relocation or major service changes. Similarly, certifying every 3 months may not align with standard industry practices unless more specific frequent evaluations are warranted due to certain conditions or risks, making every 6 months a commonly accepted standard.