What is PEC?
Primary Engineering Control: a device or zone that provides an ISO 5 environment for compounding, such as a laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI).
The PEC is where sterile manipulation actually happens: a laminar airflow workbench, biological safety cabinet, compounding aseptic isolator, or restricted-access barrier system that delivers ISO 5 first air to the critical site.
PECs must be certified at least every 6 months and after relocation or repair, cleaned on defined frequencies, and continuously monitored through the facility's viable and non-viable sampling plan. Each PEC's certification history, cleaning records, and sampling results are core inspection evidence.
See how CompliRx handles this in practice:
Environmental monitoring softwareRelated terms
Turn the standard into daily records
CompliRx helps compounding pharmacies keep environmental monitoring, qualifications, cleaning, documents, and CAPA evidence inspection-ready.