Commissioning of Clean Rooms for Cytostatics Preparation
Brief Project Description
The project involved commissioning and qualification of HVAC systems for clean rooms used for cytostatics preparation at the Golnik Clinic.
Our role included leading IQ (Installation Qualification) and OQ (Operational Qualification) processes, measurements, functional testing, and compliance with EU GMP guidelines and ISO 14644.
Challenge
The main challenge was validation of an extremely demanding HVAC system for aseptic preparation areas, where air cleanliness, pressure control, and repeatability are critical for staff safety and product quality.
The technological design specified several cleanliness classes (A, B, C, D), requiring stable performance in both operational and standby modes.
Solution and Benefits
We led a structured commissioning process including verification of installed equipment, functional testing, and extensive measurements (airflow, pressure differentials, airflow direction, temperature, humidity, HEPA integrity, and particle concentration).
Special focus was placed on the most critical areas, confirming achievement of Grade A (ISO 5) in accordance with EU GMP Annex 1. The result is a validated HVAC system ensuring safe, repeatable, and reliable long-term operation.
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