Design & Construction of the HVAC system of the new Laboratory spaces and operating rooms of Serum IVF Clinic, in Lykovrysi, Athens. Grade D purity class according to EU GGMP, was provided for the whole sterile space.
The laboratory space is in positive pressure (+ 5Pa) in relation to the operating rooms, which are in overpressure in relation to the adjacent ungraded spaces (+ 10Pa).
BCT group specialists was entrusted for the Cleanrooms’ Validation process to certify the compliance of sterile areas with the ISO 14644 standard. The system was certified according to the international standard ISO 14644 in terms of particle content in “at rest” and “at operation” condition. The achievement of overpressures and the stability of conditions were certified and DQ (Design Qualification), IQ (Installation Qualification) and OQ (Operation Qualification) protocols were developed to demonstrate full compliance with the requirements of GMP and ISO standards The operation of the space and the monitoring – regulation of the temperature and humidity of the spaces, achieved by an automation system, designed from scratch by our company, based on the special requirements of the project.