The scope of the installation includes: stainless steel enclosures and the entire architecture of the various production zones. It included three hot chambers and one cold chamber; the air treatment system to classify the ISO 8 rooms with a total of eight air handlers and nine extractors; the distribution of cold and hot water from the existing technical area, and the HVAC control system with Scada communication according to FDA 21 CFR Part 11 regulations. Valtria carried out all the tests prior to Qualification and Validation.