Over 20 years of experience in Sterile, Biological Pharmaceutical and Hospital Facilities Engineering Design, Construction and Validation.
The Alfa-1 Antitrypsin building, in Parets del Vallès, Barcelona, Spain, has a floor area of approximately 2,410 m2 and has a ground floor and two lower floors below deck and an exterior platform for equipment for production systems of service fluids.
The building is distributed, according to the design criteria in 3 different production areas and a common technical area. Access to any classified zone is always through the technical zone and its corresponding changing rooms so that to go from one classified zone to another, you must exit through the classified zone of origin to the technical zone and reenter
The building is divided into the following areas:
• Plantroom: Includes the rooms necessary for the installation of systems and services auxiliary to the process, in addition to the transit zones and common areas not classified as stairs or corridors.
• Non-Isolated Zone: Includes the access locker rooms and the classified area where Fraction VI-1 dissolution, PEG addition, centrifugation and the first stage of OSD viral inactivation are performed.
• Isolated Zone: It includes the access changing rooms and the classified zone where the second stage of the viral OSD is carried out, the protein is purified by anion chromatography, dialyzed, concentrated by ultrafilter and polished by cationic chromatography. Once the eluate from the cation column was collected, it was transferred, by planova, to the next area.
• Planova area: Includes the access changing rooms and the classified area where dialysis, concentration and final formulation are performed. This zone also includes the sterile dosing and lyophilization zone.
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