Merck has completed the expansion of its facilities in Tres Cantos, Madrid, where the German company aims to increase the production of recombinant growth hormone (r-hGH) by 50% (available under the commercial brand Saizen). The biotechnological plant in Madrid produces all of the group's growth hormone.
The project was executed by Telstar, which developed the basic and detailed global engineering for the pharmaceutical and industrial services in the production area and the new office building, as well as purchase management, project and site management, including construction supervision.
It involved construction of offices and auxiliary buildings for technical areas and the remodelling of a warehouse located in a space measuring 970m2 on the lower ground floor as a production area.
Telstar provided a multidisciplinary team of 10 specialists (pharmaceutical consultant, HVAC specialist engineers, industrial services, clean room architecture, clean utilities, process, electricity and control) for the project and used the latest tools for BIM design (Revit and Plant 3D) for smart P&ID generation and the development of a virtual model. Applying BIM tools enabled the firm to devise an integral and conceptual visualisation of the project before carrying it out. This provided the experts with the knowledge to identify any potential risks and resolve technical problems before construction started. This also assisted with the introduction of functional, safety and aesthetic improvements in the early stages of the project.
The process rooms in the production area have a large number of windows and all the lighting in the area is LED, with occupancy sensors in most of the rooms. The enclosures were built with oven painted steel sheet and rock wool sandwich panels which are fire resistant, as well as offering good thermal and acoustic resistance. The HVAC in the production area was designed to achieve Class D with terminal HEPA filters. Trying to obtain energy efficiency, the four air handling units which serve the area have EC fans and L1 air tightness, and the cold and heat contribution has been designed with a variable flow system. Furthermore, the plant has a pressure monitoring system which gathers signals from opening doors and activates sound warnings after a preselected time has elapsed.
Two water loops for injectable substances were designed for the formulations and the CIP stages of the Media Preparation facilities, Harvest and Downstream, which are supplied by one 10,000 litre accumulation tank, one at 80ºC with 11 points of use, and a cold one at 25ºC with 14 points of use. The process facilities include several production reactors, with corresponding transfer lines and sterilising filtration sets.
Existing vapour generators and water heating tanks were substituted with new units which not only service the extended area, but also the whole complex, including the installation of an additional chiller and a cooling tower.