Validation of a clinical trials facility begins during the final phases of construction and continues through the life of the facility. The ease and success of continuing validation can be integrated into the project from the early stages of the design process. Design of HVAC systems for clinical trials-type facilities presents special challenges in that flexibility of operating conditions is a basic requirement. The environmental conditions will need to vary to support a variety of processes over the life of the facility. The original HVAC system design must be flexible enough to support a variety of condition requirements, and the procedures on which the validation of the space and systems rely must support this variety. A case study is used to illustrate how requirements for flexibility in the HVAC systems, operating parameters, and continuing validation under changing conditions were designed into HVAC systems.

KEYWORDS: laboratories, pharmaceuticals industry, building services, construction, designing, validating, monitoring.