ISPE Pharmaceutical Engineering Guide, Volume 5 Guideline defines Commissioning Prior to Validation for pharmaceutical manufacturing facilities. The HVAC and site utility systems required for a pharmaceutical manufacturing or research facility must be robust in their design and precise in their operation. Commissioning builds quality into these designs and verifies correct operation through independent testing and documentation.

With Dome-Tech documentation in hand, developing and meeting validation requirements for commissioned systems is based on fact, not speculation. The proven performance of HVAC and utility systems means one less headache during validation and provides a head start for the facility. From CFM to GPM, Dome-Tech’s Commissioning Prior to Validation provides the competitive edge for production on time and on budget.