IDEA is an ACG certified Commissioning Agent with offices in three locations that has served the chemical, pharmaceutical, and bio-pharmaceutical industries since it’s inception in 1995. As part of our full service capabilities we have commissioned and/or validated numerous complex systems and facilities. Many of these projects included hazardous operations and high containment requirements either for product purity or operator safety. Our staff routinely conducts hazards analyses for our clients and is considered an expert in the identification and remediation of potential process and operational hazards.

IDEA is currently the Commissioning Authority for Boston University Medical Center’s (BUMC) National Emerging Infectious Diseases Laboratory (NEIDL) in Boston Mass. IDEA is responsible for all Cx activities and deliverables on the project. IDEA has been involved in the project from 2004 to the present.

In addition to the BUMC project nearing completion in Boston, we are confident that our related experience for the Pharmaceutical and Bio-Pharmaceutical Industries, together with a strong background in designing and commissioning process driven facilities make us ideally suited to provide commissioning services to any project.

Select Commissioning Project Examples:

• Construction and commissioning support services for a new bio-processing facility in Florida. The project cost is estimated to be $40MM. Although IDEA provided all engineering and design services, the Client requested IDEA to perform the commissioning and to assist with system and facility start up.

• IDEA was also part of a significant commissioning effort on a large scale biopharmaceutical manufacturing facility for a Major Pharmaceutical Client in Andover, Mass. The project included commissioning of all process and utility systems as well as the overall integrated facility. The facility contained many critical systems and a high level of automation. Critical systems included WFI, HVAC with HEPA filtration, Containment and product purity related design features. Analytical and developmental laboratory spaces were also part of the project.

• IDEA’s high containment experience includes our role as Program Manager on a feasibility Study for a $180 million dollar BioSafety Research Facility for a University in Manassas, VA, that included multiple BSL-2, BSL-3 and BSL-4 Suites, A large NHP Vivarium and all supporting spaces and systems. This study included all aspects of facility design from site selection and development, space programming, equipment selection, security features, operating considerations and cost development. The facility was very similar to the BUMC NEIDL in Boston.

• IDEA provided an on-site commissioning / validation remediation team to a Major Vaccine Manufacturer in Pearl River New York. The team was on-site for a 3 year period and was instrumental in ultimately achieving compliance with applicable FDA guidelines and regulations.