James T. Wagner

President , Controlled Environmental Consulting


Jim is the president of Controlled Environment Consulting (CEC). He has over 33 years of experience assuring the performance of critical environments. His consulting includes design and evaluation of sterile compounding facilities, containment facilities and other engineering controls. Jim conducts international training on cleanroom and containment device certification and is the lead instructor for the Eagleson Institute’s Advanced Certification and Certification of Sterile Compounding Facilities classes. Prior to founding CEC, Jim was the President of Micro-Clean, a certification and validation company. Recently Jim led the Controlled Environment Testing Association’s (CETA) efforts to develop guidance documents for USP Chapter 797. He serves on the USP sterile compounding expert committee for the 2010-2020 appointment cycle and was a member of the 2010-2015 USP Hazardous drug compounding expert committee. He has presented at many USP forums on engineering controls for sterile compounding. Jim is a steering committee member for NSF/ANSI Standard 49 Biosafety Cabinetry: Design, Construction, Performance and Field Certification. Until recently, he was an NSF accredited BSC certifier since the program’s inception in 1993. He has been a board member for the Controlled Environment Testing Association and served as president in 1992-1994 and 2006.