Controlled Environment Consulting (CEC)
We are a leader in the development and performance assurance of Controlled Environments used for sterile manufacturing and hazard containment.
Our experts bring decades of experience in creating and certifying cleanrooms, laboratory containment equipment, isolators, and other primary and secondary engineering controls used in regulated facilities.
We are a privately held consulting company based in Allentown, PA.
Expertly led by Jim Wagner, President and CEO, who is seasoned in many areas of the controlled environment industry, including facility related issues concerning sterile compounding and CGMP aseptic processing, engineering controls used for sterility and containment, and certification/validation of critical environments.
Jim holds over 40 years of experience specializing in the design and certification of engineering controls used for sterile compounding, manufacturing, and hazard containment. Jim was an elected member of the USP Compounding Expert Committee from 2005 to 2020, providing guidance on sterile and non-sterile compounding facilities. He is a current member of the NSF Joint Committee for Biosafety Cabinetry responsible for NSF/ANSI Standard 49. Jim served on numerous other technical committees for IEST and CETA, creating and revising guidance documents for design and testing of cleanrooms, HEPA filters, and other containment devices. He was the founding President of the Controlled Environment Testing Association (CETA), and a recipient of CETA’s most prestigious award, the Melvin First Award. Jim is a primary instructor for the Eagleson Institute’s Advanced Certification and Certification of Sterile Compounding Facilities classes.
Director of Field Operations
Lew is a Navy veteran and seasoned leader, bringing over 25 years of experience specializing in cleanroom and containment device certification. He oversees Controlled Environment Consulting’s Certification program. Lew has performed thousands of airflow visualization smoke studies, assuming a leadership role in airflow visualization, including development of industry training programs. He has held several accreditations with NSF, NEBB and CETA. Lew was instrumental in developing Cleanroom Technician Training programs and is an instructor for the Eagleson Institute.
Senior Mechanical Engineer
DJ oversees our cleanroom design and construction projects, integrating CEC’s wealth of cleanroom certification experience into the design process. He holds a Bachelor of Science in Mechanical Engineering and several certifications. DJ brings over 13 years of experience in design of mechanical, plumbing, and building automation systems, project management in commercial, educational, government, and healthcare industries, and facilities management and engineering.
CNBT and NSF-accredited certification field supervisor, Bob holds 15+ years of cleanroom and containment device certification experience. Bob led a large team of certification technicians and managed international projects, dealing with pharmaceutical and compounding pharmacy cleanrooms. Bob is CEC’s expert on troubleshooting and repairing engineering controls including Class II Biosafety Cabinets.
Training Coordinator/ Technical Writer
Lyndie is an accomplished instructional technologist, eLearning designer and training facilitator with over 18 years of experience working in the health care, manufacturing, compliance, and safety fields. She brings a scientific background with a BS in Biochemistry and practical laboratory experience to a technical training role. Lyndie has a Master’s degree in Instructional Technology Management, and specializes in technical writing, staff training & curriculum development.