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AEI has been involved in the planning and design of sophisticated, high-tech research and developmental spaces for biological, pharmaceutical, biotechnology and other similar clients for many years. A natural extension of this work has been the development of our technical staff as specialists in the design of systems for pilot/scale-up, QC/QA and manufacturing facilities.
AEI's understanding of pharmaceutical, biological and biopharmaceutical manufacturing, combined with a design practice emphasizing attention to detail and thorough understanding of occupant needs, has benefited many clients. Our engineers have the experience and expertise critical to developing flexible, functional and cost effective design solutions.
AEI's projects run the gamut of biological, fine chemical, tabletting, fill/finish and bulk pharmaceutical facilities. We have designed facilities used in the production of diagnostics and medical devices as well as topical, oral and parenteral products. Our projects have also had to meet the most stringent of requirements for aseptic environments as well as state-of-the-art barrier isolation technology.
AEI designs critical systems to meet cGMP requirements, as monitored by FDA, CDER and CBER, to accommodate effective, efficient validation. We recognize that thoughtful system design, in coordination with regulatory agencies, ensures successful initial and subsequent validation efforts.
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