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Hallway outside clean room

Clean room
  Construction & Standards

Construction on the $6 million, 4500-square foot facility began in 2001. But this was no ordinary construction job.

FDA standards for the construction and operation of “process suites” doing human cellular work are very stringent—more stringent, even, than the “clean rooms” built for microprocessors for computers. Indeed, people from all over the world have visited the $6 million facility that meets both the federal government’s “Good Manufacturing Practices” (GMP) standard (which regulates equipment, operating procedures, training, and documentation) and its “Good Tissue Practices” (CPT) (which covers the methods, facilities and controls used for the manufacture of human cellular and tissue-based products).