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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).
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