ABSTRACT
Validation is an activity that has become a preeminent
concern across the global healthcare industry. While
clearly a requirement for compliant use of a piece of
equipment, individuals and firms have obsessed about
it to the point where validation has been blamed for
delays in the implementation of numerous projects.
Perhaps nowhere has this been more evident than
where firms have endeavored to validate new isolator
installations. Much of the pain associated with the vali-
dation of isolation technology is self inflicted. This
chapter will review the qualification requirements associ-
ated with the validation of isolators. It hopes to clarify the
subject as it relates to isolators to the point where it
becomes an achievable reality.
