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Qualification Testing of sterilizers is required after installation,
relocation or a major repair of a sterilizer. This ensures that the
sterilizer is functioning properly in its new environment and performs
according to the sterilizers specifications.
For
gravity-displacement steam sterilizers, best practice recommends that
three consecutive tests be completed using
PCD’s
with biological indicators, one right after the other, all showing
negative results (no growth). For dynamic-air-removal steam
sterilizers, three PCD’s with
Bowie-Dick-type
tests should be run, one right after the other in an
empty chamber showing “passed results”, followed by three
biological indicator PCD’s, with
all results negative (no growth).
ATS,
Inc. offers Qualification Testing kits (see
Supplies). Each “SQTR” kit
comes with three pouches, each containing a BI (biological indicator)
and a CI (chemical integrator) along with one
Control Test (with matching lot
number to the BI’s).
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