The Effect of Gamma Irradiation Process Interruption on Microbial Resistance of G. stearothermophilus
Sterilization process monitoring and
control
is
key
to
product
safety
in
the
pharma
industry.
ISO/AAMI
11137-1
addresses
the
importance
of
monitoring
radiation
process
parameters
to
ensure
products
have
been
processed
according
to
specification.
Radiation
sterilization
standards
generally
state
that
any
doses
delivered
to
product
are
cumulative,
regardless
of
whether
the
dose
is
delivered
all
at
once
or
whether
there
is
a
process
interruption,
such
as
correcting
an
is
-
sue
with
the
conveyor
system.
That
is
certainly
the
case
with
regard
to
radiation
effects
on
product.
Whether
or
not
multiple
doses
delivered
with
a
process
interruption
in
between
doses
are
likewise
cumulative
with
respect
to
microbial
inactivation
requires
analysis.
Although
ISO/
AAMI
11137-1
describes
the
requirement
to
document
process
interruption,
it
does
not
include
references
to
describe
the
effect
of
process
interruption
on
microbial
resistance
to
radiation.