insufficient temperature treatment will be diverted away from
filling. Another effective method for verifying the effectiveness of product sterilization is through media fill trials, where
a microbiologically sensitive medium, such as Linden Grain, is
sterilized, aseptically filled into sterile packs and plated for total
viable count, yeast and mold. The microbial content of the
media-filled packs must show an absence of growth.
Conditions required for the sterilization of filling machines
can be verified by placing Bacillus stearothermophilus spore strips
of known spore loads in target locations and measuring the log
reduction following equipment sterilization.
Alarms on filling machines with a hydrogen peroxide im-
mersion system can be tested to show they sound when the
hydrogen peroxide bath level is below a minimum volume.
A more quantitative method for verifying the effectiveness of
packaging sterilization is by inoculation pack testing, where preformed packaging is inoculated with a known amount of bacterial spores and introduced into the packaging machine where
it is sterilized. The packaging then undergoes microbiological
testing to determine the log reduction post-sterilization. Results
from package integrity testing where filled packs are inspected
for leakages or incorrect sealing can also verify that the product
has been hermetically sealed at the filler. Record keeping is an
important part of the verification process, as it serves as documented evidence that critical limits have been reviewed and
verified to be fully functional at maintaining aseptic control.
Table 2: Example of Product Sterilization Process Documentation
Critical limit
Time and
temperature
to achieve
commercial
sterility
(time:
4 sec.;
temp.:
135 °C)
UHT: ultra-high temperature; PLC: programmable logic controller; RTD: resistance temperature detectors
Process step
Product
sterilization
at UHT
sterilizer
Hazard
Biological:
C. botulinum
spores
Monitoring
Continuous
PLC
monitoring
of the RTD
sensor on
exit of the
hold tube
Corrective action
Diversion of the
product and stop
production;
segregate and
hold affected
product for
disposition
Records
Online
records,
charts and
calibration
records
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