16
Bionova® IC10/20FR
Hygiene monitoring systems
Readout results for ISO 15883-5 Threshold Mode
The ISO 15883-5:2021 standard indicates the use of two
different protein quantity thresholds to evaluate cleaning
efficacy: An Action threshold, and an Alert threshold. ISO 15883-
5 based thresholds are expressed as ratios in µg/cm
2
units that
relates protein quantity found in a sample (µg) and the swabbing
surface (cm
2
) on which the sample was taken. According to the
standard, each threshold has different implications:
Alert threshold:
The alert levels are the target levels of
cleaning efficacy that the cleaning process should achieve.
Recommended threshold value 3µg/cm
2
. Lower values may be
recommended for particular applications.
Action threshold:
The action levels are the maximum criteria
for acceptable cleaning efficacy during testing of a sample.
Recommended threshold value 6.4µg/cm
2
. Lower values may
be recommended for particular applications.
Values between the two thresholds should be investigated,
but are considered to pass cleaning requirements.
Important:
Refer to the ISO 15883-5:2021 standard for
detailed information on how to implement the standard to
your processes.
If ISO 15883-5 Threshold Mode is selected as the readout
threshold mode on your Auto-reader, each time a readout is
completed the protein quantity will be informed by the Auto-
reader through the Quantitative Protein Level LED Indicators
and through a printed ticket:
Approximate amounts of
BSA expressed in μg
1 2 3 4 5
1 µg
2 µg
3 µg
4 µg
5 µg
Also, as a quick visual cue of the protein quantity found on the
sample, the device will turn on the Red LED Indicator if the
protein quantity is above 1 µg, or the Green Indicator if the
protein quantity is below 1 µg.
Important:
Please keep in mind that according to ISO 15833-
5:2021 standard the protein quantity found in a sample
(in µg) needs to be related to the swabbed surface area to
obtain a readout result (in µg/cm
2
) that can be comparable
with the selected Alarm and Alert thresholds (also in µg/cm
2
).
Once the protein quantity in the sample has been obtained
by the Auto-reader, and the swabbed surface information has
been obtained with the Bionova
®
Antinova APP. The information
is finally linked together by the Bionova
®
Cloud Environment to
inform the readout result. Please refer to
ISO 15883-5:2021 on
Bionova
®
Cloud Environment
section for a step by step guide to
upload and link data on Bionova Cloud Environment.
Once the data has been linked, the readout result will be
shown on the
Hygiene Monitoring > Finished
tab of Bionova
®
Cloud Web Interface. Depending on the threshold values
selected, the informed readout result can be as follows:
If the protein quantity found on the swabbed surface (µg/cm
2
) is
below the Alert Threshold. The readout result will be informed
as
NEGATIVE
.
If the protein quantity found on the swabbed surface (µg/cm
2
)
is above the Alert Threshold but below the Action Threshold.
The readout result will be informed as
ALERT
.
If the protein quantity found on the swabbed surface (µg/
cm
2
) is above the Action Threshold. The readout result will be
informed as
ACTION
.
Take action immediately whenever an
ACTION
Readout
Result is informed as this indicate that the protein quantity
found does not comply with the user defined quality standards
set for the cleaning process.
Disposal
Discard the PRO1 indicator according to your country’s sanitary
regulations. It is not possible to use or incubate a PRO1 indicator
more than once. Please refer to the PRO1 instructions for use.
Audible alarm
An audible alarm will sound every time a positive result is
detected in your Auto-reader. The alarm allows the user
to immediately detect a positive result without the need to
visually control the device. The alarm can be canceled by
pressing the
button .
Cancel a reading
The user can cancel a reading by pressing the
button
and the
button for three seconds. The device will cancel
the reading and the auto-reader will print out a ticket
confirming the cancellation.
