Use of Chemical &

Biological Indicators
Dr. Ashraf Abd Elkader El-Kelany
General Directorate,
infection Prevention and Control
MOH - KSA
Process Monitoring
Why ?
How often ?
Why Process Monitoring?
Validation is used to check that a product, service, or
system meets requirements and specifications plus
that it fulfills its intended purpose.
Regular monitoring is necessary to detect any
failure in the delivery of sterile instruments
required for safe healthcare services.
Do not confuse monitoring with validation.
A sterile product is the result of:
The right product
The right equipment
The right process
All three factors have to be checked.
Why Process Monitoring?
There are 3 fundamental methods of
monitoring sterilization processes:
Sterilisation Monitoring Concepts
Physical
Chemical
Biological
Sterilization Process Monitoring Devices include
Physical monitors, Chemical Indicators (CIs) and
Biological Indicators (BIs).
Each of these devices play a different and specific role
in sterilization process monitoring, and each is
essential for sterility assurance.
Sterilisation Process Monitoring Devices
Three legs make a
stable stand!
!Stability"
Physical Monitors
Chemical Indicators
(CIs)
Biological Indicators
(BIs)
Sterilisation Process Monitoring Devices
There are 3 fundamental methods of
monitoring sterilization processes:
Sterilisation Monitoring Concepts
Physical
Chemical
Biological
Physical Methods
These devices confirm that the specific parameters of
the sterilization cycle have been met.
Gauges
Continuous measurement of the sterilization
process parameters, e.g., pressure, temperature,
and time
Need recalibration
Recording devices (e.g., displays, and printouts)
Documentation of the measured sterilization
process parameters
Physical Methods
Thermometers
Measurement of the highest temperature of the
process
Easy to use
But no information about when it was reached or
for how long it was maintained
Thermocouples
Continuous measurement of temperature
Allows continuous recording
There are 3 fundamental methods of
monitoring sterilization processes:
Sterilisation Monitoring Concepts
Physical
Chemical
Biological
Chemical Indicators (CIs)
Reaction depends on achieving one or
more of the critical parameters:
(pressure, temperature, humidity, and time)
Result immediately available
Always follow the instructions of the
indicator manufacturer regarding storage,
expiration date, how to use, cycles it can be
used to monitor, and how to interpret results.
Chemical Indicators (CIs)
Class 5
indicator
Class 4
indicator
Chemical Indicators Classes (ISO 11140-1)
Class 1 Process Indicators
Class 2 Specific Test Indicators
Class 3 Single variable indicators
Class 4 Multivariable Indicators
Class 5 Integrating Indicators
Class 6 Emulating Indicators
Chemical Indicators Classes (ISO 11140-1)
The chemical indicators within each of these
classifications are further subdivided by the
sterilization process for which they are designed to be
used.
The classification structure used is only to denote the
characteristics and intended use of each type of
indicator as defined by the manufacturer. The
classification has no hierarchical significance."
Your choice should be based on the information you
need to get about a particular sterilization process.
Class 1 - Process Indicators
Used for Exposure Control
Designed to react to one or more of the critical
process variables
Used to demonstrate that the item has been exposed
to the sterilization process & to distinguish processed
from unprocessed items (Exposure control)
It will show !processed" result when exposed to
conditions which should not occur outside the
sterilizer.
The level and uniformity of exposure can not be
detected with such an indicator. No information about
the success or failure of the process.
Class 1 - Process Indicators
Used for Exposure Control
Practical Application
Placement
Outside of package
Frequency of Use
Each package unless internal chemical indicator is
visible
Examples of CI class 1
Indicator tapes, indicator labels, and load cards
Class 2 - Specific Test Indicators
Used for Special Tests
Intended for use in specific test procedures as
defined in relevant sterilizer/sterilization standards!
This class is generally a steam penetration air
removal test, commonly known as a !Bowie Dick
Test" which is used to evaluate the efficacy of air
removal by vacuum systems (dynamic-air-removal)
in pre-vacuum steam sterilizers.
Class 2 indicators are used to evaluate the sterilizers
performance (Equipment control).
The original "Huckaback Towel Pack"
Dr. J. H. Bowie and Mr. J. Dick
THE BOWIE AND DICK AUTOCLAVE TAPE TEST, The Lancet,
(1963), S.586
Class 2 - Specific Test Indicators
Used for Special Tests
Practical Application
Placement
In empty load, on the bottom shelf
over the drain line (coldest spot).
Frequency of Use
1) Daily for each pre-vacuum steam sterilizer (first cycle of
the day) after warming up
2) Initial installation or relocation of sterilizer, after sterilizer
malfunction, sterilization process failures and major
repairs (3 consecutive empty loads tested)
Examples of CI class 2
Dynamic Air Removal DAR (Bowie-Dick) tests used for
equipment control
Dynamic Air Removal DAR test Pack
(Bowie-Dick test)
Instructions for use:
Unless otherwise directed by the manufacturer the
DAR test should be run in an EMPTY load (nothing
else in the sterilizer) for 3 $ to 4 minutes cycle with
no dry time.
At the end of the cycle, the door should be opened
and the cart with the pack removed (the cart should
not remain inside the sterilizer to cool down).
After cooling, the pack should be opened and the
results reviewed.
Dynamic Air Removal DAR test Pack
(Bowie-Dick test)
Interpretation of the results:
A complete and even color change
of the indicator sheet = (PASS).
Any incomplete or inconclusive
results = (FAIL), that should be
immediately reported to the CSSD
supervisor and the test repeated.
If the second test fails, do not use
the sterilizer and call maintenance
services.
Class 3 " Single Variable Indicators
Used for Pack Control
A single variable indicator is designed to react to
one of the critical variables and intended to indicate
exposure to a sterilization process at a stated value
(SV) of that chosen variable!
Indicates exposure inside the pack (Pack Control) to
one critical parameter of the sterilization process
(single variable in the process e.g. temperature)
If the sterilization process has only one critical
parameter (single variable as irradiation), conclusions
can be made on the result.
Class 3 " Single Variable Indicators
Used for Pack Control
It may be used as a (Pack Control) monitoring but
would not provide as much information as Class 4,
Class 5 or Class 6 Chemical Indicators.
If more than one parameter is required, monitoring a
single parameter is inadequate and must be used in
conjunction with other indicating systems.
Class 3 " Single Variable Indicators
Used for Pack Control
Practical Application
Placement
Inside package
Frequency of Use
Inside each package in the areas considered the
greatest challenge for sterilant penetration.
Examples of CI class 3
Temperature tube that contains a chemical pellet that
melts at a specific temperature (SV).
Class 3 " Single Variable Indicators
Designed for one critical
parameter
Stated value for that single
variable
Temperature tubes
% Melt and change color if
reach stated temperature,
e.g., 134C.
Class 4 " Multivariable Indicators
Used for Pack Control
A multi-variable indicator is designed to react to two
or more of the critical variables and intended to
indicate exposure to a sterilization cycle at stated
values (SVs) of the chosen variables.!
Indicates exposure inside the pack (Pack Control) to
two or more critical parameters of the sterilization
process (multivariable, e.g. temperature & time)
They may need to be used in combination with other
indicating systems to allow proper interpretation of
the process.
Class 4 " Multivariable Indicators
Used for Pack Control
Practical Application
Placement
Inside package
Frequency of Use
Inside each package in the areas considered the
greatest challenge for sterilant penetration.
Examples of CI class 4
Multi-variable CI is used for pack control.
These internal Chemical Indicators are usually paper
strips printed with a Chemical Indicator ink.
Integrating indicators is designed to react to "all!
critical variables.!
The SVs are generated to be equivalent to, or exceed
the performance requirements given in the ISO 11138
series for Biological Indicators .!
They must therefore respond to effective
combinations of all critical parameters.
Similar to biological indicators, slight changes in one
parameter may be compensated by changes in another
parameter (e.g. slightly lower temperature
compensated by longer exposure to saturated steam).
Class 5 " Integrating Indicators
Used for Pack & Load Control
Class 5 Integrating Indicator is designed to "mimic!
the behaviour of biological indicator, frequently
referred to as "A chemical Biological!.
However they do not replace the BI, the release of
loads is still based on the result of BI, in emergency
cases we can release the load based on Class 5
Indicator but this doesn&t include implants.
For this additional monitoring the Class 5 Integrating
Indicator must be used in the appropriate challenge
test pack or Process Challenge Device (PCD).
Class 5 " Integrating Indicators
Used for Pack & Load Control
Class 5 " Integrating Indicators
Response must correlate to a BI at
three time/temperature relationships
% 121'C/250'F
% 135'C/276'F and
% a temperature in between such as
128'C/263'F
Cannot be a Class 5 CI unless have 3
stated values listed on the product or
inserted in the package.
Class 5 " Integrating Indicators
Used for Pack & Load Control
Chemical Emulating Indicators can be used only to
show that all the critical variables of sterilization
process have been achieved for a specific
sterilization cycles for which they are labeled, e.g.,
Dual Temperature 121'c / 12 minutes - 134'c / 4
minutes).
Class 6 " Emulating Indicators
Used for Pack & Load Control
Class 5 - Integrating Indicators Versus
Class 6 - Emulating Indicators
An integrator is designed to
be accurately correlated to a
biological indicator.
!One indicator for all steam
cycles"
If the combinations of the
cycle critical parameters (at
the three time / temperature
relationships) are not
achieved, class 5 integrator
fails.
An Emulator is designed to
show that a sterilizer worked
according to its settings
We can not correlate the
performance of an emulator
for a special test cycle to all
cycles used.
If the sterilizer cycle settings
(time / temperature) do not
match exactly the SVs
indicated on the emulating
indicator it fails.
Class 5 - Integrator Class 6 - Emulator
Class 5 - Integrating Indicators
& Class 6 - Emulating Indicators
Frequency of use:
Chemical Indicators must be routinely used within
each package, tray, or containment device (rigid
container, cassette, or organizing tray) to be
sterilized.
A Chemical Indicator challenge test pack or Process
Challenge Device PCD (containing a Class 6 or a
Class 5 chemical Indicator) may be routinely used for
assurance of the adequacy of the sterilization cycle
with all loads containing non-implantable items
(Load Control).
Class 5 - Integrating Indicators
& Class 6 - Emulating Indicators
Placement:
Chemical Indicators must be placed in the area of the
package, tray, or containment device considered to be
least accessible to steam penetration (spot of greatest
challenge).
For containment device, follow the manufacture's
written instructions for placement of the Chemical
Indicator.
Process Monitoring How Often? With What?
Equipment Control Every day Bowie Dick Test
Sterilization Monitoring in 5 Steps
Load Control Every load BIs / CIs Test Packs (PCD)
Exposure Control Every pack Tape, Strips, Labels
Pack Control Every pack Chemical Indicators
Record Keeping Every action Labels, Record books
Clean Prep/Pack Sterilize Store Issue/Use
Monitored by load and
exposure control
Monitored by exposure
and pack control
There are 3 fundamental methods of
monitoring sterilization processes:
Sterilisation Monitoring Concepts
Physical
Chemical
Biological
Biological Indicators
Biological indicator
Test system containing viable micro-organisms
providing a defined resistance to a specific
sterilization process.
Biological Indicators
How they work . . .
Spores are exposed to the sterilization
process along with items being
sterilized
After processing, the exposed spores
are immersed in an optimized recovery
media and incubated at optimal
temperature.
Spore viability indicates a process failure
Golden standard! is 7 days of incubation*
Attest Rapid Readout Design
Cap
Filter filters out contaminates
Media Ampule Nutrients, enzyme
substrate and pH indicator
Barrier Material Concentrates
fluorescent product
Spore strip Paper coated with spores
Vial
Attest Model 290
Auto-reader/Incubator
The system includes an
incubator (that can be
programmed for 37 or 60 (C)
and fluorescence detector.
Automatic calibration and
timing for each vail as it is
placed in the reader.
Positives (Red light with an
audible Alarm) indicated after
the 3rd reading.
Negatives (Green light) at the
end of incubation time
Instructions for
Biological Indicators use
Always follow the Biological Indicator
manufacturer's instructions for storage,
expiration date, how to use, how to incubate
(follow-up) after sterilization, and how to
interpret results.
Biological Indicators
for Steam Sterilizers (Autoclaves)
Frequency of use:
A Biological Indicator challenge test pack (containing
Biological Indicator ) Chemical Indicator [Class 5 or
Class 6]) should be used at least weekly; preferably
daily: for routine release of loads containing non-
implantable items.
After steam sterilizer installation, relocation,
malfunction, major repairs, and after sterilization
process failures. Each sterilization cycle type used
should be tested (gravity displacement, pre-vacuum, or
flash cycles).
Biological Indicators
for Steam Sterilizers (Autoclaves)
Frequency of use (con.):
A Biological Indicator challenge test pack (containing
Biological Indicator + Chemical Indicator [Class 5 or
Class 6]) should be used with for release of each load
containing implantable devices.
All implantable devices should be quarantined until
Biological Indicators results are available.
When running a gravity displacement cycle
(Biological Indicator test pack must be included in
the load since this cycle is not routinely tested)
Biological Indicators
for Steam Sterilizers (Autoclaves)
Timing:
In the first working load of the day after Dynamic Air
Removal test - DAR (Bowie-Dick test)
Placement:
Biological Indicator challenge test pack must be
placed in a fully loaded chamber, in the area of the
sterilizer chamber and load that is least favorable for
sterilization (coldest spot).
It should be identified by the manufacturer, usually in
the front, bottom section near the drain line.
Biological Indicators
for Steam Sterilizers (Autoclaves)
Activation & Incubation:
Unless there are special recommendations by the
manufacturer for incubation, "rapid readout" BI test
providing a final result for steam sterilization cycles
in three hours (wrapped loads) and one hour for flash
cycles (unwrapped load).
Control:
Control Biological Indicator vial is needed to verify
the pre-sterilization viability of the spores.
The test Biological Indicator vial must be of the same
lot number as the control Biological Indicator vial
otherwise the test is considered not valid.
Biological Indicators
Interpretation of Results
Biological Indicator
Test Vial
Biological Indicator
Control Vial
Dead Spores Viable Spores
Viable Spores Viable Spores
Dead Spores Dead Spores
Dead Spores Not Used
Sterilization
Process Success
Sterilization
Process Failure
Biological
Indicators Failure
Invalid Test
Biological Indicators
for Gas Plasma Sterilizers
Frequency of use:
BIs for Low Temperature Gas Plasma sterilizer must
be used daily.
Timing:
In the first load of the day.
Placement:
Biological Indicator test pack must be placed on the
bottom shelf, back of gas plasma sterilizer (spot of
greatest challenge).
Biological Indicators
for Gas Plasma Sterilizers
Activation & Incubation:
Unless there are special recommendations by the
manufacturer for incubation, the Biological Indicators
for gas plasma need 24 (or 48) hours to get a final
reading.
Control:
Control Biological Indicator vial is needed to verify
the pre-sterilization viability of the spores.
The test Biological Indicator vial must be of the same
lot number as the control Biological Indicator vial
otherwise the test is considered not valid.
Biological Indicators
for Ethylene Oxide gas (EtO) Sterilizers
Frequency of use:
Biological Indicators for (EtO) Ethylene Oxide gas
must be used with each load/cycle.
Placement:
Biological Indicator test pack must be placed in the
area of greatest challenge (least favorable for
sterilization). The EtO sterilizer manufacturer should
identify the exact location of this area, usually the
center of the load.
Biological Indicators
for Ethylene Oxide gas (EtO) Sterilizers
Activation & Incubation:
Unless there are special recommendations by the
manufacturer for incubation, the Biological Indicators
for EtO need 48 hours to get a final reading.
Control:
Control Biological Indicator vial is needed to verify
the pre-sterilization viability of the spores.
The test Biological Indicator vial must be of the same
lot number as the control Biological Indicator vial
otherwise the test is considered not valid.
physical + chemical +
biological monitoring +
documentation of the results
Good, meaningful control
Safe sterilization process
Final Conclusion
Any questions left?