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The use of load controls
in the sterilisationprocessCindy GrahamTuesday October 16th 2012 Pa
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Objectives
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Importance of monitoring your sterilisation process
Importance of instant result
Options available
Most diagnostic technology Relevant standards
Conclusion
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Learning Objectives
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Present the importance of ensuring sterility assurance levels
are achieved
Discuss how to manage and control the risks associated with
decontamination reprocessing
Identify the differences between options available in line with
current standards
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Sterility Assurance
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What is sterility assurance?
What is it based on?
What does it give you and the patient?
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What is Validation ?
Validation is the documented procedure for obtaining,recording
and interpreting the results required to establish that a
process will consistently yield product complying with
predetermined conditions.
And shall include
Installation Qualification
Operational Qualification
Performance QualificationPatient
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Sterility Assurance
The Sterility Assurance Level, or SAL, is a measure of the
confidence in the attainment of sterility
a probability of 1 unsterile load in 1,000,000
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First Minute of Cycle at 134C
106105
104
10310210110010-110-210-310-410-510-6
0 1 2 3 Mins.No.ofMic
ro-organisms
Assumed Bioburden
of 106
Micro-organisms
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Second Minute of Cycle at 134C
106
105
104
103
102101
100
10-1
10-2
10-3
10-4
10-5
10-6
0 1 2 3 Mins.
No.ofMicro-organisms
Assumed Bioburden
of 106 Micro-organisms
SAL 10-6
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Safety Time
106105104103102101100
10-110-210-310-410-510-6
0 1 2 3 Mins.
No.o
fMicro-organisms
Assumed Bioburden
of 106 Micro-organisms
SAL 10-6
Minimum of 1 Min.
Safety Time
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EN ISO 15882/ EN ISO11140-1
All EU member countries were bound to give this Standard a
national standard status by March 2009 and any conflicting
National standards should be withdrawn.
EN ISO 15882 provides guidance on the use of indicators as
described in the ISO 11140 series of standards - ISO 11140
specifies the performance requirements of chemical indicatorsand is intended mainly for the use of manufacturers of chemical
indicatorsPatient
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EN ISO 15882
Section 3 - General requirements 3.2 states that the value of the information provided by a
chemical indicator is dependent on the class of indicator ,
number and location of indicators being representative of
conditions throughout the load or the chamber.
3.7 Class 3,4,5 and 6 all require one or more Stated Values or
SVs these are based on the outcomes of testing undertaken in
a resistometer by the manufacturer.Patient
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Resistometers EN ISO 15882
Hospital sterilizers typically do not have the same response characteristics
or accuracy of exposure conditions as resistometers it is very difficult for
the user to replicate the manufacturers label claims.
Therefore it is suggested that third party independent laboratories with
resistometers are used to verify manufacturers claims.Patient
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BIER Vessel Biological Indicator Evaluation Resistometer
Chamber size of 10 -20 litres (less than 1 cu ft)
Sterilization temperature reached very quickly
Very accurate temperature control
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ISO11140 - Class 5
Integrating Indicators Also known as chemical biological indicators
Must react to all critical parameters of a given process
Follow the death curve of a given spore population, e.g.
G. stearothermophilius in steam as per ISO 11138 part 3
For steam the tolerances are;
time +0%, - 15%
temperature +0, -1CPatient
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Class 5 indicators at 270 / 273 F
106105
104
10310210110010-110-210-310-410-510-6
0 1 2 3 Mins.No.ofMic
ro-organisms
Assumed Bioburden
of 106
Micro-organisms
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Class 6
A Class 6 indicator would prove that all parameters of a given process
were present as per values stated on the indicator.
Monitoring all 3 critical parameters of Time, Temperature and Steam
Cycle emulating
For steam the tolerances are;
time +0%, - 6%
temperature +0, -1C
Some examples :270 F for 4 min , 273 F or 134 C for 3.5 , 134 for 4, 7,
9, or 18 m 250 or 121 C for 20 min
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Class 6
106105104103102101100
10-110-210-310-410-510-6
0 1 2 3 Mins.No.o
fMicro-organism
s
Assumed Bioburden
of 106 Micro-organisms
SAL 10-6
Minimum of 1 Min.
Safety Time
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In Pack Monitoring
Generally using a class 4,5 or 6 chemical indicator
placed in the tray or wrapped item.
The classification of the indicator would determinethe level of assurance offered by this indicator.
Classifications are set out in and ISO 11140 - 1
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Load Control
This takes the form of a biological indicator in the
U.S.
However, globally biological indicators now tend to
be used specifically for validation. purposes not forroutine monitoring.
Chemical indicator PCDs are currently the most
common form of Load control
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Indicators for use in Process
Challenge devices EN ISO 15882
6.4
Process Challenge devices have been developed to
represent a penetration challenge to the sterilization
process.
There is no PCD that can be used for all sterilizer types
and sterilization procedures.
The performance of the PCD is the combined effect of
the chemical indicator and the PCD components.
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EN ISO 15882 PCDs 6.4 cont
most commercially available PCDs are designed to assess the
penetration of a reference load. Attention must be drawn to
the fact that these PCD challenge the process and do not
represent the sterilization load.
Different products, eg. Hollow loads ( beakers tubing etc )
porous loads ( linen, dressings, textiles ) and non porous loads
( solid and surgical instruments) can be represented by
different PCDs
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What does load control offer the
CSD or unit manager It provides the assurance that the correct
parameters for effective sterilization were present inthe Chamber.
This physical evidence can be retained and storedwith the cycle printout providing proof for yourrecords.
Therefore providing an element required forAccreditation and record keeping
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Load control only as good as the
indicator
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The dimensions of most hollow lumen load controls are based
on the specifications of EN 867-5 ( 1.5m x 2mm inner
diameter. The cap has to be 6 % of the total volume of the
tube)
The conformity of the ink used for the indicator must say EN
ISO 11140-1 class 2
There are new load control systems using class 6 technology
but requirements for the standard stipulate the label claims
As per the earlier slide class 6 is the most diagnostic and can
be calibrated for specific cycles
Always ask for technical certification to ensure your load
control is truly effective for your needs
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Cycle specific load controls
Load control calibrations 134C
3.5 min
4 min 5.3 min
7 min
121C
15 min
20 min
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Lets compare the two
Load Control
Assurance of the load.
Physical evidence inspected andretained within the CSSD before
the load is released
Recordable evidence at source
(CSSD)
Indicators are generally classified(class 2 ) - important to demand all
certification of technology
calibration
.
In pack monitoring
Assurance of the pack or tray.
Physical evidence is inspected by
the end user and retained at
point of use.
Indicators classified according
to their performance and
characteristics
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Conclusion
To have piece of mind regarding sterility assurance use the
most comprehensive combination of decontamination
monitoring systems available to you
Use the standards when choosing the technology you use
Ensure the product is calibrated to your cycle
Document the results for your records
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Questions???
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Thank you
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References
En ISO standards
EN ISO 15882
EN ISO 11140-1
All classifications of indicator
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