Easi-Sterilise
Standard Operating Procedures
&
Workplace Skills Assessments
“Getting it right, every step of the way”
Section 5
Quality
5.1 Water Quality
 To ensure water used in cleaning of re-usable
medical devices is of optimum quality for
effective and efficient processing
Water quality for cleaning
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Water quality affects cleaning procedures
Water must be potable (drinking quality)
Hard water = calcium and magnesium
Damages instruments
Damages equipment
May prevent chemicals working as intended
Unfiltered tap water may contain excessive amounts of
microorganisms depending on source
5.2 Cleaning Efficacy Test (optional)
 Challenges the efficacy of the mechanical cleaners
 At commissioning of mechanical washer to
determine loading patterns/configurations
 Weekly (not mandatory)
 Conduct tests according to manufacturer’s
instructions
 Record results
5.2 Cleaning Efficacy Test (optional)
Possible Causes of Test Failure
 Overloading of baskets – impedes the free flow of
water over items
 Material incompatibility
 Blocked jets in the machine
 Blocked water inlet filter on wash chamber
 Incorrect cycle temperatures
Immediately report any test failures
5.3 Ultrasonic Machine Testing
 Ensures that the machine is functioning effectively.
 Testing can be accomplished using validated test
methods to prove that the transducers are working
effectively soil is able to be removed – new test
methods in development
 Daily test or each day of use
 Document results
 Report test failures
Ultrasonic cleaning is an effective cleaning method for
instruments prior to the reprocessing
5.4 Mechanical Washer Cycle Monitoring
Proof that the mechanical washer disinfector
attains the correct parameters for the set
cycle and thus enables the conditions for
effective cleaning and/or thermal disinfection
5.4 Mechanical Washer Cycle Monitoring
Washer/disinfectors usually operate within the following
temperature ranges
Rinsing:
40°C - 50°C
Washing:
50°C - 60°C
Disinfecting:
70º for 100mins
75º for 30 mins
80º for 10 mins
90º for 1 min
Final rinsing:
80°C - 90°C
All results shall be checked prior to the release of each load and
the printout signed
5.5 Internal & External Chemical Control
External and or internal chemical control
(indicators) shall be used to identify that an
item has been through a sterilising process.
The indicators are specific to the sterilising
process being used eg. Steam, hydrogen
peroxide, ethylene oxide, peracetic acid
5.5 Internal & External Chemical Control
Control Pouch (Mandatory)
 A separate sterilising pouch with a 'control'
Class 1 chemical indicator and batch label
attached and a Class 5 or 6 Chemical Indicator
inside, must be placed onto a sterilizer tray
and used in every sterilization cycle.
5.5 Internal & External Chemical Control
Internal
 An appropriate internal multi parameter time and
temperature chemical indicator (Class 5 or 6) is used
in the following circumstances:
 In the mandatory OH Control pouch
 Where delays to access to on-site technical support
to undertake calibration, operational qualification
and performance qualification for new sterilizers or
temporarily loaned sterilizers occur.
5.5 Internal & External Chemical Control
External (Mandatory) – Class 1 chemical indicator
Examples include;
 sterilizer indicator tape
 chemical indicators found on commercially
manufactured packs/pouches
5.6 Biological Indicators
Biological indicators are used to verify the
microbial killing power of 10-6 of the
sterilisation process by using a population of
calibrated bacterial spores, on, or in, a carrier
and packaged in a manner that the integrity of
the inoculated carrier is maintained.
 Routine biological testing is not mandatory
for steam sterilisers if process is validated
5.6 Biological Indicators
Used
 Performance qualification (PQ)
 Operational qualification (OQ)
 Recommissioning and performance requalification
 In an emergency, for loads not previously validated.
5.6 Biological Indicators
 Ensure all from the same batch
 Check expiry date
 Different types depending on the length of incubation period
and type of sterilisation – not interchangeable
 If cooling required, follow manufacturer’s instructions
 If using an incubator need to have that calibrated
 If a results shows a failure, repeat a second test.
5.7 Leak Rate (Vacuum) Test
 To verify that air has not leaked into the sterilising chamber.
 The leak rate/vacuum test is not a sterilisation cycle.
 It is a special programmed cycle that draws a vacuum and
holds the vacuum for a minimum of 10 minutes. If the rate of
air that leaks into the chamber via a leaking chamber seal or
hole in piping, a pressure rise will be measured that is greater
than 1.3 kPa/0.013 bar per min over 10 minutes, a fault
indicator and printout.
 The level of vacuum will be different for each machine. The
important thing is that it remains within 1.3 kPa/0.013 bar per
min of the vacuum over the 10 minute period.
Lisa Sterilisers vacuum test
5.7 Leak Rate (vacuum) Test
Class B and Class S sterilisers with air detector – weekly
Class B and Class S sterilisers without air detector – daily
Record the results.
5.8 BOWIE DICK TYPE TEST
5.8 Bowie Dick Type Test
To detect air entrapment and evaluate the
ability of a pre-vacuum steriliser to remove
residual air that will then allow the steam
penetration and attainment of the correct
conditions for steam sterilisation.
Needs a special cycle
Daily on a warmed up steriliser before loads
Different types on the market
5.8 BOWIE DICK TYPE TEST
5.8 Bowie Dick Type Test
Daily Test
Check expiry date of pack with indicator sheet
Ensure correct storage of BDT Test
Have a colour pass/fail reference sheet
Place in empty chamber – close to drain without
touching chamber
Start “Bowie Dick type cycle”
Document results
Report abnormal/fail results immediately
5.9 Routine Cleaning of Reprocessing
Equipment
To ensure that equipment functions correctly
oral health/csd staff need to undertake a
routine cleaning and checking program of
mechanical washers and sterilisers.
Ultrasonic cleaners, Washer disinfectors
Drying cabinets, Heat sealers
Sterilisers
5.9 Routine Cleaning of Reprocessing
Equipment
Equipment
Maintenance
example
Daily
Ultrasonic
All internal and
external surfaces
Washer
disinfector
Filters, spray arms,
drains, door seals,
gaskets,
Weekly
3 Monthly
6 monthly
Clean
chamber
Replace air
filter
clean water
chambers
Drying cabinet All surfaces
Filters, door seals,
vents, door gaskets.
Steam
sterilisers
Drain, floor of
steriliser, door seal,
Validation
IQ+OQ+PQ
Commissioning
(IQ) + (OQ)
Installation
Qualification (IQ)
Operational
Qualification (OQ)
Performance
qualification (PQ)
Physical qualification &
testing
Microbiological
qualification & testing
Commissioning of sterilisers
Installation Qualification (IQ)
Proves that the steriliser and the where installed comply
with the manufacturer’s specifications
Operational Qualifications (OQ)
Determines that the installed steriliser and equipment is
working within the defined limits when used as per
manufacturer’s procedures.
These shall documented and recorded and include
calibration of all gauges, parameter monitoring, the
recording device, specific performance tests (eg leak test)
and process indicator tests (bowie dick tests)
Installation qualification (IQ)
Heat distribution study
Temperature profile “Cold Spot”
 Service technician performs (empty chamber)
whilst calibrating the temperature gauge.
 Or may be provided by the manufacturer.
 Doesn’t need to be routinely checked every time.
Annual validation
performance qualification (PQ)
What is validation?
A documented procedure for obtaining, recording and
interpreting the results required to establish that a process
will consistently yield product complying with predetermined
specifications.
What does this mean?
The entire process is documented, challenged and
repeatable, and establishes the efficacy (or not) of the
sterilising process, that is monitored by the measurement of
the critical requirements of time, temperature and pressure
and parameters during each cycle.
Validation Documentation
Important to document all your procedures!
1. pre-cleaning
2. cleaning
3. drying of instruments
4. packaging
5. Loading steriliser
6. Unloading steriliser
7. physical checks
8. sterilisation log book
9. storage of sterile items
10.validation of YOUR sterilisation process
Annual validation for every steriliser
 Understand the process
 Document training AND COMPETENCIES of staff
protocols
 Do you use 2 different cycles?
Tell the technician both need to be validated
 Confirm requirements with service technician
 Create an annual validation report
Annual validation
Before you start:
 Determine the hardest-to-sterilise item/pack, this is
known as the “challenge packs” and “challenge load”.
 Select the process parameters including time
temperature and pressure i.e. cycles to be used
 Document pack details – description of contents and
diagram of pack layout and load.
 Document loading/unloading of the steriliser – diagram
of loading pattern.
 Information available for the technician.
Performance qualification (PQ)
penetration time – document load
 The time required for the interior of the load/packs to
reach the selected temperature after that temperature has
been reached in chamber.
 Thermocouple placement inside the densest area of the
challenge pack.
 Pouches may be zero seconds.
 Pre-vacuum sterilisers may be zero
 Penetration time must be added to the required holding
time for the selected sterilising temperature. May only
need to be done once if no changes to pack contents,
packing or loading of the chamber.
Performance qualification (PQ)
physical qualification
 Time at temperature and pressure testing
 Thermocouple testing to ensure the inside of the
packs of your challenge load has reached the
selected temperature x 3 times with BI’s
 Hold at or slightly above this temperature and at the
correct pressure
 Must be done at every validation
 Whole load that will be considered your “validated,
challenged load” needs to be available.
Performance qualification (PQ)
microbiological qualification
 Microbiological testing is of the “Challenge Load and
Pack” done at the same time as the time at temp testing.
 Label and place one biological indicator in the densest
part of the challenge pack.
 Label and place one biological indicator in the ‘coldest’
part of the chamber.
 At least, 2 biological indicators used per cycle.
 Keep a biological indicator outside the chamber as a
control (never sterilised – proves the biological indicators
were alive).
Performance qualification (PQ)
microbiological qualification
 Load the steriliser using the pre-determined loading
pattern incorporating the challenge pack.
 At least, 3 consecutive cycles are run.
 Each pack must be re-packed with room temperature
contents before each of the test cycles are re-run.
 A single control indicator must be used for all cycles
which is never sterilised (control)
 All indicators (except the control) should show no
growth
Performance qualification (PQ)
microbiological qualification
 All failures (positive growth from indicators used
inside the chamber) must be investigated and
documented
 The whole procedure repeated
 If the control held outside the chamber does not
show positive growth the batch of indicators may be
faulty.
Summary
 Staff training & competencies.
 Instrument reprocessing policies and procedures
 Completed validation/revalidation certificate
 Details of heat distribution study (cold spot)
 Details of penetration time
Summary
 Time at Temperature/Total Processing Time by
technician
 Challenge Pack,
 Challenge Load and
 Loading Details
 Results of three consecutive loads biological
indicators (7 minimum)
 Steriliser Cycle Records
More Information
 Contact:
 Email: CHRISP@health.qld.gov.au
 Intranet for SOP & WSA:
http://www.health.qld.gov.au/chrisp/sterilising/oral_health
_SOP.asp