1. “Getting it right, every step of the way”
Easi-Sterilise Standard Operating Procedures & Workplace Skills Assessments
“Getting it right, every step of the way”

2. Section 5
Quality 2

3. 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 HARDNESS:
NB. Hard water is high in minerals and can leave a residue on instruments and cleaning equipment. This can cause permanent damage and shorten the life of the instrument or machine and may also interfere with the action of the cleaning agent.
Water hardness is determined by the amount of calcium and magnesium ions present in the water
If a grey / white residue appears on the medical and surgical equipment after cleaning this can have a detrimental effect on the item and transference of this residue to a patient could have serious consequences
Hardness can affect the activity of the detergent used for cleaning and may require increased concentrations of detergent
Certain chemical formulations are only designed for soft water use and will allow hard water salts to precipitate out
Reverse Osmosis water is to be used for final cleaning rinse and in the sterilizer
TESTS & MAINTENANCE
Water testing can either be conducted by maintenance departments, or by chemical distribution representatives
Detergent precipitation is particularly difficult to remove. In all cases precipitation is accelerated as water temperature increases. E.g. Initial wash temperature too high
Report any residue left on instruments to the supervisor
TESTING FREQUENCY (OPTIONAL):
Daily:
Detergent residue
Weekly:
Water pH test
Water hardness
At least monthly, and more frequently depending on water hardness test results:
Chlorine/chlorine residue
Iron
RECORDING/DOCUMENTATION:
Record all test results
Retain test strips if applicable and affix to record/documentation

4. Water quality for cleaning
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
Source AS 4187: pg 17
Water hardness is determined by the amount of calcium and magnesium ions present in the water and can be easily tested with test kits available from most chemical manufacturers.
High water hardness will leave a white-grey coloured residue on all types of surfaces, which in the case of instruments will shorten their life span. Water hardness also affects the activity of the detergent, requiring increased concentrations. Water hardness can be determined on the following scale:
Water hardness Range, μg/g
Soft to medium 0 to 75
Medium to hard 76 to 140
Hard to very hard 141 to 240
Very hard to extreme >240
The effect of water hardness on both instruments and cleaning/disinfection equipment should be recorded. Consideration should be given to the use of softened, filtered, demineralized, or even distilled water in at least the final rinse stage of the washing process and preferably all washing stages. Water treatment, reverse osmosis or softening units should be selected having regard to the total demand, volume and rate of treated/softened water required in the instrument washing area. Water with high mineral content is unsuitable for the rinsing of instruments due to mineral deposits permanently damaging and seriously shortening the life of the instruments. High mineral content may also interfere with the efficacy of cleaning agents.
Care shall be taken in the selection of detergents and drying agents used in instrument cleaning, particularly if the water supply is not treated or softened.
NOTE: Certain detergent formulations are only designed for soft water use and will allow hard water salts to precipitate out onto equipment. In some cases, parts of the detergent will also precipitate out. Detergent precipitation is particularly difficult to remove. In all cases, precipitation is accelerated as water temperature increases.

5. 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
FREQUENCY OF TESTING
At commissioning of mechanical washer to determine loading patterns/configurations
Weekly (not mandatory)
Conduct tests according to manufactures instructions
Record results

6. 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 
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
FAILED TESTS
If any test fails the supervisor is to be notified and the machine must be place out of action until the fault is rectified

7. 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
Aluminium Foil Strip Test
Ceramic Disk Test
Other tests methods
In accordance with manufacturer’s instructions
FREQUENCY OF TESTING
Daily or each day that the ultrasonic machine is used.
Document results
FAILED TESTS
If any test fails the shift supervisor is to be notified and the machine must be place out of action until the fault is rectified

8. Effective cleaning of instruments prior to the reprocessing is a vital pre-requisite to effective sterilisation.
Minute particles of debris and/or dried blood can provide a haven allowing micro-organisms to survive the sterilisation process.
Therefore, it is absolutely essential that instruments must be clean and dried prior to sterilisation
Ultrasonic cleaning is an effective cleaning method for instruments prior to the reprocessing 8

9. 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
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
FREQUENCY
Monitoring is conducted for each cycle when thermal disinfection is the end process. The printout is checked, signed and retained for 10 years(18 years plus 10 years if items used on children) (as per QH policy - Retention and Disposal Schedule for Medical Records )
MECHANICAL WASHERS WITHOUT CYCLE PRINTOUTS
Visual check that the cycle has meet temperature requirements
These mechanical washer/disinfectors should not be used when thermal disinfection is the end process
FAILED TESTS
If any cycles fail to reach the pre-determined parameters, the supervisor is to be notified and the machine place out of action until faults are rectified

10. 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
MECHANICAL WASHERS WITH CYCLE PRINTOUTS
At the end of each mechanical wash cycle the cycle print out is checked to ensure that the cleaning/disinfection parameters have been met, e.g.
Washer/disinfectors usually operate within the following temperature ranges
Rinsing: °C - 50°C
Washing: °C - 60°C
Disinfecting: 70°C - 95°C
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
Programming of cycles may be set to suit the facility, type of machine, manufacturers’ instructions and also for use when mechanical cleaning is preferred for heat sensitive items with foul soiling
FREQUENCY
Monitoring is conducted for each cycle when thermal disinfection is the end process. The printout is checked, signed and retained for 10 years(18 years plus 10 years if items used on children) (as per QH policy - Retention and Disposal Schedule for Medical Records )
MECHANICAL WASHERS WITHOUT CYCLE PRINTOUTS
Visual check that the cycle has meet temperature requirements
These mechanical washer/disinfectors should not be used when thermal disinfection is the end process
FAILED TESTS
If any cycles fail to reach the pre-determined parameters, the supervisor is to be notified and the machine place out of action until faults are rectified

11. 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
External (Mandatory)
Visually denotes that a package has been exposed to the physical conditions present inside the steriliser chamber and not within the pack itself:
Sterilising tape on the outside of all wrapped items (Class 1 indicator)
Single items in flexible packaging to be packaged in a pouch specific to the sterilising process being used, with a visible chemical impregnated indicator, usually located in the edge seal, or on the opening end of pre-formed pouches
Closure security tags for rigid containers may also contain an impregnated indicator
After sterilisation and prior to use the external indicator is checked to ensure it indicates the item has been exposed to a sterilisation process
Internal
Internal indicators and their use depends on the oral health facilities protocols. If wrapped items are two consecutive wraps, it is usual practice for the pack to be opened by the assistant and the operator is to visually check the external indicators and the internal chemical indicator to ensure the item is sterile.
Internal chemical indicators classes are as follows
Class 3: single parameter indicators (Optional) - commonly used in dry heat sterilisers.
A single parameter indicator that responds to only one critical parameter required for specific sterilisation process eg temperature or steam
Class 4: multi-parameter indicator for two or more critical parameters (Optional)- commonly used in steam sterilizers
Is a multi parameter indicator and is designed to react to two or more critical parameters, it indicates exposure to a sterilisation cycle at stated values
Class 5: integrating indicators designed to react to all critical parameters (Optional) commonly used in steam sterilizers
Is an integrating indicator which is designed to react to all required parameters of a particular sterilisation process and at a greater than specific range? The performance and confidence level of an integrator is compared to the inactivation of a test organism
Class 6: emulating indicators designed to react to all critical parameters for cycle verification (Optional) commonly used in steam sterilizers
Used in steam sterilisers providing an integrated response to the various combinations of temperature, time and pressure and the presence of steam. Confirm the correct sterilising conditions within the sterilising chamber and aids in the detection of sterilising malfunctions and human error 11

12. 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.

13. 5.5 Internal & External Chemical Control
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.

14. 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

15. 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
Routine biological testing is not mandatory for steam sterilisers, though it remains a common practice
Biological indicators are to be used according to sterilizer and biological manufacturers instructions
If a challenge pack is not available use inside a bundle that can challenge the steriliser.
Biological testing is required to be performed during IQ (Installation qualification), OQ (Operational qualification) and PQ (Performance testing). This forms part of commissioning.
Biological testing also forms part of the testing protocol for annual re-qualification of steam sterilisers
In a steam steriliser, place the biological indicator test pack in the areas as identified as ‘cool’ spots during chamber mapping.
If supplementary testing is required the test should be carried out on the first full load of the day (label vial with batch information). The amount of vials used per load is determined by the size of the sterilizer chamber.
Always use an unprocessed vial as a control; to be from the same lot number as the vial/s being processed. Label with date and that it is the ‘control’
When the processed vial is taken out of the steriliser, check the class 1 chemical indicator on the label has changed colour correctly, prepare it and the ‘control’ ready for incubation. Follow the manufacturer’s instructions
Leave the biological indicator vials in the incubator for the directed time; 3 hours or 48 hours
The sterilised vial should have no growth – negative, and the control should have growth - positive
Recording of results shall be clear and precise (batch information & placement in the steriliser).
If the sterilised vial has growth – positive, it is recorded as a FAIL , report the result to the supervisor, isolate load contents, and steriliser to be ‘Out of Order’ until proved safe to use;
Dispose of the incubated vials in the ‘sharps’ waste.

16. 5.6 Biological Indicators
Used
Performance qualification (PQ)
Operational qualification (OQ)
Recommissioning and performance requalification
In an emergency, for loads not previously validated.
Biological indicators are to be used according to sterilizer and biological manufacturers instructions
If a challenge pack is not available use inside a bundle that can challenge the steriliser.
Biological testing is required to be performed during IQ (Installation qualification), OQ (Operational qualification) and PQ (Performance testing). This forms part of commissioning.
Biological testing also forms part of the testing protocol for annual re-qualification of steam sterilisers
“ Frequency of use of biological/enzymatic indicators
Biological/enzymatic indicators shall be used as follows:
(a) During performance and operational qualification.
(b) In an emergency, for loads not previously validated.
(c) As part of the recommissioning and performance requalification.
(d) In each load for ethylene oxide sterilization. The number of biological indicators used
in each load will be dependent on the chamber size and load density (see also
ISO 11135).
(e) For peracetic acid and hydrogen plasma sterilization, weekly.” Source: AS4187:2003 pg

17. 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.
Different types depending on the length of incubation period and type of sterilisation – not interchangeable
Ensure all from the same batch
Check expiry date
If cooling required follow manufacturer’s instructions
If using an incubator need to have that calibrated

18. 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.
Leak rate/vacuum test is undertaken on an empty chamber prior to Bowie Dick test.
Check the steriliser manufacturer’s instructions for instructions on whether the chamber should be warm or cold.
Close steriliser door and initiate leak rate cycle
Printout/Graph parameters should read
Evacuate: air removal to minus 0.9 bar or minus 90 kPa (5 mins stabilisation time)
Measure: vacuum to minus 0.9 bar or minus 90 kPa (10 mins monitoring period) this will fault if it exceeds over bar or 1.3 kPa.
Air admission: filtered sterile air is not allowed to enter the chamber until it reaches 0 bar or 0 kPa (atmospheric pressure).
End of the cycle: the buzzer will indicate the completion of a successful cycle.
Fault: the fault light will indicate an unsuccessful cycle (inform maintenance immediately). Machine cannot be used until the problem is solved. Place an out of order sign on the machine until cleared for use and report to the supervisor. 

19. Lisa Sterilisers vacuum test
A pressure reading is taken again at this point (p3)
P3 –P2 ≤ 1.3 kPa  or bar
An example of a pass leak rate /vacuum test is
P bar  (84 kPa)
P3   bar
= no change = pass= no leak detected
If there is no leak the pressure will not have changed and the printout will read Vacuum test OK  or Pass.
However, small changes in the pressure are permitted up to and including 1.3 kPa (0.013 bar)  in 10 minutes
P3   bar (83 kPa )
= a bar change = 1 kPa change which is less than a 1.3kPa change in 10 minutes = Pass
If there is a leak the pressure will have changed from a deep vacuum reading and moved closer to atmospheric pressure
P2  bar
P3  -0.82 bar
=  Change is 0.02 bar (2 kPa) which is more than 1.3kPa in 10 minutes = Fail

20. An example of a Lisa MB 17 vac test follows.
After the start of the test (P1 reading) , a deep vacuum is drawn in the chamber. A waiting/stabilisation period of 5 minutes allows the air to be removed and any remaining moisture will changes to steam,
The vacuum reading should start at a vacuum (pressure) reading after 5 mins (P2 reading) reach and stay at a pre determined vacuum/pressure (P3 reading) hold at that vacuum/pressure for a period of 10 minutes.
 A pressure reading is taken again at this point (p3)
P3 –P2 ≤ 1.3 kPa  or bar
 An example of a pass leak rate /vacuum test is
P bar  (84 kPa)
P3   bar = no change = pass= no leak detected
If there is no leak the pressure will not have changed and the printout will read Vacuum test OK  or Pass.
However, small changes in the pressure are permitted up to and including 1.3 kPa (0.013 bar)  in 10 minutes
 P bar  (84 kPa)
P3   bar (83 kPa ) = a bar change = 1 kPa change which is less than a 1.3kPa change in 10 minutes = Pass
Therefore what constitutes a fail?
If there is a leak the pressure will have changed from a deep vacuum reading and moved closer to atmospheric pressure
P2  bar
P3  -0.82 bar  =  Change is 0.02 bar (2 kPa) which is more than 1.3kPa in 10 minutes = Fail 

21. 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.
Leak rate/vacuum test is undertaken on an empty chamber prior to Bowie Dick test.
Check the steriliser manufacturer’s instructions for instructions on whether the chamber should be warm or cold.
FREQUENCY OF TESTING
Weekly (if air detector fitted) prior to air removal/steam penetration testing
Daily (no air detector) prior to air removal/steam penetration testing.
Installation qualification
Operational qualification
Performance qualification
FAILED TESTS
Report any failed leak rate/vacuum tests. If any test fails the supervisor is to be notified and the machine place out of action until the fault is rectified.

22. 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
Steam Steriliser Vacuum System
If the steriliser’s steam supply is turned off, or the steriliser has not been used in the evening/night a warm up cycle must run be performed before a Bowie Dick test is carried out.
The test shall be performed before loads are processed each day.
FREQUENCY OF TESTING
Daily (Mandatory)
Reasons for air removal from the chamber
Air hinders the penetration of steam onto porous articles and the opening of containers.
A mixture of air and steam results in a lower temperature at any pressure.
Steam and air are reluctant to mix, resulting in great variations in temperature through out the chamber.
Temperatures within the chamber shall be maintained to allow the destruction of bacteria and spores.
FAILED TESTS
If any test fails the shift supervisor is to be notified and the machine place out of action until the fault is rectified

23. 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
Using test pack with indicator sheet:
Check test pack with indicator sheet that is within the expiry date
Place cycle (batch information – cycle number, steriliser number, date and name, signature of operator) information on outside of test pack.
Place the test pack in an empty chamber by positioning it as close to the drain line as possible on a metal rack/or upside down basket or lowest shelf of steriliser carriage/trolley. This is to ensure the test is not performed on the floor of the sterilising chamber.
The test is performed on the normal holding time cycle (3 mins kill time) as this simulates cycles to be performed throughout the day.
All new sterilisers have a cycle for a specific Bowie Dick test (time saver and better result).
Close the door of the steriliser and initiate the cycle.
A colour guide for the test pack shall be available to enable interpretation of the test results (check this guide is available).
On completion of the cycle, remove the test pack and retrieve the test sheet from the middle of the bundle, interpretation of the results shall be read by two (2) staff recorded and stored for ten (10) years (as per QH policy - Retention and Disposal Schedule for Medical Records)
If the air removal stage is functioning properly an even colour change will be evident. This test will also show if temperatures exceeded or do not reach the required limit. This test also highlights steam quality (wet etc.)
If the results of the test sheet highlight a problem, record result and report to the supervisor, place an out of order sign on the steriliser until the problem is rectified and permission is given to re-commence using the machine.
FREQUENCY OF TESTING
Daily (Mandatory)
Reasons for air removal from the chamber
Air hinders the penetration of steam onto porous articles and the opening of containers.
A mixture of air and steam results in a lower temperature at any pressure.
Steam and air are reluctant to mix, resulting in great variations in temperature through out the chamber.
Temperatures within the chamber shall be maintained to allow the destruction of bacteria and spores.
FAILED TESTS
If any test fails the shift supervisor is to be notified and the machine place out of action until the fault is rectified

24. 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
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
MECHANICAL WASHERS
DRYING CABINETS
STEAM STERILISERS
REPORTING
Report any damage or concerns regarding the , the supervisor is to be notified
The machine is placed out of action until faults are rectified
Sterilising staff must facilitate regular routine maintenance by steriliser maintenance staff, either under contract or trained staff in some larger facilities for them to undertake the required preventative, routine maintenance schedules as outlined in AS/NZS4815.

25. 5.9 Routine Cleaning of Reprocessing Equipment
Maintenance example
Daily
Weekly
3 Monthly
6 monthly
Ultrasonic
All internal and external surfaces
Washer disinfector
Filters, spray arms, drains, door seals, gaskets,
Drying cabinet
All surfaces
Filters, door seals, vents, door gaskets.
Steam sterilisers
Drain, floor of steriliser, door seal,
Clean chamber
Replace air filter
clean water chambers
Example of routine maintenance schedule
ULTRASONIC CLEANERS
At the end of each day of use the ultrasonic cleaner is;
Emptied
External surfaces, lid, chamber and drain wiped with a solution of ultrasonic detergent and water rinsed
Dried with a disposable low-lint cloth
Where flushing type ultrasonic cleaner is used, run a complete empty cycle with fresh water and detergent, empty and leave dry after the final use for the day
MECHANICAL WASHERS
Daily surface cleaning
Checking and cleaning filters and
Checking and cleaning door seals
Checking and cleaning jets and spray arms
Checking and cleaning door gaskets
Checking that detergent and rinse dispensers are clear and functioning
DRYING CABINETS
Checking and cleaning vents
STEAM STERILISERS
Floor of the steriliser is free of debris
Recording devices are functioning
Door gasket is undamaged
Air filter is clean
Chamber drain is clean and free of debris
Loading tray/trolley and external surfaces are cleaned daily
Steriliser chamber is cleaned weekly
FREQUENCY OF CLEANING FOR ALL EQUIPMENT
Daily or more frequently if necessary to ensure optimal functioning (unless otherwise stated)
REPORTING
Report any damage or concerns regarding the , the supervisor is to be notified
The machine is placed out of action until faults are rectified
Sterilising staff must facilitate regular routine maintenance by steriliser maintenance staff, either under contract or trained staff in some larger facilities for them to undertake the required preventative, routine maintenance schedules as outlined in AS/NZS4815.

27. 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)
Proves that the steriliser and the where installed comply with the manufacturer’s
specifications
Operational Qualification (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 type tests)

28. 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.
Service technician performs (empty chamber) whilst calibrating the temperature gauge (if you haven’t already got this information from a previous validation report)
May be provided by the manufacturer
Doesn’t need to be routinely checked every time.
Heat distribution study
Temperature profile “Cold Spot”
Service technician performs (empty chamber) whilst calibrating the temperature gauge.
Or may be provided by the manufacturer.

29. 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.
To be performed annually or when significant changes are made to any aspect of reprocessing activities, eg changes to packaging materials, loading configurations and sterilisation process parameters.
What does it show?
It demonstrates the steriliser conditions throughout the “hardest to sterilise – documented or referenced load” have been attained.
It is done through the physical checking of the sterilisation parameters using a thermocouple or data logger, undertaking other special testing as required (air detector function tests etc).
It is done through the microbiological testing – the use of biological indicators.
AS/NZS 4815 states the annual validation process shall be performed in consultation with practice staff 29

30. Validation Documentation
Important to document all your procedures!
pre-cleaning
cleaning
drying of instruments
packaging
Loading steriliser
Unloading steriliser
physical checks
sterilisation log book
storage of sterile items
validation of YOUR sterilisation process
Important to document all your procedures!
pre-cleaning
cleaning
drying of instruments
packaging
loading and unloading steriliser
physical checks
sterilisation log book
storage of sterile items
validation of YOUR sterilisation process 30

31. 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
Understand the process
Document training AND COMPETENCIES of staff protocols
Do you use 2 different temperature cycles –
Tell the technician both need to be validated
Confirm requirements with service technician
Create an annual validation report 31

32. 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.
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 32

33. 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.
Technician performs this test. All the different tests that are undertaken as part of
Performance Qualification need to be performed in consultation with the practice staff.
“The time required for every part of a load to reach the selected sterilizing temperature after that temperature has been reached in the sterilizing chamber.” AS/NZS 4815:2006
Thermocouple placement inside the densest area of the challenge pack.
Pouches may be zero seconds.
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
Practices need to document (including a diagram or picture) the challenge pack and load and How the chamber was loaded. Eg. Pouches on top shelf, trays on bottom shelf. 33

34. 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.
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.
Appendix G of AS/NZS 4815 pages 91 and 92 describe this in detail. 34

35. 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).
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). 35

36. 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
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

37. 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.
All failures (positive growth from indicators used inside the chamber) must be
investigated and documented and the whole procedure repeated
If the control held outside the chamber does not show positive growth the batch of
indicators may be faulty

38. Summary Staff training & competencies.
Instrument reprocessing policies and procedures
Completed validation/revalidation certificate
Details of heat distribution study (cold spot)
Details of penetration time
Staff training & competencies.
Instrument reprocessing policies
Completed validation/revalidation certificate
Details of heat distribution study (cold spot)
Details of penetration time

39. 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
Time at Temperature/Total Processing Time by technician
Challenge Pack,
Challenge Load and
Loading Details
Results of seven (7 minimum) biological/enzymatic indicators
Steriliser Log

40. More Information Contact:
Intranet for SOP & WSA: