Easi-Sterilise
Standard Operating Procedures
Section 3
Sterilizing
Section 3
Sterilising
3.1 Batching & Recording of a load prior
to sterilisation
Purpose
 MUST HAVE DOCUMENTED EVIDENCE OF ALL ITEMS
of a sterilising process = tracking/tracing proof
 Assists in the recall of an item/load
 Recording of load contents assists in compiling of
statistical data on production volume
Warning: Do Not Store Unprocessed
Items In The Sterilizer
 The sterilization cycle shall be commenced immediately after
loading.
 Warm, moist atmosphere of the chamber can lead to—
 (a) release of unprocessed items for use;
 (b) contamination of packaging by condensate;
 (c) an increase in bioburden on unprocessed items; and
 (d) the deterioration of:
 (i) chemical indicators, packaging and labelling; and
 (ii) adhesive of self seal pouches, labelling and sterilizing tape.
3.2 LOADING AND RECORDING OF ITEMS
FOR STEAM STERILISATION
Purpose
 Sterilant needs to have contact and/or penetrate all surfaces
of the all items
Do not:
 crush items together
 allow items to touch the floor, top, door or walls of the
chamber
 Allow enough space between each item for:
 air removal,
 steam penetration,
 draining of condensate
 drying to occur
Loading the steriliser
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Light items on top shelves
Heavy items on lower shelves
Porous/wrapped items on upper shelf, unwrapped lower
Wrapped perforated sets/kits/cassettes may be laid flat or
vertically
 Hollow ware must be tilted on edge in a draining position
1.to facilitate the removal of air,
2.allow steam penetration to all surfaces
3.condensation will drain from the hollow.
Vertical loading of Laminated
Packaged Instruments
Horizontal loading of laminated
pouches
 Shall be placed with the paper side facing
downward
 Not overlapping – to allow air removal, steam
penetration and condensate drainage
Reference AS/NZS 4815:2006 - 3.4.3.3 Flexible packaging pg 26
Loading hollow ware & pouches
Place hollow ware on a 45 degree angle
Loading the steriliser
 All loads/cycles must have a chemical
indicator to distinguish between processed
and unprocessed loads
 A “control” pouch containing a class 5 or 6
chemical indicator and batch label attached is
included in all loads as per direction from the
Chief Dental Officer, Jan 2010
Loading of control pouch
 The “control” pouch may be placed at the
back of the sterilizer load on the lowest shelf
(as per direction from the Chief Dental Officer,
Jan 2010) or if unwrapped items are in the
load, to prevent condensation dripping onto
the control pouch, place the control pouch on
the same shelf or above the unwrapped items
Cleaning Brushes
 Reusable cleaning brushes that are unable to be
disinfected in a washer disinfector are to be
sterilized separately. If agreed to by the engineering
department it may be possible to run this sterilizing
cycle overnight.
 If time does not permit, as a minimum requirement,
instruments are to be cleaned and dried and left
unwrapped in a dry, closed, lidded, labelled
container that clearly identifies that the items are
unsterile, to prevent contamination until processing
can occur.
Note:
 No instruments are to be sterilized overnight.
 Sterilizing of any instrument (other than
brushes) is not to occur in accordance with
the requirements AS/NZS 4815: Sections 5
and 6.
The Sterilisation Cycle
 Air removal stage & steam generation &
temperature
 pre vacuum x 1 or x 3 or x 6 vacuums
 downward displacement
 Holding/sterilisation - time at temperature
 Drying – exhaust steam
 May have a post –vacuum drying stage
Downward Displacement
Validator Plus Steriliser
.
bench top class N
downward
displacement
autoclave capable
of processing both
wrapped and
unwrapped loads
Small Pre vacuum
Lisa MB17
Lisa 500 series
Examples of sterilisation cycles
Recognised International
Temperature, Pressure, Time Relationship
International Units of Pressure
Temp C
kPa
psi
mb
bar
Holding time
(minutes)
121
103
15
1030
1.03
15
126
138
20
1380
1.38
10
132
186
27
1860
1.86
4
134
203
30
2030
2.03
3
Physical checks
Cycle completed check printout for evidence:
 Temperature has reached 134°C
 Time at 134°C > 3 mins + penetration time
 Pressure 203 kPa or 2.03 bar
stand alone printer
Other types?
In built printer
Top of the printout
New Lisa 500 series manual
W&H Lisa™
Manual
3.3 Releasing & Unloading a Sterilised Load
 To ensure that the staff unloading the
steriliser check that sterilisation has occurred
in accordance with the validated process and
authorises the release of the load
3.3 Releasing & Unloading a Sterilised Load
 Immediately cycle has completed
 Printout confirms sterilisation parameters are met - sign
Remove load - Visually check
 Chemical indicators have changed colour correctly
 No visible wet packs & packs intact
 Check items unloaded correspond with load documentation
 Check and record results of process challenge devices
(if used) on sterilizing log chart
 Check and record results of biological indicator (if used) on
sterilizing log chart
3.3 Releasing & Unloading a Sterilised Load
 Only in exceptional circumstances (such as
involved in providing direct patient care)
would a delay to removing a completed
sterilization load, be considered acceptable
and no more than 30 minutes from when the
cycle has finished.
3.3 Releasing & Unloading a Sterilised Load
Document in steriliser record/log
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Sign the sterilizer cycle printout and attach
Document time of release
Signature or identification of person releasing the load
Ensure the items unloaded correspond with load
documentation
 Attach the “control” pouch batch label
 Attach the control class 5 chemical indicator
 Immediately notify the supervisor if not met.
Each Sterilizer’s
information is written
once on the front
page
Found
on
CHRISP
Oral
Health
website
Documenting a sterilization cycle
In the case where one or more items (but not all) have failed,
in a successful cycle
3.3 Releasing & Unloading a Sterilised Load
 Considerations for unwrapped items/load – written
procedures for appropriate handling to minimise
cross contamination
 Handling
 Transfer or transportation
 Storage
Cooling items

 Away from high activity areas
 Do not use forced cooling by fans or air con.
 Do not place on solid surfaces, as condensation
from vapour (still within the pack) can result.
 Items dropped on the floor, placed on a dirty
surface, compressed, torn, have broken seals,
or are wet, are considered non-sterile and shall
be reprocessed.
Following cooling
 Where plastic dust covers are used, the item shall be
cooled before being placed in the dust cover
 Plastic dust covers – new, clean, intact, sealed.
 If dust covers are used for the purpose of storage,
they shall be labelled ‘Dust cover only’.
The key pieces of legislation relating to
recordkeeping are
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Public Records Act 2002
Public Services Act 1996
Electronic Transactions (Qld) Act 2001
Evidence Act 1977
 See also QH clinical records retention and disposal
schedule
 http://paweb.sth.health.qld.gov.au/sqrm/hims/recor
ds/documents/disposal_retention_sched.pdf
3.4 Managing a failed sterilizer cycle
and load
Common Reasons for failed cycles
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Wet items
Packaging not in tack
Chemical indicator colour change
Sterilising parameters
Steriliser printout (illegible, run out of paper)
Power outages
3.4 Managing a failed sterilizer cycle
and load
Items must be:
 Unwrap
 Re-wash if the item has become wet, was dropped on
the floor or in contact with other contaminants
 Rewrapped
 Reloaded
 Resterilised
 manufacturer’s instructions provide troubleshooting
(rectification) procedures, undertake a sterilisation cycle
with an empty chamber with a class 5 or 6 chemical
indicator
3.4 Managing a failed sterilizer cycle
and load
Documenting the failed load:
 The sterilizer print out must be fixed to the log sheet with
‘FAILED LOAD” written clearly across the print out in
permanent ink in a blank area
 The steriliser log/record must indicate that the load was
identified as failed
 If the steriliser requires maintenance, place an out of order
sign on the steriliser and inform management and
maintenance immediately