SAFE WORK PROCEDURE
Activity/Task:
Sterilisation Process Monitoring - 3M Attest 1262 Biological Indicator
SWP No:
Trim No:
Version No:
Date Signed Off:
Approved: Yes / No
RISK IDENTIFICATION AND CONTROLS:
Please include all steps involved in the performance of the task
NOTE: All PPE required must be listed and the minimum PPE for each chemical must be listed as per the relevant SDS.
PROCEDURE STEPS
1.
Scope: This SWP outlines the method for monitoring the effectiveness of steam sterilisation processes in the laboratory using Geobacillus steareothermophilus spores
in media with a colour indicator. A successful sterilisation process is indicated by the media colour remaining purple. A visual colour change, from purple to yellow,
indicates a sterilisation process failure.
2.
Objectives:

To ensure the autoclave/steriliser is working optimally

To ensure sterilisation of biological/clinical waste, and podiatry instruments is successful before disposal or reuse.
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3.
References:
3M Attest Steam Incubator Operating Manual
CSU Biosafety Manual
SOP 13 Autoclave Siltex 250D
SWP - Autoclave Thermoline HS60VD – Operation and Maintenance (in progress)
SWP - Autoclave (Melag Euroklav 23VK+) – Operation and Maintenance
SWP – Personal Protective Equipment (PPE) – Appropriate Use of
AS 2182-1998 – Sterilizers – Steam – Benchtop
4.
Timing:
School of Community Health Prep Laboratory (Building 666, room 234) – Sterilisation using the biological indicator is monitored monthly during periods of high use
(i.e. session 1)
Community Engagement and Wellness Centre (Building 715, Sterilising room) – Sterilisation is monitored using the biological indicator every 6 months
5.
Responsibilities:
Technical Staff only to perform steam sterilisation process monitoring
Academics:- NA
Technical Staff: - To ensure sterilisation processes are monitored and recorded as per specific testing schedule
Ensure any unsuccessful sterilisation runs are repeated and followed up prior to any further use of the autoclave
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To ensure other users of the autoclave/sterilisers are aware of any problems associated with the sterilisation processes.
Researchers/Research Students: - To inform technical staff of any sterilisation cycles that fail so a biological indicator test can be run.
Students: Students are not to undertake sterilisation processing.
6.
In the event of: (emergency or other)
Emergency:
Follow facility guidelines and induction procedures
Equipment Failure:
7.
Contact technical staff or Facility Manager
Location:
Albury Wodonga Campus Building 666 Room 234 – Prep Laboratory
Albury Wodonga Campus – Community Engagement and Wellness Centre - Building 715 Sterilisation Room
8.
Training Requirements:
Use of autoclave, steam steriliser
Use of 3M Attest biological indicators and steam incubator
9.
Plant and Equipment Details:
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3M Attest Steam Incubator
10. PPE Requirements
Standard PPE requirements for working in the laboratory i.e. laboratory gown, gloves, safety glasses. Refer to the SWP - Personal Protective Equipment (PPE) –
Appropriate Use of.
PPE for removing items from autoclave – laboratory gown, safety glasses, heat proof gloves, closed in , impervious footwear.
11. Engineering Details, Certificates, Work Cover Approvals: NA
12. Maintenance Requirements:
Annual electrical test & tag of 3M Attest Steam Incubator
Annual steriliser calibration –
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12. Task/Activity Steps:
1.
Plug incubator in and allow to warm-up for 30 minutes before use
Possible Hazards:
Safety Controls:
 Electrical shock
 Incubator is tested for electrical safety every 12 months by
technical staff
Risk Score:
6
2:Place an Attest biological indicator horizontal or cap up with a full load in a test tray or package (depending on the load being run) in the most challenging area for the
sterilant. This is generally on the bottom shelf, near the door and over the drain.
 Process the load as usual
 After completion of the cycle, fully open the steriliser door for a minimum of 5 minutes prior to removing the Attest biological indicator
 Allow indicator to cool for 10 minutes. If the indicator has been in a sterilope bag, open bag for 5 minutes to dissipate heat prior to removing the indicator. Once
removed, allow indicator to cool for 10 minutes
Possible Hazards:





Heat / steam causing burns to skin or eyes
Microbial contamination of body or clothing
Cuts from damaged containers / glassware
Sprains/strains from lifting
electrical stock
Safe Work Procedure
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Safety Controls:
All appropriate staff members should be trained in the use and
maintenance of the Siltex 250D steam steriliser.

Refer to SOP13 – Autoclave Siltex 250D, Autoclave,
Thermoline HS60VD, SWP, Autoclave, Melag Euroclave
23VK+, SWP.

All material to be autoclaved will be stored separately
according to the type of sterilisation required.

Items to be autoclaved should be stacked inside the
Risk Score:
5
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autoclave so as not to overload.

Waste autoclave bags must be left open and a ‘ThermologS’
indicator strip added to each load to ensure successful
sterilisation. Caps on bottles should be loosened slightly.

The door of the autoclave must NOT be opened during
sterilisation or while the chamber is under pressure.
Note: A door locking mechanism prevents the door handle
rotation until pressure is the chamber drops.

Laboratory coat/gown and heat proof gloves shall be
worn to provide protection from heat.

Caution: The tray, load and steriliser are VERY HOT.

Any cuts or burns sustained from damaged containers or
hot metal should be treated in the appropriate manner. An
accident/incident report shall be forward to HR and the
Facility Manager.

Any fault associated with the autoclave should be reported
to a technical officer.

Unauthorised or untrained personnel should not work with
the autoclave.

The autoclave will be maintained according to
manufacturer’s recommendation, refer to appropriate SOP
or SWP.
3:
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
Position the indicator in the incubator’s metal block, placing the bottom of the indicator into the metal heating block so that the indicator is at an angle of approx
45o and the cap is above the metal block

Push the indicator straight back. This crushes the ampoule and activates the indicator

Push the activated indicator down to seat it in the metal heating block ensuring the cap remains above the metal block.

Incubate an unprocessed Attest biological indicator (positive control) at the same time to ensure correct incubation conditions, viability of indicators, and
capability of media to promote rapid growth. The control should be from the same lot number and manufacturing date as the processed indicator. Label it with a
‘C’

Incubate processed and control biological indicators for 48 hours at 56oC
Possible Hazards:
 Bursting of glass ampoule – possible infection
Safety Controls:

 Cuts from crushing glass ampoule by hand
 Infection from using a load from a failed sterilisation cycle
Wear safety glasses and gloves when removing the ampoule
from the autoclave or steriliser

Allow ampoule to cool before crushing or excessive handling

Wear safety glasses when crushing the ampoule

Do not use fingers to crush the glass ampoule

Handle the biological indicator by the cap when crushing
and tapping
Risk Score:
6
4:
 Observe the biological indicators for colour change
Note: The processed indicator should remain purple in colour which indicates an adequate sterilisation process. If it has changed to yellow the sterilisation process
has failed. The control indicator should change from purple to yellow which indicates the viability of the indicators, capability of the indicator media to promote
rapid growth and to ensure the correct incubation conditions. If the indicator remains purple then the observations of the processed indicator are null and void. If
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the test or control indicators have failed follow the following safety controls.
 Record the sterilised and control biological indicator results
Possible Hazards:
 Misinterpretation of the indicator colour or no change in colour resulting in
an incorrect test result
Safety Controls:

Do not use or dispose of items sterilised in the loads where
either the sterilisation has failed or the control indicator
failed

Retest the steriliser and do not use the steriliser for
sterilising items until the biological indicator results are
negative

Check sterilisation for errors

Ensure the correct biological indicators are used

Check use by date and storage conditions of indicators
(ensuring they are within their use by period and are stored
under the right conditions (15 – 30C and 35 – 60% humidity)

Check incubator for any malfunctions
Risk Score:
5
5:
Possible Hazards:
Safety Controls:
Risk Score:
Safety Controls:
Risk Score:
6:
Possible Hazards:
7:
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Possible Hazards:
Safety Controls:
Risk Score:
Safety Controls:
Risk Score:
8:
Possible Hazards:
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SAFE WORK PROCEDURE:
Assessment dates
Initial assessment date: 5 September 2013.
Current assessment date:
Reassessment due date:
Assessors:
Name:
Signature:
Date:
Amanda Eddy
5/9/2013
Recommendation: (Technical Officer/Supervisor/Manager)
Follow up required: Yes / No
Name:
Date:
Signature:
Cherryl Kolbe
05/09/2013
Approval: (Facility Manager, Head of School, Manager University Laboratories)
Name:
Kylie Kent
Safe Work Procedure
Version 1: Sept 2012
Signature:
Date:
25/10/2013
Page 10
Risk Assessment Matrix:
Evaluate the level of risk associated with the hazard identified.
SEVERITY
LIKELIHOOD
How severely could it hurt someone
How likely is it to be that bad?
or
How ill could it make someone?
!!!! Kill or cause permanent
disability or ill health
++
+
-
--
Very likely
Could happen at any time
Likely
Could happen sometime
Unlikely
Could happen, but very
rarely
Very unlikely
Could happen, but probably
never will
1
1
2
3
!!!
Long term illness or serious injury
1
2
3
4
!!
Medical attention and several days
off work
2
3
4
5
!
First aid needed
3
4
5
6
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I have read and understand this Safe Work Procedure:
Name:
Safe Work Procedure
Version 1: Sept 2012
Position/Role:
Signature:
Date:
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