Purchasing and Commissioning of Autoclave

Group
One
Purchasing and
Commissioning of Autoclave
Group 1
1.Cassandra
2. Dk Norsyafinaz
3.Mike Mac Donald.
4.Norhafizah.
1
Learning Outcomes
• Explain procedure of purchasing and
commissioning of autoclave
2
INTRODUCTION
• Without an autoclave in CSSU the sterilization
process cannot be done.
• To meet this sterilization process in CSSU, the
autoclave must be purchase and must follow
the commissioning standard requirement.
3
Purchasing
• Sterilizer and associated equipment shall be
purchased in accordance with international
Standards (e.g; AS, EN, US) or equivalent and
shall meet user’s requirement.
AS-AUSTRALIA
EN-EUROPE NATION
US-UNITED STATE
4
Cont..
• The number of sterilizers required will depends
on the cycle time and the chamber size.
• The minimum number of sterilizers required to
the workload can be calculated as below:
Number of sterilizers required =Workload/Capacity
• It is mandatory for all type of sterilizers to be
certified under the Occupational Safety and
Health Act (OSHA) before use.
5
Cont..
• Each autoclave shall have a valid design

approval and a certificate of fitness for
operation from the Department of Safety and
Health (DOSH) before it is handed over to the
department.
6
Commissioning and Records of Equipment
Testing and Maintenance.
• Before and after installation, sterilizer and
associated equipment shall be performance tested
• Details of the equipment’s performance test
outcome shall be documented.
• The data shall be kept in the vicinity of each piece
equipment.
• Commissioning data of ongoing record of
performance data and detailed data subsequent
maintenance, calibration and performance test
result shall be maintained.
7
Commissioning consist of
1. Installation
check
Commissioning
3.
Commissioning 2.
test Installation
Tests
8
9
1. Installation Check
• The sterilizer has been supplied and installed in
accordance with the contract.
• The manufacturer has supplied all the
document specified in the contract.
• No defect are apparent from a visual inspection
of the sterilizer.
• All support, bases and fixing are secured and
without imposed strain from service
connections.
10
Cont..
• Thermal insulation is in good condition and
securely attached.
• Security and setting of door safely switched
and door locking component are in
compliance with data provided by the
manufacturer.
• Keys, codes, or tools required to operate
locked control are supplied and operate
satisfactorily.
11
Cont..
• Each key, code, or tool unlocks only the control for
which it is intended and cannot unlock control on
other sterilizers in the vicinity(environment).
• Loading cart and other aids are “effective” and
safe to use
• Check electrical equipment on the sterilizer is
correctly connected to the electrical service.
• The selection of automatic or manual control is by
key, code or tool.
12
2. Installation Test
• Calibration verification certificates for the
temperature and pressure instruments and
controllers are supplies.
• Throughout the cycle, there are no leaks of
steam, water or gas.
• Calibration at least 3 monthly.
• Time and temperature-daily and with each load
carrying implantable item.
• Leak rate test daily (e.g ; vacuum leak test to
determine the air tight integrity of a pre-vacuum
autoclaves chamber and plumbing system.) 13
Commissioning Test
• Calibration by qualified person
• Letter of acceptance
• The test person should carry out a sequence
of commissioning test to evaluate basic
performance and safety
• Steam superheat test
• Steam on condensable gas test
• Steam dryness test
14
Cont..
• Vacuum leak test
• Automatic control test
• Verification of calibration of sterilizer instrument
• Chamber wall temperature test
• Air detector performance test for a small load
• Thermometric test for a full load
• Load dryness test
• Thermometric test for a small load
15
Cont..
• Vacuum leak test
• Air detector function test
• Bowie dick test
• Sound pressure test
16
Performance qualification consist of
• Thermometric tests
• Microbiological test
• Residual gas tests
17
Performance qualification
• Process of obtaining and documenting evidence that
the sterilizer, as commissioned, will produce
acceptable goods when operated in accordance with
the operational instructions.
• Thermometric PQ is required for all sterilizers.
• Microbiological PQ tests.
• PQ tests for environmental gas and load degassing
times.
Thermometric test for performance qualification
• Suitable for all steam sterilizers, that is, porous loads,

fluids, unwrapped instruments and utensils,
• Production load under test will normally consist of
discrete items such as packs, bottles or other
containers.
Place temperature sensors in the following
positions:
a. One in each of three items known to be the slowest
to attain the sterilization temperature.
b. One in each of three items known to be the fastest to

attain the sterilization temperature.
c. If the sterilizer has a thermal door interlock, one in

each of three items known to be the slowest to cool to
80 º C.
Microbiological test for performance
qualification
• Designed to be used in exceptional circumstances as
an additional PQ test for steam and dry-heat
sterilizers.
• The microbiological test should follow a satisfactory

thermometric test, and use the identical loading
condition and operating cycle.
The test should be considered satisfactory if the following
requirements
are met
During the whole of the cycle the values of the cycle

variables as shown on the batch process record are
within the permitted tolerances marked on the master
process record established during the thermometric PQ
test.
.
Environmental gas test
• Designed to determine the concentration of

formaldehyde or EO gas discharged into the loading
area from the chamber and load at the end of a cycle.
• The concentration will vary with the type of load,

wrapping material and environmental ventilation and
temperature.
Cont…
• Should follow a satisfactory thermometric PQ test.

The loading condition, preconditioning process and
operating cycle should be identical.
• The test may be combined with the microbiological

PQ test.
On Delivery of the sterilizer the contractor
should carry out the required installation checks
to establish that the sterilizer?
• Is safe to operate
• Does not interfere with nearby equipment
• All connected services are satisfactory
• Engineering service is installed correctly
• Drain removed effluent
• Has been provided and installed correctly.
On Delivery of the sterilizer the contractor
should carry out the required installation checks
to establish that the sterilizer?
• Is safe to operate
• Does not interfere with nearby equipment
• All connected services are satisfactory
• Engineering service is installed correctly
• Drain removed effluent
• Has been provided and installed correctly.
26
CONCLUSION
• In choosing of autoclave for
better sterilization the criteria
that we should emphasize are the
autoclave must be safe, accurate,
reproducible, cost effective and
validatable.
27
THANK YOU FOR YOUR
ATTENTTION 
28

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Group

• Each autoclave shall have a valid design

• Suitable for all steam sterilizers, that is, porous loads,

b. One in each of three items known to be the fastest to

c. If the sterilizer has a thermal door interlock, one in

• The microbiological test should follow a satisfactory

During the whole of the cycle the values of the cycle

• Designed to determine the concentration of

• The concentration will vary with the type of load,

• Should follow a satisfactory thermometric PQ test.

• The test may be combined with the microbiological

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