STANDARD OPERATING PROCEDURE Operation, Cleaning and Maintenance of Vertical Autoclave
STANDARD OPERATING PROCEDURE |
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Department: Quality Control
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SOP No.: QC/MB/xxxx
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Operation, Cleaning and Maintenance of Vertical
Autoclave
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Effective
Date:
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Review
Date:
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Page
No.: 1 of 4
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1.0
OBJECTIVE:
1.1
To lay down a procedure for operation, cleaning and maintenance of vertical
autoclave.
2.0
SCOPE:
2.1
This procedure is applicable for
vertical autoclave located in Microbiology Laboratory at Pharma Private
Limited.
ID. No.:xxxx
Make: xxxx
3.0
RESPONSIBILITY:
3.1
Microbiologist – Responsible for Operation of autoclave.
3.2
Section In-charge – Responsible for review the procedure and activity.
3.3
QC Head – Responsible for implementing the Procedure.
3.4
QA Head – Overall compliance.
4.0
PROCEDURE:
4.1
Operating
procedure:
4.1.1
Ensure that the equipment is clean.
4.1.2
Open the lid of autoclave by rotating the knobs in
anti-clockwise.
4.1.3
Pour sufficient water (process water) into autoclave.
4.1.4
Transfer material for destruction (used culture slants
and media flasks, plates etc.) into a stainless steel container or bowl and
place it in the autoclave.
4.1.5
Keep a
sterilization indicator in each and every destruction cycle to ensure the
destruction cycle is effective and the contents have been sterilized properly.
4.1.6
Close the lid of autoclave by rotating the knobs in
clockwise direction.
4.1.7
Each destruction load is assigned a specific load number as given below
AUT-V/YYZZZ,
Where, AUT-V stands
for Autoclave Vertical,
YY stands for last two digits of
the year,
ZZZ stands for serial number
starts from 001.
4.1.8
Load details shall be entered in Annexure –II (autoclave usage
log sheet).
4.1.9
Switch on the mains and maintain 15 lb/inch2 pressure up to 30 minutes.
4.1.10
Note down the timing of cycle start time,
sterilization start time (when the pressure reach 15 lb/inch2),
sterilization end time and cycle end time in Annexure –II (autoclave usage log
sheet).
4.1.11
By maintaining the 15 lb/inch2
pressure the temperature of the autoclave will reach up to 121°C (Destruction
parameters are 121°C/15 lb/inch2 pressure for 30 minutes).
4.1.12
Switch off the power supply and wait till pressure reading reaches ‘Zero’.
4.1.13
Open the lid by rotating the knobs in anticlockwise direction.
4.1.14
Check the sterilization indicator for colour change and it shall be
signed by the operator along with date and load number.
4.1.15
Remove the destructed material from the autoclave and allow cooling up to
approximately 40ºC to 50ºC and follow the cleaning procedure as per current
version of SOP QC/MB/xxx (Disposal of used media and
cultures).
4.1.16
Pour all destructed material into a polythene bag and send to effluent
treatment plant for disposal.
4.1.17
Record the details in Annexure – II (autoclave usage log book) and affix
the sterilization indicator also.
4.2
Cleaning:
4.2.1
Before starting the cleaning procedure, disconnect
power supply to the autoclave.
4.2.2
After completion of every destruction cycle the
autoclave shall be cleaned with any of disinfectant solution (1% Bacillocid
special or 1% Hospal -OT, 5% Dettol, 5% Savlon).
4.2.3
Finally rinse with purified water and allow to dry.
4.2.4
Entry shall be made in autoclave cleaning log sheet of Annexure – I.
4.3
Maintenance:
4.3.1
Check the outer body of autoclave for corrosion and
cracks.
4.3.2
The rubber gasket is checked for cracks and damaged
gaskets are replaced promptly.
4.3.3
Ensure the autoclave is free from leakages before
operation.
4.3.4
Check the water level before starting of autoclave.
5.0
ABBREVIATIONS:
QC: Quality Control
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QA: Quality Assurance
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%:
Percentage
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IPA:
Isopropyl alcohol
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°C:
degree centigrade
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SOP:
Standard Operating Procedure
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