STANDARD OPERATING PROCEDURE Operation, Calibration, Cleaning and Maintenance of Vertical Autoclave
|
|
STANDARD OPERATING PROCEDURE |
|
|
Department: Quality Control
|
SOP No.: QC/MB/
|
|
|
Operation,
Calibration, Cleaning and Maintenance of Vertical Autoclave
|
Effective
Date:
|
|
|
Review
Date:
|
||
|
Page
No.:
|
||
1.0
OBJECTIVE:
1.1
To lay down a procedure for operation, calibration, cleaning and maintenance
of vertical autoclave.
2.0
SCOPE:
2.1
This procedure is applicable to Vertical Autoclave located in
microbiology laboratory at Pharma Private Limited.
ID No.
Model No.:
3.0
RESPONSIBILITY:
3.1
Microbiologist: Responsible for operation of instrument.
3.2
Section In-charge: Responsible for review the
procedure.
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 direction.
4.1.3
Pour sufficient water (process water) into autoclave
(up to the stand).
4.1.4
Transfer material for destruction (used culture
slants, agar media petri plates, media conical flasks and test tubes etc.) into
a stainless steel container and place it in the autoclave along with a
sterilization indicator and close the lid by rotating the knobs in clockwise
direction.
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
Each destruction load is assigned a specific load number as given below
AUB-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.
4.1.7
Load details shall be entered in Annexure –I.
4.1.8
Switch on the mains.
4.1.9
After switch on the mains the micro-processor
controller (MPC) display will shows “Print?” press “PRN/ACK” key to print the
cycle data, then the display will show present temperature of four temperature
sensors.
4.1.10
Set the required temperature by pressing “PROG” key
then the display show “STER TEMP (° C) 120”.
4.1.11
Press UP or DOWN (▲ or ▼ ) keys to increase or
decrease the set temperature and press “ENTER” key to save the new set point
(121°C).
4.1.12
Now the display shows “STER TIME (mins) 020”.
4.1.13
Press UP or DOWN (▲ or ▼ ) keys to increase or decrease the set time and press “ENTER” key to save the new
set point (30 minutes).
4.1.14
Always run the destruction autoclave cycle with
standard parameters like 121°C
temperature, 15 psi pressure for 30 minutes.
4.1.15
To start the cycle press “START/STOP” key.
4.1.16
Air purging relay is ON and it is indicated on the LED
till the temperature reaches approximately 100°C in order to purge the air
enclosed in the autoclave after which it will automatically close and the air
exhaust relay is put OFF.
4.1.17
After this, the temperature and pressure will
gradually increase which will be indicated by MPC and pressure gauge.
4.1.18
Just before the set temperature the heater will be cut
off and then gradually attain the set temperature.
4.1.19
After attaining the set temperature the display will
shows “Sterilizing On” and the timer will starts its count down.
4.1.20
During the count down the temperature and pressure
will be maintained by the MPC by switching ON/OFF the heater.
4.1.21
During this count down the safety valve may leak
slightly which is normal.
4.1.22
After elapse of the set time the audio alarm (buzzer)
will sound, the display will shows “EXHAUST”, the heater will cut OFF and the
solenoid valve will open to exhaust the pressure.
4.1.23
For faster evacuation of the pressure manual steam
release valve (Exhaust valve) may be opened.
4.1.24
After complete exhaust of pressure the display will
shows “END OF CYCLE” and “Print?” simultaneously, then press “PRN/ACK” key to
take the print of the cycle.
4.1.25
Take and preserve the printout for each autoclave
cycle.
4.1.26
Open the lid by rotating the knobs in anticlockwise direction only after
the pressure gauge shows “0” (zero).
4.1.27
Check the sterilization indicator for colour change and it shall be
signed by the operator along with date and load number.
4.1.28
Remove the destructed material from the autoclave and allow to cool up to
approximately 40°C to 50ºC and follow as per current version SOP QC/MB/
(Disposal of used media and cultures).
4.1.29
Preserve the sterilization indicator and record the details in autoclave
usage log book (Annexure-I).
4.1.30
Mark the autoclave start time, sterilization start time, sterilization
end time in printout and enter the same details in autoclave usage log
(Annexure – I).
4.1.31
Preserve the autoclave sterilization temperature printouts for each cycle
with operator sign and date.
4.2
Calibration:
4.2.1
Calibration of Vertical Autoclave (Temperature mapping) shall be
performed by external agency.
4.2.2
Frequency: Once in a year ± 30days or after any breakdown activity.
4.3
Cleaning
Procedure:
4.3.1
Before starting the cleaning procedure, disconnect
power supply to the Autoclave.
4.3.2
Every day after completion of destruction cycle the
autoclave shall be cleaned with any one of the disinfectant solution (5% Dettol, 5% Savlon, 1% Bacillocid
special or 1% Hospal -OT solution).
4.3.3
Finally rinse with purified water and allow to dry.
4.3.4
Entry shall be made in autoclave cleaning log sheet (Annexure – II).
4.4
Maintenance:
4.4.1
Check the outer body of autoclave for corrosion and
cracks.
4.4.2
The rubber gasket is checked for cracks and damaged
gaskets are replaced promptly.
4.4.3
Ensure the autoclave is free from leakages before
operation.
5.0
ABBREVIATIONS:
|
QC:
Quality Control
|
QA:
Quality Assurance
|
|
ºC: Centigrade
|
IPA: Isopropyl
alcohol
|
|
MPC: Micro Processor Controller
|
%: Percentage
|
|
SOP: Standard Operating Procedure
|
|
Comments
Post a Comment