1. Purpose:-
To describe
the procedure for the safe operation of Autoclave in Microbiology
Lab to achieve effective sterilization.
2. Scope:-
This SOP is applicable to Shinva
Autoclave installed in Microbiological Lab.
3. HSE
Statement:-
Asbestos gloves should be used.
4. Responsibilities:-
i)
Manager Quality Control is responsible
to ensure that procedure & formats are followed entirely as approved.
ii)
Microbiologist is responsible to operate the
instrument.
5. Materials:-
N/A
6. Definitions:-
Autoclave:-
An
autoclave is a device used to sterilize
equipment and supplies by subjecting them to high pressure saturated steam at
121 °C for around 20 minutes depending on the size of the load and the
contents
7.Flow Chart:-
8. Description:-
8.1. Procedure:-
8.1.1
Before Start Up:-
8.1.1.1 Clean the equipment
around and surrounding and make a good environment.
8.1.1.2 Turn on the valve of water supply to the vacuum pump the pressure
(Should be between 0.15 -0.30 MPa).
8.1.1.3
Turn on the Compressed Air Supply having a pressure of 0.50 – 0.70 MPa.
8.1.1.4 Discharge the condensate water in the pipeline and
then turn on the steam supply
(Pressure
should be between 0.30 – 0.50 MPa.)
8.1.2
Automatic
Operation:-
8.1.2.1
Turn on the main power supply
& set the operating power switch to “---”Position. The following picture
will be available.
8.1.2.2
Touch the “front door operation”
Button in the main menu. Following menu will be available.
8.1.2.3
Open the front door by pressing
the OPEN button. Clean the equipment
thoroughly & Load the Sterilizer as per validated load. Then close the door
by pressing the CLOSE Button.
8.1.2.4
When the back door is to be opened
/ closed press open / closed button relatively from the backside. Now press the
BACK button, the menu will return
back as shown in Step # 4.2.1.
8.1.2.5
Now press the PARAMETER SETTING Button in the main menu (Step # 4.2.1) following
menu will be available for setting of basic parameter.
8.1.2.6
Touch any of three relative key
except HELP or BACK & Program setting, following menu will be available having
key board.
8.1.2.7
From the Key Board set the parameter
values & recognize it by touching the key.
From the Key Board set the parameter
values & recognize it by touching the key.
8.1.2.8
The basic standard values are as
follows:
Basic
Parameters Set Values
Sr. No.
|
Basic Parameter
|
|
Ave Set Value
|
Remarks
|
|
1
|
Pulse Upper
|
65 – 90 KPa
|
80 KPa
|
|
|
2
|
Pulse Lower
|
- 65 – 90 KPa
|
- 80 KPa
|
|
|
3
|
Platoon Zero
|
3 – 20 KPa
|
10 KPa
|
|
|
4
|
Back Zero
|
- 3 – 40 KPa
|
- 10 KPa
|
|
|
5
|
Chamber Pressure Limit
|
195 – 230 KPa
|
210 KPa
|
For Non Liquid
|
|
6
|
-do-
|
100 – 120 KPa
|
110 KPa
|
For Liquid
|
8.1.2.9
After setting the Basic Parameter values as Average set values
return to the parameter setting on the keyboard.
|
8.1.2.10
Now touch the relative
information, a keyboard will be open like in Clause 4.2.5.
8.1.2.11
Feed the relative values as per
requirement.
8.1.2.13
Then press the BACK Button; menu
will return to the S # 7 figure then again press BACK Button
in S # 7 menu of S # 5 will be displayed.
8.1.2.14
The standard values of Fabric parameter are as follows:
Sr. No.
|
Parameter
|
Range Value
|
Av. Set Value
|
|
1
|
Sterilization
Temperature
|
Up till 132 o C
|
121 o C
|
|
2
|
Sterilization
Temperature
|
0 – 9999 Sec
|
3600 Sec
|
|
3
|
Dry Times
|
0 – 9999 Sec
|
2700 Sec
|
|
4
|
Pulse Times
|
0 – 99 Times
|
03 Times
|
8.1.2.15
Press “Program Running” in the main menu in step # 5. Following menu will be
available.
8.1.2.16
Feed the operator number and open the printer mode by touching the relative
key. Before starting
the program ensure that both the doors are closed (which
can be checked through door indicator).
8.1.2.17 Now
press the “Program” Button. The program will start the following figure will be
on screen.
8.1.3
Manual
operation:-
8.1.3.1
Touch the Manual Operation button in the main menu. Following picture will be
available.
8.1.3.2
Now touch the manual / auto button
to change the present condition to the manual condition then touch the valve F1
- F7 & pump B Button for the performance of relative function.
8.1.3.3
At the end of manual operation
close all the valves & turn the manual position to auto.
8.1.3.4
Manual operation should be
performed only under the supervision of Microbiologist, QC Manager or Plant
Engineer.
8.1.3.5
The correspondence relation
between operation and valves / button is as follows:
Sr. No.
|
Operation
|
Valve / Button
|
|
1
|
Steam Entry Valve
of Interlayer (Jacket)
|
F1
|
|
2
|
Water Pump Valve
|
F6
|
|
3
|
Vacuuming Valve
|
F3
|
|
4
|
Vacuum Pump
|
B
|
|
5
|
Steam Entry Valve
of Chamber
|
F2
|
|
6
|
Condensed Water
Valve
|
F7
|
|
7
|
Slow Steam
Exhausting Valve
|
F5
|
|
8
|
Air valve
|
F4
|
8.1.4
End of
Program:-
8.1.4.1
At the end of program Alarm will
buzzer now press the “Exit” button on the screen the program will turn end.
8.1.4.2
At the completion of program
switch off power supply, steam supply, compressed air supply & water supply
to the vacuum pump.
8.2
Precautions:-
8.2.1
Do not put hand & other things
on the sealing door.
8.2.2
Open the door only when the
pressure in the chamber is zero & temperature is below 90oC.
8.2.3
Do not open the door when the other
door is not closed.
8.2.4
Do not touch the screen again & again.
|
8.2.5
Set / check the Parameter
carefully and as per requirement.
8.2.6
Check that printer mode is open
before start of operation.
8.2.7
Operate the manual program only
under the supervision of Microbiologist, Manager QC and / or Plant Engineer.
8.2.8
Turn off the manual operation to
the automatic position at the completion of manual operation.
In case of any emergency switch off power
supply & contact to the In charge pharmacist / Plant
engineer.
8.3 Calibration
Frequency:
Annually from external source
9. Records:-
Log of sterilization cycle (Autoclave)
Autoclave Monitoring by Using Ampoule
Bioindicator.
10. References:-
Manufacturer
instructions Manual
11. Distribution:-
This SOP has to be distributed in below mentioned
Departments:-
|
Sr. NO
|
Distributed to
|
Received
(Current)
|
Returned
(Obsolete)
|
|
1
|
Quality Control
Department
|
|
|
|
2
|
Quality Management
Department
|
|
|
14
Revision History:-
N/A