Professional Documents
Culture Documents
Production Department
SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010
Reviewed By:
Approved By:
Manager Production
Page 1 of 8
Purpose:1.1
The Safe operation of the Sterilizer / Autoclave in order to achieve the effective
sterilization.
Scope:2.1
Responsibility:
Officer Production
Operator Autoclave
Equipment Description:
Name of Machine:
Code:
04-AS-052
Manufacturer:
Model:
XG1-SDB 1.2B
Supplier Name:
Morgan KHI
Location:
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Production Department
SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010
Reviewed By:
Approved By:
Manager Production
5.1.4
Page 2 of 8
Discharge the condensate water in the pipeline and then turn on the valve of
the steam supply (steam pressure should be between 0.3 0.5 MPa)
Turn on the main power supply & set the operating power switch to
position. The following picture will display on touch screen.
CHM TEMP: - # # #. # C
CLK: - # #: # #: # #
AMPOULE LEAKAGE
CHECK STERILIZER
Operation
on Front
Door
5.2.2
Parameter
Set
Program
Process
Manual
Operation
Touch the Operation on Front Door Button in the main menu. Following
menu will be available.
CHM TEMP: - # # #. # C
CLK: - # #: # #: # #
Return
Close
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 Close Button.
Controlled When in Red
Do Not Duplicate
Production Department
SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010
Reviewed By:
Approved By:
Manager Production
Page 3 of 8
N.B.: When the back door is to be Opened / Closed. Press Open / Close Button relatively
from the Backside. Now press the return button the menu will return back as shown in
Step No. 5.
5.2.3
Now press the Parameter Set button. The following picture will be available.
CHM PRES: # # #
CHM TEMP:
# # #. # C
CLK: - # #: # #: # #
PARM SETTING
CHM LMT:
###
KPa
STERILIZE:
###.#
VAC LOW:
###
KPa
COOLING:
###.#
LEAK CK :
###
KPa
STERILIZE:
####
SEC
C
C
F0 VAL:
###.#
LEAK CK:
####
SEC
CONT MODE :
BOTH
CLEAN OUT:
####
SEC
HELP
RETURN
&
CONT MODE
HELP
&
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RETURN
Production Department
SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010
Reviewed By:
Approved By:
Manager Production
From the Key Board set the parameter values & recognize it by touching
Page 4 of 8
the key.
Both / Time
Ave Set
Value
138 KPa
- 80 KPa
80 KPa
3.0
Both
Below 100 C
80 C
Sterilizing Time
0 9999 Sec
1800 Sec.
Leak Check
Cleaning Time
0 9999 Sec
0 9999 Sec
180 Sec
300 Sec
Parameter
1
2
3
4
5
6
7
8
Cooling Temperature
9
10
Sterilizing Temperature
Set Range
0 230 KPa.
- 100 0 KPa
0 230 KPa
Remarks
Do Not Duplicate
Production Department
SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010
Reviewed By:
Approved By:
Manager Production
After setting the parameter value as per average set valve press
keyboard the menu will return on S # 7. Then press the
Return
Menu will return in S # 5.
5.2.4
Page 5 of 8
Button on the
button again in S # 7.
Press Program Process Button in the main menu i.e. S # 5 menu. Following
menu will be displayed on the screen.
OP NUM:
PRT MODE:
##
OPEN
######
STYLE:
STER FST
Program Start
PLC CLK
START UP
RETURN
Before starting the program ensure that both the door are closed (which can be checked
through door indicators).
START UP
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Production Department
SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010
Reviewed By:
Approved By:
Manager Production
Page 6 of 8
Do Not Duplicate
Production Department
SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010
Reviewed By:
Approved By:
Manager Production
Page 7 of 8
Touch any of button F1 F 10, JB, PB, ZB etc in the above figure following will be
available.
5.3.2
S#
Touch the AUTO button to turn into the manual condition in the above
figure, press the return button. The relative operation will start. The different
values / button controls different operation, the detail is as follows:
Valves / Button
Operatio
n
1
Vacuum Pump
ZB
2
Steam Entry
F1
3
Steam Exhaust from chamber
F3
4
Comp. Air Entry
F2
5
Color Water In
F4
6
Pump for Color / Pureness / Standby water in
JB
7
Pump for Color / Pureness / Standby water out
PB
8
Color Water out
F7
9
Pureness Water In
F5
10
Pureness Water out
F8
11
Standby Water In
F6
12
Standby Water Out
F9
13
Evacuation
F10
At the end manual operation turn the Manual state to the Auto.
Controlled When in Red
Remarks
For 2 Minutes
Sterilization Cycle
Till O Pressure
To Cool Chamber
Along with Vacuum Pump
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Production Department
SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010
Reviewed By:
Approved By:
Manager Production
Page 8 of 8
N.B.: Manual Operation should be only performed under the Supervision of Pharmacist /
Engineer.
Precautions
6.1
6.2
Open the door only when the pressure in the chamber is zero & temperature below
90 o C.
6.3 Do not open the door when the other door is not closed.
6.4 Do not touch the screen again & again.
6.5 Set / Check the parameter carefully & as per requirement.
6.6 Never press the STEPPING Button to step forward the next process without the
permission of incharge pharmacist.
6.7 Check the printer mode is open before start of operation.
6.8 Operate the manual program only under the supervision of incharge pharmacist and /
or Plant Engineer.
6.9 Turn off the manual operation to the automatic position at the completion of manual
operation.
6.10 In case of any emergency switch off power supply & contact to the incharge
pharmacist / Plant Engineer.
Record / Reference:7.1
SOP-04-001
7.2
RG-05-01
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