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SURGE Laboratories (Pvt.) Ltd.

Production Department

Title:- Standard Operating Procedure


Subject: OPERATION OF AMPOULE
STERILIZER (AUTOCLAVE)

SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010

Reviewed By:

Approved By:

Manager Production

G.M Plant & 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

This procedure is followed to operate the Ampoule Sterilizer.

Responsibility:

Officer Production

Supervisor Liquid Injectable Manufacturing

Operator Autoclave

Equipment Description:
Name of Machine:

Ampoule Sterilizer (Autoclave)

Code:

04-AS-052

Manufacturer:

Shangdon Xinhua Madical Ins. Zibo. China

Model:

XG1-SDB 1.2B

Supplier Name:

Morgan KHI

Location:

Ampoule Autoclave Area

Procedure:5.1 Before Start


5.1.1
5.1.2
5.1.3

Clean the Equipment and surrounding and make a good environment.


Turn on the valve of the water to the vacuum pump & check its pressure
(should be between 0.15 0.30 MPa.)
Turn on the valves of color water source, stand by water source & the pureness
water source & compressed Air supply.
Controlled When in Red

Do Not Duplicate

SURGE Laboratories (Pvt.) Ltd.

Production Department
SOP-04-034

Title:- Standard Operating Procedure


Subject: OPERATION OF AMPOULE
STERILIZER (AUTOCLAVE)

Revision No.: 1
Issue Date: 11-01-2010

Reviewed By:

Approved By:

Manager Production

G.M Plant & 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)

5.2 Automatic operation


5.2.1

Turn on the main power supply & set the operating power switch to
position. The following picture will display on touch screen.

5.2.1.1 CHM PRES: - # # # KPa

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 PRES: - # # # KPa

CHM TEMP: - # # #. # C
CLK: - # #: # #: # #

Front door Indicator

Back door Indicator

Operation of the Front Door


Open

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

SURGE Laboratories (Pvt.) Ltd.

Production Department
SOP-04-034

Title:- Standard Operating Procedure


Subject: OPERATION OF AMPOULE
STERILIZER (AUTOCLAVE)

Revision No.: 1
Issue Date: 11-01-2010

Reviewed By:

Approved By:

Manager Production

G.M Plant & 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

Touch any of the button in the above menu except

RETURN

&
CONT MODE

HELP

&

Following menu will be available.

Controlled When in Red

Do Not Duplicate

RETURN

SURGE Laboratories (Pvt.) Ltd.

Production Department

Title:- Standard Operating Procedure


Subject: OPERATION OF AMPOULE
STERILIZER (AUTOCLAVE)

SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010

Reviewed By:

Approved By:

Manager Production

G.M Plant & Production

From the Key Board set the parameter values & recognize it by touching

Page 4 of 8

the key.

The standard values are as follows:


S#

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

Chamber Pressure Limit


Vacuum Lower Limit
Leakage Checking up Limit
F0 Value
Cont. Mode

7
8

Cooling Temperature

9
10

Sterilizing Temperature

Set Range
0 230 KPa.
- 100 0 KPa
0 230 KPa

Remarks

Change according to the


requirement of product
NMT 90 C
Change According to the
requirement of product
NLT 120 Sec
NLT 180 Sec
Return

Controlled When in Red

Do Not Duplicate

SURGE Laboratories (Pvt.) Ltd.

Production Department
SOP-04-034

Title:- Standard Operating Procedure


Subject: OPERATION OF AMPOULE
STERILIZER (AUTOCLAVE)

Revision No.: 1
Issue Date: 11-01-2010

Reviewed By:

Approved By:

Manager Production

G.M Plant & 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

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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

PROD SER NUM:

######

STYLE:

STER FST

Front door Indicator

Back door Indicator

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).

Now press the


on the screen.

START UP

button the program will start showing the following fig

Controlled When in Red

Do Not Duplicate

SURGE Laboratories (Pvt.) Ltd.

Production Department

Title:- Standard Operating Procedure


Subject: OPERATION OF AMPOULE
STERILIZER (AUTOCLAVE)

SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010

Reviewed By:

Approved By:

Manager Production

G.M Plant & Production

Page 6 of 8

5.3 Manual Operation


5.3.1

Touch the MANUAL OPERATION


picture will be available.

Controlled When in Red

button in the main menu following

Do Not Duplicate

SURGE Laboratories (Pvt.) Ltd.

Production Department

Title:- Standard Operating Procedure


Subject: OPERATION OF AMPOULE
STERILIZER (AUTOCLAVE)

SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010

Reviewed By:

Approved By:

Manager Production

G.M Plant & 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

Do Not Duplicate

SURGE Laboratories (Pvt.) Ltd.

Production Department

Title:- Standard Operating Procedure


Subject: OPERATION OF AMPOULE
STERILIZER (AUTOCLAVE)

SOP-04-034
Revision No.: 1
Issue Date: 11-01-2010

Reviewed By:

Approved By:

Manager Production

G.M Plant & Production

Page 8 of 8

N.B.: Manual Operation should be only performed under the Supervision of Pharmacist /
Engineer.

5.4 End of Program


5.4.1

At the end of Program Alarm will buzzer showing OK Press OK on the


screen the program will turn end. At the completion of program switch off
power supply, comp. Air supply & standby, pureness, color water & water
supply to the vacuum pump.

Precautions
6.1

Do not put hand & other things on the sealing door.

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

Cleaning / Mopping & Fumigation of Aseptic Area

SOP-04-001

7.2

Machine Log Book

RG-05-01

Controlled When in Red

Do Not Duplicate

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