OPSO SALINE LIMITED

STANDARD OPERATING PROCEDURE

Department Document No. Version Page

Quality Control QC/SOP/021 1 1 of 3

TITLE: Calibration Procedure of Balance

Model: Mettler AJ150 & Mettler LJ16

Effective Date Review Date Copy

September 01, 2004 August 31, 2006

Prepared By Checked By Approved By

Sign : Sign : Sign :

Designation :QC Officer Designation :Asst. QC In -Charge Designation : QC In -Charge

Date: Date : Date:

DOCUMENT HISTORY :
Date Version Description Of Change (Summary)

01-09-2004 1 New

DISTRIBUTION LIST:

Designation Sign Copy No. Date

Executive Vice Chairman 1
Managing director 2
Production In-Charge (IV Fluid) 3
Production In-Charge (Steripack) 4
Quality Control In-Charge 5
Management Representative Original

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 OPSO SALINE LIMITED

STANDARD OPERATING PROCEDURE

Document No. Version Page Approved By

Sign :
QC/SOP/021 1 2 of 3
Designation: QC In-Charge

Date:
TITLE: Calibration Procedure of Balance
Model: Mettler AJ150 & Mettler LJ16

1.0 PURPOSE : To establish the Calibration Procedure of Balance,

Model: Mettler AJ150 & Mettler LJ16.

2.0 SCOPE : This SOP is applicable to Balance

Model: Mettler AJ150 & Mettler LJ16 in QC Lab of Opso
Saline Ltd.

3.0 DEFINITION: None

4.0 RESPONSIBILITY: QC In-Charge, QC Officer.

5.0 PROCEDURE:

5.1 Process Flow Diagram:

Leveling of the balance Unloading of any object Closing of sliding windows

Control bar pressing Worming up the balance Switching the balance on.
until –CAL- appears

Calibration weight Calibration weight Calibration weight placing

loading when calibration removing when 0.0000g on the pan when 0.0000g
weight flashes. or 0.000g flashes. or 0.000displays.

Calibration record checking Calibration result recording Calibration completion

Labeling of
CALIBRATED Tag

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 OPSO SALINE LIMITED
STANDARD OPERATING PROCEDURE
Document No. Version Page Approved By

Sign :
QC/SOP/021 1 3 of 3
Designation: QC In-Charge

Date:
TITLE: Calibration Procedure of Balance
Model: Mettler AJ150 & Mettler LJ16
5.2 Process Description:
Responsibility Description
QC Officer 1. Level the balance.
2. Remove all any load from the balance.
3. Close the sliding windows.
4. Press the switch On
5. Worm up the balance for 30 minutes before calibration.

6. Press control bar until –CAL- appears, then release; display

changes to ------ and then to calibration weight (flashes).

7. Load requested calibration weight (e.g. 100g); display changes

to ------ , then 0.0000g or 0.000g flashes.
8. Remove calibration weight; display shows ------ and then changes to
0.0000g or 0.000g.
9. Now place the calibration weight 100g on the pan.
10. Calibration is performed if the display shows 100.0000g or 100.000g
11. Record the calibration result in the CALIBRATION RECORD
sheet(Form No.:QC/FORM/011).
QC In-Charge 12. Check the report and if is found OK put your signature on the
CALIBRATION RECORD sheet.
QC Officer 13. Affix the CALIBRATED label (Form No.:QC/FORM/010) on the
balance with your signature.

14. Carry out calibration in fifteen days interval.

6.0 REFERENCE:
ISO 9001:2000 Clause 7.6
CALIBRATED label (Form No.:QC/FORM/010)
CALIBRATION RECORD sheet (Form No.:QC/FORM/011)