Standard Operating Procedure for Operation and Calibration of Osmometer

1.0 Purpose:

To lay down a procedure for Operation and Calibration of Osmometer.

2.0 Scope:

The scope of this SOP is applicable for Operation, Cleaning and Calibration of Osmometer, Make – Gonotec, Model – OSMOMAT 030.

3.0 Responsibility:

QC Personnel: To Operate, Clean and Calibrate Osmometer., To Prepare the Calibration Report and Certificate of Analysis.

Section Head-QC / Designee: To Check the Calibration Report and Certificate of Analysis., To Monitor the Activity.

Head-QC / Designee: To Approve the Calibration Report and Certificate of Analysis., To Monitor the Activity.

4.0 Definitions:

5.0 Procedure:

5.1 Ensure that the instrument is clean after every operation.

5.2 Do not use the instrument after the due date of calibration.

5.3 Use only certified standards for calibration.

5.4 Maintenance/Repairs: If the instrument does not comply with the requirements/acceptance criteria, label it as “OUT OF CALIBRATION”. The instrument should be repaired/serviced and recalibrated as per the Calibration SOP.

5.5 Ensure that the instrument is within the validity period of calibration.

5.6 Handle the instrument carefully.

5.7 Operation:

Turn “ON” the power supply using the switch provided on the backside of the instrument.
Five horizontal dashes will appear on the digital display.
Calibrate the instrument as per the Calibration Procedure, using a Calibration standard solution (NaCl) with an Osmolality of 300 mOsmol/kg.
After calibration, the instrument switches to the “ZERO” option. Fill the measuring vessel with 50 µl of diluent or distilled water.
Place the measuring vessel into the measuring position, ensuring that the lid of the measuring vessel is pointing forward. The thermistor probe should now be immersed in the diluent or distilled water.
The measuring vessel is immediately cooled by the cooling system and press the “ZERO” option key. Zero will be displayed on the screen.
After Zero, the instrument switches to “SAMPLE” option. Fill the measuring vessel with 50 µl of Sample to be measured.
Place the measuring vessel into the measuring position, ensuring that the lid of the measuring vessel is pointing forward. The thermistor probe should now be immersed in the sample.
The measuring vessel is immediately cooled by the cooling system and press “SAMPLE” option key.
The Result option lamp will illuminate in green and display on monitor or screen. Record this reading.
After recording, dip thermistor probe in 50 µl of distilled water into a clean, dry Clicklok micro Centrifuge tube using a calibrated micropipette.
5.8 Cleaning:
Turn “OFF” mains of instrument while cleaning.
Wipe outer surface of Osmometer with a dry clean cloth.
Ensure proper cleaning of Osmometer after operation.

5.9 Calibration:

Operate Osmometer as per Operation procedure.
Using a calibrated micropipette, pipette out 50 µl of distilled water into a clean, dry Clicklok micro Centrifuge tube.
Press ZERO key. The display shows 0.000 and ZERO control lamp illuminates yellow.
Pipette out 50 µl of Calibrating standard solution (NaCl) with an osmolality of 300 mOsmol/kg and 850 mOsmol/kg into a clean, dry measuring vessel.
Record results displayed on monitor.
Take three readings and fill Calibration Protocol.

6.0 Acceptance Criteria:

± 2 % of Stated Value.

7.0 Frequency:

Operation: As and when required.

Calibration: Quarterly – 5 days.

Cleaning: After every operation as per defined procedure.

8.0 Format for recording:

8.1 Format for “Instrument Usage Logbook”.

8.2 Format for “Instrument Calibration Protocol”.