SOP: Temperature & Relative Humidity Monitoring of Quality Control Laboratory

Abbreviations And Definitions 

 CRS :  Chemical Reference Substance

QC :  Quality Control

Sr. :  Senior

QA : Quality Assurance

QO : Quality Operations

Asst. : Assistant

Hygrometer: An instrument for measuring the humidity of the air or a gas.

Humidity: A quantity representing the amount of water vapor in the atmosphere or in a gas.

Relative humidity: The amount of water vapor present in air expressed as a percentage of the amount needed for saturation at the same temperature.

Precautions:

Use calibrated thermo-hygrometer for recording the data.

Procedure:

Temperature recording of indoor climate of Quality Control laboratory

1. Place dedicated thermal Hygrometer in a fixed place of Sample receiving room, weighing balance room, reference room, Analytical lab, Sensitive instrument room, Reagent glassware room.
2. Record the temperature on daily basis within 14.00 to 15.00.
3. Acceptance limit:
Room temperature: Not more than 25ºC (Range: 20º C to 25º C)


4. Laboratory Sensitive instrument room relative humidity range should be not more than 65% in addition with step 3.
5. To record maximum/minimum reading press MAX/MIN button of Thermo-hygrometer and reset the maximum/minimum reading after recording data.
6. Inform Engineering department through mail for corrective action whenever the condition values go out of limit.
7. If temperature/Relative Humidity found out of limit for more than 24 hours then deviation to be raised.


Temperature monitoring of Refrigerator/Freezer
8. Record temperature from the display of the Refrigerator/ Freezer.
9. Record the temperature twice in a day i.e., in the morning within 9.00 to 10.00 and in the evening within 15.00 to 16.00.
10. Acceptance limit:
Refrigerator: 2ºC to 8ºC
Freezer: -10⁰C to -25⁰C


11. Inform the responsible Quality Control executives/officers for corrective actions whenever temperature values go out of limit.
12. Inform Engineering Department through mail for or communicate with vendor after notified by laboratory Executives/Officers.
13. If temperature found out of limit for more than 24 hours then deviation to be raised and sample to be transferred to the identical temperature of freezer/refrigerator as per deviation recommendation.