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:
Procedure:
Temperature recording of indoor climate of Quality Control laboratory
- 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.
- Record the temperature on daily basis within 14.00 to 15.00.
- Acceptance limit:
- Laboratory Sensitive instrument room relative humidity range should be not more than 65% in addition with step 3.
- To record maximum/minimum reading press MAX/MIN button of Thermo-hygrometer and reset the maximum/minimum reading after recording data.
- Inform Engineering department through mail for corrective action whenever the condition values go out of limit.
- If temperature/Relative Humidity found out of limit for more than 24 hours then deviation to be raised.
- Record temperature from the display of the Refrigerator/ Freezer.
- 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.
- Acceptance limit:
- Inform the responsible Quality Control executives/officers for corrective actions whenever temperature values go out of limit.
- Inform Engineering Department through mail for or communicate with vendor after notified by laboratory Executives/Officers.
- 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.
Room temperature: Not more than 25ºC (Range: 20º C to 25º C)
Temperature monitoring of Refrigerator/Freezer
Refrigerator: 2ºC to 8ºC
Freezer: -100C to -250C
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