Monitoring Of Environmental Conditions Of Control Sample Room

1.0     Purpose     :   To provide an instruction for inspection of control sample.

2.0     Objective  :    To provide a documented procedure for inspection of control sample.

3.0               Scope    :   This procedure is applicable for inspection of control sample in QC laboratory

------ Pharmaceuticals Ltd, 

4.0      Responsibility  :

·       Primary: QC Chemist / QC Officer

·       Secondary : Overall: QC – Incharge

5.0       Procedure   :

·       Humidity & Temperature Recording :

Ø     Use calibrated Hygrometer for recording of Relative Humidity and Temperature by the following procedure.

Ø     Check the water level and fill the water compartment with water by using wash bottle.

Ø     Ensure that the wick is clean and soaked in water to ensure constant flow of water to the wet bulb.

Ø     Remove the hygrometer from the wall and swing it at about 45° angle about 100 rotations and check the readings till constant readings are attained. Take care while swinging the Hygrometer to avoid spillage of water from the water compartment.

Ø     Note down the temperature readings of dry and wet bulbs in degree Celsius.

Ø     Subtract wet bulb temperature reading from the dry bulb temperature reading to get the depression in temperature of wet bulb in degree Celsius.

Ø     Record the percent relative humidity from the RH table corresponding to dry bulb temperature along the left side of the table and depression of wet bulb temperature along the top of the table.

Ø     Record dry bulb temperature; wet bulb temperature and relative humidity twice in a day on the ‘Environmental Monitoring Record’ of predetermined areas.

Ø     If there are any abnormal observations, in the readings of temperature, head of the Department shall be intimated for necessary actions in coordination with Head – Engineering.

Acceptances Criteria: - Temperature should be below 25⁰ C

6.0      Reference Document:

             FORMAT FOR ENVIRONMENTAL CONDITION MONITORING RECORD            

Area/Room			Month				Acceptance Criteria:-Temp. Below 250 C
Date	Time	Temperature (°C)			% RH	Recorded By		Verified By	Remark
		Dry Bulb		Wet Bulb