SOP for Temperature, Humidity and Differential Pressure Monitoring : Pharmaguideline

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SOP for Temperature, Humidity and Differential Pressure Monitoring

Standard operating procedure to monitor the temperature, humidity and differential pressure of microbiology lab.

1.0 PURPOSE

To lay down the procedure to monitor the temperature, humidity and differential pressure of microbiology lab.

2.0 SCOPE

This is applicable to Microbiology lab

3.0 RESPONSIBILITY

Microbiologist

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Temperature and Humidity Record

5.1.1 Precaution
5.1.1.1 Check and ensure that the wick is fixed on the wet bulb thermometer.
5.1.1.2 The cistern of the wet bulb should be filled with purified water.
5.1.1.3 Check and ensure that the wick is wet.
5.1.1.4 Hygrometer should not keep under direct airflow and in front of the window where direct sun light exposed.
5.1.2 Procedure For Tempareture
5.1.2.1 Enter in the respective area and ensure that cistern of the wet bulb is filled with purified water properly.
5.1.2.2 Check the temperature of the dry and wet bulb and record the value.
5.1.3 Procedure For Relative Humidity
5.1.3.1 Calculate relative humidity value by referring humidity chart.
5.1.3.2 Refer the difference along the top line of the chart.
5.1.3.3 Follow the column down until level with dry bulb reaching for percentage humidity.
5.1.3.4 Locations:
Media preparation room
MLT and LAL testing room
Sterility lab
5.1.4 Frequency: Temperature and RH to be taken three times (Morning, afternoon and evening) in a day.
5.1.5 Acceptance criteria:
Temperature: NMT (Not More Than) 25°C
Relative Humidity: NMT 60%

5.2 Differential Pressure monitoring

5.2.1 Enter in the respective area and ensure that all doors of microbiology lab are tightly closed and HVAC in running condition before taking the pressure reading.
5.2.2 Open the door of respective area and ensure zero (0) set, while the door is opened. Then close door properly
5.2.3 Take the magnehelic reading in the reference of the negative and positive pressure of rooms and record the value.
Media preparation
Air look Media preparation
Change room
MLT and LAL testing room
Corridor
Sterility lab
5.2.5 Frequency: Twice a day in morning and afternoon.
5.2.6 Acceptance criteria:
5.3 If any discrepancy is observed, inform to Engineering Department and further action should be taken.

6.0 Abbreviations

6.1 SOP - Standard operating procedure
6.2 RH - Relative Humidity
6.3 NMT - Not More Than
6.4 NLT - Not Less Than
6.5 °C - Degree Centigrade
6.6 % - Percentage
6.7 HVAC - Heating Ventilation Air Conditioning
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