TEMPERATURE, HUMIDITY AND DIFFERENTIAL PRESSURE MONITORING IN DIFFERENT AREAS OF STORE DEPARTMENT SOP


1.0   PURPOSE:

1.1       To lay down a procedure to monitor the temperature, humidity& differential pressure of
          store department.


2.1       This is applicable to raw material store and packaging material store.

 3.1      Primary: Store officer.
3.2       Secondary: Assistant.
4.0    Definitions:

4.1       Head of the Store Department.

5.0     MATERIAL AND EQUIPMENT:

5.1       Thermometer.
5.2       Hygrometer.
5.3       Purified water

6.0      PROCEDURE:

6.1       TEMPERATURE AND HUMIDITY RECORD:
6.1.1    Precautions:
6.1.1.1 Check and ensure that the wick is fixed on the wet bulb thermometer.
6.1.1.2 The cistern of wet bulb should be filled with purified water.
6.1.1.3 Check and ensure that the wick is wet.
6.1.1.4 Hygrometer should not keep under direct airflow and in front of window where direct sun light exposed.
6.1.1.5 Store person shall ensure that all the air conditioners of the respective store areas switch “ON”.
6.1.1.6 Store person shall note down the temperature & humidity twice a day for RM store, PM store and temperature in cold room. Specific time for noting temperature shall be 8:00 to 9:30 a.m. & 12:00 to 1:00 p.m. hours.
6.1.1.7 If any abnormalities are observed during the recording, store person shall inform to store head.
6.1.1.8 Store head in turn shall inform the observed abnormalities to QA head, Plant head and Engineering head for further rectification and action.
6.1.2    Procedure for temperature:
6.1.2.1 Enter in the respective area and ensure that cistern of wet bulb is filled with purified water properly.
6.1.2.2 Check the temperature of dry and wet bulb and record value.
6.1.3    Procedure for relative humidity:
6.1.3.1 Calculate relative humidity value by referring humidity chart.
6.1.3.2 Refer the difference along the top line of chart.
6.1.3.3 Follow the column down until level with dry bulb reaching for percentage humidity.
6.1.4    Location:
6.1.4.1 Raw material area.
6.1.4.2 Packaging material area.
6.1.4.3 Cold room.
6.1.5    Frequency:
6.1.5.1 Temperature and relative humidity has been taken twice a day.
6.1.6    Acceptance criteria:
6.1.6.1 Temperature: NMT 25oC.
6.1.6.2 Humidity: NMT 60%.
6.2       DIFFERENTIAL PRESSURE MONITORING:
6.2.1    Enter in the respective area and ensure that all doors of store are tightly closed and HVAC in running condition before taking pressure reading.
6.2.2    Open the door of respective area and ensure zero (0) set, while door is opened. Then close the door properly.
6.2.3    Take the magnehelic reading in the reference of negative and positive pressure of rooms and record the value.
6.2.4    Frequency:
6.2.4.1 Twice a day in morning and afternoon.
6.3       If any discrepancy is observed, inform to Engineering Department and further action should be taken.
6.4       Notes:
6.4.1    Temperature and relative humidity is important from the point of view:
6.4.1.1 To avoid degradation of products.
6.4.1.2 To ensure comfortable and hygienic working of workmen as per GMP norms.
6.4.1.3 To avoid damage to hard gelatin capsule shells.
6.4.1.4 Ensure the thermometer/temperature indicator is calibrated.
6.4.1.5 Room temperature:The temperature prevailing in a working area. (25oC).
6.4.1.6 Cool: The temperature between 8oC to 25oC.
6.4.1.7 Cold:The temperature between 8oC to 15oC.
6.4.1.8 Deep freezer: The temperature between 2oC to 8oC.
6.4.1.9 Humidity: NMT 55±5%.



Abbreviation
Expanded Form
S
Standard operating procedure
&
And
%
percentage
06
Inventory Control


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