TEMPERATURE, HUMIDITY AND DIFFERENTIAL PRESSURE MONITORING IN
DIFFERENT AREAS OF STORE DEPARTMENT SOP
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1.0
PURPOSE:
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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.
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4.0 Definitions:
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4.1 Head
of the Store Department.
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5.0
MATERIAL AND EQUIPMENT:
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5.1 Thermometer.
5.2 Hygrometer.
5.3 Purified water
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6.0 PROCEDURE:
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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%.
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Abbreviation
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Expanded Form
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S
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Standard operating procedure
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&
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And
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%
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percentage
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06
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Inventory Control
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