1.0
OBJECTIVE:
To lay down a procedure for measurement &
recording of Temperature, Relative Humidity and Differential Pressure in
controlled areas.
2.0
SCOPE:
This SOP is applicable for monitoring and recording
the temperature (°C), Relative humidity (%) and differential pressure (Pa) in controlled
areas using wet and dry bulb or digital hygrometers or by using Psycrometer for
temperature and relative humidity and Magnehelic gauge for Differential
Pressure in controlled areas of Production, Quality Control, Warehouse and
Control Sample room at -------------------
3.0
RESPONSIBILITY:
3.1 Personnel of
concern department are responsible for monitoring and verification for
Temperature,Relative Humidity and Differential Pressure.
3.2 Head-Concerned
department is responsible to ensure the prevailing Temperature, Relative Humidity and Differential Pressure is
within limits as per SOP.
4.0
ACCOUNTABILITY:
Head-Q.A shall be accountable for implementation and
compliance of SOP.
5.0
PROCEDURE:
5.1
Procedure for Monitoring
of Temperature, Relative Humidity by Psycrometer and Wet and Dry bulb
Hygrometer.
5.1.1
Check the
calibration status of the instrument.
5.1.2
Check and
ensure that the wick is fixed on the wet bulb thermometer.
5.1.3
Fill the
cistern with purified water at the start of the shift.
5.1.4
Check and
ensure that the wick is wet.
5.1.5
Check that
both the thermometers are fixed properly.
5.1.6
Operation:
5.1.7
Swing the
Psycrometer gently for about 2 minutes and then check the reading of wet and
dry bulb thermometer in the respective area and In case of dry and wet
hygrometer (zeal type), check the reading directly without swinging.
5.1.8
Subtract the
reading of the wet bulb from that of dry bulb column and the difference will
give the depression value.
5.1.9
If the
instrument show the reading in Fahrenheit (0 F) then convert the
Fahrenheit reading in 0C by using formula given below.
°C = (0 F-32/ 9) X 5
5.1.10
Refer to the
Temperature and Humidity chart as per Annexure A/QA-045-01 to locate the readings
of dry bulb and the depression value given by the Psycrometer. Read the % RH at
the intersection of the two columns. In case, values of dry bulb and depression
of wet bulb fall as shown in example (b), interpolate the values as given
below.
5.1.11
The following
examples illustrate the method of using the table.
(a) Dry Bulb …. …. …. 30 °C
Wet Bulb …. …. …. 25 °C
Hence the
depression of the Wet Bulb: 30 °C – 25 °C = 5 °C
Reading
directly from the tables, the relative humidity is 65 % (intersection value of
30 °C of dry bulb and 5 °C of depression value)
(b) Dry Bulb …. ….
…. 23.5 °C
Wet Bulb
…. …. …. 16 °C
The
depression of the wet Bulb: 23.5 °C – 16.0 °C=7.5 °C
To find
the relative humidity, intersection value of 23.5 °C of dry bulb and 7.5 °C depression of wet bulb is required.
But 23.5
is not available in Temperature and Humidity chart, So, mean of intersection
value of 23 °C of dry bulb and 7.5 °C depression of wet bulb and 24 °C of dry bulb and 7.5 °C depression of wet bulb is noted as below
The
readings are as follows:
Dry Bulb (°C) |
Depression of Wet Bulb °C = 7.5°C |
|
23 |
41 |
|
24 |
43 |
5.1.12
The mean of
two readings i.e. 41 and 43 is 42.Hence the relative humidity is 42%.
5.1.13
The dry bulb
reading indicates the prevailing temperature of the respective area.
5.1.14
Record the
Temperature and Relative Humidity at starting of the shift + 30 min and after
every 4 hours ± 30 minutes till completion of the activity or end of shift whichever
is later in Format No.: F/QA-045-01 or F/QA-045-02
5.1.15
If the
temperature and/or humidity is not within the limits
till 15 minutes, discontinue the activity and Inform to QA and
Engineering Dept.
5.1.16
Engineering
department along with QA shall investigate the reason for deviation in
temperature and/or humidity and rectify the same. In case of major breakdown,
Final decision should be taken by QA for line of action.
5.2
Maintenance
of Psycrometer and Wet and Dry bulb Hygrometer:
5.2.1
Ensure that
sufficient purified water is available in the cistern.
5.2.2
Ensure that
the wick is clean and wet.
5.2.3
Ensure that
the top end of the wick covers the bulb completely. (To ensure, the wick may be
fastened or tied to wet bulb).
5.2.4
Check and
ensure that no scales or deposit are observed on the wick. Replace the wick as
and when required.
5.2.5
Psycrometer
and Hygrometer should be calibrated once in year by external approved party.
5.3
Precautions
to be taken During Handling of Psycrometer or Wet and Dry bulb Hygrometer :
5.3.1
Ensure that
product in the respective area is in closed condition.
5.3.2
Before
swinging the Psycrometer in the air, ensure that the Psycrometer will not touch
with any wall, nearby equipment etc.
5.3.3
Handle the
Psycrometer and hygrometer carefully.
5.3.4
While
handling if thermometer got damaged, inform to QA for further action.
5.3.5
Clean the
broken mercury thermometer in the area as per annexure A/QA-045-03.
5.4
Procedure for monitoring of Temperature and Relative
Humidity by Digital hygrometer
5.4.1
Check the
calibration status of the instrument.
5.4.2
Check the
temperature and relative humidity displayed in the digital hygrometer monitor.
5.4.3
Record the
Temperature and Relative Humidity at starting of the shift + 30 min and after
every 4 hours ± 30 minutes till completion of the activity or end of shift
whichever is later in Format No. F/QA-045-01 or F/QA-045-02.
5.4.4
Record the
previous day minimum and maximum temperature and relative humidity in the
format number F/QA-045-01 or F/QA-045-02. Record
the minimum and maximum at the time of observing and recording daily initial
reading. Recording of minimum and maximum reading as per procedure given below
in the pictorial display.
|
Displaying minimum maximum value |
|
|
5.4.5
Record the
min and max temperature and RH from hygrometer display menu by pressing “MODE”
key.
5.4.6
Delete the
minimum and maximum reading from the memory of hygrometer that is required to
leave memory space to record the next day min and max reading.
5.4.7
For resetting
the minimum value, press “MODE” key for 3 seconds and then press “SET” key, it
will reset the min value.
5.4.8
For resetting
the maximum value, press “MODE” key for 3 seconds and then press “SET” key, it
will reset the max value.
|
Resetting minimum maximum value |
|
|
5.5
Procedure
for monitoring of Differential Pressure in Different Areas:
5.5.1
AHUs of all
areas (Cubicle and adjacent area) should be started 20 to 30 minutes before
starting the activity of respective areas.
5.5.2
Ensure that
the door of the cubicle and adjacent area are in closed condition.
5.5.3
Read the
value (differential pressure between adjacently located areas) on wall mounted
Magnehelic gauge which is directly corresponding to the pointer needle, if the
indicator needle rests in between two divisions on the scale, the average of
both readings to be considered.
e.g.:
Magnehelic gauge
Range: 0 to 60 Pa.
5.5.4
Each subdivision is equal to 02 Pa. If the
pointer needle indicates on 3rd division after 10 Pa (digit 10
available in print) then the reading shall be considered to be 16 Pa.
5.5.5
Record the
difference pressure (Magnehelic gauge) at starting the shift + 30 min and after
every 4 hours ± 30 minutes till completion of the activity or end of shift
whichever is later in Format no F/QA-045-04.
5.5.6
If the difference pressure is not within the limits till 15
minutes, discontinue the activity and Inform to QA and Engineering Dept.
5.5.7
Engineering
department along with QA shall investigate the reason for deviation in
temperature and/or humidity and rectify the same. In case of major breakdown,
Final decision should be taken by QA for line of action.
5.5.8
Magnehelic
gauge should be calibrated once in six months by external approved party.
5.5.9
Ensure the
tag affixed below the magnehelic gauge as per Format no F/QA-045-04. The tag shall be
prepared as per F/QA-045-04.
The same shall be verified by QA.
5.6
If
the Temperature, Relative Humidity & Differential Pressure are out of the
acceptance criteria, in that case the person monitoring the Temperature,
Relative Humidity & Differential Pressure shall inform to Maintenance &
QA department for preventive & corrective action.
5.6.1
Final
decision should be taken by QA for line of action.
NOTE: For
monitoring and recording the temperature (°C) and Relative humidity (%) in controlled areas
either Hygrometers or Psycrometer can be used depending on the availability of
the instrument.
All the hygrometers shall
be placed at the hot spots identified in each room,
6.0
LIST OF ANNEXURE AND FORMATS :
|
Sr.
No. |
Title |
Annexure and Format Number |
|
1. |
Temperature
and Relative Humidity Record by ‘’Wet and Dry Bulb” |
F/QA-045-01 |
|
2. |
Temperature And Relative Humidity Record By
‘’Digital Hygrometer’’ |
F/QA-045-02 |
|
3. |
Record
for Differential pressure |
F/QA-045-03 |
|
4. |
Tag for Room differential pressure |
F/QA-045-04 |
|
5. |
List
of Area and Acceptance Criteria
for Temperature and RH. |
A/QA-045-01 |
|
6. |
Table of wet and dry bulb thermometer readings
with corresponding percentages of humidity. ( Psychrometric chart) |
A/QA-045-02 |
|
7. |
Cleaning
up mercury spills |
A/QA-045-03 |
7.0
REFERENCES:
7.1
8.0
REVISION HISTORY:
|
Sr. No. |
Date |
Reason for Revision |
Revision No |
|
1.
|
31/10/2018 |
New SOP |
R0 |
|
2.
|
31/10/2020 |
Schedule Revision |
R1 |
9.0
ABBREVIATIONS:
|
Sr. No. |
Abbreviations |
Details |
|
|
°C |
Degree Centigrade |
|
|
RH |
Relative Humidity |
|
|
Pa |
Pascal |
|
|
Min |
Minimum |
|
|
Max |
Maximum |
END
OF DOCUMENT
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