1.0 Objective:
To provide written procedure for Operation
and Calibration of Disintegration Test Apparatus.
2.0 Scope:
This SOP covers the Operation and
Calibration of Tablet Disintegration Test Apparatus.
3.0 Responsibility:
Jr.
Research Officer, Research Officer: Responsible for operation, calibration and
maintenance of the instrument as per procedure.
Head of Department: Responsible
for calibration and maintenance, timely as per schedule.
QA
Officer/QA Manager: Review the records and governing the document.
4.0 Operating procedure:
4.1 Ensure that the instrument is clean
& all the switches and knobs are in normal position.
4.2 Starting procedure:
4.2.1 Fill the acrylic tank with Purified
water up to the water level mark. Keep the metal plate, having two large holes,
on the tank and place the beakers in the stands provided on the plate. Fill
1000 ml beaker with purified water or with the liquid as specified in the
disintegration test.
4.2.2 Connect the instrument to mains power
supply and main switch “ON” and then put ‘ON/OFF’ switch at the rear panel is
‘ON’ position. The red light indicator is on. And the LCD screen will also
become ‘ON’.
4.2.3 The
display will indicate as “VEEGO SCIENTIFIC DEVICES” and remain ‘ON’ for few
seconds and then display will change to “TABLET DISINTEGRATION TEST APPARATUS
MODEL: DT-2D” and will remain ‘ON’ for few seconds.
4.2.4 Then it will display as “HEATING IN PROGRESS, TIME, DATE, TEMPERATURE, HEATER ‘ON/OFF’.
4.2.5 Switch
‘ON’ the Heater provides the left of front side the instrument. The green light
indicator is on.
4.3 Procedure for setting current time
and date:
4.3.1 To set the current time and date, press
“SET CLOCK” key.
4.3.2 The
following message or any random figure may appear on the display.
“TIME : HR : MIN: SEC
DATE : DD / MM / YY”
4.3.3 TIME: Message will be flashing, to set the
time with numerical key. The display will indicate “ TIME : HR : MIN: SEC DATE : DD / MM / YY”
10 : 30
: 10 00 / 00 / 00
4.3.4 Press ‘ENTER’ key. The ‘DATE’ message will
start flashing. To set the date with numerical key. The display will indicate
“ TIME : HR : MIN: SEC DATE : DD / MM / YY”
10 :
30 : 10 26 / 08 / 06
4.3.5 Press ‘ENTER’ key. The display will
indicate
“HEATING IN PROGRESS TEMERATURE INDICATE & HEATER ON”
10 : 31 : 25 26 / 08 /
06
4.4 To
set the parameters:
4.4.1 Press
“START TEST” KEY. The display will appear as
SET
TEMP : 37° C TEST TIME
: 00 : 00 : 00
ENTER TO CONTINUE 36.9°
C. HEATER ‘OFF’
4.4.2
Now one can program, when above
menu is appearing on the display. Set temperature
and set test time. If wants to
set the temperature to 37.0° C.
4.4.3
Press “SET TEMP” key the
display will indicate as “SET TEMP = 37.0° C”. Press numerical key, the display
will indicate as “SET TEMP = 37.0° C”.
4.4.4
Press “ENTER” key. The display
will indicate as
SET
TEMP : 37° C TEST TIME
: 00 : 00 : 00
ENTER TO CONTINUE 36.9° C. HEATER ‘OFF’
4.4.5
To set “TEST TIME” press “SET
TEST TIME” key. The display will indicate as
TEST TIME
HR : MIN : SEC : = 00 : 00 : 00
Press numerical key and set
require time e.g. (0) (0) (3) (0) (0) (0) and then press “ENTER” key.
4.4.6 The display will appear as TEST TIME
HR : MIN : SEC : = 00 : 30 : 00 press enter key.
4.4.7 The display will indicate as
SET
TEMP : 37° C TEST TIME : 00 : 30 : 00
ENTER TO CONTINUE 36.9°
C. HEATER ‘OFF’ press enter key.
4.4.8
This menu will remain ‘ON’ for approx 30
minutes, within 30 minutes, the temperature of the beaker will reach to 37° C. If
the media temperature is already 37.0° C, the user need not have to wait for 30
minutes. In that case by pressing ENTER key.
4.5
A long beep will sound after 30 minutes. One
can then monitor the temperature of the beaker. (It will be approx 37.0° C)
4.6
The display will indicate as
INSERT SAMPLE
ARE YOU READY
PRESS ENTER TO START
37.2° C. HEATER ‘OFF’
4.7 Place
the tablets to be tested in the basket tubes and keep the guided discs on the tablets
so that the tablets will not come out while the baskets move UP/DOWN. And then press ‘ENTER’ key. The display will
indicate as
TEST STARTED
TEST TIME : 00 : 30 : 00
ELAPSE TIME : 00 : 00 : 01
37.2° C. HEATER ‘OFF’
4.8 The
basket will start moving UP/DOWN, The RED LED lamp will glow indicating motor
is switched ‘ON’. When the elapse time reaches to set test time, the test will
stop with audio signal and Red LED lamp will also go ‘OFF’. The display will
indicate as
TEST OVER
37.2° C. HEATER ‘OFF’
4.9 PAUSE
TEST:
4.9.1 The
test is ‘ON’ and ‘PAUSE TEST’ key is pressed, the UP/DOWN motion of motor will
stop and RED LED lamp will go ‘OFF’. The display will indicate as
TEST HALTED
TEST TIME: 00: 30: 00
ELAPSE TIME: 00: 09: 22
37.1° C. HEATER ‘OFF’
4.9.2 If the
test continue and restart the test, press ‘PAUSE TEST’ key again. The display
will indicate as
TEST STARTED
TEST TIME: 00: 30: 00
ELAPSE TIME: 00: 09: 40
37.1° C. HEATER ‘OFF’
4.9.3 If stop
the test, press ‘STOP’ key the display will appear as
ARE
YOU SURE??
Press any key to continue.
Press STOP to ABORT
4.9.4
Press ‘STOP’ key again, the display will
indicate as
TEST ABORTED
11: 25:
16 26 / 08 / 06
37.0° C. HEATER ‘OFF’
4.10 Enter
the details of instrument usage as per given in Annexure – 1.
5.0 Calibration:
5.1 OSCILLATIONS:
5.1.1 Switch on the instrument. Switch ‘ON’ the
‘MOTOR’ switch so that oscillation of the basket starts.
5.1.2 Count the number of oscillations and
record the same in the Annexure - 2.
5.1.2
The oscillation observed shall be between 28
to 32 cycles per minute.
5.2 TEMPERATURE:
5.2.1 Set the temperature at 37.0° C.
5.2.2 Observe the temperature by using a
calibrated thermometer at the following intervals.
15 minutes, 30 minutes, 60
minutes, 120 minutes.
Limit: 37.0°
± 1.0 ° C.
5.2.3 Record the observation of calibration in
the Annexure - 2.
5.3 DISTANCE TRAVELED:
5.3.1 Measure the distance traveled by the
basket between the lowest and highest points of oscillation. Limit: 50 to 60 mm
5.3.2 Record the observation of calibration in
the calibration in the Annexure - 2.
5.4 FREQUENCY: Once in a 3 Month.
6.0 Routine maintenance:
6.1 Disconnect the instrument from
power supply.
6.2 Remove the water from tank. Clean the water
tank, coil with dry cloth and replace the fresh distilled water.
6.3 Clean the Basket –Rack assembly
and disc with water and than dry cloth.
6.4 Clean the instrument with dry
cloth.
7.0 Documentation:
Annexure – 1 - Disintegration apparatus usage log book. XXX/FRM/000
Annexure – 2 - Disintegration
apparatus calibration record format. XXX/FRM/000
8.0 History of Revision:
Revision No.
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Effective
Date
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Revision
details
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Reason for
revision
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Annexure – 1
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Date
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Name of Sample
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B. No.
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Used by
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Remark
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SOP No. : XXX/SOP/000-00 Format No. : XXX/FRM/000-00
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Annexure – 2
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Calibrated by :
Checked by :
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SOP No. : XXX/SOP/000-00 Format No. : XXX/FRM/000-00
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