OBJECTIVE
1.1 To lay down a procedure for Operation of Tap Density Tester.
2.0 SCOPE
2.1 This procedure applies to the Pharmaceutical Manufacturing Facility of __________________________________________________--
3.0 RESPONSIBILITY
3.1 Chemists – Quality Control.
4.0 ACCOUNTABILITY
4.1 Head – Quality Control.
5.0 PROCEDURE
5.1 Ensure that the working bench and instrument is clean.
5.2 Connect the pin to the power supply.
5.3 Switch on the mains power.
5.4 After few seconds it shows Main Menu.
5.5 Choose the mode menu either ‘USP or User’ by pressing ◄key (Shift key) followed by enter key.
5.6 CONDITION I (As per USP 1)
5.6.1 Drop height : 14mm ± 2
5.6.2 Drops/Min. : about 300 times
5.6.3 Tap count 1 : 500
5.6.4 Tap count 2 : 750
5.6.5 Tap count 3 : 1250
5.7
Press
set key, to set Tap Count –1: 500 by using shift key and increase/ decrease
key. Press enter key, to set tap count-2: 750 by using shift key and increase/
decrease key.
5.8 Press
enter key, to set Tap Count-3: 1250 by using shift key and increase/ decrease
key.
5.9
Press
enter key, set clock timely using shift key and increase /decrease key.
5.10
Press
enter key, set date by using shift key and increase /decrease key.
5.11
Press
enter key, it will ask for last results printing, shift cursor to Y otherwise to N. press enter key.
5.12
Press
reset key, now your method get saved as per USP1.
5.13
Press
start key, input weight of sample by using shift key and increase/decrease key in grams.
5.14
Press
enter key, input initial volume (V0) by using shift key and increase/decrease
key in ml.
5.15
Keep
the cylinder in holder and press start key; it will give taps
5.16
Measured
tapped volume (VA) and input it by using shift key and increase/decrease key.
5.17
Press
enter key and press start key. It will give a taps force 750 times.
5.18 Measured
tapped volume (VB) input it by using shift key and increase/decrease key.
Note: If the difference volume of 1st tap and 2nd tap i.e. VB/VA is more than 2% then proceed for tap count 3 i.e. 1250 times by some manner. Measure the final volume (VF) if so not stop the experiment in tap count 2 only.
5.19
Give
the connection to printer and go to printing mode by using SET and Enter key.
5.20
Set
printing mode to Y, automatically printing will come. We can get tap
density
initial density, compressibility index and Hausner ratio.
5.21 CONDITION II (As per USP II)
5.21.1
Drop
height : 3±0.3 mm
5.21.2
Drops/Min : about
250 times
5.21.3
Tap
count 1 : 500
5.21.4
Tap
count 2 : 750
5.21.5
Tap
count 3 : 1250
5.22
Proceed
same as condition I for step 5.8 – 5.22. CONDITION III (As per user mode)
5.22.1
The
mode to user mode by using set keys and shift key.
5.22.2
Press
set key, set taps count as per the product specification.
5.22.3
Press
start key to start the tapping.
5.22.4 Measure the volume and calculate manually.
5.23
Calculate
the bulk density of the blend according to the formula given below.
5.24
Wt. of
the sample
Bulk
Density g/cc = ¾¾¾¾¾¾¾-
Volume of the cylinder
Note: If the between tapping need stop use (STOP
KEY)
5.25
Press
reset key.
5.26
Switch off the instrument.
6.0 ABBREVIATIONS
6.1
USP –
7.0 REFERENCES
7.1 Nil
8.0 ANNEXURES
8.1
Nil
END OF THE DOCUMENT
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