12/26/22, 4:43 PM SOP on Operation and Calibration of Tap Density Tester - Pharma Qualification

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SOP on Operation and Calibration of

Tap Density Tester

Pharmaceutical SOP's

Purpose
This SOP describes the procedure for operation and
calibration of Tap density tester.
Procedure :
Operation
Place the instrument on a leveled sturdy base. 
Place the cylinder holders on the anvil of the desired
method.
Switch on the mains provided on the front panel of
instrument.
The screen will display LABINDIA TD1025 Tap Density
Tester
For setting a program follow below mentioned steps

Press Enter. The screen will display six options- 1)

Prg 2) Run 3) Prnt 4) Disp 
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12/26/22, 4:43 PM SOP on Operation and Calibration of Tap Density Tester - Pharma Qualification

Then Press 1 no. Key. The screen will display four

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options-1) Add/Edit 2) View 3) Copy 4) Delete.

Then press 1 no. Key for adding the program. Then

enter any numeric number to the program from 1 to
20. Press Enter.

Sample name appears on screen. Give sample

name in alphabetic character. Press Enter.

Now the screen will display test method. Two

options appears 1) USP 2) ASTM. Press 1 no. Key
for selecting USP method. Press Enter. Three
options appear on screen 1) USP-I

2) USP-II

3) USP-III. Then press 2 no. Press Enter.

Cylinder Volume (ml) - (100/250) appears on

screen. Set the cylinder volume as per the
requirement. Press Enter.

The screen will show mode parameter. Two options

appears in mode 1) USP

   
Labels
 

2) USER. Press 2 No. Key for selecting USER. Audits

Press Enter. Brookfield viscometer

calibration
Now the screen will display Tap Count 1. Set the tap
count. Press Enter. Calibration

Now the screen will display Tap Count 2. Set the tap Calibration of FTIR

count. Press Enter. Cleaning validation

Now the screen will display Tap Count 3. Set the tap EHS
count. Press Enter.
ETP plant operation
The program will be saved automatically.
Formulation and Rese

Formulation and Research

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12/26/22, 4:43 PM SOP on Operation and Calibration of Tap Density Tester - Pharma Qualification

NOTE- The Bulk Density Apparatus will take minimum Hospital SOP's
10 taps. Home Blog  Menu 
HPLC Calibration Procedure
For Running a Program follow below mentioned
steps HVAC

Go to main menu. Press Enter. The screen will Interview Tips

display six options- 1) Prg 2) Run 3) Prnt 4) Disp 5) IPQA
Funct 6) Cfg.
Job Description and
Then Press 2 no. Key. The screen will display two responsibilities
options-1) Run 2) View. Press 1 no. Key.
Job in Pharma
Enter program number which you have to run.
KPI | Key Performance
Press Enter to go to next parameter.
Indicator
Identification number appears on screen. Give
Management review meeting
Desired Identification number. Press Enter.
OOT | Out of Trends
Weigh the sample and fill it into a cylinder.
Performance Qualification
The screen will display sample weight (0.0001 to
Performance qualification
999.99). Enter the weight of sample taken in the
pharmaceutical equipment
measuring cylinder. Press Enter.
Pharma Engineering
Volume of measuring cylinder appears on the
screen (Vo) (1-100). Pharma ppt

  Pharma Terms

Carefully level the powder without compacting & pharmaceutical Guidlines

read the initial unsettled volume. Press Enter. Pharmaceutical SOP's

Keep the cylinder carefully in the holder & mount Pharmacovigilance

the holder.
Process Engineering
The screen will display message Keep cylinder in
Product Recall
Holder Enter to continue.
Production in Pharmaceutical
After that Tap Count 1 Finished appears on screen.
QBD
Tap count 1 denoted by Volume V10 <Va> <ml> on
the screen. Measure and note the volume after QMS

     QRM

tap 1.Press Enter for continuing the process for Tap Quality Assurance

Count 2. Quality Control

Tap Count 2 Finished appears. Tap count 2 denoted Quality Risk Management 
by Volume Vb <ml> on the screen. Measure and

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12/26/22, 4:43 PM SOP on Operation and Calibration of Tap Density Tester - Pharma Qualification

note the volume after tap 2. Press Enter. Roles and Responsibilities
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Tap Count 3 Finished appears. Tap count 3 denoted spectrophotometer
by Volume Vb <ml>. Measure and note the volume.
Stainless steel testing
Press Enter. Volume Difference appears on screen.
Testing of Raw materials
Press Enter.
validation
The screen will display two options 1) Continue 2)
Finish. If the difference between V500 & V1250 Water monitoring system
exceeds 2ml, repeat in increments Such as 1250
taps. Press 2 no. Key for finishing the program.
Press Enter.

Now the screen will display the calculated volume

of tap density.

Calibration
Connect the instrument with Main power supply and
switch ON.
Tap density apparatus USP type (Method-I and Method-
II) is characterized by the following specification.

S.No Method Acceptance criteria

.
1. Tap count
USP-I 285-315
USP-II 235-265
2. Stroke Count USP-1
10 Strokes 9-11
500 Strokes 485-515
1250 Strokes 1235-1265
3. Stroke Count USP-2
10 Strokes 9-11
500 Strokes 485-515
1250 Strokes 1235-1265
S.No Method Acceptance criteria
.
4. Minimum 250ml 2 ml
readable Most Viewed
volume of
measuring 100ml 1 ml
cylinders

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12/26/22, 4:43 PM SOP on Operation and Calibration of Tap Density Tester - Pharma Qualification

5. Weight of 250ml 220 ± 44gm

measuring Home Blog  Menu 
cylinders 100ml 130 ± 16gm
6. 250ml 450 ± 10gm
Weight of
cylinder holder 100ml 240 ± 12gm

To perform the Tap calibration for USP-I method

keep the 250ml cylinder carefully in the Holder &
mount the Holder.

Enter 300 Taps and Measure taps per minute with

the help of Stopwatch.

To perform the Tap calibration for USP-II method

keeps the 100ml Cylinder carefully in the Holder &
mount the Holder.

Enter 250 Taps and Measure taps per minute with

the help of Stopwatch.

Check the Stroke count for USP type I and type II

for 10, 500 and 1250 strokes.

Then note the readable volume of the Measuring

cylinders.

Observe the weight of the Measuring Cylinders and

of Cylinder holders. It must comply with the weights See Also
given in table.

Report any discrepancy observed during calibration

of instrument to ADL Manager or his designee for
corrective and preventive action.

ADL Manager or his designee informs the defect to

Maintenance Department

   

service engineer to rectify the defect. Affix ‘Under

Maintenance’ label on the instrument.

Note: - Calibration shall be performed once in three

months and after major maintenance.


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Do not put measuring cylinders on the holder at the time

of stroke calibration. Home Blog  Menu 

Do not press the Cylinder Holder when the Tapping

Base of Cylinder Holder is not touching the Anvil.
Place the Cylinder in the Holder only when the Holder is
placed on the Anvil.
Cleaning               
Disconnect the instrument from main power supply.
Clean the instrument with dry and lint free cloth to
remove the dust before and after use.

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