Tablet Compression Machine Principle of Tablet Compression Machine Construction of Tablet Compression Machine Working of Tablet Compression Machine Qualification of Tablet Compression Machine Installation Qualification Operational Qualification Performance Qualification References

1. Department of Pharmaceutical Quality Assurance
Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–vapi
Presented by:-
Machhi Dhruvi A.
2nd sem M.Pharm.

2.  Tablet Compression Machine
 Principle of Tablet Compression Machine
 Construction of Tablet Compression Machine
 Working of Tablet Compression Machine
 Qualification of Tablet Compression Machine
 Installation Qualification
 Operational Qualification
 Performance Qualification
 References
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3.  Tablets are being formed by
compressing the granules using
the compression machines.
 A tablet formation takes place by
the combined pressing action of
two punches & a die.
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Tablet Compression Machine

4.  The basic principle behind the tablet compression machine is
hydraulic pressure.
 This pressure is transmitted unreduced through the static fluid.
 Any externally applied pressure is transmitted via static fluid to all
the directions in the same proportion. It also makes it possible to
multiply the force as needed.
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Principle of Tablet Compression Machine

5. 5
Construction of Tablet Compression Machine

6. 1. Filling: It involves the transfer of granules into position for
compression.
2. Metering: involves removal of excess granules from the
cavity. The weight is controlled by height of lower punch in
die which is controlled by metering cam.
3. Compression: Top & bottom punch come together by
pressure within die to form a tablet.
4. Ejection: involves removal of tablet from lower punch die
station.
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Working of Tablet Compression Machine

7.  IQ check list:
 Compare all specification & write the observation.
 Machine height- measure with measuring tape
 Overall dimension- measure with measuring tape
 RPM of turret - check by tachometer.
 Hopper :
i. Conventional hopper- by visual check
ii. MOC(master of construction )-using Molybdenum
iii. Height- Measure with measuring tape
 Number of station- visually count number of holes on turret
 Type of tooling- using venire caliper check the die hole diameter
 Feeder- by visual check.
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8.  Following should be checked by visually.
 Required utilities-electricity
 Thickness & weight of controller cam
 Main drive:
i. Potentiometer
ii. Selector Switch
iii. Emergency switch
iv. ON indicator
 Dust extraction & exhaust system
 Lubrication
i. Oil pressure gauge
ii. Select switch for auto/manual
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9.  Verify alarm control.
 Perform calibration according to the manual or established by the
validation team.
 Operate the equipment at low, medium & high speed as per operation
manual to verify the operation control.
 Verify that all switches & push buttons are functioning properly
 Establish procedures for operation, maintenance & calibration
 Establish training program for relevant staff
 Run one pilot batch for each product
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Operational Qualification

10.  OQ Check List:
1. Main switch- check visually by operating the main switch of
the machine.
2. Start push button- illuminated green switch : by pressing start
button the green switch glows & the main drive motor should
start
3. Stop push button- illuminated red switch : By pressing stop
button the red switch glows & the main drive motor should
stop
4. Turret RPM challenge test- set in the digital table counter :
by rotating the knob, check by tachometer
5. Rotation direction (clockwise)- by visual check
6. Emergency switch by visual check .
7. Tablet thickness & Hardness controls : By turning the swing
lever to right/left thickness increased /decrease & vise versa
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11. 7. Machine speed adjustment : Release the locking knob &
rotate the hand wheel anticlockwise /clock wise- increased
speed/decreased speed
8. Main upper punch entry: Remove the bolt & rotate the
perforated segment to right/ left - upper punch penetration
increases/ decreases.
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12.  It is an Evaluation of compression capabilities & tablet
characteristics. The compression capabilities & tablet
characteristics are:
1. Content uniformity
2. Thickness
3. Hardness
4. Friability
5. Weight variation
6. Disintegration test
Above parameters should be investigated & result should fall under
acceptance criteria .
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Performance Qualification

13. References
1. http://www.slideshare.net/JadhavAnkushJadhav/qualification-of-
manufacturing-equipments?from_m_app=android
2. Subrahmanyam CVS, Setty JT, Sarasija S & Devi VK in “
Pharmaceutical Engineering- Principles & Practices”, Vallabh
Prakashan, New Delhi, 2001, 390-391, 397-399.
3. http://www.slideshare.net/YashMenghani2/qualification-of-tablet-
compression-machine-capsule-filling-machine?from_m_app=android
4. Ankur Choudhary, “ Working and Principle of Tablet Compression
Machine”. https://www.pharmaguideline.com/2016/02/principle-of-
tablet-compression-
machine.html?m=1#:~:text=The%20basic%20principle%20behind%20t
he,multiply%20the%20force%20as%20needed.
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14. 5. Reddy, B. Venkateswara, et al. "A Review On Qualification Of Autoclave,
RMG, FBD, Cone Blender, Tablet Compression Machine." Journal of Global
Trends in Pharmaceutical Sciences,2014, 5(1), 1450-1459.
6. http://www.slideshare.net/YashMenghani2/qualification-of-tablet-
compression-machine-capsule-filling-machine?from_m_app=android
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15. Thank you
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