VALIDATION OF TABLET
COMPRESSION MACHINE
FACILITATED TO:
Dr . N. VISHAL KUMAR GUPTA
[Link]
DEPT OF PHARMACEUTICS
JSSCP
PRESENTED BY:
[Link]
I [Link]
PHARMACEUTICAL QUALITY ASSURANCE
JSSCP
INTRODUCTION:
Tablet Compression Machine is also known
as Tablet Press in Pharmaceutical Industry
used to makes the tablets according to a
pre-determined design. Punches and dies set
in the tablet press to actually shape the
tablets.
Models - Lab Press, Single Rotary Tablet
Compression Machine, Double Rotary
Tablet Compression Machine, Heavy Duty
Tablet Compression Machine.
Compression is a critical step in the
production of a tablet dosage form. The
materials being compressed will need to
have adequate flow and compression
properties.
Factors to be considered during
compression are
1) Tooling
2) Compression speed
DIES
STEM
BARRE
L
NECK
HEAD
TOOLING:
The shape ,size and as well as certain
identification marking are determined by
compression machine tooling.
Each tooling set consist of dies , upper
and lower punches.
Production efficiency, dosage uniformity
and appearance depend upon tooling set.
The most commonly employed tools are
referred to as BB tooling and are
Punches :
Length:
Upper punch - 5.25 inches
Lower punch - 3 inches.
Barrel diameter- 0.75 inches.
Head diameter- 1 inch
D tooling : Is popular for large tablets
Punch:
Length- 5.25 inch
Head diameter- 11/4 inch
Barrel diameter- 1 inch
Dies : out side diameter – 0.945 inch are
used
VALIDATION
DESING QUALIFICATION
INSTALLATION QUALIFICATION
OPERATIONAL QUALIFICATION
PERFORAMENCE QUALIFICATION
INSTALLATION QUALIFICATION (IQ):
Check manufacturer and supplier.
Model number and serial number.
Check any physical damage.
Conform location and installation
requirements as per recommendation of
manufacturer
Verify that the required utilities are
available
Installation shall be conducted per
instructions provide in the manual.
OBJECTIVE OF IQ
To check all the critical contacts parts
which directly affect quality of the product
either visually or by kit.
To review proper installation as per
checklist.
To measure the dimension wherever
possible.
IQ CHECK LIST:
Compare all specification and write the
observation
Machine height – measure with measuring
tape.
Overall dimension- measure with measuring
tape.
Rpm of turret – check by tachometer.
Hopper
Conventional hopper- by visual check
MOC(master of construction)- using
Molybdenum kit.
Height- Measure with measuring tape
• No. of station- visually count [Link] holes
on turret.
• Type of tooling- using venire caliper check
the die hole diameter .
• Turret
• Feeder- by visual check.
• Main electrical motor.
Required utilities-electricity.
Thickness controller cam
Weight of controller cam
Emergency off buttom
Dust extraction and exhaust system
Lubrication
Oil pressure gauge
Select switch for auto/manual
OPERATIONAL
QUALIFICATION(OQ):
Verify alarm control.
Perform calibration requirements, identify
in the manual or established by the
validation team.
Operate the equipment at low medium and
high speed as per operation manual to
verify the operation control.
Verify that all switches and push buttons
are functioning properly.
Establish procedures for operation,
maintenance and calibration
Establish training program for relevant
staff
Run one pilot batch for each product.
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
and the main drive motor should start.
3) stop push button- illuminated red switch
By pressing stop button the red switch glows and
the main drive motor should stop
4) Turret RPM challenge test- set in the digital table
counter by rotating knob check by tachometer
Rotation direction (clockwise ) by visual check
5) Emergency switch (machine
should be stop) by visual check .
6)Tablet thickness & Hardness
controls
By turning the swing lever to
right/left thickness increased
hardness/decrease vise versa – by
visual check.
7) Tablet weight controls
Dozer and wedge is moved
clockwise/ anti clock wise-
decrease/ increase weight
9) Machine speed adjustment
Release the locking knob and rotate the
hand wheel anticlockwise /clock wise-
increased speed/decreased speed
10) Main upper punch entry:
Remove the bolt and rotate the perforated
segment to right/ left-upper punch
penetration increases/ decreases.
11) Agitator controller
Turn the agitator On- check by tachometer
Turn the knob and set RMP 5
PERFORMANCE
QUALIFICATION (PQ):
Evaluation of compression capabilities and tablet
characteristics.
The compression capabilities and tablet
characteristics are:
1) Content uniformity
2) Thickness
3) Hardness
4) Friability
5) weight variation
6) Disintegration test.
should be investigated.
OBJECTIVE OF PQ:
First three batches of bilary and single
layer product to be compressed on given
compression machine.
All the critical physical parameters of
product will be checked during
performance qualification.
Measure the thickness, hardness, friability
and weight for each triplicate tablet run, as
shown below
CONTENT UNIFORMITY:
Select 30 tablets randomly from batch
Assay individually
ACCEPTANCE CRITERIA:
out of 30 tablets 3 tablets can be with in
75 – 125% and all tablets should be with
in 85 -115%
THICKNESS
First 20, last 20, middle 20 tablets
(throughout the run)
Determine mean and standard deviation.
ACCEPTANCE CRITERIA:
The Relative Standard Deviation should
be less than or equal to 5%
HARDNESS :
First 20, last 20, middle 20 tablets
(throughout the run)
Determine mean and standard deviation
for baseline.
ACCEPTANCE CRITERIA:
Must meet each tablet specifications.
Chewable tablets- 3kg/cm2
Tablets- 4-8kg/cm2
sustained release tablets & troches-
10-20kg/cm2
FRIABILITY
ROCHE FRIABILATOR
First20, last 20, middle 20 tablets
% friability =(initial wt- fainal wt/initial
wt)100
ACCEPTANCE CRITERIA:
Weight loss less than or equal to 1%, per
USP
WEIGHT VARIATION:
20- TABLETS
% weight variation= (individual wt-avg
wt/avg wt)100
Determine mean and standard deviation.
ACCEPTANCE CRITERIA
For Average Weight 130 mg or less 10%
difference
For Average Weight 130 to 324 mg 7.5%
difference
For Average Weight More than 324 mg
5% difference
Not more than two tablets have a variation
as large as that shown ; no tablet is twice
the variation.
DISINTEGRATION TEST:
Disintegration test is the process of
breakdown of tablet into smaller particles.
TABLETS DISINTEGRATION
TIME
Un coated 15min
Plain coated 60min
Enteric coated 3hrs
Dispersible 3min
Effervescent <3min
Sublingual 4hrs
Buccal 4hrs
ACCEPTANCE CRITERIA:
All tablets have disintegrated completely.
If 1 or 2 tablets fails to disintegrate
completely repeat the test for 12
additional tablets.
Not less than 16 out of 18 tablets tested
disintegrated completely.
PQ CHECK LIST:
Product name Upper punches/lower
Batch no punches
Batch size Average weight of 20
Product tablets
description Individual weight
Machine rpm variation
Punch diameter Thickness(mm)
Punch shape Hardness (kg/cm2)
REFERENCES:
Pharmaceutical process validation an
international 3rd edition by Robert A. Nash,
Alfred H. Wachter, 2003 Marcel [Link]
Agalloco James, carleton J . Fredrick
“validation of pharmaceutical process” 3rd
edition.
The theory and practice of Industrial
pharmacy by Leon Lachman, Herbert A.
Liberman.
