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Tablet Compression Machine

This document outlines the validation process for a tablet compression machine. It describes installation qualification (IQ) to check that the machine is installed correctly. Operational qualification (OQ) verifies proper functioning of controls. Performance qualification (PQ) evaluates the machine's compression capabilities by testing tableted product for characteristics like thickness, hardness, friability and weight variation. The validation aims to ensure the machine reliably produces quality tablets.

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3K views

Tablet Compression Machine

This document outlines the validation process for a tablet compression machine. It describes installation qualification (IQ) to check that the machine is installed correctly. Operational qualification (OQ) verifies proper functioning of controls. Performance qualification (PQ) evaluates the machine's compression capabilities by testing tableted product for characteristics like thickness, hardness, friability and weight variation. The validation aims to ensure the machine reliably produces quality tablets.

Uploaded by

kavya nainita
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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VALIDATION OF TABLET

COMPRESSION MACHINE
FACILITATED TO:
Dr . N. VISHAL KUMAR GUPTA
ASST.PROFESSOR
DEPT OF PHARMACEUTICS
JSSCP
PRESENTED BY:
P.LALASA
I M.PHARMACY
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 no.of 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 Dekker.inc
Agalloco James, carleton J . Fredrick
“validation of pharmaceutical process” 3rd
edition.
The theory and practice of Industrial
pharmacy by Leon Lachman, Herbert A.
Liberman.

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