In this PPT we have discussed the points to be considered when performing qualification Of Tablet Compression Machine

1. Qualification Of
Tablet Compression
Machine
By: Fauzan ul Hasan
Roll no. 33
M.pharm QA
Y.B Chavan College of Pharmacy

2. Qualification
Action of proving and
documenting that any premises,
systems and equipment are
properly installed.

3. Tablet
Compression
Machine

4. Working of Tablet compression machine

5. Design Qualification
● Check manufacturer and supplier.
● Verify Model number and serial number.
● Check any physical damage.
● Measure machine height
● Machine height - measure with measuring tape
● Overall dimension- measure with measuring tape

6. Installation Qualification
IQ is done to check all critical contact parts parts which directly affect the quality of
the product.
To check for:
● Required utilities- electricity.
● Thickness of controller cam
● Main drive :
i) ON indicator
ii) Potentiometer
iii) Selector Switch
iv) Emergency switch
● Dust extraction and exhaust system

7. ● 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
Operational qualification

8. Operational Qualification Checklist
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. Operate the equipment at low medium and high speed as per operation
manual to verify the operation control.

9. Performance Qualification
• Its an 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.
All of the above parameters should be investigated.

10. Performance parameters
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%
FRIABILITY:
First 20, last 20, middle 20 tablets %
friability =( initial wt - final wt / initial
wt)
ACCEPTANCE CRITERIA:
- Weight loss less than or equal to
1%, per USP

11. Performance Parameters (contd.)
WEIGHT VARIATION:
20- TABLETS
% weight variation= (individual wt-avg
wt/ avg wt) x 100
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
Disintegration test

12. References
1. Subrahmanyam CVS, Setty JT, Sarasija S & Devi VK in " Pharmaceutical Engineering-
Principles & Practices", Vallabh Prakashan, New Delhi, 2001, 390-391, 397-399.
2. https://www.slideshare.net/YashMenghani2/qualification-of-tablet-compression-
machine-capsule-filling-machine

13. Thank you