The objective is to provide documented evidence through the verification of installation, operation &  performance of the Tablet Friability Tester to show that the instrument was was installed, operated and consistently performed according to predetermined specifications.

1. QUALIFICATION OF FRIABILITY TESTER
By
Ojas Sawalikar
M Pharm 1st year (2021-22)
Quality Assurance Techniques
NDMVP Samaj’s College of Pharmacy, Nashik

2. OBJECTIVE
Objective is to provide documented evidence through the
verification of installation, operation & performance of Tablet
Friability Tester to show that the instrument installed, operated
and consistently performed according to predetermine
specifications.

3. QUALIFICATION TEAM AND
RESPONSIBILITIES
DEPARTMENT NAME & SIGNATURE RESPONSIBILITY
Maintenance
To prepare qualification report.
To co-ordinate the entire
qualification activity.
Quality Assurance
To execute qualification study in
co-ordination with other
departments.
Production
To execute qualification study in
co-ordination with other
departments.
Maintenance
To review the qualification
documents.
Head – Quality Assurance
To approve qualification protocol
& report

4. TYPES OF QUALIFICATION
• Installation Qualification (IQ)
• User requirement specification (USR)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

5. Installation Qualification (IQ)
Sr. No Checks to be performed Acceptance criteria Observation Checked by/Date
1
Check for the receipt of the
consignment.
It shall be received in good
condition.
2
Check for any scratches on the
machine body and drums.
It shall not have any scratches
on machine body and drums.
3 Check for electrical connection
It shall not observed a loose or
damage connection.
4
Check for levelling of the
platform.
Air bubble of level indicator
should be at centre.
5
Check both drums are properly
locked with knob on the shaft.
Both drums should be properly
locked with knob on the shaft.

6. User requirement specification (USR)
Sr. No. Test Acceptance criteria Observation Checked by/ Date
1 Speed 25 Revolutions per minute (RPM)
2 Speed Accuracy ± 1 RPM
3 Time range 01 Sec. to 09 Hrs.59 Min. 59 Sec.
4 Count Range 01 to 99999 revolutions.
5 Motor DC Stepper Motor of 3.5 KgCm Torque, 6 Volts
6 Type of the Drum Electrolab AD Drum and Abrasion Drum.
7 Power Supply Single Phase, 220/230 V AC, 50/60 Hz
8 Fuse Rating
T 160 mAmp – (For I/P Supply as 220/230 V AC,
50/60 Hz)
9 Dimension 350mm (L) X 310mm X 430mm (H)
10 Weight 12 Kg. (approx.)
11 No. of Drums 02 Nos.
12 No. of Discharge Trays 02 Nos.

7. DRUMS SPECIFICATION QUALIFICATION
Sr. No. Name
Acceptance criteria (As per USP
General Chapter – 1216)
Observation Checked by / Date
1 Drums – One side removable.
2 Material
Transparent synthetic polymer with
polished internal surfaces.
3
Inside Radius of Curved
Projection
80.5 ± 5.0 mm.
4
Diameter of Central
Hole
10.0 ± 0.1 mm.
5 Diameter of Central Ring 25.0 ± 0.5 mm.
6 Inside Diameter of Drum 287.0 ± 4.0 mm.
7
Outside Diameter of
Drum
302.5 ± 4.0 mm.
8 Depth of Drum 38.0 ± 2.0 mm.
9 Tablet Dropping Height 156.0 ± 2.0 mm.

8. OPERATIONAL QUALIFICATION (OQ)
Sr. No. Operation Acceptance criteria Observations Checked by/ Date
1 Switch ‘ON’ the power switch.
– The drum shall initialize itself to
the loading position. – The display shall
now show ‘Start”
2
a) Press ‘TIME’ key to select the “TIME
MODE”.
– The MODE indicator LED shall indicate
the “TIME MODE”. -The display shall show
the previous time values.
b) Enter the desired value by using
numerical keys. Press ‘ENTER’ key to
register the value.
The display shall show ‘00’.
c) Press ‘RUN/HALT’ key.
– The drum shall start rotating in forward
direction. – The display shall show elapsed
time. – When the test is over the drum
shall rotate in reverse direction for
discharging the tablets into the tray. –
Indication of test over shall show by an
audible beep. – The display shall show
“END”.
d) Press ‘RESET’ key.
The instrument shall initialize and will stop
at the loading position.

9. 3
a) Press ‘COUNT’ key to select the
“COUNT MODE”.
– The MODE indicator LED shall indicate
the “COUNT MODE”. – The display shall
show the previous count values.
b) Enter the desired value by using
numerical keys. Press ‘ENTER’ key to
register the value.
The display shall show ‘00’.
c) Press ‘RUN/HALT’ key.
– The drum shall start rotating in forward
direction. – The display shall show elapsed
count. – When the test is over the drum shall
rotate in reverse direction for discharging
the tablets into the tray. – Indication of test
over shall show by an audible beep. – The
test over shall show “END”.
d) Press ‘RESET’ key.
The instrument shall initialize and the will
stop at the loading position.
Sr. No. Operation Acceptance criteria Observations Checked by/ Date
Contd…

11. POWER FAILURE CHALLENGE STUDY
Sr.No Test procedure Acceptance criteria Observation Checked by/Date
1 Start the instrument. Instrument shall run.
2
Turn main power to the
instrument OFF.
The instrument shall get OFF.
3 Turn Power ON.
Instrument should not start
spontaneously.
4 Start the instrument.
Instrument should resumes
from the stop condition with
all the parametrs found as
before POWER – OFF.

12. Performance Qualification (PQ)
• Procedure:
• Performance of instrument is checked by taking different size or shape of tablets (different size or
shape of tablets causes a regular and irregular tumbling). Initially weighed tablets are transferred
gently into the drum from the side slit provided on the drums. The TIME mode is set for 4 minute i.e.
100 rotations. Calculated the friability and result is recorded in following tables.
a) For regular tumbling, set the instrument at normal position, as there is no any irregular tumbling
of tablets.
b) For irregular tumbling, set the instrument with 10° tilt with the bench top to prevent any irregular
tumbling of tablets.
• Acceptance criteria: Performance of instrument shall be found satisfactory.

13. 1. For Normal Position:
Sr. No.
Time Set in
Minute
Initial weight Final weight
Friability
Checked by/Date
1
2
3
Product Name:
Batch No.:

14. 2. For 10° Tilt Position:
Sr. No.
Time Set in
Minute
Initial
weight
Final weight
Friability
Checked by/
Date
1
2
3
Product Name:
Batch No.:

15. DEVIATION REPORT:
Sr. No. Deviation (s)
Justification for
acceptance criteria
Impact on installation,
operation and
performance

16. • CHANGE CONTROL:
• SUMMARY AND CONCLUSION OF QUALIFICATION:
• CERTIFICATION OF QUALIFICATION:
• Qualification is satisfactory Yes/No
• Hence instrument can be used for routine use. Yes/No