The document summarizes the qualification of a friability test apparatus. It details the objectives, scope, team responsibilities, acceptance criteria, observations from installation verification, calibration of measuring devices, site inspection, utility verification, technical specifications of the instrument, drum specifications, operational verification, parameter challenge study, and performance testing using tablets of different sizes and shapes. The conclusion was that the qualification was satisfactory and the instrument could be used for routine friability testing.

1. Qualification of friability test
apparatus
PRESENTED BY
N.INDRAJA
M.PHARM
DEPARTMENT:QA&QC

3. 01 OBJECTIVE:
Objective of this report 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
02 SCOPE :
The scope of this Report is limited to Id No. XYZ

4. 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.
3.0 QUALIFICATION TEAM AND RESPONSIBILITIES:

5. 4.0 INSTRUMENT DESCRIPTION:
For instrument description, should match as per re qualification
protocol
5.0 ACCEPTANCE CRITERIA:
Qualification of the instrument shall be in accordance with the
parameters given in Annexures – A, B, C, D, E, F, G, H, I & J of this
report.

6. 6.0 OBSERVATIONS:
• Qualification shall be executed using following forms:
• Installation verification checklist – Refer Annexure – A.
• Calibration of measuring device– Refer Annexure – B
• .
• Site inspection checklist – Refer Annexure – C.
• Utility verification checklist – Refer Annexure – D.
• Technical specification checklist – Refer Annexure – E
• .
• Drum specification checklist – Refer Annexure – F.
• Operation verification checklist – Refer Annexure – G.
• Parameter challenge study – Refer Annexure – H.
• Power failure challenge study – Refer Annexure – I.
• Performance of instrument – Refer Annexure- J.

7. 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 electric
al 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.
Annexure- A
INSTALATION VERIFICATION CHECK LIST

8. Sr. No.
Measuring
devices
Acceptance criteria Observation Checked by/Date
1 Vernier Calliper
It should be
calibrated within
calibration period.
2 Thermometer
It should be
calibrated within
calibration period.
3 Stopwatch
It should be
calibrated within
calibration period.
4 Multimeter
It should be
calibrated within
calibration period.
Annexure- B
CALIBRATION OF MEASURING DEVICES

9. Sr.No. Parameter
Acceptance
criteria
Observation
Checked by/
Date
1
Room
Temperature
15 to 30°C
2 Room Humidity 40 to 70 % RH
3
Room
environmental
checks
– Away from
direct sunlight.
– Free from
vibration. – No
corrosive
gases. – Free
from excess
dust and
moisture.
4 Table space
Width :15”
Length : 18”
Height : 20”
Sr.No. Parameter
Acceptance
criteria
Observation
Checked by/
Date
5
Point for
electrical
connection
Single phase
of 230 V AC 50
Hz
6
Base/table
level
Levelled
sturdy, with no
vibration.
7 Earthing
Shall be
provided.
Annexure- C
SITE
INSPECTION
CHECKLIST

10. Sr.No Parameter
Acceptance
criteria
Observation
Checked
by/Date
1
Phase
Voltage:
Single Phase,
220/230 VAC,
50/60 Hz.
Annexure- D
UTILITY VERIFICATION CHECKLIST

11. 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.
No. of Discharge
Annexure- E
TECHNICAL SPECIFICATION CHECKLIST

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

13. 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.
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
Annexure- G
OPERATIONL VERIFICATION CHECKLIST

14. 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.
POWER FAILURE CHALLENGE STUDY (Annexure- I)

15. PERFORMANCE OF INSTRUMENT (Annexure- J)
1.0 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.
1.1 Acceptance criteria: Performance of instrument shall be
found satisfactory.

16. Sr. No.
Time
Set in
Minute
Initial
weight
Final
weight
Friabil
ity Checke
d by/Da
te
1
2
3
For Normal Position:
Product Name:
Batch No.:
Sr. No.
Time
Set in
Minute
Initial
weight
Final
weight
Friabil
ity Checke
d by/Da
te
1
2
3
1.3 For 10° Tilt Position:
Product Name:
Batch No.:

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

18. 8.0 CHANGE CONTROL:
9.0 LIST OF ANNEXURE:
10.0 SUMMARYAND CONCLUSION OF QUALIFICATION:
11.0 CERTIFICATION OF QUALIFICATION:
Qualification is satisfactory Yes/No
Hence instrument can be used for routine use. Yes/No