Brief description of qualification of laboratory testing apparatus : Friability Test Apparatus. share it with your friends also if they faced problem about this topic. Thank you

1. Qualification of
Friability test
apparatus
DIPANKAR PATRA

2. QUALIFICATION
Qualification is the process of establishing documented evidence that a specific
equipment, facility or system are fit and ready for their intended use.
The four qualification stages help determine if the process being tested is capable of
operating in its specific environment.
They include:
•Design Qualification (DQ)
•Installation Qualification (IQ)
•Operational Qualification (OQ)
•Performance Qualification (PQ)

3. Installation qualification (IQ)
Installation qualification is conducted to prove that
equipment/system has been installed as per user and
manufacturer recommendation.
·
Operational qualification (OQ)
The operational qualification process is intended to
demonstrate that the components are operating
properly and ready for performance or load testing.
Performance qualification (PQ)
Performance qualification is documented evidence to
prove that equipment/system is performing under
specified condition. It involve in taking trial under
“loaded condition
Design qualification (DQ)
Design qualification may verify that
design of equipment, system/facility
is according to requirement of user
and current good manufacturing
practices.

4. Friability test apparatus
 Friability is the condition of being friable, describes the
tendency of a solid substance to break into smaller
pieces under duress or contact, especially by rubbing.
 Friability is defined as the % weight loss by tablets due
to mechanical action during the test.
 Minimum weight loss of the tablet should not b NMT 1
%
 Friability is usually measured by use of Roche
Friabilator or tumbler test.
 Applicable for compressed uncoated tablet & tended to
determine the strength of tablet during transportation &
storage the tablets should retain its shape & size.

5. Qualification of Friability test apparatus
Standard Operating procedure :
Department: Quality Control Department
Title: Calibration of Friability test apparatus
Objective: Objective of this report is to provide documented evidence
through the verification of installation, operation and performance of Tablet
Friability tester to show that the instrument installed, operated and
consistently performed according predetermined specifications.
Scope : Procedure applicable for calibration of the friability apparatus.
Responsibility: Quality control chemist
• This testing involves repeatedly dropping sample of tablets over a
fixed time, using a rotating wheel.
• The result is inspected for broken tablets and the percentage of tablet
mass lost through chipping.

6. Procedure:
 Switch ON the power.
 The drum will initialize itself to the loading position at the power ON.
 The display will show "start"
 After the weighing, slide the tablets gently into the drum from the slide slit provided on the drum:
 (A) Tablets with a unit mass equal to or less than 650 mg, take sample of whole tablets corresponding to 6.5
g.
 (B) Tablets with a unit mass of more than 650 mg, take a Sample of whole 10 tablets.
 Select the "TIME MODE" or "REVOLUTION CO T ODE" as desired by pressing the
 TIME/COUNT key respectively.
 The MODE indicator LED will indicate the selected mode.
 The display will show the previous Time or Count Values.
 Enter the desired value (25 rpm, 4 minutes o described under individual monograph) for the selected mode
and press ENTER KEY to register er the value,
 Press RUN/HALT key to start the test .
 The drum will start rotating.
 The display will show elapsed Time or Count on depending on the mode selected.
 When the test is over, the drum rotates in the rev rse direction , discharging the tablets into the tray.

7.  Take weight after rotation is completed.
 Then drum will initialize itself to loading position and display will show "start" indicating that the instrument
is ready for the next test.
 In case during the test, if the user needs to Chang the Time/Count value, press RUN/HALT key.
 Pressing the RUN/HALT key again to continue the test .
 Find out the loss in weight of the tablets(i.e. A-B)

8. OBSERVATIONS
Annexure A : Calibration of measuring devices

9. Sr. No Parameter Acceptance criteria
1 Room temperature 15 to 300C
2 Room Humidity 40 to 70%
3 Room environmental cheeks -away from direct unlight.
-free from vibration
-no corrosive gases
-free from excess dust
4 Point for electrical connection Single phase of 230 AC 50
5 Base / table level Levelled sturdy, with no vibration
6 Earthing Shall be provided
Annexure : B : Site Inspection checklist
Annexure : C : Utility Verification checlist

10. Sr .No Test Acceptance criteria
1 S peed 25 revolution per minute (RPNI)
2 Speed Accuracy ± 1 RPM
3 Time Range 04 Minutes
4 Count Range 01 to 99999 revolutions
5 Motor DC Stepper Motor of 3.5 Kg Cm Torque, 6 Volts
6 Type of Drum Electro lab AD Drum and Abrasion Drum
7 Power supply Single Phase, 220/230 V AC 50/60
8 Fuse Rating T 160 m Amp
9 Dimension 350mm (L) X 310
10 Weight 12 Kg. (approx.)
11 No. of Drums 1 or 2 Nos.
12 NO Of Discharge 02 Nos.
Annexure : D : Site Inspection checklist

11. Annexure : E : Drums Specification checklist

12. Sr. No.
Operation Acceptance criteria
1
Switch ON the power Drum shall initialize itself to loading position and display switch
shall now show START.
2
a) Press TIME key to select The MODE indicator LED shall indicate the select the TIME
MODE. The display shall show the previous time Values.
b) Enter desired value by using The display shall show 00
Numerical Keys
Press ENTER key to register value.
c) Press RUN/HALT key The drum shall Start rotating in forward direction. The display shall
show elapsed time. When the test is Over rotate in reverse direction for
direction for discharging the tablet into tray. Indication of test over shall
show by an audible beep. The display shall show END.
d) Press RESET key
Annexure : E : Drums Specification checklist

13. Annexure- J Performance of Instrument
Performance of instrument is checked by taking different size or shape of tablets
(different size and shape 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 se for min. i.e., 100 rotations. Calculated the
friability and result is recorded.

14. Key References
l . Jain, K. and Bharkatiya, M., 2018. Qualification of Equipments: A Systematic Approach.
International Journal of Pharmaceutical Erudition, 8(1), pp.7-14.
2. Kapoor, D., Vyas, R.B, & Dadrwal, D., 2018. An Overview of Analytical Instrument
Qualification with Reference of Pharmaceutical Industry. Journal of Drug Delivery and
Therapeutics, 8(5), pp.99—103.
3. Frost, SEM.A., 2004. Introduction to the Validation of a Dissolution Apparatus. Dissolution
Technologies, 11(1), pp. 19—21.
Bansals S.K. et al., 2004. Qualification of analytical instruments for use in the pharmaceutical
industry: A scientific approach. AAPS PharmSciTech, 5(1), pp. 151—158