Friability test apparatus

ABOUT QUALIFICATION OF FRIABILITY TEST APPARATUS

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

2.   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

3. 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:

4. 4.0    INSTRUMENT DESCRIPTION :   For instrument description, should match as per re qualification protocol  5 .     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.

5. 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.

6. 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.     Annexure- A INSTALATION VERIFICATION CHECK LIST

7. 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

8. 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

9. 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

10. 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.       Annexure- E TECHNICAL SPECIFICATION CHECKLIST

11. 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

12. 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 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.       Annexure- G OPERATIONL VERIFICATION CHECKLIST

13. 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 )

14. 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.

15. Sr. No .  Time Set in Minute     Initial weight Final weight   Friability                                        Checked   by/Date 1                 2                 3                   For Normal Position:   Product Name:   Batch No.: Sr. No .  Time Set in Minute     Initial weight Final weight   Friability                                         Checked   by/Date 1                 2                 3                 1.3   For 10° Tilt Position:  Product Name:  Batch No.:

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

17. 8.0    CHANGE CONTROL : 9.0    LIST OF ANNEXURE : 10.0    SUMMARY AND CONCLUSION OF QUALIFICATION : 11.0   CERTIFICATION OF QUALIFICATION:          Qualification is satisfactory                                          Yes/No         Hence instrument can be used for routine use.           Yes/No