Qualification Report of Tablet Friability Tester (Electro lab)


1.0   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.

2.0   SCOPE :

The scope of this Report is limited to Id No. XYZ

3.0  QUALIFICATION TEAM AND RESPONSIBILITIES:

DEPARTMENTNAME & SIGNATURERESPONSIBILITY
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.  

4.0    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.

 6.0   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.

Annexure- A

INSTALATION VERIFICATION CHECK LIST

Sr. NoChecks to be performedAcceptance criteriaObservationChecked by/Date
1Check for the receipt of the consignment.It shall be received in good condition.  
2Check for any scratches on the machine body and drums.It shall not have any scratches on machine body and drums.  
3Check  for  electrical connectionIt shall not observed a loose or damage connection.  
4Check for levelling of the platform.  Air bubble of level indicator should be at centre.  
5Check both drums are properly locked with knob on the shaft.Both drums should be properly locked with knob on the shaft.  

Annexure- B

CALIBRATION OF MEASURING DEVICES

Sr. No.Measuring devicesAcceptance criteriaObservationChecked by/Date
1Vernier CalliperIt   should   be calibrated within calibration period.  
2ThermometerIt   should   be calibrated within calibration period.  
3StopwatchIt   should   be calibrated within calibration period.  
4MultimeterIt   should   be calibrated within calibration period.  

Annexure- C

SITE INSPECTION CHECKLIST

Sr.No.ParameterAcceptance criteriaObservationChecked by/ Date
1Room Temperature15 to 30°C  
2Room Humidity40 to 70 % RH    
3Room environmental checks– Away from direct sunlight. – Free from vibration. – No corrosive gases. – Free from excess dust and moisture.  
4Table space  Width :15” Length : 18” Height :  20”  
Sr.No.ParameterAcceptance criteriaObservationChecked by/ Date
5Point for electrical connectionSingle phase of 230 V AC 50 Hz  
6Base/table level  Levelled sturdy, with no vibration.  
7EarthingShall be provided.    

Annexure- D

UTILITY VERIFICATION CHECKLIST

Sr.NoParameterAcceptance criteriaObservationChecked by/Date
1Phase Voltage:Single Phase, 220/230 VAC, 50/60 Hz.  

Annexure- E

TECHNICAL SPECIFICATION CHECKLIST

Sr. No.TestAcceptance criteriaObservationChecked by/ Date
1Speed  25 Revolutions per minute (RPM)  
2Speed Accuracy± 1 RPM      
3Time range01 Sec. to 09 Hrs.59 Min. 59 Sec.  
4Count Range01 to 99999 revolutions.      
5Motor  DC Stepper Motor of 3.5 KgCm Torque, 6 Volts  
6Type of the DrumElectrolab AD Drum and Abrasion Drum.  
7Power SupplySingle Phase, 220/230 V AC, 50/60 Hz      
8Fuse RatingT 160 mAmp – (For I/P Supply as 220/230 V AC, 50/60 Hz)  
9Dimension350mm (L) X 310mm (W) X 430mm (H)  
10Weight12 Kg. (approx.)    
11No. of Drums02 Nos.    
12No. of Discharge Trays02 Nos.    

Annexure- F

DRUMS SPECIFICATION CHECK LIST

Sr. No.NameAcceptance criteria (As per USP General Chapter – 1216)ObservationChecked by / Date
1Drums  – 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- G

OPERATIONL VERIFICATION CHECKLIST

Sr. No.OperationAcceptance criteriaObservationsChecked by/ Date
1Switch ‘ON’ the power switch.– The drum shall initialize itself to the  loading position. – The display shall now show ‘Start”  
2a) 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.  
3a) 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.    
POWER FAILURE CHALLENGE STUDY (Annexure- I)
Sr.NoTest procedure  Acceptance criteriaObservationChecked by/Date
1Start the instrument.Instrument shall run.  
2Turn main power to the instrument OFF.The instrument shall get OFF.  
3Turn Power ON.Instrument should not start spontaneously.  
4Start the instrument.Instrument should resumes from the stop condition with all the parametrs found as before POWER – OFF.  
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.

 1.2   For Normal Position: 

 Product Name: 

 Batch No.:

Sr. No. Time Set in Minute   Initial weightFinal weight  Friability                                     Checked by/Date
1           
2           
3           

1.3   For 10° Tilt Position: 

Product Name: 

Batch No.:

Sr. No. Time Set in Minute   Initial weightFinal weight  Friability                                      Checked by/Date
1           
2           
3           

7.0 DEVIATION REPORT:

Sr. No.Deviation (s)Justification for acceptance criteriaImpact on installation, operation and performance
                        
                        
                        

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                                            

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