Cleaning, Operation and Calibration procedure of Friability tester

1. Objective

                       To lay down the procedure for Cleaning, Operation and calibration of Tablet Friability apparatus.

• Scope

This SOP is applicable for Cleaning, Operation and Calibration procedure of Friability tester Apparatus (Make: Electrolab. Model: EF-2(USP) in Quality Control.

• Responsibility

QC chemist / Officer              : To follow the procedure

• Accountability

Head Quality Control              : For SOP compliance

• Procedure
  • Cleaning
    • Before cleaning switch off the main.
    • Clean the surface of instrument by using dry lint free cloth.
    • Press the lock button remove out from the shaft then remove the drum (D 2) and open   

     the lid and remove the dust powder available inside of the drum and then thoroughly clean with wet lint free cloth and followed by dry lint free cloth.

• Repeat the same above procedure for drum (D1) cleaning.
  • Slide out the tray from their rack and clean first with wet lint free cloth and followed

     by dry lint free cloth.

• Operation:
• Ensure the cleaning and calibration of the instrument.
• Check the drum is fixed and locked properly with shaft and trays are arranged below the drum.
• Tilt the instrument (10°) if required.
• Switch ON the instrument, drum will initialize itself to the loading position, the display will now show START.
• Weigh and record the weight of the tablets.
• Adjust the counts to 100 by pressing the COUNT key followed by ‘1’, ‘0’, ‘0’ keys. (Count range 1 to 99999).Press ENTER to confirm the reading.
• To see and confirm the number of counts press COUNT key .
• On confirming the number of counts press RUN/HALT key to start, the display shows the elapsed count.
• Test can be performed by adjusting ‘TIME’ similarly as ‘COUNT’.
• When test is over drum rotates in reverse direction discharging the tablets in the tray.
• The test over is indicated by an audible beep and display shows END.
• The drum initializes itself to loading position and display shows START indicating the instrument is ready for the next run.
• Remove the tablets from the tray.
• De- dust and weigh the tablets and note down the weight of the tablets
  • Method:
    • Sample Quantity: For tablets with an average weight of 0.650 gm or less take a sample of  whole tablets to about 6.50 gm and for tablets with an average weight of more than 0.650 gm take a sample of 10 whole tablets.      .
    •  De-dust the tablets carefully.
    •  Weigh accurately the required number of tablets and record in gram (A).
    • Place the tablets in the drum and operate the apparatus as per SOP for 100 rounds.
    • After completion of test, remove the tablets, remove any dust from them and weigh them
    • Accurately and record in gram (B) and calculate as per the formula.
    • Calculation:     

                                  [A] – [B]          

                          Friability = ———————x 100

                                                  [A]

• Acceptance Criteria:
  • Not more than 1 % w/w.
  • If cracked, cleaved or broken tablets are present in the tablet sample after test, the

            sample fails.

• If the weight loss is more than 1 % w/w, repeat the test twice and the mean of (3 tests)             determined. This should not be more than 1 %.
  • Calibration procedure
    • Ensure that the equipment shall be clean.
    • Operate the apparatus as per the operation point No.5.2
    • Affix metal piece on the drum and check that the tachometer will sense it.
    • Run the apparatus and wait until reading on display of tachometer stabilizes.
    • After stabilization record the observation on annexure I.
    • Repeat the above process twice. And calibrate the timer with the help of stop watch.
    • Acceptance Criteria: 25 ± 1 RPM (24-26) and time ( 00:04:00±10sec).
    • Frequency: Monthly ± 3 Days
    • If the variation is not with in the specified tolerance limit; affix the status as out of calibration and inform to department head.
    • Do not use the equipment until all error are rectified, after rectification again calibrate the equipment and record the observation. 
• Annexure                          

     Annexure I: Calibration Record of friability test apparatus.

• Reference (S)              

      IP / USP           

• Glossary

SOP	:	Standard Operating Procedure
BMR	:	Batch Manufacturing Record
NA	:	Not Applicable
RPM	:	Rotation per minute
%	:	Percentage

• Revision History

Rev. No.	Details of changes	Reason for change