SOP for Operation and Calibration of Friability Test Apparatus

OBJECTIVE

To lay down the procedure for the operation and calibration of the friability test apparatus

RESPONSIBILITY

Quality Control Chemist

QA Chemist

ACCOUNTABILITY

Quality Control Manager

QA Manager.

PROCEDURE

Operation Procedure

1. General Cleaning

• Clean the apparatus free of dust with dry cloth from outside every day.
• Clean the rotating disc and unload the pan from the inside with a dry cloth at the start and end of every operation. A wet cloth may be used occasionally if cleaning is not proper with a dry cloth but this should follow drying of the inner surface by first wiping with a dry cloth and exposure to atmospheric air.

2. Operation Instructions

• Ensure that the apparatus is properly connected to the power supply.
• Switch on the main switch of the power supply.
• Press the MODE key and select count mode.
• Press the SET button and set the RPM to 25 with the help of numerical keys (0 to 9) & press ENTER Key located on the front side of the instrument.
• Weigh tablets to be tested and record the weight {W1}.
• Load the weighed tablets in the drum, close the lid, and secure it by tightening the screws and pressing ENTER and then press START to run the test.
• After the completion of set rotations, the apparatus will automatically unload the tablets into the tray. Observe the tablets.
• Dedust the tablets, weigh and record the weight {W2}.
• Calculate the percentage Friability by the following formula;

• Destroy the tested tablets as per SOP

ALSO READ: SOP for Operation and Calibration Procedure for Analytical Balance

Calibration Procedure

• Switch on the power supply.
• Set the RPM to 25 and start the machine simultaneously with the stopwatch. Count the actual rotations and note the time required for the same.
• Similarly set the RPM to 100 and note the time required and actual rotations.
• The apparatus is in proper working condition if, the R Time required for 25 rotations is 1 min ± 05 sec. R Time required for 100 rotations is 4 min ± 20 sec.
• Record the observation in the calibration record as per Annexure – 1.
• Affix a “Calibration Status” label on the instrument.
• In case of any discrepancy, report the observations to the QC manager / QA Manager and notify the defect to Engg. Department. Affix an ‘UNDER MAINTENANCE” label on the instrument.

Frequency

Once a month and after each maintenance job.

ANNEXURE

ANNEXURE – 1

 

REF. SOP NO.:	Revision No.:  00	Page No.: 1 of 1
	Effective from:

 

Name of Instrument:                                        Instrument ID:

Make & Model:                                                   Calibration Date:

Calibration Due on:

 

Sr. No.	Set Rotation	Rotations Displayed	Rotation Observed Manually	Time	Acceptance Criteria
1	25				1 min ± 05 sec
2	100				4 min ± 20sec

 

Remarks: Satisfactory / Not Satisfactory

 

Calibrated By / Date: ______       

Checked By / Date: _________

REVISION HISTORY

Nil

ALSO READ: SOP for Calibration of Electrolab Dissolution Apparatus