Operation And Calibration Of Friability Test Apparatus

1.0              OBJECTIVE

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

2.0              RESPONSIBILITY

Quality Control Chemist / QA Chemist

3.0              ACCOUNTABILITY

Quality Control Manager / QA Manager.

4.0              PROCEDURE

4.1        GENERAL CLEANING

Ø      Clean the apparatus free of dust with dry cloth from out side every day.

Ø      Clean the rotating disc and unloading pan from inside with dry cloth at the start and end of every operation.  Wet cloth may be used occasionally if cleaning is not proper with dry cloth but this should follow drying of the inner surface by first wiping with dry cloth and exposure to atmosphere air.

4.2        OPERATING INSTRUCTIONS

Ø      Ensure that apparatus is properly connected with power supply.

Ø      Weigh tablets to be tested  and record the weight {W_I}.

Ø      Switch on the main switch of power supply.

Ø      Press MODE key and select count mode.

Ø      Press SET button and set the RPM to 25 with the help of   numerical key’s (0 to 9) & press  ENTER

Ø      Key located on the front side of the instrument.

Ø      Load the weighed tablets in the drum, close the lid and secure it by tightening he screw and press ENTER and then press START to run test. 

Ø      After the completion of set rotations, the apparatus will automatically unload the tablets into the tray. Observe the tablets.

Ø      Dedust the tablets, weigh and record the weight {W₂}.

Ø      Calculate the percentage Friability  by the following formula;

Initial Wt. of Tablets (W₁) – Wt. of tablets After 100 rotation (W₂)      X 100

                                                                  Initial Wt. of Tablets (W₁)

Ø      Dstroy the tested tablets as per SOP

4.3        CALIBRATION PROCEDURE          

      

Ø      Switch on the power supply.

Ø      Set the RPM to 25 and start the machine simultaneously with the stop watch. Count the actual rotations and not the time required for the same.

Ø      Similarly set the RPM to 100 and note the time required and actual rotations.

Ø      Apparatus is in proper working condition if,

R      Time required for 25 rotations is 1 min ± 05 sec.

R      Time required for 100 rotations is 4 min ± 20 sec. 

Ø      Record the observation in the calibration record as per Annexure – 1.

Ø      Affix a “Calibration Status” label on the instrument.

Ø      In case of any discrepancy, report the observations to QC manager / QA Manager and notify the defect to Engg. Department. Affix an ‘UNDER MAINTENANCE” label on the instrument. 

Ø      FREQUENCY

             Once in a month and after each maintenance job.

ANNEXURE – 1

                                              

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

Name of Instrument	: Friability Test Apparatus
Instrument Ser. No.	:
Make & Model	: Electrolab.
Calibration date	:
Calibration due on	:

Sr. No.	SET ROTATION	ROTATIONS DISPLAYED	ROTATION OBSERVED MA NUALLY	TIME	ACCEPTANCE CRITERIA
1	25				1 min ± 05 sec
2	100				4 min ±  20 sec

REMARKS :  Satisfactory / Not satisfactory.

CALIBRATED BY:                                                                             CHECKED BY :

DATE:                                                                                                 DATE  : 

Prepared By

Checked By

Approved By

Authorised by