Fribilator Calibration SOP

1.0 OBJECTIVE:

To lay down the procedure for calibration of Friability test apparatus.

2.0 SCOPE:

This shall be applicable to the Friability apparatus of Quality Control Instrument Lab.

3.0 RESPONSIBILITY:

3.1 Technical Assistant/ Helper.

3.2 Q.C Analyst.

4.0 ACCOUNTABILITY:

4.1 Manager-Quality Control.

5.0 MATERIAL AND EQUIPMENT:

5.1 Friabilator.

5.2 Analytical weighing balance.

5.3 Stop watch.

5.4 Tablets. (Uncoated/ Compressed tablets).

6.0 PROCEDURE:

6.1 Before starting calibration, check cleanliness of instrument.

6.2 Switch “ON” the power supply.

6.3 Operate the apparatus according to SOP for operation of friabilator.

6.4 Set the RPM to 25 and start the machine simultaneously with the stop watch. Count the actual rotations and note the time required for the same.

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

6.6 Apparatus is in proper working condition if:

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

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

6.7 Record the observation in the calibration record as per Annexure-1.

6.8 Record the result on the “Calibration Record”, “Calibration Log Book” & paste the “Calibration Status Sticker” on Friability test apparatus.

6.9 In case of any discrepancy, report the observations to Q.C Manager/ Q.A Manager & notify the defect to Engg. Dept. Affix an “UNDER MAINTENANCE” label on the instrument.

6.10 Frequency:

6.10.1 Once in a month and after each maintenance job.

7.0 REVISION LOG:

Revision No.	Effective Date	Reason
00		New SOP

8.0 REFERENCES:

8.1 Not Applicable.

9.0 ANNEXURES:

Annexure 1: Calibration of Friability test Apparatus.

Annexure: 1

CALIBRATION OF FRIABILITY TEST APPARATUS

Calibration of Friability test Apparatus

Ref. SOP No.	Revision No.	Effective from
	00

Name of instrument:

Instrument serial No.:

Make & Model:

Calibration date:

Calibration due date:

Sr.#	Set rotation	Rotations displayed	Rotation observed manually	Time	Limits	Acceptance criteria
1.	25				24-26	1min±05sec
2.	100				98-102	4min±20sec

Remarks: Satisfactory/ Not satisfactory.

Calibrated by/date	Checked by/date	Approved by/date	Authorized by

10.0 ABBREVIATIONS:

Abbreviation	Expanded Form
SOP	Standard operating procedure
&	And
No.	Number
Ltd.	Limited
QCI	Quality control instrument lab
Sr.#	Serial number
Dept.	Department
Q.A	Quality assurance
Q.C	Quality control
Sec	Seconds
RPM	Revolution per minute
Engg.	Engineering
Min	Minute