OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN

SOP No.:
QUALITY CONTROL DEPARTMENT Page 1 of 3
QCG0016
Supersedes : Effective:
STANDARD OPERATING PROCEDURE
00 April 2010

Version No. : SOP FOR OPERATION AND CALIBRATION OF Review date:

01 FRIABILITY TEST APPARATUS March 2013

1.0 OBJECTIVE:

To describe the procedure for the Operation and Calibration Friability

Test Apparatus.

2.0 SCOPE:

This SOP is applicable to Calibration of Friability Test Apparatus at M/s.

Oasis Laboratories Private Limited, Dehradun.

3.0 RESPONSIBILITY:

Quality Control Department

4.0 ACCOUNTABILITY:

HOD QC

5.0 PROCEDURE :

5.1 Ensure that the instrument and its surrounding area is clean and
free from dust.

5.2 Weigh accurately the number of tablets and carry out the
procedure as described in the monogram.

5.3 Open the apparatus from one removable side of the drum.
5.4 Transfer the tablets in it and close the drum tightly.

5.5 Switch on the apparatus, and count the revolution as specified in

the monogram.

5.6 The tablets are tumbled at each turn of the drum by a curved
projection that extends from the middle of the drum to the outer
wall.

5.7 Rotated the drum 100 times, and after completion of revolution
remove the tablets from the drum.
5.8 Remove any loose dust or broken tablets and weigh.

Designation Signature Date

Prepared by Chemist - QC
Reviewed by Manager - QC
Approved by Manager - QA
 OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.:
QUALITY CONTROL DEPARTMENT Page 2 of 3
QCG0016
Supersedes : Effective:
STANDARD OPERATING PROCEDURE
00 April 2010

Version No. : SOP FOR OPERATION AND CALIBRATION OF Review date:

01 FRIABILITY TEST APPARATUS March 2013

5.9 Switch of the instrument when not required.

6.0 CALIBRATION RECORD:-

The apparatus is calibrated by TIME CONTROLLER and calculate RPM as

follows:-
PROCEDURE:-

Calibration of RPM Calibration of Time Controller

Set No of Observed Set observed /

Date Limit Limit
Time revolution RPM/min. time Display time

0 4 min 1 RPM 5.00 min 0.05 min

4 8 min 1 RPM 10.00 min 0.05 min

0 8 min 1 RPM 15.00 min 0.05 min

Frequency of calibration: Monthly

7.0 RECORDS:

Calibration Record of Friability Test Apparatus (Annexure-1).

8.0 ANNEXURES:

Annexure-1: Format for Calibration Record of Friability Test Apparatus.

9.0 ABBREVIATIONS & DEFINITIONS:

SOP : Standard Operating Procedure.
Dept. : Department.
HOD : Head of the Department.
QC : Quality Control
Annexure-1
CALIBRATION OF FRIABILITY TEST APPARATUS

Designation Signature Date

Prepared by Chemist - QC
Reviewed by Manager - QC
Approved by Manager - QA
 OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.:
QUALITY CONTROL DEPARTMENT Page 3 of 3
QCG0016
Supersedes : Effective:
STANDARD OPERATING PROCEDURE
00 April 2010

Version No. : SOP FOR OPERATION AND CALIBRATION OF Review date:

01 FRIABILITY TEST APPARATUS March 2013

SOP REF NO QCG0016 QC-F-019-01

Name of Instruments : Friability Test Apparatus Instruments location: Q.C. LAB.

Name of Manufacturer : Satish Enterprises Delhi
Instrument ID Number : QC/CS/016
Frequency of calibration : Monthly

Calibration of RPM Calibration OF TIME CONTROLLER Next Remark Performed Checked

due by by
Date Set No of Observed Limit Set observed / Limit date
Time revolution RPM/min. time Display
time

0 4 min 1 RPM 5.00 0.05

min min

4 8 min 1 RPM 10.00 0.05

min min

0 8 min 1 RPM 15.00 0.05

min min

Designation Signature Date

Prepared by Chemist - QC
Reviewed by Manager - QC
Approved by Manager - QA