STANDARD OPERATING PROCEDURE LAB EQUIPMENT FRIABILITY TEST APPARATUS

STANDARD OPERATING PROCEDURE

SUBJECT :                     LAB EQUIPMENT FRIABILITY TEST APPARATUS

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To provide guidelines in the handling of Friability test apparatus.

2.0       POLICY:

The resistance of tablets to chipping or breakage under condition of storage or transportation and handling can be gauged.

3.0       PROCEDURE:

3.1       Tablets (approx 20) are weighed and placed in the Friability test apparatus.

3.2         After a given number (100) of rotations the tablets are weighed and the losses of weight due to rolling and repeated shocks indicate the ability of the tablets to withstand and the wear.

3.3       Rotating disc should not be cleaned with solvents.

3.4       It should be cleaned with cloth.

3.5       Rotating disc should be cleaned before the commencement of operations.

4.0       FREQUENCY:  As and when required.

5.0       RESPONSIBILITY: Executive Q.A.

6.0       REVIEW GUIDE: Calibration log book

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

             This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x