SOP FOR FRIABILITY TEST APPARATUS | STANDARD OPERATING PROCEDURE FOR CLEANING, OPERATION & CALIBRATION OF FRIABILITY TEST APPARATUS

 1.0            OBJECTIVE

 To lay down the procedure for operation of Friability test apparatus

2.0              SCOPE

This SOP shall be applicable to the Friability test apparatus used in QC Dept.

3.0              RESPONSIBILITY

3.1              Chemist QC and above shall be responsible for the preparation and execution of this SOP

3.2              Sr. Chemist QC & above and QA Head shall be responsible for the checking and approval of this
 SOP.

4.0              ACCOUNTABILITY

Head QC

5.0              PROCEDURE

5.1              Cleaning

5.1.1        Ensure that power supply to the Friability Test apparatus is switched ‘OFF’ before cleaning and plug shall be removed from the socket.

5.1.2        Friability Test apparatus shall be kept on a clean table/platform.

5.1.3        Platform of Friability Test apparatus shall be wiped with a dry lint the free cloth on a daily basis so that there will be no dust particles on the Friability Test apparatus

5.2              Operation

5.2.1        Ensure that the power supply to the Friability test apparatus is switch “ON.”

5.2.2        The locking nut shall be unscrewing to release the drum.

5.2.3        Ensure that the accurate weighing of the tablets.

5.2.4        Weighed tablets shall transfer the in the drum and ensure for the tightly closing of the drum.

5.2.5        Ensure that the apparatus is switch on and the resolutions shall be counted as specified in the monogram.

5.2.6        Ensure that the tablets shall be tumbled at each turn of the drum by a curved projection that extends from the middle of the drum to the outer wall.

5.2.7        Ensure that the drum shall rotate 100 times and after that, the tablets shall be remove from the apparatus.

5.2.8        Ensure that any loose dust or broken tablets and shall be removed

5.2.9        Weighing of tablet shall be done after rotation.

5.2.10    Ensure that the instrument shall be switched off when not required.

5.2.11    The percentage of weight loss shall be calculated using the following formula.

% weight loss =    Initial weight – Final weight   

                                                     Initial weight               ×100%

5.2.12     Calibration Procedure

Calibration of Friability test apparatus shall be done by the external party on an annual frequency.

6.0              REFERENCES

Not Applicable

7.0              ANNEXURE

Not Applicable

8.0              ABBREVIATIONS

SOP         :           Standards Operating Procedure

QC           :           Quality Control

HOD        :           Head of the Department

QA           :           Quality Assurance

QCD        :           Quality Control Department

QAD        :           Quality Assurance Department

EQP         :            Equipment

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