Cleaning and Operation of Tablet Hardness Tester

In this post Standard Operating Procedure Cleaning and Operation of Tablet Hardness Tester  in Pharmaceuticals is describe.

1.0   OBJECTIVE:

To lay down the procedure for the Cleaning and Operation of Tablet Hardness Tester.

2.0   SCOPE:

This SOP is applicable to the Cleaning and Operation of Tablet Hardness Testers in Production department.

3.0   RESPONSIBILITY:

Operator, Officer and Executive – Production Department Manager – Production DepartmentQA Officer – In process

4.0   DEFINITION(S):

NA

5.0   PROCEDURE:

5.1   Cleaning:

5.1.1   Clean the hardness tester by wiping with a clean dry lint free cloth followed by wiping with a lint free clean cloth dipped in 70 % IPA. Dry the surface by wiping with clean dry lint free cloth.

5.2   Operation:

5.2.1  Check and ensure the hardness tester is clean.

5.2.2   Turn the screw knob in anticlockwise direction such that tablet can be hold perpendicular in between the jaws.

5.2.3   Hold the tablet between the fixed and moving jaw in edgewise position. Tablet shall be in approximately perpendicular position.

5.2.4  Align the pointer and zero Kg/cm² on scale.

5.2.5  Turn the screw knob in clockwise direction slowly until the tablet breaks.

5.2.6  Note down the reading on the scale corresponding to the pointer.

5.2.7  Record the result of hardness in the Kg/cm².

5.2.8  Release the screw knob in anti clockwise direction.

5.2.9   Ensure that holding jaw is free of tablet powder before placing next tablet for testing.

Note: Calibration of the equipment will be done by outside party yearly or whenever is required.

6.0   ABBREVIATION(S):

IPA  : Iso Propyl Alcohol

Kg/cm² : Kilograms Per Centimeter Square

7.0   REFERENCE(S):

NA

8.0   ANNEXURE(S):

Nil

9.0   DISTRIBUTION:

Master Copy    : Quality Assurance

Controlled Copy (S) : Production department, Quality Assurance

Reference Copy (S) : Production department