OPERATION AND CLEANING OF HARDNESS TESTER (MONSANTO TYPE)

1.0 PURPOSE:
To provide a written procedure for the Operation and Cleaning of Hardness Tester (Monsanto Type).
2.0 SCOPE:
Applicable to Hardness Tester (Monsanto Type ) used for checking Tablet Hardness
in production.
3.0 RESPONSIBILITY:
Executive Manufacturing and Executive QA, Assistant Manager QA.
4.0 ACCOUNTABILITY:
Manager Quality Assurance
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1
OPERATION:
6.1.1 Hold one tablet between the two faces provided by pushing forward the movable face inside by turning the plunger clockwise. Coincide the `Zero'
in the scale with the pointer.
6.1.2 Enclose front part where tablet is held in a sample polybag.
6.1.3 Start applying pressure on the tablet by gently rotating the plunger
6.1.4 When the tablet breaks, note the hardness (in kg/sqcm) directly from the scale. In case, if the pointer is in between the two divisions of scale, read the hardness as 0.5 kg / sq.cm.
6.1.5 Discard the broken tablets in water and sample polybag in waste bin.
6.2
CLEANING:
6.2.1 After use, clean the hardness Tester with clean lint free cloth and keep in its box. This procedure is to be followed during product change over and at the end of shift.
6.2.2 After batch is completed dismantle the hardness tester and clean with potable water followed by 0.1% SLS solution followed by potable water to remove the SLS solution and finally rinse with purified water, and clean with lint free cloth and keep in its box.
7.0 REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATIONS:
9.1 SLS : Sodium lauryl Sulphate (0.1%)
9.2 Kg / sq.cm : Kilogram / Square Centimeter.