1.0 Purpose: To lay down the Standard operating procedure for cleaning and operation of tablet Hardness Tester.
2.0 Scope: This SOP is an applicable tablet hardness tester in the pharmaceutical department.
3.0 Responsibility: QC/QA Officer is responsible for the implementation of this SOP.
Head QC/QA is responsible for ensuring overall compliance to this SOP.
4.1 Do not scratch the scale surface.
4.2 Do not apply too much force and avoid any shocks to the hardness tester.
5.0 Procedure for cleaning and operation of tablet hardness tester:
5.1 Take out the hardness tester from a box.
5.2 Clean the hardness tester and its tip with a lint-free cloth to remove the dust.
5.3 Place one tablet at a time in between the plunger and cover of hardness tester and turn the knob till the tablet is just held in a vertical position. In tablets other than a circular shape, e.g. for capsule shape tablets, hold them along their length in between the plunger and cover of the hardness tester.
5.4 Adjust the scale such that zero on the scale coincides with the pointer.
5.5 Hold the cover of the hardness tester in the palm so that broken tablet fragments will not splash.
5.6 Apply pressure on the tablet by turning the knob of the hardness tester in a clockwise direction till the tablet breaks.
5.7 Take the reading (kg/cm² ) where the pointer coincides with a numerical figure.
5.8 Dispose of the tested sample as per respected SOP.
5.9 Clean the hardness tester and its tip with a lint-free cloth to remove fragments.
5.10 Put the Hardness Tester in Respective Box.
6.0 Calibration Frequency:
Half-yearly by an outside party.
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
Kg/cm²: Kilo gram per centimeter square
IPQC: Inprocess Quality Control