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SOP for Operation and Calibration of Hardness Tester (MODEL- EH01P)


OBJECTIVE
To lay down a procedure for Operation and Calibration of the Hardness Tester (Model-EH01P)

SCOPE
This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.

RESPONSIBILITY
Execution : Chemist and above – QC department.
Checking : Asst. Manager and above – QC department

OPERATIONAL PROCEDURE
  • Keep the unit on a cleaned levelled table surface.
  • Switch on the tester by pressing the ‘POWER ON’ key, the unit does a self-test during which displays the firm name, model and then the gauge data. After the self-test and if no load has been applied, the display will be zeroed. This is because the tester re-zeroes itself as of the self-test routine.
  • During the operation of tester it is often necessary to zero the display; this is achieved by pressing the “ZERO” key.
  • Select the unit of measurement required by pressing the “UNITS” key. Each successive press of this key will select the next available units until the tester returns to original.
  • Choose the test mode: Force gauge provide the three kind of test mode: track mode, peak hold mode and peak hold auto cancelled mode.
  • Slide the Guard cover towards the knob end to open.
  • Place a tablet on the tablet platform.
  • Ensure that the tablet touches the load cell end jaw & is close to the axial center of the unit. Slide the safety guard cover back to the initial position to close.
  • Start turning the knob. During testing, the plunger is driven forward by turning the knob, which gives a gentle movement and presses the tablet against the load cell end jaw. The process continues till the tablet is fractured and breaking point is registered by the unit. The peak force value will be displayed and held.

CALIBRATION PROCEDURE
Frequency: Once in 3 month
  • Take out the fixed plunger from the force gauge.
  • Place the hook on the force gauge
  • Power on the force and “Zero”
  • Hook up the standard 5Kg weight & verify the reading on force gauge and record the observation in Annexure-1.
  • Acceptable Limit: ± 0.5% of certified weight

PRECAUTIONS
  1. Do not apply more speed or jerks to knob while rotating for hardness tester
  2. Do not overload the gauge. The gauge should be used in the test capacity

REFERENCE(s)
Nil.

ABBREVIATION(s)
SOP : Standard Operating Procedure
Q.A : Quality Assurance
Q.C : Quality control

ANNEXURE(s)
Annexure No. – 1 - Calibration Record of Hardness tester

 
REVISION CARD
Nil

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