Calibration Procedure for Tablet Hardness Tester (Inweka)

• Objective :To lay down procedure for Calibration of Tablet Hardness Tester (Inweka).

• Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location.

Make: Inweka.

• Responsibility
  • Operator shall be responsible for calibration of the equipment as per this SOP.
  • Production Supervisor / Officer shall be responsible for implementation of this SOP.
  • Head-Production / designee shall be responsible for compliance of this SOP.
• Abbreviations and Definitions

SOP – Standard Operating Procedure

Kg – Kilogram

Oz – Ounce

lb –  Pound

N –  Newton

KN – kilo Newton

QA -Quality Assurance

• Procedure
  • Calibration Procedure
    • Insert the four batteries in the battery pocket of equipment by taking care of ± sign.
    • Place the Tablet Hardness Tester with the back of the tester, resting on the shelf.
    • Switch ‘on’ the Tablet Hardness Tester.
    • Press ‘Max’ key until two triangular arrows pointing away from each other are showing on display.
    • Press the ‘Units Button’ until the kg symbol appears. The reading shall be displayed in units’ kg, oz, lb, N and KN.
    • Place the stirrup between the jaws of the tester.
    • Stirrup should not be clamp with anvil.
    • Carefully place the Standard Weight of 5.0 kg on to stirrup.
    • Reading of Calibrated Weight display on the screen.
    • After calibration put the calibrated tag on the equipment.
    • Calibration shall be recorded in Annexure-I.

Note: Calibration of Hardness Tester shall be done monthly / as or when required.

• Forms and Records
  • Tablet Hardness Tester Calibration Record – Annexure-I
• Distributions
  • Master Copy Documentation Cell (QA)
  • Controlled Copies Production and Quality Assurance
• History

Date	Revision Number	Reason for revision
–	00	New SOP

                                                           Annexure-I

 

                                   Tablet Hardness Tester  Calibration Record

Date and Time	Standard Weight 5.0 kg/ 49.03N	Certificate Number	Certificate Valid Upto	Actual Weight Observed	Tolerance 5.00±0.10kg 49.03N±1N	Calibration          OK/NOT OK	Next Due Date	Done by	Checked By

 

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