Calibration Procedure for Tablet Hardness Tester (Inweka)

April 6, 2016September 12, 2024 Pharmaceutical Guidanace

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

–

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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