Operating Procedure for Tablet Hardness Tester (Erweka)

April 6, 2016September 12, 2024 Pharmaceutical Guidanace

Objective:To lay down the Operating procedure for Tablet Hardness Tester.

Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location.

Make: Erweka.

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

SS – Stainless Steel

QA – Quality Assurance

SOP – Standard Operating Procedure

Kg – kilogram

Oz – Ounce

Lb – Pound

N – Newton

KN – kilo Newton

BMR- Batch Manufacturing Record

Procedure
- Operating Procedure:
  - Insert the four batteries in the battery pocket of equipment.
  - Switch ‘on’ the Tester.
  - Press ‘max’ key, the sign of hardness checking display on the screen.
  - Put the tablet sample on anvil of tablet hardness tester.
  - Rotate the knurled screw clockwise till the breaking point.
  - The reading at breakage of tablet will display on screen and remain hold on.
  - The reading shall be displayed in units’ kg, oz, lb, N and KN.
  - Check the total number of tablet as mentioned in BMR and enter detail in Inprocess Control Sheet.
  - Clean the equipment with the help of brush and switch ‘OFF’.
- Forms and Records. Not Applicable
- Distribution
  - Master Copy- Documentation Cell (QA)
  - Controlled Copies-Production and Quality Assurance
- History

Date

Revision

Number

Reason for revision

–

New SOP

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