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Operating Procedure for Tablet Hardness Tester (Erweka)

  •  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
00 New SOP

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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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