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Operating Procedure for Tablet Hardness Tester (Monsanto)

  •  Objective :To lay down the Procedure for Operating of Tablet Hardness Tester (Monsanto).
  • Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location.

Make: Monsanto.

  • 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 procedure as per SOP.
  • Abbreviations and Definitions

SS – Stainless Steel

SOP – Standard Operating Procedure

QA –  Quality Assurance

  • Procedure
    • Operating Procedure:
      • Place the sample tablet in the vertically holding edges of the anvil of Monsanto Hardness Tester.
      • Adjust the pointer at zero position on the scale by rotating the screw in forward direction.
      • Now rotate the screw till break point of the tester.
      • The breakage of tablet shows hardness on the scale.
      • Repeat the procedure 8-10 times for average reading. Record the observation in Inspection Sheet and attach in BMR.
    • Forms and Records

Not Applicable

  • Distribution
    • Master Copy – Documentation Cell (QA)
    • Controlled Copies – Production and Quality Assurance
  • History
Date Revision


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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