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

Number

Reason for revision
00 New SOP

 

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