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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