Operating Procedure for Tablet Hardness Tester (Monsanto)

April 6, 2016September 12, 2024 Pharmaceutical Guidanace

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

–

New SOP

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