SOP of Operating Procedure for Tablet Hardness Tester
Objective:To lay down the Operating procedure for Tablet Hardness Tester.
Scope:This Standard Operating Procedure is applicable for formulation plant of (Write Pharmaceutical Company Name with Location).
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 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.
Flow Chart -Annexure-1
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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