SOP for Operation of Hardness Tester

OBJECTIVE

To lay down a procedure for operation of the Hardness tester.

SCOPE

This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.

RESPONSIBILITY

The Quality Control Chemist is responsible for implementation of the process.

The Quality Control Manager is responsible for the execution of the procedure.

PROCEDURE

• Select 10 tablets at random for hardness testing from the sampled lot.
• Place one tablet on its edge and hold firmly in position. If the tablet has a break-line, then the break-line should be horizontal. Adjust the scale so that the zero on the scale coincides with the pointer.
• Turn the screw at the top of the tester slowly in order to create pressure on the plunger. Continue turning the screw slowly until the tablet breaks. Record the observed reading.

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• Repeat the above steps for nine other tablets. Determine the average hardness.
• Check the Product Specifications for compliance.
• Note: If average hardness is not within product specification range, immediately inform department in-charge for appropriate action.

REFERENCE(s)

Nil.

ABBREVIATION(s)

SOP : Standard Operating Procedure

Q.A : Quality Assurance

No. : Number

Q.C : Quality control

ANNEXURE

Nil.

REVISION HISTORY

Nil

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