G-209

Calibration and Operation of the Sotax MT-50 Hardness Tester FORMATTED

Section G — Equipment Revision 0 5 pages

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1.0 Purpose

The purpose of this procedure ~is to provide detailed guidelines for the calibration and operation

of the Sotax MT-50 hardness tester using the 5 kg weight and gage blocks.

2.0 Scope

This procedure applies to the Sotax MT-50 hardness tester. This procedure provides

comprehensive guidelines for the proper testing of tablet hardness as per USP <1217> Tablet

Breaking Force.

3.0 Responsibility

3.1 It is the responsibility of the Metrologist or designee to keep this procedure aligned with
current practices, and to calibrate the Sotax MT-50 hardness tester.

3.2 It is the responsibility of Production (Compression) personnel to follow this procedure.

3.3. ‘It is the responsibility of Production Management to ensure that this procedure is being

followed.

3.4 ‘It is the responsibility of QC Laboratory Management to keep this procedure aligned

with current practices.

4.0 Definitions

4.1 QC - Quality Control

4.2 USP- United States Pharmacopeia

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5.0 References

5.1 G-201-F2, Form, Calibration Certificate

5.2 USP <1217> Tablet Breaking Force

6.0 Use Procedure

6.1 Location and General Setup

6.1.1 Set the Sotax MT-50 hardness tester on a level surface free of vibration.

6.1.2 Ensure the ambient temperature is between 4°C and 35°C, with a relative

humidity between 10% and 75%, and no condensation.

6.1.3 Protect the unit from direct sunlight, dust, smoke, and corrosive fumes.

6.2 Preparation for Use

6.2.1 Ensure the hardness tester is connected to a power source on a level.

6.2.2 Turn on the unit and allow it to initialize. Allow unit to perform its automatic

prestart check.

6.2.3 Verify that the pre-check was performed without issue.

6.2.4 Inspect the testing area and jaws for cleanliness; clean if necessary.

6.3 Hardness Testing

6.3.1 Use the menu buttons to navigate to test then select “Easy Test”.

6.3.2 Enter the number of samples to be tested next to the “H” field. Then press the

green arrow.

6.3.3 Place a tablet in the test area according to product specifications.

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6.3.4 If no specifications are provided, follow these guidelines:

6.3.4.1 Tablets are placed face up.

6.3.4.2 Round tablets can be oriented any way.

6.3.4.3 Elongated tablets should have the longer axis parallel to the jaw.

6.3.5 Press the start arrow to initiate the test.

6.3.6 The left jaw will move to break the tablet, then retract, allowing for the next

tablet to be placed.

6.3.7. Clean the test area as needed with a brush to remove debris.

6.3.8 Repeat the test for the specified number of tablets in the sample group.

6.3.9 Data recorded can be found in the list and statistic buttons at the top of the
display.

6.4 Cleaning After Use

6.4.1 The hardness tester is a non-product contact surface.

6.4.2 Use a brush to remove broken tablets and clean the catch pan.

6.4.3. Clean the instrument carefully with a slightly dampened rag with all-purpose

cleaner.

6.4.3.1 Ensure that no liquid enters the unit and wipe it off with a soft cloth.

6.4.3.2 Remove calcification by a suitable cleaning solvent.

6.4.3.3 Handle Plexiglas cover carefully and clean it with suitable cleaning

solvent (no alcohol or acetone).

6.4.4 While cleaning, inspect the unit for wear and tear. Report any findings to the

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Metrologist or QC Laboratory Management.

7.0 Calibration Procedure

7.1 Setup for Calibration

7.1.1 Place the MT-50 hardness tester securely on a flat surface.

7.1.2 Connect the appropriate power cord and ensure the tester is powered on.

7.1.3. Navigate to Service, Calib.

7.1.4 Ensure appropriate calibration settings are selected via the Calib. Settings

option.

7.1.5 Select Hardness then rotate unit onto its left side.

7.1.6 Attach the calibration kit as described:

7.1.6.1 Remove the fixed jaw by loosening the two screws, taking care not to

drop the jaw.

7.1.6.2 Fix the guide block in place of the crushing jaw (ensure center hole is

aligned).

7.1.6.3 Insert the calibration plate into the guide block, ensuring the shaft is
fully inserted into the calibration cube.

7.2 Calibration

7.2.1 Press the “Run” button and place the 5 kg reference weight on the calibration

plate. Ensure the weight is centered correctly.

7.2.2 Press the “Run” button again to begin the calibration process.

7.2.3, Wait for the message “Please wait...” to disappear and confirm the next

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calibration date displayed on the screen.

7.2.4 Press “Ok” to complete the calibration. Remove the reference weight and

calibration kit.

7.2.5 Reinsert the fixed jaw and tighten both screws.

7.2.6 Return the MT-50 to its normal horizontal position.

8.0 Maintenance
8.1 Follow the preventive maintenance schedule as outlined in the Sotax MT-50 manual.

8.2 Ensure all maintenance activities are documented and any issues are reported to

management.

9.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 06/11/24 | New procedure. N/A J. Nicholson | - | - |