1.0 OBJECTIVE:
1.1 To describe the procedure for the operation of the Digital Tablet Hardness Tester for the determination of tablet hardness (crushing strength) and, where applicable, tablet thickness, diameter, length, width and weight, to ensure accurate, reliable and reproducible test results in accordance with established quality requirements.

2.0 SCOPE:
2.1 This SOP is applicable to the operation of the Digital Tablet Hardness Tester installed in the In-Process Quality Control (IPQC) laboratory of Caisa Pharma International.

3.0 RESPONSIBILITIES:
3.1 Designee Production / Quality Assurance (QA) / Quality Assurance (QC):
3.1.1 Operation, cleaning and documentation.
3.1.2 Shall verify the instrument status before use.
3.1.3 Shall operate the instrument in accordance with this SOP.
3.1.4 Shall record the observations and test results.
3.1.5 Shall clean the instrument after completion of analysis.

3.2 Department Head:
3.2.1 Overall compliance.

3.3 QA Department:
3.3.1 Periodic verification and SOP compliance.

4.0 DEFINATIONS:
4.1 Hardness (Crushing Strength): The force required to break a tablet by applying pressure diametrically. The hardness value is expressed in Newton (N) or Kilogram-force (kgf/Kp) as selected in the instrument settings.

5.0 PROCEDURE:
5.1 Before Operation:
5.1.1 Ensure the instrument is clean and free from dust or tablet residues.

5.1.2 Verify that the instrument bears a valid calibration status label.

5.1.3 Ensure the instrument is connected to a power supply and if an external balance or printer is required, ensure they are properly connected before switching ON the instrument.

5.1.4 Ensure the broken tablet collection tray is correctly installed.

5.2 Switching ON the Instrument:
5.2.1 Switch ON the mains power supply.

5.2.2 Turn ON the instrument.

5.2.3 The instrument performs an automatic self-check.

5.2.4 During initialization:
5.2.4.1 Software version is displayed.
5.2.4.2 The plunger moves forward to detect the home position.
5.2.4.3 The plunger automatically returns to the preset position.
5.2.4.4 The instrument enters Standby Mode.

5.2.5 Verify that no error message is displayed before proceeding.

5.3 Instrument Configuration and Setup:
5.3.1 Before performing the hardness test, verify that all instrument settings are correct.

5.3.2 Date and Time Setting:
5.3.2.1 Press F4 or select Clock Setting from the main menu.
5.3.2.2 Verify that the displayed date and time are correct.
5.3.2.3 If correction is required, Select the required field, Enter the correct date, Enter the correct time and Press ENTER to save.
5.3.2.4 Verify that the updated date and time are displayed correctly.

5.3.3 Operator Name Setting:
5.3.3.1 Press F6 or select Operator Name from the menu.
5.3.3.1.1 Enter the assigned password.
5.3.3.1.2 Select the operator’s name.
5.3.3.1.3 Verify that the displayed operator name is correct.

5.3.3.2 If a new operator is to be added:
5.3.3.2.1 Select an unused operator location.
5.3.3.2.2 Press F1.
5.3.3.2.3 Enter the operator’s name using the QWERTY keyboard.
5.3.3.2.4 Save the entry.

5.3.3.3 If password modification is required:
5.3.3.3.1 Select the operator.
5.3.3.3.2 Press F1.
5.3.3.3.3 Enter the existing password.
5.3.3.3.4 Enter the new six-digit password.
5.3.3.3.5 Press ENTER.
5.3.3.3.6 Verify that “Password Stored” is displayed.

5.3.4 Company Name Setting:
5.3.4.1 Press F7 or select Company Name.
5.3.4.1.1 Verify that the company name displayed on the screen is correct.

5.3.4.2 If modification is required:
5.3.4.2.1 Enter the company name using the QWERTY keyboard.
5.3.4.2.2 Press ENTER to save.

5.3.4.3 Verify that the updated company name is displayed correctly.

5.4 Product Library Setting:
5.4.1 Press F2 to access the Product Library.

5.4.2 Select the required product.

5.4.3 Verify the stored product information.

5.4.4 If a new product is required:
5.4.4.1 Select an empty product location.
5.4.4.2 Enter the product name.
5.4.4.3 Configure the required parameters.
5.4.4.4 Save the product.

5.4.5 Verify that the selected product corresponds to the batch being analyzed.

5.5 Setup Menu:
5.5.1 Press F12 to open the Setup Menu.

5.5.2 Verify the following settings for weight entry:
5.5.2.1 If Manual mode is selected:
5.5.2.1.1 Select Manual under Weight Entry.
5.5.2.1.2 Enter the weight of each tablet manually using the keyboard.
5.5.2.1.3 Press ENTER to save the entered value.
5.5.2.2 If Balance Mode is selected:
5.5.2.2.1 Select Balance under Weight Entry.
5.5.2.2.2 Verify that the external balance is connected through the RS-232 communication cable.
5.5.2.2.3 Select the appropriate baud rate corresponding to the connected balance.
5.5.2.2.4 Place the tablet on the balance and press the PRINT key on the balance.
5.5.2.2.5 Verify that the weight is automatically transferred to the instrument display.
5.5.2.2.6 Press ENTER to continue.

5.5.3 Plunger Position:
5.5.3.1 Verify the plunger opening according to the tablet size.
5.5.3.2 Adjust if required.

5.5.4 Diameter Unit:
5.5.4.1 Select: mm

5.5.5 Hardness Unit:
5.5.5.1 Select the required reporting unit: Newton (N) / Kilogram-force (Kg/Kp)

5.5.5.2 The selected unit shall comply with the approved specification.

5.5.6 Test Method:
5.5.6.1 Verify that the appropriate test mode has been selected.

5.5.7 Confirmation:
5.5.7.1 After verification of all parameters:
5.5.7.1.1 Press ENTER.
5.5.7.1.2 Return to Standby Mode.

5.5.8 Validation Menu (If required)
5.5.8.1 Press F10.

5.5.8.2 Select the required validation function:
5.5.8.2.1 Weight Validation
5.5.8.2.2 Diameter Validation

5.5.8.3 Perform validation only when required or as per the Calibration/Verification SOP.

5.5.8.4 Return to the Standby screen after completion.

5.6 Cleaning After Use:
5.6.1 After completion of testing, ensure that no test is in progress.

5.6.2 Switch OFF the instrument and disconnect the mains power supply.

5.6.3 Remove all broken tablet pieces and loose powder from the tablet testing area.

5.6.4 Remove the tablet collection tray carefully.

5.6.5 Dispose of the tablet fragments in the designated waste container as per the approved waste-disposal procedure.

5.6.6 Clean the collection tray using a clean, soft brush or dry lint-free cloth.

5.6.7 Clean the tablet bed, fixed jaw, movable plunger and surrounding testing area using a clean, soft brush.

5.6.8 Wipe accessible product-contact surfaces with a lint-free cloth lightly moistened with purified water, where applicable.
5.6.9 Wipe the external surface, display panel and keyboard using a clean lint-free cloth.

5.6.10 Allow all cleaned surfaces to dry completely and refit the collection tray properly.

5.6.11 Cover the instrument with a clean dust cover when not in use.

6.0 RFERENCE:
6.1 Instrument User Manual

6.2 British Pharmacopoeia / US Pharmacopoeia

7.0 RECORDS:
Sr No. Title Nature of Document Document No.
NA NA NA NA

8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01