Standard Operating Procedure for Verification of Tablet Hardness Tester
1.0 Purpose:
To lay down a procedure for Verification of Tablet Hardness Tester.
2.0 Scope:
The scope of this SOP is applicable for Verification of Tablet Hardness Tester at Quality control department.
3.0 Responsibility:
QC Personnel: To Verify the Tablet Hardness Tester.
Section Head QC/Designee: To Review the Verification Report.
Head QC/Designee: To Approve the Verification Report.
4.0 Definitions:
NA
5.0 Procedure:
- Use Personal Protective Equipment (PPE) while performing the activity.
- After verification, make necessary entries in the “Instrument Usage Logbook”.
- Handle the weights carefully during the verification of the Tablet Hardness Tester to avoid damage to Load Cells or personal injury.
- Remove the jaws (Stationary Jaws) by pressing and pulling to the left-hand side.
- Place the instrument in a vertical position (in such a way that the front display will remain on the top side).
- Insert the Plexiglas Wedge below the right-hand side of the instrument to provide enough support. Ensure that the instrument is steady.
- Fix the Calibration arm over the Load Cell shaft.
- Switch “ON” the mains and switch “ON” the instrument.
- The main screen shall automatically display the following parameters:
- Test Setup
- Product Setup
- Global Settings
- Calibration
- Verification
- Security.
- Select the Verification parameter by pressing the Down Arrow (¯) key.
- The display shall show following parameters:
- Weight
- Thickness
- Diameter
- Hardness.
- Select the Hardness parameter by pressing the Down Arrow (¯) key and then press Front Arrow (®) key.
- Select first Acceptance Range Limit by pressing Front Arrow (®) key and enter the limit as per given in the table for Acceptance Criteria.
- Select the “Verify” Menu by pressing Up Arrow () key and then press Front Arrow (®) key.
- The display shall show start Verification.
- Press RUN (F10) key. Enter Reference Weight 0.0 Kg displays on the screen.
- After entering the Reference Weight as per table using Up () and Down (¯) arrow keys (i.e., for example: 0.5 Kg), press Enter.
- The display shows “Measure Start”.
- Place 0.5 Kg weight on the arm. Press RUN key.
- Remove the 0.5 Kg weight from the arm.
- Repeat applicable steps for Reference Weight 1.0 Kg, 2.0 Kg, 3.0 Kg, 5.0 Kg, 10.0 Kg, 20.0 Kg, 25.0 Kg, 30.0 Kg, and 40.0 Kg.
- Press Stop (F11) key.
- The display shows Next Due Date in format like DD.MM.YYYY. Press Enter.
- After pressing Enter, a print will come out.
- Press Back Arrow Key (←) to return to Verification Menu.
6.0 Acceptance Criteria:
6.1 Acceptance Criteria of the Reference Standards is mentioned below :
| Sr. No. | Weight (Kg) | Limit |
| 1 | 0.5 | ± 0.1 Kg |
| 2 | 1.0 | ± 0.1 Kg |
| 3 | 2.0 | ± 0.1 Kg |
| 4 | 3.0 | ± 0.1 Kg |
| 5 | 5.0 | ± 0.1 Kg |
| 6 | 10.0 | ± 0.1 Kg |
| 7 | 20.0 | ± 0.2 Kg |
| 8 | 25.0 | ± 0.2 Kg |
| 9 | 30.0 | ± 0.3 Kg |
| 10 | 40.0 | ± 0.4 Kg |
7.0 Frequency:
Verification: Half Yearly – 15 Days.
8.0 Format for recording:
Format for “Instrument Verification”.
Observation:
| Sr. No. | Reference Weight (Kg) | Result (Kg) | Limit |
| 1. | 0.5 | ± 0.1 Kg | |
| 2. | 1.0 | ± 0.1 Kg | |
| 3. | 2.0 | ± 0.1 Kg | |
| 4. | 3.0 | ± 0.1 Kg | |
| 5. | 5.0 | ± 0.1 Kg | |
| 6. | 10.0 | ± 0.1 Kg | |
| 7. | 20.0 | ± 0.2 Kg | |
| 8. | 25.0 | ± 0.2 Kg | |
| 9. | 30.0 | ± 0.3 Kg | |
| 10. | 40.0 | ± 0.4 Kg |
| — | Verified By | Reviewed By | Approved By |
| Signature | |||
| Date | |||
| Name | |||
| Department |