Standard Operating Procedure for Verification of Tablet Hardness Tester
To lay down a procedure for Verification of Tablet Hardness Tester.
The scope of this SOP is applicable for Verification of Tablet Hardness Tester at Quality control department.
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.
- 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
- Select the Verification parameter by pressing the Down Arrow (¯) key.
- The display shall show following parameters:
- 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|
Verification: Half Yearly – 15 Days.
8.0 Format for recording:
Format for “Instrument Verification”.
|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|