SOP for Hardness Tester | SOP for Calibration of Hardness Tester | Operation and Calibration of Hardness Tester
- Hardness Tester SOP covers below points :
- Operation of Hardness Tester
- Cleanliness of Hardness Tester
- Calibration of Hardness Tester
- Safety And Precautions of Hardness Tester
- Format For Calibration Of Hardness Tester
1.0 OBJECTIVE :
- To lay down a procedure for Operation and Calibration of Hardness Tester.
2.0 SCOPE :
- This SOP is applicable for the operation and calibration of Hardness Tester (Make: Tab Machines), which is used to measure the hardness of tablets in Quality Control Department
3.0 RESPONSIBILITY :
- The QC Staff shall be responsible for:
- Following the procedure during the operation of Hardness tester.
- The Manager-QC shall be responsible for:
- Ensuring compliance of the SOP
4.0 ACCOUNTABILITY:
- Quality Control Head
5.0 PROCEDURE :
5.1 Cleanliness :
- Ensure that instrument is clean and Instrument surrounding area is free from the dust. If not clean with a soft tissue paper soaked in water and the wipe dry.
- Clean sample compartment with brush and soft tissue paper.
5.2 Operation of Hardness Tester :
- Keep the unit on the cleaned and plane level table surface.
- Connect the adaptor to 230V AC/50 Hz supply line.
- Switch on the tester by pressing the power ON key, the unit does a self test during which the display will show the firm name, model and then the gauge data.
- Then press “ZERO” key. When tester is in the process of zeroing itself a row of segments on the top & bottom of the display will be seen to alternately blink once, when completed the display will read Zero.
- Select the units of measurement required by pressing the “UNIT” key.
- Choose test mode..
- Press the “UNIT” button which is specified in the method until the Kg / lbs. / N symbol appears.
- Set the parameters which is required
- Slide the Guard cover towards knob end to open.
- Place a tablet on tablet platform.
- Ensure that the tablet must touch the load cell end jaw & close to the axial center of unit. Slide the safety guard cover back to the initial position to close.
- Start turning the knob. During testing, the plunger is driven forward by turning the knob, which gives a gentle movement and presses the tablet against the load cell end jaw. The process continues till the tablet is fractured and the breaking point is registered by the unit. The peak force value will be displayed & held.
- CAUTION: – Do not apply more speed or jerks to knob while rotating for hardness testing.
- The unit measure the compressive force every hundredth of a second with accuracy ±0.5 and the display will show the reading of force required for breaking the tablet.
- The instrument has an option to measure the hardness of tablet in Newtons (N), Kilograms forces (Kgf), Pound forces (Ibf). To change the display units, press the “UNIT” key. The newly selected unit will be shown at the bottom of the display. Each successive press of the key will select the next available unit until the tester returns to the original.
- Conversion factor and factor calculation: 1 Kg/cm2= 22.4N Where,
- Newtons 1 kg = 9.81N
- Kilopond’s 1 kp = Force of 1 kg
- Strong cob 1.4 Sc = 1 kg
- Pound apothecary 1 Lb = 0.313 kg
- Inch 1 inch = 25.4 mm
- After each operation, wipe and clean the edge surfaces of hardness tester with lint free wet cloth.
- The measurement value in flash memory can be printed & print the data through PC Software.
5.3 Calibration of Hardness Tester:
- Requirement: 5 kg test weight calibrated to confirm within OIML Class M1 Tolerance ±250 mg.
- Remove the Hardness tester from the assembly by removing the four screws.
- Attach the calibration hook at the fixed jaw’s place.
- Hold the tester firmly in place using the strap provided.
- Switch ON the tablet Hardness Tester.
- Press the UNIT Button successively until the KG symbol appears.
- Press ON/ OFF switch to reset the unit.
- Power on the force and press the “zero”.
- Attach 5 kg weight on the hook.
- Take the gauge reading. It should be equivalent to 49.03N ± 5%
- When finished remove the weight while holding the Tablet Hardness Tester firmly in place.
- Replace the hook with the jaw.
- The re-calibration is to be carried out when a major maintenance or change of major part is done.
5.4 Safety And Precautions:
- During the operation, wear hand gloves, nose mask, safety goggles and safety equipment.
6.0 Abbreviations:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| No. | Number |
| QC | Quality Control |
| QA | Quality Assurance |
| Dept. | Department |
| IPA | Isopropyl alcohol |
| Kg/cm2 | Kilogram per centimeter square |
| N | Newton’s |
| mg | milligram |
| kg | Kilogram |
7.0 Annexures:
| Annex. No. | Title |
| 01 | Format For Calibration Of Hardness Tester |
8.0 SOP References:
- In-House
END OF THE SOP
ANNEXURES :
Annex. No. 01 Format For Calibration Of Hardness Tester
