SOP FOR OPERATION AND CALIBRATION OF HARDNESS TESTER
PURPOSE: To lay down a procedure for operation and calibration of hardness taster.
SCOPE: This procedure is applicable for operation and calibration of Tablet disintegration test apparatus.
RESPONSIBILITY: IPQA Person/ Officer: Production to follow SOP accordingly & Documentation. Officer/Executive QA: To ensure Implementation of SOP.
ACCOUNTABILITY: Head Quality Assurance shall be accountable for compliance of the SOP.
PROCEDURE:
Operation: Ensure that instrument is clean and free from dust.
Switch on the mains.
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, Mode and then the gauge data. After the self test and no load have been applied, the display will be zeroed.
During operation of the tester it is often necessary to zero the display, this is achieved by pressing the zero KEY. When the tester is in the process of Zeroing itself a row of segments on the top & bottom of the Display will be seen to Alternatively blink once, When completed the display will read zero. This function will not be performed if the tester is currently in overloaded state.
Select the unit of measurement required by pressing the UNIT Key. Each successive press of this key will select the next available unit until the tester returns to the original.
Choose test mode: The Force gauge provides three kind of test mode: Track Mode, Peak Hold Mode Peak Hold Auto cancelled. The track mode is default When the gauge is turned on. In Track Mode there is no (PEAK) SHOWN on LCD. Press( PEAK), PEAK is shown on the LCD and the gauge is in Peak Hold Mode. The value shown on this gauge is the max. Value in the procedure. Press (ZERO) The value is Cleared. Press (PEAK) again (AUTO PEAK) will be shown on LCD, and the gauge is in semi-peak hold mode. The max. Value will be hold and cleaned in Setting time is chosen from 1-10 Seconds. Press ( PEAK) again, the gauge is switched in three modes.
Slide the guard cover toward knob end to open.
Place a tablet on the tablet platform.
Ensure that the tablet must touch the load cell and jaw & close to the axial centre of unit. Slide the safety guard cover back to the initial position to close.
Start turning the knob. Continue the process till the tablet is fractured and the breaking point is reached.
Cleaning:
Cleaning of hardness tester shall be done by de-dusting after compete of 75 % of broken tablet cabinet.
At the end of shift cleaning shall be done by mopping.
All cleaning activity shall be mentioned in equipment logbook.
CALIBRATION: Calibration shall be carried on yearly basis through the external agency.
REFERENCE: SOP ON SOP & GMP and cGMP Regulation