Calibration of Hardness Tester, Purpose :
Calibration of Hardness Tester, The purpose of this SOP (Standard Operating Procedure) is to describe the operation, calibration and cleaning of Hardness Tester.
Calibration of Hardness Tester, Scope :
This procedure is applicable for Hardness Tester (Model: ERWEKA, TBH125 ) used in Product Development Laboratory of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]PD: Product Development
Responsibilities:
The roles and responsibility is as follows:
Executive, PD
[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.
Sr. Executive, PD
[][]To ensure that this procedure is kept up to date.
[][]To arrange training on the SOP to all concerned personnel.
[][]To ensure implementation of the SOP after training.
Manager, Quality Assurance
[][]Approval of the SOP.
Procedure:
Precaution(s):
[][]Check the power supply before connecting the machine.
[][]Keep the tester clean.
[][]Always switch off the machine at the end of work.
Operating Procedure:
[][]Turn on the power switch of Hardness Tester.
[][]After power on, the instrument is powered up and the following display will be shown:
ERWE
A TBH
UP DOWN
STOP FORWARD
UP DOWN …. Key
[][]Continue with Start/ Enter key, then following display will be shown:
ZERO
JAW
[][]Start zeroing with the Start/Enter key. The jaw will move to the counter-jaw, measure the Zero point, and then return to the initial position.
[][]The main menu will only be displayed if a correct zero point is detected.
NUM
0006
[][]Instrument Settings: In order to setup the instrument and enter configuration details and other parameters of the TBH125 instrument proceed as follows:
[][]Pause (PAUS):The pause time of the hardness tester between measurement cycles shall be entered using right arrow keys. Setting pause time will be 0-10 time units (approximately 10 seconds).
[][]Hardness (UNIH): Breaking force such as Newton, Strong Cobb or Kilopond by using the right arrow keys.
[][]Diameter and Thickness (UNID): Select mm or inch by using the right arrow keys.
[][]Hours (HOUR): Enter current time hours by using the right arrow keys.
[][]Minutes (MINU): Enter current time minutes by using the right arrow keys.
[][]Day (DAY): Enter current date by using the right arrow keys.
[][]Month (MONT): Enter current month by using the right arrow keys.
[][]Year (YEAR): Enter current year by using the right arrow keys.
[][]Newton Factor (NFCT): This internal calibration factor will be set by using the right arrow keys.
[][]Language (LANG): Language will be selected by using the right arrow keys.
[][]Auto On: Use the “Auto On” button to activate the automatic function of the diameter. This means that the nominal diameter needs not to be entered when measuring the diameter.
[][]Date Format (DAFT): Select date format in European or US format
[][]EURO = day : month : year
[][]USA = year : month : day
[][]By using left arrow keys.
[][]Method (METH): Select between the speed or force method for actual measurement by using the left arrow keys and then press Start/ Enter key.
[][]Hardness (HARD): By using the right arrow keys select whether the hardness measurement is going to be performed or not (on/off) and then press Start/ Enter key.
[][]Diameter (DIAM): By using the right arrow keys select whether the diameter measurement is going to be performed or not (on/off) and then press Start/ Enter key.
[][]Thickness (THIC): By using the right arrow keys select whether the thickness measurement is going to be performed or not (on/off) and then press Start/ Enter key.
[][]Speed (SPED): The speed of the breaking process can be set in millimeter per second, from 0.5 to 3 mm/s by using the right arrow keys. The default value is 2.3 mm/s.
[][]Force (FORC): The default value of force of the breaking process is 0020 N/s.
[][]Results (REST): When select “REST” a list of individual values appear, which will be stored until the instrument is switched off or a new test is run, and which can be printed again in the printer menu.
[][]Statistics (STAT): When selecting ‘STAT’ a statistic evaluation of the current test appears. It will be stored until the instrument is switched off or a new test is run, can be printed again in the printer
Calibration procedure:
[][]Ensure that the instrument is clean before use, including surrounding area.
[][]Check and ensure due date of calibration.
Diameter Calibration (DIAM):
[][]By Using Start/Enter key to select diameter.
[][]Clean the jaw and counter jaw with a brush and then press Start/ Enter key to start.
[][]The jaw moves to the counter jaw, measures zero point, and then returns to the initial position.
[][]A gauge block of 10.00mm is preset. Insert gauge block and start measurement using the Start/Enter key. The jaw moves to the gauge block and registers the second point.
[][]Three different control measures must be performed in succession to test the accuracy of the test station.
[][]A gauge block of 5.00mm is preset. Insert gauge block and start measurement using the Start/Enter key.
[][]The actual value will appear on the display, continue to the control measurement using the Start/ Enter key.
[][]Thickness Calibration (THIC): The thickness calibration is not applicable because of previously performed diameter calibration.
Hardness calibration (HARD):
[][]Select hardness using Start/Enter key.
[][]The calibration weight to be adjusted.
[][]The jaw moves to the calibration position and stop. The path is set in the menu COPS for the calibration position.
[][]Place mount calibration device on the jaw.
[][]Place the device with the weight receptacle on the right side while ensuring that the printer connection is free.
[][]The actual weight is displayed (not exactly zero because of the weight of the plate).
[][]Zero the device with the help of left and right arrow keys.
[][]Carefully placed the desired weight on instrument.
[][]Press Start/ Enter key to confirm and finish the calibration.
[][]The Linearity of the load cell is verified with three different control weights. Make sure that the weights are positioned carefully and stable on the plate.
[][]Use Start/Enter key to confirm. The actual is displayed. Use Start/ Enter key to continue.
[][]When calibration is finished remove the weighing plate and reposition the instrument. Use Start/ Enter key to confirm. The jaw moves back to origin.
[][]The display returns to calibration menu. When quitting the calibration menu with the key a calibration printout is performed automatically.
Calibration Frequency:
Cleaning procedure:
[][]Before starting each day operation, clean the overall instrument by a lint-free dry cloth.
[][]Clean the star feeder using a clean cloth.
[][]Use the brush to remove the tablet debris from the transport way after each operation.
Annexure:
Annexure-I: Log Book of Hardness Tester.