Calibration of Friability Tester, Purpose :
Calibration of Friability Tester, The purpose of this SOP (Standard Operating Procedure) is to describe the operation, calibration and cleaning of friability tester.
Calibration of Friability Tester, Scope :
This procedure is applicable for friability tester (Model: Electrolab, EF-1W ) 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):
[][]Make sure the knob is properly fitted on the shaft to assure the drum is held in position.
[][]Do not hold the drum while they are rotating.
[][]Do not use abrasive, aggressive material or solvents to clean the drum and the tray. If required use mild detergent.
[][]Do not use wet drum. Make sure the drum is dry when in use.
[][]Replace the fuse with the correct rating whenever required.
Operating Procedure:
[][]Turn on the power switch of Friabilator.
[][]After power on, the drum would initialise itself to the loading position and the instrument will initialise the weighing scale and the following display will be shown:
ELECTROLAB
EF 1 W FRIABILATOR
[][]The instrument is then ready for the setting of test parameter and to run the test and following display will be shown on the screen:
ELECTROLAB EF 1 W
SET = menu, START = run
[][]Press SET key to set the test parameter as the following way.
[][]The first parameter for the test is MODE selection. Select the Time or Count mode using the MODE key on the front panel. The desired value for the selected mode can be set using or & DIGIT SCROLL keys. Set Count 100 and Time 4 minutes. Press the ENTER key to go to the next parameter.
[][]The next parameter is RPM setting. The desired value from 20 RPM to 50 RPM can be set using the key or and DIGIT SCROLL keys. Set 25 RPM. Press the ENTER key to go the next parameter.
[][]The next parameter is for drum selection. Using the or keys the Friability or the Abrasion drum can be selected. Select the Friability drum. Press the ENTER key to go the next parameter.
[][]The next parameter is for selecting the Scale Connection Option. This option can be enabled (Y) or disabled (N) using or key. If no printer is connected select disabled (N) mode. Press the ENTER key to go to the next parameter.
[][]The next menu is for Clock setting. The default setting for this menu would be the current time. The Time can be adjusted using or key & DIGIT SCROLL key. Press the ENTER key to go to the next parameter.
[][]The next menu is for Date setting. The default setting for this menu would be the current date. The Date can be adjusted using or key & DIGIT SCROLL key. Press the ENTER key to go to the next parameter.
[][]The next menu is for the selection of the option to the last test result. Select No (N) by using or key. Press the ENTER key to go to the next parameter.
[][]The next menu is for the Sound option. Select Yes (Y) using or key.
[][]Press the SET key to exit from the SET menu.
[][]After weighing the test samples as per specific Standard Test Procedure, slide them gently into the drum through the side slit and press START key, input the weight of tablets, press ENTER to run the test.
[][]After the test is over, the drum rotates in the reverse direction, discharging all the test samples into the tray located below the drum.
[][]The drum would now initialize itself to the loading position. Carefully slide the tray out and remove the loose dust from the test samples, i.e. deduct the test samples. After deducting weight the sample, input the weight of deducted tablets, press ENTER, % friability will be displayed on the screen.
[][]Press SET key for performing a new test.
Calibration procedure:
[][]Ensure that the instrument is clean before use, including surrounding area.
[][]Check and ensure due date of calibration.
[][]Switch ON the power supply.
[][]Set the time 4.0 minutes by selecting TIMER key and start the machine and calibrated stopwatch simultaneously.
[][]Note the actual time shown by a calibrated stopwatch.
[][]Take three such readings and calculate the mean time.
[][]Set 100 counts (rotation) by selecting COUNT key (some tablets may be placed into the drum for ease of counting) and start the instrument.
[][]Record the number of rotation.
[][]Take three such readings and calculate the mean of rotation per minute.
[][]Record the observations in the Calibration report (Annexure –II).
[][]After completion of calibration switch ‘OFF’ the main supply.
[][]After completion of the calibration activity, affix the duly filled and signed calibration status label on the instrument.
[][]Calibration Frequency: Every three-month ±07 days of due date and after maintenance job.
Cleaning procedure:
Remove the knob by pressing gray colored button and open the drum.
Clean the drum with suitable dry duster or cloth.
If required use water and dry in air.
Place the drum properly and replace the knob.
Annexure:
Annexure-I: Log Book Of Friability Tester.
Annexure-II: Calibration Report Of Friability Tester