FMFDUSPMBC! Automated Tap Density Tester INSTRUCTION MANUAL ETD 1020 !!FMFDUSPMBC!

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FMFDUSPMBC! Automated Tap Density Tester INSTRUCTION MANUAL ETD 1020!!FMFDUSPMBC! EL 23/24, T. T. C. Electronic Zone, M.I.D.C. Mahape, Navi Mumbai 400 710, India Tel : 91-22 - 4161 31 31 Website: www.electrolabindia.com e-mail : service@electrolabindia.com

INDEX Content Page No Packing Contents --------------------------------------------- 1 Features --------------------------------------------- 2 About ETD 1020 -------------------------------------------- 3 Front Panel --------------------------------------------- 5 System Set up --------------------------------------------- 6 System Operation --------------------------------------------- 8 Specification --------------------------------------------- 22 Precaution --------------------------------------------- 23 Trouble Shooting --------------------------------------------- 24

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Packing Contents Page 1 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Features Features Micro controller based with 24 X 2 character LCD display Complies with USP and ASTM specifications Two cylinder holders with snap lock mechanism for 100 ml and 250 ml cylinders Simultaneous rotating and tapping motion assures an evenly packed surface User friendly operation with menus, helpline and current status indicators Calculation of Test results like Tapped Density, Compressibility Index and Hausner Ratio Online validation of Strokes / Min Printer Output for documenting test results as per GMP / GLP standards. Ergonomically designed instrument & Touch sensitive membrane key pad Optional Acoustic cabinet to minimize noise level Page 2 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! About ETD - 1020 About ETD 1020 The Microcontroller based Tap Density Tester Model ETD 1020 complies with USP and ASTM specifications. The unit offers simple and standard means of measuring the tapped density of powders, granules, pellets, flakes and other bulk substances. The ETD 1020 is a Double station Tap Density tester. The test performed is as per ASTM standards using the optional adapter for cylinder holders with Snap Lock mechanism are designed to hold the 10 ml. To ensure a free drop of the cylinder from the required height, the two stations are provided with virtually friction free bearings. Each station is directly driven by independent motors to ensure maintenance free drive. A simultaneous rotating and tapping motion minimizes any possible separation of the mass during tapping down. The test can be performed in two different modes USP Mode and USER Mode in both test methods. In USP Mode, test will run in selected method with set number of taps. 1. USP Mode In this mode the number of taps (Tap Count 1 10, Tap Count 2 500, Tap Count 3 1250) as specified by USP can be programmed and stored. The user can set the taps other than the USP specified taps. The test can be performed in either USP I or USP II method. At the end of the test, results like Tapped Density, Compressibility Index and the Hausner Ratio are calculated and displayed. A validation report can be printed at the end of the test as per GMP / GLP requirements, which includes the Test Parameters, Test Results and Actual time and Date on which the test was performed. It also includes Serial Number of the Instrument along with the Entry Fields for User Name and Product Details. Page 3 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! About ETD - 1020 2. USER Mode In this mode the number of taps is programmable from 1 to 9999 for ease of operation. The value once programmed would retain in the memory. The test can be performed in either USP I or USP II method. The USER mode is very useful for finding pilot readings of a product quickly. METHODS OF TESTING a) USP Method I In this method, the cylinder is raised and dropped under its own weight by a fixed drop height of 14 mm 2 mm at a nominal rate of 300 strokes / min as specified by USP. The cylinder should be initially tapped for 10 times then measure volume (Va) to the nearest graduated unit, The cylinder is then tapped for 500 times, measure the volume (Vb) to the nearest graduated unit. If the difference between the two volumes is less than 2 ml then Vb is the final tapped volume Vf. Repeat the test in increments of 1250 taps as needed, until the difference between succeeding measurements is less than 2 ml. b) USP Method II Same process as directed under USP method I is followed except that a fixed drop height of 3 0.2 mm at a nominal rate of 250 taps per minute. During the test, the user is guided through a series of prompts on the LCD display. The on line menus and status indicators make the operation of the instrument very easy and user friendly. The drops / minute are validated on line and displayed by the instrument. The value once programmed is retained in the memory of the instrument. Page 4 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! System Set Up System Set Up 1. Place the instrument on a leveled sturdy base. 2. Place the cylinder holders on the Anvil of the desired method on ETD 1020. 3. Plug the mains cord in the socket provided at the rear side of the instrument and the other side to 100 / 110 V AC, 50 / 60 Hz power supply socket OR to 220 / 230 V AC, 50 / 60 Hz as per the instrument rating. 4. Connect the Printer cable. Keep the printer ready with the paper fed and switch on the Printer. Page 6 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! System Set Up Page 7 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! System Operation System Operation After the System Set Up is over, switch on the power. OPERATION The Instrument will initialize itself. The printer will get initialize if connected. The display will Flash & show the start up screen. DISPLAY ELECTROLAB ETD-1020 TAP DENSITY TESTER The system is now ready for Setting of the test parameter & to Run the test. Using the Digit Scroll Key, the user can set the mode of operation as USP or USER. In USP mode, the instrument will stop after every programmed Tap Count value and the validation report is available at the end of the test. In USER mode, the instrument will stop after the set tap value. No validation report and the result screen is available in this case. ( Pg. No. 13) MODE = USP / USER SET = menu, START = run Press the SET key to set the test parameter ( Set Menu, Pg. No. 10) Press the START key to run the test. ( Start Menu, Pg. No. 13) MODE = USP / USER SET = menu, START = run Page 8 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! System Operation Date & Clock Setting SETTING THE METHOD (a) The Method for the test can be set as USP I or USP II, using the METHOD key on the front panel. This is the Toggle key. When pressed the display will show the changed Test Method. The selected method for the test is indicated by METHOD indicator on the front panel. The METHOD key is active during the SET Menu and when the test is not ON. METHOD = USP I This is displayed for 2 Seconds METHOD = USP II Pressing the METHOD key will change the Method from USP I to USP II Page 9 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! System Operation Date & Clock Setting SET MENU USP MODE TAP COUNT SETTINGS (a) The first parameter is for setting the Tap Count1. The value of TAP COUNT1 can be set from 1 to 9999 taps using the UP / DOWN & DIGIT SCROLL key. Press the ENTER key to go to the next parameter. TAP COUNT1: # # # # SET = Exit / Enter = Scroll USP specified 10 Taps as Tap Count1. (b) The next parameter is for setting the Tap Count2. The value of TAP COUNT2 can be set from 1 to 9999 taps using the UP / DOWN & DIGIT SCROLL key. Press the ENTER key to go to the next parameter. TAP COUNT2: # # # # SET = Exit / Enter = Scroll USP specified 500 Taps as Tap Count2. (c) The next parameter is for setting the Tap Count3. The value of TAP COUNT3 can be set from 1 to 9999 taps using the UP / DOWN & DIGIT SCROLL key. Press the ENTER key to go to the next parameter. TAP COUNT3: # # # # SET = Exit / Enter = Scroll USP specified 1250 Taps as Tap Count3. Note: The User can exit from the SET Menu at any point by pressing the SET key. Page 10 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Set Menu USP Mode DATE & CLOCK SETTINGS (a) The next menu is for Clock setting. The default setting for this menu would be the current Time. The Time can be adjusted using the UP / DOWN & DIGIT SCROLL key. Press the ENTER key to go to the next parameter. CLOCK: # #. # #.# # SET = Exit / Enter = Scroll (b) The next menu is for Date setting. The default setting for this menu would be the current Date. The Date can be changed using the UP / DOWN & DIGIT SCROLL key. Press the ENTER key to go to the next parameter. If the Date is invalid, then the instrument will prompt the message as Invalid Date for about 2 second and the instrument will restore the last setting of the date. Example of Invalid Date: DATE: 10 JUNE 1999 SET = Exit / Enter = Scroll Invalid Date 29 FEB. 1900 31 APR. 1999 Page 11 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Set Menu USP Mode PRINTING THE LAST TEST RESULT (c) The next menu is for the selection of the option to Print the Last Test result. If this PRINT LAST RESULT? Y / N option is set to " Y ", & ENTER key is SET = EXIT / ENTER = SCROLL pressed then the result of the last test is printed before the new test has started. Exiting from SET Menu (d) Press the ENTER key to scroll back to SET Menu. (This will lead to point (a) of SET MENU) or Press the SET key to exit from the set Menu. ( Pg. No. 13 for START MENU - USER Mode and Pg. No. 14 for START MENU USP Mode) MODE = USP / USER SET = menu, START = run Page 12 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Set / Start Menu USER Mode SET MENU USER MODE TAP COUNT SETTINGS (a) In the USER Mode, the user can set the required number of Taps. The Taps are programmable from 1 to 9999 taps. The test will be ON till the number of SET TAPS = # # # # programmed taps. No test report is Press START to run test available in this case even if the printer is connected. START MENU USER MODE (a) In User Mode, Press the START key from the front panel to start the test. The display will now show the elapsed Tap. The test will continue till the programmed tap value. No test printout is available in this case even if the Printer is connected or Online. The test can be halted when in Run by pressing the STOP key from the front panel. The test can be continued from the same point by pressing the START key from the front panel. Pressing the STOP key will abort the test and the Instrument will initialize itself for the new test. ELASPED TAPS: # # # # Drops / Min. = # # # TEST HALTED START=CONT. / STOP=ABORT Page 13 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Start Menu USP Mode START MENU USP MODE (a) Press the START key to run the test. Weigh the test sample and enter the Weight of the test sample. Press the ENTER key to register the weight. WEIGH SAMPLE, ENTER WGT WEIGHT = # # #. # # gm USP has specified approximtely 100 gm of test sample, weighed with 0.1 % accuracy, into a dry 250 ml glass graduated cylinder. (b) Fill the test sample into measuring cylinder. Carefully level the test sample without compacting. Read the unsettled apparent volume Vo to the nearest graduated unit and enter the volume using UP / DOWN and DIGIT SCROLL key. Press the ENTER key to register the volume. FILL SAMPLE IN CYLINDER VOLUME (VO) = # # # # ml (c) Keep the measuring cylinder in the holder. Lock the holder assembly ( Pg. No. 7). Put the Cylinder Holder on the ETD 1020. Press the Start key to run the test. The instrument will halt. Place the cylinder Holder on ETD 1020 properly & press the START key to continue OR STOP key to Abort the test. KEEP CYLINDER IN HOLDER PRESS START TO RUN TEST Page 14 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Start Menu USP Mode (d) Pressing the Start key would start the test as per the method selected. ( Pg. No. 9). The display will show the elapsed Tap and Drops per minute. ELAPSED TAP: # # # # Drops / Min. = # # # (e) After the programmed Tap Count1 is over, measure the tapped volume Va to its nearest graduated unit. Enter the value for the Va using the UP / DOWN & DIGIT SCROLL keys. Press the ENTER key to register the value of Va. Press the Start key to start the test again. The test will continue till the programmed Tap Count2 is over. The display will now show the elasped Tap and Drops per minute. MEASURE TAPPED VOLUME VOLUME (Va) = # # # # ml PRESS START TO CONTINUE THE TEST Page 15 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Start Menu USP Mode (f) After the programmed Tap Count 2 is over, measure the tapped volume Vb to its nearest graduated unit. Enter the value for the Vb using UP / DOWN & DIGIT SCROLL key. Press the ENTER key to register the value of Vb. MEASURE TAPPED VOLUME VOLUME (Vb) = # # # # ml (g) If Volume Vb is more than Volume Va, then the insrument will prompt an error message. The operator can select the option either to Abort the test or to Reenter the volume. Volume (Va) < Volume (Vb) Test Abort / Reenter? (h) In case of Re enter, the option (f) is displayed again. This will be continue till the correct volume is enter OR the test is aborted. Diff (Va Vb) = # #. # # # ml START=CONT. / STOP = ABORT (i) The difference between the two volume Va and Vb is now calculated and displayed. Press the START key to continue the test. Pressing the Stop key will display the results ( Pg. No. 18) USP has specified to run the test till the difference between the two succesive volume measurements (Va & Vb) is less than 2 ml. MEASURE TAPPED VOLUME VOLUME (Vb) = # # # # ml Page 16 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Start Menu USP Mode (j) Pressing the START key will continue the test till the programmed Tap Count3 is over. The display will now show the elasped Tap and Drops per minute. In this case the last entered volume Vb becomes Va. (k) After the programmed Tap Count3 is over, measure the tapped volume Vb to its nearest graduated unit. Enter the value for the Vb using the UP / DOWN & DIGIT SCROLL keys. Press the ENTER key to register the value of Vb. ELAPSED TAP: # # # # Drops / Min. = # # # MEASURE TAPPED VOLUME VOLUME (Vb) = # # # # ml (l) The difference between two volume Va & Vb is calculated again and displayed. Pressing the START key will continue the test again for the Tap Count3 value. Pressing the Stop key will display the results. Diff (Va Vb) = # #. # # # ml START=CONT. / STOP = ABORT Page 17 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Start Menu USP Mode Pressing the STOP key the results like Tapped Density (T.Density), Initial Density (Init. Den). Hausner Ratio, Compressibility Index etc. are calculated and displayed. Pressing the DOWN key, the result of different parameters will be displayed one after the other. The validation report of the complete test is available if the Printer is connected and Online. If the printer is not connected or not Ready, then the Instrument will prompt the message every 5 Sec till the printer is made ready or the print option is disabled (Set to N & the ENTER key is pressed) Pressing the Set key from the front panel, will initialize the instrument for the new test. T.Density = #. # # # # gm / ml Set = New Test, = I. D. Init.Den. = #. # # # # gm / ml Set = New Test, = C. I. Comp. Index = # #. # # # % Set = New Test, = H. R. Hausner Ratio = # #. # # # Set = New Test, = T. D. PRINTER NOT RESPONDING WANT TO PRINT? Y / N MODE = USP / USER SET = menu, START = run Page 18 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Halting / Aborting the Test Halting / Aborting the Test (a) Screen when the test is running. User can halt the test when in run, While entering the volumes etc. ELAPSED TAP: # # # # Drops / Min. = # # # (b) To halt the test, press the STOP key once. The test will stop and the instrument gives an option either to Continue or to Abort the test. TEST HALTED START=CONT. / STOP=ABORT (c) Pressing the START key will start the test again from the point it had stopped. ELAPSED TAP: # # # # Drops / Min. = # # # (d) Pressing the STOP key again will initialize the instrument for the new test. In this case no test print out is available even if the printer is connected & online. The user can take this test printout before starting the new test, by enabling the PRINT LAST RESULT? Y / N (Option (f) in SET MENU) (Set to Y & Press the ENTER Key). MODE = USP / USER SET = menu, START = run Page 19 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Resetting the Instrument RESETTING THE INSTRUMENT WHEN IN RUN (a) To reset the instrument when in run, Press the RESET key. When the RESET key is pressed, the test is considered to be OVER and the display will flash the start-up screen. The instrument will be ready for the next test. In this case no test print out is available even if the printer is connected & Online. The user can take this test printout before starting the new test, by enabling the PRINT LAST RESULT? Y / N (Option (f) in SET MENU) (Set to Y & Press the ENTER Key). ELECTROLAB ETD-1020 TAP DENSITY TESTER Flashing Start Up Screen MODE = USP / USER SET = menu, START = run Page 20 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Printer Settings Printer Settings: Baud Rate : 9600 Parity : None Stop Bits : 1 Flow Control: None Page 21 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Specification SPECIFICATION TYPE USP I USP II No. of Station : 1 1 Stroke Height : 14 2 mm 3 0.2 mm Stroke / Minute : Nominal 300 Nominal 250 Motor Drive : 6 V DC, 10 KgCm Stepper Motor Drive Display : 24 X 2 character backlighted LCD No. of Tap : 1 9999 Default taps programmed : 10 in Tap Count1, 500 in Tap Count2, and 1250 in Tap Count3. (In USP Mode) Measuring Cylinder : 250 ml readable to 2 ml and 100 ml readable to 1 ml Cylinder Holder : 1 for 250 ml Cylinder with Snap Lock mechanism weighing 450 gm 10 gm 1 for 100 ml Cylinder with Snap Lock mechanism weighing 240 gm 12 gm Printer Interface : Centronics (25 pin D connector) Power Supply : 220 / 230 V AC, 50 / 60 Hz, 44 VA. 110 / 100 V AC, 50 / 60 Hz, 44 VA. Fuse Rating : Mains Fuse : T 250 mamp (For I/P As 220 / 230 VAC) T 500 mamp (For I/P As 110 / 100 VAC) Secondary Fuse : F2 = T 750 mamp & F3 = T 2 A NOTE: (Secondary Fuses are inside the Instrument) Size : L = 360 X W = 320 X H = 200 mm (Approx. Without measuring cylinder) Weight : Net- 17Kgs. Approx. with measuring cylinder Page 22 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Precaution PRECAUTION 1. Avoid any dust gathering on the bearings. 2. Do not lubricate the Bearings. 3. Keep the shaft of the Cylinder Holder and the Tip of the Cylinder Holder clean. 4. Do not press the Cylinder Holder when the Tapping Base of Cylinder Holder is not touching the Anvil. 5. Place the Cylinder in the Holder only when the Holder is placed on the Anvil. Page 23 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Trouble Shooting TROUBLE SHOOTING SR PROBLEMS CAUSE REMEDY NO. 1 Display is blank. a) Mains Fuse has blown. a) Replace the fuse with the correct rating. (Refer to Specification & Fuse Replacement Drawing (Page No: 26)) b) Replace the Mains cord. c) Check the Power Supply. 2 Front keyboard not responding. b) Bad Mains cord. c) No Power Supply present. d) Secondary Fuse F2 has blown off. e) Loose connection between Display & P card. f) Loose connection between Transformer & P card. a) Keyboard connector is not connected properly. b) Loose connection between Display card & P card. c) Front keyboard is faulty. d) P card is faulty. d) Replace fuse F2 with correct rating. (Refer to Specification) e) Fix the connector properly between Display & P card. f) Fix the connector properly between Transformer & P card. a) Fix the connector properly. b) Fix the connector properly between Display card & P card. c) Replace the keyboard. d) Replace the P card. Page 24 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Trouble Shooting 3 The strokes / minute is not proper. (300 for USP I & 250 for USP II) 4 On run, counts are not incrementing. 5 The cylinder is not getting tapped. 6 Test report is not generated. a) Proximity switch assembly may be loose. b) Connector between the Proximity Switch & the P card may be loose. c) Proximity switch is faulty a) Loose connection between proximity switch and CPU (P) card. b) Proximity switch assembly may be loose. c) Connector between the Proximity Switch & the P card may be loose. a) Driver card Fuse F3 has blown. b) Loose connection between CPU (P) and Driver card. c) Loose connection between Transformer & Motor Driver card. d) Driver card is faulty. e) Motor is Faulty. a) Printer is not on-line. b) Test mode is not selected properly. c) Printer connector may be loose or faulty. a) Tighten the Proximity Switch assembly properly. b) Fix the connector properly between the Proximity switch & the P card. c) Replace the Proximity Switch. a) Fix the connector properly between proximity switch and CPU (P) card. b) Tighten the Proximity Switch assembly. c) Fix the connector properly between the Proximity switch & the P card. a) Replace the fuse F3 with correct rating. (Refer to Specification) b) Fix the connector properly between CPU (P) and Driver card. c) Fix the connector properly between Transformer & Motor Driver card. d) Replace the motor. e) Replace the Driver card. a) Make sure the printer is On- line. b) Test report can be generated only in USP (Auto) mode. c) Fix / Replace the printer connector. Page 25 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Trouble Shooting Page 26 of 26

!!FMFDUSPMBC!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!Front Panel Description Front Panel Description Increment, Decrement & Digit Scroll key, used to change the value on options of desired parameter Start key, used to start the test Set key, to Enter & Exit from the Set Menu. Method key is used to select the USP 1 or USP 2 method for testing 24 X 2 Character LCD display Method Indicator LED Enter key, used to store the set parameter value and to scroll the parameters in Set Menu Reset Key, to Abort the test if running OR to initialize the Instrument Stop key, used to halt the test when in RUN Mode Page 5 of 26