Tablet Hardness Tester TBH 125

Transcription

1 Instruction Manual Tablet Hardness Tester TBH 125 ERWEKA GmbH Ottostr Heusenstamm Germany Tel: +49 (0) Directors: Claudia Müller, Werner G. Müller District court Offenbach HRB 2382 Fax: +49 (0)

2 Document version: 4.1 Date: Firmware version: from 1.45 Document No.: File name: TBH 125_Manual_21039_En_V4.1 Language: English Number of pages: 36 Version table Date Document version* Amendment AutoCal Editorial revision Firmware version increase; new Document No. (old No.: ), new format (11/15) Editorial revision TBH 125P cancelled Editorial revision * When the document version X.Y was changed, X means a technical change and Y a document amendment only. Copyright The material in this document is the intellectual property of ERWEKA. Any copy or reproduction of this document or its parts without the written permission of and reference to ERWEKA is prohibited and will be prosecuted according to the law. All trademarks are the property of their respective owners. Copyright 2017 by ERWEKA

3 Instruction Manual Tablet Hardness Tester TBH 125

4 4 TBH 125 Table of Contents 1 Introduction About this instruction manual Service Safety instructions and symbols Protection of the environment 6 2 Safety Safety instructions Intended use 7 3 Overview Description Device types Type label Construction Operation elements and connections Keypad and display Technical data 11 4 Installation Storage and transport conditions Unpacking and checking Setup Positioning Acclimatization Required installation environment Device connecting and first switching on 13 5 Configuration The SETT menu Pause Calibration position Hardness units Diameter and thickness units Hours Minutes Day Month Year Newton Factor Language Version Date format Method Terminology Automatic determination Printer Printer language Automatic measurement Data output Hardness Diameter Thickness 20 8 Switching the Printer on/off 21 9 Calibration Diameter calibration Hardness calibration Static calibration Dynamic calibration Control Diameter Hardness Control of the static hardness calibration Control of the dynamic hardness calibration Performing the Measurements Results Statistics Maintenance Cleaning Inspection and maintenance Spare parts 29 Appendix 31 Example printouts of the protocols 31 6 Setting the Speed 20 7 Setting the Force 21

5 TBH 125 Introduction 5 1 Introduction Thank you for purchasing the ERWEKA tablet hardness tester TBH 125 series! 1.1 About this instruction manual This instruction manual supports you in work with your ERWEKA device. It describes the device, its operation and gives you useful tips on its handling. Furthermore, read descriptions of installation and setting as well as detailed step-by-step work operations in the present manual. Pictures facilitate the understanding of processes described here. The instruction manual is a part of the product. Read this manual completely and make sure you understand its content. Keep this manual in a safe place so that it will be available for any questions at a later date. This is important for warranty of permanent and accurate operation of the corresponding device. The editorial team of ERWEKA appreciates your feedback regarding the present manual. Just send an to quality@erweka.com with your topic and technical documentation as a subject. Your reply contributes to our high quality level. 1.2 Service Contact ERWEKA at support@erweka.com to receive the firmware updates, order the spare parts, in case of technical troubles or possible repairs. Please supply the following information: Type of the device (on the type label) Serial number of the device (on the type label) A short description of the case

6 6 TBH 125 Introduction 1.3 Safety instructions and symbols WARNING indicates a possible hazardous situation which, if not avoided, could result in death or serious injury. CAUTION indicates a possible hazardous situation which, if not avoided, could result in moderate or minor injury. HAZARD of electric shock! Indicates a possible hazardous situation which, if not avoided, can lead to injuries due to electric shock. This symbol indicates a possible hazardous situation which, if not avoided, can lead to the equipment damage. This symbol emphasizes the information to ensure smooth work process. This symbol provides you with additional useful information. 1.4 Protection of the environment Note that residues of the test products must be properly disposed of in accordance with the applicable environmental regulations. According to the valid EC directives, all the electrical parts (electrical waste) must be disposed of appropriately.

7 TBH 125 Safety 7 2 Safety 2.1 Safety instructions To guarantee the health and safety, read the following safety instructions before using the device. WARNING Wear the personal protective outfit and glasses, if necessary! HAZARD of electric shock! Electric devices are to be plugged into safety sockets only. Use the delivered power cable. The voltage of the existing current supply is to be compared to the indications on the type label. Before installation works always switch the corresponding device off and disconnect it from the rear panel. ERWEKA devices should be operated by qualified and trained personnel only! Pay attention to the on-site safety instructions for work in the laboratory and with the laboratory equipment! 2.2 Intended use The ERWEKA hardness tester type TBH 125 should be used only for performing hardness tests (optional diameter and thickness measurements), associated verification and quality control of tablets. The requirements for installation environment defined by ERWEKA shall be met. ERWEKA devices should not be used for processing: products that are easily flammable or explosive products that develop vapours which may create flammable or explosive mixtures in combination with air products that release harmful or poisonous substances The device should be operated and maintained only as it is foreseen and due to the instructions presented in this manual.

8 8 TBH 125 Overview 3 Overview 3.1 Description The ERWEKA hardness tester type TBH 125 series is a compact device for the automatic measurement of hardness and optionally diameter and thickness of tablets and similar dosage forms. The hardness test of tablets plays an important role in their formulation and production. The hardness test can be performed with the TBH 125 based on two different measurement principles (constant speed, constant force). The device has been developed for customers who require robust design and easy handling. It is equipped with a membrane keypad and two LED-displays. During a test run up to 99 tablets can be tested. The tablet hardness tester can be calibrated easely using the menu. A printout of test reports from the device is possible through a printer (opt.). 3.2 Device types Function TBH 125 TBH 125 D TBH 125 TD Hardness test Diameter measurement Thickness measurement Type label The type label is placed on the rear panel of the device and looks as follows: R ERWEKA GmbH D Heusenstamm / Germany Typ: Serial No: xxxxxx.xxxx PN : VA IN : A U : V F : Hz Typ: Device type Serial No: Serial number P N : Normal output in volt-ampere [VA] I N : Nominal current in ampere [A] U: Voltage in volt [V] F: Frequency in hertz [Hz]

9 TBH 125 Overview Construction Measurement station 2 Control panel 3 USB connections 3.5 Operation elements and connections A B D F Device front panel E C Device rear panel A Mains switch D Power supply B Measurement station E USB connections C Collection container (optional) F Keypad with two displays

10 10 TBH 125 Overview Keypad and display Pict: Keypad with left and right LED display Key symbol Description/Function Arrow keys; to scroll the menus or submenus and select the values The Stop/Exit key; to abort or stop a test as well as exit the current menu The Start/Enter key; to start a test and open a selected menu All data inputs are confirmed with a beep tone.

11 TBH 125 Overview Technical data Dimensions: Height Width Depth Weight: 160 mm 310 mm 300 mm TBH 125 series 6 kg Display/ keypad: 2 x 4 digit 16-segment LED display, touch foil keypad Measuring principle: Load cell with strain gauge, constant speed ( mm/s) or constant force ( N/s) with stepper motor, setting of automatic diameter measurement Throughput: 1 99 samples per test, selectable Hardness measurement station: N (optional N) Accuracy: ± 1 N, Newton, Kilopond or Strong Cobb selectable Diameter measurement station (optional): mm Accuracy: ± 0.05 mm, mm or inch selectable Thickness measurement station (optional): mm Accuracy: ± 0.05 mm, mm or inch selectable Power supply: VAC ± 10 % / Hz / 100 W Safety: Protection class: I / EN Protection type: IP 21 / IEC 529 Fuses: 115 V / 250 V, 2 x 3.15 A Interfaces: USB A for printer connection, USB B for updating via PC, optional RS 232 for data output Printer: Compatible printer available upon request Calibration: Completely menu guided, weights (static calibration) Optional: AutoCal 2.0 (dynamic calibration) Documentation: Available through printer

12 12 TBH 125 Installation 4 Installation 4.1 Storage and transport conditions The device should not be exposed to punches and vibrations. Temperature and humidity should not be lower or higher than the values defined by ERWEKA (see Required installation environment). 4.2 Unpacking and checking After receipt of the delivery, check the packaging and the device for transport damage. Check the tilt indicator label, if it is available, for undue turning of the packaging. At a gradient of 60 colored quartz sand flows into the display field and remains visible there. If the undue transport or any damage is evident, take a photo of this and send it to our ERWEKA 1.2 Service immediately. 4.3 Setup Positioning Position the device on a horizontal, plane, stable surface, e.g. on a laboratory table, and pay attention not to displace it during operation. For ease-of-use and accessibility, when positioning the device ensure that there is sufficient distance towards walls, cabinets or other fixed components of the facility. Besides sticking to the requirements for installation environment defined by ERWEKA, avoid the following: Heat (heating, insolation) Direct draft through open windows, doors or air conditioning and ventilating systems Vibrations Dampness Acclimatization If a cold device is moved to a warm environment, condensation may occur. Therefore you should allow the device to acclimatize for approximately two hours at room temperature, leaving it unplugged Required installation environment Ambient temperature in operation: Storage and transport temperature: Relative humidity: Max. operating altitude (for balances): +10 C up to +30 C -10 C up to +55 C 25-80% no condensation 3000 m above NN

13 TBH 125 Installation Device connecting and first switching on Connect the device (connection on the device s rear panel) with a safety socket. For this purpose use the delivered power cable. HAZARD of electric shock! Electric devices are to be plugged into safety sockets only. The voltage of the existing power supply has to meet the requirements of the type label! ERWEKA accepts no liability in case of wrong connection. Defective devices are to be opened by the authorized staff only. In case of using an external printer, connect it to the USB A interface of the device. Switching on For switching on set the main switch on the device rear panel to the I position (on). After successful device initialization the splash screen is shown. Zeroing The device must be zeroed after each switching on. The splash screen is shown. Press the Start/Enter key to start the procedure of zeroing. ZERO is shown. CAUTION Squashing! While zeroing the test jaw moves. Do not touch the test station.

14 14 TBH 125 Installation To zero the device, press the Start/Enter key. The jaw moves to the counter-jaw, takes the zero point and returns to its initial position. After successful determination of the device s zero point (automatic repetition of zeroing in case of error), the number of the last measurement is displayed, see example: This display means also that the device is ready for operation the device can be calibrated the device can be configured as needed Scroll the menus using the arrow keys on the left. REST STAT SPED FORC PRIN CALI CONT SETT Menu Function Display of the test results. Display of the evaluations or statistics. Setting of the constant speed in mm/s. Setting of the constant force in N/s. Switching the printer on/off or repeating a printout. Calibration of the hardness and diameter test stations (depending on the device option, see calibration). Control measurements for calibration. Configuration of the device. Switching off For switching off set the mains switch to the 0 position (off). More information on the configuration and test performance you will find in the following chapters of this instruction manual.

15 TBH 125 Configuration 15 5 Configuration 5.1 The SETT menu This menu guides you through the device configuration. In the menu items you can set the corresponding parameters. To enter the SETT menu: 1. Using the left arrow keys select SETT on the ready-for-operation device. 2. Press the Start/Enter key for at least 8 seconds. Scroll through the configuration menu with the left arrow keys. Menu item PAUS CPOS UNIH UNID HOUR MINU DAY MONT YEAR NFCT LANG VERS DATF METH TERM AUTO PRIN PRLG AUME DOUT HARD DIAM THIC Function Pause Calibration positions Hardness units Diameter and thickness units Hours Minutes Day Month Year Newton factor Language Version Date format Measurement method Terminology Automatic determination Printer Printer language Automatic measurement Data output Hardness Diameter Thickness Read the information on each menu item below.

16 16 TBH 125 Configuration 5.2 Pause In the PAUS menu item the time between the measurement cycles is set. The operator needs a certain time between the measurements to clean the test station and restock it with a new sample. 1. Using the left arrow keys select the PAUS item in the 5.5 Diameter and thickness units In the UNID menu item set the measurement unit for diameter and thickness. 1. Using the left arrow keys select the UNID item in the 2. Using the right arrow keys select the required pause time [s]. Adjustment range of pause time: 0-10 seconds 2. Using the right arrow keys select the required measurement unit. You can select millimeter (MM) or inch (INCH). 5.6 Hours 5.3 Calibration position In the CPOS menu item the calibration position is set. ERWEKA recommends setting Using the left arrow keys select the CPOS item in the The HOUR menu item belongs to the time setting. Set the hours here. 1. Using the left arrow keys select the HOUR item in the 2. Using the right arrow keys select the required calibration position. 2. Using the right arrow keys select the required value for hours. 5.7 Minutes 5.4 Hardness units In the UNIH menu item set the measurement unit for hardness. 1. Using the left arrow keys select the UNIH item in the The MINU menu item belongs to the time setting. Set the minutes here. 1. Using the left arrow keys select the MINU item in the 2. Using the right arrow keys select the required measurement unit. 2. Using the right arrow keys select the required value for minutes. You can select Newton (N), Strong Cobb (SC) or Kilopond (KP).

17 TBH 125 Configuration Day The DAY menu item belongs to the date setting. Set the day here. 1. Using the left arrow keys select the DAY item in the 5.11 Newton Factor In the NFCT menu item you can read the Newton factor, but not change it! 1. Using the left arrow keys select the NFCT item in the 2. Using the right arrow keys select the required day. 5.9 Month 2. Press Stop/Exit to return to the The Newton factor is an internal calibration factor for the load cell and electronics. This value is saved after each calibration in the device s memory. The MONT menu item belongs to the date setting. Set the month here. 1. Using the left arrow keys select the MONT item in the 2. Using the right arrow keys select the required month Language In the LANG menu item you can select German or English as a menu language. 1. Using the left arrow keys select the LANG item in the 5.10 Year The YEAR menu item belongs to the date setting. Set the year here. 1. Using the left arrow keys select the YEAR item in the 2. Using the right arrow keys select the required language (GERM or ENGL) Version In the VERS menu item you can read the firmware version number, but not change it! 2. Using the right arrow keys select the required year. 1. Using the left arrow keys select the VERS item in the 2. Press Stop/Exit to return to the

18 18 TBH 125 Configuration 5.14 Date format In the DATF menu item you can select the European or American date display format. 1. Using the left arrow keys select the DATF item in the 5.16 Terminology In the TERM menu item you can select between calibration/control and justification/calibration. The terminology change is shown in the corresponding device menus and protocols. 1. Using the left arrow keys select the TERM item in the 2. Using the right arrow keys select the required date format. (EURO = Day:Month:Year = DD/MM/YYYY or USA = Year:Month:Day =YYYY/MM/DD) 2. Using the right arrow keys select the required terminology Automatic determination 5.15 Method In the METH menu item you can set the measurement method for hardness. 1. Using the left arrow keys select the METH item in the When using the automatic determination function you do not need to enter the nominal thickness and diameter before the test because the device determines them automatically. 1. Using the left arrow keys select the AUTO item in the 2. Using the right arrow keys select the required measurement method. (SPED = constant speed or FORC = constant force) 2. Using the right arrow keys select the ON option to switch this function on.

19 TBH 125 Configuration Printer In this menu item select the printer type according to the used printer. Select between internal (built-in) and external (conventional, e.g. HP LaserJet or portable, e.g. Martell) printer. The printed protocols differ (see Appendix). 1. Using the left arrow keys select the PRIN item in the 5.20 Automatic measurement In this menu item activate or deactivate the automatic measurement for each tablet. This function is available for devices of TBH 125 TD type only. 1. Using the left arrow keys select the AUME item in the 2. Using the right arrow keys select the required printer type. 2. Using the right arrow keys select the ON option to activate this function Printer language In this menu item select the printer language according to the used external printer. For a conventional printer (e.g. HP LaserJet) select PCL and for a portable printer (e.g. Martel) select ASCII. 1. Using the left arrow keys select the PRLG item in the 2. Using the right arrow keys select the required printer language Data output When activating this function the pause in the PAUS submenu is set to 0 (see 5.2 Pause). The data transfer from the device to a PC is optionally possible. In case of this option a RS 232 interface is available on the rear panel of the device. In this menu item activate the RS 232 interface for data output. 1. Using the left arrow keys select the DOUT item in the 2. Using the right arrow keys select the ON option to activate this function. For the data transfer the PC must be connected with the device through the RS 232 interface on the rear panel of the device. If the RS 232 interface (option) is not available on the device, deactivate the DOUT menu item.

20 20 TBH 125 Setting the Speed 5.22 Hardness Activate this function to enable the hardness measurement. 1. Using the left arrow keys select the HARD item in the Activate the function of automatic measurement in the AUTO submenu not to enter the nominal thickness during the measurement (see 5.17 Automatic determination). 2. Using the right arrow keys select the ON option to activate this function Diameter Activate this function to enable the diameter measurement. 1. Using the left arrow keys select the DIAM item in the 6 Setting the Speed In the SPED menu set the measurement speed of the movable jaw. The selected measurement speed is printed out in the test protocol. Adjustment range: mm/s The default value is 2.3 mm/s. Precondition for the use of this menu is the selection of the constant speed measurement method in the METH item of the SETT menu (see 5.15 Method). 1. Using the left arrow keys select SPED on the ready-for-operation device. 2. Using the right arrow keys select the ON option to activate this function. Activate the function of automatic measurement in the AUTO submenu not to enter the nominal diameter during the measurement (see 5.17 Automatic determination). 2. Using the right arrow keys select the required speed Thickness Activate this function to enable the thickness measurement. 1. Using the left arrow keys select the THIC item in the Comparability of the product break results is only ensured when using the same settings of the speed! 2. Using the right arrow keys select the ON option to activate this function.

21 TBH 125 Setting the Force 21 7 Setting the Force In the FORC menu set the force of the hardness measurement. The selected force is printed out in the test protocol. Adjustment range: N/s 8 Switching the Printer on/off In PRIN menu switch the connected printer for printing the test protocols on/off. 1. Using the left arrow keys select PRIN on the ready-for-operation device. The default value is 20 N/s. Precondition for the use of this menu is the selection of the constant force measurement method in the METH item of the SETT menu (see 5.15 Method). 1. Using the left arrow keys select FORC on the ready-for-operation device. 2. Using the right arrow keys select the ON option to activate the printer. 4. Press Start/Enter to repeat the last printout during the device operation. 2. Using the right arrow keys select the required force. Comparability of the product break results is only ensured when using the same settings of the force!

22 22 TBH 125 Calibration 9 Calibration The device must be calibrated regularly. The user must define the interval for this. The zeroing process is being performed. At that the jaw moves to the counter-jaw, takes the zero point and returns to its initial position. In case of high or unexpected measurement deviations a calibration must be performed immediately, even if it is outside the interval! The CALI menu contains the DIAM and HARD items to calibrate the corresponding measurement stations. If a printer is connected and the PRIN menu is activated, on completion of a calibration cycle the calibration protocol is printed out automatically. The calibration protocol contains nominal and actual values, current control units and date. 1. Using the left arrow keys select CALI on the ready-for-operation device and confirm your selection with Start/Enter. 4. Insert the 10 mm gauge block. 5. Start the measurement with the Start/Enter key. The movable jaw moves to the gauge block and registers the second calibration point. Three different control measurements follow in succession to test the accuracy of the measurement station. 6. Insert the 5 mm gauge block. 7. Press the Start/Enter key. The measured value is shown on the display. 8. Insert the 10 mm gauge block. 9. Press the Start/Enter key. The measured value is shown on the display. 2. Using the right arrow keys select the diameter (DIAM) or hardness (HARD) to calibrate the corresponding measurement station. The calibration procedures are described in the following sections. 9.1 Diameter calibration 10. Insert the 15 mm gauge block. 11. Press the Start/Enter key. The measured value is shown on the display. 12. Press the Start/Enter key to return to the Calibration menu. 1. Select the DIAM item from the Calibration menu. 2. Clean the movable and fixed jaws with a dusting brush. 3. Press the Start/Enter key.

23 TBH 125 Calibration Hardness calibration Static calibration The static hardness calibration is done by weighing a calibration weight (30 kg is recommended). Then control measurements follow. 1. Select the HARD item from the Calibration menu. WARNING Falling object! Insecure positioning can lead to damages. Be careful when placing the control weights so that they do not fall! 7. Carefully place the required weight (30 kg is recommended). 2. Press the Start/Enter key. 3. Mount the justification adapter onto the jaw. 8. Press Start/Enter to confirm the weight. The new calculated Newton factor will be shown during ca. 2 seconds. The linearity of the load cell is verified with 3 different control weights now (CON1: 30 kg, CON2: 20 kg, CON3: 10 kg). 9. Place the 30 kg weight. 10. Press the Start/Enter key for the confirmation. The current value is shown on the display. 11. Place the 20 kg weight. 4. Place the device carefully onto the side so that the justification adapter would be at the top. 12. Press the Start/Enter key for the confirmation. The current value is shown on the display. Ensure that there is no LAN-cable in the port on the right side of the device! 5. Press the Start/Enter key. 13. Place the 10 kg weight. 14. Press the Start/Enter key for the confirmation. The current value is shown on the display. The current weight, which acts upon the load cell, is shown (not exactly zero because of the justification adapter s weight). 6. Zero the weight by pressing the left arrow key. 15. When the calibration is finished, remove the plate and place the device upright again. 16. Press the Start/Enter key to return to the Calibration menu.

24 24 TBH 125 Control Dynamic calibration The dynamic hardness calibration is done with Erweka AutoCal 2.0 Windows XP. 1. Plug the Erweka AutoCal 2.0 Windows XP USB stick into the USB port. 2. Select the HARD item from the Calibration menu. 12. Wait until the third control point (nominal value 100 N) is measured. The force measured by the load cell is displayed from the left and the force measured by the AutoCal from the right. The deviation between the force measured by the load cell (device) and by the AutoCal can differ in the range of max. ± 1 N! Otherwise you must repeat the calibration! For example: 3. Press the Start/Enter key. 106 N is the force measured by the load cell N is the force measured by the AutoCal shown 10 times more precisely. The deviation constitutes only 0.8 N. 4. Place the AutoCal control unit onto the measurement station. 5. Press the Start/Enter key. 6. Wait a few seconds. The force measured by the load cell is displayed from the left and the force measured by the AutoCal from the right. The measurement range of the calibration and control is ca. ± 10 N from the given nominal values. 10 Control In this menu the device calibration is checked. The control is done similar to the calibration. The CONT menu contains the DIAM and HARD items to control the calibration of the measurement stations. 1. Using the left arrow keys select CONT on the ready-for-operation device and confirm your selection with Start/Enter. 7. Press the Start/Enter key. 8. Wait until the first control point (nominal value 300 N) is measured. The force measured by the load cell is displayed from the left and the force measured by the AutoCal from the right. 2. Using the right arrow keys select between diameter (DIAM) or hardness (HARD) to control the calibration of the corresponding measurement station. 9. Press the Start/Enter key. 10. Wait until the second control point (nominal value 200 N) is measured. The force measured by the load cell is displayed from the left and the force measured by the AutoCal from the right. The control procedures are described in the following sections. 11. Press the Start/Enter key.

25 TBH 125 Control Diameter 1. Select the DIAM item from the Control menu Hardness Control of the static hardness calibration The control of the static hardness calibration is done by weighing calibration weights. 2. Clean the movable and fixed jaws with a dusting brush. 1. Select the HARD item from the Control menu. 3. Press the Start/Enter key. 2. Press the Start/Enter key. The zeroing process is being performed. At that the jaw moves to the counter-jaw, takes the zero point and returns to its initial position. 3. Mount the justification adapter onto the jaw. Three different control measurements follow in succession to test the accuracy of the test station. 4. Insert the 5 mm gauge block. 5. Press the Start/Enter key. The measured value is shown on the display. 4. Place the device carefully onto the side so that the justification adapter would be at the top. 6. Insert the 10 mm gauge block. Ensure that there is no LAN-cable in the port on the right side of the device! 7. Press the Start/Enter key. The measured value is shown on the display. The hardness calibration is verified with 3 different control weights (CON1: 30 kg, CON2: 20 kg, CON3: 10 kg) in succession. 8. Insert the 15 mm gauge block. 9. Press the Start/Enter key. The measured value is shown on the display. 10. Press the Start/Enter key to return to the Control menu. WARNING Falling object! Insecure positioning can lead to damages. Be careful when placing the control weights so that they do not fall!

26 26 TBH 125 Control 5. Place the 30 kg weight. 6. Press Start/Enter for the confirmation. The current value is shown on the display. 5. Press the Start/Enter key. 6. Wait until the force on the first control point (nominal value 300 N) is measured. The force measured by the load cell is displayed from the left and the force measured by the AutoCal from the right. 7. Place the 20 kg weight. 8. Press Start/Enter for the confirmation. The current value is shown on the display. 7. Press the Start/Enter key. 8. Wait until the force on the second control point (nominal value 200 N) is measured. The force measured by the load cell is displayed from the left and the force measured by the AutoCal from the right. 9. Place the 10 kg weight. 10. Press Start/Enter for the confirmation. The current value is shown on the display. 11. When the control measurements are finished, remove the plate and place the device upright again. 12. Press Start/Enter for the confirmation. The jaw returns to the initial position. 9. Press the Start/Enter key. 10. Wait until the force on the third control point (nominal value 100 N) is measured. The force measured by the load cell is displayed from the left and the force measured by the AutoCal from the right Control of the dynamic hardness calibration The control of the dynamic hardness calibration is done with Erweka AutoCal 2.0 Windows XP. 1. Plug the Erweka AutoCal 2.0 Windows XP USB stick into the USB port. 2. Select the HARD item from the Control menu. The deviation between the force measured by the load cell (device) and by the AutoCal can differ in the range of max. ± 1 N! Otherwise you must repeat the calibration! For example: 106 N is the force measured by the load cell N is the force measured by the AutoCal shown 10 times more precisely. The deviation constitutes only 0.8 N. 3. Press the Start/Enter key. 4. Place the AutoCal control unit onto the measurement station. The measurement range of the calibration and control is ca. ± 10 N from the given nominal values.

27 TBH 125 Performing the Measurements Performing the Measurements The NUMB menu is shown on the display of the switched on device (see 4.4 Connecting the device and its first switching on). 1. Specify the number of samples. CAUTION Danger of squashing! During the zeroing procedure and the measurement the jaw moves. Do not touch the test station! 6. Place a sample right against the fixed test jaw vertically and as centered as possible to measure its thickness. 7. Press the Start/Enter key. The thickness is being measured. The tablet thickness will not be measured if this option in the Settings menu is disabled (see 5.24 Thickness). You can enter up to 99 samples. The number of samles entered by you is fixed and applies to all measurements that will be performed after this step. 2. Confirm the specified number of samples with Start/ Enter. Step 3 applies to TBH 125 TD devices only. 8. Place a sample right against the fixed test jaw horizontally as centered as possible to measure its hardness and diameter. 9. Press the Start/Enter key. The hardness and diameter are being measured. Hardness and diameter will not be measured if these options in the Settings menu are disabled (see 5.22 Hardness and 5.23 Diameter). 3. Specify the approximate thickness of samples. You can enter values from 0.10 to mm. Confirm your entry with Start/Enter. Step 4 applies to TBH 125 D and TD devices only. The dust produced in the test process and left on the test station can lead to false measurements. Therefore, it should be removed after each sample. Apply the delivered dusting brush for this purpose. The number of measurement repetitions (steps 6-9) depends on the specified number of samples. 4. Specify the approximate diameter of samples. You can enter values from 2.00 to mm. Confirm your entry with Start/Enter. Steps 3 and 4 are omitted when the function of automatic determination in the Settings menu is enabled (see 5.17 Automatic determination). Start/Enter must not be pressed after each tablet if the function of automatic measurement in the Settings menu is enabled (see 5.20 Automatic measurement). 5. Press the Start/Enter key to zero the test station.

28 28 TBH 125 Results 12 Results In the REST menu you can view the listed measurement results of the last test. The measurement results will be stored until the device is switched off or a new test is performed. 1. Using the left arrow keys select REST on the ready-for-operation device and confirm your selection with Start/Enter. 13 Statistics In the STAT menu you can view the statistic evaluations of the current test. The statistic evaluations will be stored until the device is switched off or a new test is performed. 1. Using the left arrow keys select STAT on the ready-for-operation device and confirm your selection with Start/Enter. 2. Using the left arrow keys scroll the listed results. 2. Using the left arrow keys scroll the statistic values. The table below represents the specific statistic values for hardness, thickness and diameter of the sample. Values on the left side indicate the number of tablet and measurement parameter (H for hardness, T for thickness and D for diameter). The measurement results are displayed on the right side. For example, the measurement result for 01T (thickness of the first sample) is 3.93mm. Designation Explanation HMIN/TMIN/DMIN Minimum value of measurement HMAX/TMAX/DMAX Maximum value of measurement HM M/TM M/DM M Difference between maximum and minimum value HAVR/TAVR/DAVR Average value HSTA/TSTA/DSTA Standard deviation HREL/TREL/DREL Relative standard deviation Interpretation of the first letters in designations: H = hardness (break resistance) T = thickness D = diameter

29 TBH 125 Maintenance Maintenance 14.1 Cleaning To guarantee the failure-free operation, it is recommended to clean the device regularly. The device is to be cleaned after each test. The dust must be removed thoroughly. Read the following instructions before you begin with the cleaning Inspection and maintenance Ensure that the device is regularly inspected and each time is clean. To ensure a long lifetime of your units and systems we recommend regular maintenance performed by our specialized staff. Instructions for cleaning HAZARD of electric shock when cleaning the electric devices! Disconnect the mains supply for cleaning the electric devices! Switch the device off and unplug it for cleaning! Clean the electric devices without liquids. 1. Disconnect the mains supply and, if available, the printer. 2. Clean the surfaces of the measurement stations to remove the tablet debris. Note that product residues must be properly disposed of in accordance with the applicable environmental regulations. In longer standstills If the device is not used for a long time, follow the instructions below: Switch the device off and unplug it. Dismount additional components. Clean the device thoroughly. Store the device, its components and manual under conditions defined for the installation environment. Non-compliance with the instructions given above can lead to damages! For thorough cleaning ERWEKA recommends to exhaust the surfaces or apply a soft brush. Inaccurate measurement results! Shaking and vibrations can displace the measuring devices. Clean the device carefully. Pay attention that no particles collect in the guide rails, grooves and chinks Spare parts Electronic and mechanical replacements are to be made by the ERWEKA personnel or approved by ERWEKA! Only original spare parts or components released by ERWEKA should be used. Only repairs or changes on the device performed by the ERWEKA technicians or approved explicitly by ERWEKA are to be made. 3. Wipe the device with a soft and slightly damped cloth. Do not use an excessively damped cloth but slightly damped one. Do not add any chemical cleansing agents to the cleaning water. For the lacquered housing parts use no cleansing agents which attack this material. If needed, e.g. in case of serious dirtying, use a damp cloth and blot the cleaned surface dry.

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31 TBH 125 Appendix 31 Appendix Example printouts of the protocols In this chapter you can find the examples of protocols printed from the device. Calibration protocol Check protocol

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33 TBH 125 Appendix 33 Measurement protocol In this example the measuring principle of constant speed (here: 2.3 mm/s) was used.

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35 Certificate of Compliance for Konformitätserklärung für Hardness Tester, Type TBH 125 We, ERWEKA GmbH, declare under our sole responsibility that the product to which this declaration relates is in conformity with the following EU-Directives and harmonized standards: Low Voltage Directive (LVD) 2014 / 35 / EU Safety requirements for electrical equipment for measurement, control and laboratory use; EN Electromagnetic Compatibility, (EMC) Directive 2014 / 30 / EU Electrical equipment for measurement, control and laboratory use; EN Wir, die ERWEKA GmbH, erklären in alleiniger Verantwortung, dass das Produkt, auf das sich diese Erklärung bezieht, mit folgenden EU-Richtlinien und harmonisierten Normen übereinstimmt: Niederspannungsrichtlinie 2014 / 35 / EU Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte; EN Elektromagnetische Verträglichkeit, EMV-Richtlinie 2014 / 30 / EU Mess-, Steuer-, Regel- und Laborgeräte, EN Heusenstamm, Manfred Koller -CTO- ERWEKA GmbH Ottostr Heusenstamm Germany Tel: Fax: info@erweka.com Managing Director & CEO: Werner G. Müller, Claudia Müller, Manfred Koller District court Offenbach HRB 2382

36 ERWEKA GmbH Ottostr Heusenstamm Germany Tel: +49 (0) Directors: Claudia Müller, Werner G. Müller District court Offenbach HRB 2382 Fax: +49 (0)