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Documenti di Professioni
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Tablet
Hardness Tester
TBH 125
Document version: 4.3
Date: 2018-01-22
Firmware version: from 1.45
Document No.: 21039
File name: TBH 125_Manual_21039_En_V4.3
Language: English
Number of pages: 36
Version table
Document
Date version* Amendment
2012 1.0
2015-02-26 2.0 AutoCal 2.0
2015-09-18 2.1 Editorial revision
2016-01-28 3.0 Firmware version increase; new Document No.
(old No.: 690-309-0001), new format (11/15)
2016-02-22 3.1 Editorial revision
2016-11-23 4.0 TBH 125P cancelled
2017-03-07 4.1 Editorial revision
2017-12-08 4.2 Editorial revision
2018-01-22 4.3 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.
1 – Introduction 5 9 – Calibration 22
1.1 – About this instruction manual 5 9.1 – Diameter calibration 22
1.2 – Service 5 9.2 – Hardness calibration 23
1.3 – Hints and symbols 6 9.2.1 – Static calibration 23
1.4 – Protection of the environment 6 9.2.2 – Dynamic calibration 24
2 – Safety 7 10 – Control 24
2.1 – Safety instructions 7 10.1 – Diameter 25
2.2 – Intended use 7 10.2 – Hardness 25
10.2.1 – Control of the static hardness calibration 25
3 – Overview 8 10.2.2 – Control of the dynamic hardness calibration
3.1 – Description 8 26
3.2 – Device types 8
3.3 – Type label 8 11 – Performing the Measurements 27
3.4 – Construction 9
3.5 – Operation elements and connections 9 12 – Results 28
3.5.1 – Keypad and display 10
3.6 – Technical data 11 13 – Statistics 28
4 – Installation 12 14 – Cleaning 29
4.1 – Storage and transport conditions 12 14.1 – Instructions for cleaning 29
4.2 – Unpacking and checking 12
4.3 – Setup 12 15 – Inspection and Maintenance 29
4.3.1 – Positioning 12 15.1 – In longer standstills 29
4.3.2 – Acclimatization 12 15.2 – Spare parts 29
4.3.3 – Required installation environment 13
4.4 – Connecting and switching the device on 13 Appendix 31
Example printouts of the protocols 31
5 – Configuration 15
5.1 – The SETT menu 15
5.2 – Pause 16
5.3 – Calibration position 16
5.4 – Hardness units 16
5.5 – Diameter and thickness units 16
5.6 – Hours 16
5.7 – Minutes 16
5.8 – Day 17
5.9 – Month 17
5.10 – Year 17
5.11 – Newton Factor 17
5.12 – Language 17
5.13 – Version 17
5.14 – Date format 18
5.15 – Method 18
5.16 – Terminology 18
5.17 – Automatic determination 18
5.18 – Printer 19
5.19 – Printer language 19
5.20 – Automatic measurement 19
5.21 – Data output 19
5.22 – Hardness 20
5.23 – Diameter 20
5.24 – Thickness 20
1 – Introduction
Thank you for purchasing the ERWEKA tablet hardness tester TBH 125 series!
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.
Read this manual completely before using the device and make sure you understand its content. The
instruction manual is a part of the product. Keep this manual in a safe place so that it will be available
for any questions at a later date. This is important for long-term and accurate function of the corres-
ponding device.
The editorial team of ERWEKA appreciates your feedback regarding the present manual. Just send
an e-mail to quality@erweka.com with your topic and “technical documentation” as a subject. Your
feedback will also help us to meet our own high quality requirements.
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:
21039 - 4.3
6 TBH 125 – Introduction
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 indicates information that will ensure smooth work processes.
Note that product residues must be properly disposed of in accordance with the respective valid environmental legis-
lation. According to the valid EC directives all the electrical parts (electrical scrap) must be disposed of appropriately.
21039 - 4.3
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.
Pay attention to the on-site safety instructions for work in the laboratory and with the laboratory equipment!
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.
The device should be operated and maintained only as intended and in accordance with the instructions presented
in this manual.
21039 - 4.3
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 100 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 (option).
Hardness test + + +
Diameter measurement - + +
Thickness measurement - - +
The type label is placed on the rear panel of the device and looks as follows:
ERWEKA
D-63150 Heusenstamm / Germany
R
GmbH
Serial No: Serial number*
PN: Normal output in volt-ampere [VA]
IN: Nominal current in ampere [A]
Typ: Serial No: xxxxxx.xxxx U: Voltage in volt [V]
PN : VA IN : A U: V F: Hz F: Frequency in hertz [Hz]
* The last 4 digits of the serial number show the calendar week (CW) and the year of manufacture of the device, e.g. xxxxxx.3217 means that the device has
been manufactured in the 32th CW 2017.
21039 - 4.3
TBH 125 – Overview 9
3.4 – Construction
2
1
1 Measurement station
2 Control panel
3 USB connections
A
B
E
F C
21039 - 4.3
10 TBH 125 – Overview
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
21039 - 4.3
TBH 125 – Overview 11
21039 - 4.3
12 TBH 125 – Installation
4 – Installation
4.1 – Storage and transport conditions
Temperature and humidity should not exceed or fall below the values defined by ERWEKA (see
4.3.3 – Required installation environment).
After receipt of the delivery, check the packaging and the device for transport damage.
On some packages you can see indicator labels, which change their colors in case of improper transporting. Check
these labels for discoloration.
If undue transporting or any damage is evident, take a photo of this and send it to our
ERWEKA Service immediately.
4.3 – Setup
4.3.1 – 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.
The currently valid directives / standards for room air in the laboratory must be observed.
4.3.2 – 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.
21039 - 4.3
TBH 125 – Installation 13
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!
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).
21039 - 4.3
14 TBH 125 – Installation
Zeroing
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.
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:
Menu Function
REST Display of the test results.
STAT Display of the evaluations or statistics.
SPED Setting of the constant speed in mm/s.
FORC Setting of the constant force in N/s.
PRIN Switching the printer on/off or repeating a printout.
CALI Calibration of the hardness and diameter test stations
(depending on the device option, see calibration).
CONT Control measurements for calibration.
SETT 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.
21039 - 4.3
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.
1. Using the left arrow keys select SETT on the ready-for-operation device.
Scroll through the configuration menu with the left arrow keys.
21039 - 4.3
16 TBH 125 – Configuration
In the PAUS menu item the time between the measu- In the UNID menu item set the measurement unit for dia-
rement cycles is set. The operator needs a certain time meter and thickness.
between the measurements to clean the test station and
restock it with a new sample. 1. Using the left arrow keys select the UNID item in the
SETT menu.
1. Using the left arrow keys select the PAUS item in the
SETT menu.
Adjustment range of pause time: 0 - 10 seconds 3. Confirm your selection with Start/Enter.
5.6 – Hours
5.3 – Calibration position The HOUR menu item belongs to the time setting. Set
the hours here.
In the CPOS menu item the calibration position is set.
ERWEKA recommends setting 0. 1. Using the left arrow keys select the HOUR item in the
SETT menu.
1. Using the left arrow keys select the CPOS item in the
SETT menu.
5.7 – Minutes
5.4 – Hardness units The MINU menu item belongs to the time setting. Set the
minutes here.
In the UNIH menu item set the measurement unit for
hardness. 1. Using the left arrow keys select the MINU item in the
SETT menu.
1. Using the left arrow keys select the UNIH item in the
SETT menu.
21039 - 4.3
TBH 125 – Configuration 17
The DAY menu item belongs to the date setting. Set the In the NFCT menu item you can read the Newton factor,
day here. but not change it!
1. Using the left arrow keys select the DAY item in the 1. Using the left arrow keys select the NFCT item in the
SETT menu. SETT menu.
2. Using the right arrow keys select the required day. 2. Press Stop/Exit to return to the SETT menu.
1. Using the left arrow keys select the MONT item in the 5.12 – Language
SETT menu.
In the LANG menu item you can select German or Eng-
lish as a menu language.
1. Using the left arrow keys select the LANG item in the
SETT menu.
2. Using the right arrow keys select the required month.
The YEAR menu item belongs to the date setting. Set the 3. Confirm your selection with Start/Enter.
year here.
1. Using the left arrow keys select the YEAR item in the
SETT menu. 5.13 – Version
In the VERS menu item you can read the firmware version
number, but not change it!
1. Using the left arrow keys select the VERS item in the
2. Using the right arrow keys select the required year. SETT menu.
21039 - 4.3
18 TBH 125 – Configuration
In the DATF menu item you can select the European or In the TERM menu item you can select between calibra-
American date display format. tion/control and justification/calibration. The terminology
change is shown in the corresponding device menus and
1. Using the left arrow keys select the DATF item in the protocols.
SETT menu.
1. Using the left arrow keys select the TERM item in the
SETT menu.
1. Using the left arrow keys select the METH item in the 1. Using the left arrow keys select the AUTO item in the
SETT menu. SETT menu.
2. Using the right arrow keys select the required measu- 2. Using the right arrow keys select the ON option to
rement method. switch this function on.
(SPED = constant speed or FORC = constant force) 3. Confirm your selection with Start/Enter.
21039 - 4.3
TBH 125 – Configuration 19
In this menu item select the printer type according to In this menu item activate or deactivate the automatic
the used printer. Select between internal (built-in) and measurement for each tablet.
external (conventional, e.g. HP® LaserJet or portable,
e.g. Martell) printer. The printed protocols differ (see
Appendix). This function is available for devices of
TBH 125 TD type only.
1. Using the left arrow keys select the PRIN item in the
SETT menu.
1. Using the left arrow keys select the AUME item in the
SETT menu.
3. Confirm your selection with Start/Enter. When activating this function the pause
in the PAUS submenu is set to 0 (see
5.2 – Pause).
1. Using the left arrow keys select the DOUT item in the
SETT menu.
2. Using the right arrow keys select the required printer
language.
21039 - 4.3
20 TBH 125 – Setting the Speed
2. Using the right arrow keys select the ON option to 6 – Setting the Speed
activate this function.
In the SPED menu set the measurement speed of the
3. Confirm your selection with Start/Enter. movable jaw. The selected measurement speed is prin-
ted out in the test protocol.
21039 - 4.3
TBH 125 – Setting the Force 21
21039 - 4.3
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 re-
In case of high or unexpected measu- turns to its initial position.
rement deviations a calibration must
be performed immediately, even if it is
outside the interval.
The CALI menu contains the DIAM and HARD items to 4. Insert the 10 mm gauge block.
calibrate the corresponding measurement stations.
5. Start the measurement with the Start/Enter key. The
If a printer is connected and the PRIN menu is activated, movable jaw moves to the gauge block and registers
on completion of a calibration cycle the calibration pro- the second calibration point.
tocol is printed out automatically. The calibration proto-
col contains nominal and actual values, current control Three different control measurements follow in
units and date. succession to test the accuracy of the measurement sta-
tion.
1. Using the left arrow keys select CALI on the
ready-for-operation device and confirm your selecti-
on with Start/Enter.
1. Select the DIAM item from the Calibration menu. 12. Press the Start/Enter key to return to the Calibration
menu.
21039 - 4.3
TBH 125 – Calibration 23
1. Select the HARD item from the Calibration menu. 7. Carefully place the required weight (30 kg is recom-
mended).
4. Place the device carefully onto the side so that the 12. Press the Start/Enter key for the confirmation. The
justification adapter would be at the top. current value is shown on the display.
5. Press the Start/Enter key. 14. Press the Start/Enter key for the confirmation. The
current value is shown on the display.
6. Zero the weight by pressing the left arrow key. 16. Press the Start/Enter key to return to the Calibration
menu.
21039 - 4.3
24 TBH 125 – Control
4. Place the AutoCal control unit onto the measurement 106 N is the force measured by the load
station. cell. 106.8 N is the force measured by the
AutoCal shown 10 times more precisely.
5. Press the Start/Enter key. The deviation constitutes only 0.8 N.
21039 - 4.3
TBH 125 – Control 25
1. Select the DIAM item from the Control menu. 10.2.1 – Control of the static
hardness calibration
2. Clean the movable and fixed jaws with a dusting 1. Select the HARD item from the Control menu.
brush.
21039 - 4.3
26 TBH 125 – Control
8. Press Start/Enter for the confirmation. The current 5. Press the Start/Enter key.
value is shown on the display.
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.
21039 - 4.3
TBH 125 – Performing the Measurements 27
You can enter up to 100 samples. The number of samles 8. Place a sample right against the fixed test jaw hori-
entered by you is fixed and applies to all measurements zontally as centered as possible to measure its hard-
that will be performed after this step. ness and diameter.
2. Confirm the specified number of samples with Start/ 9. Press the Start/Enter key. The hardness and diame-
Enter. ter are being measured.
Step 3 for TBH 125 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.
21039 - 4.3
28 TBH 125 – Results
12 – Results 13 – Statistics
In the REST menu you can view the listed measurement In the STAT menu you can view the statistic evaluations
results of the last test. of the current test.
The measurement results will be stored until the device is The statistic evaluations will be stored until the device is
switched off or a new test is performed. switched off or a new test is performed.
1. Using the left arrow keys select REST on the 1. Using the left arrow keys select STAT on the
ready-for-operation device and confirm your selection ready-for-operation device and confirm your selection
with Start/Enter. with Start/Enter.
2. Using the left arrow keys scroll the listed results. 2. Using the left arrow keys scroll the statistic values.
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
Values on the left side indicate the number of tablet and HAVR/TAVR/DAVR Average value
measurement parameter (H for hardness, T for thickness HSTA/TSTA/DSTA Standard deviation
and D for diameter). The measurement results are dis- HREL/TREL/DREL Relative standard deviation
played on the right side.
For example, the measurement result for 01T (thickness Interpretation of the first letters in designations:
of the first sample) is 3.93 mm.
• H = hardness (break resistance)
• T = thickness
• D = diameter
21039 - 4.3
TBH 125 – Cleaning 29
21039 - 4.3
TBH 125 – Attachment 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
21039 - 4.3
TBH 125 – Attachment 33
Measurement protocol
In this example the measuring principle of constant speed (here: 2.3 mm/s) was used.
21039 - 4.3
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 declara-
tion relates is in conformity with the following EU-Directives and harmonized standards:
Wir, die ERWEKA GmbH, erklären in alleiniger Verantwortung, dass das Produkt, auf das sich die-
se Erklärung bezieht, mit folgenden EU-Richtlinien und harmonisierten Normen übereinstimmt:
■ Niederspannungsrichtlinie 2014 / 35 / EU
■ Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte; EN 61010-1
■ Elektromagnetische Verträglichkeit, EMV-Richtlinie 2014 / 30 / EU
■ Mess-, Steuer-, Regel- und Laborgeräte, EN 61326-1
Heusenstamm, 22.02.2016
Manfred Koller
-CTO-
ERWEKA GmbH · Ottostr. 20-22 · 63150 Heusenstamm · Germany · Tel: +49 6104 6903-0
Fax: +49 6104 6903-40 · E-mail: info@erweka.com · www.erweka.com
Managing Director & CEO: Werner G. Müller, Claudia Müller, Manfred Koller · District court Offenbach HRB 2382
ERWEKA GmbH · Germany
E-mail: info@erweka.com
www.erweka.com