Sotax HT10 Tablet Sorter Manual PDF

Operating Instruction
Tablet Hardness Tester
HT 10
Article No. 08900
SOTAX AG Phone: +41 61 487 54 54

Nordring 1 Fax: +41 61 487 13 31
4147 Aesch BL E-mail: info@sotax.com
Switzerland Web: www.sotax.com
Translation of the Original German Operating Instruction
Version 15 / 2015-07-14
Valid after firmware V2.18
© Copyright SOTAX AG Aesch 2015. All rights reserved

Information in this Operating Instruction is subject to change without notice.
The reproduction, transmission or exploitation of this Operating Instruction or
its contents is not permitted without express written authority.
Version 15 / 2015-07-14 BA08900EN.DOCX 2 / 77

Table of Contents
Table of Contents
1. General Information 6
1.1 Read me.............................................................................................6
1.2 Glossary .............................................................................................6
2. Safety 7
2.1 Basic Safety Rules .............................................................................7
2.1.1 General Regulations ................................................................7
2.2 Used Symbols in this Operating Instruction .......................................7
2.3 Used Safety and Warning Signs ........................................................8
2.4 Specific Risks .....................................................................................8
2.5 Residual Risks ...................................................................................8
2.6 Organizational / Personnel.................................................................9
2.7 Training, Calibration, Qualification, Maintenance ..............................9
3. Product Description 10
3.1 General ............................................................................................10
3.1.1 Dedicated Use .......................................................................10
3.1.2 Conformity..............................................................................10
3.1.3 Unit Identification Label .........................................................10
3.1.4 Requirements for the Place of Use ........................................11
3.2 Technical Data .................................................................................12
3.2.1 Overview ................................................................................12
3.2.2 Electrical Characteristics .......................................................12
3.2.3 Level of Noise Emission ........................................................12
3.2.4 Dimensions and Weight .........................................................12
4. Assembly and Function 13
4.1 Mechanical Assembly of HT 10 .......................................................13
5. Function Description 14
6. Commissioning 15
6.1 Installation ........................................................................................15
6.1.1 Scope of Delivery (Standard Accessories) ............................15
6.1.2 Unpacking and Checking .......................................................15
6.2 Functional Components and Display ...............................................16
6.2.1 Diagram of the Control Panel ................................................16
6.2.2 Diagram of the Interfaces ......................................................17
6.3 Initial Startup ....................................................................................17
6.4 Configuration HT 10 .........................................................................18
6.4.1 Configuration EPROM ...........................................................27
6.4.2 Sensor....................................................................................27
6.5 Password Administration .................................................................28
6.5.1 General ..................................................................................28
6.5.2 Password Levels ....................................................................28
6.5.3 Access Authorization .............................................................30

Table of Contents
6.6 Configuration of Balance ..................................................................31
6.6.1 Mettler ....................................................................................31
6.6.2 Sartorius.................................................................................31
6.6.3 Precisa ...................................................................................31
7. Operation 32
7.1 Starting a Test without Method ........................................................32
7.1.1 Switching the Unit on .............................................................32
7.1.2 Selection of Tests to be performed ........................................32
7.1.3 Performing a Test without Method .........................................33
7.1.4 Displays shown during Measurements ..................................34
7.2 Method Programming ......................................................................36
7.2.1 Notes for Operation ...............................................................36
7.2.2 Creating and saving a Method ...............................................36
7.2.3 Editing existing Methods ........................................................39
7.3 Starting a Test with Method .............................................................41
7.4 Test Procedure.................................................................................42
7.4.1 Test ........................................................................................42
7.4.2 Displays during the Measurements .......................................44
7.4.3 Pause .....................................................................................45
7.4.4 Data .......................................................................................45
7.5 Dialog Menu .....................................................................................46
7.5.1 Existing Method .....................................................................46
7.5.2 New Method ...........................................................................46
7.5.3 Test Protocol ..........................................................................46
7.6 Calibration ........................................................................................47
7.6.1 Hardness................................................................................48
7.6.2 Diameter ................................................................................50
7.6.3 Thickness ...............................................................................51
7.7 Adjustment .......................................................................................52
7.7.1 Hardness................................................................................53
7.7.2 Diameter ................................................................................55
7.7.3 Thickness ...............................................................................56
7.8 Print-Outs and Protocols ..................................................................57
7.8.1 Calibration Print-Out ..............................................................57
7.8.2 Method Print-Out ...................................................................58
7.8.3 Test Protocol without Method ................................................63
7.8.4 Configuration Print-Out ..........................................................64
7.9 Data Transfer Protocols ...................................................................65
7.9.1 SOTAX Standard ...................................................................65
7.9.2 FreeWeigh (Mettler) ...............................................................66
7.9.3 InfinityQS ...............................................................................68
8. Maintenance 70
8.1 Scope and Frequency of Cleaning...................................................71
8.1.1 Daily Care ..............................................................................71
8.2 Spare Parts / Accessories ................................................................72
8.2.1 Spare Parts ............................................................................72
8.2.2 Accessories............................................................................73
9. Overhauling 74
9.1 Warranty...........................................................................................74

Table of Contents
9.2 Trouble-Shooting..............................................................................74
9.2.1 A Power Failure of the Unit ....................................................74
9.2.2 Change of Fuses ...................................................................74
9.2.3 Backup Battery ......................................................................75
9.2.4 Factory Reset ........................................................................75
10. Decommissioning / Storage 76
10.1 Decommissioning the Unit ...............................................................76
10.2 Storage.............................................................................................76
11. Packaging / Transport 76
12. Disposal 76
13. Declaration of Conformity 77

General Information
1. General Information
1.1 Read me
Please read the operating instruction before starting up the unit. Please take
special note of all instructions and warnings regarding danger that could arise
when using the unit.
The operating instruction forms an integral part of the product and contains
basic instructions to be followed during installation, operation and mainte-
nance. For this reason, the operating instruction must be kept at the disposal
of all persons dealing with the system.
1.2 Glossary
Abbreviation / Term Description
CE Conformité Européenne
EP European Pharmacopeia
FDA Food and Drug Administration
HT 10 SOTAX Tablet Hardness Tester
JP Japanese Pharmacopeia
IQ Installation Qualification
SOTAX Mechanical Tablet (simple verification of HT
MT
functionality between two qualifications)
OQ Operational Qualification
PL Plausibility –Limit
PQ Performance Qualification
T1, T2, T3 Tolerance Limits
The qualification activities should produce documented
evidence that provides a high degree of assurance that
Qualification
the unit consistently performs as intended and meets
specifications.
USP US Pharmacopeia
Validation is the process of checking that a product, ser-
Validation vice or system meets specifications and that it fulfills its
intended purpose.

Safety
2. Safety
2.1 Basic Safety Rules

Fundamental prerequisites for faultless, safe operation of the unit are correct
installation and assembly.
2.1.1 General Regulations

The user is obliged to operate the unit in perfect condition.
In addition to the instructions in this documentation, the following automatically
apply:
 appropriate rules to prevent accidents
 generally recognized technical safety rules
 national workplace regulations
 internal company work and safety instructions
2.2 Used Symbols in this Operating Instruction

This operating instruction contains the most important points for the safe op-
eration of the unit. The safety instructions are to be followed by every person
working in relation to the unit. Moreover the rules and prescriptions as appli-
cable to the site of use are to be followed in order to prevent accidents.
The symbols used in this operating instruction have the following meaning:
Danger:
This symbol indicates a high risk of injury to personnel. The information
given must be observed.
Warning:
This symbol indicates information which, if ignored, can lead to substantial
material damage. The safety instructions must be observed.
Important:
This symbol indicates information containing important instructions regard-
ing use. Failure to observe the instructions can lead to errors.

Safety
2.3 Used Safety and Warning Signs
Warning signs must not be removed or pasted over. These signs have been
fitted for your safety. Obsolete or inapplicable warning signs or instructions
should be removed by an authorized person and replaced by new ones if re-
quired.
Warning about hazardous voltage
Unplug before opening
2.4 Specific Risks
To prevent the risk of crushing body parts, the following notice must be fol-
lowed:
An operation of this unit shall only take place when the control box
and the cover are closed and the splinter protection cover is properly
set up.
Switch off the unit or unplug it from the power supply to cut off the electricity
completely, if e.g. the unit is not used for some time.
Place the power cable so that no one can stand on it or trip over it.
A risk management file has been created. It is only for internal use and not
intended for release to the customer. In the course of an internal audit it can
be presented to the customer for inspection.
2.5 Residual Risks

Special residual risks associated with the unit are not known.

Safety
2.6 Organizational / Personnel
Operation on the unit may only be performed by authorized and suitably
trained skilled employees. This means that they must meet the minimum train-
ing and know-how requirements and be assigned a precisely defined role.
The customer undertakes the responsibility only to allow trained employees to

work on the unit, who are familiar with the basic operational safety and acci-
dent prevention regulations and have ongoing access to the units operating
instruction and to this section containing the basic safety instructions. Person-
nel who do not have the relevant qualifications must be kept away from the
unit.
Furthermore, they must have read and understood the chapter “safety”.
Never bypass existing security and monitoring devices. They serve to protect
people from injury. Every change, ignoring or deactivation of security and sur-
veillance devices must be previously approved by SOTAX in written form.
Do not carry out changes and reconstructions on a unit without consulting

SOTAX first.
2.7 Training, Calibration, Qualification, Maintenance

SOTAX runs user-training courses for all units and systems in the SOTAX
application laboratory or in the customer’s laboratory.
Please also ask SOTAX or the local representative about the range of services
(calibration, qualification IQ/OQ, and maintenance).

Product Description
3. Product Description
3.1 General
The tablet hardness tester SOTAX HT 10 is designed to determine automati-
cally the physical properties of tablets, coated tablets, oblongs and similar ad-
ministration forms. The unit enables hardness, thickness, diameter/length and
weight of samples to be checked.
3.1.1 Dedicated Use

This unit must be used only to determine the physical properties of tablets,
coated tablets, oblongs and similar administration forms.
The dedicate use includes also the observation of these operating instruc-
tions, the adherence of personal qualifications, the safety regulations as well
as the maintenance and overhaul conditions.
3.1.2 Conformity
The HT 10 Hardness Tester meets the essential health and safety require-
ments of all relevant European Directives (see chapter 13 „Declaration of Con-
formity“).
3.1.3 Unit Identification Label

On the back of unit is a type plate provided. The following information is avail-
able:
Address of manufacturer, the unit type, the serial number and the year of man-
ufacture, the art. no. of unit, the hardness range as well as details concerning
mains voltage, frequency, power and fuse protection.
Also on the type plate shown are the CE – mark and the symbol of the directive
2002/96/EC on waste electrical and electronic equipment (crossed-out
wheeled bin symbol with a black bar underneath it) for setting collection, recy-
cling and recovery targets for all types of electrical goods.

Product Description
3.1.4 Requirements for the Place of Use
The following recommendations should be followed so that the operator has
the best possible conditions when operating the unit. The following recom-
mendations will also provide consistent performance with minimum mainte-
nance effort.
Temperature
The ambient temperature should be between 15°C and 30°C. Avoid larger
temperature fluctuations. Keep the unit sufficiently far away from radiators.
Humidity
The relative humidity should be between 10% and 75% without condensa-
tion.
Environment
The environment should be free of dust, smoke and corrosive fumes. The
unit shall not be operated in a potentially explosive atmosphere.
Exposure to light
The unit must be protected from direct sunlight. Diffuse illumination provides
the ideal lightning.
Space requirements
We advise to have at least twice the width and depth of the unit available
(see details in chapter 3.2.4 „Dimensions and Weight“).
Vibrations
Place the unit firmly to a suitable vibration-free and stable base.

Product Description
3.2 Technical Data
3.2.1 Overview
Tablet hardness tester SOTAX HT 10
Measurement principle Constant Speed and Constant Force
0.05-2.50 mm/sec and 10-99 N/sec
Measurement range hardness 5-500 N ± 1 N or
5-1000 N ±2N
Kp 0.510-51 Kp ± 0.102 Kp or
0.510-102 Kp ± 0.204 Kp
Sc 0.48-72.5 Sc ± 0.145 Sc or
0.48-145 Sc ± 0.290 Sc
Diameter / length 0.00-30.00 mm ± 0.05 mm or inch
Thickness 0.00-10.00 mm ± 0.05 mm
Interface 4 x RS-232, 1 x IEEE 1284 (parallel) for
connection of a printer
Recommended printer e.g. Label Printer EPSON TM-U220PD
(parallel), Samsung ML-2571N, OKI
B2400
3.2.2 Electrical Characteristics

Operating voltage (Volt) 230 or 115 V tolerance ± 10 %
(voltage adjustable at power switch)
Frequency (Hertz) 50 / 60 Hz
Fuses 2 x 6.3 AF
3.2.3 Level of Noise Emission

The A-rated sound pressure at the workplace is less as 70 db (A)
3.2.4 Dimensions and Weight

Width, depth, height 250 x 537 x 355 mm
Weight ca. 18 kg
H 10 355 mm
250 mm 540 mm

Assembly and Function
4. Assembly and Function
4.1 Mechanical Assembly of HT 10
4
1
2 3
5
No. Description
1 Magazine with disc
2 Cover
3 Splinter protection cover
4 Control box
5 Collecting tray
2
3 1
H 10
No. Description
Magazine with opening for feeding
1
the test samples
2 Control panel
Disc with permanent magnet and
3 numbering (turning counter-clock-
wise)

Function Description
5. Function Description
The tablet hardness tester SOTAX HT 10 is designed to determine automati-
cally the physical properties of tablets, coated tablets, oblongs and similar ad-
ministration forms. The unit enables hardness, thickness, diameter/length and
weight of samples to be checked.
The hardness of a sample can be tested with the HT 10 unit according to two
different measurement principles "Constant Speed" (the tablet is broken at a
constant speed) or "Constant Force" (linear force increase up to the breakage
of the tablet). The speed and the force increase can be freely selected in order
to simulate exactly the measurement principle of various hardness testers.
The whole dimensions (diameter/length and thickness) of a sample can be

tested automatically with the HT 10 unit. A balance may be connected to the
HT 10 in order to weigh the sample.
The revolutionary Auto AlignmentTM of HT 10 enables an automatic and rapid

alignment of the sample prior to the hardness and diameter/length measure-
ment.
During the design of HT 10, a high value has been set on a precise mecha-
nism. In addition, this testing unit, very easy to operate, is sturdy and nearly
maintenance free.

Commissioning
6. Commissioning
6.1 Installation
6.1.1 Scope of Delivery (Standard Accessories)
Tablet Hardness Tester
Model: SOTAX HT 10
Art. No.: 08900
Description Art. No. Manufacturer

Collecting tray 8912 SOTAX AG
Magazine with disk 8741 SOTAX AG
Splinter protection cover 9411 SOTAX AG
Accessories not mentioned here are listed on the delivery note accompanying
the consignment.
6.1.2 Unpacking and Checking

Unpack the individual parts carefully. Keep the packaging material for future
transport or storage.
Check the individual parts for any damage during transport.
Report any damage to the transport company immediately and inform the local
representative.

Commissioning
6.2 Functional Components and Display
6.2.1 Diagram of the Control Panel
11 10
2 3 4 5 6 7 8
No. Description
1 Display
2 Function keys
3 Alignment rollers in/out
4 Alignment rollers on/off
5 SET key
6 Help
7 Menu
8 Input confirmation (ENTER)
9 Delete (Clear)
10 Input keys
11 Movement keys

Commissioning
6.2.2 Diagram of the Interfaces
1 2
5
6
3 4
No. Description No. Description

1 RS 232 Caliper / Gage 4 RS 232 Balance
2 RS 232 PC 5 IEEE 1284Printer
3 RS 232 (reserve) 6 Voltage selector with fuses, power
switch and power connection
6.3 Initial Startup

 Check the conformity of the existing voltage and frequency with the indica-
tion on the identification plate of the unit.
Should any problems arise during installation or initial start up, switch the
unit off, unplug the power cable and contact the SOTAX service department
or your local representative.

Commissioning
6.4 Configuration HT 10
In order to enter the configuration mode proceed as follows: (see chapter 6.2.2
„Diagram of the Interfaces “)
 Press the keys 1, 5 and C simultaneously before switching the unit with the
power switch on.
 Release the keys after 5 sec.
 The start up display with the HT 10 logo is shown.
 If passwords are assigned, the following display is shown after the initiali-
zation:
After entering the password and confirmation with the ENTER-key, the unit
automatically switches over to the main menu.
If no password is assigned, the main menu display is shown right after the
initialization.
Press the F1-key (print) to print the configuration data (see chapter 7.8.4
“Configuration Print-Out”).

Commissioning
Date Enter the day, the month and the year into the “Date” field
using the Input-keys. Confirm each input with the ENTER-
key.
Time Enter the exact time into the “Time” field using the Input-
keys. The seconds shown cannot be edited. Confirm each
input with the ENTER-key.
Serial No. Enter the serial number into the “Serial No” field using the
Input-keys. Confirm the input with the ENTER-key.
Date Format Set the requested “Date Format” using the SET-key.
DD.MM.YY day / month / year (e.g. 31.08.10)
MM/DD/YY month / day / year (e.g. 08/31/10)
Balance Set the corresponding parameters using the SET-key.
None No balance connected. (Default)
Mettler Mettler balance connected.
Sartorius Sartorius balance connected.
Press the F4-key (Next) to enter the next display.
Defaults of units
Set the corresponding parameters using the SET-key.
Default Option
Weights mg g or mg
Dimensions mm mm or inch
Thickness, width,
diameter/length
Hardness N N, Kp, Sc oder UD
1N = 0.102 kp
1 kp = 9.81 N
1 Sc = 6.874 N
1 kp = 1.428 Sc
1 Sc = 0.7 kp

Commissioning
Backofft The “Backoff” distance is the distance which is added to the di-
ameter/length measured. The breaker jaw is moving at maximal
speed up to this distance and is then switched over to the meas-
urement speed.
Default 0.50 mm
Range 0.10 - 2.00 mm
Dia. Offset While using a special breaker jaw, a “Dia. Offset” can be set.
The diameter offset can be positive or negative. It is used for the
compensation calculation while making a diameter/length
measurement.
Default 00.00 mm
Range 00.00 - 30.00 mm
UD Factor The “UD Factor” (user defined hardness unit of measure) will be
User defined multiplied by the determined hardness value to calculate a user
factor defined value.
Default 10.000
Range 65.000 - 0.001
Mode Set the relevant “Mode” using the SET-key.
Const. Speed The breaker jaw is moving towards the sam-
ples at a constant speed.
Const. Force The speed of the breaker jaw is adjusted in
order to press against the sample at a con-
stant force increase.
Default: Const. Speed
Speed/Force “Speed” or “Force” is shown according to the setting in “Mode”.
At Const. Speed Speed = 1.00 mm/sec (Default)
At Const. Force Force = 10 N/sec (Default)
Range : 0.10 mm -2.50 (Const. Speed)
Range: 1-100 N/sec (Const. Force)
Sensitivity The “Sensitivity” defines the sensitivity of force measurement,
at which the tablet is detected as broken.
Default 25 %
Range 1 % - 50 %
(Notice: The smaller the percentage, the more sensitive is the
break detection )

Commissioning
Acceptance Range
Hardness Maximum admissible deviation to the nominal
weight at the calibration of the unit
Default 0.10 kg
Range 0.00 - 9.99 kg
Dimensions Maximum admissible deviation to the nominal
Thickness, diameter/length length at the calibration of the unit
Default 0.05 mm
Range 0.00 - 9.99 mm
Verif. Int. Set the requested “Verification Interval” for the
Calibration intervals next calibration using the SET-key.
None No request and also no entry in
the test protocol (print out)
1 day
1 week
1 month
3 months
6 months
1 year (Default)
Print out Specify which printer format is connected
A4
Letter
Label Printer (Default)

Commissioning
Jaw Delay After starting a test, the breaker jaw starts not until
the “jaw delay” is expired to have more orientation
time for the sample if needed.
Default 0 sec
Range 0 - 99 sec
T123 Print Set the requested test protocol parameter using the
SET-key (see chapter 7.8.2 “Method Print-Out”)
Inlimit see example below
Outlimit (Default) see example below
Lock Op. Set to “Yes”, the menu areas “Read” and “Setup” are
locked for the operator when starting a test without
method.
The access to the menu areas is possible for all user,
but changes are not possible (Default No)
Print view The “print view” can be selected either using SOTAX,
FreeWeigh (Mettler) or InfinityQS. See also the flow
chart below (Default SOTAX).
Selfcheck See description below.

Commissioning
T123 Print: Example: Classification of measuring values with „inlimit“
Pre-settings:
Nominal value of a measurement = 100 %

T1 = 10 %
T2 = 20 %
T3 = 30 % = Plausibility-Limit
Tablet
T3 = 130 %
Third tolerance range
T2 = 120 %
Second tolerance range
T1 = 110 %
100 % First tolerance range
T1 = 90 %
T2 = 80 %
T3 = 70 %
Result:
5 tablets inside first tolerance range (in printout value T1)

3 tablets inside second tolerance range (in printout value T2)
2 tablets > plausibility-limit (will be not taken over into the statistics, but will be
printed out)

Commissioning
T123 Print: Example: Classification of measuring values with „outlimit“
Pre-settings:
Nominal value of a measurement = 100 %

T1 = 10 %
T2 = 20 %
T3 = 30 % = Plausibility-Limit
Tablet
T3 = 130 %
T2 = 120 %
T1 = 110 %
100 % First tolerance range
T1 = 90 %
T2 = 80 %
T3 = 70 %
Result:
5 tablets inside the first tolerance range (with no tolerance indication for the
values in the printout).
3 tablets outside the first tolerance range (in printout value T1)
2 tablets outside the second tolerance range > plausibility-limit (in printout
value T2).

Commissioning
„Print view“ „SOTAX“ Standard or „InfinityQS“
The bold lines are showing the deviations to the SOTAX standard.

Commissioning
Selfcheck Set the corresponding parameters using the SET key.
Yes The Selfcheck starts using “Ini” and is valid for

one day.
No (Default)
Configuration HT
with 1, 5, C
Selfcheck
INI
Yes/No
Force
Check if Load Cell value is 20 % higher than last

adjustment value of 0 (~130 Counts)
>20%, the message appears

"Please check Load Cell"
<20% shows on print-out

INI
"Daily Selfcheck OK"
Diameter
Check if more than 10 Counts of last adjustment

value Diameter
>10 Counts, the message appears

"Please check Diameter"
<10 Counts shows on print-out

INI "Daily Self Check OK"
Thickness
Check if more than 10 Counts of last adjustment

value Thickness
>10 Counts, the message appears

"Please check Thicknessr"
<10 Counts shows on print-out

"Daily Self Check OK"

Commissioning
6.4.1 Configuration EPROM
PMintime Time for the rollers to go in and out again

(time in 1/50 sec.)
SensPol Sensor Polarity.
MaxOver Counts that the breaker jay is moving to get a hardness

value after reaching the tablet
(should be raised to 5000 steps with 1000 N units).
6.4.2 Sensor
Hardness Position of breaker jay after initialization

Magazin Magazine steps per position move
Thickness Thickness measuring station: possibility of adjustment
Press the F1-key (Test) to execute the relevant steps for the hardness- and
magazine sensor.

Commissioning
6.5 Password Administration
6.5.1 General
 Passwords can be assigned with a maximum of eight alphanumeric char-
acters and are only viewed with „**** ”characters.
 Password entries must be confirmed with „ENTER“.
 The password assignment is set after entering the characters in the first
row and with the confirmation in the second row. If the characters in the
second row do not match the first row, the password must be assigned
again.
 If a password is assigned, it is required when switching on the unit and is
valid until shut-off.
 It is possible to assign the same password for different levels.
 Without the "Master" password, it is not possible to assign lower levels
passwords.
 Deleting a password can only carry out the legitimate level by pressing the
"Clear" and "ENTER" and must be made at the first and the second line.
 There is no traceability for changed passwords.
6.5.2 Password Levels
Enter Password
Operator With the "Operator" password you can start a method
and print protocols.
Method With the “Method” password, you can create, modify
and delete methods, but not changing passwords.
If an "Operator" password is assigned, the unit may be
also started with the "Method" password.
If the "Method" password is not defined, the operator
can change methods.

Commissioning
Enter Password
Config. With the “Config” password you can change not only
the configuration of the unit but also the passwords
“Operator”, “Method” and “Config”.
If an "Operator" password is assigned, the unit may be
also started with the "Config" password.
If a "Config" password is not defined, the "Operator" or
"Method" user can change the unit configurations.
If a “Config" password is defined, it is always needed
when accessing the menus "New", "Edit", "Delete" or
"Device". The menus will be left automatically after 5
minutes
Master With the "Master" password you can execute all the
described activities and change all passwords.
The main reason of the "Master" password assign-
ment is to have a backup in case one or more of the
above described password has been forgotten.
With no "Operator", "Method" or "Config" password,
the "Master" password is not relevant.
Press the F3-key (Prev) to get back to the last display.
To go back to the main menu, switch of the unit and make a re-start after
approx. 5 sec.

Commissioning
6.5.3 Access Authorization
Main configuration Access

Configuration HT 10 (1, 5 and C) „Config“ or „Master“
Factory Reset „Master“
Main menu F-keys Access

F1 Initialization „ini“ All
F2 „Read“ All
The access for operators can be blocked
with the parameter "LockOp.
F3 „Start“ All
F4 „Setup“ All
The access for operators can be blocked
with the parameter "LockOp.
Method menu F-keys Access

F1 „Existing Method“ All
„View/Print“ All
„Edit/Delete“ „Method“ or „Master“
F2 „New Method“ „Method“ or „Master“
F3 „Test Protocol“ All
F4 „Device“ „Config“ or „Master“

Commissioning
6.6 Configuration of Balance
Important:
The main print in the HT 10 must have the following jumper settings:
To measure the weight of a sample, you can connect a balance using the RS-
232 port on the back of the unit (see chapter 6.2.2 “Diagram of the Interfaces”.
In order to communicate between HT 10 and the balance, it must be ensured
that the relevant parameters are set. The procedure is shown in the respective
balance manual.
The following manufacturers can be selected:
6.6.1 Mettler
Configuration:
9600 baud
8 bit
1 stop bit
No parity
The connecting cable is included in the chapter 8.2.2 “Accessories”.
6.6.2 Sartorius
Configuration:
mg units 3 1 13 (not possible with all unit types)
9600 baud 517
Space 522
1 stop bit 5 3 1 (standard)
software handshake 541
ASCII 5 5 1 (not selectable with all unit types)
for print 611
lineformat 7 2 1 (not selectable with all unit types)
The connecting cable is included in the scope of supply of manufacturer.
6.6.3 Precisa
Configuration:
9600 baud
8 bit
1 stop bit
No parity
No handshake
The connecting cable is included in the scope of supply of manufacturer.

Operation
7. Operation
7.1 Starting a Test without Method

7.1.1 Switching the Unit on
Switch the unit on using the power switch at the back of the unit. The HT 10
logo with the firmware version appears for approx. 5 sec. on the display.
If a password protection is assigned, you will see then the following display:
After entering the password and confirmation with the ENTER key (see chap-
ter 6.5 „Password Administration“) the unit switches automatically to the main
menu.
If no password protection is assigned, the main menu appears directly.
7.1.2 Selection of Tests to be performed

Press the F4-key (Setup) to access the definition display.

Operation
Use the movement-keys (see chapter 6.2.1 “Diagram of the Control Panel”) to
switch between rows and change with the SET-key “Yes” / “No” or use the
selection keys to change numeric values.
Hardness Yes/No
Diameter Yes/No
Thickness Yes/No
Weight Yes/No
Size of Pill Requested in order to position the sample exactly
onto the rollers. (Default 8 mm)
Spinning Speed Speed of the carousel to transport the sample.
10 % - 100 % (Default 100 %).
Press the F1-key (Test) to check parameters.

Press the F4-key (“Exit”) to go back to the main menu.
7.1.3 Performing a Test without Method

For the performance of a test without a method, no tolerances (T1, T2 and
T3) can be specified. Should the test to be performed with tolerances, the
samples shall be tested using a method (see chapter 7.3 „Starting a Test with
Method“)
Press the F1-key (Ini) to initialize the unit. All data from previous measure-
ments will be deleted. The counters are set to 0 (starting point).
Press the F2-key (Read) to perform the first measurement. The counter states
how many measurements already have been performed. Up to 99 samples
can be measured.
After the first measurement (counter bigger than 0), „Back“ is shown at the F3-
key instead of „Start“. Press the F3-key (Back) in order to delete the last value
and to set the counter back by 1.
After the first measurement, the statistics may be viewed using the F4-key
(Data) (see chapter 7.4.4 „Data“). At this display, a report can be generated
(see chapter 7.8.3 „Test Protocol without Method “)
The test sequence is as follows:

1. Weight
2. Thickness
3. Diameter / Hardness

Operation
If the started tests contain a weight measurement, the following display ap-
pears first when pressing the F2-key (Read):
By pressing the F3-key (Yes), the balance will be tarred.
If there is no balance connected, the HT 10 must be switched off and on again.
7.1.4 Displays shown during Measurements

Display for weight measurement:
When changing the status to “Ready”, the balance is checked if tarred. If a

value exceeds ± 1mg, the following message will appear:
By pressing the F4-key (OK), it will be re-checked again whether the balance
is tarred. If found correct, the following display will be shown:
Once the sample has been laid on the balance and the weight stays constant,
the value is automatically taken over. After a short delay time, the next display
will be shown.

Operation
Display for thickness and length / hardness measurement.
Feed the magazine manually with the sample and press the F2-key (Read) to
start the measurements.
Never turn the magazine manually.
The positioning of the tablet onto the rollers (to align the tablet) is described
in chapter 7.1.2 „Selection of Tests to be performed“).
At the first measurement, the breaker jaw moves forward with reduced speed.
The diameter is recorded by means of resistance detection and is followed by

the hardness measurement.
At the following measurements, the breaker jaw moves with a increased

speed up to the last measured diameter, plus the back off distance (see chap-
ter 6.4 “Configuration HT 10“)
The size of the sample must match with the nominal value.

Operation
7.2 Method Programming
7.2.1 Notes for Operation
Alphanumeric inputs can be entered using the control panel. Figures may be
entered directly on the corresponding keys at the control panel. For letters,
dots and spacing press the "ABC" key. The display below is shown. Use the
movement-keys (see chapter 6.2.1 „Diagram of the Control Panel“) to select
the characters and press the ENTER-key to confirm.
7.2.2 Creating and saving a Method

With the HT 10 it is possible to program and save up to 30 different testing
methods.
To program a method proceed as follows:
The main menu should be shown. If not, press the menu-key on the control
panel.
Press the F2-key (New Method). The method editing window will be shown.
With the movement-keys you can select individual rows and change the pa-
rameters. Use the ENTER-key to confirm settings.
To move between the displays, use the F4-key (Next) or F3-key (Prev).

Operation
Product No. Enter the product number.
Prod. Name Enter he product name.
Form Select the product form using the SET-key. The follow-
ing selection is available:
Oblong
Coated tablet
Tablet (Default)
Ampoule
Core
Alignm. Following settings are available to align the samples:
1. On (Default)
The alignment rollers are switched on.
2. Off
The alignment rollers are switched off.
Hardness Enter the number of hardness tests.
Diameter Enter the number of diameter and length measurements.
Thickness Enter the number of thickness measurements.
Weight Enter the number of weight measurements.
Size of Pill Requested in order to positioning the sample exactly
onto the alignment rollers.
Spinning Speed Rotating speed of the carousel 10 % - 100 % (Default
100 %).
Press the F1-key (Test) to check the “Size of Pill” and “Spinning Speed” pa-
rameters.
Press the F4-key (Next) to access the specification displays, for which a test
has to be performed.
Enter the nominal values of the parameters to be tested and confirm with the
ENTER-key.
The unit set in the configuration dialog is displayed and can be changed by
pressing the SET-key (see chapter 6.4 „Configuration HT 10 “).

Operation
Enter the requested tolerance limits.
3 different tolerance limits are available:

T1 = 1st tolerance limit
T2 = 2nd tolerance limit
T3 = plausibility limit (values > T3 will be marked with PL in the protocol, but
not included in the statistic).
The plausibility limit must be set to differ between realistic measurements and
faulty measurements.
Use the SET-key to scroll between “Nominal”, “Average” and “NoLimit”.
If “Nominal” is selected the tolerance limits are based on the nominal value.
Are faulty measurements existing, pull along as many tablets as PL deviations
have taken place during measurement.
If “Average” is selected the tolerance limits are based on the average value
of measured results.
If “No Limit” is selected no tolerance limits are considered. The test report
printout is not showing any tolerance values.
If you go with the cursor to the “%”, using the SET-key you can select the
tolerance limit between relative “%” and absolute (N, mm, mg, etc.) (Default
%).
Input values T1 > T2 and T2 > T3 will be not accepted. The tolerance limits must
not be outside of the measuring range (see chapter 3.2.1 “Overview”.
Press the F4-key (Next) to enter the last display:
Now you need to save the method. 30 storage locations are available. 10 stor-
age locations are shown. Move the cursor to one of the storage locations and
enter a name with maximum 8 characters (using the “ABC” key) or a number
under which the method has to be saved. Press the F4-key (Save) to save the
method.
By pressing the "downward" or "upward" movement-keys you can switch be-
tween 10 storage locations.
Press the F3-key (Prev) to change back to the specification display.

Operation
If the storage location is already used, a message appears, if the old method
shall be overwritten with the new method.
Press the F2-key (Exit) and Menu-key to return to the main menu.
7.2.3 Editing existing Methods

The main menu should be shown. If not, press the Menu-key on the control
panel.
Select with the F1-key (View) the function “Existing Method”. The method se-
lection display appears.
Select with the movement-keys one of the shown methods:
F1 “View” It appears the under chapter 7.2.2 „Creating and saving a

Method“ described display but without active cursor. After press-
ing the F4-key (Next) at the last display, it returns back to the
above shown “Select Method” display.
F2 “Edit” The individual parameter of a method can be changed as de-

scribed in chapter 7.2.2 „Creating and saving a Method“. After
pressing the F4-key (Next) at the last display, the “Save Method”
display appears. The above selected and changed method can
now be saved under the same name, another method overwrit-
ten or stored under a new name. With pressing the F4-key (Exit),
the menu display will be shown again.

Operation
F3 “Delete” Delete a method
The selected method will be not deleted until the confirmation F3-key (Yes) is
pressed.
Press the F3-key (Yes) or F4-key (No) to switch back to the “Select Method”
display.
F4 “Print” Print out of a method
The selected method will be not printed out until the confirmation F3-key (Yes)
is pressed.
Press the F3-key (Yes) or F4-key (No) switch back to the “Select Method”
display.
Press the Menu-key to go back to the main menu display.

Operation
7.3 Starting a Test with Method
To start a method, press in the main menu the F3-key (Start).
Select the desired method.
Enter now the needed information like “Batch No.”, “Press” and “Comment”.
Confirm each entry with the ENTER-key.
Press the F3-key (Start) to start the selected test.

Operation
7.4 Test Procedure
7.4.1 Test
The test sequence is as follows:
All weight measurements

then
Thickness
Diameter / Hardness
If the started method contains a weight measurement, the following display

appears:
Press the F3-key (Yes) and the balance will be tarred. The following display
appears:
Deposit the sample on the balance. The stable value is displayed briefly and
then taken over. The following display appears:
Take the sample from the balance and place it into the magazine position 1.

Operation
During the next measurement, the taring of the balance will be checked again.
Is a measured value outside of ± 1mg, the following display appears.
Tare the balance now manually. The following display will be shown:
Deposit the next sample on the balance, make a weight measurement and
place the sample into the magazine position 2.
Weigh all samples as described above.

Operation
7.4.2 Displays during the Measurements
The following test parameters are shown:
C D
A
B
A Status display. Shows always the status of the unit. Requests for man-
ual inputs will be shown here.
B Displays the measured values.
C Number of tests performed and remaining.
D Displays the date and time in the relevant configured format.
E Name or number of the current test. If the test has not been started
through a method, no number/name is shown under the line method.
Press the F3-key (Start) to start the predefined measurements.

Operation
7.4.3 Pause
When pressing the F1-key (Pause) during testing, the following display ap-
pears:
Press the F1-key (Cont) for the test to be continued.
If you want to finish the test, press the F2-key (Abort Test). The values meas-
ured up to this moment will be not stored.
Press the F4-key (Data) to view and print the statistics of the tests already
performed.
7.4.4 Data
The statistics of the already performed tests can be viewed.
Press the F1-key (Exit) to return to the previous display.
Press the F2-key (Print) to print the values.
Use the F3-key (Prev) and F4-key (Next) to switch among the tests (e.g. Hard-
ness and Diameter.

Operation
7.5 Dialog Menu
Press the Menu-key to enter the “dialog menu”.
To switch between the Dialog Menu and the Main Menu, press the Menu-key.
7.5.1 Existing Method

Press the F1-key (Existing Method) to enter the method dialog view.
Press the F1-key (View) to view all available methods, the F2-key (Edit) to edit
a method, the F3-key (Delete) to delete a method and the F4-key (Print) to
print a method (see chapter 7.8.2 „Method Print-Out“).
7.5.2 New Method

Press the F2-key (New Method) to enter the method dialog (see chapter 7.2.2
„Creating and saving a Method”).
7.5.3 Test Protocol

Press the F3-key (Test Protocol) to enter the print dialog.
Select the requested protocol by using the movement-keys and press the F4-
key (Print) to print it. You can select the last five generated tests protocols.
With the automatic storage of test results, the oldest test protocol will be de-
leted.

Operation
7.6 Calibration
As a basic principle, all SOTAX units will be adjusted and calibrated prior to de-
livery.
To assure, that the unit is still suitable for the intended use, SOTAX recommends
a Re-Qualification interval of half a year to be observed.
With every start up of the unit, a check is performed to make sure that the cali-
bration date for thickness, hardness and diameter has not expired. When the
calibration interval set under chapter 6.4 „Configuration HT 10 “ has passed, the
message “Calibration date expired” will be shown.
Changes to Calibration acceptance ranges can be done in setting configuration
mode.
To perform a calibration, proceed as follows:
Press the Menu-key.
Press the F4-key (Device) to enter the “device” dialog.
Select the function “calibration” by pressing the F1-key.
Select with pressing the F1-key (Hardness) or the F2-key (Diameter) the de-
sired parameter, you want to calibrate and confirm this with the ENTER-key.

Operation
7.6.1 Hardness
Make sure that all weights to be used as verification are entered into the col-
umn “Nom.” (Nominal). At least one value must be entered; maximal three
weight values can be calibrated.
In the input field no.1 is the nominal value unchangeable set to 00.00.
In the input field no.2 to no.4 the nominal values should be determined in
order.
Assembly
Open the control box (5) and tip it to the side. Unscrew and remove the two
screws on the load cell. Screw the calibration tower (4) to the unit with the two
short screws (Art.V100-3754) from the calibration set (Art.9276). Fix the load
cell in a vertical position and tighten with the two long screws (V100-4809)
from the calibration set (Art.9276).
Put the calibration disk (2) into the guidance (3). Position the weight (1) care-
fully in the middle of the calibration plate.
1
5 2
ENTER
3
C
9
3
8
?
7
0
SET
4
c
F4
F3
F2
F1
No. Description
1 Calibration weight
2 Calibration disk
3 Guidance
4 Calibration tower
5 Control box
Select the corresponding fields with the movement-keys. Enter the value of a
weight and confirm it with the ENTER-key. To delete a weight value, press the
“C” key and confirm it with the ENTER-key.

Operation
Execution of Calibration
0-value measurement
The calibration disk remains in place for the 0 value measurement (input field
no.1 taring). Move the cursor to the field "Read". Press the ENTER-key to
perform the measurement. The 0 value is recorded.
Calibration
Position the weight (1) entered at the first calibration point onto the calibration
disk (2) (input field no.2). Move the cursor to the field "Read". Press the EN-
TER-key to perform the measurement. The deviation (Dev.) to the nominal
weight is shown on the right side.
If you have entered several weight values, proceed as described above.
Once all measurements are completed, press the F4-key (Next) to enter the
next display where the “Acceptance Range” (see chapter 6.4 „Configuration
HT 10 “) and the max. determined deviation of calibration is shown.
Use the F3-key (Yes) to save the protocol. With this saving it will overwrite the
eldest protocol and set the new calibration date. If the test has to be repeated,
press the F4-key (No).
As soon as the protocol is saved, the next dialog will appear:
Press the F3-key (Yes) to print the protocol (see chapter 7.8.1 „Calibration “).
When the calibration work is finished, remove the calibration tower and install
the load cell. Make sure that the load cell is mounted free movable and paral-
lel.
Push the load cell towards the back of unit before tightening the screws.
Make sure, that the internal Plexiglas cover is in place and prevent a falling
down of the control box while carefully closing using both hands (see
also information sign “open+close carefully sensitive electronics inside!).

Operation
7.6.2 Diameter
Make sure that all lengths to be used for verification have been entered under
Nom. (Nominal). One value at least must be entered, max. four length values
can be calibrated.
Select the corresponding fields with the movement-keys. Enter the value of
the length and confirm it with the ENTER-key. To delete a length value, press
the C-key (Clear).
Remove the carousel for the calibration. Position the relevant gauge block
between the breaker jaws. Move the cursor to the field "Read". Press the EN-
TER-key to perform the measurement. The deviation (Dev.) to the nominal
value is shown on the right side.
If you have entered several nominal values, proceed as described above.
HT 10 “) and the max. determined deviation of calibration is shown.
As soon as the protocol is saved the next dialog appears:
Press the F3-key (Yes) to print the protocol (see chapter 7.8.1 „Calibration “)

Operation
7.6.3 Thickness
Make sure that all thickness values to be used for verification have been en-
tered under Nom. (Nominal). One value at least must be entered, max. four
thickness values can be calibrated.
the thickness and confirm with the ENTER-key. To delete a thickness value
press the C-key (Clear).
Remove the carousel for a more easy calibration. Position the first gauge block
entered at the first verification point below the thickness measuring station. If
you have entered thickness 0 as nominal value, do not insert any gauge block.
In this case, the plunger moves directly to the support. Move the cursor to the
field "Read". Press the ENTER-key to perform the measurement. The devia-
tion (Dev.) to the nominal thickness is shown on the right side.
If you have entered several thickness values, proceed as described above.
HT 10 “) and the max. deviation determined during the calibration is shown.
As soon as the protocol is saved the next dialog appears:
Press the F3-key (Yes) to print the protocol (see chapter 7.8.1 „Calibration “ )
Mount the carousel and the splinter cover protection. Close the cover of unit.

Operation
7.7 Adjustment
Perform an adjustment only when the equipment no longer meets the ac-
ceptance criteria of the corresponding parameter.
To perform an adjustment proceeds as follows:
Press the Menu-key.
Press the F4-key (Device) to enter the next dialog.
Press the F2-key (Adjustment) for the function “Adjustment”.

Operation
7.7.1 Hardness
Make sure that all values of the weights to be used for the adjustment have
been entered under Nom. (Nominal). One value at least must be entered, max.
three weight values can be adjusted.
Assembly
Open the control box (5) and tip it to the side. Unscrew and remove the two
screws on the load cell. Screw the calibration tower (4) to the unit with the two
short screws (Art.V100-3754) from the calibration set (Art.9276). Fix the load
cell in a vertical position and tighten with the two long screws (V100-4809)
from the calibration set (Art.9276).
Put the calibration disk (2) into the guidance (3). Position the weight (1) care-
fully in the middle of the calibration plate.
1
5 2
ENTER
3
C
9
3
8
?
7
0
SET
4
c
F4
F3
F2
F1
No. Description
1 Calibration weight
2 Calibration disk
3 Guidance
4 Calibration tower
5 Control box
the weight and confirm with the ENTER-key. To delete a weight value, press
the ‘C’ key and confirm it with the ENTER-key.

Operation
Execution of Adjustment
The weight adjustment must be performed in ascending order.
0-value measurement
The calibration disk remains in place for the 0 value measurement. Move the
cursor to the field "rd" (read) of the first line. Press the ENTER-key to perform
the measurement.
Move the cursor to the field "st" (store). Press the ENTER-key to overwrite the
current value with the new one.
Adjustment
Position the weight (1) entered at the first calibration point onto the calibration
disk (2). Move the cursor to the field "rd" (read) of the first line. Press the
ENTER-key to perform the measurement. As described above, move the cur-
sor to the field "Set". Press the ENTER-key to overwrite the current value with
the new measured value. You may perform as much measurements as you
want before confirming a value with the “set” key.
If you have entered several weight values, proceed as described above.
Once all adjustments are completed, press the F4-key (Next). The new ad-
justment date will be set and you enter automatically the “calibration menu”
display.
To use the unit after an adjustment, perform a hardness calibration.

Operation
7.7.2 Diameter
Make sure that all length values to be used for the adjustment have been en-
tered under Nom. (Nominal). One value at least must be entered, max. four
length values can be adjusted.
the length and confirm it with “Enter”. To delete a length value press the “C”
key (Clear).
Remove the carousel for the adjustment. Position the relevant gauge block
between the breaker jaws. If you have entered length 0 as nominal value, do
not insert any gauge block. In this case, the breaker jaw moves directly to the
very end. Move the cursor to the field "rd" (read). Press the ENTER-key to
perform the measurement.
Before a measurement is performed, the second column “Counts” is empty.

The currently saved value is shown in the first column. Once the measurement
is performed, the number of “Counts” is shown in the second “Counts” column.
Also the text "st" (store) is shown.
You see now both “Counts”: the currently saved one and the new measured
one. Move the cursor to the field "st" (store). Press the ENTER-key to over-
write the current value with the new one. No “Counts” are shown in the second
column. The test “st” (store) is no longer shown.
Position the gauge block entered at the second adjustment between the
breaker jaws. Move the cursor to the field "rd" (read) of the second line. Press
the ENTER-key to perform the measurement. As described above, move the
cursor to the field "st" (store). Press the ENTER-key to overwrite the current
value with the new measured value.
If you have entered several adjustments, proceed as described above.
display.
To use the unit after an adjustment, perform a diameter calibration.

Operation
7.7.3 Thickness
Make sure that all thickness values to be used for the adjustment have been
entered under Nom. (Nominal). One value at least must be entered, max. four
thickness values can be calibrated.
the thickness and confirm it with “Enter”. To delete a thickness value, press
the “C” key (Clear) and confirm it with the ENTER-key.
Remove the carousel for the adjustment. Position the gauge block entered at
the first adjustment point below the thickness measurement station. If you
have entered thickness 0 as nominal value, do not insert any gauge block. In
this case, the plunger moves directly to the support. Move the cursor to the
field "rd" (read) of the first line. Press the ENTER-key to perform the measure-
ment.
Before a measurement is performed, the second column “Counts” is empty.

The currently saved value is shown in the first column. Once the measurement
is performed, the number of “Counts” is shown in the second “Counts” column.
Also the text "st" (store) is shown.
You see now both “Counts”: the currently saved one and the new measured
one. Move the cursor to the field "st" (store). Press the ENTER-key to over-
write the current value with the new one. No “Counts” are shown in the second
column. The text “st” (store) is no longer shown.
Position the gauge block entered at the second adjustment point below the
thickness measurement station. Move the cursor to the field "rd" (read) of the
second line. Press the ENTER-key to perform the measurement. As described
above, move the cursor to the field "st" (store). Press the ENTER-key to over-
write the current value with the new measured value.
If you have entered several adjustments, proceed as described above.
display.
To use the unit after an adjustment, perform a thickness calibration.

Operation
7.8 Print-Outs and Protocols
7.8.1 Calibration Print-Out
Calibration Protocol HT 10
Hardness Tester : SOTAX HT10 V2.xx / 1.xx
Serial Number : 4xxx.xxx
Hardness
last adjustment date: : 02.08.10
used weights: : 0.00kg
: 10.00kg
: 20.00kg
Calibration date: : 02.08.10 18:17
Nominal Actual Dev.
Weight 1 [kg]: 0.00 0.00 0.00
Weight 2 [kg]: 10.00 10.03 0.03
Weight 3 [kg]: 20.00 20.05 0.05
Acceptance Range: 0.10 Max. Dev. 0.05
Calibration: within Limit
Diameter
last adjustment date: : 02.08.10
used gauge block : 0.00 mm
: 30.00 mm
Calibration date : 02.08.10 18:20
Nominal Actual Dev.
Gauge 1 [mm]: 0.00 0.00 0.00
Gauge 2 [mm]: 4.00 4.01 0.01
Gauge 3 [mm]: 16.00 15.99 -0.01
Acceptance Range: 0.05 Max. Dev. 0.01
Thickness
last adjustment date: 02.08.10
used gauge block: : 0.00mm
: 4.00mm
: 20.00mm
Calibration date: : 02.08.10 18:23
Nominal Actual Dev.
Gauge 1 [mm]: 0.00 0.01 0.01
Gauge 2 [mm]: 2.00 2.01 0.01
Gauge 3 [mm]: 4.00 4.00 0.00
Gauge 4 [mm]: 16.00 15.98 -0.02
Acceptance Range: 0.05 Max. Dev. -0.02
Operator: ………………….. Signature: ……………………

Operation
7.8.2 Method Print-Out
Test Protocol HT 10 (with Nominal „inLimit) Page: 1/1
Serial Number . 4xxx.xxx
Mode: Constant speed Speed: 1.00 mm/sec
Calibration date Hardness: 02.08.10 18:17
Diameter: 02.08.10 18:20
Thickness 02.08.10 18:23
Date of Test Start: 03.08.2010 11:02
Method No.: 4
Product No.: 2
Batch No.:
Product Name: Test Tablet
Press:
Form: Tablet
Comment:
Method Parameters
Hardness [N] Diameter [mm] Thickness [mm]
Tests 6 6 6
T3 min 150 7.84
T2 min 155 8.96
T1 min 165 10.08
Nom/Avg 171 11.20
T1 max 188 12.32
T2 max 205 13.44
T3 max 222 14.56
Measuring Parameters
1 157 T2 11.20 T1 5.42
2 169 T1 11.20 T1 5.42
3 132 >PL 11.19 T1 5.42
4 163 T2 11.20 T1 5.46
5 182 T1 11.21 T1 5.45
6 179 T1 11.20 T1 5.45
7 168 T1 11.18 T1 5.42
Statistic
Number 6 6 6
min. 157 11.18 5.42
max. 182 11.21 5.46
max.-min. 25 0.03 0.04
Avg. 169.7 11.198 5.437
Std. Dev. 9.5 0.010 0.019
RSD [%] 5.6 0.1 0.3
Operator: ……………… Signature: ………………

Operation
Test Protocol HT 10 (with Nominal „outLimit) Page: 1/1

Diameter: 02.08.10 18:20
Thickness 02.08.10 18:23
Method No.: 4
Product No.: 2
Batch No.:
Press:
Form: Tablet
Comment:
Method Parameters
Tests 6 6 6
T3 min 150 7.84
T2 min 155 8.96
T1 min 165 10.08
Nom/Avg 171 11.20
T1 max 188 12.32
T2 max 205 13.44
T3 max 222 14.56
1 159 T1 11.19 5.44
2 157 T1 11.20 5.43
3 155 T1 11.20 5.46
4 177 11.19 5.45
5 165 11.21 5.43
6 171 11.22 5.44
Statistic
Number 6 6 6
min. 155 11.19 5.43
max. 177 11.22 5.46
max.-min. 22 0.03 0.03
Avg. 164.0 11.202 5.442
Std. Dev. 8.6 0.012 0.012
RSD [%] 5.3 0.1 0.2

Operation
Test Protocol HT 10 (with Average „inLimit) Page: 1/1

Diameter: 02.08.10 18:20
Thickness 02.08.10 18:23
Method No.: 4
Product No.: 2
Batch No.:
Press:
Form: Tablet
Comment:
Method Parameters
Tests 6 6 6
T3 min 12.3 30.0 30.0
T2 min 9.4 20.0 20.0
T1 min 3.5 10.0 10.0
Nom/Avg average average average
T1 max 10.0 10.0 10.0
T2 max 20.0 20.0 20.0
T3 max 30.0 30.0 30.0
Measuring Parameters (inLimit)

1 158 T1 11.19 T1 5.44 T1
2 172 T1 11.21 T1 5.45 T1
3 130 >PL 11.21 T1 5.45 T1
4 165 T1 11.21 T1 5.43 T1
5 161 T1 11.22 T1 5.44 T1
6 160 T1 11.20 T1 5.42 T1
Statistic
Number 6 6 6
min. 130 11.19 5.42
max. 172 11.22 5.45
max.-min. 42 0.03 0.03
Avg. 157.7 11.207 5.438
Std. Dev. 14.4 0.010 0.012
RSD [%] 9.2 0.1 0.2

Operation
Test Protocol HT 10 (with Average „outLimit) Page: 1/1

Diameter: 02.08.10 18:20
Thickness 02.08.10 18:23
Method No.: 4
Product No.: 2
Batch No.:
Press:
Form: Tablet
Comment:
Method Parameters
Tests 6 6 6
T3 min 12.3 30.0 30.0
T2 min 9.4 20.0 20.0
T1 min 3.5 10.0 10.0
Nom/Avg average average average
T1 max 10.0 10.0 10.0
T2 max 20.0 20.0 20.0
T3 max 30.0 30.0 30.0
Measuring Parameters (outLimit)

1 149 T2 11.20 T1 5.40 T1
2 177 T2 11.22 T1 5.44 T1
3 123 >PL 11.21 T1 5.43 T1
4 148 T2 11.20 T1 5.44 T1
5 164 T1 11.20 T1 5.42 T1
6 175 T2 11.21 T1 5.44 T1
Statistic
Number 6 6 6
min. 123 11.20 5.40
max. 177 11.22 5.44
max.-min. 54 0.02 0.04
Avg. 156.0 11.207 5.428
Std. Dev. 20.3 0.008 0.016
RSD [%] 13.0 0.1 0.3

Operation
Method Print Out HT 10 ( with „NoLimits“)
Method No.: 12345678

Product No.: AA
Form: Tablet
Alignment: On
Method Parameters
Tests 20 20 20

Operation
7.8.3 Test Protocol without Method
Test Protocol HT 10

Mode: Const. speed 1.00 mm/sec
Calibration Date: Hardness: 02.08.10 18:17

Diameter: 02.08.10 18:20
Thickness: 02.08.10 18:23
Product No.: …………………………………………….

Batch No.: …………………………………………….
Product Name: …………………………………………….
Press: …………………………………………….
Form: …………………………………………….
Comment: …………………………………………….
1 123 11.31 5.43

2 110 11.22 5.45
Statistic
Number 2 2 2
min. 110 11.22 5.43
max. 123 11.31 5.45
max.-min. 13 0.09 0.02
Avg. 116.5 11.265 5.440
Std. Dev. 9.2 0.064 0.014
% RSD 7.9 0.6 0.3
Operator: ................................... Signature: .............................................

Operation
7.8.4 Configuration Print-Out
Configuration Data HT 10
Date format : DD.MM.YY
Balance type : Sartorius
RS232 protocol : Sotax
Unit weight : mg
Unit dimensions : mm
Unit force : Kp
Hardness range : 500N
Backoff : 0.50 mm
Diameter offset : 0.00 mm
UD Factor : 10.000
CrushMode : Const.Speed 1.00 mm/s
Sensitivity : 25 %
Acc.range hardn : 0.50 N
Acc.range diame : 0.05 mm
Verif.Intervall : 1 year
Print out : Label Printer
Crush jaw delay : 0 sec
T123 Print : outlimit
Lock Op : No
Print View : Sotax
Selfcheck : No
Print CalDate : Yes
Print MethNo : Yes
Print ProdNo : Yes
Print BatchNo : Yes
Print ProdName : Yes
Print Press : Yes
Print Form : Yes
Print Comment : Yes
Text BatchNo : Batch No.
Text Press : Press
Text Comment : Comment
Hardness : 500
Magazin : 24
PMintime : 49
SensPol : 288
MaxOver : 800
Operator : ……………..
Signature : ………….….

Operation
7.9 Data Transfer Protocols

When all measurements with a tablet are finished, a data string containing one
or more measurement values is sent via the RS232 interface. Data transfer
happens when performing a test without method or when performing a test
with method.
The data format is selectable in the configuration mode of the unit (see chapter
6.4 “Configuration HT 10”). Three different data transfer protocols are availa-
ble. The detailed format is described in the following sections:
7.9.1 SOTAX Standard
Whenever a hardness measurement is finished, a character string in the fol-
lowing format is sent via the RS232 interface.
The line always starts with a '@' character followed by the measurement num-
ber. Depending of the unit’s setup of the unit (see chapter 6.4 “Configuration
HT 10 ”), the hardness measurement value with the corresponding unit des-
ignator follows. The string (line) is terminated by the control characters
<cr><lf>.
When performing a test with method and a measured value is outside the
plausibility limit (>PL) the whole packet of this tablet is not sent and an addi-
tional tablet for testing is requested.
Only the hardness measurement will be sent using the SOTAX standard.
E.g. if the hardness unit is configured with N, the lines look like this:
@ 1 210 N<cr><lf>
@ 2 217 N<cr><lf>
@ 3 219 N<cr><lf>
@ 4 216 N<cr><lf>
@ 5 212 N<cr><lf>
@ 6 218 N<cr><lf>
@ 7 219 N<cr><lf>
@ 8 213 N<cr><lf>
@ 9 221 N<cr><lf>
@ 10 212 N<cr><lf>
@ 11 214 N<cr><lf>
@ 12 222 N<cr><lf>
E.g. if the hardness unit is configured with Kp, the lines look like this:
@ 1 22.3 Kp<cr><lf>
@ 2 22.5 Kp<cr><lf>
@ 3 22.8 Kp<cr><lf>
@ 4 22.6 Kp<cr><lf>
@ 5 23.1 Kp<cr><lf>
@ 6 23.1 Kp<cr><lf>
@ 7 22.9 Kp<cr><lf>
@ 8 22.7 Kp<cr><lf>
@ 9 22.2 Kp<cr><lf>
@ 10 22.6 Kp<cr><lf>

Operation
7.9.2 FreeWeigh (Mettler)
A data packet, ending with a empty line, is sent via the RS232 interface when-
ever all the measurements specified for the tablet have been done.
When weight measurement is specified for HT 10, first all the tablets were
weighing. If only the weight measurement is specified, the values were sent
continuously. Otherwise the tablets have to be inserted into the magazine.
The weight is stored in the HT 10 device and is sent not before other meas-
urements have been done.
Units and precision is dependent on HT 10 settings.
With a test without method, units and precision is according settings in config-
uration mode (see chapter 6.4 “Configuration HT 10 ”).
With a “test with method”, units and precision is according method

specification.
Units and precision always corresponds to units and precision shown on the
display.
A data line starts with one of the tokens : 'WGT', ' DIA', 'HRD', 'THK' according
to weight-, diameter-, hardness- and thickness-measurement. Following a '='
character is the measurement value with the corresponding unit and unit des-
ignator.
Example: DIA=20.00 mm<cr><lf>

(with diameter and HRD=362 N<cr><lf>
hardness) <cr><lf>
Example: THK=20.00 mm<cr><lf>

(with thickness, diameter DIA=20.00 mm<cr><lf>
and hardness) HRD=363 N<cr><lf>
<cr><lf>
Example: WGT= 5.1 mg<cr><lf>

(with weight, diameter , DIA= 0.79 inch<cr><lf>
and hardness) HRD= 37.27 Kp<cr><lf>
<cr><lf>

Operation
Configuration of FreeWeigh Software:
Interface configuration:
Baud rate: 9600
Data bits: 8
Stop bits: 1
Parity: none
Handshake: none
String terminator: CR / LF
Example of a strings:
HRD = 123.1VN
WGT = 567.8Vmg
DIA = 9.87Vmm
THK = 13.45Vmm
Parser definition:
3x Reply: Individual value:
Header HRD WGT DIA THK
Header position 1 1 1 1
# of strings to ignore 0 0 0 0
# of separators value 1 1 1 1
Separator = = = =
Unit N mg mm mm
Variable type Hardness Weight Thickness Length

Operation
7.9.3 InfinityQS
A data packet is sent via the RS232 interface whenever all the measurement
specified for the tablet have been done (test without method) or when all
tablets specified in the method have been tested (test with method, HT 10
only).
With a “test with method” (HT 10 only) first all weight measurements are sent,
then all thickness, all diameter and finally all hardness measurements (see
example).
Line format:
@<tablet number>, <abbreviation of measurement>, <measurement value>,
<unit>, <cr> <lf>
Abbreviations of the measurements are:

h Hardness
d Diameter
w Weight
t Thickness
Units and resolution are always independent of configuration and method

unit decimal places
Sc SCU 1
g grams 4
in inches 4
Example “test without method”:

@1, w, 0.0051, g<cr><lf>
@1, t, 0.2705, in<cr><lf>
@1, d, 0.7102, in<cr><lf>
@1, h, 8.8, Sc <cr><lf>
@2, w, 0.0051, g<cr><lf>
@2, t, 0.2705, in<cr><lf>
@2, d, 0.7102, in<cr><lf>
@2, h, 10.8, Sc <cr><lf>
@3, w, 0.0051, g<cr><lf>
@3, t, 0.2720, in<cr><lf>
@3, d, 0.7110, in<cr><lf>
@3, h, 9.3, Sc<cr><lf>

Operation
Example “test with method”:
@1, w, 0.0051, g<cr><lf>
@2, w, 0.0051, g<cr><lf>
@3, w, 0.0051, g<cr><lf>
@4, w, 0.0051, g<cr><lf>
@5, w, 0.0051, g<cr><lf>
@6, w, 0.0051, g<cr><lf>
@7, w, 0.0051, g<cr><lf>
@8, w, 0.0051, g<cr><lf>
@9, w, 0.0051, g<cr><lf>
@10, w, 0.0051, g<cr><lf>
@1, t, 0.2701, in<cr><lf>
@2, t, 0.2709, in<cr><lf>
@3, t, 0.2661, in<cr><lf>
@4, t, 0.2677, in<cr><lf>
@5, t, 0.2693, in<cr><lf>
@6, t, 0.2713, in<cr><lf>
@7, t, 0.2701, in<cr><lf>
@8, t, 0.2693, in<cr><lf>
@9, t, 0.2681, in<cr><lf>
@10, t, 0.2705, in<cr><lf>
@1, d, 0.7091, in<cr><lf>
@2, d, 0.7094, in<cr><lf>
@3, d, 0.7091, in<cr><lf>
@4, d, 0.7102, in<cr><lf>
@5, d, 0.7083, in<cr><lf>
@6, d, 0.7083, in<cr><lf>
@7, d, 0.7102, in<cr><lf>
@8, d, 0.7091, in<cr><lf>
@9, d, 0.7087, in<cr><lf>
@10, d, 0.7091, in<cr><lf>
@1, h, 11.1, Sc<cr><lf>
@2, h, 9.6, Sc<cr><lf>
@3, h, 7.1, Sc<cr><lf>
@4, h, 8.2, Sc<cr><lf>
@5, h, 9.4, Sc<cr><lf>
@6, h, 10.1, Sc<cr><lf>
@7, h, 9.5, Sc<cr><lf>
@8, h, 10.5, Sc<cr><lf>
@9, h, 9.4, Sc<cr><lf>
@10, h, 9.4, Sc<cr><lf>

Maintenance
8. Maintenance
Maintenance and repair work should only be carried out by certified SOTAX
service department technicians or by certified SOTAX distributors.
To guarantee a trouble-free operation for many years, we recommend carry-

ing out an annual maintenance organized by the SOTAX service department.
This can be arranged with the help of a service contract.
Service Contract
In the service contract the following will be defined:
Invoice- and delivery address, service contract number, start of contract, ser-
vice interval, serial numbers of main system / auxiliary components, reserva-
tions, description of work to performed with required hours and cost (mainte-
nance, eventually qualification, travel time, board and lodging).
Preventive Maintenance (PM) Report

As described in the service contract, the service technician executes the work
using the PM report. In the PM report the following will be defined:
Document handling (review, signing rules, copy etc.). Responsibility of the
technician and user (timing of work to execute, testing, procedures, impact to
qualification). Checklist with detailed listing of the inspection- and mainte-
nance work as well as the required PM kits for the system / unit to maintain.
The SOTAX Service Department Europe can be reached as follows:

Address: SOTAX AG
Nordring 1
CH-4147 Aesch BL
Hotline Phone: +41 61 487 54 60

E-mail: services@sotax.com
The SOTAX Technical Support Department USA can be reached as follows:

Address: SOTAX Corporation
2400 Computer Drive
US-Westborough, MA 01581
General phone: +1 888 768 29 87 (toll free)

General e-mail: sotaxusa@sotax.com
Tech Support: +1 508 544 40 40
E-mail: techsupport_america@sotax.com

Maintenance
The SOTAX Technical Support Asia-Pacific can be reached as follows:

Address: SOTAX India (Pvt) Limited
601, Eco House
Vishweshwar Nagar
Goregoan East
Mumbai 400063
Phone: +91 22 42 95 01 91
E-mail: services_asia@sotax.com
Before maintenance-, repair- and cleaning work:

Switch the power switch of the unit off and unplug the power cable.
Simply switching the unit off is not enough, since dangerous voltages could
still pass through certain parts of the unit.
8.1 Scope and Frequency of Cleaning

For the construction of the tablet hardness tester are high quality components
used. The unit is very easy to maintain. Nevertheless, the following care in-
structions should be followed:
8.1.1 Daily Care

Use a damp cloth to wipe the unit. Make sure that no liquid enters the unit and
wipe it with a soft cloth.
Handle the Plexiglas parts carefully and clean them with suitable cleaning sol-
vent only (no alcohol, acetone or benzene!)

Maintenance
8.2 Spare Parts / Accessories
8.2.1 Spare Parts

Art. No. Description
8741 Magazine with 24 positions
8741-02 Magazine with 20 positions
8937 Cover
8912 Collecting tray
9411 Splinter protection cover
8686 Face
8686-02 Face, coated with Teflon
8680 Block
8680-02 Block, coated with Teflon
E020-0100 Fuse 6.3 AF
8969 Floor brushes
11188 Side brushes

Maintenance
8.2.2 Accessories
Art. No. Description
9276 Calibration set
W005-0090 Block shaped weight 5 kg
W005-0198 Caliper gauge 2 mm
230554-1 Mechanical Tablet with breaking force 5 Kp ± 0.3
230597 Empty storage box avec foam for up to 5 MT’s
230598 Storage box with HT 10 / HT 100 test disc (230596) and

MT holder (230585)
230596 Test disc
230585 MT holder
C100-0170 Balance cable (Mettler)
C100-0176 Computer cable RS232 9F/9F 3m
C100-0180 Printer cable Centronics 3m (IBM)
C100-0181 LPT to USB adapter 3m

(interface from SOTAX parallel port to USB printer port)

Overhauling
9. Overhauling
9.1 Warranty
 The manufacturer grants a 12-month warranty from date of delivery in the
event of material or manufacturing faults. Any claims extending there be-
yond are expressly declined.
 The warranty does not cover damage due to incorrect use or handling to
normal wear and tear.
 If the user carries out his own repairs (without approval by SOTAX) during
the warranty period, these are not covered by the SOTAX warranty.
 Liability for consequential damage or plant standstill is expressly excluded.
 Products that are defective or objected should be returned to SOTAX, free
factory. Any travel and transport costs for delivery and return will be
charged to the customer.
 The manufacturer grants a 6-month warranty for spare parts installed dur-
ing regular repair/maintenance work.
9.2 Trouble-Shooting
9.2.1 A Power Failure of the Unit
could be caused by the following:
 The fuses at the power switch are damaged.
Always switch the unit off and unplug the power cable before replacing the fuses.
9.2.2 Change of Fuses
HT 10
Voltage 230 V 115 V
Fuses 2 x 6.3 AF 2 x 6.3 AF
1
No. Description
1 Voltage selector with fuses
I 2 2 Power switch
0 3 Power plug

Overhauling
9.2.3 Backup Battery
The life time end of the backup battery can be identified as follows:
 When starting the unit, the following display appears first:
If this display appears, the backup battery must be replaced as soon as pos-
sible. Another indication for a weak backup battery is a black point in the
main menu.
Print out the configuration of the unit and all programmed methods and con-
tact your local representative.
9.2.4 Factory Reset
Attention:
When making a “Factory Reset”, all customer specific adjustments will be
overwritten with the factory settings.
To reset the unit, proceed as follows:

 Before switching the unit on, press the three keys <7>, <A/B/C>, <9> and
switch the unit on with the main switch.
 Release the keys after approx. 5 sec.
 The message “Factory Reset done” appears.

Decommissioning / Storage
10. Decommissioning / Storage
10.1 Decommissioning the Unit

 Switch off the unit using the power switch.
 Check if all loose parts of the unit are present.
 Clean the unit before storing.
10.2 Storage
SOTAX recommends using the original shipment wrapping of the unit for stor-
age.
11. Packaging / Transport

Do not expose the unit to extreme temperatures, shocks, vibration and mois-
ture.
Please contact SOTAX or your local representative, if you have any questions.
12. Disposal
SOTAX recommends contacting the local representative regarding decom-
missioning and disposal of the unit and the packaging material.
Do not throw batteries into the household waste.
According to the “European Guideline 2002/96/EC for Waste Electrical and

Electronic Equipment” (WEEE), equipment that are no longer usable must be
collected separately and disposed of in an environmentally correct manner.

Declaration of Conformity
13. Declaration of Conformity

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Operating Instruction

Tablet Hardness Tester

Article No. 08900

SOTAX AG Phone: +41 61 487 54 54

© Copyright SOTAX AG Aesch 2015. All rights reserved

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2.1 Basic Safety Rules

2.1.1 General Regulations

2.2 Used Symbols in this Operating Instruction

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Warning about hazardous voltage

Unplug before opening

2.4 Specific Risks

2.5 Residual Risks

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The customer undertakes the responsibility only to allow trained employees to

Do not carry out changes and reconstructions on a unit without consulting

2.7 Training, Calibration, Qualification, Maintenance

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3.1.1 Dedicated Use

3.1.3 Unit Identification Label

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3.2.2 Electrical Characteristics

3.2.3 Level of Noise Emission

3.2.4 Dimensions and Weight

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4. Assembly and Function

4.1 Mechanical Assembly of HT 10

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The whole dimensions (diameter/length and thickness) of a sample can be

The revolutionary Auto AlignmentTM of HT 10 enables an automatic and rapid

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Description Art. No. Manufacturer

6.1.2 Unpacking and Checking

Check the individual parts for any damage during transport.

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No. Description No. Description

6.3 Initial Startup

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Press the F4-key (Next) to enter the next display.

Press the F4-key (Next) to enter the next display.

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Press the F4-key (Next) to enter the next display.

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Press the F4-key (Next) to enter the next display.

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Nominal value of a measurement = 100 %

100 % First tolerance range

5 tablets inside first tolerance range (in printout value T1)

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Nominal value of a measurement = 100 %

100 % First tolerance range

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Yes The Selfcheck starts using “Ini” and is valid for