Hardness Tester
Hardness Tester
Hardness Tester
Testing of five essential physical parameters: hardness, thickness, diameter/length, width and
weight of a tablet
Equipped with the patented Auto Alignment™ device, even the most difficult of tablet shapes are
automatically aligned properly to prevent erroneous hardness measurements
Two hardness measurement principles “Constant Speed” or “Constant Force” with a measuring
range of up to 500 or 1000 N can be applied to match existing testers on the market
Meets the USP chapter 1217 requirements: three points calibration and tablet orientation
SOTAX AG Binningerstrasse 106 CH-4123 Allschwil 1 Switzerland Phone +41 61 487 54 54 Fax +41 61 482 13 31
Hardness Tester
Description
The standard SOTAX HT 1 measures tablet thickness, diameter or length,
width and hardness. It is also equipped with a connection for an optional
balance (to record tablet weight) as well as a connection for an optional
external digital caliper (to record tablet thickness). The unit is manufactured
with high-quality material made of galvanized, powder-coated sheet metal to
endure the toughest of production sites. It requires no regular maintenance.
Features
The SOTAX HT 1 is the only tester available with the patented Auto
Alignment™ device to automatically align correctly the tablet for proper
measurements. Special jaws are no longer needed for small or oblong
tablets. Thickness measurements can also be reported with the test jaws
by turning the tablet on its side. The use of an external caliper is also no
longer needed. The SOTAX HT 1 is available in a variety of options to meet
your specific testing requirments: standard 500 N load cell, optional 1000 N
load cell, standard auto-alignment and optional without auto-alignment.
The measurement of tablet hardness can be switched from the “Constant
Technical data Speed” or “Constant Force” principle to match your existing hardness tester.
Measurement Constant Speed,
Principles Constant Force
The movement of the jaw speed and force as well as the sensitivity is also
adjustable.
Range 0.05 – 2.5 mm/sec
10 – 99 N/sec The program menu allows the user to define and store methods for various
Measurement Range products including predetermined product specifications. Hardness can
Hardness 5 – 500 (+/-1 N) be measured in any of Newton, Strong Cobb or Kilo pounds. Thickness,
Accuracy 500 – 1000 N (+/-2 N)
diameter and length can be reported in inches or millimeters. Tablet weights
Diameter/Length 0.00 – 30.00 mm
(0.00 – 1.2 in) can be read in milligrams or grams.
(Optional) 30.00 – 60.00 mm
(1.2 in – 2.4 in) Print-outs of the report and statistics can be sent to a label or standard
Accuracy +/-0.05 mm printer. It is also possible to connect the unit to a PC for reporting to Q-Doc
Power 230 V/50 Hz or Quality Documentation Software. Q-Doc can be connected to a LIMS and
110 V/60 Hz
can be networked.
Width/depth/height 290/290/250 mm
(11.6/11.6/10 in) SOTAX has also greatly improved the ease of calibrating. The adjustable
Weight Approx. 10 kg (22 lb) calibration date can be set to expire and can be printed out.
Optional accessories
Balance: Mettler, Sartorius or Precisa
Order information Digital caliper
Part # Description The Q-Doc Quality Documentation Software with a PC. Q-Doc permits
8700 SOTAX HT 1 storage of a large number of methods as well as test reports. Customized
8700-01 SOTAX HT 1 500 N reports are also possible. Q-Doc is a validated Windows 2000/XP/Vista
8700-02 SOTAX HT 1 1000 N software which fully complies with 21 CFR Part 11. Q-Doc is also available
8700-03 SOTAX HT 1 500 N with LIMS capabilities.
No Auto Alignment
8700-04 SOTAX HT 1 1000 N Validation and qualification
No Auto Alignment
8707 Set for manual The SOTAX Hardness Tester HT 1 meets all pharmacopoeia requirements.
weight calibration The appropriate qualification documentation (IQ/OQ) can be supplied with
(weights not included)
each system. Q-Doc software is delivered with IQ documents and a
9248 Label printer
support stand validation certificate. If required, system and software validation and
C100-0051 Label printer
qualification can also be carried out in the customer’s laboratory by SOTAX
Epson TM-220PD or by SOTAX qualified agents.
Z500-2602/11
SOTAX AG Binningerstrasse 106 CH-4123 Allschwil 1 Switzerland Phone +41 61 487 54 54 Fax +41 61 482 13 31