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Convincing Solutions for your drug testing

Company
SOTAX, founded in 1973, began as an engineering company to service
the pharmaceutical and other industries. Today SOTAX is a leader in the
development and manufacturing of test instruments and software for tablet
testing and is a leading solution provider for the pharmaceutical industry.
SOTAX is owned privately by the Benz family.
Worldwide, SOTAX has a staff of over 100 skilled and motivated employees.
Its headquarter is in Allschwil, near Basel, the center of the pharmaceutical
industry in Switzerland: manufacturing, engineering,
research and development, as well as administration, sales
and marketing departments are all located there together
with a demo and application laboratory as well as an
auditorium for conferences and seminars. SOTAX has sales
and service organizations in Asia, Canada, France, Germany, Great Britain,
Italy, Switzerland and the USA and is represented in other markets through
local distributors. The US organization is located in Horsham, Pennsylvania,
with administration, demo and application laboratory, maintenance center and
warehouse. SOTAX Corporation has a network of sales and service specialists
throughout Canada and the USA.
SOTAX has established an excellent international reputation as a specialist
in the development and production of sophisticated test equipment and
automated systems. We work with major pharmaceutical companies to
develop customized hardware/ software solutions for their products. Our
management focuses on very high quality standards in all operation levels
and is continuously improving the quality of its systems to meet GMP, GAMP
and ISO 9000-3 standards. In 1996 SOTAX received the ISO 9001 Certification.
SOTAX instruments meet all USP, EP, FDA and FIP guidelines and most SOTAX
products are in compliance with 21 CFR Part 11.
SOTAX also offers its know-how as a service to the pharmaceutical
industry, including installations, maintenance and repair services as well
as a comprehensive and careful validation service in compliance with FDA
regulations.

Products

Page 2, 3

SOTAX AT 7smart

SOTAX AT 7smart
UV on-line

Page 4, 5

SOTAX AT 7smart
HPLC on-line

SOTAX AT 7smart
off-line

Page 6, 7

SOTAX AT 7smart ASD

SOTAX OPT-DISS

Page 8, 9

SOTAX AT 70smart

SOTAX AT 70smart
with BS 60

Page 10, 11

SOTAX CE 7smart
UV on-line

SOTAX CE 7smart
off-line open system

Page 12, 13

SOTAX CE 7smart
off-line closed system

SOTAX MPS

Page 14, 15

SOTAX FS 7

WinSOTAX

Page 16, 17

SOTAX CTS

SOTAX CTS

Page 18, 19

SOTAX DT 2

SOTAX HT 1

Page 20, 21

SOTAX HT 10

SOTAX HT 100

Page 22, 23

SOTAX FT 300

SOTAX F 1/F 2

Page 24, 25

SOTAX TD 2

Q-Doc

The loyalty displayed by our regular customers in more than 40 countries


throughout the world encourages us to continue to deliver the highest quality.

SOTAX AT 7smart UV on-line

SOTAX AT 7smart

Compact and space-saving design


Complies with the latest USP/EP/FDA regulations
Seven stirrer stations with identical test
conditions for 6 test samples and 1 placebo or
blank solution
Easy method handling with front key pad
Off-line programming for fraction collection
built-in
Different sampling methods possible

Controlled by 21 CFR Part 11 compliant


WinSOTAX advanced dissolution software

Protocol printout of test parameters incl.


temperature, rpm, sampling times by any
printer

Sample on-line analyses for USP apparatus


1, 2, 5 & 6 with different UV-VIS photometer
types possible

Integrated vessel lids; i.e. no manual


removal or positioning of vessel lids

Shortest measuring intervals for determining


optimally the release profile

Elimination of routine validation due


to unique Autocompliance concept:
automated vessel centering and stirrer
positioning

Trouble-free use for longterm tests and tests


extending beyond normal working hours
pH can be changed automatically by buffer
addition during the dissolution test

Handy feeder device for test samples with


simultaneous and staggered tablet feeding

Measured values are available in graphical


and statistical form as soon as the test is
completed

RS-232-C interface utilize for PC


communication, automation or for printer
connection

Autocompliance minimizes routine physical


validation checks

Base modular concept permits


substantially customized automation
solutions with additional hardware and
WinSOTAX advanced dissolution software

SOTAX AT 7smart

Unique Hollow Shaft sampling


The system is easy to clean

SOTAX AT 7smart UV on-line

The workhorse for every dissolution laboratory designed with the


Autocompliance concept which eliminates daily routine validation.
The SOTAX AT 7smart can be used as a standalone unit or upgraded
to a semi-automated system

Custom-designed on-line automation system with integrated


photometric analysis, solvent addition and pH change offers
optimum flexibility to laboratories which have to meet the most
varied test requirements

SOTAX AT 7smart off-line

SOTAX AT 7smart HPLC on-line

A flexible system for collecting and


evaluating; samples are filtered first and
then collected in the fraction collector
Unique Hollow Shaft sampling
SOTAX piston pump for adsorption-free
sampling
Operated by WinSOTAX for different HPLC
types

Free selection of analytical method (HPLC or


photometer)

Unique Hollow Shaft sampling

Possibility to dilute samples or add reagents


before evaluation

SOTAX piston pump for adsorption-free


sampling

Possibility to use analytical equipment for


different purposes during time-consuming
dissolution tests (sustained-release products)

Transfer Station TS 70 for simultaneous


samples draw and storage in 5 rows of 7
closed flow-through cells (volume 9 ml)

SOTAX AT 7smart HPLC on-line

pH can be changed automatically by adding


a buffer concentrate during the dissolution test

Multifunction interface MF 70 for sample


handling via an 8/1 way valve into the HPLC
injection loop

Sample volumes removed can be replaced by


fresh solvent

Dilution option up to 1:20 with a choice of


3 different dilution media

Off-line sample collection into open and closed


HPLC vials

SOTAX AT 7smart off-line

Custom-designed HPLC on-line automation system


with sample storage, sample dilution and HPLC injection

Custom-designed off-line automation system with sample


collection, solvent addition and pH change offers optimum
flexibility to laboratories which have to meet the most varied
test requirements

SOTAX OPT-DISS

SOTAX AT 7smart ASD

X-Y-Z robotic system mounted on


SOTAX AT 7smart

Dilution of samples with one-step prefilling of HPLC vials

Lowest hydrodynamical perturbation in the


vessel on the market

8 or 12 UV Fiber Optic channels for USP 2


in-situ measurement

Built-in software for method programming


and reporting

Monitoring of speed and temperature

200 400 nm Range

No filtering, no tubing, no sampling

Automated tablet drop-in

0.25 to 10 mm pathlength for ARCH


probes, >10 mm with classical FO probes

High sensitivity CCD detector for real


simultaneous measurements

Second Generation of SOTAX Advanced


Dissolution Software

ARCH probes with a unique fully


transmitting design

Definition of sampling time points and volumes


Filtration of samples
Sampling into closed HPLC vials
Sample media replacement possible

Basket and paddle start procedures


Built-in syringe cleaning
Conforms to USP/EP/FDA

No possible bubble entrapment or excipient


build-up due to the patented ARCH probes
open architecture

Designed as an alternative for long tests


with few sample points or in case of
adsorption problems on teflon tubing or
very low dosage of active substances
(e.g. hormones)

Based on AT 7smart design and components


Fast scanning measurement ideal for flash
release forms (microspheres, sublingual forms)

Report includes vessel temperature and rpm

SOTAX AT 7smart ASD

Robotic sampling system for SOTAX AT 7smart


dissolution testers, a flexible liquid handling
system

SOTAX OPT-DISS

SOTAX OPT-DISS The only UV Fiber Optic system


designed for Dissolution
7

SOTAX AT 70smart with BS 60

SOTAX AT 70smart

Fully automated tablet dissolution system for


series of 1015 dissolution tests using the
USP 2 method

A very short and extremely thorough


cleaning cycle prevents carryover from test
to test

Fulfils all requirements of USP, EP, FDA, GAMP


and FDA 21 CFR Part 11 guidelines

Customized on- and/or off-line automation


concepts

Fully controlled by WinSOTAX advanced


dissolution software

Fully automated pellet testing using SOTAX


patented pellet device

Unique Hollow Shaft sampling system

Fully automated basket testing USP 1 in


combination with Basket Station BS 60

All functional steps (media preparation, supply,


test execution with sampling and filter changes,
cleaning) are carried out automatically
Very high sample throughput due to
simultaneous media dispensing for all test
vessel

SOTAX AT 70smart

The Basket Station BS 60 is attached to the


SOTAX AT 70smart and provides a flexible
and fully automated dissolution system for
USP 1 and 2 methods
Fulfils all requirements of USP, FIP, GAMP
and FDA 21 CFR Part 11 guidelines
Fully controlled by WinSOTAX advanced
dissolution software
Up to 10 dissolution tests for USP 1 methods

Media change procedures allow additions


or replacement of media or a full change of
media

Up to 15 dissolution tests for USP 2 methods

Media replacement after off-line sampling

Simultaneous attaching and removing of


test baskets

System uses conventional disposable syringe


filters

Used baskets slide into a collection container


filled with cleaning water

Testing of a variety of dosage forms such as


capsules, pellets and granulates is possible
with sinkers and pellet device

A very short and extremely thorough


cleaning cycle prevents carryover from test
to test

Complete validation and qualification


documentation

Automatic lifting of the stirring unit of the


AT 70smart when changing baskets

High sample throughput combined with a


very efficient cleaning system and easy to
validate

SOTAX AT 70smart with BS 60

Maximum in flexibility and sample


throughput combined with a very efficient
cleaning system and easy to validate
9

SOTAX CE 7smart
off-line open system

SOTAX CE 7smart UV on-line

Cell block with 7 flow-through cells for 6 test


samples and 1 placebo, capsule shell or blank
solution
Five different cell types for tablets and
capsules, powders and granulates, implants
and suppositories
Simple medium change for changing pH
during the test
Automatic test preparation functions

Fulfils all requirements of USP, FIP, GAMP


and FDA 21 CFR Part 11 guidelines

A flexible system for collecting and evaluating;


samples are filtered first and then collected in the
fraction collector

Fully controlled by WinSOTAX advanced


dissolution software

Fulfils all requirements of USP, EP, GAMP and FDA


21 CFR Part 11 guidelines

SOTAX CP 7-35 ceramic piston pump for


accurate and adsorption-free sampling
Direct sample analysis during the dissolution
test with different brands of UV-VIS
photometers

Fully controlled by WinSOTAX advanced dissolution


software

Variable sample collection points and sample


volumes
Possibility to dilute samples or add reagents
before evaluation which can be carried out
either photometrically or using an HPLC
system
Test preparation, test running and cleaning
functions are fully integrated into the
dissolution system

Short measuring intervals and individual


evaluation for optimal determination of the
release profile

SOTAX CE 7smart
UV on-line

SOTAX CP 7-35 ceramic piston pump for


accurate and adsorption-free sampling

Trouble-free use for long-term tests

Eluates collected directly into the sample


tubes of the SOTAX C 615 fraction collector

Automated cleaning function at test end

Automated cleaning functions at test end

SOTAX CE 7smart
off-line open system

Custom-designed on-line dissolution system for dissolution tests


according to the Flow-Through Method (USP 4) with integrated
online analysis for all dosage forms with easy media and pH changes
for accurate in-vivo simulation

10

Custom-designed off-line dissolution system for dissolution


tests according to the Flow-Through Method (USP 4) with sample
collection for all dosage forms with easy media and/or pH changes
for simple in-vivo simulation

11

SOTAX CE 7smart
off-line closed system

Rapid sampling capability

SOTAX MPS

Test preparation, test running and cleaning


functions are fully integrated into the
dissolution system

Designed for Low Dosage forms, e.g.


Drug Eluting Stents requirements

Efficient preparation of dissolution media


with a mobile space-saving unit

Small volume Dissolution and Elution


testing down to 5 ml

Mobile system, easy to clean, observe and


validate

Double offline system, Peltier effect and


media replacement (options)

Off-line sampling in HPLC vials accurately


down to 100 l on 29 rows

Exact preheating of the media to test


temperature and reliable degassing
Continuous checks of selected temperature

Neadle flushing feature to prevent carryover

Fast and accurate volumetric filling of test


vessels at 2000 ml/min. with an accuracy
better than 1%

Driven by CE 7smart firmware with


password protection and report printing
function

Use of concentrates with on-line preparation


or by sequential addition

Follows USP, EP, GAMP, FDA guidelines

Option of gravimetric self-calibration with


built-in balance and automatic report
generation

SOTAX CP 7-35 ceramic piston pump for


accurate and adsorption-free sampling

SOTAX CE 7smart
off-line closed system

SOTAX MPS

SOTAX CE 7smart Custom-designed small volumes


closed system for dissolution tests according to the
Flow-Through Method (USP 4) with sample collection
in HPLC vials

12

Increased productivity with automated media preparation

13

WinSOTAX

SOTAX FS 7

Solves filter clogging or saturation


problems associated with 25 mm diameter
filters

Stand-Alone design with manual control


allows use with other manufacturers
dissolution baths with piston style pumps

Validated Windows 2000/XP/Vista advanced


dissolution software with a high level of data
security

For use with on-line UV/VIS, off-line


sample collection or on-/off-line semiautomated SOTAX dissolution systems; no
retrofit needed

Uses common brand 25 mm luer-lock


filters including Pall/ Gelman,
Millipore and Schleicher & Schuell
down to 0.45 micron pore size

Wide range of functionalities which fully


complies with FDA 21 CFR Part 11 regulations

Calibrate standard tool for determining


standards

Convenient handling as users see only menus


and dialogs which conform to their hardware
configuration and user rights

Log file for all parameter with real time


protocol

Easy load with storage of up to 140


filters at a time and collection tray for
dispensed used filters
Controllable by 21 CFR Part 11 compliant
WinSOTAX advanced dissolution software
Useful for filter validations and method
transfers to full automation

Module for batch processing with a


SOTAX AT 70smart for multiple analysis

Automates filter changes after each


sampling point for extended testing and
media change methods

SOTAX FS 7

On-line modules for UV/VIS spectrophotometric


measurements with the most common
spectrophotometers and calculation of
concentration and % dissolved including
statistical functions

Cell grouping function multiple tests and virtual


dilution

The SOTAX FS 7 Filter Station for reliable


automated filter changes after sampling in semiautomated dissolution systems
14

WinSOTAX

Interface for pH measurements and


protocolling
On-line standard monitoring

Protocol of rpm, temperature, pH including


statistical functions min./max., mean and
standard deviation
Excipient (placebo) or impurity subtraction
Context based on-line help system
Test execution Windows with real time
display of tabular data or graphics and status
monitors for devices
Single and multi-component analysis

The most advanced dissolution software with an easyto-handle, menu-driven architecture controls all SOTAX
peripheral system components in a single software
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SOTAX CTS

SOTAX CTS

Simultaneous sample processing, up to


three times faster than comparable systems
available in the market

Efficient cleaning systems to eliminate


carry-over, using a minimum amount of
solvent

Up to 240 samples in 16 x 160 mm tubes


or up to 80 samples in 32 x 115 mm tubes

Off-line sampling for sample archival with


optional cooling option

Sample volumes from 25 to 1000 ml of


solvent

Compatible with all the most common


UV/VIS spectrophotometers on the market

Up to eight solvents available

Flexible concept to allow customized


solutions

Superior handling of tablets, capsules,


effervescent tablets, powder, pellets and
liquids

Inject sample in up to two HPLC systems


on-line

Sample weights and dilutions are


gravimetrically confirmed and recorded
over a 4-place balance. Dilution ratio up
to 1:~(infinity)

Complete control via 21 CFR Part 11


compliant software with LIMS access for
paperless reporting

Brushless homogenizer motor for


maintenance-free use

Optional barcode reader with the possibility


to test weight variation

Homogenizer tool without bearing in


contact with solvent

Optional waste management with level


control

SOTAX CTS

SOTAX CTS

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The fastest and most reliable system for automated


Content Uniformity, Blend Uniformity and Composite
Assay testing on the market
17

SOTAX DT 2

SOTAX HT 1

Disintegration time testing unit with two basketrack assemblies


Each basket-rack assembly can be controlled,
started and stopped individually for individual
disintegration time tests

Electronic temperature sensor for display


and documentation of temperature in each
beaker

Testing of five essential physical parameters:


hardness, thickness, width, diameter or length and
weight of a tablet

The results (Newton, Strong Cobb or


Kilopond; mm or inch; mg or g) are shown
on the graphic display or may be printed

Operating conditions programmable on


front key pad with graphic display

Balance can be connected if tablet weight required

Operating conditions are programmable


via front key pad with graphic display

Automatically lowers the baskets at test start


and raises the baskets at test end

Report printout with test results, statistics


and temperature protocol

Acoustic signal on completion of test run time

Connection to PC with RS-232-C and to


printer with parallel interface
Automated detection of disintegration end
point based on contact of the USP fluted
disk with USP stainless steel mesh

HT 1 is equipped with the Auto Alignment


device (patented), to align automatically all
common forms of tablets rapidly before testing
The hardness can be measured either with the
Constant Speed or with the Constant Force
measurement principle

The most efficient way of disintegration testing

Validated Windows 2000/XP Q-Doc quality


documentation software which fully complies
with 21 CFR Part 11

SOTAX HT 1

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The program menu allows the user to set


specification for the tablets as T1/T2/T3.
Printout of results and statistical data are
possible with a standard or a label printer
Simple calibration of the Hardness Tester

Validated Windows 2000/XP Q-Doc quality


documentation software which fully
complies with 21 CFR Part 11

SOTAX DT 2

Connection to PC with RS-232-C interface


and to printer with parallel interface

The hardness tester with the revolutionary


patented Auto Alignment device rapidly aligns
all common forms of tablets before testing
19

SOTAX HT 10

SOTAX HT 100

Automated testing of the three essential


physical parameters (thickness, diameter/length,
and hardness) of up to 20 tablets
Balance can be connected if tablet weight required
The 20-chamber feeder automatically moves samples
to the testing stations for accurate measurements
Equipped with the Auto Alignment device
(patented), even the most difficult of tablet shapes
are automatically aligned correctly to prevent
erroneous hardness measurements
Unique self-cleaning brushes eliminate problems
associated with tablet debris and dust

Two hardness measurements principles


Constant Speed or Constant Force with
a measuring range of up to 1000 N can be
applied to match existing hardness testers
in the market
With the integrated balance option, tablet
weights can be reported
Programmable operating conditions can be
entered via the front key pad with graphical
display
Simplified calibration method with
intelligent reporting

Automated testing of the most important


physical parameters (weight, thickness, diameter
or length and hardness) of up to 10 different
products or batches, e.g. tablets, drages,
oblongs, effervescent tablets or similar drug
delivery systems
Separates all shapes and sizes of tablets with
ease, using the vibration-free Auto Separator, no
manual adjustments required
Equipped with the Auto Alignment device
(patented) which automatically aligns even
the most difficult of tablet shapes, to prevent
erroneous hardness measurements

Connection to PC with RS-232-C interface


and to printer with parallel interface
Optional control via 21 CFR Part 11
compliant Q-Doc quality documentation
software with LIMS for paperless reporting

SOTAX HT 10

20

Unique tablet weighing station eliminates


problems associated with tablet debris and
dust
Two hardness measurement principles
Constant Speed or Constant Force,
measuring range up to 1000 Newton
Simplified calibration method
Controlled by our 21 CFR Part 11 compliant
and LIMS capable Q-Doc quality
documentation software for Windows
2000/XP
Optionally available with fully functional
built-in computer

SOTAX HT 100

The SOTAX HT 10 automated tablet testing system for


fast, accurate and trouble-free measurements of all tablet
shapes and sizes

HT 100 has ten chambers with a capacity


of 115 ml each (equivalent 200 medium-sized
tablets) for the automated handling of up
to 10 different products or batches

The fastest automated tablet testing system with the


revolutionary Auto Alignment and Auto Separator device
ensures consistent, trouble-free results for all shapes and
sizes of tablets batch after batch

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SOTAX FT 300

and

SOTAX F 1 / F 2

Performs a variety of test conditions


including mixing and vibration settings
Produces precise and reproducible results
on the flowability characteristics of
powders and granulates

The microprocessor-controlled SOTAX F 1


and F 2 meet USP, EUR, DAB pharmacopeial
requirements

Standardize test conditions to ensure


optimum correlation of processing
conditions

Counter and timer modes of operation

Uses Mettler precision balance

Unique loading system resets automatically


for new samples

Operator-independent results, eliminating


human error

In-situ filling of samples into the drum

Selectable test methods

Post-run samples are automatically


discharged without removing the drum

Compact, robust construction and simple


to use

As per USP, it comes with 10 tilt built into


the base of the instrument

Controlled by our 21 CFR Part 11 compliant


Q-Doc quality documentation software for
Windows 2000/XP

SOTAX FT 300

The SOTAX FT 300 to determine the


flowability characteristics of powders and
granulates during processing conditions

Built-in LCD display


Supports abrasion drum

SOTAX F 1 / F 2

22

The Friability Testers built with unique


front loading and automatic discharge system
23

Q-Doc

SOTAX TD 2

Designed for Microsoft Windows 2000/XP

Complies with USP, EP and ASTM


specifications
Supports both USP 1 and USP 2 test methods
Testing of powders, granulates, pellets,
flakes and other bulk substances
Two cylinder holders with easy snaplock
mechanism for 100 ml and 250 ml cylinders
Simultaneous rotating and tapping motion
assures an evenly packed surface
24 x 2 alphanumeric LCD display
User-friendly operation with menus, helpline
and current status indicators
Calculation of test results like tapped density,
compressibility index and Hausner ratio
Printer port for documenting test results as
per GMP/GLP standards

SOTAX TD 2

A very compact microcontroller-based


Tap Density Tester for simple measuring of
the tapped density

User-friendly, users see menus and


dialogs for their hardware respective of device
configuration and user rights
LIM System:
- Data acquisition from different instruments
- Calculate data for preset product
specifications
- Decision for product specifications
- Simple pass / fail of batch
- Archive
- Reports of each specification and batch
Network environments, e.g.:
- Single system with one or more devices
- Two PCs each connected with one or more
devices
- Server solutions can be tailored to your
specific requirements

Q-Doc

24

Graphic view of devices with real time


status
Data from different devices can be
collected simultaneously
Data export to Excel
Delayed start function
Automated decision in principle, using
electronic signature for confirmation
Different search functions allow the
status of every batch in everyproduct to
be seen
Help system for administrators and users
Context-based online help system
Currently available in English or German
language

The SOTAX Q-Doc Quality Management Software for


automated control, reporting and data management
for the in-process control measurements of tablets
25

SOTAX services at a glance

Installation
SOTAX includes the system installation and training in its offers. The customer
has the guarantee that the instrument functions to specification and that the
users are properly trained. SOTAX specialists install the systems including the
control device and software in the SOTAX test laboratory prior to shipping to
ensure correct functionality to individual specification. Upon delivery to the
customers laboratory the system is installed and again tested to specification
prior to train its users. If the customer wishes, the required operational and / or
performance validation work can be performed by the SOTAX specialist.

SOTAX, as a customer-oriented company, offers comprehensive aftersales service


covering installation, maintenance, validation and repair. An extensive network
of service engineers represents SOTAX in a variety of countries in Europe and the
rest of the world. In addition to installation, maintenance and
repair SOTAX also offers both operational and performance
validation services (OQ and PQ) as many companies outsource
these functions nowadays. Thoroughly trained SOTAX specialists
qualify the units according to the cGMP and GAMP guidelines.
Buying a SOTAX instrument ensures complete care during its lifetime and gives the
security that it is working to specification and meeting all validation requirements.

Repair
If a SOTAX instrument becomes defective, our service technician can repair it
on site or in the repair center. SOTAX also offers maintenance and repair
contracts to ensure maximum operational efficiency. Guaranteed reaction times
keep fault-related interruption in use to an absolute minimum.

Validation
SOTAX offers a validation and calibration service in accordance with the USP, FIP
and GMP guidelines. Some services are not only available for SOTAX products but
also for others. This includes Design Qualification (DQ), Installation Qualification (IQ),
Operational Qualification (OQ), FDA Mechanical Qualification (MQ), each with the
corresponding validation documents. In addition the required system suitability test
or performance qualification (PQ) using USP calibration tablets can be performed
by our specialists. SOTAX actively participates in the USP multi-centre studies to
determine the limits for these single lots. SOTAX validation specialists frequently
perform these PQ tests and are therefore experienced in their execution. Moreover,
SOTAX bears the costs for repeating any PQ test that initially fails and therefore
gives a supplementary qualification guarantee to the customer. These services are
utilised by a wide variety of companies worldwide.

Validation contracts for manual and automatic systems


Six-month OQ and PQ of the instrument on site.
Full service
All maintenance, repair and validation activities can be covered by a
comprehensive service contract to secure operational readiness.
Full service contract
Guaranteed 72-hour reaction time with all services for restoring operational
readiness in the event of a fault, yearly maintenance of the
instrument on site and six-month OQ and PQ, incl. spare parts
and travel expenses.

Maintenance
Though SOTAX test instruments are highly reliable and generally trouble-free,
regular preventative maintenance visits made by specialists are recommended.
The FDA requires routine maintenance procedures for the test instruments for the
development and quality control of the medicaments. If this is not sufficiently
performed by laboratories, it can lead to non-conformance during an audit.
SOTAX offers various maintenance solutions. Maintenance can be performed once
or twice a year and can be written into a maintenance contract. The maintenance
works are performed, recorded and accepted by that companys responsible
person and the laboratory is provided with all the necessary documentation in case
of an inspection.

Technical Hotline
Phone +41 61 487 5460
E-mail services@sotax.com
Info and news
www.sotax.com

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27

Corporate Mission

Contacts

Who we are and what we want


SOTAX leads the way in the development and manufacture of high-quality
pharmaceutical testing equipment and associated services.
Our equipment is used worldwide in the development and production processes
of our customers the pharmaceutical and science industries. SOTAX develops,
produces and markets system solutions for pharmaceutical testing and does so in
close cooperation with pharmaceutical and scientific partners.
Our extensive market and process know-how enables us to meet our customers
requirements and comply with the key directives relevant to them. We are also
open to cooperation with new industries.
SOTAX is a leading independent company for pharmaceutical testing equipment.
The company owes its independence to its sustained economic success.
The SOTAX Group is a global success story and has subsidiaries around the world
who are familiar with local needs and practices.
We maintain our competitive edge by excelling in flexibility, performance, quality
and safety.

Asia

Germany

SOTAX (Shanghai) Trading


Company Ltd.
800 Nanjing Road East
Room G, 15/F, No. 1 Plaza
CN-200001 Shanghai

SOTAX GmbH
Wallbrunnstrasse 24
DE-79539 Lrrach

Phone
Fax
E-mail

+86 21 6352 1008


+86 21 6352 2213
sotaxchina@sotax.com

Phone
Fax
E-mail

+49 7621 16 5635


+49 7621 16 5715
info@sotax.com

Great Britain
Austria and Switzerland
SOTAX AG
Binningerstrasse 106
CH-4123 Allschwil 1
Phone
Fax
E-mail

Our customers
The customer is in the centre of our activities. His satisfaction is our goal and
quality standard.
We set great store by efficiency and professionalism in meeting customer
requirements. We also work with customers to turn visions for our business
operations and future development into reality.

+41 61 487 5454


+41 61 482 1331
info@sotax.com

SOTAX (Canada) Ltd.


1-335 Deerhurst Drive
CA-Brampton, ON L6T 5K3
Phone
Toll Free
Fax
Toll Free
E-mail

Phone
Fax
E-mail

+44 20 8349 6947


+44 20 8349 6948
info@sotax.com

Italy

Canada

Our employees
SOTAX values skilled, highly capable and enterprising staff who work for the
greater good of the company, combining a sense of individual responsibility with
team spirit. We also encourage creativity and personal skills through ongoing
training.
Our employees cultivate a positive corporate culture through a friendly, open
approach to both their fellow workers and our partners.

SOTAX Limited
13 Station Road
GB-London N3 2SB

+1 905 494 0114


+1 866 826 4448
+1 905 494 0723
+1 866 767 6077
sotaxcanada@sotax.com

SOTAX S.r.l.
Via Milazzo 14
IT-24124 Bergamo
Phone
Fax
E-mail

+39 035 21 9555


+39 035 21 3643
sotaxitalia@sotax.com

USA

Our suppliers
SOTAX sees its relationship with its suppliers as a partnership. Suppliers
are expected to contribute to our joint success through their efficiency and
professionalism.

France
SOTAX Srl.
24, avenue de Ble
FR-68300 Saint-Louis

Our environment
We have a keen sense of our economic and social responsibility, and our
actions, products and services make a significant contribution to protecting our
environment.

+33 3 8970 0846


+33 3 8970 1781
info@sotax.com

Phone
Toll Free
Fax
E-mail

+1 215 442 1500


+1 888 302 9925
+1 215 442 1514
sotaxusa@sotax.com

Z500-0302/08

Phone
Fax
E-mail

SOTAX Corporation
411 Caredean Drive
Suite A
US-Horsham, PA 19044-1316

28

29

Europe
SOTAX AG
Binningerstrasse 106
CH-4123 Allschwil 1
Phone +41 61 487 5454
Fax
+41 61 482 1331
E-mail info@sotax.com
America
SOTAX Corporation
411 Caredean Drive
Suite A
US-Horsham, PA 19044-1316
Phone +1 215 442 1500
Fax
+1 215 442 1514
E-mail sotaxusa@sotax.com
Asia
SOTAX (Shanghai) Trading
Company Ltd.
800 Nanjing Road East
Room G, 15/F, No. 1 Plaza
CN-200001 Shanghai
Phone +86 21 6352 1008
Fax
+86 21 6352 2213
E-mail sotaxchina@sotax.com

Technical Hotline
Phone +41 61 487 5460
E-mail services@sotax.com
Info and news
www.sotax.com

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