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SOTAX Product Catalogue 2010 PDF
SOTAX Product Catalogue 2010 PDF
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 140 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 Canada, China, France,
Germany, Great Britain, Italy, Switzerland and the USA and is represented in other
markets through local distributors. The US organization is located in Hopkinton,
Massachusetts, 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 also offers SPS Pharma Services (CRO), contract research lab dedicated to
dissolution testing research, method development and advanced training. In 2008,
SOTAX integrated the Zymark® automation product line, resources and services. With
the addition of the Hopkinton facility in Massachusetts, customers benefit from
SOTAX’s increase US and global presence and network of direct sales and services.
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.
The loyalty displayed by our regular customers in more than 40 countries throughout the
world encourages us to continue to deliver the highest quality.
Products
Dissolution Testing
Physical Testing
1
SOTAX AT 7smart
2
SOTAX AT 7smart UV On-line
4
SOTAX AT 7smart Off-line
6
SOTAX AT 7smart OPT-DISS™
7
SOTAX AT 70smart
11
SOTAX FS 7
www.sotax.com
16
Advanced
WinSOTAX plus Dissolution Software
17
Zymark ® APW3
SOTAX CTS
20
SOTAX CTS
22
SOTAX HT 1
Manual Tablet Testing System
27
SOTAX TD 1 - Tap Density Tester
Installation
SOTAX includes system installation and training with all new purchases. We guarantee you
that the instrument functions to specification and that its 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 specification. Upon delivery to
the customer’s 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 qualification
work can be performed by the SOTAX specialist.
Maintenance
Though SOTAX test instruments are highly reliable and generally trouble-free, regular
anticipated 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 work performed is recorded and accepted by that company’s responsible person
and the laboratory is provided with all the necessary documentation in case of an inspection
Qualification
SOTAX offers a calibration and qualification service in accordance with the USP, EP, FDA
and GMP guidelines. This includes Design Qualification (DQ), Installation Qualification (IQ),
Operational Qualification (OQ), Mechanical Qualification (MQ), each with the corresponding
validation documents. In addition the required system suitability test or performance
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qualification (PQ) using USP PVT tablets can be performed by our specialists. SOTAX
actively participates in the USP multi-centre studies to determine the limits for these PVT
lots and participates in the FDA collaborative studies. SOTAX qualification specialists
continuously perform these PQ tests and are therefore the most 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. SOTAX
also performs MQ testing to the latest ASTM standards and service technicians are
regularly trained to the latest MQ practices. These services are utilized by a wide variety
of companies worldwide.
Repair
If a SOTAX instrument becomes defective, our service technician can repair it on site
or in the SOTAX 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.
Contracts
Full service, all maintenance, repair and qualification 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. Contact us at [email protected] to get your
own contract.
Technical Hotline
Europe / Asia
Phone +41 61 487 5460
E-mail [email protected]
America
Toll Free +1 888 SOTAXUS
E-mail [email protected]
31
Corporate Mission
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.
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.
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.
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.
Z500-0302/10
32
Contacts
Asia Germany
SOTAX (Shanghai) Trading SOTAX GmbH
Company Ltd. Wallbrunnstrasse 24
800 Nanjing Road East DE-79539 Lörrach
Room G, 15/F, No. 1 Plaza Phone +49 7621 16 5635
CN-200001 Shanghai Fax +49 7621 16 5715
Phone +86 21 6352 1008 E-mail [email protected]
Fax +86 21 6352 2213
E-mail [email protected]
Canada
SOTAX (Canada) Ltd.
1-335 Deerhurst Drive Italy
CA-Brampton, ON L6T 5K3 SOTAX S.r.l.
Phone +1 905 494 0114 Via Milazzo 14
Toll Free +1 866 826 4448 IT-24124 Bergamo
Fax +1 905 494 0723 Phone +39 035 21 9555
Toll Free +1 866 767 6077 Fax +39 035 21 3643
E-mail [email protected] E-mail [email protected]
France
SOTAX Sàrl.
USA
24, avenue de Bâle
FR-68300 Saint-Louis SOTAX Corporation
68A Elm Street
Phone +33 3 8970 0846
Hopkinton, MA, USA
Fax +33 3 8970 1781
01748-1668
E-mail [email protected]
Phone +1 508 417 1112
Toll Free +1 888 SOTAXUS
Tech Support Hotline +1 508 544 4040
France Fax +1 508 435 4691
SPS Pharma Services E-mail [email protected]
Bâtiment CBRV, 28 Place Henri Dunant
FR-63000 Clermont-Ferrand SOTAX Horsham
Phone +33 4 73 17 83 98 411 Caredean Drive
Fax +33 4 73 17 83 99 Suite A
E-mail [email protected] Horsham, PA 19044-1316
Z500-0302/10
33
Technical Hotline
Europe / Asia
Phone +41 61 487 5460
E-mail [email protected]
America
Toll Free +1 888 SOTAXUS
E-mail [email protected]
www.sotax.com