Through the publication of press releases, we keep our customers, partners and trade press informed on all important topics. Here we bring together news and information about our company as well as our products and services in one convenient place.
The partnership encompasses marketing and sales of a new dissolution system solution based on the METTLER TOLEDO UV7 Excellence spectrophotometer integrated with the SOTAX Xtend™ Dissolution Line.
Thanks to the system's modularity, the joint solution is very flexible and is designed to meet customer needs ranging from manual operations to fully automated processes. The various Xtend modules, with the UV7, CuvetteChanger and automatic optical performance verification CertiRef™ allow for seamless UV/VIS measurement integration. Automatic sampling and analyses at predefined intervals can be achieved in real time without operator intervention.
The UV7 Excellence spectrophotometer FastTrack™ array technology provides instant measurement readiness, rapid delivery of results and maximized compactness to optimize precious bench space. A selection of easily connected automation accessories completes the modular design of the instrument. Most notably, the CertiRef module, which renders the UV7 spectrophotometer fully compliant with US and European Pharmacopeia regulations, allows the required optical performance tests to be integrated into the analytical workflow, automatically executed and traceably documented. For maximal automation requirements, the CuvetteChanger offers efficient sample handling for up to eight cuvette positions. METTLER TOLEDO and SOTAX offer robust and modular dissolution systems with seamlessly integrated UV/VIS spectrophotometers. Together, they keep pharmaceutical dissolution testing processes in R&D and QC laboratories efficient and keep pace with regulatory requirements.
Find out more on www.mt.com/uvvis-dissolution-test or contact your local sales representative for more information.
Agreement gives SOTAX distribution rights to Waters ACQUITY UPLC H-Class System within Small Molecule Pharmaceutical Accounts.
SOTAX Group announced today that it has entered into an agreement with Waters Corporation. Under the terms of the agreement, Waters will make available to SOTAX its ACQUITY UPLC® H-Class System for sale to drug manufacturers performing small-molecule, solid-dosage analysis in Quality Control and Analytical R&D.
The Waters systems will be offered in both stand-alone configurations and directly connected to SOTAX dissolution and automated sample preparation instruments for on-line analysis.
"Working closely with Waters will allow us to generate significant value for our mutual customers in the current, data integrity driven environment. We are excited to have been selected by Waters to collaborate in the dissolution testing and sample preparation space", said Patrick Ballmer, Vice President at SOTAX Group.
Under the terms of the agreement, Waters licenses SOTAX as an independent distributor for the Waters ACQUITY UPLC H-Class System. SOTAX will market, sell and distribute the ACQUITY UPLC H-Class System through its own direct sales force to pharmaceutical laboratories in the following countries: United States, Canada, United Kingdom, France, Germany, Italy, Switzerland and the Czech Republic.
"Improved sample preparation to keep pace with the speed of our ACQUITY UPLC instrumentation platform has often been requested by our customers," said Mike Harrington, Ph.D., Senior Vice President – Global Markets. "This exciting new collaboration links Waters and SOTAX technologies enabling our mutual customers to streamline their analysis, characterization and preparation of pharmaceutical samples, and improve their productivity and profitability."
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SOTAX has launched the C+, an automated centrifuge module for clarification of samples during fully automated sample preparations.
SOTAX has launched the C+, an automated centrifuge module for clarification of samples during fully automated sample preparations. The SOTAX TPW and APW Automated Work Stations already include robust sample filtration capabilities.
However, several sample prep methods require centrifugation as primary mode for sample clarification such as:
Lotions, Pastes, Ointments
Polymer-heavy tablet formulations
Food Science Applications
Suspensions (Pharma, Food, Manufacturing Industries)
Bob Houser, Product Manager for Fully Automated Sample Preparation on the new module: "The SOTAX C+, Centrifuge Addition (C+) provides enhanced sample clarification capabilities. We’ve seen many cases where the addition of this step will help to solve the challenge of samples that REQUIRE centrifugation or centrifugation followed by filtration".
SOTAX has chosen the Hettich Rotina 380 Robotic Centrifuge for connection to its fully automated sample prep systems. The Hettich benchtop centrifuge is available in cooled and non-cooled configurations. It is also available as a standalone system or connected to the fully automated unit. Combined with the C+, it will elegantly handle the entire centrifuge process including robotic transfer of tubes to and from TPW / APW, automated speed, time and temperature control, and automated tube "balancing" for uneven sample numbers / weight. The C+ can be ordered with all new TPW / APW systems and is and upgradable addition to existing units.
Further information on Automated Sample Preparation: www.sotax.com/asp
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SOTAX Group’s corporate headquarters in Switzerland have moved to a brand new facility to meet the increasing demand for SOTAX products and services and to allow for process improvements and optimization.
SOTAX Group’s corporate headquarters in Switzerland have moved to a brand new facility. The new premises are another milestone in the company’s 40+ year history. The site has been constructed in Aesch just outside Basel, Switzerland. In order to maintain the company’s close relationship with the pharmaceutical industry, SOTAX stands by its commitment to the Basel region, one of Europe’s largest pharma hubs.
The facility has been built to meet the increasing demand for SOTAX products and services and to allow for process improvements and optimization. “With the construction of the new corporate headquarters in Aesch, the company adds a key pillar in the SOTAX Group’s long-term growth strategy. The new site will benefit not only us, but also our clients, partners and suppliers,” says Rolf Benz, President and CEO of the SOTAX Group, “our colleagues will enjoy a modern and attractive working environment that motivates, promotes innovation, and enables us to provide the familiar SOTAX technical perfection, satisfying the most stringent quality demands”.
Constructed in accordance with the latest environmental and energy-efficiency standards, the new headquarters house various corporate functional groups as well as a state-of-the-art production facility. Modern meeting and training facilities as well as demo labs complete the newly built site.
To mark this milestone, the company has now celebrated the inauguration with more than 250 invited guests including clients, partners and suppliers.
The new address of the SOTAX Corporate Headquarters in Switzerland is:
4147 Aesch (BL)
The previous site at Binningerstrasse 106 in 4123 Allschwil, Switzerland has been closed; the address is no longer available.
The FT 2 Tablet Friability Tester is now available in the well-known Dr. Schleuniger® Pharmatron design. Robust, user-friendly operation and GMP/GLP-compliant reporting remain as key features of the FT 2.
The FT 2 Tablet Friability Tester, formally branded as SOTAX, is now re-branded under the Dr. Schleuniger® Pharmatron product line. The well-established FT 2 Tablet Friability Tester is now available in the well-known Dr. Schleuniger® Pharmatron design. Robust, user-friendly operation and GMP/GLP-compliant reporting remain as key features of the FT 2.
The FT 2 uses a maintenance-free drive with programmable rotational speed (20 - 50 rpm) and ensures gentle starting and stopping of the drum. The anti-static drums are designed to fully engage with the drive to prevent any slippage.
At test start, the drum is automatically positioned for tablet loading. An opening in the anti-static drum allows tablets to be conveniently inserted without having to remove the drum. At the end of the test, the tablets are automatically discharged into a tray.
Weight readings before and after each test run can be either entered manually or collected automatically from a connected analytical balance. Printed reports include test parameters, time and date, and serial number of the instrument along with entry fields for user name and product details.
q-doc prolab® PC software complements the system allowing users to collect and manage data from all SOTAX and Dr. Schleuniger® Pharmatron physical testing instruments – from tablet hardness testers to disintegration, tap density and flowability testers. In addition, other equipment such as analytical balances, thickness gauges, and halogen moisture analyzers can all be connected.
In a networked environment, batches only need to be registered once in order to collect measurement data from different instruments. Measurement reports and batch reports can be electronically judged and released directly in q-doc if desired – and import/export functionalities for LIMS are readily available.
The fully modular and scalable Xtend™ concept allows lab scientists to tailor dissolution testing to both their current and future needs – making their investment future-proof
The SOTAX Group, a global leader in the development and manufacturing of dissolution testing, automated sample preparation and physical testing equipment for the pharmaceutical industry, is launching the brand new Xtend™ Dissolution Line.
The ability to flexibly respond to permanent change in today’s fast-paced pharmaceutical environment can make the difference between success and failure. Fast time-to-market requirements, outsourcing, relocations, shift of manufacturing capacities and short return on investment considerations ask for equally flexible testing solutions in R&D and quality control laboratories. The fully modular and scalable Xtend™ concept is 100% based on this basic premise and allows lab scientists to tailor dissolution testing to both their current and future needs – making their investment future-proof.
This new concept consists of new individual and standardized Xtend™ modules such as the AT dissolution bath, the CP pump, the FS filter station and the SAM sample manager which can be flexibly combined for different automation requirements – from manual bath to semi- and fully automated dissolution system. Irrespective of the chosen configuration, all modules and components of the Xtend™ Dissolution Line are extremely robust as they are designed for the most demanding conditions of a fully automated system running 24 hours per day.
The Xtend™ Dissolution Line also simplifies method transfer – making scale-up from R&D to QC with different throughput requirements and changing workloads easier than ever. From qualification to writing SOP’s, lab scientists can keep in place what is already used, described, and validated.
Lab scientists’ investments are secure as they can flexibly manage tomorrow’s demands. With a proven track record of thousands of systems installed world-wide and more than 40 years of experience in dissolution testing, the Xtend™ Dissolution Line is a safe investment. All system modules incorporate the very latest technology for maximum efficiency and provide for highly reliable dissolution testing based on precision-made high quality components.
Whether used as a manual apparatus or as the core component in an automated dissolution system – the AT has been designed for the most demanding environments
The SOTAX Group, a global leader in the development and manufacturing of dissolution testing, automated sample preparation and physical testing equipment for the pharmaceutical industry, is launching the new AT dissolution apparatus as part of its Xtend™ Dissolution Line.
This new concept consists of new individual and standardized Xtend™ modules such as the AT dissolution bath, the CP pump, the FS filter station and the SAM sample manager which (depending on the required automation level) can be flexibly combined for different automation requirements – from a manual bath to semi- and fully automated dissolution system. Irrespective of the chosen configuration, all modules and components of the Xtend™ Dissolution Line are extremely robust as they are designed for the most demanding conditions of a fully automated system running 24 hours per day.
The new AT dissolution bath is the heart of the Xtend™ Dissolution Line. Whether used as a manual apparatus or as the core component in an automated dissolution system – the AT has been designed for the most demanding environments. Built on the success of preceding SOTAX dissolution systems, the AT can be flexibly configured for USP 1,2,5,6 dissolution methods. Its unique design combines robust quality components with state-of-the-art technology to guarantee reproducible testing conditions, day after day.
The AT dissolution bath with 6-8 vessels sets new standards for quick and easy operation. At the same time, it opens up a new dimension of observation possibilities for R&D visualization and OOS troubleshooting with the new and unique CenterView™ design: this technology provides perfect visualization and video recording of release processes in each dissolution vessel. Located in the center of the dissolution bath, all video cameras can be adjusted and controlled for height and focal distance.
The AT dissolution apparatus fully complies with all harmonized Pharmacopeia requirements and features “built-in” compliance without any adjustment. The proven SOTAX AutoCompliance™ concept with fixed shaft height and vessel positioning guarantees 100% compliance without requiring time-consuming adjustments by the analyst. For fast change-overs, quick-lock systems and a vertical bath closing mechanism (manual or motorized) provide for simple handling processes.
The AT also features the simple and intuitive EasyTouch™ touch screen operation making dissolution test set-up and method programming easier than ever. Logical, icon-based menu structures and multi-language capability reduce analyst training times to a minimum.
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The innovative circular design of the AT dissolution bath opens up a new dimension of observation possibilities for R&D visualization and OOS troubleshooting
The SOTAX Group, a global leader in the development and manufacturing of dissolution testing, automated sample preparation and physical testing equipment for the pharmaceutical industry launches the 4th generation SOTAX AT MD fully-automated dissolution system.
Fully automated dissolution testing is defined as several unattended lots being run in succession with media preparation, gravimetric dispensing to the vessels and cleaning of the bath between lots. The cued dissolution methods can be different, or the user can run the same product back to back.
The SOTAX AT MD fully automated dissolution system consists of the AT dissolution bath and the MD workstation. The innovative circular design of the AT dissolution bath opens up a new dimension of observation possibilities for R&D visualization and OOS troubleshooting with the new and unique CenterView™ design: this technology provides perfect visualization and video recording of release processes in each dissolution vessel. Located in the center of the dissolution bath, all video cameras can be adjusted and controlled for height and focal distance.
The MD is derived from the Zymark MultiDose Platform, a unit that is in active service globally. The upgraded MD unit is used for media preparation, sample withdrawal and cleaning. The new media tank now prepares media twice as fast and is easily removable for system cleaning. The MD’s ability to work with a variety of surfactant concentrations has been improved along with a universal power supply for simple global implementation.
With hundreds of installations processing thousands of samples, SOTAX Fully Automated Dissolution systems have proven to be a reliable and compliant solution to enhance a customer’s laboratory efficiency and accelerate the workflow.
Robust multi-purpose tablet tester perfectly suited for in-process control and QC laboratories
The new generation MultiTest 50 tablet hardness tester sets new standards for fast and userfriendly operation. Based on the proven high-precision Dr. Schleuniger® Pharmatron hardness measuring technology, the MultiTest 50 is a robust multi-purpose tablet tester perfectly suited for in-process control and QC laboratories in the pharmaceutical industry.
Equipped with a large EasyTouch™ user interface, the new MultiTest 50 allows operators to quickly take single measurements or to perform complete tests of five physical parameters. By connecting an analytical balance, the instrument combines weight, thickness, width, diameter/length and hardness measurements in a single report. Results are automatically compared to product specifications – eliminating time-consuming manual evaluation by operators.
All measuring processes of the MultiTest 50 have been optimized for quickly obtaining highly accurate results – allowing operators to quickly perform a series of tests without unproductive waiting times due to jaw homing procedures commonly seen with other hardness testers. An integrated FastTest™ thickness gauge and tablet positioning carousel assist in quickly orienting even convex tablet shapes. To save time, operators can take thickness and weight measurements while a hardness test is running.
To start a test, the operator needs to select a product name and push start. All measurements taken are then immediately evaluated using programmed product specifications. Integrated 3-level user administration ensures that only authorized personnel can create or modify data. Comprehensive test reports can be easily configured to include all required information. At the end of a test run, a report is automatically printed on a USB, LAN or serial printer. If required, measurement data can also be electronically collected in a 21 CFR, Part 11 compliant PC software or for R&D simply saved on a USB flash drive in Excel® compatible format for further analysis.
SmartTest 50 is awarded for high design quality
Dr. Schleuniger® Pharmatron convinced the 40-member expert panel for the Red Dot Award: Product Design 2014 with the high design quality of its SmartTest 50. In the current competition, the international experts discussed and evaluated 4,815 entries from 53 countries. But only designs which won over the jury with quality and innovative strength won an award. The tablet hardness testing system by Dr. Schleuniger® Pharmatron was successful and received the coveted Red Dot quality seal as its deserved reward.
On 7 July 2014, the highlight of the internationally renowned product competition will be celebrated in Essen, Germany: the presentation of the acclaimed Red Dot during the traditional Red Dot Gala and subsequent Designers’ Night. On that evening, roughly 1,200 guests from around the world gather in Essen in order to experience the awards ceremony. In the course of the party in the Red Dot Design Museum Essen, the winners’ exhibition will also be opened, presenting the award-winning product SmartTest 50 to a wide audience for four weeks before it enters the museum’s permanent exhibition.
The SmartTest 50 sets new standards in fast and efficient semi-automatic testing of up to 5 physical parameters. Weight, thickness, width, diameter/length and hardness of virtually all tablet shapes can be tested in full compliance with current Pharmacopeia requirements. Proven Dr. Schleuniger hardness measuring technology guarantees accurate and highly reliable test data that can be evaluated immediately.
An integrated color touch screen with simple icon-based navigation makes operating the SmartTest 50 very intuitive consequently reducing operator training time to an absolute minimum.
Prof. Dr. Peter Zec, initiator and CEO of Red Dot, on the decision process in the Red Dot Award: “The 40 experts assessed the quality of the entries with the utmost care and attention. Due to their backgrounds, they also assessed the special cultural aspects of the designs from 53 countries. But only the best products receive an award from the jury. This is especially reflected in the percentage of successful entries in the Red Dot Award, which is much smaller in contrast to other international design competitions. Therefore, the winners can be proud of their achievements – with their entries, they stood out from the rest and were able to pass the test in front of the critical eyes of the experts. This success will be perceptible during the Red Dot Gala, when the laureates will receive the recognition of the international audience.”
The award-winning products in the Red Dot Design Museum Essen
With around 2,000 exhibits spread over an area of more than 4,000 square metres, the Red Dot Design Museum houses the largest exhibition of contemporary design worldwide. The award-winning products from the Red Dot Award: Product Design 2014 will be presented in an impressive special exhibition from 8 July to 3 August 2014. Since touching and testing is expressly encouraged in the hands-on exhibition, visitors experience the current best achievements at close quarters in “Design on Stage”. This way, design enthusiasts can find out about the trends in international product design and assure themselves of the good quality of SmartTest 50 by Dr. Schleuniger® Pharmatron.
The Red Dot Design Award
With the Red Dot Design Award, the Design Zentrum Nordrhein Westfalen created an internationally renowned product competition. Its prize, the Red Dot, has established itself worldwide as one of the most sought-after quality marks for excellent design. The Design Zentrum Nordrhein Westfalen displays the award-winning products in the Red Dot Design Museum Essen for at least one year.
In order to appraise the diversity in the field of design in a professional manner, the Red Dot Design Award breaks down into the three disciplines Red Dot Award: Product Design, Red Dot Award: Communication Design and Red Dot Award: Design Concept.
Further information at: www.red-dot.de/press
APW and TPW now provide even greater sample preparation productivity
The SOTAX Group, a global leader in the development and manufacturing of dissolution testing, automated sample preparation and physical testing equipment for the pharmaceutical industry, is relaunching its Automated Sample Preparation (ASP) Platforms, the APW and TPW. Formerly branded as Zymark, the APW and TPW are well-established and now newly enhanced as part of the SOTAX ASP product line.
While the APW can process APIs, creams, gels and more for up to 300 samples with up to 10 mL extraction volume using ultrasonic, the TPW can process up to 100 samples for Content, Blend and Assay Uniformity testing for 20 – 520 mL extraction volumes.
The APW and TPW now provide even greater sample preparation productivity while streamlining the laboratory workflow for a broad variety of laboratories, products and applications. Typical applications range from Content and Blend Uniformity, Potency and Related Substance Assays for solid or liquid oral dosage forms for the pharmaceutical industry to tooth paste and lipstick for the consumer products industry. The TPW and APW provide a range of support from simple sample preparation to barcoded sample ID and preparation with on-line HPLC analysis with compliant data transfer to your validated CDS.
Recent initiatives to incorporate QbD (Quality by Design) and Continuous Process Improvement principles into the drug product lifecycle have increasingly raised laboratory productivity expectations. APW and TPW’s powerful dEsign™ variables fully automate Analytical QbD to ensure robust, fit-for-purpose methods that deliver consistent results throughout the method lifecycle. Regardless of the industry or the degree of regulation, these platforms maximize efficiency and throughput for a vast array of applications for up to 300 samples.
With 100’s of installations globally, processing hundreds of thousands of samples, SOTAX Automated Sample Preparation systems have proven to be reliable and compliant solutions for automating the sample preparation process to enhance a customer’s laboratory efficiency and accelerate the workflow.