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.
The SOTAX Group 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."
Testing the hardness of sticky tablets (e.g. tablets that are still moist directly after compacting) requires frequent cleaning of the breaking jaws’ surfaces, because residue tends to stick to the jaw faces. This buildup of sticky material over time can cause a change in diameter/length/width measuring – and it can also impact on the hardness measuring itself.
With the new DLC coated jaws SOTAX now offers a solution to help testing sticky tablets.
The new “diamond-like-carbon” (DLC) coated jaws provide a non-adhesive surface in combination with the required robustness. They significantly reduce the buildup of sticky residue on the breaking jaw surfaces and remain fully intact for thousands of hardness tests. While other coatings quickly wear off over time, no such effects could be observed during long-term stress tests with the new DLC coated jaws.
DLC coated jaws are now optionally available for all Dr. Schleuniger® hardness testers – the MultiTest 50, SmartTest 50, and the AutoTest 4.
SOTAX hereby announces that the AT 7smart is officially discontinued. We kindly inform all customers that SOTAX will ensure spare part availability of all main components for the next 10 years. The AT 7smart has been succeeded by the new, fully scalable AT Xtend™ series.
SOTAX Application Services has expanded its offering to include method feasibility including full development for automated sample preparation and fully automated dissolution.
This value added support will help our customers convert manual methods to robust, fully automated ones quickly! SOTAX is partnered with SPS Pharma Services in Europe, an FDA inspected, GMP CRO focused on this task. Application scientists are also located in the Westborough, MA facility in the US and our Mumbai office in India. Contact SOTAX today to expedite your automation project.
The new FS Xtend™ has the broadest filter selection in the industry. Most popular styles of luer lock filter types can be used with the remarkably fast filter changer.
In combination with the new CP pump, the FS can change more filter types faster while pushing through pore sizes as low as 0.2 um with the powerful CP pump. To reduce the overall footprint, the CP is fully stackable with other Xtend™ modules.
The CP Xtend™ pump is both faster and stronger than peristaltic or syringe based dissolution pumps. This powerful piston pump can push through filters as low as 0.2 microns with sampling rates as frequent as every one minute, even while using surfactant-containing media.
Many modern dissolution methods require this fine filtration for HPLC injection and the increase in poorly soluble formulations require high levels of surfactants. The tough CP Xtend™ pump allows for increased pushing power without sacrificing sampling speed giving its users the ability to collect a tight profile of sampling points. The industry leading ceramic pump heads are valve-free and require minimum maintenance. To reduce the overall footprint, the CP is fully stackable with other Xtend™ modules.
SOTAX TPW and APW Automated Sample Preparation Work Stations already include robust sample filtration capabilities. However, several sample preparation methods require centrifugation as primary mode for sample clarification, for example in Pharma, Food/Feed, Fine Chemical, and Cosmetics Industries.
There are many cases where the addition of this step will help to solve the challenge of samples that require centrifugation or centrifugation followed by filtration. The new C+ addition is an automated centrifuge module providing enhanced sample clarification capabilities during fully automated sample preparations.
• Lotions, pastes, ointments
• Polymer-heavy tablet formulations
• Hormone formulations
• Food science applications
TPW and APW workstations automate the most common sample preparation steps:
- Barcode identification
- Sample weighing
- Solvent addition
- Filtration / centrifugation
- Dilution / reagent addition
- Vortex mixing
- Vial filling
- Online HPLC injection with Empower
- Transfer to UV cell
For challenging samples requiring centrifugation or centrifugation followed by filtration, the C+ addition provides enhanced sample clarification capabilities. Two additional modules, a service robot and a high quality Hettich centrifuge, automate the complete sample preparation process.
The Hettich benchtop centrifuge is available as a standalone system or connected to the fully automated sample preparation systems. 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 an upgradable addition to existing units.
From pre-run to post-run system cleaning – with the AT 70smart SOTAX streamlines the dissolution testing workflow through the design of features that guide method development and simplify routine operation.
The AT 70smart BS 60 can handle basket, paddle, and methods requiring sinkers. By automating vessel filling and cleaning steps, much of the hands-on time required to run up to 40 lots of dissolution in a row is eliminated. The ability to use 8 different media per batch allows the user to either run several different products in a row or to use the system as a DoE tool in formulation screening.
The AT 70smart is driven by the 21 CFR Part 11 compliant WinSOTAXplus Advanced Dissolution Software. The design of SOTAX dissolution systems is compliant with all harmonized pharmacopeia requirements for paddle and basket methods. The SOTAX AutoCompliance™ (Compliance by Design) concept with fixed shaft height and vessel auto-centering ensures reproducible and compliant vessel-shaft assembly without any manual adjustment.
From this set-up, through the complete dissolution test, to mechanical calibration (executed by SOTAX Services with the MQD Mechanical Qualification Device): all compendial requirements are satisfied. With hundreds of systems in operation worldwide, SOTAX sets the benchmark for fully automated dissolution testing.
CLICK HERE to see the new video and learn more about the AT 70smart fully automated dissolution system!
SOTAX Group’s corporate headquarters has moved to a new facility. The new premises are yet another milestone in the 40-year history of the company. The site has been constructed in Aesch, not far from our previous facility. SOTAX herewith stands by its commitment to the Basel region, a major European hub for pharmaceuticals.
Built to meet the increasing demand for SOTAX products and services, the new facility also allows for process improvements and optimization. It therefore benefits not only SOTAX but also our partners and customers.
The new headquarters houses corporate management, sales and service administration departments of business unit Europe / Middle East / Africa, as well as a state-of-the-art production facility. Meeting and training facilities are also incorporated in Aesch.
The new address of our Corporate Headquarters is:
4147 Aesch (BL)
The previous site at Binningerstrasse 106 in 4123 Allschwil, Switzerland has been closed, the address is no longer available. We would like to ask all our customers and partners to update their databases accordingly.
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 excels with simple and user-friendly operation: fast “SingleButton” operation allow for quick navigation through the user menu.
Efficient tablet loading is another feature of the friability tester: At test start, the drum automatically rotates to its loading position – an opening in the anti-static drum allows samples to be conveniently inserted without having to remove the drum. At the end of the test, tablets are automatically discharged into a tray.
The capacity of the front-load FT 2 friability tester can be extended by using two drums instead of just one drum.
The FT 2 fulfills all requirements of USP <1216>, EP 2.9.7 and other Pharmacopoeias. It is available with friability drums as well as abrasion drums (Rus. Pharm.).
For more information go to www.sotax.com/FT2
Fast. Simple. Precise. This new tablet hardness tester offers highest precision, robustness, and exceptional user-friendliness. From a basic tablet hardness test to complete measuring of up to 5 parameters - the MultiTest 50 has been designed for efficient operation.
Equipped with a large touch screen user interface, the new MultiTest 50 allows operators to quickly take single measurements or to perform complete tests of five physical parameters: hardness, diameter/length, width, thickness (internal or with integrated thickness gauge), and weight.
CLICK HERE to see the new video and learn more about the new MultiTest 50!
SOTAX launches a new dissolution system at Analytica exhibition in Munich. Based on standardized Xtend modules, all system components can be flexibly combined to meet different automation requirements in R&D and QC. The modular design allows to quickly respond to changing work loads, while making method transfer and scale-up easier than ever. From qualification to writing SOP's: Keep in place what is already used, described and validated.
Irrespective of the configuration, all modules and components are extremely robust having been designed for the most demanding conditions of a fully automated system running 24 hours per day. Built on the success of preceding SOTAX dissolution systems, the Xtend Dissolution Line can be configured for USP 1,2,5,6 dissolution methods. Secure your investment today and flexibly manage tomorrow's demands.
SOTAX introduces the new AT dissolution apparatus for USP 1,2,5,6 testing. Whether used as a manual bath or as the core component in an automated dissolution system - the AT has been designed for the most demanding environments.
Equipped with 6-8 vessels, the circular design opens up a new dimension of observation possibilities for R&D visualization and OOS troubleshooting. Depending on your observation needs, the AT allows visual observation of each vessel from the outside and additionally from the inside using CenterView video monitoring.
Simple and intuitive touch screen operation makes test set-up and method programming easier than ever. User rights, method programming, data visualization, data transfer and reporting are readily available at the touch of a button.
The new AT MD is a fully automated benchtop dissolution system for running several unattended lots in succession including media preparation, gravimetric dispensing to the vessels and cleaning of the bath between lots. The cued dissolution methods can be different or the same product can be run back to back.
Derived from the Zymark MultiDose platform, which is in active service globally, the upgraded MD unit now runs with the new circular SOTAX dissolution bath. To increase productivty and shorten cycle times, the MD prepares media twice as fast and can work with an even greater variety of surfactant concentrations.
The new generation MultiTest 50 sets new standards for fast and user-friendly operation. Based on proven Dr. Schleuniger Pharmatron hardness measuring technology, the innovative MultiTest 50 is a robust multi-purpose tablet tester perfectly suited for in-process control (IPC), quality control (QC), and research laboratories (R&D).
Equipped with a large touch screen user interface, the new MultiTest 50 allows operators to quickly take single measurements or to perform complete tests of five physical parameters:
- Thickness (internal or with integrated thickness gauge)
By connecting an analytical balance, the MultiTest 50 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 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 assists in quickly orienting even convex tablet shapes. To save time, operators can take thickness and weight measurements while a hardness test is running.
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The SmartTest 50 tablet testing system convinced a 40-member expert panel and has been awarded the prestigeous Red Dot Award 2014 for Product Design. In the current competition, the international experts discussed and evaluated 4'815 entries from 53 countries. On 7 July 2014, the award ceremony with 1'200 international guests will take place in Essen, Germany.
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 entires with the outmost care and attention. 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. 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."
Formerly branded as Zymark products, the well-established APW and TPW platforms have been further enhanced and are now re-launched as SOTAX products - providing an even greater sample preparation productivity while streamlining the laboratory workflow for a broad variety of products and applications.
Typical applications range from content and blend uniformity, potency and related substance assays for solid or liquid oral dosage forms to tooth paste and lipstick. The TPW and APW provide for 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.
With hundreds of installations globally, processing hundreds of thousands of samples, the TPW and APW have proven to be reliable and compliant solutions for automating the sample preparation process in order to increase laboratory efficiency and to accelerate the workflow.