SOTAX Group Launches New AT Dissolution Apparatus as Part of Its Xtend™ Dissolution Line

AT dissolution apparatus
EasyTouch™ touch screen operation of AT dissolution apparatus

March 2014—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, and 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, technology that 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 changeovers, 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 setup and method programming easier than ever. Logical, icon-based menu structures and multi-language capability reduce analyst training time to a minimum.

About SOTAX:

The SOTAX Group is an international leader in the development and manufacturing of equipment for dissolution testing, automated sample preparation, and physical testing of pharmaceutical dosage forms. With a global network of service engineers, the company is also a trusted provider of installation, maintenance, repair, and qualification services for its SOTAX, Dr. Schleuniger ® Pharmatron, and legacy Zymark products.

The brand SOTAX is part of the SOTAX Group.

Press contact:

SOTAX AG
Binningerstrasse 106
4123 Allschwil
Switzerland
Contact: Ms. Petra Silbereisen
Phone: +41 61 487 54 54
E-mail: info@sotax.com
Web: www.sotax.com

SOTAX Group Launches Brand New Xtend™ Dissolution Line

March 2014—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-tomarket 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 that 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 SOPs, 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.

About SOTAX:

The SOTAX Group is an international leader in the development and manufacturing of equipment for dissolution testing, automated sample preparation, and physical testing of pharmaceutical dosage forms. With a global network of service engineers, the company is also a trusted provider of installation, maintenance, repair, and qualification services for its SOTAX, Dr. Schleuniger ® Pharmatron, and legacy Zymark products.

The brand SOTAX is part of the SOTAX Group.

Press contact:

SOTAX AG
Binningerstrasse 106
4123 Allschwil
Switzerland
Contact: Ms. Petra Silbereisen
Phone: +41 61 487 54 54
E-mail: info@sotax.com
Web: www.sotax.com

SOTAX Group Launches 4th Generation AT MD Fully Automated Benchtop Dissolution System

AT MD for full automation of up to eight lots of dissolution.
Robust media preparation, sampling, and cleaning is performed and monitored.

March 2014—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 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 continuously.

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, which 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 medium 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 proved to be a reliable and compliant solution to enhance customer laboratory efficiency and accelerate the workflow.

About SOTAX:

The SOTAX Group is an international leader in the development and manufacturing of equipment for dissolution testing, automated sample preparation, and physical testing of pharmaceutical dosage forms. With a global network of service engineers, the company is also a trusted provider of installation, maintenance, repair, and qualification services for its SOTAX, Dr. Schleuniger ® Pharmatron, and legacy Zymark products.

The brand SOTAX is part of the SOTAX Group.

Press contact:

SOTAX AG
Binningerstrasse 106
4123 Allschwil
Switzerland
Contact: Ms. Petra Silbereisen
Phone: +41 61 487 54 54
E-mail: info@sotax.com
Web: www.sotax.com

Distek’s sensIR 3200 “Bathless” Disintegrator with Auto Endpoint Detection is Now Available

North Brunswick, NJ—April 7, 2014—Distek, Inc., an industry leader in pharmaceutical laboratory testing instruments, accessories, and validation services, is pleased to announce the availability of auto detection on the sensIR 3200 “Bathless” Disintegrator.

The sensIR 3200 utilizes patent pending near infrared to monitor and determine the disintegration endpoint for solid dosages. This state-of-the-art technology provides endpoint detection without the need of a modified fluted disk, therefore eliminating the accelerated disintegration and disparity caused by the use of a fluted disk with monographs not requiring disks.

“Unattended endpoint detection saves time and increases throughput,” says Jeff Seely, Vice President of Sales & Business Development. “The release of the sensIR 3200 is another example of Distek’s innovation and leadership in the pharmaceutical testing market space. The use of IR to detect the presence of the tablet is a leap forward in disintegration testing providing reliable results and compliance with all monographs.”

For additional information, contact Distek’s Corporate Office at +1 732 422 7585, by email at info@distekinc.com, or visit www.distekinc.com.

ABOUT DISTEK, INC.

Distek, Inc., headquartered in North Brunswick, NJ, is a leading manufacturer of pharmaceutical laboratory test equipment, specializing in dissolution products and services. Distek also provides solutions for UV fiber optics, media preparation, physical testing, disintegration, and validation services.

Logan Instruments Corp. Launches Successful Dry Heat Transdermal Diffusion Cell Console Labeled DHC-6T

Somerset, NJ—March 4, 2014—On the forefront of transdermal instrumentation, Logan Instruments Corp. released its dry heat transdermal diffusion cell system named the DHC-6T. Similar to its best selling FDC-6T, the new DHC-6T features a tilting plate and modified cells to purge annoying bubbles from the testing process.

The new DHC-6T dry heat transdermal diffusion cell system has many advances and cost-saving features. This new dry heat system does not use a water circulator, thereby saving lab space, cost, and test preparation. The thermo-controlled housing design produces more efficient and evenly distributed temperatures to each cell. DHC-6T is also equipped with a bronze cover for lightsensitive products. Franz cells are very costly as they are handmade and can easily break. Logan Instruments Corp. has developed a Dry Heat Cell using precision glass and Teflon parts to create a new economical cell for the DHC-6T; such cells are designed to change glass tube lengths for different media volumes.

For more information, please contact us at info@loganinstruments.com.
To learn more about Logan Instruments Corp.:
Jensen Lee
Logan Instruments Corp.
19 C Schoolhouse Rd.
Somerset, NJ 08873
Office: 732-302-9888
Fax: 732-302-9898
jensen@loganinstruments.com

Pion Launches the μDISPENSER™ Automated Small Volume Dispenser Apparatus

January 14, 2014—The μDISPENSER™ is one of Pion’s latest additions to the μDISS Profiler™. This latest development allows μDISS Profiler™ users to automate their media dispensing and to conduct media change-over assays (i.e., SIF to SGF) with minimal user intervention. The μDISPENSER is designed to be mounted on top of Pion’s miniaturized dissolution bath (Mini-Bath) and is operated via the Au PRO Software that controls the Mini-Bath and the detection system. The μDISPENSER can also work in conjunction with Pion’s μFLUX™ for in situ concentration monitoring of API and formulations in chamber pair of cells separated by a biomimetic artificial membrane.

Pion’s Director of Science & Research, Dr. Konstantin Tsinman, said, “μDISPENSER™ integrated with μDISS Profiler™ instrument provides the means for streamlining in situ concentration monitoring of kinetic processes in the changing environment, which is not achievable by other sampling and offline analysis procedures.”

About Pion Inc.

Pion Inc. develops and manufactures instrumentation for compound testing in pharmaceutical R&D. These include high-precision fiber optic-based analytical instruments for solubility and dissolution measurements, as well as complete systems for permeability (PAMPA), solubility, and ionization. Additionally, Pion provides CRO services for solubility, permeability, dissolution, pKa, lipophilicity testing, and excipient screening.

Contact Us:

For more information, please visit www.pion-inc.com, call us at +1-978-528-2020 (x22), or send us an email at sales@pion-inc.com.

VORTEX Sales Group Receives ISO 9001:2008 Certification as a Laboratory Instrumentation Service Provider

Benson, NC—February 1, 2014—VORTEX Sales Group, LLC, has announced the receipt of its certification as an ISO 9001:2008 company by the certification body of TÜV SÜV America, Inc. The certification confirms that VORTEX has implemented a quality management system in accordance with ISO 9001:2008 standards, the scope and scale of which include sales, service, and support of laboratory and analytical instrumentation to the pharmaceutical and other regulated life sciences industries that operate under cGMP/ GLP. Important commitments of our certification include continuous improvements through feedback from our customers and frequent auditing of our quality standards.

“The best part of ISO certification is that it requires complete dedication by our company for quality and continuous improvement initiatives,” said VORTEX Director of Operations, Scott Stephenson. “Our customers know VORTEX as a trusted partner and leader in providing instrumentation and consulting services to the dissolution lab, and our ISO9001:2008 certification further shows our dedication to excellence in everything we do.”

VORTEX has been offering maintenance, calibration, and compliance services to the Dissolution Laboratory since 2007 and continues to expand its offerings. VORTEX implemented in 2009 a certification laboratory that specializes in offering USP Conformity Certificates required for Mechanical Qualification- ASTM Method E2503-07 for dissolution baskets, paddles, shafts, and vessels. In addition, VORTEX has the capabilities to recertify all dissolution measurement tools and QA Stations and offers comprehensive pan and jet sieve inspection according to ASTM E11-09 for Inspection Test Sieves.

About VORTEX:

With facilities near the Research Triangle Park, NC, including a 4000 sq. ft. office, certification lab, warehouse, and support center, our experienced and knowledgeable team services, sells, and supports instrumentation used in the Dissolution, Analytical, Quality Control, and Formulation labs. We offer cost-effective service solutions including maintenance, calibration, and full service contracts on all brands of dissolution testers, HPLCs, GCs, UVs, and physical testing equipment. We represent Pharmatest Dissolution and Tablet Testing Equipment, Two Square Science Automated Dissolution Systems, PION UV Fiber Optic Dissolution Monitors, Dissolution Accessories and Filters, and Dissolution Training, Testing, and Consulting Services. Our goal is nothing less than excellence in service, support, and instrumentation.

In Vivo Predictive Dissolution Conference to Take Place on University of Michigan Campus!

Ann Arbor, MI—April 18, 2014—The University of Michigan, College of Pharmacy, with its long history of scientific contributions to transport phenomena, invites you to participate in an In Vivo Predictive Dissolution conference to be held on The University of Michigan campus August 4-6, 2014.

This conference is planned and hosted by the College of Pharmacy Department of Pharmaceutical Sciences and will include presentations by 31 of the world’s leaders in current and futuristic thinking on mass transport analysis and mythological approaches to in vivo predictive dissolution, plus a poster session with reception. This will provide ample opportunity to meet with scientists from around the world and discuss the future evolution of oral dissolution methodologies.

Further details can be found on our website: pharmacy.umich.edu/invivodissolution Register Today!

Department of Pharmaceutical Sciences
428 Church Street
Ann Arbor, MI 48109-1065
Gordon L. Amidon, Ph.D.
Charles R. Walgreen Jr. Professor, of Pharmacy and Pharmaceutical Sciences
734-764-2226 • Fax: 734-764-6282
e-mail: glamidon@umich.edu

Agilent Technologies Introduces Next-Generation Diode Array UV Dissolution System for the Pharmaceutical Industry

Santa Clara, CA—May 1, 2014—Agilent Technologies Inc. (NYSE: A) today introduced the Cary 8454 UV Dissolution System, which incorporates new Cary 8454 UV-Vis Spectrophotometer technology and enables researchers to sample the entire UV spectrum for fast, efficient diode array analysis. The 8454 UV Dissolution System is available in several scalable solutions to support both online and offline dissolution analysis.

The 8454 UV Dissolution System is an ideal solution for both single and multicomponent products. The system is available in three configurations to support a variety of laboratory needs:

• Multicell-based single apparatus for dedicated flow-cell lines, eliminating cross-contamination and supporting simultaneous or sequential UV analysis.
• Valve-based single apparatus for sequential sampling, offering the most economical option with use of a single-flow cell line.
• Valve-based multi-apparatus, enhancing the productivity of up to four apparatus and supporting the testing of large amounts of samples.

The 8454 system uses Agilent’s UV-ChemStation Dissolution Software, which seamlessly integrates with OpenLAB ECM. To complete an entire dissolution test and UV analysis, the UV-ChemStation software controls the spectrophotometer as well as Agilent and legacy Varian and VanKel dissolution apparatus, all in a 21 CFR Part 11-compliant environment.

“In addition to our UV scanning technologies, the next-generation 8454 UV Dissolution System reinforces Agilent’s commitment to diode array UV detection,” said Allan Little, Agilent’s director of marketing, Dissolution Systems. “The system, with a history of more than 30 years of reliability, meets all the pharmacopeial requirements, and the latest UV-ChemStation software further enhances 21 CFR Part 11 compliance.”

For more information about the Agilent 8454 UV Dissolution System and Agilent’s entire portfolio of UV dissolution systems, visit www.agilent.com/lifesciences/UVDissolution

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is the world’s premier measurement company and a technology leader in chemical analysis, life sciences, diagnostics, electronics, and communications. The company’s 20,600 employees serve customers in more than 100 countries. Agilent had revenues of $6.8 billion in fiscal 2013. Information about Agilent is available at www.agilent.com.

On Sept. 19, 2013, Agilent announced plans to separate into two publicly traded companies through a tax-free spinoff of its electronic measurement business. The new company is named Keysight Technologies, Inc. The separation is expected to be completed in early November 2014.

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