Distek, Inc., Awarded U.S. Patent for Modularity Design and Position Software Control

North Brunswick, NJ—February 19, 2015—Distek, Inc., an industry leader in pharmaceutical laboratory testing instruments, accessories, and validation services, has been awarded U.S. Patent 8,903,673 for its modularity design and the individual position software control.

Distek’s patented, self-contained, modularity design is configurable for up to eight positions when in use on the symphony 7100 “Bathless” Dissolution Instrument and six positions when in use on the sensIR 3200 “Bathless” Disintegrator. This modularity design allows users unprecedented ease and scalability.

“Distek is excited to have been awarded this patent, which exemplifies our commitment to providing technically innovative products offering valuable feature benefits to our customer base,” says Jeff Brinker, President, Distek, Inc. “This patent in particular allows our customers a great deal of flexibility in the symphony 7100 and sensIR 3200 platforms in its modularity, both mechanically as well as in the user-interface design.”

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

Distek, Inc., Releases Wireless In-Shaft Temperature Control and Monitoring for Model 2500 Dissolution Instrument

North Brunswick, NJ—July 13, 2015—Distek, Inc., an industry leader in pharmaceutical laboratory testing instruments, accessories and validation services, is excited to release an “optional” wireless in-shaft temperature control for the Model 2500 dissolution instrument.

The patent-pending wireless in-shaft temperature sensors offer continuous vessel temperature control and monitoring from within the vessel without the need of an additional wired temperature probe and raising and lowering manifold.

“The innovative use of our patent-pending wireless temperature sensor technology further enhances the Model 2500, returning much needed time and labor savings back to the dissolution laboratory,” says Jeff Seely, Vice President of Sales & Business Development, Distek, Inc.

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

ERWEKA Releases DT 126/128 light, MultiCheck 6 and ZT 720 Series

Heusenstamm, Germany—2015—ERWEKA GmbH, a leading global manufacturer of all-purpose and pharmaceutical testing equipment, is proud to announce the release of the new DT 126/128 light Series Dissolution Tester for manual, budget dissolution testing; the MultiCheck 6 fully automated combination tablet tester; and the ZT 720 Series automated disintegration tester. All three products can be ordered starting September 1.

ABOUT THE DT 126/128 LIGHT

The new ERWEKA light series delivers the proven ERWEKA quality for simple dissolution testing with USP Method 2 (paddle) in a comprehensive economical package for a budget.

The DT 126 light is equipped with six test stations and a fixed drive head (high-head), allowing easy access to each of the 1000-mL vessels for manual sampling. The DT 128 light is delivered with eight test stations accordingly. Furthermore, the delivered package includes centering rings with shafts, low evaporation covers, paddles and shafts, as well as a distance ball for correct height adjustment of the paddles, all managed in a light and compact design.

ABOUT THE MULTICHECK 6

The new MultiCheck 6 offers ease of operation, maximum efficiency, and enhanced operator convenience.

This fully automatic combination tester is packed with innovative technology. An intuitive touch display with the ability to store up to 100 products/methods with 1 million results, the integrated functionality of the MC.net software, the capsule-weight measurement system, and the patented Oblong Navigator® are only some of the innovative new features. In addition, the new MultiCheck 6 provides an unsurpassed low noise level and cleanest operation in its class. Proven features have been retained: MultiCheck 6 can test up to five tablet parameters fully automated and 100% compliant with all pharmacopoeias around the world—a true all-rounder.

ABOUT THE ZT 720 SERIES

The ERWEKA ZT 720 series automatically determines the disintegration time of each sample by use of a unique system of magnets and sensors. It also tests whether or not a sample completely disintegrates. ZT 720 is available with one (ZT 721) or two (ZT 722) individually driven test stations equipped with an integrated flow-through heater. Its temperature sensor PT 100 allows constant control of the water bath temperature. The ZT 720 series is controlled through an innovative 7” touch screen and is capable of storing and retrieving up to 100 products/methods with 1 million results and parameters.

To find out more, visit our partner STEQ America at the AAPS Meeting and Exposition from October 15-29, 2015 in the Orange County Convention Center, Orlando, Florida at booth no. 225 or check out our Web site at www.erweka.com!

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Hanson Research Introduces New Easi-Lock™ Vessel Cover Design

New Molded Design Reduces Cost and Keeps Evaporation to a Minimum

Los Angeles, CA—June 9, 2015—Hanson Research, the pioneer of dissolution and diffusion equipment, today announced the launch of its new Easi-Lock vessel cover design, now available in two styles: the standard Easi-Lock vessel cover (p/n 74-107-022) and the Easi-Lock Auto-Dosage Delivery (“ADD”) vessel cover (p/n 74-107-023).

Hanson’s new Easi-Lock design provides improved performance in vessel evaporation, less condensation sticking to the underside of the cover, and ease of use due to minimal effort in opening and closing the vessel cover. Both vessel cover styles can be washed in nearly any laboratory dishwasher, and each has a visible part number embossed on its surface for efficient reordering.

The new Easi-Lock ADD vessel cover is the simplest and least expensive auto pill dropper available. These revolutionary vessel covers have a sealed protected dosage chamber that is compatible with a variety of dosage forms including traditional tablets, capsules, gel caps, and even liquid suspensions. They can be used in either a manual or automated environment to ensure uniform, reliable, and reproducible dropping of the dosage form into the dissolution vessels.

“To address the needs of the ever-shrinking lab budgets, we designed the new Easi-Lock vessel covers using a mold process that reduces the cost significantly,” stated Steve Shaw, Chief Engineer of Hanson Research. “This allows Hanson Research to continue offering high quality products while still supporting local jobs without the need to outsource this product overseas.”

The new Easi-Lock vessel cover will be replacing the Easi-Lock CS vessel cover (p/n 74-107-012) and the previous Easi-Lock vessel cover (p/n 74-104-151). The new Easi-Lock ADD vessel cover will be replacing the Easi-Lock ADD CS vessel cover (p/n 74-107-013) and the previous Easi-Lock ADD vessel cover (p/n 74-104-152).

For more information, please visit hansonresearch.com/contact-us/ or contact us at sales@hansonresearch.com.

Hanson Research Announces New Board Member

Los Angeles, CA—July 9, 2015—Hanson Research, the pioneer of dissolution and diffusion equipment, today announced the appointment of Mr. David Boudreau to its Board of Directors.

David Boudreau is an experienced industry professional with expertise in life science technology, manufacturing, multi-site operations management, quality systems, and global supply. During his distinguished career, Mr. Boudreau served at Alere

Beckman Coulter, Nanogen, IGEN, and Analog Devices. He holds a B.S. in Chemistry from the University of California, and an M.B.A. from Cornell Johnson School of Management.

“Mr. Boudreau brings an incredible amount of technological and operational expertise to our team,” stated Royal Hanson, CEO of Hanson Research. “We are confident that the combined experience of our new team of directors will position Hanson Research to better serve our worldwide customers.”

New Accessory from Hanson Research Eliminates Need for Frequent Waterbath Cleaning

The Hanson UV Bath Clean Maintains a Clear Waterbath for Six Months or More

Los Angeles, CA—July 15, 2015—Hanson Research, the pioneer of dissolution and diffusion equipment, today introduced the Hanson UV Bath Clean, a new accessory that will help maintain a clear dissolution waterbath for months on end.

“Regular waterbath cleaning is a tedious aspect of using dissolution technology, and it is not unusual for scientists to perform this maintenance every 2 weeks,” stated Royal Hanson, CEO of Hanson Research. “Hanson’s new UV Bath Clean will eliminate this burden by helping scientists maintain a clear waterbath for six months or longer.”

The UV Bath Clean is a non-chemical, water purification system that incorporates an Aqua® Ultraviolet sterilizer into a waterbath’s circulation system. The sterilizer contains an ultraviolet lamp that safely emits a germicidal ray that alters or disrupts the DNA or RNA of single-celled organisms such as algae, bacteria, and protozoa, helping to maintain a consistently clean waterbath.

The UV Bath Clean system is easily connected to Hanson Vision® Classic 6™ and Elite 8™ dissolution testers. For more information about this product, please e-mail us at sales@hansonresearch.com.

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Enhanced Agilent Dissolution Workstation Software Offers More Features and Greater Efficiency

Figure 1. Export information into your laboratory information management system (LIMS) or business applications from a single desktop.

As you have come to know—Agilent’s Dissolution Workstation Software supports laboratory capabilities to build, edit, search, retrieve, execute, and archive all dissolution methods and test information from a single interface. Today this versatile software offers even more features for controlling multiple dissolution systems thanks to new enhancements that enable greater data integration, tracking, and instrument monitoring.

Check out all that we’ve done to improve your efficiency. Now with Agilent Dissolution Workstation Software you can:

• Consolidate and maintain data in one paperless location, with options of exporting information into your laboratory information management system (LIMS) or business tools such as SAP, Crystal Reports or Microsoft Excel (Figure 1).
• Add an automated system cleaning cycle to the end of each method, extending the life of your dissolution equipment.
• Comply with the latest enhanced mechanical68 qualification (MQ) guidelines, including verifying accessories prior to each test.
• Improve failure investigations related to environmental impacts by monitoring the dissolution apparatus for vibration using the Instrument Module (IM) of the 280-DS Mechanical Qualification System.

EXCLUSIVE IM MODULE MONITORING PROVIDES IMPORTANT INSIGHTS

Figure 2. Method monitoring screen, visible during method setup and testing.

The importance of adding vibration and environmental impact monitoring to the Agilent Dissolution Workstation Software cannot be overstated as this feature provides the user with important information that is not available elsewhere. It has been known for many years that vibration can dramatically impact dissolution results. Regulatory bodies suggest companies monitor and control the level of vibration—you now have a tool to do just this. The lack of an industry-wide norm demonstrates how internal and external vibrations may affect each product and individual environment differently. With baseline values for vibration on the x-, y-, and z-axes, dissolution systems as well as their environments can be monitored consistently in real time.

This added benefit may be used during early research to develop internal tolerances for specific methods, as part of a quality control initiative for well-established methods - or to watch for wear and tear to prevent instrument failure. If failure should occur, this feature speeds problem solving and helps to get instruments back online faster.

CONSOLIDATING DATA SAVES TIME AND EFFORT AND IMPROVES SECURITY

Dissolution Workstation Software allows you to organize, execute, and manage methods and information for all of your Agilent dissolution equipment from a single computer (Figure 2). This consolidation enables continuous audit trails that provide reliable traceability of methods and system operation. It also reduces the time required to manually document information. In addition, the software also offers secure access, so that you can protect your valuable data by using integrated Microsoft Windows security and the electronic signature functionality required for a 21 CFR Part 11 environment.

Agilent Dissolution Workstation Software offers a host of advantages to anyone who is responsible for maintaining and organizing dissolution methods and test reports. Now take a moment and explore our interactive Dissolution resources and training that can make your lab more efficient and productive.

Sirius Unveils the First In Vitro Model for the Subcutaneous Injection of Biopharmaceuticals

Forest Row, East Sussex, UK—June 25, 2015—Sirius Analytical Instruments Ltd., the leader in instrumentation and services for the determination of physicochemical properties, today announces the upcoming release of a new product, Sirius Scissor. Too little is understood about the physical behavior of parenteral drugs in the period immediately after administration. Sirius Scissor is the first instrument designed to mimic the stresses a biopharmaceutical experiences when transitioning from formulation conditions to a subcutaneous (SC) environment. By simulating events that occur at the injection site, Sirius Scissor will enable users to investigate bioavailability under simulated subcutaneous and intraocular conditions and compare biopharmaceutical formulation performance during development, after manufacture, and after storage.

Randy Mrsny, Professor of pharmacy at the University of Bath and inventor of the system, explains, “Our lab at the University of Bath has focused on asking simple questions related to solving problems involving drug delivery. The pharmaceutical industry has struggled with the fact that some, but not all, protein and peptide drugs injected subcutaneously can have low or variable bioavailability. Importantly, no predictive in vitro systems and no in vivo models have been identified to date to help pharmaceutical scientists understand the basis for these outcomes. I was lucky enough to team up with a very talented postdoc, Hanne Kinnunen. Her studies identified principles that provided the basis for development of the Sirius Scissor system, which we feel can be a useful tool for pharmaceutical scientists to follow the physical and chemical status of a protein or peptide drug as it transitions from conditions used to keep it stable on the shelf prior to injection into the conditions of the human body.”

Karl Box, Chief Scientific Officer of Sirius Analytical, adds, “Sirius and the University of Bath have a long history of successful collaborations, so when we decided to expand our product portfolio into the large-molecule world, Bath was an obvious development partner. Professor Mrsny has many years of experience working with biological drugs gained both in industry and academia. His and Hanne Kikkunen’s robust approach to research has led to our ability to release a system to market in which we have great confidence—indeed initial in vitro-in vivo correlation results have been extremely encouraging. We are extremely proud of the Sirius Scissor platform and have been delighted by the overwhelmingly positive response from our customers, with the first commercial systems shipping to the first wave of customers in mid-July.”

ABOUT SIRIUS ANALYTICAL INSTRUMENTS LIMITED

Established in 1989, Sirius Analytical offers instrumentation and services for pKa, logP/logD, solubility and dissolution, and particle size/shape analysis including detailed studies of solubility, supersaturation, and dissolution. Our unique solutions for supersaturation measurement reveal insights about the pH-dependent supersaturation a compound can exhibit and how it may be enhanced or suppressed via additives and excipients. Our expertise in automation and miniaturization means data is obtained at early stages of preformulation and development, improving efficiency and allowing informed decisions to be made earlier in the drug development process.

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