Industry News August 2006

Varian Inc Makes Dissolution Tester Operation and Data Management Simple and 21 CFR part 11 Compliant

Cary,North Carolina �Varian Inc.,the leader in dissolution systems,is proud to announce the new Dissolution Workstation for data management and operation of automated off-line dissolution testing.The Dissolution Workstation will greatly increase the ability of laboratories to manage dissolution systems, record and run methods, store and track serial numbers without the need for physical logbooks or a LIMS system.

The Dissolution Workstation is able to run and collect data from four dissolution tests simultaneously,and can store an unlimited amount of dissolution systems,methods,and runs. All essential parameters of the dissolution run,such as temperature and RPM,are recorded at user-defined intervals by the software and displayed graphically.The data is captured in a MSDE 2000 Database which can be backed up using existing backup procedures.

21 CFR part 11 compliance is facilitated by use of the Dissolution Workstation�s security, record retention,and audit features. User groups are created to allow graduated access to software features,and an automatic “lock” feature can be activated to further block any unauthorized access. Each method,system configuration,and test result has a unique document ID using a 128 bit algorithm. Any time a file is changed,a new 128 bit algorithm is created and the document ID gives complete traceability of all changes. Furthermore, all user activity is recorded in a separate audit log,and changes to reports are easily traceable.

Complete and accurate reports are created automatically by the software,and are viewable in both human readable and electronic form. Reports can also be exported to PDF and RTF files.

Automation of dissolution tests with the Dissolution Workstation can be performed following Varian,Inc. instruments:

The Dissolution Workstation is the ultimate solution for dissolution systems data management and operation, all without need for a LIMS system.

If you would like to know more about the Dissolution Workstation software or any of the other products Varian Inc. manufactures,please visit www.varianinc.com or call us at 919-677-1108.


Agilent Technologies and Distek Form Alliance to Extend Agilent Lab Resource Management Program

Agreement Extends Integrated, Efficient Service Delivery to Dissolution Instrumentation

Palo Alto,Calif.,and NORTH BRUNSWICK,N.J., July 12,2006 � Agilent Technologies Inc. (NYSE: A) and Distek, Inc. today announced an agreement for Distek to become a preferred provider in North America for dissolution instrumentation service under Agilent�s Lab Resource Management program. Distek will also support Agilent engineers in other geographies with parts, tools,protocols and training so that Agilent can directly service dissolution systems.

Agilent�s Lab Resource Management (LRM) program streamlines laboratory operations through a tailored, integrated service delivery model that improves efficiency, simplifies administration,boosts analyst productivity and facilitates regulatory compliance.

“This agreement affirms Agilent�s strategic direction to make instrument service management more personalized, more efficient and more cost effective,” said May Van,vice president and general manager of Agilent�s Services and Support Division.“Now our LRM customers will benefit from integrated support for all of their dissolution equipment from the clear market leader in dissolution.”

“Helping Agilent�s customers achieve the best dissolution service in the industry is the natural extension of our longstanding relationship with Agilent,” said Gerry Brinker,president and owner of Distek,Inc.“We have resold Agilent�s 8453- based dissolution solution for years and are delighted to partner with them to strengthen their Lab Resource Management service portfolio.”

Dissolution testing, in vitro analysis of how solid drugs are released, is performed throughout the lifecycle of drugdelivery products,and pharmaceutical companies are increasingly turning to single-source lab instrument service contracts. Now Agilent and Distek can service dissolution testing equipment under the same agreement that covers gas chromatographs,high performance liquid chromatographs, mass spectrometers and ancillary apparatus.

About Distek,Inc.
Distek,Inc. is a leading manufacturer of pharmaceutical testing instruments that provide solutions for dissolution, disintegration and physical measurement testing as well as validation support services. Information about Distek is available on the Web at www.distekinc.com.

About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is the world�s premier measurement company and a technology leader in communications,electronics, life sciences and chemical analysis.The company�s 20,000 employees serve customers in more than 110 countries. Agilent had net revenue of $5.1 billion in fiscal year 2005. Information about Agilent is available on the Web at www.agilent.com.


Global Launch of the New SOTAX CTS � Fully Automated Content Uniformity and Assay Testing System

Learn more about the SOTAX CTS at AAPS,San Antonio, Texas,Oct 29-Nov 2,2006 Booth #1245

SOTAX AG (Basel,Switzerland),SOTAX Corporation, (Horsham,PA,USA),and SOTAX (Canada) Ltd., (Brampton, ON,Canada)the worldwide market leader in automated dissolution innovation launches its new fully automated Tablet Content Uniformity and Assay Testing System,the SOTAX CTS.

In cooperation with leading pharmaceutical companies, SOTAX has developed the new SOTAX CTS to be ideally suited for quality control departments in the routine analysis of content uniformity and assay of tablets, capsules,pellets, effervescent tablets,powder and liquids.

This new CTS system has a capacity of up to 240 analyses and uses a unique mixing vessel with solvent sample volumes ranging from 25 ml up to 1000 ml. Due to this innovative design, three analyses can be processed in parallel.

With the application of a modern homogenizer equipped with a temperature detector, the user can optimize and reduce the test sample. The in-line filter station uses commercial filters such as Pall™/Gelman™,Millipore™ and Schleicher & Schuell™. A high-precision Mettler-Toledo balance allows for subsequent dilutions of up to 1:40�000. Collection for sample archival is also possible with filling into HPLC or UV vials for a worry free back up system.

Sample injection into an existing HPLC system is achieved via a full loop system. It is also possible to inject into a secondary HPLC system,to report optimal saturation and benefiting combined products. An optional UV-Vis analytical finish with drivers available for common spectrophotometers on the market can also be incorporated.

Once the test has been completed,the vessel is cleaned with up to three different rinsing media and with 20 ml organic solvent.After the cleaning cycle,which can be repeated as often as required,the vessel is dried with pressurized air.

The SOTAX CTS has complete 21 CFR Part 11 Compliant software control, reporting and LIMS access available. It has been validated on Windows 2000/XP operating systems. A full installation,validation package and support is available by your local SOTAX office.

To learn more about the new SOTAX CTS Content Testing System,please contact:
Marc Finn,
Marketing Manager
marc.finn@sotax.com
+1 888-302-9925


SOTAX introduces the New FS 7 Automated or Stand Alone Filter Station

SOTAX Corporation,(Horsham,PA,USA),SOTAX (Canada) Ltd.,(Brampton,ON,Canada) and SOTAX AG (Basel,Switzerland), the worldwide market leader in automated dissolution innovation launches its new filter station for automated filter changes after each sampling point for extended release testing,dissolution profiling and media change methods.

Filter clogging and filter saturation problems associated with 25 mm syringe filters can interrupt the dissolution test. The new Sotax FS 7 can store up to 140 filters at a time and uses common brand filters including Gelman™,Millipore™, Pall™ and Schleiche & Schuel™ down to 0.45 micron pore size. Controllable by our WinSotax Advanced Dissolution Software,the Sotax FS 7 can be integrated with your existing on-line UV-Vis or off-line sample collection systems without the need for any upgrades or retrofits. Used filters are dispensed into a collection tray for quick disposal.

As a stand alone unit with manual control,the SOTAX FS 7 can also be used with other manufacturer�s baths with piston or syringe style pumps.

The SOTAX FS 7 was designed from our fully automated dissolution system,the AT 70smart filter station module.The AT 70smart is a fully automated dissolution testing system for up to 15 unattended tests for USP 2.The system automates media preparation and delivery,tablet drop and basket change, filter change,sample analysis and wash cycles. The AT70smart has been used for non-stop daily routine dissolution testing worldwide since 1989.

For more information or to schedule a demonstration, please contact:
Marc Finn,
Marketing Manager
+1 888-302-9925
sotaxusa@sotax.com sotaxcanada@sotax.com


Hanson Research Corp. Promotes “Takao” Precision Dissolution Vessel

Kyoto,Japan � July 5,2006 � Exclusive worldwide distribution of the Takao Precision Dissolution Vessel has been awarded to Hanson Research Corp.,Los Angeles,CA,by Hiroyasu Fujiwara,President of Takao Manufacturing Co., Ltd.,Kyoto,Japan.

“The Takao Vessel provides the best precision,geometry, and repeatability that I have seen,” states Royal Hanson,CEO, Hanson Research Corp. “As well,Hanson will provide this vessel to all dissolution vendors on an even basis,so that pharmaceutical analysts worldwide may benefit from the Takao Vessel�s performance, regardless of their vendor of choice.”

For further reference,see Dissolution Technologies,12(4) November 2005,pages 15-19.

Contact:
Royal Hanson
President and CEO
Hanson Research Corp.
Phone:(800) 821-8165 / (818) 882-7266
Fax:(818) 882-9470
rhanson@hansonresearch.com
http://www.hansonresearch.com


Dissolution Media with Surfactant

Fort Collins,CO,June 29,2006 � CHATA Biosystems offers pre-mixed dissolution media containing surfactants conveniently packaged in disposable CHEM+NECT™ flexible bag technology. The media contained within a sterile bag, is equipped with a delivery system which can be easily connected directly to an automated dissolution system,or can be dispensed with an available pump accessory from CHATA.

CHATA�s pre-packaged dissolution media is designed to help pharmaceutical companies address the inherent challenges of preparing surfactants. CHATA�s proprietary filtration technique removes micro globules from surfactant media providing stable pH. Use of pre-blended surfactants eliminates the atomization of surfactant in the laboratory which can cause technicians to suffer pulmonary discomfort. In addition,the pre-packaged CHEM+NECT media greatly reduces preparation time and cost while improving laboratory consistency.

CHATA adheres to stringent cGMP manufacturing standards, documented in a 13-page batch record. Expiration dates are generated by “in-use” stability testing. CHATA solutions are further validated by a variety of analytical QC release tests such as SDS concentration,ion concentration, pH certification,UV scan,and sterility testing according to USP <71>. Every product comes with a lot specific Certificate of Analysis that details actual test results for your batch of dissolution media.

For 7 years,CHATA has manufactured a wide range of prepackaged reagents for today�s leading pharmaceutical companies,specializing in commercial and custom manufactured dissolution media,mobile phases, test solutions and other laboratory reagents.

For more information,please contact:
Customer Service
CHATA Biosystems
877-246-2428
customerservice@chatasolutions.com
www.chatasolutions.com