Automated Dissolution Systems leader SOTAX introduces the new Ceramic Piston Pump CP 7SOTAX AG,Allschwil,Switzerland, is pleased to announce the all new SOTAX CP 7 Ceramic Piston Pump. SOTAX – as a pioneer and leader in Fully Automated USP 1 & 2 Dissolution Systems and USP 4 Flow-Through Dissolution Systems – has designed the new SOTAX CP 7 to meet the ever changing needs of today’s dissolution test. Flow-Through Dissolution has been gaining recognition for its use in the testing of unique and novel dosage forms like implants, stents,ER suspensions,microspheres,APIs, powders,poorly soluble compounds and CR tablets and capsules. Under careful considerations from industry experts,the new SOTAX CP 7 meets and exceeds all USP requirements as well as greatly improves reliability, accuracy,validation and maximizes testing flexibility. Designed with 7 valveless, self priming ceramic piston pump heads,a high level of reproducibility and consistent flow rates can be achieved. With a new lower flow rate range from 1.5 to 35 ml/min,The SOTAX CP 7 can now be set automatically without the need for manual adjustments through the digital display or through our WinSOTAX advanced dissolution software.The most exciting new feature is the capability of running completely different flow rates channel per channel.Valveless,self priming piston heads also eliminate the need for frequent cleaning as well as sticking and clogging problems. The calibration and validation has been greatly improved by the implementation of an automated calibration feature with integrated balance and printer for a gravimetric calibration report. The SOTAX CP 7 Ceramic Piston Pump can be integrated with existing systems from SOTAX and is also available in our Fully Automated USP 1 & 2 Dissolution Systems for critical sampling, replacement and addition methods (as pH changes). SOTAX specialises in developing and manufacturing sophisticated top-quality dissolution and physical testing equipment.More than 90 motivated and skilled employees in 9 subsidiaries on 3 continents and a comprehensive distributor network ensure SOTAX’worldwide presence. For more information or a demonstration in your lab, please call 1-888-302-9925 or visit us at www.sotax.com. |
Distek, Inc. and LEAP Technologies, Inc Announce Distribution Agreement for UV Fiber Optic System.North Brunswick,NJ/Carrboro,NC – January 15,2005 – Distek,Inc has received an exclusive distribution agreement by LEAP Technologies (Carrboro,NC) for the OPT- DISS™ Fiber Optic UV for In-Situ Dissolution Analysis.The agreement provides Distek with exclusive sales and support rights for the OPT DISS™ in the US and Canada as well as on a non-exclusive basis in Puerto Rico. LEAP is the designer and manufacturer of this state of the art equipment and will concentrate on further developments and the international opportunities. Gerry Brinker,President and founder of Distek,Inc. says “We are very excited about the strengthening alliance between Distek and LEAP. Having exclusive access to the latest in fiber optic technology continues to demonstrate to our customers that Distek is the source for cutting edge technology in Dissolution Testing.” Werner Martin,President of LEAP Technologies says that having Distek,Inc. as a partner in distribution and support is just what is needed to keep the recently gained momentum with OPT-DISSTM in several key pharmaceutical accounts going.The new agreement takes full advantage of each company’s strengths. Distek,Inc. is a leading manufacturer of pharmaceutical testing instruments that provide solutions for dissolution, disintegration,friability,and hardness testing. LEAP Technologies is a solutions provider of analytical lab automation specializing in front-end automation for Mass Spec,LC,GC,SPE,Proteomics,and Dissolution Testing Systems. |
Change of Ownership at Schleicher & Schuell BioScience and MicroScienceSchleicher & Schuell,the German filtration company,has been purchased by the UK firm,Whatman plc subject to approval by the shareholders of Whatman. As of November 30,2004 Whatman will purchase Schleicher &Schuell Micro- Science GmbH,Schleicher & Schuell BioScience GmbH and Schleicher & Schuell GmbH for 50.2 million Euro and including an estimated net debt on completion of Euro 4.4 million. Whatman plc,headquartered in London,will be in a stronger growth position with the acquisition of Schleicher & Schuell’s MicroScience and Bioscience business centers. With the addition of around 40 % of sales from Schleicher & Schuell,the enlarged group will have a combined share of approximately 16 % of the global LabSciences sector, making it the clear No. 3 in the industry and enhancing its competitive position against the sector leaders,Millipore and Pall Corporation.The remainder of the sector below these three major groups is more fragmented. “Whatman has approached us because of our highquality products and the company’s excellent reputation in the market.We expect that employees and customers of both companies will benefit from this proposed merger,”said Dr.Werner Specht, Schleicher & Schuell’s chief executive. “Schleicher & Schuell’s leading position in Germany gives Whatman a significant presence in Europe’s largest economy”,commented Dr. Simon May,Vice Chairman of Whatman plc,when the proposed acquisition was announceed to Schleicher & Schuell’s employees. Both companies started off as paper making companies and emerged into leading suppliers in the filtration business segment. Both companies offer paper filters,membranes and filtration systems.Overlaps of products will be thoroughly analysed and eventually rationalized.The BioScience products of both companies complement one another. Customers of Schleicher & Schuell can place their orders in the familiar way and will receive their shipments as usual. Hahnem�hle FineArt GmbH and DIA-Nielsen MicroTech GmbH will remain independent.Trading relationships between these companies and the future Whatman business centres will continue. For more information,please contact:Bettina Scheerbarth, Public Relations,Phone:+49 5561 791 681;Email: pr@schleicher-schuell.de |
Thermo Electron partners with SOTAX AGMADISON,Wis.(November 1,2004) -Thermo Electron Corporation (NYSE:TMO),the leader in spectroscopy,and SOTAX AG (Basel,Switzerland),the number one dissolution bath manufacturer in Europe and a market leader in automated dissolution innovation worldwide,entered into a partnership under which SOTAX dissolution baths will be offered with Thermo’s Evolution™ 300 UV-Vis spectrophotometers. SOTAX has earned an excellent international reputation in the pharmaceutical industry for the development of high-quality,innovative dissolution and tablet testing tools. The company is the exclusive provider of the unique Hollow-Shaft™ sampling technology, the AUTOCOMPLIANCE ™ concept,which simplifies bath validation,pioneers in Flow-Through Dissolution and automated testing solutions. SOTAX products meet and exceed USP and FIP guidelines and their WinSOTAX™ dissolution software offers the tools necessary to achieve 21 CFR Part 11 Compliance. The Evolution 300 UV-Vis spectrophotometer offered with SOTAX dissolution baths delivers excellent optical performance.The Evolution 300 is the first UV-Vis product on the market that uses the Smart Accessory™ sampling concept providing automatic accessory recognition,initialization, and logging. Enhanced and automated validation qualification performed with NIST or NPL traceable standards and primary standard mercury emission lines are the integral part of this unique system. Combined SOTAX and Thermo products will allow both companies to offer pharmaceutical customers high-quality, complete,automated turn-key systems supporting various pharmacopeia methods,control of up to two dissolution baths with a single UV-Vis instrument,state-of-the-art validation, and 21 CFR Part 11 compliant software. For more information,please call +1 800-532-4752 or email analyze@thermo.com or +1 888-302-9925 or email sotaxusa@sotax.com |
Large Volume Pre-Packaged Dissolution Media SystemsFORT COLLINS,CO, January 18,2005– CHATA Biosystems now offers CHEM+NECT™ pre-mixed dissolution media packaged in 100L systems. The system includes the innovative patented, impermeable CHEM+NECT bag technology filled with pre-mixed dissolution media. The media are available in off-the-shelf USP buffer formulations such as 0.1N HCl and 0.01N HCl, or can be manufactured to customer specifications. The CHEM+NECT dissolution system eliminates analyst handling and exposure to caustic reagents such as concentrated HCI. In addition,the system eradicates frequent media preparation, re-works, and nonconformance investigations due to inaccurate solution preparation. The 100L system arrives in a 30 gallon fiber barrel,which either connects directly to an automated system,or can be dispensed into a carboy with a pump assembly available from CHATA. CHATA can also perform stability studies for custom solutions, complete with GMP process and results. These studies can be customized by choosing from a variety of QC tests including sterility performed according to USE <71>,pH,ion concentration tests and UV scans. For 5 years,CHATA has manufactured a wide range of pre-packaged solutions, specializing in custom HPLC mobile phases,high purity water and dissolution media. CHATA serves over 60 major companies in the pharmaceutical, biotechnology, agricultural & fine chemicals, beverage and electronics industries. For more information, please contact: Jerald Kuiken,CEO, CHATA Biosystems,970-530-2207; 970-221-9488 (fax); jkuiken@chatasolutions.com. |
Delphian Technology Launches The μDISS™ An Ultra-Small Dissolution Apparatus for Drug DevelopmentWoburn,Mass.,Jan 25,2005– Delphian Technology Inc.,a pioneer provider of fiber-optic analytical tools for pharmaceutical dissolution analysis,today announced it has exclusively developed the world’s first very -small volume dissolution apparatus,the μDISS™.Designed for use with Delphian Technology Inc.’s patented fiber optic dissolution monitoring systems,the μDISS handles volumes as small as 2 mL for intrinsic dissolution measurements on powders and for polymorph screening during scaling-up of compound production. Due to the real-time, in situ measurements taken by Delphian’s Rainbow Dynamic Dissolution Monitor™,the μDISS requires no removal of samples during measurement. High data density and detailed, real-time dissolution profiles are the results. “We are excited to be able to fill this long-standing need in the pharmaceutical discovery process,“ said Per Nielsen, President of Delphian Technology Inc.,“only the combination of μDISS with the Rainbow Dynamic Dissolution Monitor makes this possible.” The system will be available with two options,micro, for volumes from 5 mL to 20 mL,and ultra-micro, for volumes from 2 mL to 4 mL. Other features include:
Developed in cooperation with a major pharmaceutical customer, μDISS is available immediately in North America and Europe. For information,contact Delphian Technology Sales at #781-935-8939,ext. 27, or your local Delphian Technology Inc. sales representative. |
Distek, Inc.Announces Alliance with Waters CorporationNorth Brunswick,NJ–February 2,2005–Distek, Inc has released an updated revision of the Evolution Series and Model 2100C Dissolution System with Waters Alliance Integration for On-Line HPLC Dissolution. This latest release from Distek creates a seamless integration with the Waters 2695D with firmware rev 2.03D,providing total control of the Dissolution System parameters via the Alliance system,Millenium32 or Empower Software. Gerry Brinker,President and founder of Distek,Inc. says “We are very excited about the opportunities a partnership with Waters will offer Distek and our customers. Our innovative dissolution system designs will further enhance the capabilities of the Alliance 2695D for Dissolution applications.” Distek is a leading manufacturer of pharmaceutical testing instruments that provide solutions for dissolution, disintegration, friability, and hardness testing. |
Tribute to Charles BarnsteinWe received the news with great sadness that Charles Barnstein passed away on January 18,2005. Charles Barnstein served more than 35 years as a USP staff member.His name is synonymous with the highest standards of USP because for years he was involved directly in the publication of the United States Pharmacopeia and the National Formulary (USP–NF),Pharmacopeial Forum and the USP Dictionary of Drug Names. He was also involved with the United States Adopted Names (USAN) Council for many years. He served as mentor to several generations of USP staff,imparting his scientific and technical knowledge and his rigorous editorial expertise to the development and production of USP publications. Charles was a member of the National Formulary (NF) staff at the American Pharmaceutical Association (now American Pharmacists Association).When the NFwas purchased by USP in 1975, he joined USP staff. He officially retired from USP in 2000,but USP retained his invaluable expertise as a consultant in the area of nomenclature and labeling. He continued to serve as a USP observer on the USAN Council. His dedication to USP–NF, to the Committee of Revision/Council of Experts,and to the Expert Committees was exemplary and serves as a model for anyone involved with USP. For those of us who knew him,his passing leaves a void that will be very difficult to fill. |