PRESS RELEASE
Analytical Solutions, Inc. (ASI) Celebrates 15-Year Anniversary
ASI, specializing in CMC-related analytical services with worldwide leadership in IVRT testing design, completes 15 years in RTP(Research Triangle Park, N.C.) � ASI, a pharmaceutical development and analytical services company with over 100 past and present customers, celebrated its 15-year anniversary, achieving a significant operating milestone. The company, founded by Dr. Kailas Thakker, a respected scientist and well-known authority on IVRT testing design, began operations as a small analytical testing company. ASI has developed an excellent reputation in providing GLP- and GMP-compliant solutions that meet U.S. FDA requirements to both multinational pharmaceutical houses and early stage biotechnology companies. ASI also provides GLP- and GMP-compliant analytical services to the nutraceutical industry.
"We pride ourselves on exceeding our customers' expectations. We apply creative approaches born from our experiences doing a wide variety of testing designs and methodologies," says ASI President Dr. Kailas Thakker. "ASI will continue to grow by meeting the increasing market demand for IVRT and semi-solid testing services as well as other pharmaceutical development services."
After obtaining her doctoral degree in Pharmaceutical Chemistry from the University of Kansas, Dr. Thakker worked for the U.S. Pharmacopeia in the Drug Research and Testing Laboratory with emphasis on developing dissolution methods. She founded ASI to pursue her passion after working at Sphinx Pharmaceuticals for 4 years.
Analytical Solutions, Inc. (ASI) is a contract analytical laboratory that provides quality, timely, and cost-efficient analytical services to the pharmaceutical, biotechnology, and consumer-products industries. ASI is a leading provider of IVRT testing services and delivers a wide variety of other CMC-related testing services working within the U.S. FDA requirements for GLP and GMP compliance. Among the services provided are develop- ment and validation of performance tests for solid and semisolid dosage forms, release and stability testing, HPLC method development and validation for API and drug product, and raw material testing from discovery through clinical trials to post production. Discover more at www.ASI-RTP.com
Hanson Offers HRCare™ ASTM Program & Super Precision Vessels
Los Angeles, CA, May 26, 2009—Hanson Research Corp., a world leader in dissolution test technology, provides ASTM E 2503-07 mechanical qualification in addition to our comprehensive HRCare IQOQPQ, service, and extended warranty programs.
While we continue to recommend and provide instrument performance qualification (PQ) with the USP Performance Verification Test (PVT), a rigorous mechanical calibration also carries benefit. To support laboratories that desire to comply with the new ASTM standard, we provide a complete ASTM mechanical qualification and certification program for our equipment and accessories. Hanson HRCare ASTM mechanical qualification is available for Hanson SR8-Plus™ and Vision® dissolution testers, including older units already installed and in use. A suitable PM program is recommended for all older equipment, and a convenient "pre-scan" to evaluate previously installed equipment is available prior to full ASTM mechanical qualification.
Hanson ASTM Certificates of Conformity (COC), detail- ing all relevant ASTM dimensions and tolerances, are available for USP accessories (vessels, paddles, baskets, and shafts). These quality accessories, with corresponding COCs, are required for ASTM.
Hanson Super Precision vessels, manufactured with a unique proprietary method providing a "super" precision inside diameter and spherical radius, are recommended for ASTM mechanical qualification. Super Precision vessels also come with an ASTM COC and are available for Hanson SR8-Plus™ and Vision® dissolution testers.
The Hanson HRCare team is factory-trained and certified on all aspects of instrument qualification, service, and preventive maintenance. HRCare service, maintenance, installation, and validation programs are designed to bring you the confidence of "audit-proof" dissolution lab validation. We support every maintenance, calibration, and validation protocol with ISO 9001:2008 quality documentation. HRCare programs are available to all U.S. customers. Similar programs are available worldwide�please consult Hanson for details or visit us at www.hansonresearch.com
About Hanson
Hanson Research is a world leader in dissolution test
technology for the pharmaceutical industry. Founded in
California in 1951, we design, manufacture, install, and
service equipment for pharmaceutical research and
quality control. We offer a complete line of tablet
dissolution, topical, and transdermal test systems and
premiered our Vision® dissolution testers in March 2008.
We support customers throughout the United States
and over 75 countries worldwide.
Contact
Amie C. Martin
Hanson Research Corporation
T. 818.882.7266 x225
F. 818.280.0831
amartin@hansonresearch.com
hansonresearch.com
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A New Tool for Fully Automated Dissolution Systems Integrated Video Monitoring
Automated dissolution testing systems have been used extensively in QC environments to increase productivity and reduce testing costs. For these same reasons, it has also become a matter of urgency in the Analytical R&D and formulation laboratories. SOTAX, the market leader in automated solutions for dissolution, content uniformity, and assay testing, announces the integration of video monitoring within our new client/server WinSOTAX plus Dissolution Software.
Within the QC lab, video monitoring can record exactly what happens to quickly source errors and prevent extensive test-failure investigations. Used as a great troubleshooting tool, the camera can be set up to turn on at the start of the test as the dosage form drops into the vessel, at time points during the test, and at the test finish. In some instances, it is important to visually document the behavior of products such as sticky tablets or capsules, the effects of sinker geometry, the introduction and evacuation of dosage forms, the vessel cleaning process, or the effects of the dosage within the basket.
Within the Analytical R&D and formulation labs, the new video monitoring option can be used to record the physical behavior of the dosage form throughout the duration of the test. It can be critical to observe the disintegration and diffusion process. Recent trends for imaging have also enhanced this necessity.
Within the new WinSOTAX plus Dissolution Software, a variety of video-monitoring options can be selected. Once the tests starts, an analysis screen with information such as lot number, test parameters, sampling times, RPM, temperature profiles, pH, dissolution data, drug release profile, user log files, and video can be viewed. Once the test has been completed, data including the video file linked with dissolution data can be reviewed, stored, sent to a network, or backed up on a server.
With the new client/server features of WinSOTAX plus, it�s even possible to monitor the dissolution videos of the test remotely (e.g., supervisor in an office or at home) or at a workstation (e.g., user in the lab).
WinSOTAX plus has a Microsoft SQL database and can control all semi-automated or fully automated SOTAX dissolution instruments within the lab. An audit trail can track every instrument configuration or method parameter change within the lab to fulfill 21 CFR part 11.
The new integrated video-monitoring option for WinSOTAX plus Dissolution Software is one more powerful solution offered by SOTAX.
For more information contact your SOTAX representative.
