Thermo Fisher Scientific's incurred sample reanalysis
information kit for reliable quality assessment of bioanalytical methods

Thermo Fisher Scientific's incurred sample reanalysis (ISR) information packet is a vendor-neutral ISR guide, designed to educate pharmaceutical scientists on using the technique to effectively assess the quality of bioanalytical methods. It contains up-to-date information on changing regulatory guidance, including the official US Food and Drug Administration CDER bioanalytical method validation guidance paper, the latest Crystal City workshop report and a selection of papers from the AAPS Journal exploring ISR methods and best practices. This comprehensive kit provides scientists with the information required to establish a robust ISR program and is available to download from www.thermoscientific.com/isr

ISR was recently established as a viable method for re-analyzing samples obtained from in-vivo studies in order to test the reproducibility of bioanalytical methods. To facilitate efficient use of the ISR method, pharmaceutical companies and contract research organizations need detailed guidance. Thermo Fisher developed this new kit to provide thorough direction for ISR assessment, studies that should be conducted, the selection of samples, acceptance criteria and reporting of results. During drug development, bioanalytical methods are validated and used to quantify drugs and their metabolites in a variety of biological matrices.

In response to industry requirements for dependable laboratory information management systems (LIMS) that incorporate superior ISR capabilities as standard, Thermo Fisher offers a comprehensive solution for ISR which includes Thermo Scientific Watson LIMS 7.4 software integrated with the TSQ series mass spectrometers. The data processing and reporting features of the LIMS have been substantially improved, yielding better functionality and greater ease-of-use. Watson LIMS, the most commonly used bioanalytical data system in the pharmaceutical industry, is now capable of accommodating the ISR samples within the same run as the regular bioanalytical samples.

For further information about Thermo Fisher's new ISR information kit, e-mail: analyze@thermo.com or view website: www.thermoscientific.com/isr  Refer to page 218

iCE 3000 Series of Atomic Absorption spectrometers

Thermo Scientific's iCE 3000 Series of Atomic Absorption (AA) spectrometers comprises the iCE 3300, iCE 3400 and iCE 3500. The innovative iCE 3000 Series has been designed to facilitate prolonged and trouble-free operation - even with the most difficult samples - and offers unparalleled functionality. Featuring a small footprint, these new AA spectrometers are the most compact available and have been developed to accommodate both flame and furnace analysis. The easy-to-use Thermo Scientific AA range of instruments primarily addresses the Analytical needs of users working in food safety as well as in environmental clinical, pharmaceutical, metals and materials industries.

Refer to the picture on the left: The Thermo Fisher  iCE 3000 Series of AA spectrometers that operate on the intuitive Thermo Scientific iCE SOLAAR software platform.

With more than fifty years of experience in atomic absorption, Thermo Fisher is building on its reputation as an innovator in AA with the introduction of this comprehensive iCE 3000 range. The iCE 3000 Series of AA spectrometers operate on the intuitive Thermo Scientific iCE SOLAAR software platform. The extensive wizards of the iCE SOLAAR software guide users quickly and easily through various operational procedures, providing a step-by-step guide to routine activities and demonstrating the correct sequence of operations to achieve a specific objective.

Designed as a dual flame and furnace AA system, with standard or Zeeman furnace option and D2 background correction, the iCE 3000 is ideal for high-throughput environments requiring fast and regular flame and furnace analysis. Changeover from flame to furnace analysis is entirely software -controlled allowing for unattended operation. The iCE 3400, which also features Zeeman and D2  background correction, is a single furnace atomiser AA system designed to achieve outstanding performance even in cases of challenging detection limits. The iCE 3300 is a complete solution for laboratories that primarily perform flame analysis but also occasionally process furnace samples.

The help text and cookbook provide additional information on the operational conditions for any elemental analysis, while application tips for sample preparation and matrix modifiers are also available in the software to ensure maximum confidence in results. The SOLAAR Security is able to secure data for compliance purposes or just for good practice. It provides all the tools needed to comply with the FDA 21 CFR part 11 ruling by adding e-signatures, event logs, audit trails and access controls.

For further information on the Thermo Scientific iCE 3000 Series of AA spectrometers, e-mail: analyze@thermofisher.com    Refer to page 218

Four industry specific analytical packages for fast, accurate
and reliable routine X-ray analysis from Thermo Fisher Scientific

Four analytical packages from Thermo Fisher Scientific Inc., are designed to enhance industry specific routine X-ray analysis. The packages are based on the successful Thermo Scientific ARL OPTIM'X WDXRF spectrometer, enabling the company to offer a range of unique sequential and simultaneous spectrometers with pre-configured analytical packages. These packages are specifically tailored to meet the analytical testing requirements of metallurgy, petrochemical, cement and central laboratories.

Continuing its tradition of innovation and leadership in WDXRF, Thermo Fisher has developed four pre-calibrated, turnkey solutions for the analysis of sulfur in fuels and oils, slags, clinker and cement as well as varied materials in central laboratories.  Quick and easy to install, the regulatory compliant series of instruments are carefully calibrated in the factory using a series of reference samples, or optimized on-site using the customer's own standard samples to provide an accurate and reliable solution:

1) For ultra-low sulfur analysis in heavy and light fuels and oils, the Thermo Scientific ARL OPTIM'X Sulfur Analyzer is a compact, fast and reliable WDXRF platform configured with dedicated Multichromators.

2) The Thermo Scientific ARL OPTIM'X Cement Analyzer delivers reliable analysis of major and minor oxides present in the raw materials and products found in the cement industry.
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3) For routine analysis of samples in the metals industry, the Thermo Scientific ARL OPTIM'X Slag Analyzer provides precise analysis of major and minor oxides in slags.

4) The Thermo Scientific ARL OPTIM'X Optiquantometer is a powerful instrument allowing the analysis of 73 elements, from fluorine to uranium, in a range of conductive or non-conductive materials. Specifically targeted at central laboratories, this enables the replacement of wet chemical analysis or as a complement to AA and ICP analyzers.

Thanks to the innovative UCCO™ (ultra closely coupled optics) technology, the instruments generate the equivalent of a 200W analytical performance from 50W X-ray power. Temperature regulation of both the spectrometer and the crystals ensures outstanding stability and repeatability to comply with ASTM and ISO regulations. The compact instruments offer consistent performance without the need for water cooling and powerful and user-friendly Thermo Scientific OXSAS software supports the spectrometer operation and data handling.

For further information, e-mail: analyze@thermofisher.com or view website: www.thermo.com/optilab    Refer to page 218

Thermo Fisher Scientific simplifies UV-Vis spectroscopy

The Evolution 200 series of next-generation UV-Visible spectrophotometers from Thermo Fisher Scientific Inc. features new INSIGHT software with CUE (Customized User Environment) scripting capabilities. The series includes three instruments which satisfy specific applications from standard quantitative analysis to research life science assays. Designed for routine QA/QC analyses in the life science, food and beverage and material science industries as well as offering fast data collection rates for kinetics measurements (up to 100 data points/sec), the instruments combine high performance and straightforward software, enabling personalized operation for greater productivity.

The Thermo Scientific Evolution 200 instruments feature high quality accessories and application specific technology to meet a wide range of sampling needs. Innovative Smart accessories enable accurate, cost-effective sample handling with automated software recognition and programmable control. Adding temperature control and fiber optic accessories can increase the instrument's productivity and extend sampling options. In addition, the Evolution 220 and Evolution 260 Bio feature Application Focused Beam Geometry (AFBG) technology that tailors the instrument's optical system to specific applications for microcells, solid sampling and fiber optics. The Evolution 260 Bio includes enhanced Thermo Scientific INSIGHT life science software designed specifically for the needs of life science laboratories, offering pre-programmed assay methods for increased accuracy and convenience.

Next-generation INSIGHT software has been designed to improve the user experience by simplifying method creation and results interpretation. The software's data browser feature allows users to preview a thumbnail of results before opening the file and to sort by workbook type, file name and date for greater convenience. In addition, the workbook format helps organize data, method and accessory options by saving them all in one place.

The workbook can be reopened to continue capturing data using the same instrument configuration, with the aim to save time and improve the accuracy of results. INSIGHT software also includes CUE scripting capabilities, which enables the user to create a completely customized interface and simplified workflow. CUE works with INSIGHT to display only the most relevant information for the given application, to help improve accuracy, reproducibility and throughput in the laboratory.

The Evolution 200 series instruments are available in both local and computer controlled configurations. A locally controlled instrument with an embedded computer can be used to drive the new INSIGHT software package using touch screen technology. This easy-to-use ergonomic option allows users to perform all software functions using an embedded computer, increasing ease-of-use and saving valuable bench space while allowing sophisticated analysis and data reporting. Both local and computer controlled configurations can be run externally using the same INSIGHT software.

"We are very excited to be introducing our latest UV-Vis platform that simplifies the UV-Vis spectroscopy technique for users performing QA/QC analyses, but who still require high performance. The advanced interface as well as next generation INSIGHT software results in more straightforward and streamlined measurements of up to 100 data points per second from a single sample," said Mike Jost, vice president and general manager of molecular spectroscopy and microanalysis for Thermo Fisher Scientific. "The Evolution 200 series was designed at our Center of Excellence for molecular spectroscopy in Madison, and further strengthens our portfolio of UV-Vis solutions ranging from entry-level through to high-end to best meet our customers' needs."

For further information, e-mail: analyze@thermo.com or view website: www.thermoscientific.com/evo200  Refer to page 218