Advanced tools for pharmaceutical and high-value QA/QC testing

2021-11-25 06:22:49 By : Ms. Sophia Cai

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For more than 60 years, customers in world-renowned research, QA/QC and education laboratories have been relying on the excellent value and high performance provided by Thermo Scientific™ UV-Vis spectrophotometers.

Thermo Scientific™ Evolution™ 201 and 220 UV-Visible spectrophotometers simplify the workflow; various accessories and cutting-edge technologies consistently produce the high-quality results you rely on.

The Thermo Scientific™ Evolution™ 260 Bio UV-Vis spectrophotometer adds technology to quantify nucleic acids and proteins. If pre-programmed life science technology is required, thermal denaturation studies can also be performed.

If additional operational flexibility and advanced performance are required, the Thermo Scientific™ Evolution™ 350 UV-Visible Spectrophotometer provides solutions designed to simplify complex operations for your advanced applications.

For ultraviolet-visible spectrophotometers in regulated laboratories, performance verification is required during installation and at a set time interval thereafter. The internationally influential national pharmacopoeia defines specific performance levels for many standards in the pharmaceutical industry.

Due to its superior specifications, Evolution 350 will meet the performance requirements of all global pharmacopoeias, including the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).

The Evolution 200 series will now meet all EP and USP requirements due to manufacturing changes to improve specifications.

Regardless of the operating range, Thermo Scientific has standard options for any pharmacopoeial needs. The new set of USP and EP UV standards includes a complete list of standards required for performance verification in the UV region.

If you need to evaluate the performance of the instrument in the visible light region, please add a new set of USP and EP visible light standards.

If you only need general instrument certification instead of complete pharmacopoeial performance verification, you can use the UV-Visible certification filter kit to fully certify the spectrophotometer.

The UV-Visible Qualification Filter Kit contains some standards for USP and EP performance verification. In order to supplement the kit, other standards can be purchased in the future.

Optional mercury lamp accessories can be purchased for each type of instrument.

The Thermo Scientific Validator suite provides support for verification activities and system certification of software, instruments, and accessories.

For convenience, all reference materials and documents required to facilitate compliance with FDA, GxP, ISO 9001:2008, and ISPE 2001 guidelines and regulatory requirements are included for the Thermo Scientific spectrophotometer system.

For simple and effective use, the validator package simplifies Operational Qualification (OQ), Installation Qualification (IQ), and assists in performance certification (PQ) procedures and development.

If your laboratory needs to comply with 21 CFR Part 11, Insight Security software can simplify the process. Insight Security software utilizes the same easy-to-use interface, combining security and data integrity assurance with the versatility required by a multi-user laboratory.

To promote end-to-end traceability of samples and related laboratory processes, provide a central repository for data and test results, and ensure compliance, laboratory informatics is an important part of any laboratory.

Thermo Scientific Laboratory Information Management System (LIMS) provides complete informatics solutions for technology execution, laboratory and data management.

Combined with their integrated manager (IM), laboratory execution system (LES) and scientific data management system (SDMS), Thermo Scientific LIMS provides the most comprehensive paperless laboratory solution available today.

Now, laboratory managers and scientists in all industries can:

A key part of quality control analysis is reliable results. From standard curves based on peak area to simple single-standard comparisons, Thermo Scientific has tools to gather the answers you need every time.

The dual-beam optical design of the Evolution UV-Vis spectrophotometer provides precise performance, excellent reliability and minimal downtime.

Thermo Scientific offers a variety of bundles that can provide ideal configurations to meet various requirements. Each bundle will include:

This information is derived from materials provided by Thermo Fisher Scientific-Materials & Structural Analysis and has been reviewed and adapted.

For more information on this source, please visit Thermo Fisher Scientific-Material and Structural Analysis.

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